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[Discussion Draft]
[Discussion Draft]
July 2, 2015
114th CONGRESS
1st Session
Rules Committee Print 114-22
Text of H.R. 6, 21st Century Cures Act
[Showing text based on H.R. 6 as ordered reported by the Committee on Energy and Commerce.]
1.
Short title; table of contents
(a)
This Act may be cited as the 21st Century Cures Act
.
(b)
The table of contents for this Act is as follows:
Sec. 1. Short title; table of contents.
Sec. 2. NIH and Cures Innovation Fund.
Title I—Discovery
Subtitle A—National Institutes of Health Funding
Sec. 1001. National Institutes of Health reauthorization.
Subtitle B—National Institutes of Health Planning and Administration
Sec. 1021. NIH research strategic plan.
Sec. 1022. Increasing accountability at the National Institutes of Health.
Sec. 1023. Reducing administrative burdens of researchers.
Sec. 1024. Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements.
Sec. 1025. NIH travel.
Sec. 1026. Other transactions authority.
Sec. 1027. NCATS phase IIB restriction.
Sec. 1028. High-risk, high-reward research.
Sec. 1029. Sense of Congress on increased inclusion of underrepresented communities in clinical trials.
Subtitle C—Supporting Young Emerging Scientists
Sec. 1041. Improvement of loan repayment programs of the National Institutes of Health.
Sec. 1042. Report.
Subtitle D—Capstone Grant Program
Sec. 1061. Capstone award.
Subtitle E—Promoting Pediatric Research through the National Institutes of Health
Sec. 1081. National pediatric research network.
Sec. 1082. Global pediatric clinical study network sense of Congress.
Sec. 1083. Appropriate age groupings in clinical research.
Subtitle F—Advancement of the National Institutes of Health Research and Data Access
Sec. 1101. Standardization of data in Clinical Trial Registry Data Bank on eligibility for clinical trials.
Subtitle G—Facilitating Collaborative Research
Sec. 1121. Clinical trial data system.
Sec. 1122. National neurological diseases surveillance system.
Sec. 1123. Data on natural history of diseases.
Sec. 1124. Accessing, sharing, and using health data for research purposes.
Subtitle H—Council for 21st Century Cures
Sec. 1141. Council for 21st Century Cures.
Title II—Development
Subtitle A—Patient-Focused Drug Development
Sec. 2001. Development and use of patient experience data to enhance structured risk-benefit assessment framework.
Subtitle B—Qualification and Use of Drug Development Tools
Sec. 2021. Qualification of drug development tools.
Sec. 2022. Accelerated approval development plan.
Subtitle C—FDA advancement of Precision Medicine
Sec. 2041. Precision medicine guidance and other programs of Food and Drug Administration.
Subtitle D—Modern Trial Design and Evidence Development
Sec. 2061. Broader application of Bayesian statistics and adaptive trial designs.
Sec. 2062. Utilizing evidence from clinical experience.
Sec. 2063. Streamlined data review program.
Subtitle E—Expediting Patient Access
Sec. 2081. Sense of Congress.
Sec. 2082. Expanded access policy.
Sec. 2083. Finalizing draft guidance on expanded access.
Subtitle F—Facilitating responsible manufacturer communications
Sec. 2101. Facilitating dissemination of health care economic information.
Sec. 2102. Facilitating responsible communication of scientific and medical developments.
Subtitle G—Antibiotic Drug Development
Sec. 2121. Approval of certain drugs for use in a limited population of patients.
Sec. 2122. Susceptibility test interpretive criteria for microorganisms.
Sec. 2123. Encouraging the development and use of DISARM drugs.
Subtitle H—Vaccine Access, Certainty, and Innovation
Sec. 2141. Timely review of vaccines by the Advisory Committee on Immunization Practices.
Sec. 2142. Review of processes and consistency of ACIP recommendations.
Sec. 2143. Meetings between CDC and vaccine developers.
Subtitle I—Orphan product extensions now; incentives for certain products for limited populations
Sec. 2151. Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition.
Sec. 2152. Reauthorization of rare pediatric disease priority review voucher incentive program.
Subtitle J—Domestic Manufacturing and Export Efficiencies
Sec. 2161. Grants for studying the process of continuous drug manufacturing.
Sec. 2162. Re-exportation among members of the European Economic Area.
Subtitle K—Enhancing combination products review
Sec. 2181. Enhancing combination products review.
Subtitle L—Priority Review for Breakthrough Devices
Sec. 2201. Priority review for breakthrough devices.
Subtitle M—Medical Device Regulatory Process Improvements
Sec. 2221. Third-party quality system assessment.
Sec. 2222. Valid scientific evidence.
Sec. 2223. Training and oversight in least burdensome appropriate means concept.
Sec. 2224. Recognition of standards.
Sec. 2225. Easing regulatory burden with respect to certain class I and class II devices.
Sec. 2226. Advisory committee process.
Sec. 2227. Humanitarian device exemption application.
Sec. 2228. CLIA waiver study design guidance for in vitro diagnostics.
Subtitle N—Sensible Oversight for Technology Which Advances Regulatory Efficiency
Sec. 2241. Health software.
Sec. 2242. Applicability and inapplicability of regulation.
Sec. 2243. Exclusion from definition of device.
Subtitle O—Streamlining Clinical Trials
Sec. 2261. Protection of human subjects in research; applicability of rules.
Sec. 2262. Use of non-local institutional review boards for review of investigational device exemptions and human device exemptions.
Sec. 2263. Alteration or waiver of informed consent for clinical investigations.
Subtitle P—Improving Scientific Expertise and Outreach at FDA
Sec. 2281. Silvio O. Conte Senior Biomedical Research Service.
Sec. 2282. Enabling FDA scientific engagement.
Sec. 2283. Reagan-Udall Foundation for the Food and Drug Administration.
Sec. 2284. Collection of certain voluntary information exempted from Paperwork Reduction Act.
Sec. 2285. Hiring authority for scientific, technical, and professional personnel.
Subtitle Q—Exempting from sequestration certain user fees
Sec. 2301. Exempting from sequestration certain user fees of Food and Drug Administration.
Title III—Delivery
Subtitle A—Interoperability
Sec. 3001. Ensuring interoperability of health information technology.
Subtitle B—Telehealth
Sec. 3021. Telehealth services under the Medicare program.
Subtitle C—Encouraging Continuing Medical Education for Physicians
Sec. 3041. Exempting from manufacturer transparency reporting certain transfers used for educational purposes.
Subtitle D—Disposable Medical Technologies
Sec. 3061. Treatment of certain items and devices.
Subtitle E—Local coverage decision reforms
Sec. 3081. Improvements in the Medicare local coverage determination (LCD) process.
Subtitle F—Medicare Pharmaceutical and Technology Ombudsman
Sec. 3101. Medicare pharmaceutical and technology ombudsman.
Subtitle G—Medicare site-of-Service price transparency
Sec. 3121. Medicare site-of-Service price transparency.
Subtitle H—Medicare Part D Patient Safety and Drug Abuse Prevention
Sec. 3141. Programs to prevent prescription drug abuse under Medicare parts C and D.
Title IV—Medicaid, Medicare, and Other Reforms
Subtitle A—Medicaid and Medicare Reforms
Sec. 4001. Limiting Federal Medicaid reimbursement to States for durable medical equipment (DME) to Medicare payment rates.
Sec. 4002. Excluding authorized generics from calculation of average manufacturer price.
Sec. 4003. Medicare payment incentive for the transition from traditional x-ray imaging to digital radiography and other Medicare imaging payment provision.
Sec. 4004. Treatment of infusion drugs furnished through durable medical equipment.
Sec. 4005. Extension and expansion of prior authorization for power mobility devices (PMDs) and accessories and prior authorization audit limitations.
Sec. 4006. Civil monetary penalties for violations related to grants, contracts, and other agreements.
Subtitle B—Other Reforms
Sec. 4041. SPR drawdown.
Subtitle C—Miscellaneous
Sec. 4061. Lyme disease and other tick-borne diseases.
2.
NIH and Cures Innovation Fund
(a)
There is hereby established in the Treasury of the United States a fund to be known as the NIH and Cures Innovation Fund.
(b)
Amounts made available to Fund
(1)
There is authorized to be appropriated, and appropriated, to the NIH and Cures Innovation Fund, out of any funds in the Treasury not otherwise appropriated, $1,860,000,000 for each of fiscal years 2016 through 2020. The amounts appropriated to the NIH and Cures Innovation Fund by the preceding sentence shall be in addition to any amounts otherwise made available to the Department of Health and Human Services.
(2)
Of the amounts made available from the NIH and Cures Innovation Fund for a fiscal year—
(A)
$1,750,000,000 shall be for biomedical research of the National Institutes of Health under subsection (c)(1), of which—
(i)
not less than $500,000,000 shall be for the Accelerating Advancement Program under subsection (d)(2);
(ii)
not less than 35 percent of such amounts remaining after subtracting the allocation for the Accelerating Advancement Program shall be for early stage investigators as defined in subsection (g);
(iii)
not less than 20 percent of such amounts remaining after subtracting the allocation for the Accelerating Advancement Program shall be for high-risk, high-reward research under section 409K of the Public Health Service Act, as added by section 1028; and
(iv)
not more than 10 percent of such amounts (without subtracting the allocation for the Accelerating Advancement Program) shall be for intramural research; and
(B)
$110,000,000 shall be for carrying out the provisions listed in subsection (c)(2).
(3)
Inapplicability of certain provisions
Amounts in the NIH and Cures Innovation Fund (including amounts made available to the National Institutes of Health) shall not be subject to—
(A)
any transfer authority of the Secretary of Health and Human Services or the Director of the National Institutes of Health under sections 241, 402A(c), or 402A(d) of the Public Health Service Act (42 U.S.C. 238j, 282a(c) and (d)) or any other provision of law (other than this section); or
(B)
the Nonrecurring expenses fund under section 223 of division G of the Consolidated Appropriations Act, 2008 (42 U.S.C. 3514a).
(c)
(1)
Amounts in the NIH and Cures Innovation Fund that are allocated pursuant to subsection (b)(2)(A) may only be used for the purpose of conducting or supporting biomedical research (including basic, translational, and clinical research) through the following:
(A)
Research in which—
(i)
a principal investigator has a specific project or specific objectives; and
(ii)
funding is tied to pursuit of such project or objectives.
(B)
Research in which—
(i)
a principal investigator has shown promise in biomedical research; and
(ii)
funding is not tied to a specific project or specific objectives.
(C)
Research to be carried out by an early stage investigator (as defined in subsection (g)).
(D)
Research to be carried out by a small business concern (as defined in section 3 of the Small Business Act).
(E)
The Accelerating Advancement Program under subsection (d)(2).
(F)
Development and implementation of the strategic plan under subsection (d)(3).
(2)
Amounts in the NIH and Cures Innovation Fund that are allocated pursuant to subsection (b)(2)(B) may only be used for the purpose of carrying out the following provisions:
(A)
Section 229A of the Public Health Service Act, as added by section 1123 (relating to data on natural history of diseases).
(B)
Section 2001 and the amendments made by such section (relating to development and use of patient experience data to enhance structured risk-benefit assessment framework).
(C)
Section 2021 and the amendments made by such section (relating to qualification of drug development tools).
(D)
Section 2062 and the amendments made by such section (relating to utilizing evidence from clinical experience).
(E)
Section 2161 (relating to grants for studying the process of continuous drug manufacturing).
(F)
Section 2201 and the amendments made by such section (relating to priority review for breakthrough devices).
(G)
Section 2221 and the amendments made by such section (relating to third-party quality system assessments).
(H)
Sections 2241, 2242, and 2243 and the amendments made by such sections (relating to health software).
(I)
Section 513(j) of the Federal Food, Drug, and Cosmetic Act, as added by section 2223 (relating to training and oversight in least burdensome appropriate means concept).
(d)
(1)
In conducting or supporting biomedical research pursuant to funds allocated pursuant to subsection (b)(2)(A), the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health, shall—
(A)
ensure coordination among the national research institutes, the national centers, and other departments, agencies, and offices of the Federal Government; and
(B)
minimize unnecessary duplication.
(2)
Accelerating Advancement Program
The Director of the National Institutes of Health shall establish a program, to be known as the Accelerating Advancement Program, under which—
(A)
the Director partners with national research institutes and national centers to accomplish important biomedical research objectives; and
(B)
for every $1 made available by the Director to a national research institute or national center for a research project, the institute or center makes $1 available for such project from funds that are not derived from the NIH and Cures Innovation Fund.
(3)
(A)
The Director of the National Institutes of Health shall ensure that scientifically based strategic planning is implemented in support of research priorities, including through development, use, and updating of a research strategic plan that—
(i)
is designed to increase the efficient and effective focus of biomedical research in a manner that leverages the best scientific opportunities through a deliberative planning process;
(ii)
identifies areas, to be known as strategic focus areas, in which the resources of the NIH and Cures Innovation Fund can contribute to the goals of expanding knowledge to address, and find more effective treatments for, unmet medical needs in the United States, including the areas of—
(I)
biomarkers;
(II)
precision medicine;
(III)
infectious diseases, including pathogens listed as a qualifying pathogen under section 505E(f) of the Federal Food, Drug, and Cosmetic Act or listed or designated as a tropical disease under section 524 of such Act; and
(IV)
antibiotics;
(iii)
includes objectives for each such strategic focus area; and
(iv)
ensures that basic research remains a priority.
(B)
The Director of the National Institutes of Health shall review and, as appropriate, update the research strategic plan under subparagraph (A) not less than every 18 months.
(e)
The Committee on Appropriations of the Senate and the Committee on Appropriations of the House of Representatives may provide for the transfer of funds in the NIH and Cures Innovation Fund for the purposes specified in subsection (c).
(f)
Supplement, not supplant; limitations
Funds appropriated by subsection (b)—
(1)
shall be used to supplement, not supplant, amounts otherwise made available to the Department of Health and Human Services;
(2)
are subject to the requirements and limitations of the most recently enacted regular or full-year continuing appropriation Act or resolution (as of the date of obligation) for programs of the National Institutes of Health or the Food and Drug Administration, as applicable; and
(3)
notwithstanding any transfer authority in any appropriation Act, shall not be used for any purpose other than the purposes specified in subsection (c).
(g)
In this subsection:
(1)
The term early stage investigator
means an investigator who—
(A)
will be the principal investigator or the program director of the proposed research;
(B)
has never been awarded, or has been awarded only once, a substantial, competing grant by the National Institutes of Health for independent research; and
(C)
is within 10 years of having completed—
(i)
the investigator’s terminal degree; or
(ii)
a medical residency (or the equivalent).
(2)
The terms national center
and national research institute
have the meanings given to those terms in section 401(g) of the Public Health Service Act (42 U.S.C. 281(g)).
<enum>I</enum>
<header>Discovery</header>
<subtitle id="HC941BCE13EFD479AB1FDE8F25E8AA8D4">
<enum>A</enum>
<header>National Institutes of Health Funding</header>
<section id="H3BD9F99464A148B3B1CB23FA9D0DEBC5" section-type="subsequent-section">
<enum>1001.</enum>
<header>National Institutes of Health reauthorization</header>
<text display-inline="no-display-inline">Section 402A(a)(1) of the Public Health Service Act (42 U.S.C. 282a(a)(1)) is amended—</text>
<paragraph id="H7132A57CF58C430A8D051796863276CD">
<enum>(1)</enum>
<text>in subparagraph (B), by striking at the end <quote>and</quote>;</text>
</paragraph>
<paragraph id="H42052A63D5634AF0B56A2D8EB059F813">
<enum>(2)</enum>
<text>in subparagraph (C), by striking at the end the period and inserting a semicolon; and</text>
</paragraph>
<paragraph id="H2451684676834CADB8535F749E2F19B3">
<enum>(3)</enum>
<text>by adding at the end the following new subparagraphs:</text>
<quoted-block style="OLC" id="HE1ECA14E31564BB2B11E8ADE727B4EA6" display-inline="no-display-inline">
<subparagraph id="HF8DB790EC94246D4865E4E2E323BC872">
<enum>(D)</enum>
<text display-inline="yes-display-inline">$31,811,000,000 for fiscal year 2016;</text>
</subparagraph>
<subparagraph id="HBD026FBFDDF44E30BBEC59DF8856205C">
<enum>(E)</enum>
<text>$33,331,000,000 for fiscal year 2017; and</text>
</subparagraph>
<subparagraph id="H22E8EC798532455FA46A5ABD4350B188">
<enum>(F)</enum>
<text>$34,851,000,000 for fiscal year 2018.</text>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</section>
</subtitle>
<subtitle id="HA39968A7786249BCBB50F90F9784E8C3">
<enum>B</enum>
<header>National Institutes of Health Planning and Administration</header>
<section id="H651226437F544ACF92756F8C4C965A10">
<enum>1021.</enum>
<header>NIH research strategic plan</header>
<text display-inline="no-display-inline">Section 402 of the Public Health Service Act (42 U.S.C. 282) is amended—</text>
<paragraph id="H98F37DF948CD40D6B9BB0229CD6B725C">
<enum>(1)</enum>
<text>in subsection (b), by amending paragraph (5) to read as follows:</text>
<quoted-block style="OLC" id="HC75639D8E9584156A95602729DF8AFA0" display-inline="no-display-inline">
<paragraph id="HC4B426669B0A448283A2A3DB3958C9C4">
<enum>(5)</enum>
<text display-inline="yes-display-inline">shall ensure that scientifically based strategic planning is implemented in support of research priorities as determined by the agencies of the National Institutes of Health, including through development, use, and updating of the research strategic plan under subsection (m);</text>
</paragraph>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H84A09A7F5EC84898B0ECD912AF951897">
<enum>(2)</enum>
<text>by adding at the end the following:</text>
<quoted-block style="OLC" id="H0D894DC08F8F49F8B8A72E49CEC77096" display-inline="no-display-inline">
<subsection id="HAABC732FE8ED48379459B85A341BFE28">
<enum>(m)</enum>
<header>Research strategic plan</header>
<paragraph id="H033E9D97D45C4A7F9D6368DAF72AAB2D">
<enum>(1)</enum>
<header>Five-year plans for biomedical research strategy</header>
<subparagraph id="H2F6E744DC4644F7EBC91C406E4C7C518">
<enum>(A)</enum>
<header>In general</header>
<text>For each successive five-year period beginning with the period of fiscal years 2016 through 2020, the Director of NIH, in consultation with the entities described in subparagraph (B), shall develop and maintain a biomedical research strategic plan that—</text>
<clause id="H2F902835CA2A4C8E8F605C6C6EBCA0B4">
<enum>(i)</enum>
<text>is designed to increase the efficient and effective focus of biomedical research in a manner that leverages the best scientific opportunities through a deliberative planning process;</text>
</clause>
<clause id="H44BF94ECB2FC4EB8ADA75BDD737B11D3">
<enum>(ii)</enum>
<text>identifies areas, to be known as strategic focus areas, in which the resources of the National Institutes of Health can best contribute to the goal of expanding knowledge on human health in the United States through biomedical research; and</text>
</clause>
<clause id="HF134FC91BC524B1DAF6155996F8B9C87">
<enum>(iii)</enum>
<text>includes objectives for each such strategic focus area.</text>
</clause>
</subparagraph>
<subparagraph id="HD81D2594D9874321A933F6D34876BDED">
<enum>(B)</enum>
<header>Entities described</header>
<text>The entities described in this subparagraph are the directors of the national research institutes and national centers, researchers, patient advocacy groups, and industry leaders.</text>
</subparagraph>
</paragraph>
<paragraph id="HA7CA122213524402A38A1F93FC33DF85">
<enum>(2)</enum>
<header>Use of plan</header>
<text>The Director of NIH and the directors of the national research institutes and national centers shall use the strategic plan—</text>
<subparagraph id="HE2A2FB5D401F49BDB588900091471F67">
<enum>(A)</enum>
<text display-inline="yes-display-inline">to identify research opportunities; and</text>
</subparagraph>
<subparagraph id="H9FAE65C02B77497CAD4C6E21B2835364">
<enum>(B)</enum>
<text display-inline="yes-display-inline">to develop individual strategic plans for the research activities of each of the national research institutes and national centers that—</text>
<clause id="H5E2463C2AEE74C789824E98928ECBD8B">
<enum>(i)</enum>
<text>have a common template; and</text>
</clause>
<clause id="H4EACDD5CE844464AA9D2DA956D81891F">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">identify strategic focus areas in which the resources of the national research institutes and national centers can best contribute to the goal of expanding knowledge on human health in the United States through biomedical research. </text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="HF1E7EBCC31D24771B061F8F7D3CD2A9D" display-inline="no-display-inline">
<enum>(3)</enum>
<header>Contents of plans</header>
<subparagraph id="H6D6E8B6C33C64B0C9CB144FC1A4BFD01">
<enum>(A)</enum>
<header>Strategic focus areas</header>
<text display-inline="yes-display-inline">The strategic focus areas identified pursuant to paragraph (1)(A)(ii) shall—</text>
<clause id="HA5A8849DA7F64B46941055145BCC58D1">
<enum>(i)</enum>
<text>be identified in a manner that—</text>
<subclause id="H654C3BE876034A3DA846B3D7F15B5B16">
<enum>(I)</enum>
<text>considers the return on investment to the United States public through the investments of the National Institutes of Health in biomedical research; and</text>
</subclause>
<subclause id="H79FCD30875984E2B9A57C117E530AE5B">
<enum>(II)</enum>
<text>contributes to expanding knowledge to improve the United States public’s health through biomedical research; and</text>
</subclause>
</clause>
<clause id="HEE22E89A01224956BF38975856D1A44C">
<enum>(ii)</enum>
<text>include overarching and trans-National Institutes of Health strategic focus areas, to be known as Mission Priority Focus Areas, which best serve the goals of preventing or eliminating the burden of a disease or condition and scientifically merit enhanced and focused research over the next 5 years.</text>
</clause>
</subparagraph>
<subparagraph id="H4E2547F0C5C241A39142E034E02FA420">
<enum>(B)</enum>
<header>Rare and pediatric diseases and conditions</header>
<text>In developing and maintaining a strategic plan under this subsection, the Director of NIH shall ensure that rare and pediatric diseases and conditions remain a priority.</text>
</subparagraph>
<subparagraph id="H70D8A6FCD44C4D6EBD8AD71330E502F8">
<enum>(C)</enum>
<header>Workforce</header>
<text display-inline="yes-display-inline">In developing and maintaining a strategic plan under this subsection, the Director of NIH shall ensure that maintaining the biomedical workforce of the future, including the participation by scientists from groups traditionally underrepresented in the scientific workforce, remains a priority.</text>
</subparagraph>
</paragraph>
<paragraph id="HD4E7332A310F44DDB3359F4F779F1EE2">
<enum>(4)</enum>
<header>Initial plan</header>
<text display-inline="yes-display-inline">Not later than 270 days after the date of enactment of this subsection, the Director of NIH and the directors of the national research institutes and national centers shall—</text>
<subparagraph id="HB14006DCD67D4B43B1A171D196EC4B02">
<enum>(A)</enum>
<text>complete the initial strategic plan required by paragraphs (1) and (2); and</text>
</subparagraph>
<subparagraph id="H90A180A177274760B1400091FBEB744F">
<enum>(B)</enum>
<text>make such initial strategic plan publicly available on the website of the National Institutes of Health.</text>
</subparagraph>
</paragraph>
<paragraph id="H6CD46904F38F43B3A7DC4EFE8FE4C20F">
<enum>(5)</enum>
<header>Review; updates</header>
<subparagraph id="H085B55E9A8CD4DA8B513C3ED14798FCD">
<enum>(A)</enum>
<header>Progress reviews</header>
<text display-inline="yes-display-inline">Not less than annually, the Director of NIH, in consultation with the directors of the national research institutes and national centers, shall conduct progress reviews for each strategic focus area identified under paragraph (1)(A)(ii).</text>
</subparagraph>
<subparagraph id="H84510247C4434702AF757E35D92CA218">
<enum>(B)</enum>
<header>Updates</header>
<text display-inline="yes-display-inline">Not later than the end of the 5-year period covered by the initial strategic plan under this subsection, and every 5 years thereafter, the Director of NIH, in consultation with the directors of the national research institutes and national centers, stakeholders in the scientific field, advocates, and the public at large, shall—</text>
<clause id="H927F6CD9A31D487FB0DE325D20C3BA55">
<enum>(i)</enum>
<text>conduct a review of the plan, including each strategic focus area identified under paragraph (2)(B); and</text>
</clause>
<clause id="H8BA509C9DEF24042895A4A62B820C442">
<enum>(ii)</enum>
<text>update such plan in accordance with this section.</text>
</clause>
</subparagraph>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</section>
<section id="HC92F85CC039C4FE989C83B7C3AAC2089" section-type="subsequent-section">
<enum>1022.</enum>
<header>Increasing accountability at the National Institutes of Health</header>
<subsection id="H93362684304D422290E8530D3CDCF3B1">
<enum>(a)</enum>
<header>Appointment and terms of directors of national research institutes and national centers</header>
<text display-inline="yes-display-inline">Subsection (a) of section 405 of the Public Health Service Act (42 U.S.C. 284) is amended to read as follows: </text>
<quoted-block style="OLC" id="HC5B77EA1E25149FFADC28A122B24D9B5" display-inline="yes-display-inline">
<subsection id="HE521393F461E410CAEFDAA757467A8D7" display-inline="yes-display-inline">
<enum>(a)</enum>
<header>Appointment; terms</header>
<paragraph id="H7BD7244E1E234E588D9B230CE70CEC99">
<enum>(1)</enum>
<header>Appointment</header>
<text display-inline="yes-display-inline">The Director of the National Cancer Institute shall be appointed by the President and the directors of the other national research institutes, as well as the directors of the national centers, shall be appointed by the Director of NIH. The directors of the national research institutes, as well as national centers, shall report directly to the Director of NIH.</text>
</paragraph>
<paragraph id="H72DF0F4AC4EB4C2D97516D15D892072F">
<enum>(2)</enum>
<header>Terms</header>
<subparagraph id="H51566DEA778941D6ACB9831E92B56573">
<enum>(A)</enum>
<header>In general</header>
<text>The term of office of a director of a national research institute or national center shall be 5 years.</text>
</subparagraph>
<subparagraph id="H13F987B262CB4EAFBFAB6FC7ACEE0156">
<enum>(B)</enum>
<header>Removal</header>
<text>The director of a national research institute or national center may be removed from office by the Director of NIH prior to the expiration of such director’s 5-year term.</text>
</subparagraph>
<subparagraph id="HEAFC9C5D54654562BD8FA2AB9158E05A">
<enum>(C)</enum>
<header>Reappointment</header>
<text>At the end of the term of a director of a national research institute or national center, the director may be reappointed. There is no limit on the number of terms a director may serve.</text>
</subparagraph>
<subparagraph id="H691A13B9EABB4D1E8954AD687DFD04E6">
<enum>(D)</enum>
<header>Vacancies</header>
<text>If the office of a director of a national research institute or national center becomes vacant before the end of such director’s term, the director appointed to fill the vacancy shall be appointed for a 5-year term starting on the date of such appointment.</text>
</subparagraph>
<subparagraph id="H66289DE41CB84A0E823DF03A1F627DEA">
<enum>(E)</enum>
<header>Transitional provision</header>
<text>Each director of a national research institute or national center serving on the date of enactment of the <short-title>21st Century Cures Act</short-title> is deemed to be appointed for a 5-year term under this subsection starting on such date of enactment.</text>
</subparagraph>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="H955170A4B79346969FEB129F19054B80" commented="no">
<enum>(b)</enum>
<header>Compensation to consultants or individual scientists</header>
<text>Section 202 of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 1993 (Public Law 102–394; 42 U.S.C. 238f note) is amended by striking <quote>portable structures;</quote> and all that follows and inserting <quote>portable structures.</quote>.</text>
</subsection>
<subsection id="H70AC6944ADD64CE286487DC0F2D9C6A3">
<enum>(c)</enum>
<header>Review of certain awards by directors</header>
<text display-inline="yes-display-inline">Section 405(b) of the Public Health Service Act (42 U.S.C. 284(b)) is amended by adding at the end the following:</text>
<quoted-block style="OLC" id="H7ED61B0404AF4132994010E09CE23977" display-inline="no-display-inline">
<paragraph id="H2FAC44FC300C450E8DCDFC7178DBFA52" indent="up1">
<enum>(3)</enum>
<text display-inline="yes-display-inline">Before an award is made by a national research institute or by a national center for a grant for a research program or project (commonly referred to as an <quote>R-series grant</quote>), other than an award constituting a noncompeting renewal of such grant, or a noncompeting administrative supplement to such grant, the director of such national research institute or national center—</text>
<subparagraph id="HD33F90BDD97A4BC0A371D1E770C3BB4C">
<enum>(A)</enum>
<text>shall review and approve the award; and</text>
</subparagraph>
<subparagraph id="HF9E2DA0F083F4D2C8A46A3B58D8C4DFB">
<enum>(B)</enum>
<text>shall take into consideration—</text>
<clause id="H7A20C71FBE4D460A8C3B6402B54D0F20" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline">the mission of the national research institute or national center and the scientific priorities identified in the strategic plan under section 402(m); and</text>
</clause>
<clause id="H08EBD64C31354C5EA007C909D0D651DF">
<enum>(ii)</enum>
<text>whether other agencies are funding programs or projects to accomplish the same goal.</text>
</clause>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="HECA1B6C0E36A414B85A3CED19947C960">
<enum>(d)</enum>
<header>IOM study on duplication in Federal biomedical research</header>
<text display-inline="yes-display-inline">The Secretary of Health and Human Services shall enter into an arrangement with the Institute of Medicine of the National Academies (or, if the Institute declines, another appropriate entity) under which the Institute (or other appropriate entity) not later than 2 years after the date of enactment of this Act will—</text>
<paragraph id="H1E243BC76BE04FBF899BA57509D101B5">
<enum>(1)</enum>
<text>complete a study on the extent to which biomedical research conducted or supported by Federal agencies is duplicative; and</text>
</paragraph>
<paragraph id="H23884812E137483A8EDBD0B25BE66B3E">
<enum>(2)</enum>
<text>submit a report to the Congress on the results of such study, including recommendations on how to prevent such duplication.</text>
</paragraph>
</subsection>
</section>
<section id="HEC613BFF934E42558AB47140970553EF" section-type="subsequent-section" commented="no">
<enum>1023.</enum>
<header>Reducing administrative burdens of researchers</header>
<subsection id="HBABD002DE5824FE4A312EDF82781EC28" commented="no">
<enum>(a)</enum>
<header>Plan Preparation and implementation of measures To reduce administrative burdens</header>
<text display-inline="yes-display-inline">The Director of the National Institutes of Health shall prepare a plan, including time frames, and implement measures to reduce the administrative burdens of researchers funded by the National Institutes of Health, taking into account the recommendations, evaluations, and plans researched by the following entities:</text>
<paragraph id="HE31C427A5873412A983A42FF17C2AF37" commented="no">
<enum>(1)</enum>
<text>The Scientific Management Review Board.</text>
</paragraph>
<paragraph id="HF7F55527CCEA4B5DBA6CC72F4AE2B463" commented="no">
<enum>(2)</enum>
<text>The National Academy of Sciences.</text>
</paragraph>
<paragraph id="H3B3A4D122ECC4B08894B32F2D4198C70" commented="no">
<enum>(3)</enum>
<text>The 2007 and 2012 Faculty Burden Survey conducted by The Federal Demonstration Partnership. </text>
</paragraph>
<paragraph id="HB5C71F45F2F8425B9E558A65EC5A937C" commented="no">
<enum>(4)</enum>
<text>Relevant recommendations from the Research Business Models Working Group.</text>
</paragraph>
</subsection>
<subsection id="HCE7AF1C040324B51BAA62E9D48AE521D" commented="no">
<enum>(b)</enum>
<header>Report</header>
<text display-inline="yes-display-inline">Not later than two years after the date of enactment of this Act, the Director of the National Institutes of Health shall submit to Congress a report on the extent to which the Director has implemented measures pursuant to subsection (a).</text>
</subsection>
</section>
<section id="HC55D072A4B244207BBE4BB3E88262BA6">
<enum>1024.</enum>
<header>Exemption for the National Institutes of Health from the Paperwork Reduction Act requirements</header>
<text display-inline="no-display-inline">Section 3518(c)(1) of title 44, United States Code, is amended—</text>
<paragraph id="H4812FE708A674494825550869DF6F562">
<enum>(1)</enum>
<text display-inline="yes-display-inline">in subparagraph (C), by striking <quote>; or</quote> and inserting a semicolon;</text>
</paragraph>
<paragraph id="H518072888F994CCDBF73992A64F2B10C">
<enum>(2)</enum>
<text display-inline="yes-display-inline">in subparagraph (D), by striking the period at the end and inserting <quote>; or</quote>; and</text>
</paragraph>
<paragraph id="H6C12DAD0FA904C879E734A630919ABD1">
<enum>(3)</enum>
<text>by inserting at the end the following new subparagraph:</text>
<quoted-block style="USC" display-inline="no-display-inline" id="HEC74DBCC44B44BEBAF3A6B64B18A96E1">
<subparagraph id="HBC1DC0CB0DEC43DBBA14F065A8DF00BC" indent="up1">
<enum>(E)</enum>
<text display-inline="yes-display-inline">during the conduct of research by the National Institutes of Health.</text>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</section>
<section id="HC5B9B2285CB54722BBA34C552C7C7DD1" commented="no">
<enum>1025.</enum>
<header>NIH travel</header>
<text display-inline="no-display-inline">It is the sense of Congress that participation in or sponsorship of scientific conferences and meetings is essential to the mission of the National Institutes of Health.</text>
</section>
<section id="HB7AAAAFB7B77466CB52439BAD8F7068D">
<enum>1026.</enum>
<header>Other transactions authority</header>
<text display-inline="no-display-inline">Section 480 of the Public Health Service Act (42 U.S.C. 287a) is amended—</text>
<paragraph id="H71AE44580B3A49C38C5F4A80A11E5ED1">
<enum>(1)</enum>
<text>in subsection (b), by striking <quote>the appropriation of funds as described in subsection (g)</quote> and inserting <quote>the availability of funds as described in subsection (f)</quote>; </text>
</paragraph>
<paragraph id="HE29A777D66E548E3B3C11B650291D889">
<enum>(2)</enum>
<text>in subsection (e)(3), by amending subparagraph (C) to read as follows:</text>
<quoted-block style="OLC" id="H5E037B6E3FBB468C8CC44BB124FC8BC2" display-inline="no-display-inline">
<subparagraph id="HB60D68A009524FE9BF67ED44764A6D0F">
<enum>(C)</enum>
<header>Other Transactions Authority</header>
<text display-inline="yes-display-inline">The Director of the Center shall have other transactions authority in entering into transactions to fund projects in accordance with the terms and conditions of this section.</text>
</subparagraph>
<after-quoted-block>;</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H6AEE87E40E38484FB38CB1726FE7A38C">
<enum>(3)</enum>
<text>by striking subsection (f); and</text>
</paragraph>
<paragraph id="H5E512E721A4A40CB95EDA302FE066F25">
<enum>(4)</enum>
<text>by redesignating subsection (g) as subsection (f). </text>
</paragraph>
</section>
<section id="H093D5AFAD4124758B6C9CD8415E312D2">
<enum>1027.</enum>
<header>NCATS phase IIB restriction</header>
<text display-inline="no-display-inline">Section 479 of the Public Health Service Act (42 U.S.C. 287) is amended—</text>
<paragraph id="H38A38A8CD33143F093149E7AEFB1AD95">
<enum>(1)</enum>
<text>prior to making the amendments under paragraph (2), by striking <quote>IIB</quote> each place it appears and inserting <quote>III</quote>; and</text>
</paragraph>
<paragraph id="H06C26B73A2484A2DAAEA336B4E4FE499">
<enum>(2)</enum>
<text>by striking <quote>IIA</quote> each place it appears and inserting <quote>IIB</quote>.</text>
</paragraph>
</section>
<section id="H57E6BC21B05346D3A78DABDF2E3D152F">
<enum>1028.</enum>
<header>High-risk, high-reward research</header>
<text display-inline="no-display-inline">Part B of title IV of the Public Health Service Act (42 U.S.C. 284 et seq.) is amended by adding at the end the following:</text>
<quoted-block style="OLC" id="H7A2EC41A726E444EA68AB9436A0BB97B" display-inline="no-display-inline">
<section id="HC89916D2D5724A6780D1A15B33DE9F03">
<enum>409K.</enum>
<header>High-risk, high-reward research program</header>
<text display-inline="no-display-inline">The director of each national research institute shall, as appropriate—</text>
<paragraph id="HF3CE1126040242F3BFABE298BF7D5CBF">
<enum>(1)</enum>
<text>establish programs to conduct or support research projects that pursue innovative approaches to major contemporary challenges in biomedical research that involve inherent high risk, but have the potential to lead to breakthroughs; and</text>
</paragraph>
<paragraph id="H6D380F150B3D4B2A871F5CDDBDEF9142">
<enum>(2)</enum>
<text>set aside a specific percentage of funding, to be determined by the Director of NIH for each national research institute, for such projects.</text>
</paragraph>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
<section id="H962034E00D8444F485E91CC4CE170802">
<enum>1029.</enum>
<header>Sense of Congress on increased inclusion of underrepresented communities in clinical trials</header>
<text display-inline="no-display-inline">It is the sense of Congress that the National Institute on Minority Health and Health Disparities (NIMHD) should include within its strategic plan ways to increase representation of underrepresented communities in clinical trials.</text>
</section>
</subtitle>
<subtitle id="HF04BC2BE69CB485A80C87DD233B37CC7">
<enum>C</enum>
<header>Supporting Young Emerging Scientists</header>
<section id="HE7146BBE8C004C19B5CDE3185A09754A">
<enum>1041.</enum>
<header>Improvement of loan repayment programs of the National Institutes of Health</header>
<subsection id="H09E9D195D04F4DDBAE9B961CD011708D">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Part G of title IV of the Public Health Service (42 U.S.C. 288 et seq.) is amended—</text>
<paragraph id="H801E36EB6B964208A1406ED8F677CDEA">
<enum>(1)</enum>
<text>by redesignating the second section 487F (42 U.S.C. 288–6; relating to pediatric research loan repayment program) as section 487G; and</text>
</paragraph>
<paragraph id="HBF86B55B21D74045AF6176CCA47D2EDD">
<enum>(2)</enum>
<text>by inserting after section 487G, as so redesignated, the following:</text>
<quoted-block id="H5BD9767217D3483D8FEC4D81B3E71055" style="OLC">
<section id="HC0D4A175F0C5468391B5ABEB284A9CFD">
<enum>487H.</enum>
<header>Loan repayment program</header>
<subsection id="H595A5E5EB6FC4AD3843EC8231545517B">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall establish a program, based on workforce and scientific needs, of entering into contracts with qualified health professionals under which such health professionals agree to engage in research in consideration of the Federal Government agreeing to pay, for each year of engaging in such research, not more than $50,000 of the principal and interest of the educational loans of such health professionals.</text>
</subsection>
<subsection id="HBDEE0243E3A247CCB626EFB2BF061C0F">
<enum>(b)</enum>
<header>Adjustment for inflation</header>
<text>Beginning with respect to fiscal year 2017, the Secretary may increase the maximum amount specified in subsection (a) by an amount that is determined by the Secretary, on an annual basis, to reflect inflation.</text>
</subsection>
<subsection id="HCB9E3C9677A746F2971840647FD0E782">
<enum>(c)</enum>
<header>Limitation</header>
<text>The Secretary may not enter into a contract with a health professional pursuant to subsection (a) unless such professional has a substantial amount of educational loans relative to income.</text>
</subsection>
<subsection id="H6DEAD5B0F716460DA77FB06483B0570B">
<enum>(d)</enum>
<header>Applicability of certain provisions regarding obligated service</header>
<text>Except to the extent inconsistent with this section, the provisions of sections 338B, 338C, and 338E shall apply to the program established under this section to the same extent and in the same manner as such provisions apply to the National Health Service Corps Loan Repayment Program established under section 338B.</text>
</subsection>
<subsection id="HF7FC49EAE192418CA53F596BD4F77793">
<enum>(e)</enum>
<header>Availability of appropriations</header>
<text>Amounts appropriated for a fiscal year for contracts under subsection (a) are authorized to remain available until the expiration of the second fiscal year beginning after the fiscal year for which the amounts were appropriated.</text>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="HC2F035EEA1574D70811C7414C92A5CFA">
<enum>(b)</enum>
<header>Update of other loan repayment programs</header>
<paragraph id="H75244747FA4846DD83537B268C29280A">
<enum>(1)</enum>
<text display-inline="yes-display-inline">Section 464z–5(a) of the Public Health Service Act (42 U.S.C.285t–2(a)) is amended—</text>
<subparagraph id="H1111E3D9F14C4B4D9722F03867BF066F">
<enum>(A)</enum>
<text>by striking <quote>$35,000</quote> and inserting <quote>$50,000</quote>; and</text>
</subparagraph>
<subparagraph id="HB2463B15A5304306BC66435CB0700413">
<enum>(B)</enum>
<text>by adding at the end the following new sentence: <quote>Subsection (b) of section 487H shall apply with respect to the maximum amount specified in this subsection in the same manner as it applies to the maximum amount specified in subsection (a) of such section.</quote>. </text>
</subparagraph>
</paragraph>
<paragraph id="H56C5D88C4A2644C5A78F54C9E4A68126">
<enum>(2)</enum>
<text>Section 487A(a) of such Act (42 U.S.C. 288–1(a)) is amended—</text>
<subparagraph id="H6ECF5AEF952240D6961DEBF74934F1F2">
<enum>(A)</enum>
<text>by striking <quote>$35,000</quote> and inserting <quote>$50,000</quote>; and</text>
</subparagraph>
<subparagraph id="H466BB699E5F44777B4C24D7D7CB22A9E">
<enum>(B)</enum>
<text>by adding at the end the following new sentence: <quote>Subsection (b) of section 487H shall apply with respect to the maximum amount specified in this subsection in the same manner as it applies to the maximum amount specified in subsection (a) of such section.</quote>. </text>
</subparagraph>
</paragraph>
<paragraph id="H63C91D8A0D7047B9B5208B3DAC8C1140">
<enum>(3)</enum>
<text display-inline="yes-display-inline">Section 487B(a) of such Act (42 U.S.C. 288–2(a)) is amended—</text>
<subparagraph id="H209E390A42AA413997D2B563782FC7F3">
<enum>(A)</enum>
<text>by striking <quote>$35,000</quote> and inserting <quote>$50,000</quote>; and</text>
</subparagraph>
<subparagraph id="HF5DFA57A5D674C25A7A57A99684BE53C">
<enum>(B)</enum>
<text>by adding at the end the following new sentence: <quote>Subsection (b) of section 487H shall apply with respect to the maximum amount specified in this subsection in the same manner as it applies to the maximum amount specified in such subsection (a) of such section.</quote>. </text>
</subparagraph>
</paragraph>
<paragraph id="HEF9505BC285142E9808641D66E45581E">
<enum>(4)</enum>
<text display-inline="yes-display-inline">Section 487C(a)(1) of such Act (42 U.S.C. 288–3(a)(1)) is amended—</text>
<subparagraph id="H163DD61F731B4FC9AA1C19FAF8657552">
<enum>(A)</enum>
<text>by striking <quote>$35,000</quote> and inserting <quote>$50,000</quote>; and</text>
</subparagraph>
<subparagraph id="H0DCB38394345455787C971CD2140FB72">
<enum>(B)</enum>
<text>by adding at the end the following new sentence: <quote>Subsection (b) of section 487H shall apply with respect to the maximum amount specified in this paragraph in the same manner as it applies to the maximum amount specified in such subsection (a) of such section.</quote>. </text>
</subparagraph>
</paragraph>
<paragraph id="H5C52D967B5C94F43836EBDFCB40DCC41">
<enum>(5)</enum>
<text display-inline="yes-display-inline">Section 487E(a)(1) of such Act (42 U.S.C. 288–5(a)(1)) is amended—</text>
<subparagraph id="HB147EDDE688146D18F369C2B1E71E3FC">
<enum>(A)</enum>
<text>by striking <quote>$35,000</quote> and inserting <quote>$50,000</quote>; and</text>
</subparagraph>
<subparagraph id="HC1C64E5DB9A140D39C4480C4C00AFC3A">
<enum>(B)</enum>
<text>by adding at the end the following new sentence: <quote>Subsection (b) of section 487H shall apply with respect to the maximum amount specified in this paragraph in the same manner as it applies to the maximum amount specified in such subsection (a) of such section.</quote>. </text>
</subparagraph>
</paragraph>
<paragraph id="HE006F43172424E5BB43B41262D68F758">
<enum>(6)</enum>
<text display-inline="yes-display-inline">Section 487F(a) of such Act (42 U.S.C. 288–5a(a)), as added by section 205 of Public Law 106–505, is amended—</text>
<subparagraph id="H1476F77A906A4C209F36ABA8CCB83441">
<enum>(A)</enum>
<text>by striking <quote>$35,000</quote> and inserting <quote>$50,000</quote>; and</text>
</subparagraph>
<subparagraph id="H37B8357C3C3F442A83CA6B9BE6B43E0D">
<enum>(B)</enum>
<text>by adding at the end the following new sentence: <quote>Subsection (b) of section 487H shall apply with respect to the maximum amount specified in this subsection in the same manner as it applies to the maximum amount specified in such subsection (a) of such section.</quote>. </text>
</subparagraph>
</paragraph>
<paragraph id="H093F39C9983A4532AA6FE1196FA69FBF">
<enum>(7)</enum>
<text display-inline="yes-display-inline">Section 487G of such Act (42 U.S.C. 288–6, as redesignated by subsection (a)(1)), is further amended—</text>
<subparagraph id="HB49599295B034478BCBFB93224FB3BE4">
<enum>(A)</enum>
<text>in subsection (a)(1), by striking <quote>$35,000</quote> and inserting <quote>$50,000</quote>; and</text>
</subparagraph>
<subparagraph id="H7435E824A774491EB40B5D26F50B73BD">
<enum>(B)</enum>
<text>in subsection (b), by adding at the end the following new sentence: <quote>Subsection (b) of section 487H shall apply with respect to the maximum amount specified in subsection (a)(1) in the same manner as it applies to the maximum amount specified in such subsection (a) of such section.</quote>.</text>
</subparagraph>
</paragraph>
</subsection>
</section>
<section id="HD35574D871BC44B3BDDB1A1AE71E8968">
<enum>1042.</enum>
<header>Report</header>
<text display-inline="no-display-inline">Not later than 18 months after the date of the enactment of this Act, the Director of the National Institutes of Health shall submit to Congress a report on efforts of the National Institutes of Health to attract, retain, and develop emerging scientists.</text>
</section>
</subtitle>
<subtitle id="H533DB34DDFB04A4FA41266F2B946C97E">
<enum>D</enum>
<header>Capstone Grant Program</header>
<section id="HF62E3B3AE6BE43C7A497F51D6385255B">
<enum>1061.</enum>
<header>Capstone award</header>
<text display-inline="no-display-inline">Part G of title IV of the Public Health Service Act (42 U.S.C. 288 et seq.) is amended by adding at the end the following:</text>
<quoted-block id="H7A97D46B3D624DA1B58EFB9B1DF82AD0" style="OLC">
<section id="H546AAE645B2E43CA8BBEA68EA1A86987">
<enum>490.</enum>
<header>Capstone award</header>
<subsection id="H8BFDF52281BA48FF80C9085AE33A2C44">
<enum>(a)</enum>
<header>In general</header>
<text>The Secretary may make awards (each of which, hereafter in this section, referred to as a <quote>Capstone Award</quote>) to support outstanding scientists who have been funded by the National Institutes of Health.</text>
</subsection>
<subsection id="H6500BFC26B50402FB17649F18D1EE004">
<enum>(b)</enum>
<header>Purpose</header>
<text display-inline="yes-display-inline">Capstone Awards shall be made to facilitate the successful transition or conclusion of research programs, or for other purposes, as determined by the Director of NIH, in consultation with the directors of the national research institutes and national centers.</text>
</subsection>
<subsection id="H528AF001873249EF95FA801FECE775E5">
<enum>(c)</enum>
<header>Duration and amount</header>
<text>The duration and amount of each Capstone Award shall be determined by the Director of NIH in consultation with the directors of the national research institutes and national centers.</text>
</subsection>
<subsection id="H6A7C437D69334FDF804FC037F570A237">
<enum>(d)</enum>
<header>Limitation</header>
<text display-inline="yes-display-inline">Individuals who have received a Capstone Award shall not be eligible to have principle investigator status on subsequent awards from the National Institutes of Health.</text>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
</subtitle>
<subtitle id="HFE2543536B734889B1846DF721647800">
<enum>E</enum>
<header>Promoting Pediatric Research through the National Institutes of Health</header>
<section id="H0E6A214B566244728A1DA137F4DFF4B0" section-type="subsequent-section">
<enum>1081.</enum>
<header>National pediatric research network</header>
<text display-inline="no-display-inline">Section 409D(d) of the Public Health Service Act (42 U.S.C. 284h(d)) is amended—</text>
<paragraph id="H76B1F948E61B442698DCA3AE4566AAB3">
<enum>(1)</enum>
<text display-inline="yes-display-inline">in paragraph (1)—</text>
<subparagraph id="H1D89833AE013435B93B88D147AC6CF6F">
<enum>(A)</enum>
<text>by striking <quote>in consultation with the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and in collaboration with other appropriate national research institutes and national centers that carry out activities involving pediatric research</quote> and inserting <quote>in collaboration with the national research institutes and national centers that carry out activities involving pediatric research</quote>;</text>
</subparagraph>
<subparagraph id="H700ADE1397374077BE75D386B67C479D">
<enum>(B)</enum>
<text>by striking subparagraph (B);</text>
</subparagraph>
<subparagraph id="H6EF0F68740E74CCCB573965D00DF9B6C">
<enum>(C)</enum>
<text display-inline="yes-display-inline">by striking <quote>may be comprised of, as appropriate</quote> and all that follows through <quote>the pediatric research consortia</quote> and inserting <quote>may be comprised of, as appropriate, the pediatric research consortia</quote>; and</text>
</subparagraph>
<subparagraph id="H5A9E8EDB2B4144229205CCB2B98320D0">
<enum>(D)</enum>
<text>by striking <quote>; or</quote> at the end and inserting a period; and</text>
</subparagraph>
</paragraph>
<paragraph id="H988E251648774E39A5261C47D7AED1AB">
<enum>(2)</enum>
<text>in paragraph (1), paragraph (2)(A), the first sentence of paragraph (2)(E), and paragraph (4), by striking <quote>may</quote> each place it appears and inserting <quote>shall</quote>.</text>
</paragraph>
</section>
<section id="H3EB58F541C854D51969C2D647BC58A36">
<enum>1082.</enum>
<header>Global pediatric clinical study network sense of Congress</header>
<text display-inline="no-display-inline">It is the sense of Congress that—</text>
<paragraph id="H8E66512D949B41B68C68C96E95EF75CD">
<enum>(1)</enum>
<text display-inline="yes-display-inline">the National Institutes of Health should encourage a global pediatric clinical study network through the allocation of grants, contracts, or cooperative agreements to supplement the salaries of new and early investigators who participate in the global pediatric clinical study network; </text>
</paragraph>
<paragraph id="H0048BB9E15944699B64F7C048EF14837">
<enum>(2)</enum>
<text display-inline="yes-display-inline">National Institutes of Health grants, contracts, or cooperative agreements should be awarded, solely for the purpose of supplementing the salaries of new and early investigators, to entities that participate in the global pediatric clinical study network; </text>
</paragraph>
<paragraph id="H945D1876B9B44324A2D480949D5F5552">
<enum>(3)</enum>
<text>the Food and Drug Administration should engage the European Medicines Agency and other foreign regulatory entities during the formation of the global pediatric clinical study network to encourage their participation; and </text>
</paragraph>
<paragraph id="H0EC2B59289514835B881AA1932D55BB8">
<enum>(4)</enum>
<text>once a global pediatric clinical study network is established and becomes operational, the Food and Drug Administration should continue to engage the European Medicines Agency and other foreign regulatory entities to encourage and facilitate their participation in the network with the goal of enhancing the global reach of the network.</text>
</paragraph>
</section>
<section id="HA6F1C3DD66504FA7BD10C7DEB9E7B0C1">
<enum>1083.</enum>
<header>Appropriate age groupings in clinical research</header>
<subsection id="HCC24446F12544018AA8E8C1F1A7FD6F5">
<enum>(a)</enum>
<header>Input from experts</header>
<text display-inline="yes-display-inline">Not later than 180 days after the date of enactment of this Act, the Director of the National Institutes of Health shall convene a workshop of experts on pediatrics and experts on geriatrics to provide input on—</text>
<paragraph id="H2044181CF6A54320938C2E38E767D494">
<enum>(1)</enum>
<text>appropriate age groupings to be included in research studies involving human subjects; and</text>
</paragraph>
<paragraph id="HE98A74AD3DAC4D59BF2279AD1A05F89E">
<enum>(2)</enum>
<text>acceptable scientific justifications for excluding participants from a range of age groups from human subjects research studies.</text>
</paragraph>
</subsection>
<subsection id="HCDD27278D597448F8136F298CDA69FCC">
<enum>(b)</enum>
<header>Guidelines</header>
<text>Not later than 180 days after the conclusion of the workshop under subsection (a), the Director of the National Institutes of Health shall publish guidelines—</text>
<paragraph id="H17EA372E102141478A16567B4B9CC0A4">
<enum>(1)</enum>
<text>addressing the consideration of age as an inclusion variable in research involving human subjects; and</text>
</paragraph>
<paragraph id="H4B157B68382C4622A474C233124C30AB">
<enum>(2)</enum>
<text>identifying criteria for justifications for any age-related exclusions in such research.</text>
</paragraph>
</subsection>
<subsection id="H297DC52FDC6446D9A30AAD80766FC7BC">
<enum>(c)</enum>
<header>Public availability of findings and conclusions</header>
<text>The Director of the National Institutes of Health shall—</text>
<paragraph id="H342FC1B9B7E644EF9426C4FCCBE60631">
<enum>(1)</enum>
<text display-inline="yes-display-inline">make the findings and conclusions resulting from the workshop under subsection (a) available to the public on the website of the National Institutes of Health; and</text>
</paragraph>
<paragraph id="HB706A73C507A4F818B724D04B50D1BF4">
<enum>(2)</enum>
<text>not less than biennially, disclose to the public on such website the number of children included in research that is conducted or supported by the National Institutes of Health, disaggregated by developmentally appropriate age group, race, and gender.</text>
</paragraph>
</subsection>
</section>
</subtitle>
<subtitle id="HC6367DE007934945B00DF8C7867E3908">
<enum>F</enum>
<header>Advancement of the National Institutes of Health Research and Data Access</header>
<section id="H49407F65A9314411A01643A2107C4A07" display-inline="no-display-inline">
<enum>1101.</enum>
<header>Standardization of data in Clinical Trial Registry Data Bank on eligibility for clinical trials</header>
<subsection id="H99CD78650E0240ABB6C9FE590E16CD29">
<enum>(a)</enum>
<header>Standardization</header>
<text display-inline="yes-display-inline">
</text>
<paragraph id="HBB104D5D67014CC9822101B7D880948B">
<enum>(1)</enum>
<header>In general</header>
<text>Section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) is amended—</text>
<subparagraph id="H52F16E2C85724983BA61FC0EA05DA5A8">
<enum>(A)</enum>
<text>by redesignating paragraph (7) as paragraph (8); and</text>
</subparagraph>
<subparagraph id="H5AC2951184894C3F88CA5C515C1C568E">
<enum>(B)</enum>
<text>by inserting after paragraph (6) the following:</text>
<quoted-block style="OLC" id="H65834927E23F4F51B67EA1E6D09BFE79" display-inline="no-display-inline">
<paragraph id="HC90B2AA925514B5DA4B1C95960893356">
<enum>(7)</enum>
<header>Standardization</header>
<text display-inline="yes-display-inline">The Director of NIH shall—</text>
<subparagraph id="H4DCAD4A3999048A2BED957578C57962D">
<enum>(A)</enum>
<text>ensure that the registry and results data bank is easily used by the public;</text>
</subparagraph>
<subparagraph id="H5492F45E396C4846A9C4992FAFE1022E">
<enum>(B)</enum>
<text>ensure that entries in the registry and results data bank are easily compared;</text>
</subparagraph>
<subparagraph id="H832502CD095C463CB4918994A65514D3">
<enum>(C)</enum>
<text display-inline="yes-display-inline">ensure that information required to be submitted to the registry and results data bank, including recruitment information under paragraph (2)(A)(ii)(II), is submitted by persons and posted by the Director of NIH in a standardized format and includes at least—</text>
<clause id="HF3CEECCBD64B42D880C7EF53BC74747C">
<enum>(i)</enum>
<text display-inline="yes-display-inline">the disease or indication being studied;</text>
</clause>
<clause id="H2CF05DF4D6EF42FCBDA9438EB360A5DE">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">inclusion criteria such as age, gender, diagnosis or diagnoses, laboratory values, or imaging results; and</text>
</clause>
<clause id="HE819263750884349907C68AF6BDB34D8">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">exclusion criteria such as specific diagnosis or diagnoses, laboratory values, or prohibited medications; and</text>
</clause>
</subparagraph>
<subparagraph id="H0FF52EDBA2DC48558B07966E2A270DCF">
<enum>(D)</enum>
<text>to the extent possible, in carrying out this paragraph, make use of standard health care terminologies, such as the International Classification of Diseases or the Current Procedural Terminology, that facilitate electronic matching to data in electronic health records or other relevant health information technologies.</text>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subparagraph>
</paragraph>
<paragraph id="H6B5BC3202EA94BB292B7815028539D79">
<enum>(2)</enum>
<header>Conforming amendment</header>
<text display-inline="yes-display-inline">Clause (iv) of section 402(j)(2)(B) of the Public Health Service Act (42 U.S.C. 282(j)(2)(B)) is hereby stricken.</text>
</paragraph>
</subsection>
<subsection id="HD60F5628CBC34C54A7F7A59104DBAC12">
<enum>(b)</enum>
<header>Consultation</header>
<text display-inline="yes-display-inline">Not later than 90 days after the date of enactment of this Act, the Secretary of Health and Human Services shall consult with stakeholders (including patients, researchers, physicians, industry representatives, health information technology providers, the Food and Drug Administration, and standard setting organizations such as CDISC that have experience working with Federal agencies to standardize health data submissions) to receive advice on enhancements to the clinical trial registry data bank under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)) (including enhancements to usability, functionality, and search capability) that are necessary to implement paragraph (7) of section 402(j) of such Act, as added by subsection (a).</text>
</subsection>
<subsection id="HAF04EDCAF5D241A593AC33C454E5C7A7">
<enum>(c)</enum>
<header>Applicability</header>
<text>Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall begin implementation of paragraph (7) of section 402(j) of the Public Health Service Act, as added by subsection (a).</text>
</subsection>
</section>
</subtitle>
<subtitle id="H952CC401FCAB4A55BCC94E35FE9CFB03">
<enum>G</enum>
<header>Facilitating Collaborative Research</header>
<section id="H19D9D89A3B884F9581EB04E3EED2EDCC" commented="no">
<enum>1121.</enum>
<header>Clinical trial data system</header>
<subsection id="H9A391FB2D6204D648271E8FB5CEF9DF8" commented="no">
<enum>(a)</enum>
<header>Establishment</header>
<text display-inline="yes-display-inline">The Secretary, acting through the Commissioner of Food and Drugs and the Director of the National Institutes of Health, shall enter into a cooperative agreement, contract, or grant for a period of 7 years, to be known as the Clinical Trial Data System Agreement, with one or more eligible entities to implement a pilot program with respect to all clinical trial data obtained from qualified clinical trials for purposes of registered users conducting further research on such data.</text>
</subsection>
<subsection id="H13285D8C7A4D405A9B33C35FE327D003" commented="no">
<enum>(b)</enum>
<header>Application</header>
<text display-inline="yes-display-inline">Eligible entities seeking to enter into a cooperative agreement, contract, or grant with the Secretary under this section shall submit to the Secretary an application in such time and manner, and containing such information, as the Secretary may require in accordance with this section. The Secretary shall not enter into a cooperative agreement, contract, or grant under this section with an eligible entity unless such entity submits an application including the following:</text>
<paragraph id="HF221694A63DB44D497B64FC9A99DE3A0" commented="no">
<enum>(1)</enum>
<text display-inline="yes-display-inline">A certification that the eligible entity is not currently and does not plan to be involved in sponsoring, operating, or participating in a clinical trial nor collaborating with another entity for the purposes of sponsoring, operating, or participating in a clinical trial.</text>
</paragraph>
<paragraph id="H0DEC752CB858457D8CC02BEF559ED035" commented="no">
<enum>(2)</enum>
<text display-inline="yes-display-inline">Information demonstrating that the eligible entity can compile clinical trial data in standardized formats using terminologies and standards that have been developed by recognized standards developing organizations with input from diverse stakeholder groups, and information demonstrating that the eligible entity can de-identify clinical trial data consistent with the requirements of section 164.514 of title 45, Code of Federal Regulations (or successor regulations).</text>
</paragraph>
<paragraph id="HF4224BF5C43D41B48453470BA561B73F">
<enum>(3)</enum>
<text display-inline="yes-display-inline">A description of the system the eligible entity will use to store and maintain such data, and information demonstrating that this system will comply with applicable standards and requirements for ensuring the security of the clinical trial data.</text>
</paragraph>
<paragraph id="H6AAB334472D049B8901BBC1B78D8466C" commented="no">
<enum>(4)</enum>
<text display-inline="yes-display-inline">A certification that the eligible entity will allow only registered users to access and use de-identified clinical trial data, gathered from qualified clinical trials, and that the eligible entity will allow each registered user to access and use such data only after such registered user agrees in writing to the terms described in (e)(4)(B), and such other carefully controlled contractual terms as may be defined by the Secretary.</text>
</paragraph>
<paragraph id="H4C34194A5AF1422EAEA05F6024C98FB8" commented="no">
<enum>(5)</enum>
<text display-inline="yes-display-inline">Evidence demonstrating the ability of the eligible entity to ensure that registered users disseminate the results of the research conducted in accordance with this section to interested parties to serve as a guide to future medical product development or scientific research.</text>
</paragraph>
<paragraph id="H10D192A1E24F4001A97ACEB70B3695D6" commented="no">
<enum>(6)</enum>
<text display-inline="yes-display-inline">The plan of the eligible entity for securing funding for the activities it would conduct under the clinical trial data system agreement from governmental sources and private foundations, entities, and individuals.</text>
</paragraph>
<paragraph id="HF1065C2A5F6242C88149C1764A95F33A" commented="no">
<enum>(7)</enum>
<text display-inline="yes-display-inline">Evidence demonstrating a proven track record of—</text>
<subparagraph id="H04318031BF894C968C8F94A6DD25F52A" commented="no">
<enum>(A)</enum>
<text>being a neutral third party in working with medical product manufacturers, academic institutions, and the Food and Drug Administration; and</text>
</subparagraph>
<subparagraph id="H3DE0974FE0064806821D34A785A49FEA" commented="no">
<enum>(B)</enum>
<text>having the ability to protect confidential data.</text>
</subparagraph>
</paragraph>
<paragraph id="HEB45709F508144AFAC01711C4C3C02F1">
<enum>(8)</enum>
<text display-inline="yes-display-inline">An agreement that the eligible entity will work with the Comptroller General of the United States for purposes of the study and report under subsection (d).</text>
</paragraph>
</subsection>
<subsection id="HC1872E197CBA4AB2A8745FAF7EDA8270" commented="no">
<enum>(c)</enum>
<header>Extension, expansion, termination</header>
<text display-inline="yes-display-inline">The Secretary, acting through the Commissioner of Food and Drugs and the Director of the National Institutes of Health, upon the expiration of the 7-year period referred to in subsection (a), may extend (including permanently), expand, or terminate the pilot program established under such subsection, in whole or in part. </text>
</subsection>
<subsection id="H0CE4BD7E7D524E91A0BEF7A474390178" commented="no">
<enum>(d)</enum>
<header>Study and report</header>
<paragraph id="HECADB2E29F4D4337A4844EE8FC87EE68">
<enum>(1)</enum>
<header>In general</header>
<text>The Comptroller General of the United States shall conduct a study and issue a report to the Congress and the Secretary with respect to the pilot program established under subsection (a), not later than 6 years after the date on which the pilot program is established under subsection (a).</text>
</paragraph>
<paragraph id="H84FB05F1FAC7456585135A70FAFB8B26" commented="no">
<enum>(2)</enum>
<header>Study</header>
<text>The study under paragraph (1) shall—</text>
<subparagraph id="H511A1C67FF6B48D8AC589D830CF4E85F" commented="no">
<enum>(A)</enum>
<text>review the effectiveness of the pilot program established under subsection (a); and</text>
</subparagraph>
<subparagraph id="H759CC7E462924ED59815DAF3CED29B99" commented="no">
<enum>(B)</enum>
<text>be designed to formulate recommendations on improvements to the program.</text>
</subparagraph>
</paragraph>
<paragraph id="H7B54A6FAABA64784A5DC4BFA4C071495" commented="no">
<enum>(3)</enum>
<header>Report</header>
<text>The report under paragraph (1) shall contain at least the following information:</text>
<subparagraph id="H24CA311AAEDE46CF944E3E5CBD0D5AFF" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">The new discoveries, research inquiries, or clinical trials that have resulted from accessing clinical trial data under the pilot program established under subsection (a).</text>
</subparagraph>
<subparagraph id="H7F1785F727B3427B9CC164DBFDBCDCEB" commented="no">
<enum>(B)</enum>
<text>The number of times scientists have accessed such data, disaggregated by research area and clinical trial phase.</text>
</subparagraph>
<subparagraph id="H255B9ECADD034C6F88334815E839A745" commented="no">
<enum>(C)</enum>
<text>An analysis of whether the program has helped to reduce adverse events in clinical trials.</text>
</subparagraph>
<subparagraph id="H5B26B0D02B224BF3A160D6E430E56A3F" commented="no">
<enum>(D)</enum>
<text display-inline="yes-display-inline">An analysis of whether scientists have raised any concerns about the burden of having to share data with the system established under the program and, if so, a description of such concerns.</text>
</subparagraph>
<subparagraph id="HF9A5723DA8664B9FBC555BE20AD14BBC" commented="no">
<enum>(E)</enum>
<text>An analysis of privacy and data integrity practices used in the program.</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H72D5453B06C74100B5110EFA273F3848" commented="no">
<enum>(e)</enum>
<header>Definitions</header>
<text>In this section:</text>
<paragraph id="H53D185C3BD994F269144B1E79BB98F8E" commented="no">
<enum>(1)</enum>
<text display-inline="yes-display-inline">The term <quote>eligible entity</quote> means an entity that has experienced personnel with clinical and other technical expertise in the biomedical sciences and biomedical ethics and that is—</text>
<subparagraph id="H329365F685CA44698FB7FD20E43C5CCC" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">an institution of higher education (as such term is defined in section 1001 of the Higher Education Act of 1965 (20 U.S.C. 1001)) or a consortium of such institutions; or</text>
</subparagraph>
<subparagraph id="H1E528882B228461993017E48C1B7418E" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">an organization described in section 501(c)(3) of title 26 of the Internal Revenue Code of 1986 and exempt from tax under section 501(a) of such title.</text>
</subparagraph>
</paragraph>
<paragraph id="H25C11CBB849541F2942B193625B8BD7B" commented="no">
<enum>(2)</enum>
<text display-inline="yes-display-inline">The term <quote>medical product</quote> means a drug (as defined in section 201(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(g))), a device (as defined in section 201(h) of such Act (21 U.S.C. 331(h)), a biological product (as defined in section 351 of the Public Health Service Act (42 U.S.C. 262)), or any combination thereof.</text>
</paragraph>
<paragraph id="H68DB48A658E547E9A56E17638BEA1E73" commented="no">
<enum>(3)</enum>
<text>The term <quote>qualified clinical trial</quote> means a clinical trial sponsored solely by an agency of the Department of Health and Human Services with respect to a medical product—</text>
<subparagraph id="H4D007FF49BC84AA5A0315DBBBCC6121E" commented="no">
<enum>(A)</enum>
<text>that—</text>
<clause id="H1F5029D64BBA41D2B3212D3C5DFDE625" commented="no">
<enum>(i)</enum>
<text>was approved or cleared under section 505, 510(k), or 515, or has an exemption for investigational use in effect under section 505 or 520(m), of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 301 et seq.); or</text>
</clause>
<clause id="H6BA3D12C6EB44892B3D19E04BBA31F32" commented="no">
<enum>(ii)</enum>
<text>was licensed under section 351 of the Public Health Service Act (42 U.S.C. 262) or has an exemption for investigational use in effect under such section 351; or</text>
</clause>
</subparagraph>
<subparagraph id="H0C0EB165075C4D9295A7E90E2404C9EE" commented="no">
<enum>(B)</enum>
<text>that is an investigational product for which the original development was discontinued and with respect to which—</text>
<clause id="HEEC93B0E34E745C2B523E09C1D7788F9" commented="no">
<enum>(i)</enum>
<text>no additional work to support approval, licensure, or clearance of such medical product is being or is planned to be undertaken by the sponsor of the original development program, its successors, assigns, or collaborators; and</text>
</clause>
<clause id="HF67D9513E98B4C16A311B63464136D32" commented="no">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">the sponsor of the original investigational development program has provided its consent to the Secretary for inclusion of data regarding such product in the system established under this section.</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H922805D4C47A452F92A354AFB8576A91">
<enum>(4)</enum>
<text>The term <quote>registered user</quote> means a scientific or medical researcher who has—</text>
<subparagraph id="H7F56BEA5B4AE43938314D9B6DC0937A5">
<enum>(A)</enum>
<text>a legitimate biomedical research purpose for accessing information from the clinical trials data system and has appropriate qualifications to conduct such research; and</text>
</subparagraph>
<subparagraph id="HB0ACA7A645AB43E9AFED3D7552D1FBD9">
<enum>(B)</enum>
<text>agreed in writing not to transfer to any other person that is not a registered user de-identified clinical trial data from qualified clinical trials accessed through an eligible entity, use such data for reasons not specified in the research proposal, or seek to re-identify qualified clinical trial participants.</text>
</subparagraph>
</paragraph>
<paragraph id="H7377997B805844358527E866B6B9A114">
<enum>(5)</enum>
<text>The term <quote>Secretary</quote> means the Secretary of Health and Human Services. </text>
</paragraph>
</subsection>
</section>
<section id="HF56CBE5DC082497FB910544B2369088E">
<enum>1122.</enum>
<header>National neurological diseases surveillance system</header>
<text display-inline="no-display-inline">Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="H6382B4AA3CC84681B275240177143845" style="OLC">
<section id="HBC1F6CC50A714901A24995751A8A6BF8">
<enum>399V–6</enum>
<header>Surveillance of neurological diseases</header>
<subsection commented="no" id="H66B052E2614B4F8F83D3E19F2AA7C5E0">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary, acting through the Director of the Centers for Disease Control and Prevention and in coordination with other agencies as determined appropriate by the Secretary, shall—</text>
<paragraph commented="no" id="HA571DF9A55D94CD48E0C55F58914C9CF">
<enum>(1)</enum>
<text>enhance and expand infrastructure and activities to track the epidemiology of neurological diseases, including multiple sclerosis and Parkinson’s disease; and</text>
</paragraph>
<paragraph commented="no" id="H54199CD03D954BCC8D33733105B2AFA8">
<enum>(2)</enum>
<text>incorporate information obtained through such activities into a statistically sound, scientifically credible, integrated surveillance system, to be known as the National Neurological Diseases Surveillance System.</text>
</paragraph>
</subsection>
<subsection commented="no" id="H2438FBA896D24BAC9CFF5DDB851AF280">
<enum>(b)</enum>
<header>Research</header>
<text>The Secretary shall ensure that the National Neurological Diseases Surveillance System is designed in a manner that facilitates further research on neurological diseases.</text>
</subsection>
<subsection id="HB2A3489315EF4ACC99C3F6C6DA19B76C">
<enum>(c)</enum>
<header>Content</header>
<text>In carrying out subsection (a), the Secretary—</text>
<paragraph id="H7BC8453368F34B77B26FD432E37FECA9">
<enum>(1)</enum>
<text>shall provide for the collection and storage of information on the incidence and prevalence of neurological diseases in the United States;</text>
</paragraph>
<paragraph commented="no" id="H50179BF8B2BF4B62BFBC3B9FD471EB32">
<enum>(2)</enum>
<text>to the extent practicable, shall provide for the collection and storage of other available information on neurological diseases, such as information concerning—</text>
<subparagraph commented="no" id="H66FBB01B7D7243169304264257D956D9">
<enum>(A)</enum>
<text>demographics and other information associated or possibly associated with neurological diseases, such as age, race, ethnicity, sex, geographic location, and family history;</text>
</subparagraph>
<subparagraph commented="no" id="H3C25FBC519FC41E88B4AC1F07A6AE5F7">
<enum>(B)</enum>
<text>risk factors associated or possibly associated with neurological diseases, including genetic and environmental risk factors; and</text>
</subparagraph>
<subparagraph commented="no" id="H1B0F39F0FD1C4BECA651FD89EBFCBFC5">
<enum>(C)</enum>
<text>diagnosis and progression markers;</text>
</subparagraph>
</paragraph>
<paragraph id="H60E19D052CBC48EABB2E5EFF2C3BFD68">
<enum>(3)</enum>
<text display-inline="yes-display-inline">may provide for the collection and storage of information relevant to analysis on neurological diseases, such as information concerning—</text>
<subparagraph id="HDB1E849F12D6495BB0D0AC5D8D109C69">
<enum>(A)</enum>
<text>the epidemiology of the diseases;</text>
</subparagraph>
<subparagraph id="H4538DC45500F49EFB5E6FEA8776059A7">
<enum>(B)</enum>
<text>the natural history of the diseases;</text>
</subparagraph>
<subparagraph id="HB2B0D062FD704F249D1474F327FFFFB4">
<enum>(C)</enum>
<text>the prevention of the diseases;</text>
</subparagraph>
<subparagraph id="HE16C8CB74A604C6E9F238A5B7B9AA6F7">
<enum>(D)</enum>
<text>the detection, management, and treatment approaches for the diseases; and</text>
</subparagraph>
<subparagraph id="H1B4894E68B7C4CE89E5A743F33A26382">
<enum>(E)</enum>
<text>the development of outcomes measures; and</text>
</subparagraph>
</paragraph>
<paragraph id="H52A3EA3D8ACE4CF1A49BDB24E9DF701F">
<enum>(4)</enum>
<text>may address issues identified during the consultation process under subsection (d).</text>
</paragraph>
</subsection>
<subsection id="H6101A45CEC2E40D8A66259DA34098D8B">
<enum>(d)</enum>
<header>Consultation</header>
<text>In carrying out this section, the Secretary shall consult with individuals with appropriate expertise, including—</text>
<paragraph id="H418BA81E7F5B48F99CAF1256A5E837F9">
<enum>(1)</enum>
<text>epidemiologists with experience in disease surveillance or registries;</text>
</paragraph>
<paragraph id="HFA6C9FDF249F4DFA8F962A780C606415">
<enum>(2)</enum>
<text>representatives of national voluntary health associations that—</text>
<subparagraph id="HE3C91051126348EEA5016DD9C26EA53D">
<enum>(A)</enum>
<text>focus on neurological diseases, including multiple sclerosis and Parkinson’s disease; and</text>
</subparagraph>
<subparagraph id="H4D6AE38148D84CCD98288D08D28BA158">
<enum>(B)</enum>
<text>have demonstrated experience in research, care, or patient services;</text>
</subparagraph>
</paragraph>
<paragraph id="H88579A17D53E4D16A3832AB6D6807C07">
<enum>(3)</enum>
<text>health information technology experts or other information management specialists;</text>
</paragraph>
<paragraph id="H227FDDE8252849D4B814F343606E6456">
<enum>(4)</enum>
<text>clinicians with expertise in neurological diseases; and</text>
</paragraph>
<paragraph id="HABEB7F72F00B4459B7E51BA8C8B7FB8A">
<enum>(5)</enum>
<text>research scientists with experience conducting translational research or utilizing surveillance systems for scientific research purposes.</text>
</paragraph>
</subsection>
<subsection id="HE9458A7E28464CF9AA6290EE2FF439CC">
<enum>(e)</enum>
<header>Grants</header>
<text>The Secretary may award grants to, or enter into contracts or cooperative agreements with, public or private nonprofit entities to carry out activities under this section.</text>
</subsection>
<subsection id="H7187C665442E4800B3FDF0DEDC0290D4" commented="no">
<enum>(f)</enum>
<header>Coordination with other Federal, State, and local agencies</header>
<text>Subject to subsection (h), the Secretary shall make information and analysis in the National Neurological Diseases Surveillance System available, as appropriate—</text>
<paragraph id="HB97CCC08E95C421BB9589264DD05ECAB">
<enum>(1)</enum>
<text>to Federal departments and agencies, such as the National Institutes of Health, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Agency for Healthcare Research and Quality, the Department of Veterans Affairs, and the Department of Defense; and</text>
</paragraph>
<paragraph id="H0DA83F04DD814CD2916CE0E4900AA5D6">
<enum>(2)</enum>
<text>to State and local agencies.</text>
</paragraph>
</subsection>
<subsection id="HFE8AB681675E4481A6CDE8FD1282E01E">
<enum>(g)</enum>
<header>Public access</header>
<text>Subject to subsection (h), the Secretary shall make information and analysis in the National Neurological Diseases Surveillance System available, as appropriate, to the public, including researchers.</text>
</subsection>
<subsection id="HEF4B1310499640F38F827F4033CB8041">
<enum>(h)</enum>
<header>Privacy</header>
<text display-inline="yes-display-inline">The Secretary shall ensure that privacy and security protections applicable to the National Neurological Diseases Surveillance System are at least as stringent as the privacy and security protections under HIPAA privacy and security law (as defined in section 3009(a)(2)).</text>
</subsection>
<subsection id="H07FBDC874CD14F969072069AF13D6F77">
<enum>(i)</enum>
<header>Report</header>
<text>Not later than 4 years after the date of the enactment of this section, the Secretary shall submit a report to the Congress concerning the implementation of this section. Such report shall include information on—</text>
<paragraph id="H2949C3D3B53E462CA66F0DFB2A019517">
<enum>(1)</enum>
<text>the development and maintenance of the National Neurological Diseases Surveillance System;</text>
</paragraph>
<paragraph id="H7E8C27A1A542424E9BD4B408A33F9595">
<enum>(2)</enum>
<text>the type of information collected and stored in the System;</text>
</paragraph>
<paragraph id="H147B23EA8298427C9BC5B5969B42C67B">
<enum>(3)</enum>
<text>the use and availability of such information, including guidelines for such use; and</text>
</paragraph>
<paragraph id="H55CA1FC4F9E346DAA6D88E9A500AD21C">
<enum>(4)</enum>
<text>the use and coordination of databases that collect or maintain information on neurological diseases.</text>
</paragraph>
</subsection>
<subsection id="HD4224742785F4EF89B53002C1C8E9044">
<enum>(j)</enum>
<header>Definition</header>
<text>In this section, the term <term>national voluntary health association</term> means a national nonprofit organization with chapters, other affiliated organizations, or networks in States throughout the United States.</text>
</subsection>
<subsection id="HD691F383C31341E3B7922AB145C28FA5">
<enum>(k)</enum>
<header>Authorization of appropriations</header>
<text>To carry out this section, there is authorized to be appropriated $5,000,000 for each of fiscal years 2016 through 2020.</text>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
<section id="H0DD0E6E9E6B643609ADBBF2DD482ADDB">
<enum>1123.</enum>
<header>Data on natural history of diseases</header>
<subsection id="HB51DBCF921B5401EB02118466304B416">
<enum>(a)</enum>
<header>Sense of Congress</header>
<text display-inline="yes-display-inline">It is the sense of the Congress that studies on the natural history of diseases can help to facilitate and expedite the development of medical products for such diseases.</text>
</subsection>
<subsection id="HAA0263BBF3854EA9BF819DD62F69187D">
<enum>(b)</enum>
<header>Authority</header>
<text display-inline="yes-display-inline">Part A of title II of the Public Health Service Act (42 U.S.C. 202 et seq.) is amended by adding at the end the following:</text>
<quoted-block style="OLC" id="H6D14DAB0BFB240039675139822D879E5" display-inline="no-display-inline">
<section id="HF727371351E14AB8BD36E9A008B68A03">
<enum>229A.</enum>
<header>Data on natural history of diseases</header>
<subsection id="HE1A6FD65E2434075BE7A5D917EE1AB3B">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary, acting through the Commissioner of Food and Drugs, may, for the purposes described in subsection (b)—</text>
<paragraph id="HDDC4F118D4BC4BDF82229BB8A85E2B46">
<enum>(1)</enum>
<text>participate in public-private partnerships engaged in one or more activities specified in subsection (c); and</text>
</paragraph>
<paragraph id="HA5014E3CF54C457589487DC5242227E1">
<enum>(2)</enum>
<text>award grants to patient advocacy groups or other organizations determined appropriate by the Secretary.</text>
</paragraph>
</subsection>
<subsection id="H8679C06B9D904FBFB08B0C7B59135167">
<enum>(b)</enum>
<header>Purposes described</header>
<text display-inline="yes-display-inline">The purposes described in this subsection are to establish or facilitate the collection, maintenance, analysis, and interpretation of data regarding the natural history of diseases, with a particular focus on rare diseases.</text>
</subsection>
<subsection id="H962AE4D99A9C4CE2BDE6A0D0ECDB579C">
<enum>(c)</enum>
<header>Activities of public-Private partnerships</header>
<text display-inline="yes-display-inline">The activities of public-private partnerships in which the Secretary may participate for purposes of this section include—</text>
<paragraph id="H7366EA5A07F241838BE74A1C406B4DFB">
<enum>(1)</enum>
<text>cooperating with other entities that sponsor or maintain disease registries, including disease registries and disease registry platforms for rare diseases;</text>
</paragraph>
<paragraph id="HC3611A2641734D87B97FCCC34C940B63">
<enum>(2)</enum>
<text>developing or enhancing a secure information technology system that—</text>
<subparagraph id="HCCF51A78CDE94FAE9023F5426C2BFF40">
<enum>(A)</enum>
<text>has the capacity to support data needs across a wide range of disease studies;</text>
</subparagraph>
<subparagraph id="H914D13CDB6BE46868932D5F330C3CB11">
<enum>(B)</enum>
<text>is easily modified as knowledge is gained during such studies; and</text>
</subparagraph>
<subparagraph id="H2704D4CBD37545FB80F42F048A608253">
<enum>(C)</enum>
<text>is capable of handling increasing amounts of data as more studies are carried out; and</text>
</subparagraph>
</paragraph>
<paragraph id="H97C8B7C26FAF4DC79B9C9621C1133EA5">
<enum>(3)</enum>
<text display-inline="yes-display-inline">providing advice to clinical researchers, patient advocacy groups, and other entities with respect to—</text>
<subparagraph id="HD47D4992FC2F4AF9ABB5DC6F1F64C352">
<enum>(A)</enum>
<text>the design and conduct of disease studies;</text>
</subparagraph>
<subparagraph id="HA004CBB38FD94F8CA75D8DD798DBDC19">
<enum>(B)</enum>
<text>the modification of any such ongoing studies; and</text>
</subparagraph>
<subparagraph id="HA2F3A7D2276A431F911B58A5FE461DDF">
<enum>(C)</enum>
<text>addressing associated patient privacy issues.</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H95B3290AEC5B433CBBFC7CE4DB57EDC4">
<enum>(d)</enum>
<header>Availability of data on natural history of diseases</header>
<text display-inline="yes-display-inline">Data relating to the natural history of diseases obtained, aggregated, or otherwise maintained by a public-private partnership in which the Secretary participates under subsection (a) shall be made available, consistent with otherwise applicable Federal and State privacy laws, to the public (including patient advocacy groups, researchers, and drug developers) to help to facilitate and expedite medical product development programs.</text>
</subsection>
<subsection id="H8A5F17A2FEF0451CAD2E4DEF16397B75">
<enum>(e)</enum>
<header>Confidentiality</header>
<text display-inline="yes-display-inline">Notwithstanding subsection (d), nothing in this section authorizes the disclosure of any information that is a trade secret or commercial or financial information that is privileged or confidential and subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.</text>
</subsection>
<subsection id="H92CA491B9BA24BEB8B21DECD347096AA">
<enum>(f)</enum>
<header>Authorization of appropriations</header>
<text>There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2016 through 2020. </text>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
</section>
<section id="H17CADDAD88CC46C298F0E8812185F544">
<enum>1124.</enum>
<header>Accessing, sharing, and using health data for research purposes</header>
<subsection id="HD86E958F95E24037BFCC4C58E2452CB2">
<enum>(a)</enum>
<header>In general</header>
<paragraph id="H242073E91C9D491B9DD1A5D492E8F3C4" display-inline="yes-display-inline">
<enum>(1)</enum>
<text>The HITECH Act (title XIII of division A of Public Law 111–5) is amended by adding at the end of subtitle D of such Act (42 U.S.C. 17921 et seq.) the following:</text>
<quoted-block style="OLC" id="H453F5D12A7734F44915039FF38C22D30" display-inline="no-display-inline">
<part id="HD50D51D8E26347BD81AE166E60D2A9FD">
<enum>4</enum>
<header>Accessing, sharing, and using health data for research purposes</header>
<section id="H4B6AF215957344BE9035D4A5336E7207">
<enum>13441.</enum>
<header>References</header>
<text display-inline="no-display-inline">In this part:</text>
<paragraph id="HD64FF843043840FF8478EAE70E53AE24">
<enum>(1)</enum>
<header>The rule</header>
<text display-inline="yes-display-inline">References to <quote>the Rule</quote> refer to part 160 or part 164, as appropriate, of title 45, Code of Federal Regulations (or any successor regulation).</text>
</paragraph>
<paragraph id="H9296013FE9154764B8C323A642BE4478">
<enum>(2)</enum>
<header>Part 164</header>
<text display-inline="yes-display-inline">References to a specified section of <quote>part 164</quote>, refer to such specified section of part 164 of title 45, Code of Federal Regulations (or any successor section).</text>
</paragraph>
</section>
<section id="H169432CB35DB4CB6B9CF1B759A9CC581">
<enum>13442.</enum>
<header>Defining health data research as part of health care operations</header>
<subsection id="HD6A0F7D73EC04DC3B84DE45441DD931B">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Subject to subsection (b), the Secretary shall revise or clarify the Rule to allow the use and disclosure of protected health information by a covered entity for research purposes, including studies whose purpose is to obtain generalizable knowledge, to be treated as the use and disclosure of such information for health care operations described in subparagraph (1) of the definition of health care operations in section 164.501 of part 164.</text>
</subsection>
<subsection id="H14CABE11EFF54E9183F116E362FB73C6">
<enum>(b)</enum>
<header>Modifications to rules for disclosures for health care operations</header>
<text display-inline="yes-display-inline">In applying section 164.506 of part 164 to the disclosure of protected health information described in subsection (a)—</text>
<paragraph id="H9F95757AD5CB410C9AEE63A9C924F302">
<enum>(1)</enum>
<text>the Secretary shall revise or clarify the Rule so that the disclosure may be made by the covered entity to only—</text>
<subparagraph id="HFE363082A32C4B2E9EFDBB71241AED48">
<enum>(A)</enum>
<text>another covered entity for health care operations (as defined in section 164.501 of part 164);</text>
</subparagraph>
<subparagraph id="HB6D53ABC9523467D83C803E4D40EDCDF">
<enum>(B)</enum>
<text display-inline="yes-display-inline">a business associate that has entered into a contract under section 164.504(e) of part 164 with a disclosing covered entity to perform health care operations; or</text>
</subparagraph>
<subparagraph id="H67CD480839C845C6A18BB9DE2F0FC8C2">
<enum>(C)</enum>
<text display-inline="yes-display-inline">a business associate that has entered into a contract under section 164.504(e) of part 164 for the purpose of data aggregation (as defined in section 164.501 of part 164); and</text>
</subparagraph>
</paragraph>
<paragraph id="H2141A466A5A74F4181593D029EFE2913">
<enum>(2)</enum>
<text>the Secretary shall further revise or clarify the Rule so that the limitation specified by section 164.506(c)(4) of part 164 does not apply to disclosures that are described by subsection (a).</text>
</paragraph>
</subsection>
<subsection id="HCD1060AFE1B0420F90E06B5D135DC36F">
<enum>(c)</enum>
<header>Rule of construction</header>
<text display-inline="yes-display-inline">This section shall not be construed as prohibiting or restricting a use or disclosure of protected health information for research purposes that is otherwise permitted under part 164.</text>
</subsection>
</section>
<section id="H0EC103B563CF47EA923CEF68A7AB858E">
<enum>13443.</enum>
<header>Treating disclosures of protected health information for research similarly to disclosures of such information for public health purposes</header>
<subsection id="H3E387AEBEDA747F4ABED0C9B6CBC707B">
<enum>(a)</enum>
<header>Remuneration</header>
<text display-inline="yes-display-inline">The Secretary shall revise or clarify the Rule so that disclosures of protected health information for research purposes are not subject to the limitation on remuneration described in section 164.502(a)(5)(ii)(B)(2)(ii) of part 164.</text>
</subsection>
<subsection id="H54799A15CB9D4D459A216A990ADF4F83">
<enum>(b)</enum>
<header>Permitted uses and disclosures</header>
<text display-inline="yes-display-inline">The Secretary shall revise or clarify the Rule so that research activities, including comparative research activities, related to the quality, safety, or effectiveness of a product or activity that is regulated by the Food and Drug Administration are included as public health activities for purposes of which a covered entity may disclose protected health information to a person described in section 164.512(b)(1)(iii) of part 164.</text>
</subsection>
</section>
<section id="H88655C9CB2A442B687E99BE2147946CC">
<enum>13444.</enum>
<header>Permitting remote access to protected health information by researchers</header>
<text display-inline="no-display-inline">The Secretary shall revise or clarify the Rule so that subparagraph (B) of section 164.512(i)(1)(ii) of part 164 (prohibiting the removal of protected health information by a researcher) does not prohibit remote access to health information by a researcher so long as—</text>
<paragraph id="H1A7AADB14DD5468E894371BB1B63E871">
<enum>(1)</enum>
<text display-inline="yes-display-inline">appropriate security and privacy safeguards are maintained by the covered entity and the researcher; and</text>
</paragraph>
<paragraph id="HADB26F9029A94AEBB587B7BE11EF3262">
<enum>(2)</enum>
<text>the protected health information is not copied or otherwise retained by the researcher.</text>
</paragraph>
</section>
<section id="HD40F4A677C2445AC9351BCA2737C71FE">
<enum>13445.</enum>
<header>Allowing one-time authorization of use and disclosure of protected health information for research purposes</header>
<subsection id="HFB062DB9356648219F8B9A9901D76095">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall revise or clarify the Rule to specify that an authorization for the use or disclosure of protected health information, with respect to an individual, for future research purposes shall be deemed to contain a sufficient description of the purpose of the use or disclosure if the authorization—</text>
<paragraph id="HFA51C93EFD3945E5915EBD87312E4A1A">
<enum>(1)</enum>
<text>sufficiently describes the purposes such that it would be reasonable for the individual to expect that the protected health information could be used or disclosed for such future research;</text>
</paragraph>
<paragraph id="H8F4EBA672D884FA39DF70C0A09B531AE">
<enum>(2)</enum>
<text>either—</text>
<subparagraph id="H28A49D7A67804B17B0645D95AFB5B816">
<enum>(A)</enum>
<text display-inline="yes-display-inline">states that the authorization will expire on a particular date or on the occurrence of a particular event; or</text>
</subparagraph>
<subparagraph id="H8384541C8EBF40D8B9A9FBA7AE6F7763">
<enum>(B)</enum>
<text>states that the authorization will remain valid unless and until it is revoked by the individual; and</text>
</subparagraph>
</paragraph>
<paragraph id="H5223CED2A1FF4C768A8441C18D1229D3">
<enum>(3)</enum>
<text>provides instruction to the individual on how to revoke such authorization at any time.</text>
</paragraph>
</subsection>
<subsection id="HAF7B7AC08DB8486793F8944272936B94">
<enum>(b)</enum>
<header>Revocation of authorization</header>
<text display-inline="yes-display-inline">The Secretary shall revise or clarify the Rule to specify that, if an individual revokes an authorization for future research purposes such as is described by subsection (a), the covered entity may not make any further uses or disclosures based on that authorization, except, as provided in paragraph (b)(5) of section 164.508 of part 164, to the extent that the covered entity has taken action in reliance on the authorization.</text>
</subsection>
</section>
</part>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="HA8CD2F18D24D4347B4ACEB59F1B999A6" indent="up1">
<enum>(2)</enum>
<text display-inline="yes-display-inline">The table of sections in section 13001(b) of such Act is amended by adding at the end of the items relating to subtitle D the following new items:</text>
<quoted-block style="OLC" id="H89E306AB4F114003B64722BE5F16999C" display-inline="no-display-inline">
<toc container-level="part-container" quoted-block="no-quoted-block" lowest-level="section" idref="HD50D51D8E26347BD81AE166E60D2A9FD" regeneration="yes-regeneration" lowest-bolded-level="division-lowest-bolded">
<toc-entry level="part">Part 4—Accessing, Sharing, and Using Health Data for Research Purposes</toc-entry>
<toc-entry idref="H4B6AF215957344BE9035D4A5336E7207" level="section">Sec. 13441. References.</toc-entry>
<toc-entry idref="H169432CB35DB4CB6B9CF1B759A9CC581" level="section">Sec. 13442. Defining health data research as part of health care operations.</toc-entry>
<toc-entry idref="H0EC103B563CF47EA923CEF68A7AB858E" level="section">Sec. 13443. Treating disclosures of protected health information for research similarly to disclosures of such information for public health purposes.</toc-entry>
<toc-entry idref="H88655C9CB2A442B687E99BE2147946CC" level="section">Sec. 13444. Permitting remote access to protected health information by researchers.</toc-entry>
<toc-entry idref="HD40F4A677C2445AC9351BCA2737C71FE" level="section">Sec. 13445. Allowing one-time authorization of use and disclosure of protected health information for research purposes.</toc-entry>
</toc>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="H6E372F2AE6304251AFAAAA51CED905C3" commented="no">
<enum>(b)</enum>
<header>Revision of regulations</header>
<text display-inline="yes-display-inline">Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall revise and clarify the provisions of title 45, Code of Federal Regulations, for consistency with part 4 of subtitle D of the HITECH Act, as added by subsection (a).</text>
</subsection>
</section>
</subtitle>
<subtitle id="HC4B5061ED60E463687234B5C9E9F3CD9">
<enum>H</enum>
<header>Council for 21st Century Cures</header>
<section id="HA7F0859473D449C18343CE4DE01EDF89" section-type="subsequent-section">
<enum>1141.</enum>
<header>Council for 21st Century Cures</header>
<text display-inline="no-display-inline">Title II of the Public Health Service Act (42 U.S.C. 202 et seq.) is amended by adding at the end the following: </text>
<quoted-block style="OLC" id="HDBFC5EC3652D4B9C82DE42ABFF5AB42E" display-inline="no-display-inline">
<part id="HD6DF8CE5321B4BEEB8EB03A4ED9E398B">
<enum>E</enum>
<header>Council for 21st Century Cures</header>
<section id="H2594584748994F58AFD296EFDFEEB2C4">
<enum>281.</enum>
<header>Establishment</header>
<text display-inline="no-display-inline">A nonprofit corporation to be known as the Council for 21st Century Cures (referred to in this part as the <quote>Council</quote>) shall be established in accordance with this section. The Council shall be a public-private partnership headed by an Executive Director (referred to in this part as the <quote>Executive Director</quote>), appointed by the members of the Board of Directors. The Council shall not be an agency or instrumentality of the United States Government. </text>
</section>
<section id="H863485177098466087E11FD8A82BA0E4">
<enum>281A.</enum>
<header>Purpose</header>
<text display-inline="no-display-inline">The purpose of the Council is to accelerate the discovery, development, and delivery in the United States of innovative cures, treatments, and preventive measures for patients.</text>
</section>
<section id="H8B972A373B5F44859B0080822EF1D12E">
<enum>281B.</enum>
<header>Duties</header>
<text display-inline="no-display-inline">For the purpose described in section 281A, the Council shall—</text>
<paragraph id="HE58B9D3540E24E66BB9D8A290011CD00">
<enum>(1)</enum>
<text display-inline="yes-display-inline">foster collaboration and coordination among the entities that comprise the Council, including academia, government agencies, industry, health care payors and providers, patient advocates, and others engaged in the cycle of discovery, development, and delivery of life-saving and health-enhancing innovative interventions;</text>
</paragraph>
<paragraph id="HAA6E0F7013C2456CB45967C5F023CF2C">
<enum>(2)</enum>
<text>undertake communication and dissemination activities;</text>
</paragraph>
<paragraph id="H07F8F2B6A4F746BD8E80BB46BCF15F46">
<enum>(3)</enum>
<text>publish information on the activities funded under section 281D;</text>
</paragraph>
<paragraph id="H18EFD5DDEB7849FBBB9D048A79D6E37D">
<enum>(4)</enum>
<text display-inline="yes-display-inline">establish a strategic agenda for accelerating the discovery, development, and delivery in the United States of innovative cures, treatments, and preventive measures for patients;</text>
</paragraph>
<paragraph id="H9CBF21F738634B068CBA3A51B6911C3A">
<enum>(5)</enum>
<text>identify gaps and opportunities within and across the discovery, development, and delivery cycle;</text>
</paragraph>
<paragraph id="HB16E7277BE7D420993CABBAF7CDE74A7">
<enum>(6)</enum>
<text>develop and propose recommendations based on the gaps and opportunities so identified; </text>
</paragraph>
<paragraph id="H668D3A117ECC4E0EA66645886338F54A">
<enum>(7)</enum>
<text>facilitate the interoperability of the components of the discovery, development, and delivery cycle;</text>
</paragraph>
<paragraph id="HAD96F4EC778F40F08AD8D789DBCE30A1">
<enum>(8)</enum>
<text>propose recommendations that will facilitate precompetitive collaboration; </text>
</paragraph>
<paragraph id="H91A5FF405A30401796D8F0FEE1D21DE7">
<enum>(9)</enum>
<text>identify opportunities to work with, but not duplicate the efforts of, nonprofit organizations and other public-private partnerships; and</text>
</paragraph>
<paragraph id="H196EF8C55E4D4D3385013882747FCAD5">
<enum>(10)</enum>
<text>identify opportunities for collaboration with organizations operating outside of the United States, such as the Innovative Medicines Initiative of the European Union.</text>
</paragraph>
</section>
<section id="HFAECF384ABE74D8C8A2128200E5B3F55">
<enum>281C.</enum>
<header>Organization; administration</header>
<subsection id="HE29FD70662FB46B7B730AC3116F68A5C">
<enum>(a)</enum>
<header>Board of directors</header>
<paragraph id="HF9E6DB08A3CC4E639607926C8E921F11">
<enum>(1)</enum>
<header>Establishment</header>
<subparagraph id="HA9B905EC71B04D2A8805AD9314A52546">
<enum>(A)</enum>
<header>In general</header>
<text>The Council shall have a Board of Directors (in this part referred to as the <quote>Board of Directors</quote>), which shall be composed of the ex officio members under subparagraph (B) and the appointed members under subparagraph (C). All members of the Board shall be voting members.</text>
</subparagraph>
<subparagraph id="HA2971C6E9151494A984195CC66B25628">
<enum>(B)</enum>
<header>Ex officio members</header>
<text>The ex officio members of the Board shall be the following individuals or their designees:</text>
<clause id="H3401B7DAFE3244519BFBA70E4102C4CF">
<enum>(i)</enum>
<text>The Director of the National Institutes of Health.</text>
</clause>
<clause id="HFCD9424ACDAF46F3B496C6300D50803A">
<enum>(ii)</enum>
<text>The Commissioner of Food and Drugs.</text>
</clause>
<clause id="H9EC3A8984B204EE7B315134FEC1B803C">
<enum>(iii)</enum>
<text>The Administrator of the Centers for Medicare & Medicaid Services.</text>
</clause>
<clause id="HC8EABA94F14F4661BF9A9A0708DE7736">
<enum>(iv)</enum>
<text display-inline="yes-display-inline">The heads of five other Federal agencies deemed by the Secretary to be engaged in biomedical research and development.</text>
</clause>
</subparagraph>
<subparagraph id="HEE5BCC582E4A41A282A112188EE528FA">
<enum>(C)</enum>
<header>Appointed members</header>
<text display-inline="yes-display-inline">The appointed members of the Board shall consist of 17 individuals, of whom—</text>
<clause id="H3232A6EE679843EDB1F8309D3A5CDF3B">
<enum>(i)</enum>
<text display-inline="yes-display-inline">8 shall be appointed by the Comptroller General of the United States from a list of nominations submitted by leading trade associations—</text>
<subclause id="HDF0362C25B21418F80A809DAB841055E">
<enum>(I)</enum>
<text>4 of whom shall be representatives of the biopharmaceutical industry;</text>
</subclause>
<subclause id="H1C89DCE2716F49318480C07A3A57833A">
<enum>(II)</enum>
<text>2 of whom shall be representatives of the medical device industry; and</text>
</subclause>
<subclause id="H383B4088585949A6A492377F927D7CB3">
<enum>(III)</enum>
<text>2 of whom shall be representatives of the information and digital technology industry; and</text>
</subclause>
</clause>
<clause id="HFDB226A124334BF995B3D81D1A5DD2E1">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">9 shall be appointed by the Comptroller General of the United States, after soliciting nominations—</text>
<subclause id="H850437ED72E84F9098AA0D008E868CC2">
<enum>(I)</enum>
<text>2 of whom shall be representatives of academic researchers;</text>
</subclause>
<subclause id="H269AE36B77254941AE4BEF10C2309C3B">
<enum>(II)</enum>
<text>3 of whom shall be representatives of patients;</text>
</subclause>
<subclause id="H4936EC6514414734B1026EF7AA6A7E93">
<enum>(III)</enum>
<text>2 of whom shall be representatives of health care providers; and</text>
</subclause>
<subclause id="H1FB0A050B0904131A15AEC4A14D17239">
<enum>(IV)</enum>
<text>2 of whom shall be representatives of health care plans and insurers.</text>
</subclause>
</clause>
</subparagraph>
<subparagraph id="H0FE482685A2C430CA6E3133684A7C979">
<enum>(D)</enum>
<header>Chair</header>
<text display-inline="yes-display-inline">The Chair of the Board shall be selected by the members of the Board by majority vote from among the members of the Board.</text>
</subparagraph>
</paragraph>
<paragraph id="H83761CA6BC3547F2B2104186024BAA89">
<enum>(2)</enum>
<header>Terms and vacancies</header>
<subparagraph id="H8D83D714D15A49C2BADD43FA0D11E82A">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The term of office of each member of the Board appointed under paragraph (1)(C) shall be 5 years.</text>
</subparagraph>
<subparagraph id="H83703ED5F2914AD0A88D3A3E0C4683B4">
<enum>(B)</enum>
<header>Vacancy</header>
<text display-inline="yes-display-inline">Any vacancy in the membership of the Board—</text>
<clause id="H805A3F6FF7E248338F521B0D04CC19E8">
<enum>(i)</enum>
<text>shall not affect the power of the remaining members to execute the duties of the Board; and </text>
</clause>
<clause id="HA76DFDEA318445D9B5E19B5A3319D465">
<enum>(ii)</enum>
<text>shall be filled by appointment by the appointed members described in paragraph (1)(C) by majority vote. </text>
</clause>
</subparagraph>
<subparagraph id="H91E24172D4D241D3AD0FEC5DCA0CD44C">
<enum>(C)</enum>
<header>Partial term</header>
<text display-inline="yes-display-inline">If a member of the Board does not serve the full term applicable under subparagraph (A), the individual appointed under subparagraph (B) to fill the resulting vacancy shall be appointed for the remainder of the term of the predecessor of the individual.</text>
</subparagraph>
</paragraph>
<paragraph id="HE096A62F474448CEACA1C8EACE7591FD">
<enum>(3)</enum>
<header>Responsibilities</header>
<text display-inline="yes-display-inline">Not later than 90 days after the date on which the Council is incorporated and its Board of Directors is fully constituted, the Board of Directors shall establish bylaws and policies for the Council that—</text>
<subparagraph id="HEF22BF81A94148A0A23FC67DC3DEFA54">
<enum>(A)</enum>
<text display-inline="yes-display-inline">are published in the Federal Register and available for public comment;</text>
</subparagraph>
<subparagraph id="H68A33FAA4809422F9FEC91DF96E29197">
<enum>(B)</enum>
<text>establish policies for the selection and, as applicable, appointment of—</text>
<clause id="H55A685A0AAC34A15AB25A59D3278527F">
<enum>(i)</enum>
<text display-inline="yes-display-inline">the officers, employees, agents, and contractors of the Council; and</text>
</clause>
<clause id="H522658CA81A14883B998612B810758E5">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">the members of any committees of the Council;</text>
</clause>
</subparagraph>
<subparagraph id="HCA8F6DED9C674093BE4AECF2807C8ED8">
<enum>(C)</enum>
<text display-inline="yes-display-inline">establish policies, including ethical standards, for the conduct of programs and other activities under section 281D; and</text>
</subparagraph>
<subparagraph id="H13347FFBE7894A28A5F8F48F37E782BB">
<enum>(D)</enum>
<text>establish specific duties of the Executive Director.</text>
</subparagraph>
</paragraph>
<paragraph id="H06B850362F4D40FD95B655D70AB91420">
<enum>(4)</enum>
<header>Meetings</header>
<subparagraph id="H1CE1277627C64C6EA475358996C79CED">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Board of Directors shall—</text>
<clause id="H155EE9715ADC4CEA960B4DAC5075CC3F">
<enum>(i)</enum>
<text>meet on a quarterly basis; and</text>
</clause>
<clause id="HCCA671C2D5134A19823465CE8D464113">
<enum>(ii)</enum>
<text>submit to Congress, and make publicly available, the minutes of such meetings. </text>
</clause>
</subparagraph>
<subparagraph id="H657AF9B00B274FB199E889133928C135">
<enum>(B)</enum>
<header>Agenda</header>
<text display-inline="yes-display-inline">The Board of Directors shall, not later than 3 months after the incorporation of the Council—</text>
<clause id="HC9A962197B90433180ED5B4FB22D7A77">
<enum>(i)</enum>
<text>issue an agenda (in this part referred to as the <quote>agenda</quote>) outlining how the Council will achieve the purpose described in section 281A; and</text>
</clause>
<clause id="H1BCCD89396164A599BF9BA60A94F1CA0">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">annually thereafter, in consultation with the Executive Director, review and update such agenda.</text>
</clause>
</subparagraph>
</paragraph>
</subsection>
<subsection id="HD8E135B1E73A46A99CA1AC8E5AE8460C">
<enum>(b)</enum>
<header>Appointment and incorporation</header>
<text display-inline="yes-display-inline">Not later than 6 months after the date of enactment of the <short-title>21st Century Cures Act</short-title>—</text>
<paragraph id="H2D919A55902F4EBD93CDE6EE3132631D">
<enum>(1)</enum>
<text>the Comptroller General of the United States shall appoint the appointed members of the Board of Directors under subsection (a)(1)(C); and</text>
</paragraph>
<paragraph id="HBB693A265C3341FB8CE7735B7C75756A">
<enum>(2)</enum>
<text>the ex officio members of the Board of Directors under subsection (a)(1)(B) shall serve as incorporators and shall take whatever actions are necessary to incorporate the Council.</text>
</paragraph>
</subsection>
<subsection id="H94E058E8804340558CE8B68B902730C6">
<enum>(c)</enum>
<header>Nonprofit Status</header>
<text display-inline="yes-display-inline">In carrying out this part, the Board of Directors shall establish such policies and bylaws, and the Executive Director shall carry out such activities, as may be necessary to ensure that the Council maintains status as an organization that—</text>
<paragraph id="H16CFD5A24B0046BA8999461B5A7312AB">
<enum>(1)</enum>
<text>is described in subsection (c)(3) of section 501 of the Internal Revenue Code of 1986; and</text>
</paragraph>
<paragraph id="H6FDE8FB03BB14456BE3EB08150910864">
<enum>(2)</enum>
<text>is, under subsection (a) of such section, exempt from taxation.</text>
</paragraph>
</subsection>
<subsection id="H184361D463934F65A889077D523F679B">
<enum>(d)</enum>
<header>Executive Director</header>
<text display-inline="yes-display-inline">The Executive Director shall—</text>
<paragraph id="H9EAA9ACE5D65435E893FAD01FB7148BA">
<enum>(1)</enum>
<text display-inline="yes-display-inline">be the chief executive officer of the Council; and</text>
</paragraph>
<paragraph id="H5F4D21ED231B4F9E821B79DD1200B571">
<enum>(2)</enum>
<text display-inline="yes-display-inline">subject to the oversight of the Board of Directors, be responsible for the day-to-day management of the Council.</text>
</paragraph>
</subsection>
</section>
<section id="H86296DA92D0D4864B84E4EE95D2DFC00">
<enum>281D.</enum>
<header> Operational activities and assistance</header>
<subsection id="H4F9A1497CAF24E569B06F60D1DBD0DFB">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Council shall establish a sufficient operational infrastructure to fulfill the duties specified in section 281B.</text>
</subsection>
<subsection id="H94B8D1B61C034058A15E79F9EE2F9268" display-inline="no-display-inline">
<enum>(b)</enum>
<header>Private sector matching funds</header>
<text>The Council may accept financial or in-kind support from participating entities or private foundations or organizations when such support is deemed appropriate.</text>
</subsection>
</section>
<section id="H7CA6328F25034FC89CB223F9FFF309DE">
<enum>281E.</enum>
<header>Termination; report</header>
<subsection id="HBD122902CC934FE2A19DB842D15597DE">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Council shall terminate on September 30, 2023.</text>
</subsection>
<subsection id="H1FE71AD2D64C4EBB97D578D607C75889">
<enum>(b)</enum>
<header>Report</header>
<text display-inline="yes-display-inline">Not later than one year after the date on which the Council is established and each year thereafter, the Executive Director shall submit to the appropriate congressional committees a report on the performance of the Council. In preparing such report, the Council shall consult with a nongovernmental consultant with appropriate expertise.</text>
</subsection>
</section>
<section id="HA5C2A0665A644CE8B03A997A5ADCE55F">
<enum>281F.</enum>
<header>Funding</header>
<text display-inline="no-display-inline">For the each of fiscal years 2016 through 2023, there is authorized to be appropriated $10,000,000 to the Council for purposes of carrying out the duties of the Council under this part.</text>
</section>
</part>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
</subtitle>
<enum>II</enum>
<header>Development</header>
<subtitle id="HA5F6CD7A438C4E4CB5CBBE74F509EB8F">
<enum>A</enum>
<header>Patient-Focused Drug Development</header>
<section id="HB6F0C9A45A9E4A76B5F1CC1C4CD6DC1B">
<enum>2001.</enum>
<header>Development and use of patient experience data to enhance structured risk-benefit assessment framework</header>
<subsection id="HF838218E7372463DB446731043719E43">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended—</text>
<paragraph id="H8C9D54EF58A6467593FF60202DBACC2E">
<enum>(1)</enum>
<text>in subsection (d), by striking <quote>The Secretary shall implement</quote> and all that follows through <quote>premarket approval of a drug.</quote>; and</text>
</paragraph>
<paragraph id="HB575C0B21AC14376B1C5B5B6539E7886">
<enum>(2)</enum>
<text>by adding at the end the following new subsections:</text>
<quoted-block style="OLC" id="H621B898599854788806DB64ABE147E7D" display-inline="no-display-inline">
<subsection id="H4F4D0D2380D540BBA0426C6F14B74198">
<enum>(x)</enum>
<header>Structured risk-Benefit assessment framework</header>
<paragraph id="H740E6FC879D04596B1E311A6E6101EFF">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall implement a structured risk-benefit assessment framework in the new drug approval process—</text>
<subparagraph id="HC61BBE036C144E50864AEB53737278C8">
<enum>(A)</enum>
<text>to facilitate the balanced consideration of benefits and risks; and</text>
</subparagraph>
<subparagraph id="H3360777C54694348946845B0327FDE25">
<enum>(B)</enum>
<text>to develop and implement a consistent and systematic approach to the discussion of, regulatory decisionmaking with respect to, and the communication of, the benefits and risks of new drugs.</text>
</subparagraph>
</paragraph>
<paragraph id="HDE2F8E389B964F1A9E62954CA0D3CD93">
<enum>(2)</enum>
<header>Rule of construction</header>
<text>Nothing in paragraph (1) shall alter the criteria for evaluating an application for premarket approval of a drug.</text>
</paragraph>
</subsection>
<subsection id="H8C37DB8909EA4D21BC5F0DEE01241213">
<enum>(y)</enum>
<header>Development and use of patient experience data To enhance structured risk-Benefit assessment framework</header>
<paragraph id="HBEB756281BBF432093CA2361015009A5">
<enum>(1)</enum>
<header>In general</header>
<text>Not later than two years after the date of the enactment of this subsection, the Secretary shall establish and implement processes under which—</text>
<subparagraph id="H3E5676093F4E4ECA90EA234CCA302CFA">
<enum>(A)</enum>
<text display-inline="yes-display-inline">an entity seeking to develop patient experience data may submit to the Secretary—</text>
<clause id="HCC7578CB24774D4D8BEEB5E123DDFECD">
<enum>(i)</enum>
<text>initial research concepts for feedback from the Secretary; and</text>
</clause>
<clause id="H496F9BCD88ED4D2D85C28A10E9907C29">
<enum>(ii)</enum>
<text>with respect to patient experience data collected by the entity, draft guidance documents, completed data, and summaries and analyses of such data;</text>
</clause>
</subparagraph>
<subparagraph id="H1DF0846EB0444CAC883608E5CAF43C37">
<enum>(B)</enum>
<text>the Secretary may request such an entity to submit such documents, data, and summaries and analyses; and</text>
</subparagraph>
<subparagraph id="H0AFB048475554F1688C868442CFF48CF">
<enum>(C)</enum>
<text>patient experience data may be developed and used to enhance the structured risk-benefit assessment framework under subsection (x).</text>
</subparagraph>
</paragraph>
<paragraph id="H306049C814F542359927319515E3A3BA">
<enum>(2)</enum>
<header>Patient experience data</header>
<text display-inline="yes-display-inline">In this subsection, the term <quote>patient experience data</quote> means data collected by patients, parents, caregivers, patient advocacy organizations, disease research foundations, medical researchers, research sponsors, or other parties determined appropriate by the Secretary that is intended to facilitate or enhance the Secretary’s risk-benefit assessments, including information about the impact of a disease or a therapy on patients’ lives.</text>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="HEBC2DCF6C68D467C850FF5D829573C83">
<enum>(b)</enum>
<header>Guidance</header>
<paragraph id="H1104AD2BE9B945519C53E880EA51AC8D">
<enum>(1)</enum>
<header>In general</header>
<text>The Secretary of Health and Human Services shall publish guidance on the implementation of subsection (y) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as added by subsection (a). Such guidance shall include—</text>
<subparagraph id="HFA8B2C57D126423FB306741364DD3576">
<enum>(A)</enum>
<text display-inline="yes-display-inline">with respect to draft guidance documents, data, or summaries and analyses submitted to the Secretary under paragraph (1)(A) of such subsection, guidance—</text>
<clause id="H67FCF3C5A7544CFEB5471C87717587BD">
<enum>(i)</enum>
<text display-inline="yes-display-inline">specifying the timelines for the review of such documents, data, or summaries and analyses by the Secretary; and</text>
</clause>
<clause id="H435A9B06D2DB4354868D7AB86C5042D6">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">on how the Secretary will use such documents, data, or summaries and analyses to update any guidance documents published under this subsection or publish new guidance;</text>
</clause>
</subparagraph>
<subparagraph id="H2D5B8B328EFA463CAF80498BF27EAF80">
<enum>(B)</enum>
<text display-inline="yes-display-inline">with respect to the collection and analysis of patient experience data (as defined in paragraph (2) of such subsection (y)), guidance on—</text>
<clause id="H14FB2CE00435404DB79BF677D57B8050">
<enum>(i)</enum>
<text display-inline="yes-display-inline">methodological considerations for the collection of patient experience data, which may include structured approaches to gathering information on—</text>
<subclause id="H92FAA9E97D4E42F69E08E9685433B673">
<enum>(I)</enum>
<text display-inline="yes-display-inline">the experience of a patient living with a particular disease;</text>
</subclause>
<subclause id="HC4519E7F3D8D43D083180CF844283083">
<enum>(II)</enum>
<text display-inline="yes-display-inline">the burden of living with or managing the disease;</text>
</subclause>
<subclause id="HBA86799BA3C54048B6ED7562C063B8CA">
<enum>(III)</enum>
<text>the impact of the disease on daily life and long-term functioning; and</text>
</subclause>
<subclause id="H5A494C2ECE4C46BA9F546F13C1C6D2FA">
<enum>(IV)</enum>
<text>the effect of current therapeutic options on different aspects of the disease; and</text>
</subclause>
</clause>
<clause id="HE2D3887A2E8D4D77845FFD608CF3669A">
<enum>(ii)</enum>
<text>the establishment and maintenance of registries designed to increase understanding of the natural history of a disease;</text>
</clause>
</subparagraph>
<subparagraph id="H50B565BED4964E939868F22E4E11A496">
<enum>(C)</enum>
<text display-inline="yes-display-inline">methodological approaches that may be used to assess patients’ beliefs with respect to the benefits and risks in the management of the patient’s disease; and </text>
</subparagraph>
<subparagraph id="H220F851E61E9449DBEE24C5AC58212AB">
<enum>(D)</enum>
<text>methodologies, standards, and potential experimental designs for patient-reported outcomes.</text>
</subparagraph>
</paragraph>
<paragraph id="H7BC3DF9ED62141798B58B942652BB085">
<enum>(2)</enum>
<header>Timing</header>
<text display-inline="yes-display-inline">Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance on the implementation of subsection (y) of section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as added by subsection (a). The Secretary shall issue final guidance on the implementation of such subsection not later than one year after the date on which the comment period for the draft guidance closes. </text>
</paragraph>
<paragraph id="H6E73D939DAFF41158B3D6D7CC79C90B9">
<enum>(3)</enum>
<header>Workshops</header>
<subparagraph id="H7024BB1F53134886A31E0BA75ABF8406">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Not later than 6 months after the date of the enactment of this Act and once every 6 months during the following 12-month period, the Secretary of Health and Human Services shall convene a workshop to obtain input regarding methodologies for developing the guidance under paragraph (1), including the collection of patient experience data. </text>
</subparagraph>
<subparagraph id="H7546A2CFB83E497384A51B77D71811F7">
<enum>(B)</enum>
<header>Attendees</header>
<text>A workshop convened under this paragraph shall include—</text>
<clause id="HF448FD67B9944238904C66F10F5E245B">
<enum>(i)</enum>
<text>patients;</text>
</clause>
<clause id="H87BF8D60CB324340BD4B8B2B0EAAC559">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">representatives from patient advocacy organizations, biopharmaceutical companies, and disease research foundations;</text>
</clause>
<clause id="HFB7EDBB2ABE74D6A9B746E8A8220BF04">
<enum>(iii)</enum>
<text>representatives of the reviewing divisions of the Food and Drug Administration; and</text>
</clause>
<clause id="H2EBD1BF6745844AFB4D72B463D54C11D">
<enum>(iv)</enum>
<text>methodological experts with significant expertise in patient experience data.</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="HF93B66086DBB44A585D5BEA610866949">
<enum>(4)</enum>
<header>Public meeting</header>
<text display-inline="yes-display-inline">Not later than 90 days after the date on which the draft guidance is published under this subsection, the Secretary of Health and Human Services shall convene a public meeting to solicit input on the guidance.</text>
</paragraph>
</subsection>
</section>
</subtitle>
<subtitle id="H5811E4FEC35246D3A3D492CAC2CC827E" commented="no">
<enum>B</enum>
<header>Qualification and Use of Drug Development Tools</header>
<section id="HB4696D64FAC64D9788E74A5445169967" section-type="subsequent-section" commented="no">
<enum>2021.</enum>
<header>Qualification of drug development tools</header>
<subsection id="HBDC3161A48244424AEA6B5C9DFC2DCE6" commented="no">
<enum>(a)</enum>
<header>Findings</header>
<text display-inline="yes-display-inline">Congress finds the following:</text>
<paragraph id="H12B13087643C40FEA6C4D113E873A3F4" commented="no">
<enum>(1)</enum>
<text display-inline="yes-display-inline">Development of new drugs has become increasingly challenging and resource intensive. </text>
</paragraph>
<paragraph id="HC23EAD1DDDA449BB8944004EA1844C16" commented="no">
<enum>(2)</enum>
<text>Development of drug development tools can benefit the availability of new medical therapies by helping to translate scientific discoveries into clinical applications.</text>
</paragraph>
<paragraph id="H588A40AA68D041E885AC5A8498D73DB8" commented="no">
<enum>(3)</enum>
<text>Biomedical research consortia (as defined in section 507(f) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c)) can play a valuable role in helping to develop and qualify drug development tools.</text>
</paragraph>
</subsection>
<subsection id="H1D9A6D25AFC0452DA6FB01635B4CD038" commented="no">
<enum>(b)</enum>
<header>Sense of Congress</header>
<text display-inline="yes-display-inline">It is the sense of Congress that—</text>
<paragraph id="H3CC74F29CEC94B01A4146B284DE9E8AA" commented="no">
<enum>(1)</enum>
<text>Congress should promote and facilitate a collaborative effort among the biomedical research consortia described in subsection (a)(3)— </text>
<subparagraph id="HD3580500E62E41F88BE6D1BFCB9B5F2C" commented="no">
<enum>(A)</enum>
<text>to develop, through a transparent public process, data standards and scientific approaches to data collection accepted by the medical and clinical research community for purposes of qualifying drug development tools; </text>
</subparagraph>
<subparagraph id="HB134929E817A4B8B94419D4FD3735F36" commented="no">
<enum>(B)</enum>
<text>to coordinate efforts toward developing and qualifying drug development tools in key therapeutic areas; and </text>
</subparagraph>
<subparagraph id="H7EE017D116694F90BE5263FBA90851C7" commented="no">
<enum>(C)</enum>
<text>to encourage the development of accessible databases for collecting relevant drug development tool data for such purposes; and</text>
</subparagraph>
</paragraph>
<paragraph id="H8C9470D2F8F942C19D269FA5FD0D259E" commented="no">
<enum>(2)</enum>
<text display-inline="yes-display-inline">an entity seeking to qualify a drug development tool should be encouraged, in addition to consultation with the Secretary, to consult with biomedical research consortia and other individuals and entities with expert knowledge and insights that may assist the requestor and benefit the process for such qualification. </text>
</paragraph>
</subsection>
<subsection id="H99289452CE1A43BB91BFB0AC4E86FF5F" commented="no">
<enum>(c)</enum>
<header>Qualification of drug development tools</header>
<text display-inline="yes-display-inline">Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 506F the following new section: </text>
<quoted-block style="OLC" id="HF899B9FC26E74DDBB64CC05A0844D362" display-inline="no-display-inline">
<section id="H312E295AA0484A7BBF0C67C9F302828C" commented="no">
<enum>507.</enum>
<header>Qualification of drug development tools</header>
<subsection id="H82AA3C1C108E4B1B85CBF97FA8D457AD" commented="no">
<enum>(a)</enum>
<header>Process for qualification</header>
<paragraph id="H6672E4B44AA64B4DABCA152D36C48DE5" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall establish a process for the qualification of drug development tools for a proposed context of use under which—</text>
<subparagraph id="HF793E2ED7FEC44D99E2CC61993558123" commented="no">
<enum>(A)</enum>
<clause id="H98A1264B46CC4BF09277D1770AF265E7" display-inline="yes-display-inline" commented="no">
<enum>(i)</enum>
<text>a requestor initiates such process by submitting a letter of intent to the Secretary; and</text>
</clause>
<clause id="H6E14C6D86113424BA75B716660683810" indent="up1" commented="no">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">the Secretary accepts or declines to accept such letter of intent; </text>
</clause>
</subparagraph>
<subparagraph id="HD909000570F0488B8EFDC93C8FB41AED" commented="no">
<enum>(B)</enum>
<clause id="H885F4697CA384038BC2CFEEFD8104DD6" display-inline="yes-display-inline" commented="no">
<enum>(i)</enum>
<text>if the Secretary accepts the letter of intent, a requestor submits a qualification plan to the Secretary; and</text>
</clause>
<clause id="H3051B70BCE3C4DBC95C529C877646105" indent="up1" commented="no">
<enum>(ii)</enum>
<text>the Secretary accepts or declines to accept the qualification plan; and</text>
</clause>
</subparagraph>
<subparagraph id="H851CF95046844C57B169A853DDCC4A03" commented="no">
<enum>(C)</enum>
<clause id="H6CACA47BD67E4EB39B63A4D9F0D0885D" display-inline="yes-display-inline" commented="no">
<enum>(i)</enum>
<text>if the Secretary accepts the qualification plan, the requestor submits to the Secretary a full qualification package;</text>
</clause>
<clause id="H4AFDC4FF7EE24F35BAE5FFAA2B6C9458" indent="up1" commented="no">
<enum>(ii)</enum>
<text>the Secretary determines whether to accept such qualification package for review; and</text>
</clause>
<clause id="H19193E5B0C7E455AB3535B56B858D56C" indent="up1" commented="no">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">if the Secretary accepts such qualification package for review, the Secretary conducts such review in accordance with this section.</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H195E861C1BFA48528368BD919A220BD6" commented="no">
<enum>(2)</enum>
<header>Acceptance and review of submissions</header>
<subparagraph id="HA2E50D115BFE426CB1AD548D8CBAB155" commented="no">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The succeeding provisions of this paragraph shall apply with respect to the treatment of a letter of intent, a qualification plan, or a full qualification package submitted under paragraph (1) (referred to in this paragraph as <quote>qualification submissions</quote>).</text>
</subparagraph>
<subparagraph id="H8D09324A507C40E5B665D5EFB7B54024">
<enum>(B)</enum>
<header>Acceptance factors; nonacceptance</header>
<text display-inline="yes-display-inline">The Secretary shall determine whether to accept a qualification submission based on factors which may include the scientific merit of the submission and the available resources of the Food and Drug Administration to review the qualification submission. A determination not to accept a submission under paragraph (1) shall not be construed as a final determination by the Secretary under this section regarding the qualification of a drug development tool for its proposed context of use. </text>
</subparagraph>
<subparagraph id="H5C6B37B47FBC43559311C225195A3DA8" commented="no">
<enum>(C)</enum>
<header>Prioritization of qualification review</header>
<text>The Secretary may prioritize the review of a full qualification package submitted under paragraph (1) with respect to a drug development tool, based on factors determined appropriate by the Secretary, including— </text>
<clause id="H8EEA1240A7AB44C5910DD9C09A7B0157" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline">as applicable, the severity, rarity, or prevalence of the disease or condition targeted by the drug development tool and the availability or lack of alternative treatments for such disease or condition; and</text>
</clause>
<clause id="H5E5B675E958048A4B1362C37F1FFBB08" commented="no">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">the identification, by the Secretary or by biomedical research consortia and other expert stakeholders, of such a drug development tool and its proposed context of use as a public health priority.</text>
</clause>
</subparagraph>
<subparagraph id="H3593E30825DE4EC5B6861C110B96020B" commented="no">
<enum>(D)</enum>
<header>Engagement of external experts</header>
<text display-inline="yes-display-inline">The Secretary may, for purposes of the review of qualification submissions, through the use of cooperative agreements, grants, or other appropriate mechanisms, consult with biomedical research consortia and may consider the recommendations of such consortia with respect to the review of any qualification plan submitted under paragraph (1) or the review of any full qualification package under paragraph (3). </text>
</subparagraph>
</paragraph>
<paragraph id="HE8A0E889A3F64C65805D16CA73D53837" commented="no">
<enum>(3)</enum>
<header>Review of full qualification package</header>
<text>The Secretary shall—</text>
<subparagraph id="H941635FE361247DCAC6271933A1F8CA5" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">conduct a comprehensive review of a full qualification package accepted under paragraph (1)(C); and</text>
</subparagraph>
<subparagraph id="H7ED891F0AFB24D72AAF5A75F29C55945" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">determine whether the drug development tool at issue is qualified for its proposed context of use.</text>
</subparagraph>
</paragraph>
<paragraph id="H4CDF9B173A0D4775A7FF7C9CE1E104A8" commented="no">
<enum>(4)</enum>
<header>Qualification</header>
<text display-inline="yes-display-inline">The Secretary shall determine whether a drug development tool is qualified for a proposed context of use based on the scientific merit of a full qualification package reviewed under paragraph (3).</text>
</paragraph>
</subsection>
<subsection id="H99AA137A081E47B3B6A581FB049998E5" commented="no">
<enum>(b)</enum>
<header>Effect of qualification</header>
<paragraph id="HDB47E677E4464011B03F3228028D050C" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">A drug development tool determined to be qualified under subsection (a)(4) for a proposed context of use specified by the requestor may be used by any person in such context of use for the purposes described in paragraph (2).</text>
</paragraph>
<paragraph id="H2E72553DA0774D10B30F13F8C7FF8850" commented="no">
<enum>(2)</enum>
<header>Use of a drug development tool</header>
<text display-inline="yes-display-inline">Subject to paragraph (3), a drug development tool qualified under this section may be used for—</text>
<subparagraph id="H3914A2FB579F48CA82BDD1D139D48883" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">supporting or obtaining approval or licensure (as applicable) of a drug or biological product (including in accordance with section 506(c)) under section 505 of this Act or section 351 of the Public Health Service Act; or</text>
</subparagraph>
<subparagraph id="HE8BA1A347083471B97DE14AAF3C029D9" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">supporting the investigational use of a drug or biological product under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act.</text>
</subparagraph>
</paragraph>
<paragraph id="HB6348966C25D45A5B0F7E559AF29D45A" commented="no">
<enum>(3)</enum>
<header>Rescission or modification</header>
<subparagraph id="HABF6D709138D4899B32D54325B27EA10" commented="no">
<enum>(A)</enum>
<header>In general</header>
<text>The Secretary may rescind or modify a determination under this section to qualify a drug development tool if the Secretary determines that the drug development tool is not appropriate for the proposed context of use specified by the requestor. Such a determination may be based on new information that calls into question the basis for such qualification.</text>
</subparagraph>
<subparagraph id="H9FE1185FC4264334A871038FEE21E9A4" commented="no">
<enum>(B)</enum>
<header>Meeting for review</header>
<text display-inline="yes-display-inline">If the Secretary rescinds or modifies under subparagraph (A) a determination to qualify a drug development tool, the requestor involved shall, on request, be granted a meeting with the Secretary to discuss the basis of the Secretary’s decision to rescind or modify the determination before the effective date of the rescission or modification.</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="HB439C1BE2DE944C18CB6DE9D38C79F3C" commented="no">
<enum>(c)</enum>
<header>Transparency</header>
<paragraph id="H7612B004F0844196B9F3EF9CD97A4C3A" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Subject to paragraph (3), the Secretary shall make publicly available, and update on at least a biannual basis, on the Internet website of the Food and Drug Administration the following:</text>
<subparagraph id="HB9E749AB1A6A4E7F9CC32733B4FFE001" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">Information with respect to each qualification submission under the qualification process under subsection (a), including—</text>
<clause id="H4EFDFAB535274524B5E6EB22390A88D9" commented="no">
<enum>(i)</enum>
<text>the stage of the review process applicable to the submission;</text>
</clause>
<clause id="H3D611F8BEF534ACCA4114814EDBC989D" commented="no">
<enum>(ii)</enum>
<text>the date of the most recent change in stage status; </text>
</clause>
<clause id="H7EC1119749C745D491B045C3CFF8E58C" commented="no">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">whether the external scientific experts were utilized in the development of a qualification plan or the review of a full qualification package; and</text>
</clause>
<clause id="H55C58C2BEF014581B6BFB1A8C73CE31A">
<enum>(iv)</enum>
<text display-inline="yes-display-inline">submissions from requestors under the qualification process under subsection (a), including any data and evidence contained in such submissions, and any updates to such submissions.</text>
</clause>
</subparagraph>
<subparagraph id="H7EE22E6618674270810C458D4B6A3271" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">The Secretary’s formal written determinations in response to such qualification submissions.</text>
</subparagraph>
<subparagraph id="H4184544274744D778793286398C21D6F" commented="no">
<enum>(C)</enum>
<text>Any rescissions or modifications under subsection (b)(3) of a determination to qualify a drug development tool.</text>
</subparagraph>
<subparagraph id="H5A0DBD81311043AD9123840F9AAF876B" commented="no">
<enum>(D)</enum>
<text>Summary reviews that document conclusions and recommendations for determinations to qualify drug development tools under subsection (a).</text>
</subparagraph>
<subparagraph id="H9398C016B18F4E219850EB0A6D9F3781" commented="no">
<enum>(E)</enum>
<text>A comprehensive list of—</text>
<clause id="H6121EC36AC3F4D8DB5B52EE007C99761">
<enum>(i)</enum>
<text>all drug development tools qualified under subsection (a); and</text>
</clause>
<clause id="HA333D5EBDC0A47AE945A83CE4AE9D409">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">all surrogate endpoints which were the basis of approval or licensure (as applicable) of a drug or biological product (including in accordance with section 506(c)) under section 505 of this Act or section 351 of the Public Health Service Act. </text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="HD29CD5AFC99347ECACBE9D2B81254475" commented="no">
<enum>(2)</enum>
<header>Relation to Trade Secrets Act</header>
<text display-inline="yes-display-inline">Information made publicly available by the Secretary under paragraph (1) shall be considered a disclosure authorized by law for purposes of section 1905 of title 18, United States Code.</text>
</paragraph>
<paragraph id="H269949D360D84AC4856D83A751991784" commented="no">
<enum>(3)</enum>
<header>Applicability</header>
<text display-inline="yes-display-inline">Nothing in this section shall be construed as authorizing the Secretary to disclose any information contained in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act that is confidential commercial or trade secret information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.</text>
</paragraph>
</subsection>
<subsection id="H40B04DE9037847B7A241F010D2EB61C9" commented="no">
<enum>(d)</enum>
<header>Rule of construction</header>
<text>Nothing in this section shall be construed—</text>
<paragraph id="H517B08B708A74F0199537011EF3E989C" commented="no">
<enum>(1)</enum>
<text display-inline="yes-display-inline">to alter the standards of evidence under subsection (c) or (d) of section 505, including the substantial evidence standard in such subsection (d), or under section 351 of the Public Health Service Act (as applicable); or</text>
</paragraph>
<paragraph id="H6E984E00769442C9A61C223A21994145" commented="no">
<enum>(2)</enum>
<text display-inline="yes-display-inline">to limit the authority of the Secretary to approve or license products under this Act or the Public Health Service Act, as applicable (as in effect before the date of the enactment of the 21st Century Cures Act).</text>
</paragraph>
</subsection>
<subsection id="H86A7CF0765564D4CBCF0BDECA3408757" commented="no">
<enum>(e)</enum>
<header>Definitions</header>
<text>In this section:</text>
<paragraph id="H782548C6EADA4D5CB7CD083FE18AD79D" commented="no">
<enum>(1)</enum>
<header>Biomarker</header>
<subparagraph id="HD25804F9E1AD4321BE7B114B33450730" display-inline="yes-display-inline" commented="no">
<enum>(A)</enum>
<text>The term <quote>biomarker</quote> means a characteristic (such as a physiologic, pathologic, or anatomic characteristic or measurement) that is objectively measured and evaluated as an indicator of normal biologic processes, pathologic processes, or biological responses to a therapeutic intervention; and</text>
</subparagraph>
<subparagraph id="HC86A7CA93CA2427CB9B698B1F60EE919" indent="up1" commented="no">
<enum>(B)</enum>
<text>such term includes a surrogate endpoint. </text>
</subparagraph>
</paragraph>
<paragraph id="HB0565A5E7EB343E9A663B8704F30999C" commented="no">
<enum>(2)</enum>
<header>Biomedical research consortia</header>
<text display-inline="yes-display-inline">The term <quote>biomedical research consortia</quote> means collaborative groups that may take the form of public-private partnerships and may include government agencies, institutions of higher education (as defined in section 101(a) of the Higher Education Act of 1965, patient advocacy groups, industry representatives, clinical and scientific experts, and other relevant entities and individuals.</text>
</paragraph>
<paragraph id="H0FA2B24AE05F4C41ACB0E3876EBF7CC7" commented="no">
<enum>(3)</enum>
<header>Clinical outcome assessment</header>
<subparagraph id="H4EFB06BB36274EF28E44BEBA44403F8C" display-inline="yes-display-inline" commented="no">
<enum>(A)</enum>
<text>The term <quote>clinical outcome assessment</quote> means a measurement of a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions; and</text>
</subparagraph>
<subparagraph id="HCF1A6ED8F6244C76BE7FA6CAC83A84C3" indent="up1" commented="no">
<enum>(B)</enum>
<text>such term includes a patient-reported outcome. </text>
</subparagraph>
</paragraph>
<paragraph id="H6DEB18B81027412AB15E0D12887F36B3" commented="no">
<enum>(4)</enum>
<header>Context of use</header>
<text>The term <quote>context of use</quote> means, with respect to a drug development tool, the circumstances under which the drug development tool is to be used in drug development and regulatory review. </text>
</paragraph>
<paragraph id="HB3C5AEA1D2A6457CA94E038E7AC553CD" commented="no">
<enum>(5)</enum>
<header>Drug development tool</header>
<text>The term <quote>drug development tool</quote> includes—</text>
<subparagraph id="HF4E7E262BB1D4E46B344942107CEE0B4" commented="no">
<enum>(A)</enum>
<text>a biomarker; </text>
</subparagraph>
<subparagraph id="H8864E4156BF74E93AB132060F9C0F23B" commented="no">
<enum>(B)</enum>
<text>a clinical outcome assessment; and </text>
</subparagraph>
<subparagraph id="HE49E594F4C794761BC744710B1CBE2A5" commented="no">
<enum>(C)</enum>
<text>any other method, material, or measure that the Secretary determines aids drug development and regulatory review for purposes of this section.</text>
</subparagraph>
</paragraph>
<paragraph id="H23457CB618CE4887A8534337B28B6CD1" commented="no">
<enum>(6)</enum>
<header>Patient-reported outcome</header>
<text>The term <quote>patient-reported outcome</quote> means a measurement based on a report from a patient regarding the status of the patient’s health condition without amendment or interpretation of the patient’s report by a clinician or any other person. </text>
</paragraph>
<paragraph id="H7B02F9C7BD574BB49A78CEC45EB2007F" commented="no">
<enum>(7)</enum>
<header>Qualification</header>
<text>The terms <quote>qualification</quote> and <quote>qualified</quote> mean a determination by the Secretary that a drug development tool and its proposed context of use can be relied upon to have a specific interpretation and application in drug development and regulatory review under this Act.</text>
</paragraph>
<paragraph id="H5FC105C9B9B64A0CBA17C7FD6011CD11" commented="no">
<enum>(8)</enum>
<header>Requestor</header>
<text display-inline="yes-display-inline">The term <quote>requestor</quote> means an entity or entities, including a drug sponsor or a biomedical research consortia, seeking to qualify a drug development tool for a proposed context of use under this section. </text>
</paragraph>
<paragraph id="H32E764BF2CAE4FB3AD3EF2085C3867EA" commented="no">
<enum>(9)</enum>
<header>Surrogate endpoint</header>
<text>The term <quote>surrogate endpoint</quote> means a marker, such as a laboratory measurement, radiographic image, physical sign, or other measure, that is not itself a direct measurement of clinical benefit, and—</text>
<subparagraph id="H79ED51A4EA5242589CB5E42AC97ABBF1" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">is known to predict clinical benefit and could be used to support traditional approval of a drug or biological product; or</text>
</subparagraph>
<subparagraph id="H7C0E02F8D1514784A62120D658A30563" commented="no">
<enum>(B)</enum>
<text>is reasonably likely to predict clinical benefit and could be used to support the accelerated approval of a drug or biological product in accordance with section 506(c). </text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="HCEEA6658942340038EF0F22DC28E5A2C" commented="no">
<enum>(f)</enum>
<header>Authorization of appropriations</header>
<text display-inline="yes-display-inline">There are authorized to be appropriated to carry out this section, $10,000,000 for each of fiscal years 2016 through 2020.</text>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="H1CBCF0250A9F480094CCA719DC9846AD" commented="no">
<enum>(d)</enum>
<header>Guidance</header>
<paragraph id="HBDE73D8F1BC540E8A780FB674736A47E" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary of Health and Human Services shall, in consultation with biomedical research consortia (as defined in subsection (f) of section 507 the Federal Food, Drug, and Cosmetic Act (as added by subsection (c))) and other interested parties through a collaborative public process, issue guidance to implement such section 507 that—</text>
<subparagraph id="H5DBAC194D2F34993A1BD1A3E6E992340" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">provides a conceptual framework describing appropriate standards and scientific approaches to support the development of biomarkers delineated under the taxonomy established under paragraph (3);</text>
</subparagraph>
<subparagraph id="H44DE5281A2264990A52AE1B871AE9F45" commented="no">
<enum>(B)</enum>
<text>makes recommendations for demonstrating that a surrogate endpoint is reasonably likely to predict clinical benefit for the purpose of supporting the accelerated approval of a drug under section 506(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(c));</text>
</subparagraph>
<subparagraph id="HAC70D77D209B4DCDAAC398AF0C7DA182" commented="no">
<enum>(C)</enum>
<text display-inline="yes-display-inline">with respect to the qualification process under such section 507—</text>
<clause id="H226C78A3CC044849802E7744A9A33F26" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline">describes the requirements that entities seeking to qualify a drug development tool under such section shall observe when engaging in such process;</text>
</clause>
<clause id="H9609118B55BD41A1B0CB8661F51B5607" commented="no">
<enum>(ii)</enum>
<text>outlines reasonable timeframes for the Secretary’s review of letters, qualification plans, or full qualification packages submitted under such process; and</text>
</clause>
<clause id="H8A02948B356941DC880AAC6BA3CE8DC8" commented="no">
<enum>(iii)</enum>
<text>establishes a process by which such entities or the Secretary may consult with biomedical research consortia and other individuals and entities with expert knowledge and insights that may assist the Secretary in the review of qualification plans and full qualification submissions under such section; and</text>
</clause>
</subparagraph>
<subparagraph id="H83780D94A5D44F60AAAFA465B0E891E6" commented="no">
<enum>(D)</enum>
<text>includes such other information as the Secretary determines appropriate.</text>
</subparagraph>
</paragraph>
<paragraph id="HDDBF89E3AF544D79BBECE03F62D748E2" commented="no">
<enum>(2)</enum>
<header>Timing</header>
<text display-inline="yes-display-inline">Not later than 24 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance under paragraph (1) on the implementation of section 507 of the Federal Food, Drug, and Cosmetic Act (as added by subsection (c)). The Secretary shall issue final guidance on the implementation of such section not later than 6 months after the date on which the comment period for the draft guidance closes.</text>
</paragraph>
<paragraph id="H380443D91A3845D2A5FFD51100F35413" commented="no">
<enum>(3)</enum>
<header>Taxonomy</header>
<subparagraph id="H3A6D3781DE0E46958A8B7F1D292501CE" commented="no">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">For purposes of informing guidance under this subsection, the Secretary of Health and Human Services shall, in consultation with biomedical research consortia and other interested parties through a collaborative public process, establish a taxonomy for the classification of biomarkers (and related scientific concepts) for use in drug development.</text>
</subparagraph>
<subparagraph id="HB218C97B757D4B33A61B7F66B7095442" commented="no">
<enum>(B)</enum>
<header>Public availability</header>
<text>Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall make such taxonomy publicly available in draft form for public comment. The Secretary shall finalize the taxonomy not later than 12 months after the close of the public comment period.</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H5CC75CF0C8E04E7B8AA43B2C366CD446" commented="no">
<enum>(e)</enum>
<header>Meeting and report</header>
<paragraph id="H620D8336CB024F64BB8EF4B404CBF6DA" commented="no">
<enum>(1)</enum>
<header>Meeting</header>
<text display-inline="yes-display-inline">Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall convene a public meeting to describe and solicit public input regarding the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c).</text>
</paragraph>
<paragraph id="HF05E899EADFA4289A45341A1BC828011" commented="no">
<enum>(2)</enum>
<header>Report</header>
<text display-inline="yes-display-inline">Not later than 5 years after the date of the enactment of this Act, the Secretary shall make publicly available on the Internet website of the Food and Drug Administration a report. Such report shall include, with respect to the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act, as added by subsection (c), information on—</text>
<subparagraph id="H2F0AE56E6B7B41ECAF81A44F6AB916B6" display-inline="no-display-inline" commented="no">
<enum>(A)</enum>
<text>the number of requests submitted, as a letter of intent, for qualification of a drug development tool (as defined in subsection (f) of such section);</text>
</subparagraph>
<subparagraph id="HCFE397672E6C4BCD8192136F524C88A9" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">the number of such requests accepted and determined to be eligible for submission of a qualification plan or full qualification package (as such terms are defined in such subsection), respectively;</text>
</subparagraph>
<subparagraph id="H02F021DB0C96459295F91D9B68B03C47" commented="no">
<enum>(C)</enum>
<text display-inline="yes-display-inline">the number of such requests for which external scientific experts were utilized in the development of a qualification plan or review of a full qualification package; and</text>
</subparagraph>
<subparagraph id="HDB579000EA9548ADB6E09D0A48FBA740" commented="no">
<enum>(D)</enum>
<text display-inline="yes-display-inline">the number of qualification plans and full qualification packages, respectively, submitted to the Secretary; and </text>
</subparagraph>
</paragraph>
<paragraph id="HA439E27178A64EE6AC8B34AE7D7B88FE" commented="no">
<enum>(3)</enum>
<text>the drug development tools qualified through such qualification process, specified by type of tool, such as a biomarker or clinical outcome assessment (as such terms are defined in subsection (f) of such section 507).</text>
</paragraph>
</subsection>
</section>
<section id="H3E4FD6045C3546B296DA25545A281FE9" section-type="subsequent-section" commented="no">
<enum>2022.</enum>
<header>Accelerated approval development plan</header>
<subsection id="H6DDC5461AC6B4DA0B4E210305F2D5777" commented="no">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) is amended by adding the following subsection: </text>
<quoted-block style="OLC" id="HD37B2F74FC5148809801AACB00DCC1D3" display-inline="no-display-inline">
<subsection id="HF55D049FA13848588D5D30FD6BC05CD6" commented="no">
<enum>(g)</enum>
<header>Accelerated approval development plan</header>
<paragraph id="H9F2AE93D5CA84F6CBA490BF2748D53D8" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">In the case of a drug that the Secretary determines may be eligible for accelerated approval in accordance with subsection (c), the sponsor of such drug may request, at any time after the submission of an application for the investigation of the drug under section 505(i) of this Act or section 351(a)(3) of the Public Health Service Act, that the Secretary agree to an accelerated approval development plan described in paragraph (2).</text>
</paragraph>
<paragraph id="H1DBAFB4533C140A6A0B11FDB8F340551" commented="no">
<enum>(2)</enum>
<header>Plan described</header>
<text display-inline="yes-display-inline">A plan described in this paragraph, with respect to a drug described in paragraph (1), is an accelerated approval development plan, which shall include agreement on—</text>
<subparagraph id="H4A98C4631C81472EA68A2A1A0CF7808A" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">the surrogate endpoint to be assessed under such plan;</text>
</subparagraph>
<subparagraph id="HE32311D83C054494AF19033B289A376C" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">the design of the study that will utilize the surrogate endpoint; and</text>
</subparagraph>
<subparagraph id="HB23B5C570FCE42699A48C0278081ADC9" commented="no">
<enum>(C)</enum>
<text display-inline="yes-display-inline">the magnitude of the effect of the drug on the surrogate endpoint that is the subject of the agreement that would be sufficient to form the primary basis of a claim that the drug is effective.</text>
</subparagraph>
</paragraph>
<paragraph id="H59A960C34BDA4EF1AB38220D4044EAAD" commented="no">
<enum>(3)</enum>
<header>Modification; termination</header>
<text display-inline="yes-display-inline">The Secretary may require the sponsor of a drug that is the subject of an accelerated approval development plan to modify or terminate the plan if additional data or information indicates that—</text>
<subparagraph id="H9FCEB7447A9C4DCE8DEA444FD86286AE" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">the plan as originally agreed upon is no longer sufficient to demonstrate the safety and effectiveness of the drug involved; or</text>
</subparagraph>
<subparagraph id="H74871517CCD14C568D0E6643309F5554" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">the drug is no longer eligible for accelerated approval under subsection (c).</text>
</subparagraph>
</paragraph>
<paragraph id="HE49C956D2C024D46B8489C505D4D1059" commented="no">
<enum>(4)</enum>
<header>Sponsor consultation</header>
<text display-inline="yes-display-inline">If the Secretary requires the modification or termination of an accelerated approval development plan under paragraph (3), the sponsor shall be granted a request for a meeting to discuss the basis of the Secretary’s decision before the effective date of the modification or termination.</text>
</paragraph>
<paragraph id="H465611E3BD5B42D4A7667125DEFCFBF0" commented="no">
<enum>(5)</enum>
<header>Definition</header>
<text display-inline="yes-display-inline">In this section, the term <quote>accelerated approval development plan</quote> means a development plan agreed upon by the Secretary and the sponsor submitting the plan that contains study parameters for the use of a surrogate endpoint that—</text>
<subparagraph id="HD107E79AE4E94347843DD834B583E419" commented="no">
<enum>(A)</enum>
<text>is reasonably likely to predict clinical benefit; and</text>
</subparagraph>
<subparagraph id="H342DE945E774486697CDD8D4B864F449" commented="no">
<enum>(B)</enum>
<text>is intended to be the basis of the accelerated approval of a drug in accordance with subsection (c).</text>
</subparagraph>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="H17CAF8B5886C49999BE3EF20CC8AA4D4" commented="no">
<enum>(b)</enum>
<header>Technical amendments</header>
<text>Section 506 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356) is amended—</text>
<paragraph id="HB770AFCBBF774E31B5F8708ECC4983F0" commented="no">
<enum>(1)</enum>
<text>by striking <quote><header-in-text level="subsection" style="OLC"><enum-in-header>(f)<header-in-text level="subsection" style="OLC"> Awareness efforts</header-in-text></enum-in-header></header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC"><enum-in-header>(e) <header-in-text level="subsection" style="OLC">Awareness efforts</header-in-text></enum-in-header></header-in-text></quote>; and</text>
</paragraph>
<paragraph id="HF228067D1F4649F6AD93EE7776531AC7" commented="no">
<enum>(2)</enum>
<text>by striking <quote><header-in-text level="subsection" style="OLC"><enum-in-header>(e) <header-in-text level="subsection" style="OLC">Construction</header-in-text></enum-in-header></header-in-text></quote> and inserting <quote><header-in-text level="subsection" style="OLC"><enum-in-header>(f) <header-in-text level="subsection" style="OLC">Construction</header-in-text></enum-in-header></header-in-text></quote>. </text>
</paragraph>
</subsection>
</section>
</subtitle>
<subtitle id="H20786423A19F4531A9D7B776FEB1FDF6" commented="no">
<enum>C</enum>
<header>FDA advancement of Precision Medicine</header>
<section id="HA860E5CD406B4F7FA76AE3B114A81857" commented="no">
<enum>2041.</enum>
<header>Precision medicine guidance and other programs of Food and Drug Administration</header>
<text display-inline="no-display-inline">Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by adding at the end the following:</text>
<quoted-block style="OLC" id="HFC15CF75EBA94DC28380430D94BCE685" display-inline="no-display-inline">
<subchapter id="H1F8972B2F3174F92A02DBB71A8837C9E" commented="no">
<enum>J</enum>
<header>Precision Medicine</header>
<section id="H1239038B7F1C48208DB22EBA0BF5284A" commented="no">
<enum>591.</enum>
<header>General agency guidance on precision medicine</header>
<subsection id="H252CCDDDE1B54053A311DDC6E87C1F1C" commented="no">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall issue and periodically update guidance to assist sponsors in the development of a precision drug or biological product. Such guidance shall—</text>
<paragraph id="H106681CA27A44442A1348C4DC537F57B" commented="no">
<enum>(1)</enum>
<text>define the term <quote>precision drug or biological product</quote>; and</text>
</paragraph>
<paragraph id="H0C3386C2676F41489E59B0905B82B660" commented="no">
<enum>(2)</enum>
<text>address the topics described in subsection (b).</text>
</paragraph>
</subsection>
<subsection id="H420ABDD8D7DD4CDA99875EEDA5D60E69" commented="no">
<enum>(b)</enum>
<header>Certain issues</header>
<text>The topics to be addressed by guidance under subsection (a) are—</text>
<paragraph id="HF6FBF07E3CEB4DED9DB0DAE14435E1F7" commented="no">
<enum>(1)</enum>
<text display-inline="yes-display-inline">the evidence needed to support the use of biomarkers (as defined in section 507(e)) that identify subsets of patients as likely responders to therapies in order to streamline the conduct of clinical trials;</text>
</paragraph>
<paragraph id="H4D731BB1E3524AB2B124BB895387D64F" commented="no">
<enum>(2)</enum>
<text>recommendations for the design of studies to demonstrate the validity of a biomarker as a predictor of drug or biological product response;</text>
</paragraph>
<paragraph id="HD72B03CB146E49FDBAC6D684CFAAED12" commented="no">
<enum>(3)</enum>
<text>the manner and extent to which a benefit-risk assessment may be affected when clinical trials are limited to patient population subsets that are identified using biomarkers;</text>
</paragraph>
<paragraph id="HC9489CA26050426BB91E4B937D4DA9FF" commented="no">
<enum>(4)</enum>
<text>the development of companion diagnostics in the context of a drug development program; and</text>
</paragraph>
<paragraph id="H045B3D24C78A4ED49D765BDA8B1E2169" commented="no">
<enum>(5)</enum>
<text>considerations for developing biomarkers that inform prescribing decisions for a drug or biological product, and when information regarding a biomarker may be included in the approved prescription labeling for a precision drug or biological product. </text>
</paragraph>
</subsection>
<subsection id="HA914872ABEAE4E7AAC61087A9241B95E" commented="no">
<enum>(c)</enum>
<header>Date certain for initial guidance</header>
<text>The Secretary shall issue guidance under subsection (a) not later than 18 months after the date of the enactment of the 21st Century Cures Act.</text>
</subsection>
</section>
<section id="H46B13CF5E2DB44618741B3DC56C9BB16" commented="no">
<enum>592.</enum>
<header>Precision medicine regarding orphan-drug and expedited-approval programs</header>
<subsection id="H608958E378CD4F92A6956A4F99A384BD">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">
<italic>
</italic>In the case of a precision drug or biological product that is the subject of an application submitted under section 505(b)(1), or section 351(a) of the Public Health Service Act, for the treatment of a serious or life-threatening disease or condition and has been designated under section 526 as a drug for a rare disease or condition, the Secretary may—</text>
<paragraph id="H3C8D69F8DEC0419896DCFE3600951A8E">
<enum>(1)</enum>
<text display-inline="yes-display-inline">consistent with applicable standards for approval, rely upon data or information previously submitted by the sponsor of the precision drug or biological product, or another sponsor, provided that the sponsor of the precision drug or biological product has obtained a contractual right of reference to such other sponsor’s data and information, in an application approved under section 505(c) or licensed under section 351(a) of the Public Health Service Act, as applicable—</text>
<subparagraph id="H937AD21284A6469A935C2A1D5A3550B2">
<enum>(A)</enum>
<text>for a different drug or biological product; or</text>
</subparagraph>
<subparagraph id="H70EEB37841634A1793C136F11E5B476C">
<enum>(B)</enum>
<text>for a different indication for such precision drug or biological product,</text>
</subparagraph>
<continuation-text continuation-text-level="paragraph">in order to expedite clinical development for a precision drug or biological product that is using the same or similar approach as that used to support approval of the prior approved application or license, as appropriate; and</continuation-text>
</paragraph>
<paragraph id="H1E1F0E9AC1E840DF9FCA3FE5B452BAEC" commented="no">
<enum>(2)</enum>
<text>as appropriate, consider the application for approval of such precision drug or biological product to be eligible for expedited review and approval programs described in section 506, including accelerated approval in accordance with subsection (c) of such section.</text>
</paragraph>
</subsection>
<subsection id="HB512FE6041C54553ABB48D9BAB592A29">
<enum>(b)</enum>
<header>Rule of construction</header>
<text display-inline="yes-display-inline">Nothing in this section shall be construed to—</text>
<paragraph id="H1F446B67190D4185A16045A0748B9E64">
<enum>(1)</enum>
<text>limit the authority of the Secretary to approve products pursuant to this Act and the Public Health Service Act as authorized prior to the date of enactment of this section; or</text>
</paragraph>
<paragraph id="H43128344165243939134BDF1492DC27A">
<enum>(2)</enum>
<text>confer any new rights, beyond those authorized under this Act prior to enactment of this section, with respect to a sponsor’s ability to reference information contained in another application submitted under section 505(b)(1) of this Act or section 351(a) of the Public Health Service Act.</text>
</paragraph>
</subsection>
</section>
</subchapter>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
</subtitle>
<subtitle id="H04D2C8B526AA48D4BA21DE7662578B3C">
<enum>D</enum>
<header>Modern Trial Design and Evidence Development</header>
<section id="H953AC4A4BFDC41EAA5531FBD23CE83AB" section-type="subsequent-section" commented="no">
<enum>2061.</enum>
<header>Broader application of Bayesian statistics and adaptive trial designs</header>
<subsection id="HA65E7A4BB50248379CFBB2C524B46A84" commented="no">
<enum>(a)</enum>
<header>Proposals for use of innovative statistical methods in clinical protocols for drugs and biological products</header>
<text display-inline="yes-display-inline">For purposes of assisting sponsors in incorporating adaptive trial design and Bayesian methods into proposed clinical protocols and applications for new drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) and biological products under section 351 of the Public Health Service Act (42 U.S.C. 262), the Secretary shall conduct a public meeting and issue guidance in accordance with subsection (b).</text>
</subsection>
<subsection id="H82BEECCD768A41A3A8BABCE77C59E043" commented="no">
<enum>(b)</enum>
<header>Guidance addressing use of adaptive trial designs and Bayesian methods</header>
<paragraph id="H7C2DD8A7E60B4541B5B315250869C05D" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs (in this subsection referred to as the <quote>Secretary</quote>), shall—</text>
<subparagraph id="H2E4B3D3FA4E243B68B81F745369801E0" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">update and finalize the draft guidance addressing the use of adaptive trial design for drugs and biological products; and</text>
</subparagraph>
<subparagraph id="H6A6B8A073E43402984C73C468FF99153" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">issue draft guidance on the use of Bayesian methods in the development and regulatory review and approval or licensure of drugs and biological products.</text>
</subparagraph>
</paragraph>
<paragraph id="H731BE997AC7449A193A2CF59530DEB08" commented="no">
<enum>(2)</enum>
<header>Contents</header>
<text>The guidances under paragraph (1) shall address—</text>
<subparagraph id="H830A0180B3214B7F85DFD6D29DCEC34A" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">the use of adaptive trial designs and Bayesian methods in clinical trials, including clinical trials proposed or submitted to help to satisfy the substantial evidence standard under section 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(d));</text>
</subparagraph>
<subparagraph id="H651F65E2E4434784BD4797C2FE42A95B" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">how sponsors may obtain feedback from the Secretary on technical issues related to modeling and simulations prior to—</text>
<clause id="H86D3E26C69274B569F526D35EC08BBE9" commented="no">
<enum>(i)</enum>
<text>completion of such modeling or simulations; or</text>
</clause>
<clause id="H4F893303D5E8424A9F3DDF696A6BBEE3" commented="no">
<enum>(ii)</enum>
<text>the submission of resulting information to the Secretary;</text>
</clause>
</subparagraph>
<subparagraph id="H5AF3976A496F443C9DBC16DDFCA2A0C9" commented="no">
<enum>(C)</enum>
<text display-inline="yes-display-inline">the types of quantitative and qualitative information that should be submitted for review; and</text>
</subparagraph>
<subparagraph id="H6FB4176072384518A238AEDBEAC81C81" commented="no">
<enum>(D)</enum>
<text display-inline="yes-display-inline">recommended analysis methodologies.</text>
</subparagraph>
</paragraph>
<paragraph id="HCE90681AC40C4F9DAD8A79EBE37B1229" commented="no">
<enum>(3)</enum>
<header>Public meeting</header>
<text display-inline="yes-display-inline">Prior to updating or developing the guidances required by paragraph (1), the Secretary shall consult with stakeholders, including representatives of regulated industry, academia, patient advocacy organizations, and disease research foundations, through a public meeting to be held not later than 1 year after the date of enactment of this Act. </text>
</paragraph>
<paragraph id="HC3B8A14501564C3899EFF958BF0BF252" commented="no">
<enum>(4)</enum>
<header>Schedule</header>
<text>The Secretary shall publish—</text>
<subparagraph id="HC892C94469084FFAB33EC1E247A7CCE6" commented="no">
<enum>(A)</enum>
<text>the final guidance required by paragraph (1)(A) not later than 18 months after the date of the public meeting required by paragraph (3); and</text>
</subparagraph>
<subparagraph id="HF2AA71C3FB074315A98DE3C43B3B6BB1" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">the guidance required by paragraph (1)(B) not later than 48 months after the date of the public meeting required by paragraph (3).</text>
</subparagraph>
</paragraph>
</subsection>
</section>
<section id="H4AAB0879E6634F14801D8AA857E476FF" commented="no">
<enum>2062.</enum>
<header>Utilizing evidence from clinical experience</header>
<text display-inline="no-display-inline">Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 505E of such Act (21 U.S.C. 355f) the following:</text>
<quoted-block style="OLC" id="H1E08AC428A45486088A02D5E9A2BB2CE" display-inline="no-display-inline">
<section id="H21AC61A245B6455688097E8C8616051D" commented="no">
<enum>505F.</enum>
<header>Utilizing evidence from clinical experience</header>
<subsection id="H3F8E0ED63C9740EBB805249D8F9A55E9" commented="no">
<enum>(a)</enum>
<header>In general</header>
<text>The Secretary shall establish a program to evaluate the potential use of evidence from clinical experience—</text>
<paragraph id="H0685AB75723149DE86A858CE6C00553A" commented="no">
<enum>(1)</enum>
<text>to help to support the approval of a new indication for a drug approved under section 505(b); and</text>
</paragraph>
<paragraph id="H8C73A88F0194425D9D005D5D2419F08E" commented="no">
<enum>(2)</enum>
<text>to help to support or satisfy postapproval study requirements.</text>
</paragraph>
</subsection>
<subsection id="H9FA50E71CCAB4D87A3A6D8E0922CF849" commented="no">
<enum>(b)</enum>
<header>Evidence from clinical experience defined</header>
<text>In this section, the term <quote>evidence from clinical experience</quote> means data regarding the usage, or the potential benefits or risks, of a drug derived from sources other than randomized clinical trials, including from observational studies, registries, and therapeutic use.</text>
</subsection>
<subsection id="H7009D84AF37B42A3AB6ABAA4CC41E75F" commented="no">
<enum>(c)</enum>
<header>Program framework</header>
<paragraph id="H23BAE3FF7D474B0EA8C9C11336A735AC" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of this section, the Secretary shall establish a draft framework for implementation of the program under this section.</text>
</paragraph>
<paragraph id="H7BCCF6A8ACE04A0D9C21285167F48849" commented="no">
<enum>(2)</enum>
<header>Contents of framework</header>
<text>The framework shall include information describing—</text>
<subparagraph id="H25726C4A31B644FDA291D2AF01AC64B5" commented="no">
<enum>(A)</enum>
<text>the current sources of data developed through clinical experience, including ongoing safety surveillance, registry, claims, and patient-centered outcomes research activities;</text>
</subparagraph>
<subparagraph id="HFEAEB0097F7443DC9762E94AB90165CD" commented="no">
<enum>(B)</enum>
<text>the gaps in current data collection activities;</text>
</subparagraph>
<subparagraph id="HD580E547BC634973A35D4ED77FC77F1A" commented="no">
<enum>(C)</enum>
<text>the current standards and methodologies for collection and analysis of data generated through clinical experience; and</text>
</subparagraph>
<subparagraph id="H5292C46FFC864E89B38408385F0256BB" commented="no">
<enum>(D)</enum>
<text>the priority areas, remaining challenges, and potential pilot opportunities that the program established under this section will address.</text>
</subparagraph>
</paragraph>
<paragraph id="H65EF8504DFA04860842E28B297A01DF8" commented="no">
<enum>(3)</enum>
<header>Consultation</header>
<subparagraph id="H3EC96784FDD6470E8F81E9CAB35746E5">
<enum>(A)</enum>
<header>In general</header>
<text>In developing the program framework under this subsection, the Secretary shall consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organizations, disease research foundations, and other interested parties.</text>
</subparagraph>
<subparagraph id="H38005365B03C419494311E6A21777CE2">
<enum>(B)</enum>
<header>Process</header>
<text display-inline="yes-display-inline">The consultation under subparagraph (A) may be carried out through approaches such as—</text>
<clause id="H9E0A62DDB4E044E2A12928CCBBCFE43A">
<enum>(i)</enum>
<text>a public-private partnership with the entities described in such subparagraph in which the Secretary may participate; or</text>
</clause>
<clause id="H15FE09BC692641AB94D27CF767D7E5D6">
<enum>(ii)</enum>
<text>a contract, grant, or other arrangement, as determined appropriate by the Secretary with such a partnership or an independent research organization.</text>
</clause>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H2643747533A9462C8C424CFC419E9D9A" commented="no">
<enum>(d)</enum>
<header>Program implementation</header>
<text>The Secretary shall, not later than 24 months after the date of enactment of this section and in accordance with the framework established under subsection (c), implement the program to evaluate the potential use of evidence from clinical experience.</text>
</subsection>
<subsection id="H64ADF1CE86A04AA6A4ED9BD5CA63AC84" commented="no">
<enum>(e)</enum>
<header>Guidance for industry</header>
<text display-inline="yes-display-inline">The Secretary shall—</text>
<paragraph id="H664CD7CB82104307A1684FA8A689C1A9" commented="no">
<enum>(1)</enum>
<text>utilize the program established under subsection (a), its activities, and any subsequent pilots or written reports, to inform a guidance for industry on—</text>
<subparagraph id="HF34521BE629E43959EAC774FEA4EB03D" commented="no">
<enum>(A)</enum>
<text>the circumstances under which sponsors of drugs and the Secretary may rely on evidence from clinical experience for the purposes described in subsection (a)(1) or (a)(2); and</text>
</subparagraph>
<subparagraph id="HD55B542E5ABC4AC49C8828DA1CE48E58" commented="no">
<enum>(B)</enum>
<text>the appropriate standards and methodologies for collection and analysis of evidence from clinical experience submitted for such purposes; </text>
</subparagraph>
</paragraph>
<paragraph id="HE20095C5072A428B9FD37C86FA4E0105" commented="no">
<enum>(2)</enum>
<text>not later than 36 months after the date of enactment of this section, issue draft guidance for industry as described in paragraph (1); and</text>
</paragraph>
<paragraph id="H4671A967530C4476A00A2054AF955BCD" commented="no">
<enum>(3)</enum>
<text>not later than 48 months after the date of enactment of this section, after providing an opportunity for public comment on the draft guidance, issue final guidance.</text>
</paragraph>
</subsection>
<subsection id="HD7A0FF1675704B9291C44100EE678476" commented="no">
<enum>(f)</enum>
<header>Rule of construction</header>
<paragraph id="H42E3246EF36D4E73A0C3175A383E7364" commented="no">
<enum>(1)</enum>
<text>Subject to paragraph (2), nothing in this section prohibits the Secretary from using evidence from clinical experience for purposes not specified in this section, provided the Secretary determines that sufficient basis exists for any such nonspecified use.</text>
</paragraph>
<paragraph id="HB547DDCBA0ED4D0B87ED7B4DCB87A475" commented="no">
<enum>(2)</enum>
<text>This section shall not be construed to alter—</text>
<subparagraph id="H799B2FF27ACE47ED9CED47977C12E21B" commented="no">
<enum>(A)</enum>
<text>the standards of evidence under—</text>
<clause id="H8284AD3510E549B7AAAA78AEE11E7610" commented="no">
<enum>(i)</enum>
<text>subsection (c) or (d) of section 505, including the substantial evidence standard in such subsection (d); or</text>
</clause>
<clause id="HF4228523EF48491FA262F4EF96F85390" commented="no">
<enum>(ii)</enum>
<text>section 351(a) of the Public Health Service Act; or</text>
</clause>
</subparagraph>
<subparagraph id="H700862EBF74E44C39B887C8D0AE5DDD0" commented="no">
<enum>(B)</enum>
<text>the Secretary’s authority to require postapproval studies or clinical trials, or the standards of evidence under which studies or trials are evaluated.</text>
</subparagraph>
</paragraph>
</subsection>
</section>
<section id="H315FD4187F1545758C740E5D57E9D374" commented="no">
<enum>505G.</enum>
<header>Collecting evidence from clinical experience through targeted extensions of the Sentinel System</header>
<subsection id="H68AAED45ACF147368BA69EC99C737679" commented="no">
<enum>(a)</enum>
<header>In general</header>
<text>The Secretary shall, in parallel to implementing the program established under section 505F and in order to build capacity for utilizing the evidence from clinical experience described in that section, identify and execute pilot demonstrations to extend existing use of the Sentinel System surveillance infrastructure authorized under section 505(k).</text>
</subsection>
<subsection id="H3E977AD3C5A94E53840AE0B6C8CCF936" commented="no">
<enum>(b)</enum>
<header>Pilot demonstrations</header>
<paragraph id="H0747E8A2EB854D66AAF7B7486B7D7216" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary—</text>
<subparagraph id="HD1CE0ECF79FB41DAB83F290286D8B113" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">shall design and implement pilot demonstrations to utilize data captured through the Sentinel System surveillance infrastructure authorized under section 505(k) for purposes of, as appropriate—</text>
<clause id="H995C924CFA6C47C7BDF1DA90AC4B1149" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline">generating evidence from clinical experience to improve characterization or assessment of risks or benefits of a drug approved under section 505(c);</text>
</clause>
<clause id="H078EE36E94EF4D1BBE7D97E412F0B529" commented="no">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">protecting the public health; or</text>
</clause>
<clause id="HBBB040E378E343B6AF1E6FF25F38E2EA" commented="no">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">advancing patient-centered care; and</text>
</clause>
</subparagraph>
<subparagraph id="H6FDB45352D934773A35AE9D2E3FF7E32" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">may make strategic linkages with sources of complementary public health data and infrastructure the Secretary determines appropriate and necessary.</text>
</subparagraph>
</paragraph>
<paragraph id="H7DE2E6B87F1144C89C15D94DB21E784D" commented="no">
<enum>(2)</enum>
<header>Consultation</header>
<text>In developing the pilot demonstrations under this subsection, the Secretary shall—</text>
<subparagraph id="H0D0C1DE60B61422EAD4A9A497110123B" commented="no">
<enum>(A)</enum>
<text>consult with regulated industry, academia, medical professional organizations, representatives of patient advocacy organizations, disease research foundations, and other interested parties through a public process; and</text>
</subparagraph>
<subparagraph id="H17C8C78A2973461F97EFC46B3E152966" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">develop a framework to promote appropriate transparency and dialogue about research conducted under these pilot demonstrations, including by—</text>
<clause id="HF94ACB27E01B4EE9A49BB0A0134B302C" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline">providing adequate notice to a sponsor of a drug approved under section 505 or section 351 of the Public Health Service Act of the Secretary’s intent to conduct analyses of such sponsor’s drug or drugs under these pilot demonstrations;</text>
</clause>
<clause id="HB4DE25780831403BB12979FAA401244E" commented="no">
<enum>(ii)</enum>
<text>providing adequate notice of the findings related to analyses described in clause (i) and an opportunity for the sponsor of such drug or drugs to comment on such findings; and</text>
</clause>
<clause id="H951E17273B7946C9B3E01C340189249F" commented="no">
<enum>(iii)</enum>
<text>ensuring the protection from public disclosure of any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code.</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="HD32646A6F8F140F794C55B9AC9217B2A" commented="no">
<enum>(3)</enum>
<header>HIPAA privacy rule; human subject research regulation</header>
<text>The Secretary may deem such pilot demonstrations—</text>
<subparagraph id="HF42A5AE3859F47F8828650E8CF96E980" commented="no">
<enum>(A)</enum>
<text>public health activities, for purposes of which a use or disclosure of protected health information would be permitted as described in section 164.512(b)(1) of title 45, Code of Federal Regulations (or any successor regulation); and</text>
</subparagraph>
<subparagraph id="HD4B8198C9F714E14A8B4BBB087E46EF2">
<enum>(B)</enum>
<text>outside the scope of <quote>research</quote> as defined in section 46.102(d) of title 45, Code of Federal Regulations (or any successor regulation).</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="HD46538C5C1404CB5AA2566925E7DE6DD" commented="no">
<enum>(c)</enum>
<header>Authorization of appropriations</header>
<text>There are authorized to be appropriated to carry out this section $3,000,000 for each of fiscal years 2016 through 2020.</text>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
<section id="H251056CADF6D4828905BD9B644D11249">
<enum>2063.</enum>
<header>Streamlined data review program</header>
<subsection id="H0EC471DD52864530BB7FCD2BD70EA41E">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Chapter V of the Federal Food, Drug, and Cosmetic Act, as amended by section 2062, is further amended by inserting after section 505G of such Act the following:</text>
<quoted-block id="H2A8472E152914DF0A0F2B5163D4473BC" style="OLC">
<section id="H62A613D36C23493B84B1E3C869C12F11">
<enum>505H.</enum>
<header>Streamlined data review program</header>
<subsection id="H15BDBCAD42DC489495F9707558181969">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall establish a streamlined data review program under which a holder of an approved application submitted under section 505(b)(1) or under section 351(a) of the Public Health Service Act may, to support the approval or licensure (as applicable) of the use of the drug that is the subject of such approved application for a new qualified indication, submit qualified data summaries.</text>
</subsection>
<subsection id="H3914035BECAB4841BDA7718CA248DB9B">
<enum>(b)</enum>
<header>Eligibility</header>
<text display-inline="yes-display-inline">In carrying out the streamlined data review program under subsection (a), the Secretary may authorize the holder of the approved application to include one or more qualified data summaries described in subsection (a) in a supplemental application if—</text>
<paragraph id="HAC2ADA963BAE449BACBC2393FDD152B3">
<enum>(1)</enum>
<text>the drug has been approved under section 505(c) of this Act or licensed under section 351(a) of the Public Health Service Act for one or more indications, and such approval or licensure remains in effect;</text>
</paragraph>
<paragraph id="H1230A16C7389464782E6B6F0461F0520">
<enum>(2)</enum>
<text display-inline="yes-display-inline">the supplemental application is for approval or licensure (as applicable) under such section 505(c) or 351(a) of the use of the drug for a new qualified indication under such section 505(c) or 351(a);</text>
</paragraph>
<paragraph id="HEE90912744C04F57A799595B8040B9E7">
<enum>(3)</enum>
<text display-inline="yes-display-inline">there is an existing database acceptable to the Secretary regarding the safety of the drug developed for one or more indications of the drug approved under such section 505(c) or licensed under such section 351(a);</text>
</paragraph>
<paragraph id="H3E8816B8FC324D90BEAB5CE636DF9234">
<enum>(4)</enum>
<text>the supplemental application incorporates or supplements the data submitted in the application for approval or licensure referred to in paragraph (1); and</text>
</paragraph>
<paragraph id="HF129D9B4D2AB4CA1A5D3459B2440546C">
<enum>(5)</enum>
<text display-inline="yes-display-inline">the full data sets used to develop the qualified data summaries are submitted, unless the Secretary determines that the full data sets are not required.</text>
</paragraph>
</subsection>
<subsection id="HDEE2037238A7463A911B84072916AA5A">
<enum>(c)</enum>
<header>Public availability of information on program</header>
<text display-inline="yes-display-inline">The Secretary shall post on the public website of the Food and Drug Administration and update annually—</text>
<paragraph id="H735707CFCB1349A3B795DAEAFCFAF208">
<enum>(1)</enum>
<text>the number of applications reviewed under the streamlined data review program;</text>
</paragraph>
<paragraph id="HA401DA8C689044C685125B60AF22D6E5">
<enum>(2)</enum>
<text>the average time for completion of review under the streamlined data review program versus other review of applications for new indications; and</text>
</paragraph>
<paragraph id="H89B9BBC1DF7C4469B45563D398AB25A5">
<enum>(3)</enum>
<text>the number of applications reviewed under the streamlined data review program for which the Food and Drug Administration made use of full data sets in addition to the qualified data summary.</text>
</paragraph>
</subsection>
<subsection id="H813DCD4C028749F1A79A3BD0362C2300">
<enum>(d)</enum>
<header>Definitions</header>
<text display-inline="yes-display-inline">In this section:</text>
<paragraph id="H4C10FCA3FDCF4FF09EE30D4C8EBB4373">
<enum>(1)</enum>
<text display-inline="yes-display-inline">The term <quote>qualified indication</quote> means—</text>
<subparagraph id="H7D97C328695845AB8905479A6AA0789A">
<enum>(A)</enum>
<text display-inline="yes-display-inline">an indication for the treatment of cancer, as determined appropriate by the Secretary; or</text>
</subparagraph>
<subparagraph id="H0FE8016A458B44758F01CF18482AD956">
<enum>(B)</enum>
<text>such other types of indications as the Secretary determines to be subject to the streamlined data review program under this section.</text>
</subparagraph>
</paragraph>
<paragraph id="H04E7B1AC4D2F4D2DA2CC193DD5A115C9">
<enum>(2)</enum>
<text>The term <quote>qualified data summary</quote> means a summary of clinical data intended to demonstrate safety and effectiveness with respect to a qualified indication for use of a drug.</text>
</paragraph>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="H58F263B578724E69AB29811FE936E736">
<enum>(b)</enum>
<header>Sense of Congress</header>
<text display-inline="yes-display-inline">It is the sense of Congress that the streamlined data review program under section 505H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), should enable the Food and Drug Administration to make approval decisions for certain supplemental applications based on qualified data summaries (as defined in such section 505H). </text>
</subsection>
<subsection id="HD9A4D07375A4426F89A83EE792826C87">
<enum>(c)</enum>
<header>Guidance; regulations</header>
<text>The Commissioner of Food and Drugs—</text>
<paragraph id="HED1FD91349B04924A5298B4ACF8E826D">
<enum>(1)</enum>
<text display-inline="yes-display-inline">shall—</text>
<subparagraph id="H09D77FFAF70A453F9F87D36B8CEE6735">
<enum>(A)</enum>
<text>issue final guidance for implementation of the streamlined data review program established under section 505H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), not later than 24 months after the date of enactment of this Act; and</text>
</subparagraph>
<subparagraph id="HBAE045C7F0BD4D079AD32E1A436F27CB">
<enum>(B)</enum>
<text>include in such guidance the process for expanding the types of indications to be subject to the streamlined data review program, as authorized by section 505H(c)(1)(B) of such Act; and</text>
</subparagraph>
</paragraph>
<paragraph id="H04E8DB1C3102488186DC2EBE8FEEB603">
<enum>(2)</enum>
<text>in addition to issuing guidance under paragraph (1), may issue such regulations as may be necessary for implementation of the program.</text>
</paragraph>
</subsection>
</section>
</subtitle>
<subtitle id="H6ED27AD382064DBBBCE55A80DFB69615">
<enum>E</enum>
<header>Expediting Patient Access</header>
<section id="HDEA910BE84654EC09A79FA22BF22F3F7">
<enum>2081.</enum>
<header>Sense of Congress</header>
<text display-inline="no-display-inline">It is the sense of Congress that the Food and Drug Administration should continue to expedite the approval of drugs designated as breakthrough therapies pursuant to section 506(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356(a)) by approving drugs so designated as early as possible in the clinical development process, regardless of the phase of development, provided that the Secretary of Health and Human Services determines that an application for such a drug meets the standards of evidence of safety and effectiveness under section 505 of such Act (21 U.S.C. 355), including the substantial evidence standard under subsection (d) of such section or under section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)).</text>
</section>
<section id="H9D8F0B7062954278A19CE155B5B4620F" commented="no">
<enum>2082.</enum>
<header>Expanded access policy</header>
<text display-inline="no-display-inline">Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 561 (21 U.S.C. 360bbb) the following:</text>
<quoted-block style="OLC" id="H8421924ECC9647F8A2567DBB5A7CA68C" display-inline="no-display-inline">
<section id="HB026593505F44E1286C3BAE60D3E7B90">
<enum>561A.</enum>
<header>Expanded access policy required for investigational drugs</header>
<subsection id="H82F160DB4303419C8369853D47A5A9BE">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make publicly available the policy of the manufacturer or distributor on evaluating and responding to requests submitted under section 561(b) for provision of such a drug. A manufacturer or distributor may satisfy the requirement of the preceding sentence by posting such policy as generally applicable to all of such manufacturer’s or distributor’s investigational drugs.</text>
</subsection>
<subsection id="HB22363C72D154C1E9B2143A72E76EB16">
<enum>(b)</enum>
<header>Content of policy</header>
<text>A policy described in subsection (a) shall include making publicly available—</text>
<paragraph id="H338D57F4CF50475C8699CDA6A8F83610">
<enum>(1)</enum>
<text>contact information for the manufacturer or distributor to facilitate communication about requests described in subsection (a);</text>
</paragraph>
<paragraph id="HF96ECF5B17444DF0926468A279B9D546">
<enum>(2)</enum>
<text display-inline="yes-display-inline">procedures for making such requests;</text>
</paragraph>
<paragraph id="HC55534BE48FE4ACBBFA6E83529CBB84E">
<enum>(3)</enum>
<text display-inline="yes-display-inline">the general criteria the manufacturer or distributor will consider or use to approve such requests; and</text>
</paragraph>
<paragraph id="H023FD07B90B644AD960DC0B8E1A76D29">
<enum>(4)</enum>
<text display-inline="yes-display-inline">the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests.</text>
</paragraph>
</subsection>
<subsection id="HFAAD4E1EB902428ABFEF99E41763973A">
<enum>(c)</enum>
<header>No guarantee of access</header>
<text>The posting of policies by manufacturers and distributors under subsection (a) shall not serve as a guarantee of access to any specific investigational drug by any individual patient.</text>
</subsection>
<subsection id="HFEC034B831F546E39247305ED7D1FF7C">
<enum>(d)</enum>
<header>Revised policy</header>
<text>A manufacturer or distributor that has made a policy publicly available as required by this section may revise the policy at any time.</text>
</subsection>
<subsection id="H3DA2D42ED2324326B9726116BFC2A015">
<enum>(e)</enum>
<header>Application</header>
<text>This section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the later of—</text>
<paragraph id="H11E59857DA044ED3AB401B2B4254F3A3">
<enum>(1)</enum>
<text>the date that is 60 days after the date of enactment of the <short-title>21st Century Cures Act</short-title>; or</text>
</paragraph>
<paragraph id="H1FBAB152439842A0BFA6035C34A67864">
<enum>(2)</enum>
<text display-inline="yes-display-inline">the first initiation of a phase 2 or phase 3 study (as such terms are defined in section 312.21(b) and (c) of title 21, Code of Federal Regulations (or any successor regulations)) with respect to such investigational new drug.</text>
</paragraph>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
<section id="H21B4301C1EFE4C40B397B0FF8C379ED7" commented="no">
<enum>2083.</enum>
<header>Finalizing draft guidance on expanded access</header>
<subsection id="HA29C49C5E4934CA18374C988E6A973E4" commented="no">
<enum>(a)</enum>
<header>In general</header>
<text>Not later than 12 months after the date of enactment of this Act, the Secretary of Health and Human Services shall finalize the draft guidance entitled <quote>Expanded Access to Investigational Drugs for Treatment Use—Qs & As</quote> and dated May 2013.</text>
</subsection>
<subsection id="HCCF60959551B44FAAFCAD68BA1A5C7ED" commented="no">
<enum>(b)</enum>
<header>Contents</header>
<text display-inline="yes-display-inline">The final guidance referred to in subsection (a) shall clearly define how the Secretary of Health and Human Services interprets and uses adverse drug event data reported by investigators in the case of data reported from use under a request submitted under section 561(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb(b)).</text>
</subsection>
</section>
</subtitle>
<subtitle id="H4079BC7F5B994AEEA921F923D5E715E4">
<enum>F</enum>
<header>Facilitating responsible manufacturer communications</header>
<section id="HB9CAFA37435B4512A753A94DA2066BBC" commented="no">
<enum>2101.</enum>
<header>Facilitating dissemination of health care economic information</header>
<text display-inline="no-display-inline">Section 502(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(a)) is amended—</text>
<paragraph id="H17995FF57914459F8B47B7E0E9546D1C" commented="no">
<enum>(1)</enum>
<text>by striking <quote>(a) If its</quote> and inserting <quote>(a)(1) If its</quote>;</text>
</paragraph>
<paragraph id="H400EBDCD65D14254A715FB2DB812D0F3" commented="no">
<enum>(2)</enum>
<text display-inline="yes-display-inline">by striking <quote>a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations</quote> and inserting <quote>a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs for coverage or reimbursement</quote>;</text>
</paragraph>
<paragraph id="H242950435EAB439CB8A414CF782B75E2" commented="no">
<enum>(3)</enum>
<text>by striking <quote>directly relates</quote> and inserting <quote>relates</quote>;</text>
</paragraph>
<paragraph id="HF579EBDA6BF74D78B1CFAA21C3EB81A9" commented="no">
<enum>(4)</enum>
<text display-inline="yes-display-inline">by striking <quote>and is based on competent and reliable scientific evidence. The requirements set forth in section 505(a) or in section 351(a) of the Public Health Service Act shall not apply to health care economic information provided to such a committee or entity in accordance with this paragraph</quote> and inserting <quote>, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug under section 505 or under section 351 of the Public Health Service Act. The requirements set forth in section 505(a) or in subsections (a) and (k) of section 351 of the Public Health Service Act shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph</quote>; and</text>
</paragraph>
<paragraph id="H75D66DB4296E4CA983D17ACBB9FED228" commented="no">
<enum>(5)</enum>
<text>by striking <quote>In this paragraph, the term</quote> and all that follows and inserting the following:</text>
<quoted-block style="OLC" id="H01432CBA70D74C96BB6C83210CA3E524" display-inline="no-display-inline">
<paragraph id="HCE169A39B84341C3B222D785C83B7091" indent="up1" commented="no">
<enum>(2)</enum>
<subparagraph id="H71D0EEF64EAB415AA0ECBD1AE829D198" display-inline="yes-display-inline">
<enum>(A)</enum>
<text>For purposes of this paragraph, the term <quote>health care economic information</quote> means any analysis (including the clinical data, inputs, clinical or other assumptions, methods, results, and other components underlying or comprising the analysis) that identifies, measures, or describes the economic consequences, which may be based on the separate or aggregated clinical consequences of the represented health outcomes, of the use of a drug. Such analysis may be comparative to the use of another drug, to another health care intervention, or to no intervention.</text>
</subparagraph>
<subparagraph id="HC96F015573164421A93876DE2D80EC32" indent="up1">
<enum>(B)</enum>
<text display-inline="yes-display-inline">Such term does not include any analysis that relates only to an indication that is not approved under section 505 or under section 351 of the Public Health Service Act for such drug.</text>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</section>
<section id="HBBDD5FE172E04BA7B5DAF0F02B83AD20" section-type="subsequent-section">
<enum>2102.</enum>
<header>Facilitating responsible communication of scientific and medical developments</header>
<subsection id="H8314F868CE6C4050AD587B204E0A88BA">
<enum>(a)</enum>
<header>Guidance</header>
<text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue draft guidance on facilitating the responsible dissemination of truthful and nonmisleading scientific and medical information not included in the approved labeling of drugs and devices. </text>
</subsection>
<subsection id="H4DEC01C16C314653B0D95310FEA9B591">
<enum>(b)</enum>
<header>Definition</header>
<text display-inline="yes-display-inline">In this section, the terms <quote>drug</quote> and <quote>device</quote> have the meaning given to such terms in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).</text>
</subsection>
</section>
</subtitle>
<subtitle id="H925B2D07857645028640F6D6D5581DE2">
<enum>G</enum>
<header>Antibiotic Drug Development</header>
<section id="H1B605EDECA4A4DC982655CA7985498B2">
<enum>2121.</enum>
<header>Approval of certain drugs for use in a limited population of patients</header>
<subsection id="H6CE0C81377E54A668EAAE1537DE390E7">
<enum>(a)</enum>
<header>Purpose</header>
<text>The purpose of this section is to help to expedite the development and availability of treatments for serious or life-threatening bacterial or fungal infections in patients with unmet needs, while maintaining safety and effectiveness standards for such treatments, taking into account the severity of the infection and the availability or lack of alternative treatments.</text>
</subsection>
<subsection id="HB5E20728D7104901906A71DF1BE7B4E3" commented="no">
<enum>(b)</enum>
<header>Approval of certain antibacterial and antifungal drugs</header>
<text>Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355), as amended by section 2001, is further amended by adding at the end the following new subsection:</text>
<quoted-block id="HC9C15F10A3634347A5E23B70EDD5C798" style="OLC">
<subsection id="H165589C528224FC494662903C45C7F63" commented="no">
<enum>(z)</enum>
<header>Approval of certain antibacterial and antifungal drugs for use in a limited population of patients</header>
<paragraph id="H152B118EA5FE4B2097BF79E7CC13D469" commented="no">
<enum>(1)</enum>
<header>Process</header>
<text>At the request of the sponsor of an antibacterial or antifungal drug that is intended to treat a serious or life-threatening infection, the Secretary—</text>
<subparagraph id="H547BC700758D479A9BE14E7488A0675D" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">may execute a written agreement with the sponsor on the process for developing data to support an application for approval of such drug, for use in a limited population of patients in accordance with this subsection; </text>
</subparagraph>
<subparagraph id="H2D60473696AC4D27948BD808B0E1114A" commented="no">
<enum>(B)</enum>
<text>shall proceed in accordance with this subsection only if a written agreement is reached under subparagraph (A);</text>
</subparagraph>
<subparagraph id="H93C607D4B7164A20853ADFB0D5E1FFDE" commented="no">
<enum>(C)</enum>
<text>shall provide the sponsor with an opportunity to request meetings under paragraph (2); </text>
</subparagraph>
<subparagraph id="H47F7C345BE41435980FB8E2CA212E2A6" commented="no">
<enum>(D)</enum>
<text display-inline="yes-display-inline">if a written agreement is reached under subparagraph (A), may approve the drug under this subsection for such use—</text>
<clause id="H5857041186564226AFF710892E0F3004" commented="no">
<enum>(i)</enum>
<text>in a limited population of patients for which there is an unmet medical need;</text>
</clause>
<clause id="HA379DF32F95D4680A1438804725B278A" commented="no">
<enum>(ii)</enum>
<text>based on a streamlined development program; and</text>
</clause>
<clause id="H31221F2F2C004F9F8DA4CF49951304AD" commented="no">
<enum>(iii)</enum>
<text>only if the standards for approval under subsections (c) and (d) of this section or licensure under section 351 of the Public Health Service Act, as applicable, are met; and</text>
</clause>
</subparagraph>
<subparagraph id="HDD0CB8015F5C48CEAB691F49EF1C5F08" commented="no">
<enum>(E)</enum>
<text>in approving a drug in accordance with this subsection, subject to subparagraph (D)(iii), may rely upon—</text>
<clause id="H5A56738DC19D4972A5928B0CDF35EB6E" commented="no">
<enum>(i)</enum>
<text>traditional endpoints, alternate endpoints, or a combination of traditional and alternate endpoints, and, as appropriate, data sets of a limited size; and</text>
</clause>
<clause id="H7132DE117A2F45C8B31BAD4C98E288B4" commented="no">
<enum>(ii)</enum>
<subclause id="H1315DFA5E16D4268882D5FA91F82A982" display-inline="yes-display-inline" commented="no">
<enum>(I)</enum>
<text>additional data, including preclinical, pharmacologic, or pathophysiologic evidence;</text>
</subclause>
<subclause id="H7900EC68812F4C4A9BB24C32835FC454" indent="up1" commented="no">
<enum>(II)</enum>
<text>nonclinical susceptibility and pharmacokinetic data;</text>
</subclause>
<subclause id="H2FE49A768C354629BB55ED45A700E2FB" indent="up1">
<enum>(III)</enum>
<text>data from phase 2 clinical trials; and</text>
</subclause>
<subclause id="H7B5187265F7342ACBB8378186D228B13" indent="up1" commented="no">
<enum>(IV)</enum>
<text>such other confirmatory evidence as the Secretary determines appropriate to approve the drug.</text>
</subclause>
</clause>
</subparagraph>
</paragraph>
<paragraph id="HFA627CB225E14B6DA20FBC7C137C423B" commented="no">
<enum>(2)</enum>
<header>Formal meetings</header>
<subparagraph id="H483854B640134ACD972C4F4F9C39E63A" commented="no">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">To help to expedite and facilitate the development and review of a drug for which a sponsor intends to request approval in accordance with this subsection, the Secretary may, at the request of the sponsor, conduct meetings that provide early consultation, timely advice, and sufficient opportunities to develop an agreement described in paragraph (1)(A) and help the sponsor design and conduct a drug development program as efficiently as possible, including the following types of meetings:</text>
<clause id="H4C23620BEAFE4075BC8CB56570DD4A12" commented="no">
<enum>(i)</enum>
<text>An early consultation meeting.</text>
</clause>
<clause id="HFE2EDEF14D354701AF2F3E356AC7E4A7" commented="no">
<enum>(ii)</enum>
<text>An assessment meeting.</text>
</clause>
<clause id="H3A04C585299844FFA388B13970A5082C" commented="no">
<enum>(iii)</enum>
<text>A postapproval meeting.</text>
</clause>
</subparagraph>
<subparagraph id="H9F848BA676F648328D98360974EEBE4B" commented="no">
<enum>(B)</enum>
<header>No altering of goals</header>
<text>Nothing in this paragraph shall be construed to alter agreed upon goals and procedures identified in the letters described in section 101(b) of the Prescription Drug User Fee Amendments of 2012.</text>
</subparagraph>
<subparagraph id="H3152F66C56D044DF94CBADB79AA1A61F" commented="no">
<enum>(C)</enum>
<header>Breakthrough therapies</header>
<text>In the case of a drug designated as a breakthrough therapy under section 506(a), the sponsor of such drug may elect to utilize meetings provided under such section with respect to such drug in lieu of meetings described in subparagraph (A).</text>
</subparagraph>
</paragraph>
<paragraph id="H4CA37BBDB8F142C392B16EA890746F42" commented="no">
<enum>(3)</enum>
<header>Labeling requirement</header>
<text display-inline="yes-display-inline">The labeling of an antibacterial or antifungal drug approved in accordance with this subsection shall contain the statement <quote>Limited Population</quote> in a prominent manner and adjacent to, and not more prominent than, the brand name of the product. The prescribing information for such antibacterial or antifungal drug required by section 201.57 of title 21, Code of Federal Regulations (or any successor regulation) shall also include the following statement: <quote>This drug is indicated for use in a limited and specific population of patients.</quote>.</text>
</paragraph>
<paragraph id="H261C6C799C9F48D5864048CCE0F0D0E5" commented="no">
<enum>(4)</enum>
<header>Promotional materials</header>
<text>The provisions of section 506(c)(2)(B) shall apply with respect to approval in accordance with this subsection to the same extent and in the same manner as such provisions apply with respect to accelerated approval in accordance with section 506(c)(1).</text>
</paragraph>
<paragraph id="H19E815D1D01E4936BE252D4719565EA2" commented="no">
<enum>(5)</enum>
<header>Termination of requirements or conditions</header>
<text>If a drug is approved in accordance with this subsection for an indication in a limited population of patients and is subsequently approved or licensed under this section or section 351 of the Public Health Service Act, other than in accordance with this subsection, for—</text>
<subparagraph id="HF36AA74ECB16429D890A4DB29BF3F826" commented="no">
<enum>(A)</enum>
<text>the same indication and the same conditions of use, the Secretary shall remove any labeling requirements or postmarketing conditions that were made applicable to the drug under this subsection; or</text>
</subparagraph>
<subparagraph id="HABDE7318DAE94DA39FFC7633F3B64166" commented="no">
<enum>(B)</enum>
<text>a different indication or condition of use, the Secretary shall not apply the labeling requirements and postmarketing conditions that were made applicable to the drug under this subsection to the subsequent approval of the drug for such different indication or condition of use.</text>
</subparagraph>
</paragraph>
<paragraph id="H8085AA8B92F34EDC9BC51648C856934D" commented="no">
<enum>(6)</enum>
<header>Relation to other provisions</header>
<text display-inline="yes-display-inline">Nothing in this subsection shall be construed to prohibit the approval of a drug for use in a limited population of patients in accordance with this subsection, in combination with—</text>
<subparagraph id="HA46A806D74444011897B38F6383DE1FE" commented="no">
<enum>(A)</enum>
<text>an agreement on the design and size of a clinical trial pursuant to subparagraphs (B) and (C) of subsection (b)(5);</text>
</subparagraph>
<subparagraph id="HF422BBA05391484CA332F5606EE9ADFE" commented="no">
<enum>(B)</enum>
<text>designation and treatment of the drug as a breakthrough therapy under section 506(a);</text>
</subparagraph>
<subparagraph id="H33C0DBF42B67469388A2040D380FA499" commented="no">
<enum>(C)</enum>
<text>designation and treatment of the drug as a fast track product under section 506(b); or</text>
</subparagraph>
<subparagraph id="HD636ECFFF899439291B8D11F4302E61A" commented="no">
<enum>(D)</enum>
<text>accelerated approval of the drug in accordance with section 506(c).</text>
</subparagraph>
</paragraph>
<paragraph id="H4941F8DC90B4468F871DD1812A30906B" commented="no">
<enum>(7)</enum>
<header>Rule of construction</header>
<text>Nothing in this subsection shall be construed—</text>
<subparagraph id="HB40D2C2EA4F744A597B571283A46E443" commented="no">
<enum>(A)</enum>
<text>to alter the standards of evidence under subsection (c) or (d) (including the substantial evidence standard in subsection (d));</text>
</subparagraph>
<subparagraph id="H0737D46E2CF14AB8882C4FED610E6769" commented="no">
<enum>(B)</enum>
<text>to waive or otherwise preclude the application of requirements under subsection (o); </text>
</subparagraph>
<subparagraph id="HDBF1A81A1CD94EE4997D47315B9CF6FF" commented="no">
<enum>(C)</enum>
<text>to otherwise, in any way, limit the authority of the Secretary to approve products pursuant to this Act and the Public Health Service Act as authorized prior to the date of enactment of this subsection; or</text>
</subparagraph>
<subparagraph id="H0C87E20B5E494D39AFEB701A07F47201" commented="no">
<enum>(D)</enum>
<text>to restrict in any manner, the prescribing of antibiotics or other products by health care providers, or to otherwise limit or restrict the practice of health care.</text>
</subparagraph>
</paragraph>
<paragraph id="HC92C945896B14D01A5E2FA2025A357CC" commented="no">
<enum>(8)</enum>
<header>Effective immediately</header>
<text>The Secretary shall have the authorities vested in the Secretary by this subsection beginning on the date of enactment of this subsection, irrespective of when and whether the Secretary promulgates final regulations or guidance.</text>
</paragraph>
<paragraph id="HFC8D171F04594544B424EB87C1EDC6D5" commented="no">
<enum>(9)</enum>
<header>Definitions</header>
<text>In this subsection:</text>
<subparagraph id="H593412ECF6C54C9CBAB2CB74BD5A2E87" commented="no">
<enum>(A)</enum>
<header>Early consultation meeting</header>
<text>The term <quote>early consultation meeting</quote> means a pre-investigational new drug meeting or an end-of-phase-1 meeting that—</text>
<clause id="H283D95FFCC824519A3212190059DD9E4" commented="no">
<enum>(i)</enum>
<text>is conducted to review and reach a written agreement—</text>
<subclause id="H1678D3A7AF7A4746B38260554A74B083" commented="no">
<enum>(I)</enum>
<text>on the scope of the streamlined development plan for a drug for which a sponsor intends to request approval in accordance with this subsection; and</text>
</subclause>
<subclause id="HAF1044AFF424400CAB96B7877CD1C62E" commented="no">
<enum>(II)</enum>
<text display-inline="yes-display-inline">which, as appropriate, may include agreement on the design and size of necessary preclinical and clinical studies early in the development process, including clinical trials whose data are intended to form the primary basis for an effectiveness claim; and</text>
</subclause>
</clause>
<clause id="HE433BF48C1554963B77B82445DB0CA6E" commented="no">
<enum>(ii)</enum>
<text>provides an opportunity to discuss expectations of the Secretary regarding studies or other information that the Secretary deems appropriate for purposes of applying paragraph (5), relating to the termination of labeling requirements or postmarketing conditions.</text>
</clause>
</subparagraph>
<subparagraph id="HCACA90FA96DD4432B37F36AF9AEECBCD" commented="no">
<enum>(B)</enum>
<header>Assessment meeting</header>
<text>The term <quote>assessment meeting</quote> means an end-of-phase 2 meeting, pre-new drug application meeting, or pre-biologics license application meeting conducted to resolve questions and issues raised during the course of clinical investigations, and details addressed in the written agreement regarding postapproval commitments or expansion of approved uses.</text>
</subparagraph>
<subparagraph id="H43545AC699F44B28B77EB9C5408E8F21" commented="no">
<enum>(C)</enum>
<header>Postapproval meeting</header>
<text>The term <quote>postapproval meeting</quote> means a meeting following initial approval or licensure of the drug for use in a limited population, to discuss any issues identified by the Secretary or the sponsor regarding postapproval commitments or expansion of approved uses.</text>
</subparagraph>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="H0A72FFA8BBC742009EEA2FF0CAB848F9">
<enum>(c)</enum>
<header>Guidance</header>
<text>Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance describing criteria, process, and other general considerations for demonstrating the safety and effectiveness of antibacterial and antifungal drugs to be approved for use in a limited population in accordance with section 505(z) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b).</text>
</subsection>
<subsection id="H7483BCABB1DB4BBC8504E51BCBDC968F">
<enum>(d)</enum>
<header>Conforming amendments</header>
<paragraph id="H65525AC11A4E4B69B5DEDBD03D5CE03A">
<enum>(1)</enum>
<header>Licensure of certain biological products</header>
<text>Section 351(j) of the Public Health Service Act (42 U.S.C. 262(j)) is amended—</text>
<subparagraph id="H83A6721979144147A4514AA54D19FCD2">
<enum>(A)</enum>
<text>by striking <quote>(j)</quote> and inserting <quote>(j)(1)</quote>;</text>
</subparagraph>
<subparagraph id="HE2210A725F42406D878B96E4AD1F0741">
<enum>(B)</enum>
<text>by inserting <quote>505(z),</quote> after <quote>505(p),</quote>; and</text>
</subparagraph>
<subparagraph id="H0AD80175B1414BD2BBFF61943BC0322B">
<enum>(C)</enum>
<text>by adding at the end the following new paragraph:</text>
<quoted-block id="HE604F28C20464AD39E5248E795C0B0C6" style="OLC">
<paragraph id="HFEEB09E13F9F4111BDC33B6940D707C9" indent="up1">
<enum>(2)</enum>
<text>In applying section 505(z) of the Federal Food, Drug, and Cosmetic Act to the licensure of biological products under this section—</text>
<subparagraph id="H902250C3BD164FB1A43963FA326A81DC">
<enum>(A)</enum>
<text>references to an antibacterial or antifungal drug that is intended to treat a serious or life-threatening infection shall be construed to refer to a biological product intended to treat a serious or life-threatening bacterial or fungal infection; and</text>
</subparagraph>
<subparagraph id="HF16B8B70B1DD4C53AC2B504DA6C277A7">
<enum>(B)</enum>
<text>references to approval of a drug under section 505(c) of such Act shall be construed to refer to a licensure of a biological product under subsection (a) of this section.</text>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subparagraph>
</paragraph>
<paragraph id="HCEC9F825EEEA4C3FB9B6F89B123F3EC6">
<enum>(2)</enum>
<header>Misbranding</header>
<text display-inline="yes-display-inline">Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the following new subsection: </text>
<quoted-block style="traditional" id="H51FDECE1867B4CB0BDC7D864D104761B" display-inline="no-display-inline">
<subsection id="HF8312FA15EA74CA093EAD5924CBE5BBA">
<enum>(dd)</enum>
<text display-inline="yes-display-inline">If it is a drug approved in accordance with section 505(z) and its labeling does not meet the requirements under paragraph (3) of such subsection, subject to paragraph (5) of such subsection.</text>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="H5B174AFFE676448281CBCC30AB76509F">
<enum>(e)</enum>
<header>Evaluation</header>
<paragraph id="HC091B693DA6143A0BA6616C36BC4B969">
<enum>(1)</enum>
<header>Assessment</header>
<text>Not later than 48 months after the date of enactment of this Act, the Secretary of Health and Human Services shall publish for public comment an assessment of the program established under section 505(z) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b). Such assessment shall determine if the limited-use pathway established under such section 505(z) has improved or is likely to improve patient access to novel antibacterial or antifungal treatments and assess how the pathway could be expanded to cover products for serious or life-threatening diseases or conditions beyond bacterial and fungal infections.</text>
</paragraph>
<paragraph id="H19512D9122434A128BF584BC45EC4A41">
<enum>(2)</enum>
<header>Meeting</header>
<text display-inline="yes-display-inline">Not later than 90 days after the date of the publication of such assessment, the Secretary, acting through the Commissioner of Food and Drugs, shall hold a public meeting to discuss the findings of the assessment, during which public stakeholders may present their views on the success of the program established under section 505(z) of the Federal Food, Drug, and Cosmetic Act, as added by subsection (b), and the appropriateness of expanding such program.</text>
</paragraph>
</subsection>
<subsection id="HBA5C54AB3A4E4BF1802228330C265B0E">
<enum>(f)</enum>
<header>Expansion of program</header>
<text>If the Secretary of Health and Human Services determines, based on the assessment under subsection (e)(1), evaluation of the assessment, and any other relevant information, that the public health would benefit from expansion of the limited-use pathway established under section 505(z) of the Federal Food, Drug, and Cosmetic Act (as added by subsection (b)) beyond the drugs approved in accordance with such section, the Secretary may expand such limited-use pathway in accordance with such a determination. The approval of any drugs under any such expansion shall be subject to the considerations and requirements described in such section 505(z) for purposes of expansion to other serious or life-threatening diseases or conditions.</text>
</subsection>
<subsection id="H70C2E83067CB40D183CDA0F642717672">
<enum>(g)</enum>
<header>Monitoring</header>
<text>The Public Health Service Act is amended by inserting after section 317T (42 U.S.C. 247b–22) the following:</text>
<quoted-block style="OLC" id="HB98A9E14A0EF471C950D0EF3C4790F75" display-inline="no-display-inline">
<section id="H2938884BE19F40ABB34983F929368B89">
<enum>317U.</enum>
<header>Monitoring antibacterial and antifungal drug use and resistance</header>
<subsection id="H4F2F5F9A73694227AF1CA066ABD948A4">
<enum>(a)</enum>
<header>Monitoring</header>
<text>The Secretary shall use an appropriate monitoring system to monitor—</text>
<paragraph id="HB35E8745BE944B8E8B5C0E6D1FE13433">
<enum>(1)</enum>
<text>the use of antibacterial and antifungal drugs, including those receiving approval or licensure for a limited population pursuant to section 505(z) of the Federal Food, Drug, and Cosmetic Act; and</text>
</paragraph>
<paragraph id="H580794C402104C0188719A20BB891889">
<enum>(2)</enum>
<text>changes in bacterial and fungal resistance to drugs.</text>
</paragraph>
</subsection>
<subsection id="HA791CB9059304E388BD5F23105C4FB5D">
<enum>(b)</enum>
<header>Public availability of data</header>
<text>The Secretary shall make summaries of the data derived from monitoring under this section publicly available for the purposes of—</text>
<paragraph id="HD29029E0E9A0458D9D1EE277A06EE5A6">
<enum>(1)</enum>
<text>improving the monitoring of important trends in antibacterial and antifungal resistance; and</text>
</paragraph>
<paragraph id="H7329BE5F156847FCAA9443488B4E67DD">
<enum>(2)</enum>
<text>ensuring appropriate stewardship of antibacterial and antifungal drugs, including those receiving approval or licensure for a limited population pursuant to section 505(z) of the Federal Food, Drug, and Cosmetic Act.</text>
</paragraph>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
</section>
<section id="H1EC2A2549CFF4A9DA176FA7BC3FD7675" commented="no">
<enum>2122.</enum>
<header>Susceptibility test interpretive criteria for microorganisms</header>
<subsection id="HCEFC3524819E4A398666ADAE6B147D5B" commented="no">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 511 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360a) is amended to read as follows:</text>
<quoted-block id="H6890A30D9E6C469BA5E570BA890896C6" style="OLC">
<section id="HBC1AC9915F87490F8EF0F1524F20B6BF" commented="no">
<enum>511.</enum>
<header>Identifying and updating susceptibility test interpretive criteria for microorganisms</header>
<subsection id="HBCA918AEDBB748C6A98C37838B8CEE9D" commented="no">
<enum>(a)</enum>
<header>Purpose; Identification of criteria</header>
<paragraph id="HDAD517A92F2D4DB6A51908D623B0BC74" commented="no">
<enum>(1)</enum>
<header>Purpose</header>
<text>The purpose of this section is to provide the Secretary with an expedited, flexible method for—</text>
<subparagraph id="HDB05A1C92F77479DA7C8A71E126BF5D9" commented="no">
<enum>(A)</enum>
<text>clearance or premarket approval of antimicrobial susceptibility testing devices utilizing updated, recognized susceptibility test interpretive criteria to characterize the in vitro susceptibility of particular bacteria, fungi, or other microorganisms to antimicrobial drugs; and</text>
</subparagraph>
<subparagraph id="H8E526314275D49CE90E49A05237E7EF1" commented="no">
<enum>(B)</enum>
<text>providing public notice of the availability of recognized interpretive criteria to meet premarket submission requirements or other requirements under this Act for antimicrobial susceptibility testing devices.</text>
</subparagraph>
</paragraph>
<paragraph id="H6E2084E281F747DBB5F2A7A8A8D0F835" commented="no">
<enum>(2)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall identify appropriate susceptibility test interpretive criteria with respect to antimicrobial drugs—</text>
<subparagraph id="H677C1E9F5CCE4D49979F34578D43774D" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">if such criteria are available on the date of approval of the drug under section 505 of this Act or licensure of the drug under section 351 of the Public Health Service Act (as applicable), upon such approval or licensure; or</text>
</subparagraph>
<subparagraph id="H1A9E5D6604EF4161AE040F7F3EA1FE23" commented="no">
<enum>(B)</enum>
<text>if such criteria are unavailable on such date, on the date on which such criteria are available for such drug.</text>
</subparagraph>
</paragraph>
<paragraph id="HD8D9DA84AF36493FA68C1D3DE7FF165E" commented="no">
<enum>(3)</enum>
<header>Bases for initial identification</header>
<text display-inline="yes-display-inline">The Secretary shall identify appropriate susceptibility test interpretive criteria under paragraph (2), based on the Secretary’s review of, to the extent available and relevant—</text>
<subparagraph id="H68C1C4CA56B64CE2AB675957E45F61A1" commented="no">
<enum>(A)</enum>
<text>preclinical and clinical data, including pharmacokinetic, pharmacodynamic, and epidemiological data;</text>
</subparagraph>
<subparagraph id="HC505BDA108FC487B9654A1623529B68B" commented="no">
<enum>(B)</enum>
<text>Bayesian and pharmacometric statistical methodologies; and</text>
</subparagraph>
<subparagraph id="H09A0286044D54687ACD733283ED4BE3B" commented="no">
<enum>(C)</enum>
<text>such other evidence and information as the Secretary considers appropriate.</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H1A6681F70BD5469397003B9ECB07BA4B" commented="no">
<enum>(b)</enum>
<header>Susceptibility test Interpretive Criteria Website</header>
<paragraph id="HECFC67B9D0784B1E92C473C89DFD3442" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Not later than 1 year after the date of the enactment of the <short-title>21st Century Cures Act</short-title>, the Secretary shall establish, and maintain thereafter, on the website of the Food and Drug Administration, a dedicated website that contains a list of any appropriate new or updated susceptibility test interpretive criteria standards in accordance with paragraph (2) (referred to in this section as the <quote>Interpretive Criteria Website</quote>).</text>
</paragraph>
<paragraph id="H8DE695B494F64F06804C2BD985B2115A" commented="no">
<enum>(2)</enum>
<header>Listing of susceptibility test interpretive criteria standards</header>
<subparagraph id="HB985A99B72134D4BA5819AD13F898B0F" commented="no">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The list described in paragraph (1) shall consist of any new or updated susceptibility test interpretive criteria standards that are—</text>
<clause id="HE8075D7343C1440E80D1485871D14837" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline">established by a nationally or internationally recognized standard development organization that—</text>
<subclause id="H882DCEFEA16B4423950AD39D33333A41" commented="no">
<enum>(I)</enum>
<text display-inline="yes-display-inline">establishes and maintains procedures to address potential conflicts of interest and ensure transparent decisionmaking; </text>
</subclause>
<subclause id="HA5C857CE4C424A3EBFBC66C626AF6905" commented="no">
<enum>(II)</enum>
<text display-inline="yes-display-inline">holds open meetings to ensure that there is an opportunity for public input by interested parties, and establishes and maintains processes to ensure that such input is considered in decisionmaking; and</text>
</subclause>
<subclause id="H3923884452D045A1B748C138A06F6824" commented="no">
<enum>(III)</enum>
<text display-inline="yes-display-inline">permits its standards to be made publicly available, through the National Library of Medicine or another similar source acceptable to the Secretary; and</text>
</subclause>
</clause>
<clause id="HCB07E168CA0E4F288E2FA3C3C6C4045D" commented="no">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">recognized in whole, or in part, by the Secretary under subsection (c).</text>
</clause>
</subparagraph>
<subparagraph id="H11893506C64D48D3894BEB3B8F00C734" commented="no">
<enum>(B)</enum>
<header>Other list</header>
<text display-inline="yes-display-inline">The Interpretive Criteria Website shall, in addition to the list described in subparagraph (A), include a list of interpretive criteria, if any, that the Secretary has determined to be appropriate with respect to legally marketed antimicrobial drugs, where—</text>
<clause id="H38ACA54E1C344F259FCAD2BAE1B08FCB" commented="no">
<enum>(i)</enum>
<text>the Secretary does not recognize, in whole or in part, an interpretive criteria standard described under subparagraph (A) otherwise applicable to such a drug;</text>
</clause>
<clause id="HB7AAF688237D4CDB985DADBF1C118D9A" commented="no">
<enum>(ii)</enum>
<text>the Secretary withdraws under subsection (c)(1)(B) recognition of a standard, in whole or in part, otherwise applicable to such a drug;</text>
</clause>
<clause id="H5CD7750038964CBEB7BE2B8180668CF6" commented="no">
<enum>(iii)</enum>
<text>the Secretary approves an application under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, with respect to marketing of such a drug for which there are no relevant interpretive criteria included in a standard recognized by the Secretary under subsection (c); or</text>
</clause>
<clause id="H6E35CE8B260442B28F3454AC6E9898C1" commented="no">
<enum>(iv)</enum>
<text>because the characteristics of such a drug differ from other drugs with the same active ingredient, the interpretive criteria with respect to such drug—</text>
<subclause id="H00C0EA00E41E4025A0EF1F61CC162C37" commented="no">
<enum>(I)</enum>
<text>differ from otherwise applicable interpretive criteria included in a standard listed under subparagraph (A) or interpretive criteria otherwise listed under this subparagraph; and</text>
</subclause>
<subclause id="HF22C89CBBE624BC48FD8AD5C2A02C6F1" commented="no">
<enum>(II)</enum>
<text>are determined by the Secretary to be appropriate for the drug.</text>
</subclause>
</clause>
</subparagraph>
<subparagraph id="H8B7324E3DA574D06806059C7D9A9DDD8" commented="no">
<enum>(C)</enum>
<header>Required statements of limitations of information</header>
<text>The Interpretive Criteria Website shall include the following:</text>
<clause id="H61BA767A6FFB459B9C018BAA9D4A8CE7" commented="no">
<enum>(i)</enum>
<text>A statement that—</text>
<subclause id="HDAA39BBA4B404E768E32F7ABA35C991D" commented="no">
<enum>(I)</enum>
<text>the website provides information about the susceptibility of bacteria, fungi, or other microorganisms to a certain drug (or drugs); and</text>
</subclause>
<subclause id="H6CDC93DCC2B5450C98171CB60902A91E" commented="no">
<enum>(II)</enum>
<text>the safety and efficacy of the drug in treating clinical infections due to such bacteria, fungi, or other microorganisms may not have been established in adequate and well-controlled clinical trials and the clinical significance of such susceptibility information in such trials is unknown.</text>
</subclause>
</clause>
<clause id="HE3A1CD2009F94BDFBCDA660ED17D4597" commented="no">
<enum>(ii)</enum>
<text>A statement that directs health care practitioners to consult the approved product labeling for specific drugs to determine the uses for which the Food and Drug Administration has approved the product.</text>
</clause>
<clause id="H7D8CC6E74AC246658DEC1D721D992B95" commented="no">
<enum>(iii)</enum>
<text>Any other statement that the Secretary determines appropriate to adequately convey the limitations of the data supporting susceptibility test interpretive criteria standard listed on the website.</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H67A119C0B472443690BA15342C4CCAFF" commented="no">
<enum>(3)</enum>
<header>Notice</header>
<text>Not later than the date on which the Interpretive Criteria Website is established, the Secretary shall publish a notice of that establishment in the Federal Register.</text>
</paragraph>
<paragraph id="HFEDED3738052414FA75CDF46FFDE0623" commented="no">
<enum>(4)</enum>
<header>Inapplicability of misbranding provision</header>
<text display-inline="yes-display-inline">The inclusion in the approved labeling of an antimicrobial drug of a reference or hyperlink to the Interpretive Criteria Website, in and of itself, shall not cause the drug to be misbranded in violation of section 502, or the regulations promulgated thereunder.</text>
</paragraph>
<paragraph id="H64A4D9DFA7E84FDDBF2F1FB527C4C757" commented="no">
<enum>(5)</enum>
<header>Trade secrets and confidential information</header>
<text display-inline="yes-display-inline">Nothing in this section shall be construed as authorizing the Secretary to disclose any information that is a trade secret or confidential information subject to section 552(b)(4) of title 5, United States Code.</text>
</paragraph>
</subsection>
<subsection id="H768A66EA26F14089A5411B83A624CB0D" commented="no">
<enum>(c)</enum>
<header>Recognition of susceptibility test interpretive criteria from standard development organizations</header>
<paragraph id="HF735AEC2AA9D4C67BEAA87507A5A9688" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Beginning on the date of the establishment of the Interpretive Criteria Website, and at least every 6 months thereafter, the Secretary shall—</text>
<subparagraph id="H7951C7ED020745C8992168CF9FEB82A2" commented="no">
<enum>(A)</enum>
<text>evaluate any appropriate new or updated susceptibility test interpretive criteria standards established by a nationally or internationally recognized standard development organization described in subsection (b)(2)(A)(i); and</text>
</subparagraph>
<subparagraph id="H93CCA115600743AA874B17A1F0D7D96D" commented="no">
<enum>(B)</enum>
<text>publish on the public website of the Food and Drug Administration a notice<italic></italic>—</text>
<clause id="H2AC9C50BE79642EDA1FFE551795A3792" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline">withdrawing recognition of any different susceptibility test interpretive criteria standard, in whole or in part;</text>
</clause>
<clause id="HC82D7BBE189144C8BB3EED45A73A6B1E" commented="no">
<enum>(ii)</enum>
<text>recognizing the new or updated standards;</text>
</clause>
<clause id="H0BA6845ADA2447BB92BC5416DAAA8C5F" commented="no">
<enum>(iii)</enum>
<text>recognizing one or more parts of the new or updated interpretive criteria specified in such a standard and declining to recognize the remainder of such standard; and</text>
</clause>
<clause id="HF44DE2B6AB35446CBBB25FCB12D390E1" commented="no">
<enum>(iv)</enum>
<text>making any necessary updates to the lists under subsection (b)(2).</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H3BDC16DA9CCF4B979B67C469B95E002D" commented="no">
<enum>(2)</enum>
<header>Bases for updating interpretive criteria standards</header>
<text display-inline="yes-display-inline">In evaluating new or updated susceptibility test interpretive criteria standards under paragraph (1)(A), the Secretary may consider—</text>
<subparagraph id="HDB2BFD3E34104926A43CCF89114E45BA" commented="no">
<enum>(A)</enum>
<text>the Secretary’s determination that such a standard is not applicable to a particular drug because the characteristics of the drug differ from other drugs with the same active ingredient;</text>
</subparagraph>
<subparagraph id="HDE4577821B1F4C71A681C8B5AF40AF83" commented="no">
<enum>(B)</enum>
<text>information provided by interested third parties, including public comment on the annual compilation of notices published under paragraph (3);</text>
</subparagraph>
<subparagraph id="HF197FA4455C94D37A1C5F5836E56FE2C" commented="no">
<enum>(C)</enum>
<text>any bases used to identify susceptibility test interpretive criteria under subsection (a)(2); and</text>
</subparagraph>
<subparagraph id="H0036BB46A7384BA4AD43CF8BDE386FC6" commented="no">
<enum>(D)</enum>
<text>such other information or factors as the Secretary determines appropriate.</text>
</subparagraph>
</paragraph>
<paragraph id="H84AF69511CC04141A0C0B128712F5970" commented="no">
<enum>(3)</enum>
<header>Annual compilation of notices</header>
<text display-inline="yes-display-inline">Each year, the Secretary shall compile the notices published under paragraph (1)(B) and publish such compilation in the Federal Register and provide for public comment. If the Secretary receives comments, the Secretary shall review such comments and, if the Secretary determines appropriate, update pursuant to this subsection susceptibility test interpretive criteria standards—</text>
<subparagraph id="HADFDDED16A8F40F797ACE76BC789EDFA" commented="no">
<enum>(A)</enum>
<text>recognized by the Secretary under this subsection; or</text>
</subparagraph>
<subparagraph id="H8BAA87393E5442F6AC5E9B16A45EF0FF" commented="no">
<enum>(B)</enum>
<text>otherwise listed on the Interpretive Criteria Website under subsection (b)(2).</text>
</subparagraph>
</paragraph>
<paragraph id="HB38047306B304B588193192A4F941D0D" commented="no">
<enum>(4)</enum>
<header>Relation to section 514(<enum-in-header>c</enum-in-header>)</header>
<text display-inline="yes-display-inline">Any susceptibility test interpretive standard recognized under this subsection or any criteria otherwise listed under subsection (b)(2)(B) shall be deemed to be recognized as a standard by the Secretary under section 514(c)(1). </text>
</paragraph>
<paragraph id="HCA9E4C123C224EE89DF64D793515F5E1" commented="no">
<enum>(5)</enum>
<header>Voluntary use of interpretive criteria</header>
<text>Nothing in this section prohibits a person from seeking approval or clearance of a drug or device, or changes to the drug or the device, on the basis of susceptibility test interpretive criteria standards which differ from those recognized pursuant to paragraph (1).</text>
</paragraph>
</subsection>
<subsection id="H2C9E8D245FAE40BCAE34A2EF08E517CD" commented="no">
<enum>(d)</enum>
<header>Antimicrobial drug labeling</header>
<paragraph id="H4E423CA89917455D9C67890A020CC064" commented="no">
<enum>(1)</enum>
<header>Drugs marketed prior to establishment of Interpretive Criteria Website</header>
<text>With respect to an antimicrobial drug lawfully introduced or delivered for introduction into interstate commerce for commercial distribution before the establishment of the Interpretive Criteria Website, a holder of an approved application under section 505 of this Act or section 351 of the Public Health Service Act, as applicable, for each such drug—</text>
<subparagraph id="H4AFE3C96432046BBB09E554DA8154ECB" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">not later than 1 year after establishment of the Interpretive Criteria Website, shall submit to the Secretary a supplemental application for purposes of changing the drug’s labeling to substitute a reference or hyperlink to such Website for any susceptibility test interpretive criteria and related information; and</text>
</subparagraph>
<subparagraph id="H2A6F85F7C1F0446DAB1284FAA2F1FB11" commented="no">
<enum>(B)</enum>
<text>may begin distribution of the drug involved upon receipt by the Secretary of the supplemental application for such change.</text>
</subparagraph>
</paragraph>
<paragraph id="HE88CF0B9E3234B15BA5614C385C5CA4D" commented="no">
<enum>(2)</enum>
<header>Drugs marketed subsequent to establishment of Interpretive Criteria Website</header>
<text display-inline="yes-display-inline">With respect to antimicrobial drugs lawfully introduced or delivered for introduction into interstate commerce for commercial distribution on or after the date of the establishment of the Interpretive Criteria Website, the labeling for such a drug shall include, in lieu of susceptibility test interpretive criteria and related information, a reference to such Website. </text>
</paragraph>
</subsection>
<subsection id="HB1737DEF26FD45F5875304C28BDA32C3" commented="no">
<enum>(e)</enum>
<header>Special condition for marketing of antimicrobial susceptibility testing devices</header>
<paragraph id="HCFF22ECFD21D4E68AC961ED8A86C3A86" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Notwithstanding sections 501, 502, 510, 513, and 515, if the conditions specified in paragraph (2) are met (in addition to other applicable provisions under this chapter) with respect to an antimicrobial susceptibility testing device described in subsection (f)(1), the Secretary may authorize the marketing of such device for a use described in such subsection.</text>
</paragraph>
<paragraph id="HC5DF6C955F064CAB848132F2D76A36BF" commented="no">
<enum>(2)</enum>
<header>Conditions applicable to antimicrobial susceptibility testing devices</header>
<text display-inline="yes-display-inline">The conditions specified in this paragraph are the following:</text>
<subparagraph id="HCD358084DB494A03A280425E3AC73376" commented="no">
<enum>(A)</enum>
<text>The device is used to make a determination of susceptibility using susceptibility test interpretive criteria that are—</text>
<clause id="H74D066F0EEB94109BC6A3BDB99CB1210" commented="no">
<enum>(i)</enum>
<text>included in a standard recognized by the Secretary under subsection (c); or </text>
</clause>
<clause id="H0C0D761C6E2F42EFB75328925D43312D" commented="no">
<enum>(ii)</enum>
<text>otherwise listed on the Interpretive Criteria Website under subsection (b)(2).</text>
</clause>
</subparagraph>
<subparagraph id="H1CCF3B133CA948C2AB69E3DE0622FA31" commented="no">
<enum>(B)</enum>
<text>The labeling of such device prominently and conspicuously—</text>
<clause id="H1DD8EF6C8A35474E964ED2BBD0A29064" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline">
<italic>
</italic>
<italic>
</italic>includes a statement that—</text>
<subclause id="HECA14C9027E240D894054004D46F4CEB" commented="no">
<enum>(I)</enum>
<text>the device provides information about the susceptibility of bacteria and fungi to certain drugs; and</text>
</subclause>
<subclause id="H959357E9F2384810B643A4FC6EC9A21E" commented="no">
<enum>(II)</enum>
<text display-inline="yes-display-inline">the safety and efficacy of such drugs in treating clinical infections due to such bacteria or fungi may not have been established in adequate and well-controlled clinical trials and the clinical significance of such susceptibility information in those instances is unknown;</text>
</subclause>
</clause>
<clause id="H56187A43DC8545C5826C4F4C1FF36002" commented="no">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">includes a statement directing health care practitioners to consult the approved labeling for drugs tested using such a device, to determine the uses for which the Food and Drug Administration has approved such drugs; and</text>
</clause>
<clause id="HFC5FFDDBE2CE4C5EB3739B6CC1BBEFAB" commented="no">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">includes any other statement the Secretary determines appropriate to adequately convey the limitations of the data supporting the interpretive criteria described in subparagraph (A).</text>
</clause>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H011F207DD57D4011BD4E8011F52C481C" commented="no">
<enum>(f)</enum>
<header>Definitions</header>
<text>In this section:</text>
<paragraph id="HD108D87C31704D79B4893F13535FB711" commented="no">
<enum>(1)</enum>
<text display-inline="yes-display-inline">The term <quote>antimicrobial susceptibility testing device</quote> means a device that utilizes susceptibility test interpretive criteria to determine and report the in vitro susceptibility of certain microorganisms to a drug (or drugs).</text>
</paragraph>
<paragraph id="H15D98111FEA64E85A2732760166410F4" commented="no">
<enum>(2)</enum>
<text>The term <quote>qualified infectious disease product</quote> means a qualified infectious disease product designated under section 505E(d).</text>
</paragraph>
<paragraph id="H9844522C829A42B794E43AD4878EEB8F" commented="no">
<enum>(3)</enum>
<text display-inline="yes-display-inline">The term <term>susceptibility test interpretive criteria</term> means—</text>
<subparagraph id="H692E6328A7E144D29F94921DC0E2C623" commented="no">
<enum>(A)</enum>
<text>one or more specific numerical values which characterize the susceptibility of bacteria or other microorganisms to the drug tested; and</text>
</subparagraph>
<subparagraph id="HCD2D474B66E243A0BD7676185AFF6934" commented="no">
<enum>(B)</enum>
<text>related categorizations of such susceptibility, including categorization of the drug as susceptible, intermediate, resistant, or such other term as the Secretary determines appropriate.</text>
</subparagraph>
</paragraph>
<paragraph commented="no" id="H0065779909AD4A5BB54AA2FA75E52120">
<enum>(4)</enum>
<subparagraph id="H6E49C945BAA742ECA47A5E91C1F61563" display-inline="yes-display-inline" commented="no">
<enum>(A)</enum>
<text>The term <quote>antimicrobial drug</quote> means, subject to subparagraph (B), a systemic antibacterial or antifungal drug that—</text>
<clause id="H59EEA065571342B4A7086C166E31C7A7" indent="up1" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline">is intended for human use in the treatment of a disease or condition caused by a bacterium or fungus;</text>
</clause>
<clause id="HFE9C5C3D08F9480DB17EB824F9CC8F90" indent="up1" commented="no">
<enum>(ii)</enum>
<text>may include a qualified infectious disease product designated under section 505E(d); and</text>
</clause>
<clause id="H027574C18DCD42CFBFDC1A3F2E6C0AF6" indent="up1" commented="no">
<enum>(iii)</enum>
<text>is subject to section 503(b)(1).</text>
</clause>
</subparagraph>
<subparagraph id="H66AF8D29DDA84EF6907437E32328B1C8" indent="up1" commented="no">
<enum>(B)</enum>
<text>If provided by the Secretary through regulations, such term may include—</text>
<clause id="H43D438E01038429FB474AD06A459E450" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline"> drugs other than systemic antibacterial and antifungal drugs; and</text>
</clause>
<clause id="H0B209A621E5340FD9D5EF97356C2B7E1" commented="no">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">biological products (as such term is defined in section 351 of the Public Health Service Act) to the extent such products exhibit antimicrobial activity. <italic></italic></text>
</clause>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H246B5D6A61B5457392B2EC2DCB24A62E" commented="no">
<enum>(g)</enum>
<header>Rule of construction</header>
<text display-inline="yes-display-inline">Nothing in this section shall be construed—</text>
<paragraph id="H91DB226E53E849EE93832B4A158EDDF1" commented="no">
<enum>(1)</enum>
<text>to alter the standards of evidence—</text>
<subparagraph id="H08C76DEA16D84030A4C8802A2D511DCC" commented="no">
<enum>(A)</enum>
<text>under subsection (c) or (d) of section 505, including the substantial evidence standard in section 505(d), or under section 351 of the Public Health Service Act (as applicable); or</text>
</subparagraph>
<subparagraph id="HB7424CCF39A74EC39E27544B2C8FCA3D" commented="no">
<enum>(B)</enum>
<text>with respect to marketing authorization for devices, under section 510, 513, or 515; </text>
</subparagraph>
</paragraph>
<paragraph id="H883AA85500434095A9711C77375F01B3" commented="no">
<enum>(2)</enum>
<text>to apply with respect to any drug, device, or biological product, in any context other than—</text>
<subparagraph id="H6618E694D335407D9B4640669C542B48">
<enum>(A)</enum>
<text>an antimicrobial drug; or</text>
</subparagraph>
<subparagraph id="H7BF4BC2D9BF443F59ECDCDDF1456CC75">
<enum>(B)</enum>
<text display-inline="yes-display-inline">an antimicrobial susceptibility testing device that uses susceptibility test interpretive criteria to characterize and report the in vitro susceptibility of certain bacteria, fungi, or other microorganisms to antimicrobial drugs in accordance with this section; or</text>
</subparagraph>
</paragraph>
<paragraph id="H5027B6BD8B3949F09638B9B25398B030" commented="no">
<enum>(3)</enum>
<text>unless specifically stated, to have any effect on authorities provided under other sections of this Act, including any regulations issued under such sections.</text>
</paragraph>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="H338FE02D57984F6789E3AAC0474BF712" commented="no">
<enum>(b)</enum>
<header>Conforming amendments</header>
<paragraph id="H213BF316B0E047BEBC7759DBA3BAC7A6" commented="no">
<enum>(1)</enum>
<header>Repeal of related authority</header>
<text>Section 1111 of the Food and Drug Administration Amendments Act of 2007 (42 U.S.C. 247d–5a; relating to identification of clinically susceptible concentrations of antimicrobials) is repealed.</text>
</paragraph>
<paragraph id="HD32393E1D91B45DBBA66376D877EFB00">
<enum>(2)</enum>
<header>Clerical amendment</header>
<text display-inline="yes-display-inline">The table of contents in section 2 of the Food and Drug Administration Amendments Act of 2007 is amended by striking the item relating to section 1111.</text>
</paragraph>
<paragraph id="HEE81AF36E58340A4856874C26E92D584" commented="no">
<enum>(3)</enum>
<header>Misbranding</header>
<text display-inline="yes-display-inline">Section 502 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352), as amended by section 2121, is further amended by adding at the end the following:</text>
<quoted-block style="traditional" id="HFDE3FA592B5B4B8894A1DC9A200158C8" display-inline="no-display-inline">
<subsection id="HD98DDB90A04F4CB99E0CCDD29CFF7164" commented="no">
<enum>(ee)</enum>
<text display-inline="yes-display-inline">If it is an antimicrobial drug and its labeling fails to conform with the requirements under section 511(d).</text>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H9891A3D89B524CEF9C5DA41209727BE5" commented="no">
<enum>(4)</enum>
<header>Recognition of interpretive criteria as device standard</header>
<text display-inline="yes-display-inline">Section 514(c)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)(1)(A)) is amended by inserting after <quote>the Secretary shall, by publication in the Federal Register</quote> the following: <quote>(or, with respect to susceptibility test interpretive criteria or standards recognized or otherwise listed under section 511, by posting on the Interpretive Criteria Website in accordance with such section)</quote>.<italic></italic></text>
</paragraph>
</subsection>
<subsection id="HF7D801D2C85C4C17A39F6C0649C7E9D0" commented="no">
<enum>(c)</enum>
<header>Report to Congress</header>
<text display-inline="yes-display-inline">Not later than two years after the date of enactment of this Act, the Secretary of Health and Human Services shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report on the progress made in implementing section 511 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360a), as amended by this section.</text>
</subsection>
<subsection id="H43DD1385A98C4BDAB9D2631668981641" commented="no">
<enum>(d)</enum>
<header>Requests for updates to Interpretive Criteria Website</header>
<text display-inline="yes-display-inline">Chapter 35 of title 44, United States Code, shall not apply to the collection of information from interested parties regarding the updating of lists under paragraph (2) of subsection (b) section 511 of the Federal Food, Drug, and Cosmetic Act (as amended by subsection (a)) and posted on the Interpretive Criteria Website established under paragraph (1) of such subsection (b).</text>
</subsection>
<subsection id="HC7B0CFB63DD64D94B3206097D909445B" commented="no">
<enum>(e)</enum>
<header>No effect on health care practice</header>
<text>Nothing in this subtitle (including the amendments made by this subtitle) shall be construed to restrict, in any manner, the prescribing or administering of antibiotics or other products by health care practitioners, or to limit the practice of health care.</text>
</subsection>
</section>
<section id="H079C44E6C0C845768EA17E36FD339CE7" section-type="subsequent-section">
<enum>2123.</enum>
<header>Encouraging the development and use of DISARM drugs</header>
<subsection id="HDA4DC00B923546E98E371FE84569030F">
<enum>(a)</enum>
<header>Additional payment for DISARM drugs under Medicare</header>
<paragraph id="H128E263F33884E5895C0BB40DBB2B4D1">
<enum>(1)</enum>
<header>In general</header>
<text>Section 1886(d)(5) of the Social Security Act (42 U.S.C. 1395ww(d)(5)) is amended by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" id="H2EE0488E52A4413D81E2E6DEFCAC4BF4">
<subparagraph id="H4A4A28E8B97A44728A4EF3C9AAA1D8EA" commented="no" indent="up2">
<enum>(M)</enum>
<clause id="H865102C91AFE4AA59F1320282348344E" commented="no" display-inline="yes-display-inline">
<enum>(i)</enum>
<text display-inline="yes-display-inline">As part of the annual rulemaking conducted with respect to payment for subsection (d) hospitals for each fiscal year beginning with fiscal year 2018, the Secretary shall—</text>
<subclause id="HE75A994BE618405CA05620BAC672860B" display-inline="no-display-inline" indent="up1">
<enum>(I)</enum>
<text display-inline="yes-display-inline">include a list of the DISARM drugs for such fiscal year; and</text>
</subclause>
<subclause id="H198DDDA4C147457392C8441A566F8B14" indent="up1">
<enum>(II)</enum>
<text display-inline="yes-display-inline">with respect to discharges by eligible hospitals that involve a drug so listed, provide for an additional payment to be made under this subsection in accordance with the provisions of this subparagraph.</text>
</subclause>
</clause>
<clause id="H84B37A3718514B2798B71D0C698DBAB5" indent="up1">
<enum>(ii)</enum>
<text>Additional payments may not be made for a drug under this subparagraph—</text>
<subclause id="H66F0C41EDB9944AFB798C4540930303B">
<enum>(I)</enum>
<text>other than during the 5-fiscal-year period beginning with the fiscal year for which the drug is first included in the list described in clause (i)(I); and</text>
</subclause>
<subclause id="H018E852163CD467E85E4A55437AD63B7">
<enum>(II)</enum>
<text>with respect to which payment has ever been made pursuant to subparagraph (K).</text>
</subclause>
</clause>
<clause id="HBC1C7B623A1240CEBD9883F5290E60D4" indent="up1" commented="no">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">For purposes of this subparagraph, the term <term>DISARM drug</term> means a product that is approved for use, or a product for which an indication is first approved for use, by the Food and Drug Administration on or after December 1, 2014, and that the Food and Drug Administration determines is an antimicrobial product (as defined in clause (iv)) and is intended to treat an infection—</text>
<subclause id="H857DE064D6BA4A0EB82D04DDD851FB0A">
<enum>(I)</enum>
<text display-inline="yes-display-inline">for which there is an unmet medical need; and</text>
</subclause>
<subclause id="H5E0F574252B6429D854AE774A8A37686">
<enum>(II)</enum>
<text>which is associated with high rates of mortality or significant patient morbidity, as determined in consultation with the Director of the Centers for Disease Control and Prevention and the infectious disease professional community.</text>
</subclause>
</clause>
<clause id="HAF58AB3671CF4C92A869E30A442C784A" commented="no" display-inline="no-display-inline" indent="up1">
<enum>(iv)</enum>
<text display-inline="yes-display-inline">For purposes of clause (iii), the term <quote>antimicrobial product</quote> means a product that either—</text>
<subclause id="H3F71360CF51740A68A6D24C0E8ADCBDE" commented="no" display-inline="no-display-inline">
<enum>(I)</enum>
<text>is intended to treat an infection caused by, or likely to be caused by, a qualifying pathogen (as defined under section 505E(f) of the Federal Food, Drug, and Cosmetic Act); or</text>
</subclause>
<subclause id="HC5BFA5A8B1B04547A14965A4BBEE7408">
<enum>(II)</enum>
<text>meets the definition of a qualified infectious disease product under section 505E(g) of the Federal Food, Drug, and Cosmetic Act.</text>
</subclause>
<continuation-text>Such determination may be revoked only upon a finding that the request for such determination contained an untrue statement of material fact.</continuation-text>
</clause>
<clause id="H23DB8B8362574AE688171D1F62ED4118" indent="up1" commented="no">
<enum>(v)</enum>
<text display-inline="yes-display-inline">For purposes of this subparagraph, the term <quote>eligible hospital</quote> means a subsection (d) hospital that participates in the National Healthcare Safety Network of the Centers for Disease Control and Prevention (or, to the extent a similar surveillance system that includes reporting about antimicrobial drugs is determined by the Secretary to be available to such hospitals, such similar surveillance system as the Secretary may specify).</text>
</clause>
<clause id="HE790800E816848D1819451BE200B1A6A" indent="up1">
<enum>(vi)</enum>
<text>Subject to the succeeding provisions of this subparagraph, the additional payment under this subparagraph, with respect to a drug, shall be in the amount provided for such drug under section 1847A.</text>
</clause>
<clause id="HC37B5441CAC44E488F865602023A25C9" indent="up1">
<enum>(vii)</enum>
<text>As part of the rulemaking referred to in clause (i) for each fiscal year, the Secretary shall estimate—</text>
<subclause id="H8E2A9B73E57342C0AB4353796B71A1C9">
<enum>(I)</enum>
<text display-inline="yes-display-inline">total add-on payments (as defined in subclause (I) of clause (ix)); and</text>
</subclause>
<subclause id="HDC1D1321F6034641971010ADF8D9336F">
<enum>(II)</enum>
<text display-inline="yes-display-inline">total hospital payments (as defined in subclause (II) of such clause).</text>
</subclause>
</clause>
<clause id="HB9B75D1149DE49B198A8C7FB88C99B1B" indent="up1">
<enum>(viii)</enum>
<text display-inline="yes-display-inline">If the total add-on payments estimated pursuant to clause (vii)(I) for a fiscal year exceed 0.02 percent of the total hospital payments estimated pursuant to clause (vii)(II) for such fiscal year, the Secretary shall reduce in a pro rata manner the amount of each additional payment under this subsection pursuant to this subparagraph for such fiscal year in order to ensure that the total add-on payments estimated for such fiscal year do not exceed 0.02 percent of the total hospital payments estimated for such fiscal year.</text>
</clause>
<clause id="H58D986881B734A0F828F7FAB0B2B6043" indent="up1">
<enum>(ix)</enum>
<text>In this subparagraph:</text>
<subclause id="H4860D4034FB74D0DA24D332E293CB4EA">
<enum>(I)</enum>
<text display-inline="yes-display-inline">The term <quote>total add-on payments</quote> means, with respect to a fiscal year, the total amount of the additional payments under this subsection pursuant to this subparagraph for discharges in such fiscal year without regard to the application of clause (viii).</text>
</subclause>
<subclause id="H86F77B05C7094681A7A4870A58D04B73">
<enum>(II)</enum>
<text display-inline="yes-display-inline">The term <quote>total hospital payments</quote> means, with respect to a fiscal year, the total amount of payments made under this subsection for all discharges in such fiscal year.</text>
</subclause>
</clause>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="HECEF8A6713154F4989F75016F95E2D20">
<enum>(2)</enum>
<header>Conforming amendments</header>
<subparagraph id="H48F51E07BAEA40539F2236AE8263845F">
<enum>(A)</enum>
<header>No duplicative NTAP payments</header>
<text display-inline="yes-display-inline">Section 1886(d)(5)(K)(vi) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(K)(vi)) is amended by inserting <quote>and if additional payment has never been made under this subsection pursuant to subparagraph (M) with respect to the service or technology</quote> before the period at the end.</text>
</subparagraph>
<subparagraph id="H06D18F3089C44BBF830775DAA9198169">
<enum>(B)</enum>
<header>Access to price information</header>
<text display-inline="yes-display-inline">Section 1927(b)(3)(A) of the Social Security Act (42 U.S.C. 1396r–8(b)(3)(A)) is amended—</text>
<clause id="HAAE256667F2D4F27A80CA814ACE8E1BB">
<enum>(i)</enum>
<text>in clause (ii)—</text>
<subclause id="H022296597E8E46669CC4DF62EA9E00BC">
<enum>(I)</enum>
<text>by striking <quote>for each</quote> and inserting <quote>, for each</quote>; and</text>
</subclause>
<subclause id="HF14815456DB34062A8B8BA3FC27614E8">
<enum>(II)</enum>
<text>by striking <quote>and</quote> at the end; </text>
</subclause>
</clause>
<clause id="H142C0E7E553A444FAE7BFE05083E2890">
<enum>(ii)</enum>
<text>in clause (iii)—</text>
<subclause id="H1824E26C43AC4AAC98CAE03263DDB147">
<enum>(I)</enum>
<text>in subclause (II), by inserting <quote>or under section 1886(d) pursuant to paragraph (5)(M) of such section,</quote> after <quote>1847A,</quote>; </text>
</subclause>
<subclause id="H90859C36DCB949C3877DE7E1653CC547">
<enum>(II)</enum>
<text>in the matter following subclause (III), by striking <quote>or 1881(b)(13)(A)(ii)</quote> and inserting <quote>, section 1881(b)(13)(A)(ii), or section 1886(d)(5)(M)</quote>; and</text>
</subclause>
<subclause id="HC08636847F8D4795B1F03AE6122D4A68">
<enum>(III)</enum>
<text>by striking the period at the end and inserting <quote>; and</quote>; and</text>
</subclause>
</clause>
<clause id="H02266BC8ED5B4443A2A79375CAEB42A5">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">in clause (iv), by striking the semicolon at the end and inserting a period.</text>
</clause>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H91996E566E4344A1896FF60F27FCBA56">
<enum>(b)</enum>
<header>Study and report on removing barriers to development of DISARM drugs</header>
<paragraph id="HF1770C1BEE9B48C787541EEB0634BB9C" commented="no">
<enum>(1)</enum>
<header>Study</header>
<text>The Comptroller General of the United States shall, in consultation with the Director of the National Institutes of Health, the Commissioner of Food and Drugs, and the Director of the Centers for Disease Control and Prevention, conduct a study to—</text>
<subparagraph id="H77E90B3D59B64556A9FC773F3296F489" commented="no">
<enum>(A)</enum>
<text>identify and examine the barriers that prevent the development of DISARM drugs, as defined in section 1886(d)(5)(M)(iii) of the Social Security Act (42 U.S.C. 1395ww(d)(5)(M)(iii)), as added by subsection (a)(1); and</text>
</subparagraph>
<subparagraph id="H0ED98DAC6DC64B3BA728D768AB3251CC" commented="no">
<enum>(B)</enum>
<text>develop recommendations for actions to be taken in order to overcome any barriers identified under subparagraph (A).</text>
</subparagraph>
</paragraph>
<paragraph id="HDA3DB794040347E5A1ACB30FA9D97FDF" commented="no" display-inline="no-display-inline">
<enum>(2)</enum>
<header>Report</header>
<text>Not later than 1 year after the date of the enactment of this Act, the Comptroller General shall submit to Congress a report on the study conducted under paragraph (1).</text>
</paragraph>
</subsection>
</section>
</subtitle>
<subtitle id="H1B60A53B6FD547A5BC40A3EF20B63859" commented="no">
<enum>H</enum>
<header>Vaccine Access, Certainty, and Innovation</header>
<section id="HB4DE03822A7D4C8A9A661654DDD03967" commented="no">
<enum>2141.</enum>
<header>Timely review of vaccines by the Advisory Committee on Immunization Practices</header>
<text display-inline="no-display-inline">Section 2102(a) of the Public Health Service Act (42 U.S.C. 300aa–2(a)) is amended by adding at the end the following:</text>
<quoted-block style="OLC" id="H4458C0E4669745AE991158CB45E9A8A2" display-inline="no-display-inline">
<paragraph id="H18842484289743BE9A982F89AAB3FB30" commented="no">
<enum>(10)</enum>
<header>Advisory Committee on Immunization Practices</header>
<subparagraph id="H6913FCECF733459CA52C61FD883DB7BB" commented="no">
<enum>(A)</enum>
<header>Standard periods of time for making recommendations</header>
<text display-inline="yes-display-inline">Upon the licensure of any vaccine or any new indication for a vaccine, the Director of the Program shall direct the Advisory Committee on Immunization Practices, at its next regularly scheduled meeting, to consider the use of the vaccine.</text>
</subparagraph>
<subparagraph id="HF812541730614CF89667162B3B5F0517" commented="no">
<enum>(B)</enum>
<header>Expedited review pursuant to request by sponsor or manufacturer</header>
<text display-inline="yes-display-inline">If the Advisory Committee does not make recommendations with respect to the use of a vaccine at the Advisory Committee’s first regularly scheduled meeting after the licensure of the vaccine or any new indication for the vaccine, the Advisory Committee, at the request of the sponsor of the vaccine, shall make such recommendations on an expedited basis.</text>
</subparagraph>
<subparagraph id="HF990A51021A64EB49F1E650B292F7B3B" commented="no">
<enum>(C)</enum>
<header>Expedited review for breakthrough therapies and for use during public health emergencies</header>
<text display-inline="yes-display-inline">If a vaccine is designated as a breakthrough therapy under section 506 of the Federal Food, Drug, and Cosmetic Act and is licensed under section 351 of this Act, the Advisory Committee shall make recommendations with respect to the use of the vaccine on an expedited basis.</text>
</subparagraph>
<subparagraph id="H89943DB3BFA145FD8081332225FD036B" commented="no">
<enum>(D)</enum>
<header>Definition</header>
<text display-inline="yes-display-inline">In this paragraph, the terms <quote>Advisory Committee on Immunization Practices</quote> and <quote>Advisory Committee</quote> mean the advisory committee on immunization practices established by the Secretary pursuant to section 222, acting through the Director of the Centers for Disease Control and Prevention.</text>
</subparagraph>
</paragraph>
<after-quoted-block display="yes">.</after-quoted-block>
</quoted-block>
</section>
<section id="H6A21C64DD2F34900B32A01A7D82599E4" commented="no">
<enum>2142.</enum>
<header>Review of processes and consistency of ACIP recommendations</header>
<subsection id="H6E8C50651C4A4E5A9013500FE95B134C" commented="no">
<enum>(a)</enum>
<header>Review</header>
<text display-inline="yes-display-inline">The Director of the Centers for Disease Control and Prevention shall conduct a review of the process used by the Advisory Committee on Immunization Practices to evaluate consistency in formulating and issuing recommendations pertaining to vaccines.</text>
</subsection>
<subsection id="HC5998973DAB944DDBF0875EC32C920BB" commented="no">
<enum>(b)</enum>
<header>Considerations</header>
<text>The review under subsection (a) shall include assessment of—</text>
<paragraph id="HDFFC230A79C8405FBFA0E0C5A4DBF151" commented="no">
<enum>(1)</enum>
<text>the criteria used to evaluate new and existing vaccines;</text>
</paragraph>
<paragraph id="HF03BC5AF60AE4F7F9232FCD4C13CC6AE" commented="no">
<enum>(2)</enum>
<text>the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to the review and analysis of scientific and economic data, including the scientific basis for such approach; and</text>
</paragraph>
<paragraph id="H277759455F23499BAD061520E792E533" commented="no">
<enum>(3)</enum>
<text display-inline="yes-display-inline">the extent to which the processes used by the working groups of the Advisory Committee on Immunization Practices are consistent among groups.</text>
</paragraph>
</subsection>
<subsection id="HA33D77DB8C24436DA1347DB9318D21DD" commented="no">
<enum>(c)</enum>
<header>Stakeholders</header>
<text>In carrying out the review under subsection (a), the Director of the Centers for Disease Control and Prevention shall solicit input from vaccine stakeholders.</text>
</subsection>
<subsection id="HACFC0ED0B94F47DDBF7086F591BFAD75" commented="no">
<enum>(d)</enum>
<header>Report</header>
<text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of this Act, the Director of the Centers for Disease Control and Prevention shall submit to the appropriate committees of the Congress and make publicly available a report on the results of the review under subsection (a), including recommendations on improving the consistency of the process described in such subsection.</text>
</subsection>
<subsection id="H74245EBD072F485EA37E208C1D7647D4" commented="no">
<enum>(e)</enum>
<header>Definition</header>
<text display-inline="yes-display-inline">In this section, the term <quote>Advisory Committee on Immunization Practices</quote> means the advisory committee on immunization practices established by the Secretary of Health and Human Services pursuant to section 222 of the Public Health Service Act (42 U.S.C. 217a), acting through the Director of the Centers for Disease Control and Prevention.</text>
</subsection>
</section>
<section id="H495C40EB9282416B9951F5DE211EDC06" commented="no">
<enum>2143.</enum>
<header>Meetings between CDC and vaccine developers</header>
<text display-inline="no-display-inline">Section 310 of the Public Health Service Act (42 U.S.C. 242o) is amended by adding at the end the following:</text>
<quoted-block id="H61B9FB4EDA434AB5A964510D58A9852D" style="OLC">
<subsection id="H622FF292E0464657B1EAAA4020FE0B36" commented="no">
<enum>(c)</enum>
<paragraph id="H3B39193CD54E4CBCB7688FA06FA7C5A3" display-inline="yes-display-inline" commented="no">
<enum>(1)</enum>
<text>In this subsection, the term <quote>vaccine developer</quote> means a nongovernmental entity engaged in—</text>
<subparagraph id="H73037EB677C64BC597285F2EF45CD934" indent="up1" commented="no">
<enum>(A)</enum>
<clause id="H50CE6D351B4645D9A3B9EC53D08A13B2" display-inline="yes-display-inline" commented="no">
<enum>(i)</enum>
<text>the development of a vaccine with the intent to pursue licensing of the vaccine by the Food and Drug Administration; or</text>
</clause>
<clause id="HCC8FA64F2BF149B081DA3CC3FB6C8542" indent="up1" commented="no">
<enum>(ii)</enum>
<text>the production of a vaccine licensed by the Food and Drug Administration; and</text>
</clause>
</subparagraph>
<subparagraph id="H09E1EB2737FB4098A2BE9323484E95F4" indent="up1" commented="no">
<enum>(B)</enum>
<text>vaccine research.</text>
</subparagraph>
</paragraph>
<paragraph id="H80143CB118B9491C80AA59F30AE1B538" indent="up1" commented="no">
<enum>(2)</enum>
<subparagraph id="H75F326929CCA4BFDBB860F194E4EA377" display-inline="yes-display-inline" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">Upon the submission of a written request for a meeting by a vaccine developer, that includes a valid justification for the meeting, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall convene a meeting of representatives of the vaccine developer and experts from the Centers for Disease Control and Prevention in immunization programs, epidemiology, and other relevant areas at which the Director (or the Director’s designee), for the purpose of informing the vaccine developer’s understanding of public health needs and priorities, shall provide the perspectives of the Centers for Disease Control and Prevention and other relevant Federal agencies regarding—</text>
<clause id="HE764A409270D4FD4932D83FC65952725" indent="up1" commented="no">
<enum>(i)</enum>
<text>public health needs, epidemiology, and implementation considerations with regard to a vaccine developer’s potential vaccine profile; and</text>
</clause>
<clause id="HBC56C390A75940429220180C9454D99E" indent="up1" commented="no">
<enum>(ii)</enum>
<text>potential implications of such perspectives for the vaccine developer’s vaccine research and development planning.</text>
</clause>
</subparagraph>
<subparagraph id="H2C713DF16B724D43B5920378CA7A2984" indent="up1" commented="no">
<enum>(B)</enum>
<text>In addition to the representatives specified in subparagraph (A), the Secretary may, with the agreement of the vaccine developer requesting a meeting under such subparagraph, include in such meeting representatives of—</text>
<clause id="H706B553EB3B24482BB182DCBEA1E10EF" commented="no">
<enum>(i)</enum>
<text>the Food and Drug Administration; and</text>
</clause>
<clause id="H12C0CD2138BA466ABA1EDA877DE344B1" commented="no">
<enum>(ii)</enum>
<text>the National Vaccine Program.</text>
</clause>
</subparagraph>
<subparagraph id="HC03668E11193413DB339FE54927A64BE" indent="up1" commented="no">
<enum>(C)</enum>
<text display-inline="yes-display-inline">The Secretary shall convene a meeting requested with a valid justification under subparagraph (A) not later than 120 days after receipt of the request for the meeting.</text>
</subparagraph>
</paragraph>
<paragraph id="HE59B9C640D09463DACD99BD16D858C6B" indent="up1" commented="no">
<enum>(3)</enum>
<subparagraph id="HC1CD1032A434483B9291F6D925D01FFA" display-inline="yes-display-inline" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">Upon the submission of a written request by a vaccine developer, the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall provide to the vaccine developer any age-based or other demographically assessed disease epidemiological analyses or data that—</text>
<clause id="H172C2C07DA804A49BFF35A97BD375BA4" indent="up1" commented="no">
<enum>(i)</enum>
<text>are specified in the request;</text>
</clause>
<clause id="H3DA2F08504464E03A21F731FA0317AB9" indent="up1" commented="no">
<enum>(ii)</enum>
<text>have been published;</text>
</clause>
<clause id="HD5899C4FEF3C411F92BFDF36E619C027" indent="up1" commented="no">
<enum>(iii)</enum>
<text>have been performed by or are in the possession of the Centers;</text>
</clause>
<clause id="HDBECDA5838914FCEBA87F8DAEF4638E5" indent="up1" commented="no">
<enum>(iv)</enum>
<text display-inline="yes-display-inline">are not a trade secret or commercial or financial information that is privileged or confidential and subject to section 552(b)(4) of title 5, United States Code, or section 1905 of title 18, United States Code; and</text>
</clause>
<clause id="HD29AA883FC9E4E0D91646F02B9387063" indent="up1" commented="no">
<enum>(v)</enum>
<text>do not contain individually identifiable information.</text>
</clause>
</subparagraph>
<subparagraph id="H9E87632CD2084E5B8FA4C3926F40B9F8" indent="up1" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">The Secretary shall provide analyses requested by a vaccine manufacturer under subparagraph (A) not later than 120 calendar days after receipt of the request for the analyses. </text>
</subparagraph>
</paragraph>
<paragraph id="H29FF84F9B89E406182736C53DE947B90" indent="up1" commented="no">
<enum>(4)</enum>
<text>The Secretary shall promptly notify a vaccine developer if—</text>
<subparagraph id="HDE5C514987AF448284D3BE3EE5065310" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">the Secretary becomes aware of any significant change to information that was—</text>
<clause id="HD03D542947CE453685A47F380EFA1000" commented="no">
<enum>(i)</enum>
<text>shared by the Secretary with the vaccine developer during a meeting under paragraph (2); or</text>
</clause>
<clause id="HFB35C22B789E4CC8B9031E789ED92058" commented="no">
<enum>(ii)</enum>
<text>provided by the Secretary to the vaccine developer in one or more analyses under paragraph (3); and</text>
</clause>
</subparagraph>
<subparagraph id="HF1F99A3412F84310AC4007F7E11849BA" commented="no">
<enum>(B)</enum>
<text>the change to such information may have implications for the vaccine developer’s vaccine research and development.</text>
</subparagraph>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
</subtitle>
<subtitle id="H3B80A3E6FF3942E8BCD38ECAB1D425EF">
<enum>I</enum>
<header>Orphan product extensions now; incentives for certain products for limited populations</header>
<section id="H336C9D8F495244F3AE28E7318A0D0ADC">
<enum>2151.</enum>
<header>Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition</header>
<subsection id="H15DEA6672C904A3EA46331A29F0B71E0">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Chapter V of the Federal Food, Drug, and Cosmetic Act, as amended by sections 2062 and 2063, is further amended by inserting after section 505H of such Act the following:</text>
<quoted-block style="OLC" id="H757CBE629D9D4CD095A5864546A71932" display-inline="no-display-inline">
<section id="H43AFFC53BDE740D78FF9712A2E6DBED0">
<enum>505I.</enum>
<header>Extension of exclusivity periods for a drug approved for a new indication for a rare disease or condition</header>
<subsection id="H02739AAF2DB94982B4109336332EC5F4">
<enum>(a)</enum>
<header>Designation</header>
<paragraph id="H02EFD5F04090422CA8A3F9E16C4C754C">
<enum>(1)</enum>
<header>In general</header>
<text>The Secretary shall designate a drug as a drug approved for a new indication to prevent, diagnose, or treat a rare disease or condition for purposes of granting the extensions under subsection (b) if—</text>
<subparagraph id="H1C15017CADC246758F0F55EE4B5620AC" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">prior to approval of an application or supplemental application for the new indication, the drug was approved or licensed for marketing under section 505(c) of this Act or section 351(a) of the Public Health Service Act but was not so approved or licensed for the new indication;</text>
</subparagraph>
<subparagraph id="HD5E524E734A441DC9911C1B9E8FC5B73">
<enum>(B)</enum>
<clause id="HBFE68C1E899C4300AB6300CEB7840AD0" display-inline="yes-display-inline" commented="no">
<enum>(i)</enum>
<text>the sponsor of the approved or licensed drug files an application or a supplemental application for approval of the new indication for use of the drug to prevent, diagnose, or treat the rare disease or condition; and</text>
</clause>
<clause id="HA039268B965E49F9B6C5C2CFDA36C160" indent="up1" commented="no">
<enum>(ii)</enum>
<text>the Secretary approves the application or supplemental application; and</text>
</clause>
</subparagraph>
<subparagraph id="H6713D4F98EE7447C9CE86A09AE284FED">
<enum>(C)</enum>
<text display-inline="yes-display-inline">the application or supplemental application for the new indication contains the consent of the applicant to notice being given by the Secretary under paragraph (4) respecting the designation of the drug.</text>
</subparagraph>
</paragraph>
<paragraph id="H66444E6C6AF6460FB4BBEF24E3C7707E">
<enum>(2)</enum>
<header>Revocation of designation</header>
<text display-inline="yes-display-inline">
</text>
<subparagraph id="HD6F587C843C5495F93440CF04CB3D122">
<enum>(A)</enum>
<header>In general</header>
<text>Except as provided in subparagraph (B), a designation under paragraph (1) shall not be revoked for any reason.</text>
</subparagraph>
<subparagraph id="H8AD55DB6D0DD43BEB155A825EAACA69E">
<enum>(B)</enum>
<header>Exception</header>
<text>The Secretary may revoke a designation of a drug under paragraph (1) if the Secretary finds that the application or supplemental application resulting in such designation contained an untrue statement of material fact.</text>
</subparagraph>
</paragraph>
<paragraph id="H907FF4674FFA40A3BB3F5DF48D733DF6">
<enum>(3)</enum>
<header>Notification prior to discontinuance of production for solely commercial reasons</header>
<text>A designation of a drug under paragraph (1) shall be subject to the condition that the sponsor of the drug will notify the Secretary of any discontinuance of the production of the drug for solely commercial reasons at least one year before such discontinuance.</text>
</paragraph>
<paragraph id="H92B2184BE3D747FEA20A7D5BD9ECBCDC">
<enum>(4)</enum>
<header>Notice to public</header>
<text>Notice respecting the designation of a drug under paragraph (1) shall be made available to the public.</text>
</paragraph>
</subsection>
<subsection id="HD226169C58E74CE895C7098DD4AFC03F">
<enum>(b)</enum>
<header>Extension</header>
<text>If the Secretary designates a drug as a drug approved for a new indication for a rare disease or condition, as described in subsection (a)(1)—</text>
<paragraph id="H3BD2FCA6749E48AC8F5EDDCB493CE31A">
<enum>(1)</enum>
<subparagraph id="HB4BD7D4B85AB4FACBD79BED8011432E2" display-inline="yes-display-inline">
<enum>(A)</enum>
<text>the 4-, 5-, and 7<fraction>½</fraction>-year periods described in subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-year periods described in clauses (iii) and (iv) of subsection (c)(3)(E) and clauses (iii) and (iv) of subsection (j)(5)(F) of section 505, and the 7-year period described in section 527, as applicable, shall be extended by 6 months; or</text>
</subparagraph>
<subparagraph id="HAA7CD302C7CE421C9C23EF3018891021" indent="up1">
<enum>(B)</enum>
<text>the 4- and 12-year periods described in subparagraphs (A) and (B) of section 351(k)(7) of the Public Health Service Act and the 7-year period described in section 527, as applicable, shall be extended by 6 months; and</text>
</subparagraph>
</paragraph>
<paragraph id="H0F4D76E9415648759A95156A94D43BFB">
<enum>(2)</enum>
<subparagraph id="H2A2BEA81686441928EB8B3C573151BF9" display-inline="yes-display-inline">
<enum>(A)</enum>
<text>if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) of section 505 or a listed patent for which a certification has been submitted under subsections (b)(2)(A)(iii) or (j)(2)(A)(vii)(III) of section 505, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of 6 months after the date the patent expires (including any patent extensions); or</text>
</subparagraph>
<subparagraph id="H37478EFF0D37458C84F4574693D919FA" indent="up1">
<enum>(B)</enum>
<text>if the drug is the subject of a listed patent for which a certification has been submitted under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in the patent infringement litigation resulting from the certification the court determines that the patent is valid and would be infringed, the period during which an application may not be approved under section 505(c)(3) or section 505(j)(5)(B) shall be extended by a period of 6 months after the date the patent expires (including any patent extensions).</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H49B3E509D32049D3A3B157362F5A38AD">
<enum>(c)</enum>
<header>Relation to pediatric and qualified infectious disease product exclusivity</header>
<text>Any extension under subsection (b) of a period shall be in addition to any extension of the periods under sections 505A and 505E of this Act and section 351(m) of the Public Health Service Act, as applicable, with respect to the drug. </text>
</subsection>
<subsection id="HFD60FD4405C3445FA55A03B01E648AEF">
<enum>(d)</enum>
<header>Limitations</header>
<text>The extension described in subsection (b) shall not apply if the drug designated under subsection (a)(1) has previously received an extension by operation of subsection (b).</text>
</subsection>
<subsection id="HEB239230C82E4DBD8F76916E51A593A4">
<enum>(e)</enum>
<header>Definition</header>
<text>In this section, the term <term>rare disease or condition</term> has the meaning given to such term in section 526(a)(2).</text>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="HF50EE2AA7F3445C8B7DA6B0DFAA838FD">
<enum>(b)</enum>
<header>Application</header>
<text display-inline="yes-display-inline">Section 505G of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a), applies only with respect to a drug for which an application or supplemental application described in subsection (a)(1)(B)(i) of such section 505G is first approved under section 505(c) of such Act (21 U.S.C. 355(c)) or section 351(a) of the Public Health Service Act (42 U.S.C. 262(a)) on or after the date of the enactment of this Act.</text>
</subsection>
<subsection id="H89A8AB922743467EB4B05AAE23B5FCC9">
<enum>(c)</enum>
<header>Conforming amendments</header>
<paragraph id="H00E2208E20C348E1AF4EF850C0D67546">
<enum>(1)</enum>
<header>Relation to pediatric exclusivity for drugs</header>
<text display-inline="yes-display-inline">Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended—</text>
<subparagraph id="HF0555B50C69643F8AF0216560F72E6F8">
<enum>(A)</enum>
<text>in subsection (b), by adding at the end the following:</text>
<quoted-block style="OLC" id="H323CF2A0245842F3A498CAABB534B41A" display-inline="no-display-inline">
<paragraph id="HEAC64B6D52664F1B8F07FC2D92111C35">
<enum>(3)</enum>
<header>Relation to exclusivity for a drug approved for a new indication for a rare disease or condition</header>
<text display-inline="yes-display-inline">Notwithstanding the references in paragraph (1) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in paragraph (1) shall be in addition to any extensions under section 505G.</text>
</paragraph>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</subparagraph>
<subparagraph id="H80E0D33EE1C14A55BED6C31466135E81">
<enum>(B)</enum>
<text>in subsection (c), by adding at the end the following:</text>
<quoted-block style="OLC" id="HFD144EFCD7B647A2855AA3506AB6601C" display-inline="no-display-inline">
<paragraph id="HC8396FB442F34F0C9AA6E0091AABF295">
<enum>(3)</enum>
<header>Relation to exclusivity for a drug approved for a new indication for a rare disease or condition</header>
<text display-inline="yes-display-inline">Notwithstanding the references in paragraph (1) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in paragraph (1) shall be in addition to any extensions under section 505G.</text>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subparagraph>
</paragraph>
<paragraph id="H2791BE7CB4AB4949A7A5066BAAF08762">
<enum>(2)</enum>
<header>Relation to exclusivity for new qualified infectious disease products that are drugs</header>
<text>Subsection (b) of section 505E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355f) is amended—</text>
<subparagraph id="HBAC70189F17442A799D86FE52F7A81A4">
<enum>(A)</enum>
<text>by amending the subsection heading to read as follows: <quote><header-in-text level="subsection" style="OLC">Relation to pediatric exclusivity and exclusivity for a drug approved for a new indication for a rare disease or condition.—</header-in-text></quote>; and</text>
</subparagraph>
<subparagraph id="HBFE13726A46642DFA00BA49A2C133D50">
<enum>(B)</enum>
<text>by striking <quote>any extension of the period under section 505A</quote> and inserting <quote>any extension of the periods under sections 505A and 505G, as applicable,</quote>.</text>
</subparagraph>
</paragraph>
<paragraph id="H68B8AAD381A9494EA69E313A5EC599C7">
<enum>(3)</enum>
<header>Relation to pediatric exclusivity for biological products</header>
<text display-inline="yes-display-inline">Section 351(m) of the Public Health Service Act (42 U.S.C. 262(m)) is amended by adding at the end the following:</text>
<quoted-block style="OLC" id="H06050AE1943C406DAC7963461024BA2D" display-inline="no-display-inline">
<paragraph id="HD1B5C284A90E412CA2BF9B17EF992332">
<enum>(5)</enum>
<header>Relation to exclusivity for a biological product approved for a new indication for a rare disease or condition</header>
<text display-inline="yes-display-inline">Notwithstanding the references in paragraphs (2)(A), (2)(B), (3)(A), and (3)(B) to the lengths of the exclusivity periods after application of pediatric exclusivity, the 6-month extensions described in such paragraphs shall be in addition to any extensions under section 505G.</text>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
</section>
<section id="H19D151415C384EA1B8FCE982FD641B83" commented="no">
<enum>2152.</enum>
<header>Reauthorization of rare pediatric disease priority review voucher incentive program</header>
<subsection id="H77A0B092FF43438AB86F3EAB4EBD50E9" commented="no">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff) is amended—</text>
<paragraph id="HCB8A731A23804E7F8468EEB80CA4E957" commented="no">
<enum>(1)</enum>
<text>in subsection (a)—</text>
<subparagraph id="H13E6716537E0448DB2EA30506B6DBB67" commented="no">
<enum>(A)</enum>
<text>in paragraph (3), by amending subparagraph (A) to read as follows:</text>
<quoted-block style="OLC" id="H10B70B6740AC47CABF35EDECA33AD6CD" display-inline="no-display-inline">
<subparagraph id="HBBC718202D6A4576BFEE7A59EAB779B2" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">The disease is a serious or life-threatening disease in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates, infants, children, and adolescents.</text>
</subparagraph>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</subparagraph>
<subparagraph id="H1F91E806A07142FF884399D6800BBAD7" commented="no">
<enum>(B)</enum>
<text>in paragraph (4)—</text>
<clause id="H0742E3262B3146118077EA501E691ED6" commented="no">
<enum>(i)</enum>
<text>in subparagraph (E), by striking <quote>and</quote> at the end;</text>
</clause>
<clause id="HFC379AF5A91D4DBB8FDC3AD1D73A7E50" commented="no">
<enum>(ii)</enum>
<text>in subparagraph (F), by striking the period at the end and inserting <quote>; and</quote>; and</text>
</clause>
<clause id="H7B1EA8CA3AD74A00BCE4CC865FC162C8" commented="no">
<enum>(iii)</enum>
<text>by adding at the end the following:</text>
<quoted-block id="H851368A0C07D40419F7D05EFAA0F58D8" style="OLC">
<subparagraph id="H0AC4525379264CE9B2D7C6CBBC87D3CC" commented="no">
<enum>(G)</enum>
<text>is for a drug or biological product for which a priority review voucher has not been issued under section 524 (relating to tropical disease products).</text>
</subparagraph>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</clause>
</subparagraph>
</paragraph>
<paragraph id="HF6027436431146EDB39A0AEB7012D903" commented="no">
<enum>(2)</enum>
<text>in subsection (b), by striking paragraph (5) and inserting the following:</text>
<quoted-block id="HE63C576B0C0C447FA96A77CB3ADDE13E" style="OLC">
<paragraph id="HE5B7D582A22A40CF89499164E318166A" commented="no">
<enum>(5)</enum>
<header>Termination of authority</header>
<subparagraph id="H16CE5E9F911245ADA094D5C0A83C464D">
<enum>(A)</enum>
<header>In general</header>
<text>The Secretary may not award any priority review vouchers under paragraph (1) after December 31, 2018.</text>
</subparagraph>
<subparagraph id="H37C9275759FD47378DC2F528A314C741">
<enum>(B)</enum>
<header>Exception</header>
<text display-inline="yes-display-inline">Notwithstanding subparagraph (A), the sponsor of a drug that is designated under subsection (d) as a drug for a rare pediatric disease and that is the subject of a rare pediatric disease product application that is submitted during the period beginning on the date of enactment of the <short-title>21st Century Cures Act</short-title> and ending the date specified in subparagraph (A) shall remain eligible to receive a priority review voucher under paragraph (1) irrespective of whether the rare pediatric disease product application with respect to such drug is approved after the end of such period.</text>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="HAD21784A7C634A9C8CE886851ED1B554" commented="no">
<enum>(b)</enum>
<header>GAO study and report</header>
<paragraph id="H11C789EC4C514E7EBD43E431A09764AC" commented="no">
<enum>(1)</enum>
<header>Study</header>
<text display-inline="yes-display-inline">The Comptroller General of the United States shall conduct a study on the effectiveness of awarding priority review vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff) in providing incentives for the development of drugs that treat or prevent rare pediatric diseases (as defined in subsection (a)(3) of such section) that would not otherwise have been developed. In conducting such study, the Comptroller General shall examine the following:</text>
<subparagraph id="HE5E53A9BF8334D41802949D5D3E8FED0" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">The indications for which each drug for which a priority review voucher was awarded under such section 529 was approved under section 505 of such Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262).</text>
</subparagraph>
<subparagraph id="H5C19D016FE3A4B9DB3E6480227D88DC2" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">Whether the priority review voucher impacted a sponsor’s decision to invest in developing a drug to treat or prevent a rare pediatric disease. </text>
</subparagraph>
<subparagraph id="H3F8BF89C5FFC483C803F4A0EF7C870EC" commented="no">
<enum>(C)</enum>
<text display-inline="yes-display-inline">An analysis of the drugs that utilized such priority review vouchers, which shall include—</text>
<clause id="H9E7D57C295C94FD3979AAEFF5C9E89AA" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline">the indications for which such drugs were approved under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or section 351 of the Public Health Service Act (42 U.S.C. 262);</text>
</clause>
<clause id="H8384490DF94649759ABE5C2B7A581B8F" commented="no">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">whether unmet medical needs were addressed through the approval of such drugs, including, for each such drug—</text>
<subclause id="HCC90A5FAB2E44669A4ED8099659B70C9" commented="no">
<enum>(I)</enum>
<text display-inline="yes-display-inline">if an alternative therapy was previously available to treat the indication; and</text>
</subclause>
<subclause id="HE9B9CC7A7FA24D42A224B270D03D7235" commented="no">
<enum>(II)</enum>
<text display-inline="yes-display-inline">the benefit or advantage the drug provided over another available therapy;</text>
</subclause>
</clause>
<clause id="H6A009B29FE4E488BAD751D8CA6FEA36F" commented="no">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">the number of patients potentially treated by such drugs;</text>
</clause>
<clause id="HCCDCB692D15F4A0DA939F7FAE6B810AC">
<enum>(iv)</enum>
<text>the value of the priority review voucher if transferred; and</text>
</clause>
<clause id="HF70CB4CD03994F939350B8197D3F5BA4" commented="no">
<enum>(v)</enum>
<text display-inline="yes-display-inline">the length of time between the date on which a priority review voucher was awarded and the date on which it was used.</text>
</clause>
</subparagraph>
<subparagraph id="H98E1F7E5C1DF4F6D902692AA325EAF17" commented="no">
<enum>(D)</enum>
<text display-inline="yes-display-inline">With respect to the priority review voucher program under section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff)—</text>
<clause id="H3AEC23AC02134F9396B9881C81917943">
<enum>(i)</enum>
<text>the resources used by, and burden placed on, the Food and Drug Administration in implementing such program, including the effect of such program on the Food and Drug Administration’s review of drugs for which a priority review voucher was not awarded or used;</text>
</clause>
<clause id="HBFFE6C48F4BA4A80822273114D750568">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">the impact of the program on the public health as a result of the expedited review of applications for drugs that treat or prevent non-serious indications that are generally used by the broader public; and </text>
</clause>
<clause id="H7BBD3CBDB49F4C0E932B5771A0DB88D7" commented="no">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">alternative approaches to improving such program so that the program is appropriately targeted toward providing incentives for the development of clinically important drugs that—</text>
<subclause id="H9D0CE81256844AA9A4E717612DCE1BB1" commented="no">
<enum>(I)</enum>
<text>prevent or treat rare pediatric diseases; and</text>
</subclause>
<subclause id="HAC0E244DD7224365B94BF2FAFA1C1750" commented="no">
<enum>(II)</enum>
<text>would likely not otherwise have been developed to prevent or treat such diseases.</text>
</subclause>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H092D91D93E784087A636679405C3D5C4" commented="no">
<enum>(2)</enum>
<header>Report</header>
<text>Not later than December 31, 2017, the Comptroller General of the United States shall submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report containing the results of the study of conducted under paragraph (1). </text>
</paragraph>
</subsection>
</section>
</subtitle>
<subtitle id="H97D822DEB89F43EA804DCF20ADF962E5">
<enum>J</enum>
<header>Domestic Manufacturing and Export Efficiencies</header>
<section id="HCC17C2C6DCC64001B7F89B7DB286B8CE" section-type="subsequent-section">
<enum>2161.</enum>
<header>Grants for studying the process of continuous drug manufacturing</header>
<subsection id="HE3AEA54E256D4E28A7FEB22F13680100">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Commissioner of Food and Drugs may award grants to institutions of higher education and nonprofit organizations for the purpose of studying and recommending improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.</text>
</subsection>
<subsection id="HEAE2F3E5EE56462EAF5FA97A666B852A">
<enum>(b)</enum>
<header>Definitions</header>
<text>In this section:</text>
<paragraph id="H970DCF8B5C7146E4AEB375850E43784D">
<enum>(1)</enum>
<text>The term <quote>drug</quote> has the meaning given to such term in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321).</text>
</paragraph>
<paragraph id="HDBF2DAE130E14E7080F5CF383F4CD4BC">
<enum>(2)</enum>
<text>The term <quote>biological product</quote> has the meaning given to such term in section 351(i) of the Public Health Service Act (42 U.S.C. 262(i)).</text>
</paragraph>
<paragraph id="H53B138CDAEC84B34BA7E381A2EEB263E">
<enum>(3)</enum>
<text>The term <quote>institution of higher education</quote> has the meaning given to such term in section 101 of the Higher Education Act of 1965 (20 U.S.C. 1001). </text>
</paragraph>
</subsection>
<subsection id="H0A8115BA08BC4A5295B24DA8B9501627">
<enum>(c)</enum>
<header>Authorization of appropriations</header>
<text display-inline="yes-display-inline">There is authorized to be appropriated to carry out this section $5,000,000 for each of fiscal years 2016 through 2020.</text>
</subsection>
</section>
<section id="H5D82557E1F5D439697FB5075CC4E84A2" commented="no">
<enum>2162.</enum>
<header>Re-exportation among members of the European Economic Area</header>
<text display-inline="no-display-inline">Section 1003 of the Controlled Substances Import and Export Act (21 U.S.C. 953) is amended—</text>
<paragraph id="HE15493DEA3CE40F8ABA6BBD166C132B6" commented="no">
<enum>(1)</enum>
<text>in subsection (f)—</text>
<subparagraph id="HF5ADB8EA61764C588AFA33C7919B2764">
<enum>(A)</enum>
<text>in paragraph (5)—</text>
<clause id="H2345CFAB50544A49A52B2848821F86F2" commented="no">
<enum>(i)</enum>
<text>by striking <quote>(5)</quote> and inserting <quote>(5)(A)</quote>;</text>
</clause>
<clause id="H2E33AC616FA84F4196E064B045BE7F9A" commented="no">
<enum>(ii)</enum>
<text>by inserting <quote>, except that the controlled substance may be exported from the second country to another country that is a member of the European Economic Area</quote> before the period at the end; and</text>
</clause>
<clause id="HFC657E5EA8994B25B692BB97A1CD7A49" commented="no">
<enum>(iii)</enum>
<text>by adding at the end the following:</text>
<quoted-block style="OLC" id="H93B281AAF91F4D5B8E481FC19B026584" display-inline="no-display-inline">
<subparagraph id="HD7729CD2727942DDA45A81DA90080985" indent="up1" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">Subsequent to any re-exportation described in subparagraph (A), a controlled substance may continue to be exported from any country that is a member of the European Economic Area to any other such country, provided that—</text>
<clause id="H4AD2BB3D9B67484797B635227AFAFB10" commented="no">
<enum>(i)</enum>
<text>the conditions applicable with respect to the first country under paragraphs (1), (2), (3), (4), (6), and (7) are met by each subsequent country from which the controlled substance is exported pursuant to this paragraph; and</text>
</clause>
<clause id="HF20B9A946AAE4BA98F76D54EBEFD5B99" commented="no">
<enum>(ii)</enum>
<text>the conditions applicable with respect to the second country under such paragraphs are met by each subsequent country to which the controlled substance is exported pursuant to this paragraph.</text>
</clause>
</subparagraph>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</clause>
</subparagraph>
<subparagraph id="H6F5D4B89DE2447C3892482F5E95A8EA0">
<enum>(B)</enum>
<text>in paragraph (6)—</text>
<clause id="H6DD7D67827654A9EA8D014DF8786BE59">
<enum>(i)</enum>
<text>by striking <quote>(6)</quote> and inserting <quote>(6)(A)</quote>; and</text>
</clause>
<clause id="H5D9B4D62AD4E47D99A87A1FDD0C639CC">
<enum>(ii)</enum>
<text>by adding at the end the following:</text>
<quoted-block id="HA859A8D6DCFE40759D64247AD16382EA" style="OLC">
<subparagraph id="H9EA5E7C88BAA47BFB382A1B5FA12A7B9" indent="up1">
<enum>(B)</enum>
<text>In the case of re-exportation among members of the European Economic Area, within 30 days after each re-exportation, the person who exported the controlled substance from the United States delivers to the Attorney General—</text>
<clause id="HA613C0AAE41547A1A821B6D96C3D0D50">
<enum>(i)</enum>
<text>documentation certifying that such re-exportation has occurred; and</text>
</clause>
<clause id="HDF66141B857F4E3F8CC27BFAB733BD37">
<enum>(ii)</enum>
<text>information concerning the consignee, country, and product.</text>
</clause>
</subparagraph>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</clause>
</subparagraph>
</paragraph>
<paragraph id="HB391DF76AF3047B18D8E633106A19A81" commented="no">
<enum>(2)</enum>
<text>by adding at the end the following:</text>
<quoted-block style="OLC" id="H99D52642C8CC46B5BAF6B004079FADAB" display-inline="no-display-inline">
<subsection id="HB72AA7EB4F424B10986CF040B356E0C2" commented="no">
<enum>(g)</enum>
<header>Limitation</header>
<text display-inline="yes-display-inline">Subject to paragraphs (5) and (6) of subsection (f) in the case of any controlled substance in schedule I or II or any narcotic drug in schedule III or IV, the Attorney General shall not promulgate nor enforce any regulation, subregulatory guidance, or enforcement policy which impedes re-exportation of any controlled substance among European Economic Area countries, including by promulgating or enforcing any requirement that—</text>
<paragraph id="H797560805E1745A1BC58670DFE60D898" commented="no">
<enum>(1)</enum>
<text>re-exportation from the first country to the second country or re-exportation from the second country to another country occur within a specified period of time; or</text>
</paragraph>
<paragraph id="H6128D91D272A4CC09DE091DBDA9A1C8F" commented="no">
<enum>(2)</enum>
<text display-inline="yes-display-inline">information concerning the consignee, country, and product be provided prior to exportation of the controlled substance from the United States or prior to each re-exportation among members of the European Economic Area.</text>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</section>
</subtitle>
<subtitle id="H08492F1310E045DA9C7A6AB3D2CF9188">
<enum>K</enum>
<header>Enhancing combination products review</header>
<section id="HBF7399F47A22468EABB9670E7BA201A7">
<enum>2181.</enum>
<header>Enhancing combination products review</header>
<text display-inline="no-display-inline">Section 503(g)(4)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(g)(4)(C)) is amended by adding at the end the following new clause: </text>
<quoted-block style="traditional" id="H3719059B0F38479BA03947DDD8E5E15F" display-inline="no-display-inline">
<clause id="H07C1958E20444DF48A9137A4AC2090F7" indent="up3">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">Not later than 18 months after the date of the enactment of the <short-title>21st Century Cures Act</short-title>, the Secretary shall issue final guidance that describes the responsibilities of each agency center regarding its review of combination products. The Secretary shall, after soliciting public comment, review and update the guidance periodically.</text>
</clause>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
</subtitle>
<subtitle id="H450025907EA743C2A560AD7FE09AA33F">
<enum>L</enum>
<header>Priority Review for Breakthrough Devices</header>
<section id="H56641E40C15946C2B29EBD84539FE15E">
<enum>2201.</enum>
<header>Priority review for breakthrough devices</header>
<subsection id="H5F3C15C292D94F199605A7558A5E31F4">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Chapter V of the Federal Food, Drug, and Cosmetic Act is amended—</text>
<paragraph id="HE3B22B987CF54B5394A60C3E9595E924">
<enum>(1)</enum>
<text>in section 515(d)—</text>
<subparagraph id="HEC9898777EB448A396796348FA7546F2">
<enum>(A)</enum>
<text>by striking paragraph (5); and</text>
</subparagraph>
<subparagraph id="H7ACFC28E33D54179884735886BF7F75E">
<enum>(B)</enum>
<text>by redesignating paragraph (6) as paragraph (5); and</text>
</subparagraph>
</paragraph>
<paragraph id="HDF229C8568494AA7A17BAFE2E76A7E7D">
<enum>(2)</enum>
<text>by inserting after section 515A (21 U.S.C. 360e–1) the following:</text>
<quoted-block id="H5F6F27A8F46442C7A302E15A4C6A1E42" style="OLC">
<section id="HDAE6A94B519E41BD855624B6E213BBD6">
<enum>515B.</enum>
<header>Priority review for breakthrough devices</header>
<subsection id="HD0F270CAF2B94CE4AA5932031A153610">
<enum>(a)</enum>
<header>In general</header>
<text>In order to provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human diseases or conditions, the Secretary shall establish<italic></italic> a program to provide priority review for devices—</text>
<paragraph id="H3735B8852A2C449D9C5ACB83F756C5E1">
<enum>(1)</enum>
<text>representing breakthrough technologies;</text>
</paragraph>
<paragraph id="HDF77F32F12A44124A2D0D09ED32B2647">
<enum>(2)</enum>
<text>for which no approved alternatives exist;</text>
</paragraph>
<paragraph id="HCFC2F15A45BA490FB3AD5865CC813C62">
<enum>(3)</enum>
<text display-inline="yes-display-inline">offering significant advantages over existing approved or cleared alternatives, including the potential to, compared to existing approved or cleared alternatives, reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or </text>
</paragraph>
<paragraph id="H0444582B600340C2BE2D2BE7B09ED18A">
<enum>(4)</enum>
<text display-inline="yes-display-inline">the availability of which is in the best interest of patients.</text>
</paragraph>
</subsection>
<subsection id="H4A16CFCB510244CD908261E6095CD2E1">
<enum>(b)</enum>
<header>Request for designation</header>
<text>A sponsor of a device may request that the Secretary designate the device for priority review under this section. Any such request for designation may be made at any time prior to the submission of an application under section 515(c), a petition for classification under section 513(f)(2), or a notification under section 510(k).</text>
</subsection>
<subsection id="H5F5DDFDB75BE4E68BB4F62C3C55F80EF">
<enum>(c)</enum>
<header>Designation process</header>
<paragraph id="HD9758D0FA331455EA6361F5F6FD46B45">
<enum>(1)</enum>
<header>In general</header>
<text>Not later than 60 calendar days after the receipt of a request under subsection (b), the Secretary shall determine whether the device that is the subject of the request meets the criteria described in subsection (a). If the Secretary determines that the device meets the criteria, the Secretary shall designate the device for priority review.</text>
</paragraph>
<paragraph id="H88E98723F2B443BB86E735E80DF93331">
<enum>(2)</enum>
<header>Review</header>
<text>Review of a request under subsection (b) shall be undertaken by a team that is composed of experienced staff and managers of the Food and Drug Administration and is chaired by a senior manager. <italic></italic></text>
</paragraph>
<paragraph id="HFFD17E3CA1314833B4C9CC28EEB8E8AF">
<enum>(3)</enum>
<header>Designation determination</header>
<text display-inline="yes-display-inline">A determination approving or denying a request under subsection (b) shall be considered a significant decision under section 517A and the Secretary shall provide a written, substantive summary of the basis for the determination in accordance with section 517A(a).</text>
</paragraph>
<paragraph id="H1E6EEAE6C31446E4A0CB4764EB66CF16">
<enum>(4)</enum>
<header>Reconsideration</header>
<subparagraph id="H54305217408545F39DAE11484DEA768E">
<enum>(A)</enum>
<header>Request for reconsideration</header>
<text display-inline="yes-display-inline">Any person whose request under subsection (b) is denied may, within 30 days of the denial, request reconsideration of the denial in accordance with section 517A(b)—</text>
<clause id="H5DB32177BAD04A03AF950C361587A991">
<enum>(i)</enum>
<text>based upon the submission of documents by such person; or</text>
</clause>
<clause id="H13CA05AED4AC4E4FBD52F5862EE41090">
<enum>(ii)</enum>
<text>based upon such documents and a meeting or teleconference.</text>
</clause>
</subparagraph>
<subparagraph id="H66936315465142649F834149016E3306">
<enum>(B)</enum>
<header>Response</header>
<text display-inline="yes-display-inline">Reconsideration of a designation determination under this paragraph shall be conducted in accordance with section 517A(b).</text>
</subparagraph>
</paragraph>
<paragraph id="HD03B3E8112F44DBC95946DADCA51DC8C">
<enum>(5)</enum>
<header>Withdrawal</header>
<text display-inline="yes-display-inline">If the Secretary approves a priority review designation for a device under this section, the Secretary may not withdraw the designation based on the fact that the criteria specified in subsection (a) are no longer met because of the subsequent clearance or approval of another device that was designated under—</text>
<subparagraph id="HA33595CFA9934DCD9E11EBF1370488A9">
<enum>(A)</enum>
<text display-inline="yes-display-inline">this section; or</text>
</subparagraph>
<subparagraph id="H5996FB356BBB47DB84EDEC6AE2965350">
<enum>(B)</enum>
<text display-inline="yes-display-inline">section 515(d)(5) (as in effect immediately prior to the enactment of the 21st Century Cures Act).</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H879AD3B2EFFD44EDB634EA6328734E9F">
<enum>(d)</enum>
<header>Priority review</header>
<paragraph id="H4DA26CAE3025432792DAE1BDAE495E3F">
<enum>(1)</enum>
<header>Actions</header>
<text display-inline="yes-display-inline">For purposes of expediting the development and review of devices designated under subsection (c), the Secretary shall—</text>
<subparagraph id="H0D815A28C57541F3BE361472EF7C8C43">
<enum>(A)</enum>
<text>assign a team of staff, including a team leader with appropriate subject matter expertise and experience, for each device for which a request is submitted under subsection (b);</text>
</subparagraph>
<subparagraph id="HC08B5A6466C34A95BCB021B27A811C2B">
<enum>(B)</enum>
<text>provide for oversight of the team by senior agency personnel to facilitate the efficient development of the device and the efficient review of any submission described in subsection (b) for the device;</text>
</subparagraph>
<subparagraph id="H90EAC2EE1E704E63AD69F8EDC197FB90">
<enum>(C)</enum>
<text>adopt an efficient process for timely dispute resolution;</text>
</subparagraph>
<subparagraph id="HA4C8546A77FF45D4B669EDD9C66BA471">
<enum>(D)</enum>
<text>provide for interactive communication with the sponsor of the device during the review process;</text>
</subparagraph>
<subparagraph id="H636D5B970D274395A5C65B7500962E9F">
<enum>(E)</enum>
<text>expedite the Secretary’s review of manufacturing and quality systems compliance, as applicable;</text>
</subparagraph>
<subparagraph id="H50BB6A060E324BCFA363006166A7051C">
<enum>(F)</enum>
<text display-inline="yes-display-inline">disclose to the sponsor in advance the topics of any consultation concerning the sponsor’s device that the Secretary intends to undertake with external experts or an advisory committee and provide the sponsor an opportunity to recommend such external experts;</text>
</subparagraph>
<subparagraph id="H00E29F4780484BABB72838B0A135D070">
<enum>(G)</enum>
<text display-inline="yes-display-inline">for applications submitted under section 515(c), provide for advisory committee input, as the Secretary determines appropriate (including in response to the request of the sponsor); and</text>
</subparagraph>
<subparagraph id="HF0277E3F262D4BA2B6D0CDC3A99B6A44">
<enum>(H)</enum>
<text display-inline="yes-display-inline">assign staff to be available within a reasonable time to address questions posed by institutional review committees concerning the conditions and clinical testing requirements applicable to the investigational use of the device pursuant to an exemption under section 520(g).</text>
</subparagraph>
</paragraph>
<paragraph id="H5EC1ED71EFD74646AC233BF45CBEC3CA">
<enum>(2)</enum>
<header>Additional actions</header>
<text display-inline="yes-display-inline">In addition to the actions described in paragraph (1), for purposes of expediting the development and review of devices designated under subsection (c), the Secretary, in collaboration with the device sponsor, may, as appropriate—</text>
<subparagraph id="H96C422D65E7C40678BFFAF8E08B4B186">
<enum>(A)</enum>
<text>coordinate with the sponsor regarding early agreement on a data development plan;</text>
</subparagraph>
<subparagraph id="HF13E0E7861DA4D9786A7FA3A1A9CCE28">
<enum>(B)</enum>
<text>take steps to ensure that the design of clinical trials is as efficient as practicable, such as through adoption of shorter or smaller clinical trials, application of surrogate endpoints, and use of adaptive trial designs and Bayesian statistics, to the extent scientifically appropriate;</text>
</subparagraph>
<subparagraph id="HBBCBAC3E10AA40BE966550F2C686CC3B">
<enum>(C)</enum>
<text>facilitate, to the extent scientifically appropriate, expedited and efficient development and review of the device through utilization of timely postmarket data collection, with regard to applications for approval under section 515(c); and</text>
</subparagraph>
<subparagraph id="H03A1AE1A7E7E48F68CD558877433E4A4">
<enum>(D)</enum>
<text>agree to clinical protocols that the Secretary will consider binding on the Secretary and the sponsor, subject to—</text>
<clause id="H386C01B78DC84BD8B9ACC1AD43122437">
<enum>(i)</enum>
<text>changes agreed to by the sponsor and the Secretary;</text>
</clause>
<clause id="H6FABA44C92FC49C58DFDA21114B0B60E">
<enum>(ii)</enum>
<text>changes that the Secretary determines are required to prevent an unreasonable risk to the public health; or</text>
</clause>
<clause id="H5C9F16B0B384430FBEE2221CDD28A795">
<enum>(iii)</enum>
<text>the identification of a substantial scientific issue determined by the Secretary to be essential to the safety or effectiveness of the device involved.</text>
</clause>
</subparagraph>
</paragraph>
</subsection>
<subsection id="HE2BE9EFEED40466BA4BAEEC83207E3DA">
<enum>(e)</enum>
<header>Priority review guidance</header>
<paragraph id="HDFEF47A119724E0B994B7352E9AF7FC7">
<enum>(1)</enum>
<header>Content</header>
<text>The Secretary shall issue guidance on the implementation of this section. Such guidance shall include the following:</text>
<subparagraph id="HA104D8D4131B44028C8BB2863AB96030">
<enum>(A)</enum>
<text>The process for a person to seek a priority review designation.</text>
</subparagraph>
<subparagraph id="H00CD22B8A9CC41FD9DAF3458B1D2E3F7">
<enum>(B)</enum>
<text>A template for requests under subsection (b).</text>
</subparagraph>
<subparagraph id="H2B7F22DD01B54B49A8FE12AE5760622F">
<enum>(C)</enum>
<text>The criteria the Secretary will use in evaluating a request for priority review.</text>
</subparagraph>
<subparagraph id="H5BC90385750F48AD92545B7811EE5993">
<enum>(D)</enum>
<text>The standards the Secretary will use in assigning a team of staff, including team leaders, to review devices designated for priority review, including any training required for such personnel on effective and efficient review.</text>
</subparagraph>
</paragraph>
<paragraph id="HF1DA57DCBEF6453AB7C957E377ED0311">
<enum>(2)</enum>
<header>Process</header>
<text>Prior to finalizing the guidance under paragraph (1), the Secretary shall propose such guidance for public comment.</text>
</paragraph>
</subsection>
<subsection id="HE416C2B63A7B4888AAA071E4CFF28222">
<enum>(f)</enum>
<header>Construction</header>
<paragraph id="HF4095FE6F76E4162AED49AB14F8937DC">
<enum>(1)</enum>
<header>Purpose</header>
<text>This section is intended to encourage the Secretary and provide the Secretary sufficient authorities to apply efficient and flexible approaches to expedite the development of, and prioritize the agency’s review of, devices that represent breakthrough technologies.</text>
</paragraph>
<paragraph id="H14B68A613C344E619454C27D68F86ECE">
<enum>(2)</enum>
<header>Construction</header>
<text display-inline="yes-display-inline">
<italic>
</italic>Nothing in this section shall be construed to alter the criteria and standards for evaluating an application pursuant to section 515(c), a report and request for classification under section 513(f)(2), or a report under section 510(k), including the recognition of valid scientific evidence as described in section 513(a)(3)(B), and consideration of the least burdensome means of evaluating device effectiveness or demonstrating substantial equivalence between devices with differing technological characteristics, as applicable. Nothing in this section alters the authority of the Secretary to act on an application pursuant to section 515(d) before completion of an establishment inspection, as the Secretary deems appropriate.</text>
</paragraph>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="H81DDAEE13AD04BBC861639302D4A0116">
<enum>(b)</enum>
<header>Conforming amendment related to designation determinations</header>
<text>Section 517A(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g–1(a)(1)) is amended by inserting <quote>a request for designation under section 515B,</quote> after <quote>an application under section 515,</quote>.</text>
</subsection>
</section>
</subtitle>
<subtitle id="HBD8E8BFC43334AC1B9D2FC1AD4B5CC90">
<enum>M</enum>
<header>Medical Device Regulatory Process Improvements</header>
<section id="HE368FE389F9A486CA08454C91DC33D85">
<enum>2221.</enum>
<header>Third-party quality system assessment</header>
<subsection id="HA66205A8430C488BA8E01ECA1BD8E372">
<enum>(a)</enum>
<header>Establishment of third-Party quality system assessment program</header>
<text>Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 524A (21 U.S.C. 360n–1) the following new section:</text>
<quoted-block id="H72960DCE0E22461498BD4A5DA05739D7" style="OLC">
<section id="H38D47817189E40A6A01F078CAF6912FF">
<enum>524B.</enum>
<header>Third-party quality system assessment</header>
<subsection id="HC2EF029F6457448A923FC157E6DF08D8">
<enum>(a)</enum>
<header>Accreditation and assessment</header>
<paragraph id="H7963A7F916B34510A1A6AD94EEE3BE4C">
<enum>(1)</enum>
<header>In general; certification of device quality system</header>
<text>The Secretary shall, in accordance with this section, establish a third-party quality system assessment program—</text>
<subparagraph id="HC185138487CE44F283F638DAEB8F9D2F">
<enum>(A)</enum>
<text>to accredit persons to assess whether a requestor’s quality system, including its design controls, can reasonably assure the safety and effectiveness of in-scope devices subject to device-related changes;</text>
</subparagraph>
<subparagraph id="HF3EB63FC83274EF19991EA15DB7510E4">
<enum>(B)</enum>
<text>under which accredited persons shall (as applicable) certify that a requestor’s quality system meets the criteria included in the guidance issued under paragraph (5) with respect to the in-scope devices at issue; and</text>
</subparagraph>
<subparagraph id="HC57839D8CC1A48468DBF54140CC0EB13">
<enum>(C)</enum>
<text>under which the Secretary shall rely on such certifications for purposes of determining the safety and effectiveness (or as applicable, substantial equivalence) of in-scope devices subject to the device-related changes involved, in lieu of compliance with the following submission requirements:</text>
<clause id="HE607093364F9486D85CCCAB43826DF08">
<enum>(i)</enum>
<text>A premarket notification.</text>
</clause>
<clause id="H18974ED0D8E54CC3932AA737B7E54C02">
<enum>(ii)</enum>
<text>A thirty-day notice.</text>
</clause>
<clause id="HCCA37B5B97BE43CE89FEAFD442D5A238">
<enum>(iii)</enum>
<text>A Special PMA supplement.</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H333928D3D030458998A3F1C1DB84661E">
<enum>(2)</enum>
<header>Definitions</header>
<text>For purposes of this section─</text>
<subparagraph id="H3D5B55FFF14B4E43AE17F1B92E2C714E">
<enum>(A)</enum>
<text>the term <quote>device-related changes</quote> means changes made by a requestor with respect to in-scope devices, which are—</text>
<clause id="H4AAC5DA121C84803A40FB929BC4C1836">
<enum>(i)</enum>
<text>changes to a device found to be substantially equivalent under sections 513(i) and 510(k) to a predicate device, that—</text>
<subclause id="H33E54551F58248C49B32E2C8EAE43374">
<enum>(I)</enum>
<text>would otherwise be subject to a premarket notification; and</text>
</subclause>
<subclause id="HDA55A4FC76574850AE423AC96CFB4946">
<enum>(II)</enum>
<text>do not alter—</text>
<item id="H5AB62D0AC85248B08166CAA6A3DEC5D6">
<enum>(aa)</enum>
<text>the intended use of the changed device; or</text>
</item>
<item id="HA5339207F9904592A99BC540DFA7CA89">
<enum>(bb)</enum>
<text>the fundamental scientific technology of such device;</text>
</item>
</subclause>
</clause>
<clause id="H7ACAF1609FF4469EBF8E9D5095F7D4CD">
<enum>(ii)</enum>
<text>manufacturing changes subject to a 30-day notice;</text>
</clause>
<clause id="HE0C6C8E6039640BC9149771B9A150ABB">
<enum>(iii)</enum>
<text>changes that qualify for a Special PMA Supplement; and</text>
</clause>
<clause id="H2A2C07FA24E34729B94A1B4B9987D136">
<enum>(iv)</enum>
<text>such other changes relating to the devices or the device manufacturing process as the Secretary determines appropriate;</text>
</clause>
</subparagraph>
<subparagraph id="H1A23F2B9349D46C9A3A79DCD77A098F7">
<enum>(B)</enum>
<text>the term <quote>in-scope device</quote> means a device within the scope of devices agreed to by the requestor and the accredited person for purposes of a request for certification under this section;</text>
</subparagraph>
<subparagraph id="HD098D6DC8E614CB6887FA6E01E2736CF">
<enum>(C)</enum>
<text>the term <quote>premarket notification</quote> means a premarket notification under section 510(k);</text>
</subparagraph>
<subparagraph id="H6D1F54DE43BF4115BF551DEEC46F8ED5">
<enum>(D)</enum>
<text>the term <quote>quality system</quote> means the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of devices, as described in section 520(f);</text>
</subparagraph>
<subparagraph id="H56CC7607621044029CB724BCF635C453">
<enum>(E)</enum>
<text>the term <quote>requestor</quote> means a device manufacturer that is seeking certification under this section of a quality system used by such manufacturer;</text>
</subparagraph>
<subparagraph id="H72A9610C97BC41A6811AC30FC33015C0">
<enum>(F)</enum>
<text>the term <quote>Special PMA</quote> means a Special PMA supplement under section 814.39(d) of title 21, Code of Federal Regulations (or any successor regulations); and</text>
</subparagraph>
<subparagraph id="H1D9AC313729042D8A5E861A63B68D926">
<enum>(G)</enum>
<text>the term <quote>thirty-day notice</quote> means a notice described in section 515(d)(6).</text>
</subparagraph>
</paragraph>
<paragraph id="HF86407BBCB794E3993ACE548130E9D04">
<enum>(3)</enum>
<header>Accreditation process; accreditation renewal</header>
<text>Except as inconsistent with this section, the process and qualifications for accreditation of persons and renewal of such accreditation under section 704(g) shall apply with respect to accreditation of persons and renewal of such accreditation under this section.</text>
</paragraph>
<paragraph id="H8F1816A801A143ADAB56B260885F07A2">
<enum>(4)</enum>
<header>Use of accredited parties to conduct assessments</header>
<subparagraph id="H85D6B592F7744C939C3BE49F47CB2C22">
<enum>(A)</enum>
<header>Initiation of assessment services</header>
<clause id="H0B01996E70DB4C0A94B4C7701B0E865E">
<enum>(i)</enum>
<header>Date assessments authorized</header>
<text>Beginning after the date on which the final guidance is issued under paragraph (5), an accredited person may conduct an assessment under this section.</text>
</clause>
<clause id="H3A7F0EC3CA2A429387E80DCFB69DA92C">
<enum>(ii)</enum>
<header>Initiation of assessments</header>
<text>Use of one or more accredited persons to assess a requestor’s quality system under this section with respect to in-scope devices shall be at the initiation of the person who registers and lists the devices at issue under section 510.</text>
</clause>
</subparagraph>
<subparagraph id="H22DFD91E529B413F972D07B6C58DFBA8">
<enum>(B)</enum>
<header>Compensation</header>
<text>Compensation for such accredited persons shall—</text>
<clause id="H9EA2D4526362410482A8FC20B3A78B25">
<enum>(i)</enum>
<text>be determined by agreement between the accredited person and the person who engages the services of the accredited person; and</text>
</clause>
<clause id="H0D596A0EEC9D4E06A0BCD1CE93D3EB22">
<enum>(ii)</enum>
<text>be paid by the person who engages such services.</text>
</clause>
</subparagraph>
<subparagraph id="HBFBBAF0D9A8B416590EE48037222FD44">
<enum>(C)</enum>
<header>Accredited person selection</header>
<text>Each person who chooses to use an accredited person to assess a requestor’s quality system, as described in this section, shall select the accredited person from a list of such persons published by the Secretary in accordance with section 704(g)(4).</text>
</subparagraph>
</paragraph>
<paragraph id="H2B973D6B06664935B845CFFD09DFD7FC">
<enum>(5)</enum>
<header>Guidance; criteria for certification</header>
<subparagraph id="H1D01B09FD0AF44CDAA855AF8F94587D9">
<enum>(A)</enum>
<header>In general</header>
<text>The criteria for certification of a quality system under this section shall be as specified by the Secretary in guidance issued under this paragraph.</text>
</subparagraph>
<subparagraph id="H0D869B11A6024548BA2E36C8E4B1D47B">
<enum>(B)</enum>
<header>Contents; criteria</header>
<text>The guidance under this paragraph shall include specification of—</text>
<clause id="H1782F14884D748D687A37D7D5B3F0BC1">
<enum>(i)</enum>
<text>evaluative criteria to be used by an accredited person to assess and, as applicable, certify a requestor’s quality system under this section with respect to in-scope devices; and</text>
</clause>
<clause id="H0C4F01C6428D44B990EAAE2D0C40CBD1">
<enum>(ii)</enum>
<text>criteria for accredited persons to apply for a waiver of, and exemptions from, the criteria under clause (i).</text>
</clause>
</subparagraph>
<subparagraph id="H49803853A9D04BF1A94DE58DE899FE02">
<enum>(C)</enum>
<header>Timeframe for issuing guidance</header>
<text>The Secretary shall issue under this paragraph—</text>
<clause id="H460BBB6B46524590BA40EA714D93EB3B">
<enum>(i)</enum>
<text>draft guidance not later than 12 months after the enactment of the 21st Century Cures Act; and</text>
</clause>
<clause id="HD186440905D04078A55F8020F3DD2A75">
<enum>(ii)</enum>
<text>final guidance not later than 12 months after issuance of the draft guidance under clause (i).</text>
</clause>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H534DC154F1B840AB943EA0CBA5BE9223">
<enum>(b)</enum>
<header>Use of third-Party assessment</header>
<paragraph id="H633D5A5D85194336855C34090BF80D6C">
<enum>(1)</enum>
<header>Assessment summary; certification</header>
<subparagraph id="H63CED4E6E3624A1592EC77A4B7B6C721">
<enum>(A)</enum>
<header>Submission of assessment to secretary</header>
<text>An accredited person who assesses a requestor’s quality system under subsection (a) shall submit to the Secretary a summary of the assessment—</text>
<clause id="H4F99D5CA828A4A33AE2693CEE634FCFD">
<enum>(i)</enum>
<text>within 30 days of the assessment; and</text>
</clause>
<clause id="HF3ADD48678764A6AA891B1D35080B14F">
<enum>(ii)</enum>
<text>which shall include (as applicable)—</text>
<subclause id="H48F9D0F86D4F49209B8354EFED88BDAF">
<enum>(I)</enum>
<text>the accredited person’s certification that the requestor has satisfied the criteria specified in the guidance issued under subsection (a)(5) for quality system certification with respect to the in-scope devices at issue; and</text>
</subclause>
<subclause id="HDD6D67DA712647758895CBE01350DF56">
<enum>(II)</enum>
<text>any waivers or exemptions from such criteria applied by the accredited person.</text>
</subclause>
</clause>
</subparagraph>
<subparagraph id="HB04A036BCA6849CDAA37F9623FCD5040">
<enum>(B)</enum>
<header>Treatment of assessments</header>
<text>Subject to action by the Secretary under subparagraph (C), with respect to assessments which include a certification under this section—</text>
<clause id="H849D59E201E340CC9F30EDF393035C90">
<enum>(i)</enum>
<text>the Secretary’s review of the assessment summary shall be deemed complete on the day that is 30 days after the date on which the Secretary receives the summary under subparagraph (A); and</text>
</clause>
<clause id="H589B564C63F44E399BF47BB739913EC2">
<enum>(ii)</enum>
<text>the assessment summary and certification of the quality system of a requestor shall be deemed accepted by the Secretary on such 30th day.</text>
</clause>
</subparagraph>
<subparagraph id="HA776D07EF9B64FF998D4FE6908893776">
<enum>(C)</enum>
<header>Actions by secretary</header>
<clause id="H503D184A52D540DE852B750C311B1250">
<enum>(i)</enum>
<header>In general</header>
<text>Within 30 days of receiving an assessment summary and certification under subparagraph (A), the Secretary may, by written notice to the accredited person submitting such assessment certification, deem any such certification to be provisional beyond such 30-day period, suspended pending further review by the Secretary, or otherwise qualified or cancelled, based on the Secretary’s determination that (as applicable)—</text>
<subclause id="H1CB883E599FE4A50B3CEF6CDBEBDD414">
<enum>(I)</enum>
<text>additional information is needed to support such certification;</text>
</subclause>
<subclause id="H6B80558B7B144AEF8A3806A4A4EF6CD2">
<enum>(II)</enum>
<text>such assessment or certification is unwarranted; or</text>
</subclause>
<subclause id="HC8D5334DA63C4389B606963CFA5E841B">
<enum>(III)</enum>
<text>such action with regard to the certification is otherwise justified according to such factors and criteria as the Secretary finds appropriate.</text>
</subclause>
</clause>
<clause id="H3D861746BCAD424C85E16ABCC7D92794">
<enum>(ii)</enum>
<header>Acceptance of certification</header>
<text>If following action by the Secretary under clause (i) with respect to a certification, the Secretary determines that such certification is acceptable, the Secretary shall issue written notice to the applicable accredited person indicating such acceptance.</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H57B62DB5B95840A7AF4D20DFFDC4FC11">
<enum>(2)</enum>
<header>Notifications to Secretary by certified requestors or accredited persons for program evaluation purposes</header>
<subparagraph id="HCF16D12EE6BF412BAD014391ABE53614">
<enum>(A)</enum>
<header>Annual summary report for device-related changes otherwise subject to premarket notification</header>
<text>A requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices, without prior submission of a premarket notification, shall ensure that an annual summary report is submitted to the Secretary by the accredited person which—</text>
<clause id="H5ABD3C3372D2495689D8898E1DA28A72">
<enum>(i)</enum>
<text>describes the changes made to the in-scope device; and</text>
</clause>
<clause id="HEF50F75792EC4C79A82A784545011E3A">
<enum>(ii)</enum>
<text>indicates the effective dates of such changes.</text>
</clause>
</subparagraph>
<subparagraph id="H7857C0B0CD9C4370A9799316A883A374">
<enum>(B)</enum>
<header>Periodic notification for manufacturing changes otherwise subject to thirty-day notice</header>
<text display-inline="yes-display-inline">A requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices, without prior submission of a thirty-day notice, shall provide notification to the Secretary of such changes in the requestor’s next periodic report under section 814.84(b) of title 21, Code of Federal Regulations (or any successor regulation). Such notification shall—</text>
<clause id="H5AFA3DCF82BB45E68D0FDD8DF669C9A6">
<enum>(i)</enum>
<text>describe the changes made; and</text>
</clause>
<clause id="HD6AB5CCB2928415D8A69A893F02F1441">
<enum>(ii)</enum>
<text>indicate the effective dates of such changes.</text>
</clause>
</subparagraph>
<subparagraph id="HF095B5BA5B444D99A6125E3E1F5A6C48">
<enum>(C)</enum>
<header>Periodic notification for device-related changes otherwise subject to special pma supplement</header>
<text display-inline="yes-display-inline">A requestor whose quality system is certified under this section that effectuates device-related changes with respect to in-scope devices, without prior submission of a Special PMA Supplement, shall provide notification to the Secretary of such changes in the requestor’s next periodic report under section 814.84(b) of title 21, Code of Federal Regulations (or any successor regulation). Such notification shall—</text>
<clause id="H7E27DD32EB5A49C58AF4C13F10AD34CD">
<enum>(i)</enum>
<text>describe the changes made, including a full explanation of the basis for the changes; and</text>
</clause>
<clause id="HC2BAB7D1938C4DE98A7D9F1CD09696D3">
<enum>(ii)</enum>
<text>indicate the effective dates of such changes.</text>
</clause>
</subparagraph>
<subparagraph id="HEBFA0993B6744D1B86B7F0AEEE17B5CC">
<enum>(D)</enum>
<header>Use of notifications for program evaluation purposes</header>
<text>Information submitted to the Secretary under subparagraphs (A) through (C) shall be used by the Secretary for purposes of the program evaluation under subsection (d).</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H9BAFAE62AE6A44ADAA1363EE33A3E978">
<enum>(c)</enum>
<header>Duration and effect of certification</header>
<text>A certification under this section—</text>
<paragraph id="H386DC9355E474EBFB4D8B02F9DBA8FB1">
<enum>(1)</enum>
<text>shall remain in effect for a period of 2 years from the date such certification is accepted by the Secretary, subject to paragraph (6);</text>
</paragraph>
<paragraph id="H0B035615011647D99666C25A4CE29B0B">
<enum>(2)</enum>
<text>may be renewed through the process described in subsection (a)(3);</text>
</paragraph>
<paragraph id="H7B57CE544FB24F4A898F57DAF71760A4">
<enum>(3)</enum>
<text>shall continue to apply with respect to device-related changes made during such 2-year period, provided the certification remains in effect, irrespective of whether such certification is renewed after such 2-year period;</text>
</paragraph>
<paragraph id="HEADFF2D94ACC48C093B3FD150CCBCE19">
<enum>(4)</enum>
<text>shall have no effect on the need to comply with applicable submission requirements specified in subsection (a)(1)(C) with respect to any change pertaining to in-scope devices which is not a device-related change under subsection (a)(2);</text>
</paragraph>
<paragraph id="H997F6CCAD71F4C2BB06CA58885792C87">
<enum>(5)</enum>
<text>shall have no effect on the authority of the Secretary to conduct an inspection or otherwise determine whether the requestor has complied with the applicable requirements of this Act; and</text>
</paragraph>
<paragraph id="H9E7CEB42267C4F2E8930F3AB8ACD149C">
<enum>(6)</enum>
<text>may be revoked by the Secretary upon a determination that the requestor’s quality system no longer meets the criteria specified in the guidance issued under subsection (a)(5) with respect to the in-scope devices at issue.</text>
</paragraph>
</subsection>
<subsection id="HE95C5EF9569349A5AA1BBEA293E9262F">
<enum>(d)</enum>
<header>Notice of revocation</header>
<text>The Secretary shall provide written notification to the requestor of a revocation pursuant to subsection (c)(6) not later than 10 business days after the determination described in such subsection. Upon receipt of the written notification, the requestor shall satisfy the applicable submission requirements specified in subsection (a)(1)(C) for any device-related changes effectuated after the date of such determination. After such revocation, such requestor is eligible to seek re-certification under this section of its quality system.</text>
</subsection>
<subsection id="H3B77130EBA4149B387054239C27F217B">
<enum>(e)</enum>
<header>Program evaluation; sunset</header>
<paragraph id="HD0662DB5A09C425DB4D5DA681613BC9E">
<enum>(1)</enum>
<header>Program evaluation and report</header>
<subparagraph id="H3E121590FB354655B71F5A3D589D2E24">
<enum>(A)</enum>
<header>Evaluation</header>
<text>The Secretary shall complete an evaluation of the third-party quality system assessment program under this section no later than January 31, 2021, based on—</text>
<clause id="H7CE9227FCB024CA9A31B22B913BC0210">
<enum>(i)</enum>
<text>analysis of information from a representative group of device manufacturers obtained from notifications provided by certified requestors or accredited persons under subsection (b)(2); and</text>
</clause>
<clause id="H63C8AFC18DC045EEA21F82753CEFBAC4">
<enum>(ii)</enum>
<text>such other available information and data as the Secretary determines appropriate.</text>
</clause>
</subparagraph>
<subparagraph id="HA8AE5AAED6C741CCAFCBB99B2AD06CCA">
<enum>(B)</enum>
<header>Report</header>
<text>No later than 1 year after completing the evaluation under subparagraph (A), the Secretary shall issue a report of the evaluation’s findings on the website of the Food and Drug Administration, which shall include the Secretary’s recommendations with respect to continuation and as applicable expansion of the program under this section to encompass—</text>
<clause id="H3975AF079BD1464085A22C8972C84195">
<enum>(i)</enum>
<text>device submissions beyond those identified in subsection (a)(1)(C); and</text>
</clause>
<clause id="HECB60229257446BCA8FBC5EE19F07436">
<enum>(ii)</enum>
<text>device changes beyond those described in subsection (a)(2)(A).</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H2868B75CA3EE43979B3C9838743B0A5B">
<enum>(2)</enum>
<header>Sunset</header>
<text>This section shall cease to be effective October 1, 2022.</text>
</paragraph>
</subsection>
<subsection id="H80CA22712C5F4433A2B9F91BC5893660">
<enum>(f)</enum>
<header>Rule of construction</header>
<text>Nothing in this section shall be construed to limit the authority of the Secretary to request and review the complete assessment of a certified requestor under this section on a for-cause basis.</text>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="HCD5AC7216E3548B28B3A1F7D5EE24F29">
<enum>(b)</enum>
<header>Conforming amendments</header>
<paragraph id="H2B7A8D11BF774147BD3E1950AD152774">
<enum>(1)</enum>
<header>Requirements for premarket approval supplements</header>
<text>Section 515(d)(5)(A)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)(5)(A)(i)), as redesignated by section 2201, is further amended by inserting <quote>, subject to section 524B</quote> after <quote>that affects safety or effectiveness</quote>.</text>
</paragraph>
<paragraph id="H5919806B01074267BEEB7351DFD65346">
<enum>(2)</enum>
<header>Requirements for thirty-day notice</header>
<text>Section 515(d)(5)(A)(ii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)(5)(A)(ii)), as redesignated by section 2201, is further amended by inserting <quote>, subject to section 524B</quote> after <quote>the date on which the Secretary receives the notice</quote>.</text>
</paragraph>
<paragraph id="HB23544DF470940CFBB05774F4FC291D4">
<enum>(3)</enum>
<header>Requirements for premarket notification; technical correction to reference to section 510(k)</header>
<text>Section 510(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amended by striking <quote>of this subsection under subsection (m)</quote> and inserting <quote>of subsection (k) under subsection (m) or section 524B</quote>. </text>
</paragraph>
<paragraph id="HB6B13DFE9F5F4BBC8001D0B9458FE251">
<enum>(4)</enum>
<header>Misbranded devices</header>
<text>Section 502(t) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(t)) is amended by inserting <quote>or 524B</quote> after <quote>section 519</quote>.</text>
</paragraph>
</subsection>
</section>
<section id="H912CE7C1E07141CFA4DB28BA5EC4A312" section-type="subsequent-section" commented="no">
<enum>2222.</enum>
<header>Valid scientific evidence</header>
<text display-inline="no-display-inline">Section 513(a)(3)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(a)(3)(B)) is amended—</text>
<paragraph id="HA4B97613BFEA4B0FB016481C91C049E6" commented="no">
<enum>(1)</enum>
<text>by redesignating clauses (i) and (ii) as subclauses (I) and (II), respectively;</text>
</paragraph>
<paragraph id="HFD9D0D62086546D3B29869A7ED6B36E6" commented="no">
<enum>(2)</enum>
<text>by striking <quote>(B) If the Secretary</quote> and inserting <quote>(B)(i) If the Secretary</quote>; and</text>
</paragraph>
<paragraph id="H7DAA74C891CD4FD981DDE8A8CDF8B818" commented="no">
<enum>(3)</enum>
<text>by adding at the end the following:</text>
<quoted-block id="H067B64C49508452CA10302964485DD10" style="OLC">
<clause id="H97E94659DC264BA5B8394F5CED9A6DFD" indent="up3" commented="no">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">For purposes of clause (i), valid scientific evidence may include—</text>
<subclause id="HF45C1AC61679487AB813EE4F83AFE22B" commented="no">
<enum>(I)</enum>
<text>evidence described in well-documented case histories, including registry data, that are collected and monitored under a protocol determined to be acceptable by the Secretary;</text>
</subclause>
<subclause id="HD0B13245E724420CA8E2851D05FB062A" commented="no">
<enum>(II)</enum>
<text>studies published in peer-reviewed journals; and</text>
</subclause>
<subclause id="HACEABD6CCCAB41B38FDE31CD123C4F5E" commented="no">
<enum>(III)</enum>
<text>data collected in countries other than the United States so long as such data otherwise meet the criteria specified in this subparagraph.</text>
</subclause>
</clause>
<clause id="HD7806CD303B84564B4C1166F1C728C40" indent="up3" commented="no">
<enum>(iii)</enum>
<text>In the case of a study published in a peer-reviewed journal that is offered as valid scientific evidence for purposes of clause (i), the Secretary may request data underlying the study if—</text>
<subclause id="H4EA4F4ABA2C24BE3B51FAF2FE981956A" commented="no">
<enum>(I)</enum>
<text>the Secretary, in making such request, complies with the requirement of subparagraph (D)(ii) to consider the least burdensome appropriate means of evaluating device effectiveness or subsection (i)(1)(D) to consider the least burdensome means of determining substantial equivalence, as applicable;</text>
</subclause>
<subclause id="H94FD58B39C114CEC8210499E8054F3EF" commented="no">
<enum>(II)</enum>
<text>the Secretary furnishes a written rationale for so requesting the underlying data together with such request; and</text>
</subclause>
<subclause id="H37782C64705C4CE08B234600554211CF" commented="no">
<enum>(III)</enum>
<text>if the requested underlying data for such a study are unavailable, the Secretary shall consider such study to be part of the totality of the evidence with respect to the device, as the Secretary determines appropriate.</text>
</subclause>
</clause>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</section>
<section id="H421AE1B5375540B9A347B16FB9D66D29">
<enum>2223.</enum>
<header>Training and oversight in least burdensome appropriate means concept</header>
<subsection id="H9482967D44C04F109CB4DAFB27C6DB77">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end the following:</text>
<quoted-block id="HEBEA8D571C6D47DAA5A65B699CCC14E0" style="OLC">
<subsection id="H4D84802DB1ED4FFE98B9D7BD185ED5E8">
<enum>(j)</enum>
<header>Training and oversight in least burdensome appropriate means concept</header>
<text display-inline="yes-display-inline">
</text>
<paragraph id="H74F70298E64B4201B0DEDB534D7821E2">
<enum>(1)</enum>
<header>Training</header>
<text display-inline="yes-display-inline">Each employee of the Food and Drug Administration who is involved in the review of premarket submissions under section 515 or section 510(k), including supervisors, shall receive training regarding the meaning and implementation of the least burdensome appropriate means concept in the context of the use of that term in subsections (a)(3)(D) and (i)(1)(D) of this section and in section 515(c)(5).</text>
</paragraph>
<paragraph id="HB5021BB5880D4C6FA0CFF2A5DF03CC6B">
<enum>(2)</enum>
<header>Guidance documents</header>
<subparagraph id="H1822BDF4B6884D9BB463F16BF7D4E601">
<enum>(A)</enum>
<header>Draft updated guidance</header>
<text display-inline="yes-display-inline">Not later than 12 months after the date of enactment of the <short-title>21st Century Cures Act</short-title>, the Secretary shall issue a draft guidance document updating the October 4, 2002, guidance document entitled <quote>The Least Burdensome Provision of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry</quote>.</text>
</subparagraph>
<subparagraph id="HC4509A0AD5F6428ABD6B6F091DE31380">
<enum>(B)</enum>
<header>Meeting of stakeholders</header>
<text>In developing such draft guidance document, the Secretary shall convene a meeting of stakeholders to ensure a full record to support the publication of such document.</text>
</subparagraph>
</paragraph>
<paragraph id="H536DAA4A4DE54E3FA868388459FCCEF3">
<enum>(3)</enum>
<header>Ombudsman audit</header>
<text display-inline="yes-display-inline">Not later than 18 months after the date of issuance of final version of the draft guidance under paragraph (2), the ombudsman for the organizational unit of the Food and Drug Administration responsible for the premarket review of devices shall—</text>
<subparagraph id="H02A9DDE48C56485BB5C3DF76285A3833">
<enum>(A)</enum>
<text>conduct, or have conducted, an audit of the training described in paragraph (1); and</text>
</subparagraph>
<subparagraph id="H612B79926E35404A9228D42040713DF6">
<enum>(B)</enum>
<text>include in such audit interviews with a representative sample of persons from industry regarding their experience in the device premarket review process.</text>
</subparagraph>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="H0DDE597C5DD24B78A203799661BE6340">
<enum>(b)</enum>
<header>Additional information regarding premarket applications</header>
<text display-inline="yes-display-inline">Subsection (c) of section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) is amended by adding at the end the following:</text>
<quoted-block style="OLC" id="H5323D6E9F8B54A2C838C164F6190F81E" display-inline="no-display-inline">
<paragraph id="H60D4A9495BC147C3A08FA1BDF54643CF" indent="up1">
<enum>(5)</enum>
<subparagraph id="HFD03CC5047404D0B9D04B2816A7BC887" display-inline="yes-display-inline">
<enum>(A)</enum>
<text display-inline="yes-display-inline">Whenever the Secretary requests additional information from an applicant regarding an application under paragraph (1), the Secretary shall consider the least burdensome appropriate means necessary to demonstrate device safety and effectiveness, and request information accordingly.</text>
</subparagraph>
<subparagraph id="H65418B4286B54FDABA53257BE39D3C26" indent="up1">
<enum>(B)</enum>
<text>For purposes of subparagraph (A), the term <quote>necessary</quote> means the minimum required information that would support a determination by the Secretary that an application provides a reasonable assurance of the safety and effectiveness of the device.</text>
</subparagraph>
<subparagraph id="H66242F71E0B34468BB86368C2FF2E4AF" indent="up1">
<enum>(C)</enum>
<text>Nothing in this paragraph alters the standards for premarket approval of a device.</text>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
</section>
<section id="HD423D1382DD44151A9DC6603B155289A">
<enum>2224.</enum>
<header>Recognition of standards</header>
<text display-inline="no-display-inline">Section 514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d(c)) is amended—</text>
<paragraph id="H6B8F448E5E634AA597244007B949E49E">
<enum>(1)</enum>
<text>in paragraph (1), by inserting after subparagraph (B) the following new subparagraphs:</text>
<quoted-block id="H8954E954D6A54379A285C7E906602528" style="OLC">
<subparagraph id="HDAD86F628387495981EFAFF149EBE673" indent="up2">
<enum>(C)</enum>
<clause id="H1E6434A1333D479A80E4BC0C84D16C3F" display-inline="yes-display-inline">
<enum>(i)</enum>
<text>Any person may submit a request for recognition under subparagraph (A) of all or part of an appropriate standard established by a nationally or internationally recognized standard organization.</text>
</clause>
<clause id="H2DA91067EDEC4BF7954ECF7DDB85445C" indent="up1">
<enum>(ii)</enum>
<text>Not later than 60 days after the Secretary receives such a request, the Secretary shall—</text>
<subclause id="HDFD1B4DE9C1C416E982B7C0AD5DCC7DC">
<enum>(I)</enum>
<text>make a determination to recognize all, part, or none of the standard that is the subject of the request; and</text>
</subclause>
<subclause id="HC1CDB90790154B8889D6F02CF9C69C92">
<enum>(II)</enum>
<text>issue to the person who submitted such request a response in writing that states the Secretary’s rationale for that determination, including the scientific, technical, regulatory, or other basis for such determination.</text>
</subclause>
</clause>
<clause id="H3369CAD873CA4C18A56DE45CF7AE3EAE" indent="up1">
<enum>(iii)</enum>
<text>The Secretary shall make a response issued under clause (ii)(II) publicly available, in such manner as the Secretary determines appropriate.</text>
</clause>
<clause id="HC8CFC571A6E64E5D85FA046468D9E615" indent="up1">
<enum>(iv)</enum>
<text>The Secretary shall take such actions as may be necessary to implement all or part of a standard recognized under clause (i)(I), in accordance with subparagraph (A). <italic></italic></text>
</clause>
</subparagraph>
<subparagraph id="HB728A6C87C504679A55E44FC46CAE95F" indent="up2">
<enum>(D)</enum>
<text>The Secretary shall make publicly available, in such manner as the Secretary determines appropriate, the rationale for recognition under subparagraph (A) of part of a standard, including the scientific, technical, regulatory, or other basis for such recognition.<italic></italic></text>
</subparagraph>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H8B1EDD7B5E5C48F3BED9E8030A9CCA4D">
<enum>(2)</enum>
<text>by adding at the end the following new paragraphs:</text>
<quoted-block id="HE7E42232FE89449A82FEC0FBFC4F13ED" style="OLC">
<paragraph id="HA1143EE5A33543CFA162E2A457949B66">
<enum>(4)</enum>
<header>Training on use of standards</header>
<text display-inline="yes-display-inline">The Secretary shall provide to all employees of the Food and Drug Administration who review premarket submissions for devices periodic training on the concept and use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement under this Act, including standards relevant to an employee’s area of device review.</text>
</paragraph>
<paragraph id="H6B739F6493D24BB993C6022DB5F19A96">
<enum>(5)</enum>
<header>Guidance</header>
<subparagraph id="HCA544730E5184BBBBEB3B53241F68B9E">
<enum>(A)</enum>
<header>Draft guidance</header>
<text>The Secretary shall publish guidance identifying the principles for recognizing standards under this section. In publishing such guidance, the Secretary shall consider—</text>
<clause id="H71AF51DBDB2E493A823DFC994CF4E9E9">
<enum>(i)</enum>
<text>the experience with, and reliance on, a standard by other Federal regulatory authorities and the device industry; and</text>
</clause>
<clause id="H60B6FAEA36E540BBBAC91FE9F24CD0E3">
<enum>(ii)</enum>
<text>whether recognition of a standard will promote harmonization among regulatory authorities in the regulation of devices.</text>
</clause>
</subparagraph>
<subparagraph id="HDD35FA55FBE64BDA96010F84B5386132">
<enum>(B)</enum>
<header>Timing</header>
<text display-inline="yes-display-inline">The Secretary shall publish—</text>
<clause id="H8BE2FC335B904FD0A233E5E5D5C4739D">
<enum>(i)</enum>
<text>draft guidance under subparagraph (A) not later than 12 months after the date of the enactment of the 21st Century Cures Act; and</text>
</clause>
<clause id="HB470B7F494D04C9D9478752884B9621D">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">final guidance not later than 12 months after the close of the public comment period for the draft guidance under clause (i).</text>
</clause>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</section>
<section id="HE38FED56EDCF43DDA17DDFE90FDD3B49" section-type="subsequent-section">
<enum>2225.</enum>
<header>Easing regulatory burden with respect to certain class I and class II devices</header>
<subsection id="H79BA662DCDA047A59EA3B66C533AD7B4">
<enum>(a)</enum>
<header>Class I devices</header>
<text display-inline="yes-display-inline">Section 510(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amended—</text>
<paragraph id="HAB2FDB4858C14E0FA98FF09F000E18AA">
<enum>(1)</enum>
<text display-inline="yes-display-inline">by striking <quote>A report under subsection (k)</quote> and inserting <quote>(1) A report under subsection (k)</quote>; and</text>
</paragraph>
<paragraph id="H96CE1C1B5E4F4B8BA7AB85BBA408D473">
<enum>(2)</enum>
<text>by adding at the end the following new paragraph: </text>
<quoted-block style="traditional" id="H33D578270914432D9B8D4664A0E24F86" display-inline="no-display-inline">
<paragraph id="H37EE3D0E2B9341C9B9ABFBBFF7CA078C" indent="up1">
<enum>(2)</enum>
<text display-inline="yes-display-inline">Not later than 120 days after the date of the enactment of the <short-title>21st Century Cures Act</short-title>, the Secretary shall identify, through publication in the Federal Register, any type of class I device that the Secretary determines no longer requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness. Upon such publication—</text>
<subparagraph id="HF7207EBCC8474A38ABC30A78BCB5E74D">
<enum>(A)</enum>
<text display-inline="yes-display-inline">each type of class I device so identified shall be exempt from the requirement for a report under subsection (k); and</text>
</subparagraph>
<subparagraph id="H6A8711F38B6A4FEFA5AFF47E3C0B7FF9">
<enum>(B)</enum>
<text display-inline="yes-display-inline">the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption.</text>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="H0D37AFC9D4624C43B52A15CBD1FADFCF">
<enum>(b)</enum>
<header>Class II devices</header>
<text display-inline="yes-display-inline">Section 510(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) is amended—</text>
<paragraph id="HAD6710364A254F2BA20F5E85987EDAAD">
<enum>(1)</enum>
<text display-inline="yes-display-inline">by striking paragraph (1) and inserting the following new paragraph: </text>
<quoted-block style="traditional" id="H6F6533D832E447D48ECC40484883100D" display-inline="yes-display-inline">
<paragraph id="HB510DB676AAA44388847F3A200E1A141" indent="up1" display-inline="yes-display-inline">
<enum>(1)</enum>
<text>The Secretary shall—</text>
<subparagraph id="HEFE46024232E48FEB9C7494721CDA535">
<enum>(A)</enum>
<text display-inline="yes-display-inline">not later than 60 days after the date of the enactment of the <short-title>21st Century Cures Act</short-title>—</text>
<clause id="H68D2C151FDCA4B578E0FC36F9EA9390A">
<enum>(i)</enum>
<text display-inline="yes-display-inline">publish in the Federal Register a notice that contains a list of each type of class II device that the Secretary determines no longer requires a report under subsection (k) to provide reasonable assurance of safety and effectiveness; and</text>
</clause>
<clause id="HD3C34F68BEEF496FA9E4B1DF8E30F861">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">provide for a period of not less than 60 days for public comment beginning on the date of the publication of such notice; and</text>
</clause>
</subparagraph>
<subparagraph id="H5D52AEBC2A444313BD8FD28C52AD7961">
<enum>(B)</enum>
<text display-inline="yes-display-inline">not later than 180 days after the date of the enactment of <short-title>21st Century Cures Act</short-title>, publish in the Federal Register a list representing the Secretary’s final determination with respect to the devices included in the list published under subparagraph (A). </text>
</subparagraph>
</paragraph>
<after-quoted-block>;</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H843B1684DB1E48F9865A0A8C54377F83">
<enum>(2)</enum>
<text>in paragraph (2)—</text>
<subparagraph id="H2CEBDA8C8B1C4D4782B2170EBE92D2B1">
<enum>(A)</enum>
<text display-inline="yes-display-inline">by striking <quote>1 day after the date of the publication of a list under this subsection,</quote> and inserting <quote>1 day after the date of publication of the final list under paragraph (1)(B),</quote>; and</text>
</subparagraph>
<subparagraph id="H43E7914DB6DB40CDB6A4D9A4414F3813">
<enum>(B)</enum>
<text>by striking <quote>30-day period</quote> and inserting <quote>60-day period</quote>; and</text>
</subparagraph>
</paragraph>
<paragraph id="H2588CCD8E615400BAA8A67203C4181B6">
<enum>(3)</enum>
<text display-inline="yes-display-inline">by adding at the end the following new paragraph: </text>
<quoted-block style="traditional" id="H08B36E1135AB4715BB55491C93D24906" display-inline="no-display-inline">
<paragraph id="H84B32C939E5A4EA48A65DAA9A4C6EA90" indent="up1">
<enum>(3)</enum>
<text>Upon the publication of the final list under paragraph (1)(B)—</text>
<subparagraph id="H3EC5EAD1931B49D5A299868635971AC5">
<enum>(A)</enum>
<text display-inline="yes-display-inline">each type of class II device so listed shall be exempt from the requirement for a report under subsection (k); and</text>
</subparagraph>
<subparagraph id="HA4375FF002FE4CE5979FA3EBA1471438">
<enum>(B)</enum>
<text display-inline="yes-display-inline">the classification regulation applicable to each such type of device shall be deemed amended to incorporate such exemption. </text>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
</section>
<section id="H3DF89FBD429746E090AB84641A57C68F">
<enum>2226.</enum>
<header>Advisory committee process</header>
<subsection id="HB92B7CFC60614500B80618879AD51AE5">
<enum>(a)</enum>
<header>Classification panels</header>
<text>Paragraph (5) of section 513(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended—</text>
<paragraph id="H6BF764FBCCF0408ABDB4FBFE1BD933C2">
<enum>(1)</enum>
<text>by striking <quote>(5)</quote> and inserting <quote>(5)(A)</quote>; and</text>
</paragraph>
<paragraph id="H0FCEF0843A2C41B8B740AC984BEE1BDE">
<enum>(2)</enum>
<text>by adding at the end the following:</text>
<quoted-block id="H65098B9487044554BAF3D30DB1C3F4A6" style="OLC">
<subparagraph id="H13B1B071648F421792BE2A852D9D9AB6" indent="up2">
<enum>(B)</enum>
<text display-inline="yes-display-inline">When a device is specifically the subject of review by a classification panel, the Secretary shall—</text>
<clause id="H3D8E366976684DE2926A1E4811EF256A">
<enum>(i)</enum>
<text>ensure that adequate expertise is represented on the classification panel to assess—</text>
<subclause id="HC33A209CA9734A6E90DC25DB6367523F">
<enum>(I)</enum>
<text>the disease or condition which the device is intended to cure, treat, mitigate, prevent, or diagnose; and</text>
</subclause>
<subclause id="HF82C8FFC91C5424DBF2E98912FF6189C">
<enum>(II)</enum>
<text>the technology of the device; and</text>
</subclause>
</clause>
<clause id="HE2E1D767CCE341E8A4605C7D8D88AC26">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">as part of the process to ensure adequate expertise under clause (i), give due consideration to the recommendations of the person whose premarket submission is subject to panel review on the expertise needed among the voting members of the panel.</text>
</clause>
</subparagraph>
<subparagraph id="H85D96427F6504CFBA1EAA018EFDC2EA5" indent="up2">
<enum>(C)</enum>
<text>For purposes of subparagraph (B)(ii), the term <quote>adequate expertise</quote> means, with respect to the membership of the classification panel reviewing a premarket submission, that such membership includes—</text>
<clause id="HA436A1A5591D4B778F40AD09DB792906">
<enum>(i)</enum>
<text>two or more voting members, with a specialty or other expertise clinically relevant to the device under review; and</text>
</clause>
<clause id="HF50D61B61E8E43578A153E4C33BBFA46">
<enum>(ii)</enum>
<text>at least one voting member who is knowledgeable about the technology of the device.</text>
</clause>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="H152457CE74FB4EBAA7316516252B6DDB">
<enum>(b)</enum>
<header>Panel review process</header>
<text>Section 513(b)(6) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is amended—</text>
<paragraph id="H0C79712E2710471C82BAE6A617251358">
<enum>(1)</enum>
<text>in subparagraph (A)(iii), by inserting before the period at the end <quote>, including by designating a representative who will be provided a time during the panel meeting to address the panel individually (or accompanied by experts selected by such representative) for the purpose of correcting misstatements of fact or providing clarifying information, subject to the discretion of the panel chairperson</quote>; and</text>
</paragraph>
<paragraph id="H3D4C65ACC9AD4A59B8C91E5C8B390CB4">
<enum>(2)</enum>
<text>by striking subparagraph (B) and inserting the following new subparagraph:</text>
<quoted-block id="HBCB2E28BFF9547C2923477C74741A191" style="OLC">
<subparagraph id="HF0EF6B11C508498DBA484BC0556AAEC2" indent="up2">
<enum>(B)</enum>
<clause id="H952C3F0A66D34B1898A8B2E458A70212" display-inline="yes-display-inline">
<enum>(i)</enum>
<text display-inline="yes-display-inline">Any meeting of a classification panel for a device that is specifically the subject of review shall—</text>
<subclause id="H769CD103FF0D4599A25426F302AF8F1B" indent="up1">
<enum>(I)</enum>
<text display-inline="yes-display-inline">provide adequate time for initial presentations by the person whose device is specifically the subject of a classification panel review and by the Secretary; and</text>
</subclause>
<subclause id="H007818B8FB4D4CBA989CC1C0E7187694" indent="up1">
<enum>(II)</enum>
<text>encourage free and open participation by all interested persons.</text>
</subclause>
</clause>
<clause id="H298F299EFEF84FF9AD2B66C18BCE2F5B" indent="up1">
<enum>(ii)</enum>
<text>Following the initial presentations described in clause (i), the panel may—</text>
<subclause id="H207460AAF0C94C5888A7AE96DDC093F7">
<enum>(I)</enum>
<text>pose questions to a designated representative described in subparagraph (A)(iii); and</text>
</subclause>
<subclause id="H140593B5D3924243B41C27AA6BDA1D63">
<enum>(II)</enum>
<text display-inline="yes-display-inline">consider the responses to such questions in the panel’s review of the device that is specifically the subject of review by the panel.</text>
</subclause>
</clause>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
</section>
<section id="HAD0AE5DE77C64D46BDDEFCFB36A76B20">
<enum>2227.</enum>
<header>Humanitarian device exemption application</header>
<subsection id="HF8CADD9266894EF4812075A6453B4392">
<enum>(a)</enum>
<header>In general</header>
<text>Section 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended—</text>
<paragraph id="H75484D65218F4D74BA9D1077C7685177">
<enum>(1)</enum>
<text>in paragraph (1) by striking <quote>fewer than 4,000</quote> and inserting <quote>not more than 8,000</quote>;</text>
</paragraph>
<paragraph id="H8CF6F1A1A6DC44F2923509353BDA8057">
<enum>(2)</enum>
<text>in paragraph (2)(A) by striking <quote>fewer than 4,000</quote> and inserting <quote>not more than 8,000</quote>; and</text>
</paragraph>
<paragraph id="H0F1A6D035ECE4AEA883E4974B51E1D24">
<enum>(3)</enum>
<text>in paragraph (6)(A)(ii), by striking <quote>4,000</quote> and inserting <quote>8,000</quote></text>
</paragraph>
</subsection>
<subsection id="HB6DCFCA2493B48A4A8E645517DEA51B8">
<enum>(b)</enum>
<header>Guidance document on probable benefit</header>
<text>Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall publish a draft guidance document that defines the criteria for establishing <quote>probable benefit</quote> as that term is used in section 520(m)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)(C)).</text>
</subsection>
</section>
<section id="H63B3BD0210D1447EB9AD327B4F087B1F">
<enum>2228.</enum>
<header>CLIA waiver study design guidance for in vitro diagnostics</header>
<subsection id="H7A01E6230AE94F2DBCE1397843B68942">
<enum>(a)</enum>
<header>Draft revised guidance</header>
<text>Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall publish a draft guidance that— </text>
<paragraph id="H5FDB67DE12CD440798A24A9CF7118BB5">
<enum>(1)</enum>
<text>revises <quote>Section V. Demonstrating Insignificant Risk of an Erroneous Result—<quote>Accuracy</quote></quote> of the guidance entitled <quote>Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices</quote> and dated January 30, 2008; and </text>
</paragraph>
<paragraph id="H416B7F23A0C44EF3B0F05F9BE2956B07">
<enum>(2)</enum>
<text>includes guidance on the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.</text>
</paragraph>
</subsection>
<subsection id="H3F94D995FBA94417BE0EF78C79E0AF50">
<enum>(b)</enum>
<header>Final revised guidance</header>
<text>The Secretary of Health and Human Services shall finalize the draft guidance published under subsection (a) not later than 12 months after the comment period for such draft guidance closes. </text>
</subsection>
</section>
</subtitle>
<subtitle id="HC70025A5F4724C51AA8C7D59512E9B0F" commented="no">
<enum>N</enum>
<header>Sensible Oversight for Technology Which Advances Regulatory Efficiency</header>
<section id="HAE504B1A8E1A4907A178A5D83927E56E" commented="no">
<enum>2241.</enum>
<header>Health software</header>
<text display-inline="no-display-inline">Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding at the end the following:</text>
<quoted-block id="H5ACA08309BDA453E80389511B1563B63" style="OLC">
<subsection id="HD836262CD687469F98EBE2281C3F80C9" commented="no">
<enum>(ss)</enum>
<paragraph id="H6D585AA3948546E1A21142D0AD30ADB7" display-inline="yes-display-inline" commented="no">
<enum>(1)</enum>
<text display-inline="yes-display-inline">The term <quote>health software</quote> means software that does not, through use of an in vitro diagnostic device or signal acquisition system, acquire, process, or analyze an image or physiological signal, is not an accessory, is not an integral part of a device necessary to support the use of the device, is not used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans, and—</text>
<subparagraph id="H056879AC08A44C7F8D41F007DC5A55A9" commented="no" indent="up1">
<enum>(A)</enum>
<text display-inline="yes-display-inline">is intended for use for administrative or operational support or the processing and maintenance of financial records;</text>
</subparagraph>
<subparagraph id="HBEB27ED1D3B6413B8B88B599C7BCD51F" commented="no" indent="up1">
<enum>(B)</enum>
<text>is intended for use in clinical, laboratory, or administrative workflow and related recordkeeping;</text>
</subparagraph>
<subparagraph id="HC3B4E634C7CE4887B9FCE85CEF67FF9D" commented="no" indent="up1">
<enum>(C)</enum>
<clause id="H479EF2D59641476BBF28527906061941" display-inline="yes-display-inline" commented="no">
<enum>(i)</enum>
<text>is intended for use solely in the transfer, aggregation, conversion (in accordance with a present specification), storage, management, retrieval, or transmission of data or information;</text>
</clause>
<clause id="HCD55161916D2457B938981F4F6BC7576" indent="up1" commented="no">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">utilizes a connectivity software platform, electronic or electrical hardware, or a physical communications infrastructure; and</text>
</clause>
<clause id="H370CCF01D91342918C3C6520BF1E639E" indent="up1" commented="no">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">is not intended for use—</text>
<subclause id="H4432FD760AE24DE79B6799FF17A9B7C4" commented="no">
<enum>(I)</enum>
<text display-inline="yes-display-inline">in active patient monitoring; or</text>
</subclause>
<subclause id="H14170F317B0642C88141273C416B6CB0" commented="no">
<enum>(II)</enum>
<text display-inline="yes-display-inline">in controlling or altering the functions or parameters of a device that is connected to such software;</text>
</subclause>
</clause>
</subparagraph>
<subparagraph id="HA98B80B290CE49E78B8A8251716CFD3D" commented="no" indent="up1">
<enum>(D)</enum>
<text display-inline="yes-display-inline">is intended for use to organize and present information for health or wellness education or for use in maintaining a healthy lifestyle, including medication adherence and health management tools; </text>
</subparagraph>
<subparagraph id="HD93EA35527CC4DECB496979E8CD3A921" commented="no" indent="up1">
<enum>(E)</enum>
<text display-inline="yes-display-inline">is intended for use to analyze information to provide general health information that does not include patient-specific recommended options to consider in the prevention, diagnosis, treatment, cure, or mitigation of a particular disease or condition; or</text>
</subparagraph>
<subparagraph id="H3576D5C745E4416E9AC61030579DE301" commented="no" indent="up1">
<enum>(F)</enum>
<text display-inline="yes-display-inline">is intended for use to analyze information to provide patient-specific recommended options to consider in the prevention, diagnosis, treatment, cure, or mitigation of a particular disease or condition.</text>
</subparagraph>
</paragraph>
<paragraph id="H9E377D282B9B40B78BD83CDA69513CB6" indent="up1" commented="no">
<enum>(2)</enum>
<text>The term <quote>accessory</quote> means a product that—</text>
<subparagraph id="HF452900A17E1453E9C39A4AA539DA76A" commented="no">
<enum>(A)</enum>
<text>is intended for use with one or more parent devices;</text>
</subparagraph>
<subparagraph id="H80B6800295BD4744B0ED56D1D271D3A6" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">is intended to support, supplement, or augment the performance of one or more parent devices; and</text>
</subparagraph>
<subparagraph id="HA8943FB9EBF1452399E8CFA83202EEF9" commented="no">
<enum>(C)</enum>
<text>shall be classified by the Secretary—</text>
<clause id="H68E6D5DE985349DB91874D2A5A74795B" commented="no">
<enum>(i)</enum>
<text>according to its intended use; and</text>
</clause>
<clause id="H02668749B0994ACE8B77FB6AE20ECDE6" commented="no">
<enum>(ii)</enum>
<text>independently of any classification of any parent device with which it is used. </text>
</clause>
</subparagraph>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
<section id="H53FBEBDEF75C4D12A9FBDCDB595FD526" commented="no">
<enum>2242.</enum>
<header>Applicability and inapplicability of regulation</header>
<text display-inline="no-display-inline">Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.), as amended by section 2221(a), is further amended by adding at the end the following:</text>
<quoted-block display-inline="no-display-inline" id="HECA2E41BCE0648419AAD85DAF2A51EA2" style="OLC">
<section id="H7988D6D148424237AB46CEEAC74B4BFF" commented="no">
<enum>524C.</enum>
<header>Health software</header>
<subsection id="HF56E0D751D504369B23A75385FB3E13A" commented="no">
<enum>(a)</enum>
<header>Inapplicability of regulation to health software</header>
<text display-inline="yes-display-inline">Except as provided in subsection (b), health software shall not be subject to regulation under this Act.</text>
</subsection>
<subsection id="H019489451D7D4B9A8B8001455042EFE8" commented="no">
<enum>(b)</enum>
<header>Exception</header>
<paragraph id="H89E6EF3E79B640388BECE7849E8BF501">
<enum>(1)</enum>
<header>In general</header>
<text>Subsection (a) shall not apply with respect to a software product—</text>
<subparagraph id="H19B177060E9F4AF798B67186E71AE355">
<enum>(A)</enum>
<text>of a type described in subparagraph (F) of section 201(ss)(1); and</text>
</subparagraph>
<subparagraph id="H8FC35E10E5894F57A99CB3D351AFFAB3">
<enum>(B)</enum>
<text>that the Secretary determines poses a significant risk to patient safety.</text>
</subparagraph>
</paragraph>
<paragraph id="H5AF7A88192C1464392160290076EC391">
<enum>(2)</enum>
<header>Considerations</header>
<text>In making a determination under subparagraph (B) of paragraph (1) with respect to a product to which such paragraph applies, the Secretary shall consider the following:</text>
<subparagraph id="HA618AEC830B04945BE1710A8672C7DC8" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">The likelihood and severity of patient harm if the product were to not perform as intended.</text>
</subparagraph>
<subparagraph id="H00DF7B596BC448948EE09A55C6051560" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">The extent to which the product is intended to support the clinical judgment of a medical professional.</text>
</subparagraph>
<subparagraph id="H7F23EE8737284BB69676C20EE1595011" commented="no">
<enum>(C)</enum>
<text display-inline="yes-display-inline">Whether there is a reasonable opportunity for a medical professional to review the basis of the information or treatment recommendation provided by the product.</text>
</subparagraph>
<subparagraph id="H4A8C71A904214A96B42F635629AF06CA" commented="no">
<enum>(D)</enum>
<text display-inline="yes-display-inline">The intended user and user environment, such as whether a medical professional will use a software product of a type described in subparagraph (F) of section 201(ss)(1).</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H529B83B440004EA49F2B732754400FA6" display-inline="no-display-inline" commented="no">
<enum>(c)</enum>
<header>Delegation</header>
<text display-inline="yes-display-inline">The Secretary shall delegate primary jurisdiction for regulating a software product determined under subsection (b) to be subject to regulation under this Act to the center at the Food and Drug Administration charged with regulating devices. <italic></italic></text>
</subsection>
<subsection id="H38DEB94DC64D4DC99B574C8897F9857E" commented="no">
<enum>(d)</enum>
<header>Regulation of software</header>
<paragraph id="H648E867F6DD543198041E958A5E89340" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall review existing regulations and guidance regarding the regulation of software under this Act. The Secretary may implement a new framework for the regulation of software and shall, as appropriate, modify such regulations and guidance or issue new regulations or guidance. </text>
</paragraph>
<paragraph id="H3BC1BB36082E48C9A6CE9214FBABA4B5" commented="no">
<enum>(2)</enum>
<header>Issuance by order</header>
<text>Notwithstanding subchapter II of chapter 5 of title 5, United States Code, the Secretary may modify or issue regulations for the regulation of software under this Act by administrative order published in the Federal Register following the publication of a proposed order.</text>
</paragraph>
<paragraph id="HFE2FBE05851246DF9E12EE39955BEE90" commented="no">
<enum>(3)</enum>
<header>Areas under review</header>
<text>The review of existing regulations and guidance under paragraph (1) may include review of the following areas:</text>
<subparagraph id="HB1678D4401F54D6783AEA5C8DFE8E2E2" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">Classification of software.</text>
</subparagraph>
<subparagraph id="H1FD00258D6D148F9AAA2FAAB16A9E57D" commented="no">
<enum>(B)</enum>
<text>Standards for development of software.</text>
</subparagraph>
<subparagraph id="H511C821378BE4AD689B029FF128AAE17" commented="no">
<enum>(C)</enum>
<text>Standards for validation and verification of software.</text>
</subparagraph>
<subparagraph id="H85F33B5BA5474491A8DEF58C9C84040A" commented="no">
<enum>(D)</enum>
<text>Review of software.</text>
</subparagraph>
<subparagraph id="H3CCD7A69AE8648E3A32CC7CA5A519CFF" commented="no">
<enum>(E)</enum>
<text>Modifications to software.</text>
</subparagraph>
<subparagraph id="H1F8719DED4AE49BC8D70AB5C11F513F0" commented="no">
<enum>(F)</enum>
<text>Manufacturing of software.</text>
</subparagraph>
<subparagraph id="H1B6D5F2794464371979F65A37E822B90" commented="no">
<enum>(G)</enum>
<text>Quality systems for software.</text>
</subparagraph>
<subparagraph id="HD3F7D910BCCB4C30A3A31C534F7B6E6B" commented="no">
<enum>(H)</enum>
<text>Labeling requirements for software.</text>
</subparagraph>
<subparagraph id="HF5E3B96579734839A67DA4880BCBE472" commented="no">
<enum>(I)</enum>
<text>Postmarketing requirements for reporting of adverse events.</text>
</subparagraph>
</paragraph>
<paragraph id="H58FD4ABEBC114D34AB14409344F7950D" commented="no">
<enum>(4)</enum>
<header>Process for issuing proposed regulations, administrative order, and guidance</header>
<text display-inline="yes-display-inline">Not later than 18 months after the date of enactment of this section, the Secretary shall consult with external stakeholders (including patients, industry, health care providers, academia, and government) to gather input before issuing regulations, an administrative order, and guidance under this subsection.</text>
</paragraph>
</subsection>
<subsection id="H28D967117EDE4D9DB5109FCF0DA962B5">
<enum>(e)</enum>
<header>Rule of construction</header>
<text>Nothing in this section shall be construed as providing the Secretary with the authority to regulate under this Act any health software product of the type described in subparagraph (F) of section 201(ss)(1) unless and until the Secretary has made a determination described in subsection (b)(1)(B) with respect to such product.</text>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
<section id="HE014AB80854E479B951B2F4948CCBB14" commented="no">
<enum>2243.</enum>
<header>Exclusion from definition of device</header>
<text display-inline="no-display-inline">Section 201(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended—</text>
<paragraph id="HFE66B03FBEC240A88270D2E2916DAB20" commented="no">
<enum>(1)</enum>
<text>in subparagraph (2), by striking <quote>or</quote> after <quote>or other animals,</quote>;</text>
</paragraph>
<paragraph id="H95B6F826F2F341BCB1DAF0676EE47A01" commented="no">
<enum>(2)</enum>
<text>in subparagraph (3), by striking <quote>and</quote> and inserting <quote>or</quote>; and</text>
</paragraph>
<paragraph id="HACF1609A5E104EC1A8B927FA878107C3" commented="no">
<enum>(3)</enum>
<text>by inserting after subparagraph (3) the following:</text>
<quoted-block display-inline="no-display-inline" id="HDC3FCBE0EFED46BCA7EA6D6AEB796584" style="OLC">
<paragraph id="HE8A8E1438C76432B96202C645BD83D9C" commented="no">
<enum>(4)</enum>
<text display-inline="yes-display-inline">not health software (other than software determined to be a risk to patient safety under section 524B(b)), and</text>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</section>
</subtitle>
<subtitle id="H1CFAD1EEB5A14DDAA1A0A623302BAB2F">
<enum>O</enum>
<header>Streamlining Clinical Trials</header>
<section id="HEB61A62B36FB45BFBF49EC46D8B1A42A">
<enum>2261.</enum>
<header>Protection of human subjects in research; applicability of rules</header>
<subsection id="H4AE90D4FF07A40F09D70913CD3F5321B">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">In order to simplify and facilitate compliance by researchers with applicable regulations for the protection of human subjects in research, the Secretary of Health and Human Services shall, to the extent possible and consistent with other statutory provisions, harmonize differences between the HHS Human Subject Regulations and the FDA Human Subject Regulations in accordance with subsection (b).</text>
</subsection>
<subsection id="H29390DFFE72F48C8BB48A3E637DB5964" commented="no">
<enum>(b)</enum>
<header>Avoiding regulatory duplication and unnecessary delays</header>
<paragraph id="H086D979E6EE8465E8F9BF53A5E53F391" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall—</text>
<subparagraph id="H2F845D52B0DA40B784F61C2B1BCE5432" commented="no">
<enum>(A)</enum>
<text>make such modifications to the provisions of the HHS Human Subject Regulations, the FDA Human Subject Regulations, and the vulnerable-populations rules as may be necessary—</text>
<clause id="H577E66A26FA44A9DA0DE53D6A9893ECC" commented="no">
<enum>(i)</enum>
<text>to reduce regulatory duplication and unnecessary delays;</text>
</clause>
<clause id="HEFB934737B57493A9E98104CB7242750" commented="no">
<enum>(ii)</enum>
<text>to modernize such provisions in the context of multisite and cooperative research projects; and</text>
</clause>
<clause id="H51DA3B8CA8B643B0ABE380F3B68BEB0F" commented="no">
<enum>(iii)</enum>
<text display-inline="yes-display-inline">to incorporate local considerations, community values, and mechanisms to protect vulnerable populations; and </text>
</clause>
</subparagraph>
<subparagraph id="HAE3BEA326ABA42D994BC2039117B6304" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">ensure that human subject research that is subject to the HHS Human Subject Regulations or to the FDA Human Subject Regulations may—</text>
<clause id="H931859E3F1554FB1819523C0B80DFF48" commented="no">
<enum>(i)</enum>
<text>use joint or shared review;</text>
</clause>
<clause id="HF7B0C4580EF44837ACB09A9395EA54BA" commented="no">
<enum>(ii)</enum>
<text>rely upon the review of—</text>
<subclause id="H963EC011A2A84CAC8D9474608A7F3B2F" commented="no">
<enum>(I)</enum>
<text>an independent institutional review board; or</text>
</subclause>
<subclause id="HEC7AAFC60548462F80C585C8510369C8" commented="no">
<enum>(II)</enum>
<text>an institutional review board of an entity other than the sponsor of the research; or</text>
</subclause>
</clause>
<clause id="H0890AADE17D34D6890E30FB9AFB67BD0" commented="no">
<enum>(iii)</enum>
<text>use similar arrangements to avoid duplication of effort.</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H37F7FD655FB3494E8651B5A3AA9CDAA4" commented="no">
<enum>(2)</enum>
<header>Regulations and guidance</header>
<text display-inline="yes-display-inline">Not later than 36 months after the date of enactment of this <short-title>Act</short-title>, the Secretary, acting through the relevant agencies and offices of the Department of Health and Human Services, including the Office for Human Research Protections and relevant agencies and offices of the Food and Drug Administration, shall issue such regulations and guidance and take such other actions as may be necessary to implement this section and help to facilitate the broader use of single, central, or lead institutional review boards. Such regulations and guidance shall clarify the requirements and policies relating to the following:</text>
<subparagraph id="H6A6B7166793E4F989F191B9E70E8A9BB" commented="no">
<enum>(A)</enum>
<text>Arrangements to avoid duplication described in paragraph (1)(A)(i), including—</text>
<clause id="H67C2D8BA5883433C884C256778AA10E8" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline">delineating the roles of institutional review boards in multisite or cooperative, multisite studies where one or more local institutional review boards are relied upon, or similar arrangements are used;</text>
</clause>
<clause id="H8427BF9EE8844E58A0135549B4C8B5FE" commented="no">
<enum>(ii)</enum>
<text>the risks and benefits to human subjects;</text>
</clause>
<clause id="HBA56B53591FB4E5683B5FF595A5AE8D9" commented="no">
<enum>(iii)</enum>
<text>standardizing the informed consent and other processes and legal documents; and</text>
</clause>
<clause id="HBFFB99EB9F2E4710AF9760E0BAD96600" commented="no">
<enum>(iv)</enum>
<text>incorporating community values through the use of local institutional review boards while continuing to use central or lead institutional review boards.</text>
</clause>
</subparagraph>
<subparagraph id="H30B04632FD0A413F836AB80C08786510" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">Concerns about regulatory and legal liability contributing to decisions by the sponsors of research to rely on local institutional review boards for multisite research.</text>
</subparagraph>
</paragraph>
<paragraph id="H1C55D689B017479983582E83E4EE8E6F" commented="no">
<enum>(3)</enum>
<header>Consultation</header>
<text>In issuing regulations or guidance under paragraph (2), the Secretary shall consult with stakeholders (including researchers, academic organizations, hospitals, institutional research boards, pharmaceutical, biotechnology and medical device developers, clinical research organizations, patient groups, and others).</text>
</paragraph>
</subsection>
<subsection id="H78622FCA7CB44D74BEA201EEF75F80C7">
<enum>(c)</enum>
<header>Timing</header>
<text display-inline="yes-display-inline">The Secretary shall complete the harmonization described in subsection (a) not later than 36 months after the date of enactment of this Act.</text>
</subsection>
<subsection id="HCB4FB1C04B93408F911A3AD97AC273E0">
<enum>(d)</enum>
<header>Progress report</header>
<text display-inline="yes-display-inline">Not later than 24 months after the date of enactment of this Act, the Secretary shall submit to Congress a report on the progress made toward completing such harmonization.</text>
</subsection>
<subsection id="H827C070FD0134B04AF45D849ADBFAC7B">
<enum>(e)</enum>
<header>Draft NIH policy</header>
<text display-inline="yes-display-inline">Not later than 12 months after the date of enactment of this Act, the Secretary, acting through the Director of the National Institutes of Health, shall finalize the draft policy entitled <quote>Draft NIH Policy on Use of a Single Institutional Review Board for Multi-Site Research</quote>. </text>
</subsection>
<subsection id="H9587D02AB40B4C85A99645E32490F755">
<enum>(f)</enum>
<header>Definitions</header>
<paragraph id="H6DA1389455EC45F3B6BA1325E40FA99F">
<enum>(1)</enum>
<header>Human subject regulations</header>
<text display-inline="yes-display-inline">In this section:</text>
<subparagraph id="H8951237089B94862A2941EE9A8BBB3B6">
<enum>(A)</enum>
<header>FDA human subject regulations</header>
<text>The term <quote>FDA Human Subject Regulations</quote> means the provisions of parts 50, 56, 312, and 812 of title 21, Code of Federal Regulations (or any successor regulations).</text>
</subparagraph>
<subparagraph id="HF978572D37264761A3362922682846DA">
<enum>(B)</enum>
<header>HHS human subject regulations</header>
<text display-inline="yes-display-inline">The term <quote>HHS Human Subject Regulations</quote> means the provisions of subpart A of part 46 of title 45, Code of Federal Regulations (or any successor regulations).</text>
</subparagraph>
<subparagraph id="H3DE562A4E5A040B08B64F48A869DB106">
<enum>(C)</enum>
<header>Vulnerable-populations rules</header>
<text display-inline="yes-display-inline">The term <quote>vulnerable-populations rules</quote>—</text>
<clause id="HA8E7AB4528BA4998A6005203A4FDAE0C">
<enum>(i)</enum>
<text>subject to clause (ii), means the provisions of subparts B through D of such part 46 (or any successor regulations); or</text>
</clause>
<clause id="H5AEDAAF71A414D4BBB35178690E3E70A">
<enum>(ii)</enum>
<text>as applicable to research that is subject to the FDA Human Subject Regulations, means the provisions applicable to vulnerable populations under part 56 of such title 21 (or any successor regulations) and subpart D of part 50 of such title 21 (or any successor regulations).</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H53F54E03C310457CB229443B2975F6FA">
<enum>(2)</enum>
<header>Other definitions</header>
<text display-inline="yes-display-inline">In this section:</text>
<subparagraph id="H22CFC3155F61489499AAEC347BAB9083">
<enum>(A)</enum>
<header>Institutional review board</header>
<text display-inline="yes-display-inline">The term <quote>institutional review board</quote> has the meaning that applies to the term <quote>institutional review board</quote> under the HHS Human Subject Regulations.</text>
</subparagraph>
<subparagraph id="HFA14F28BABC54B5EBB0304064534EEC1">
<enum>(B)</enum>
<header>Lead institutional review board</header>
<text>The term <quote>lead institutional review board</quote> means an institutional review board that otherwise meets the requirements of the HHS Human Subject Regulations and enters into a written agreement with an institution, another institutional review board, a sponsor, or a principal investigator to approve and oversee human subject research that is conducted at multiple locations. References to an institutional review board include an institutional review board that serves a single institution as well as a lead institutional review board.</text>
</subparagraph>
</paragraph>
</subsection>
</section>
<section id="HBBE72E267B9B4517B0CB303367C110D6">
<enum>2262.</enum>
<header>Use of non-local institutional review boards for review of investigational device exemptions and human device exemptions</header>
<subsection id="HA0A6A228736E4A70B533374CAB187774">
<enum>(a)</enum>
<header>In general</header>
<text>Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(j)) is amended—</text>
<paragraph id="H9EC55DF6A2964999BEE00FCDDFA4AC28">
<enum>(1)</enum>
<text>in subsection (g)(3)—</text>
<subparagraph id="H2C2DB019A04A43A6BE346B414B181ED3">
<enum>(A)</enum>
<text>by striking <quote>local</quote> each place it appears; and </text>
</subparagraph>
<subparagraph id="H93F7EE761B964CE0874A6A8587DD3C92">
<enum>(B)</enum>
<text>in subparagraph (A)(i), by striking <quote>which has been</quote>; and</text>
</subparagraph>
</paragraph>
<paragraph id="H6A5FC905A7EA49CCB71C323105E175E6">
<enum>(2)</enum>
<text>in subsection (m)(4)—</text>
<subparagraph id="HDD3EB613391C430BB986F1E3FECE81AC">
<enum>(A)</enum>
<text>by striking <quote>local</quote> each place it appears; and</text>
</subparagraph>
<subparagraph id="HE690A3707ED24997A02F6A2F41F09273">
<enum>(B)</enum>
<text>by striking subparagraph (A) and inserting the following new subparagraph:</text>
<quoted-block id="H642964088ECC4110A3FB6E9942B70787" style="OLC">
<subparagraph id="HC831910B398946FFA2624E49B0B7307A" indent="up1">
<enum>(A)</enum>
<text>in facilities in which clinical testing of devices is supervised by an institutional review committee established in accordance with the regulations of the Secretary, and</text>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H3462987EDACD469D9092DDEB8FA328FB">
<enum>(b)</enum>
<header>Regulations</header>
<text>Not later than 12 months after the date of the enactment of this Act, the Secretary of Health and Human Services shall revise or issue such regulations or guidance as may be necessary to carry out the amendments made by subsection (a). </text>
</subsection>
</section>
<section id="H4726B76732B944B4BB1AD92E873C1621">
<enum>2263.</enum>
<header>Alteration or waiver of informed consent for clinical investigations</header>
<subsection id="HC96B62CC61C2445993F5ABECD1D1876F">
<enum>(a)</enum>
<header>Devices</header>
<text display-inline="yes-display-inline">Section 520(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended—</text>
<paragraph id="HAA84038FE6EB4BB1AB18E1A41BF47689">
<enum>(1)</enum>
<text>in subparagraph (D), by striking <quote>except where subject to such conditions as the Secretary may prescribe, the investigator</quote> and inserting the following:</text>
<quoted-block style="OLC" id="HDF50C37B5DE146FC8833928F06A6AF08" display-inline="yes-display-inline">
<text display-inline="yes-display-inline">except where, subject to such conditions as the Secretary may prescribe—</text>
<clause id="H2CECC5B7C8FE4FEEA89F2198679EE1A8" indent="up1">
<enum>(i)</enum>
<text display-inline="yes-display-inline">the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject; or</text>
</clause>
<clause id="H32D126DC221B4E12A829F4FCABF0C7A4" indent="up1">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">the investigator</text>
</clause>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H7F83904C44794DF3B0FD1E9C312C0204">
<enum>(2)</enum>
<text>in the matter following subparagraph (D), by striking <quote>subparagraph (D)</quote> and inserting <quote>subparagraph (D)(ii)</quote>.</text>
</paragraph>
</subsection>
<subsection id="HC49A4D4DFFF64CCB8FBFAC248D4C2C35">
<enum>(b)</enum>
<header>Drugs</header>
<text display-inline="yes-display-inline">Section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking <quote>except where it is not feasible or it is contrary to the best interests of such human beings</quote> and inserting <quote>except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings</quote>. </text>
</subsection>
</section>
</subtitle>
<subtitle id="H99D66E789D8A440BB091ED860523C139">
<enum>P</enum>
<header>Improving Scientific Expertise and Outreach at FDA</header>
<section id="H8EA24B6C45414B26AEEAE65EEDB50B81">
<enum>2281.</enum>
<header>Silvio O. Conte Senior Biomedical Research Service</header>
<subsection id="H1A3E41B534AD4547BC22B20D09D3802B">
<enum>(a)</enum>
<header>Hiring and retention authority</header>
<text>Section 228 of the Public Health Service Act (42 U.S.C. 237) is amended—</text>
<paragraph id="HE71608FCC00445D9BD0220DFA5D41062">
<enum>(1)</enum>
<text>in the section heading, by inserting <quote><header-in-text level="section" style="traditional">and Biomedical Product Assessment</header-in-text></quote> after <quote><header-in-text level="section" style="traditional">Research</header-in-text></quote>; </text>
</paragraph>
<paragraph id="H8E56E3CE4AF74617989D3855972D8A35">
<enum>(2)</enum>
<text>in subsection (a)(1), by striking <quote>Silvio O. Conte Senior Biomedical Research Service, not to exceed 500 members</quote> and inserting <quote>Silvio O. Conte Senior Biomedical Research and Biomedical Product Assessment Service (in this section referred to as the <quote>Service</quote>), the purpose of which is to recruit and retain competitive and qualified scientific and technical experts outstanding in the field of biomedical research, clinical research evaluation, and biomedical product assessment</quote>;</text>
</paragraph>
<paragraph id="H1D9BA9DA59BF49AE807B7933B3D30473" commented="no">
<enum>(3)</enum>
<text display-inline="yes-display-inline">by amending subsection (a)(2) to read as follows:</text>
<quoted-block style="OLC" id="HD2056A79AC834A978FA358325F04C2B9" display-inline="no-display-inline">
<paragraph id="H938EEA7E79C94C74B55768BF7CD802EC" indent="up1">
<enum>(2)</enum>
<text display-inline="yes-display-inline">The authority established in paragraph (1) may not be construed to require the Secretary to reduce the number of employees serving under any other employment system in order to offset the number of members serving in the Service.</text>
</paragraph>
<after-quoted-block>;</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H104F78C7F1F94FAC97A83F0EFBAE73F8">
<enum>(4)</enum>
<text>in subsection (b)—</text>
<subparagraph id="H8B88D42D204D4C73A96623DE5E3E1BFC">
<enum>(A)</enum>
<text>in the matter preceding paragraph (1), by striking <quote>or clinical research evaluation</quote> and inserting <quote>, clinical research evaluation or biomedical product assessment</quote>; and</text>
</subparagraph>
<subparagraph id="H9CFAD4BA806747159AF40787E50222E5">
<enum>(B)</enum>
<text>in paragraph (1), by inserting <quote>or a master's level degree in engineering, bioinformatics, or a related or emerging field,</quote> after the comma;</text>
</subparagraph>
</paragraph>
<paragraph id="H28CC3602EA054BB2BBE081DE326E0902">
<enum>(5)</enum>
<text>in subsection (d)(2), by striking <quote>and shall not exceed the rate payable for level I of the Executive Schedule unless approved by the President under section 5377(d)(2) of title 5, United States Code</quote> and inserting <quote>and shall not exceed the rate payable for the President</quote>;</text>
</paragraph>
<paragraph id="H11A6E68C696B453D945001B0898D1AA0">
<enum>(6)</enum>
<text display-inline="yes-display-inline">by striking subsection (e); and</text>
</paragraph>
<paragraph id="HB6EE5730D911409A8E4AA465C5347C1E">
<enum>(7)</enum>
<text>by redesignating subsections (f) and (g) as subsections (e) and (f), respectively.</text>
</paragraph>
</subsection>
<subsection id="HE6FE9F2D23914E1D8C2A360A248CA369">
<enum>(b)</enum>
<header>Report</header>
<text display-inline="yes-display-inline">Not later than 3 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall submit, and publish on the website of the Department of Health and Human Services a report on the implementation of the amendments made by subsection (a), including whether the amendments have improved the ability of the Food and Drug Administration to hire and retain qualified experts to fulfill obligations specified under user fee agreements. </text>
</subsection>
</section>
<section id="HA8E679EF66C746FD824C219A63807744" commented="no">
<enum>2282.</enum>
<header>Enabling FDA scientific engagement</header>
<text display-inline="no-display-inline">It is the sense of Congress that the participation in, or sponsorship of, scientific conferences and meetings is essential to the mission of the Food and Drug Administration.</text>
</section>
<section id="HD95CAA2532B9415792B006B1E32AB431">
<enum>2283.</enum>
<header>Reagan-Udall Foundation for the Food and Drug Administration</header>
<subsection id="H7509460EFB184E33BBDEBEEEBBE69853">
<enum>(a)</enum>
<header>Board of Directors</header>
<paragraph id="HA27607E9A1744C98948DD8FE4E4B1B5E">
<enum>(1)</enum>
<header>Composition and size</header>
<text>Section 770(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)) is amended—</text>
<subparagraph id="H93B51B90ABE243B5A7ACDE217CD1C0A3">
<enum>(A)</enum>
<text>by redesignating clause (ii) as clause (iii); </text>
</subparagraph>
<subparagraph id="H6C129FFFA97040EE8A7069F14CF5B201">
<enum>(B)</enum>
<text>by inserting after clause (i) the following: </text>
<quoted-block style="OLC" id="H39A3EB600F1D4839857CF7A6B1834E6E" display-inline="no-display-inline">
<clause id="HAD7C736E541741B597408A0C5EA295FE" commented="no">
<enum>(ii)</enum>
<header>Additional members</header>
<text display-inline="yes-display-inline">The Board, through amendments to the bylaws of the Foundation, may provide that the number of voting members of the Board shall be a number (to be specified in such amendment) greater than 14. Any Board positions that are established by any such amendment shall be appointed (by majority vote) by the individuals who, as of the date of such amendment, are voting members of the Board and persons so appointed may represent any of the categories specified in subclauses (I) through (V) of clause (i), so long as no more than 30 percent of the total voting members of the Board (including members whose positions are established by such amendment) are representatives of the general pharmaceutical, device, food, cosmetic, and biotechnology industries. </text>
</clause>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</subparagraph>
<subparagraph id="H691842589A5C4ABDAC372E925C3330F4">
<enum>(C)</enum>
<text>in clause (iii)(I), as redesignated by subparagraph (A), by striking <quote>The ex officio members shall ensure</quote> and inserting <quote>The ex officio members, acting pursuant to clause (i), and the Board, acting pursuant to clause (ii), shall ensure</quote>.<italic></italic></text>
</subparagraph>
</paragraph>
<paragraph id="HF47822F12C99484E90388EFBC3B8CE97">
<enum>(2)</enum>
<header>Federal employees allowed to serve on Board</header>
<text display-inline="yes-display-inline">Clause (iii)(II) of section 770(d)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(1)(C)), as redesignated by paragraph (1)(A), is amended by adding at the end the following: <quote>For purposes of this section, the term <quote>employee of the Federal Government</quote> does not include a <quote>special Government employee</quote>, as that term is defined in section 202(a) of title 18, United States Code.</quote>.</text>
</paragraph>
<paragraph id="HEFB4CAD23D7342C6AD507B670387E34A">
<enum>(3)</enum>
<header>Staggered terms</header>
<text display-inline="yes-display-inline">Subparagraph (A) of section 770(d)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(d)(3)) is amended to read as follows:</text>
<quoted-block style="OLC" id="H7619B833EABC4CC1B06F4B27F23CC767" display-inline="no-display-inline">
<subparagraph id="HCF709A988A084027A417D9D1D437422C" commented="no">
<enum>(A)</enum>
<header>Term</header>
<text display-inline="yes-display-inline">The term of office of each member of the Board appointed under paragraph (1)(C)(i), and the term of office of any member of the Board whose position is established pursuant to paragraph (1)(C)(ii), shall be 4 years, except that—</text>
<clause id="H0507BCB3BED749429C367909C199B769" commented="no">
<enum>(i)</enum>
<text>the terms of offices for the members of the Board initially appointed under paragraph (1)(C)(i) shall expire on a staggered basis as determined by the ex officio members; and</text>
</clause>
<clause id="H70CD0F899EC44A2CBEDDCC8DE696053A" commented="no">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">the terms of office for the persons initially appointed to positions established pursuant to paragraph (1)(C)(ii) may be made to expire on a staggered basis, as determined by the individuals who, as of the date of the amendment establishing such positions, are members of the Board.</text>
</clause>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="H07684113A227407DAC8C0BE4081A3A55">
<enum>(b)</enum>
<header>Executive Director compensation</header>
<text display-inline="yes-display-inline">Section 770(g)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(g)(2)) is amended by striking <quote>but shall not be greater than the compensation of the Commissioner</quote>. </text>
</subsection>
<subsection id="H2935D5D02E9B415DBD250DE344B3F2CE">
<enum>(c)</enum>
<header>Separation of Funds</header>
<text display-inline="yes-display-inline">Section 770(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(m)) is amended by striking <quote>are held in separate accounts from funds received from entities under subsection (i)</quote> and inserting <quote>are managed as individual programmatic funds under subsection (i), according to best accounting practices</quote>.</text>
</subsection>
</section>
<section id="H2E07E362DAE2487ABDA6DC7639D7A45B" section-type="subsequent-section">
<enum>2284.</enum>
<header>Collection of certain voluntary information exempted from Paperwork Reduction Act</header>
<text display-inline="no-display-inline"> Chapter VII of the Federal Food, Drug, and Cosmetic Act is amended by inserting after section 708 of such Act (21 U.S.C. 379) the following:</text>
<quoted-block style="OLC" id="H848576AF68FD4EE39871DFEB06A82B0A" display-inline="no-display-inline">
<section id="H71EECDB087AA4C01BAB43D6598D1E23B">
<enum>708A.</enum>
<header>Collection of certain voluntary information exempted from Paperwork Reduction Act</header>
<text display-inline="no-display-inline">Chapter 35 of title 44, United States Code, shall not apply to the collection from patients, industry, academia, and other stakeholders, of voluntary information such as through voluntary surveys or questionnaires, initiated by the Secretary.</text>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
<section id="HB3DE93A98E10404AB57DF9188771BEBA">
<enum>2285.</enum>
<header>Hiring authority for scientific, technical, and professional personnel</header>
<subsection id="H9011B2933F7140F8A22CF58EFFC56B5A">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Federal Food, Drug, and Cosmetic Act is amended by inserting after section 714 (21 U.S.C. 379d–3) the following:</text>
<quoted-block style="OLC" id="HFFA3DA730A134C929A4D0F30F7CBD615" display-inline="no-display-inline">
<section id="HB21D1E553E494C4994688C8CB63320F8">
<enum>714A.</enum>
<header>Additional hiring authority</header>
<subsection id="H159DD0E93B154F3594B73B3D74EDF16F">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary may, without regard to the provisions of title 5, United States Code, governing appointments in the competitive service, appoint qualified candidates to scientific, technical, or professional positions within the following centers of the Food and Drug Administration: </text>
<paragraph id="HCCD85BF038C0477F8472C7ABB7387229">
<enum>(1)</enum>
<text display-inline="yes-display-inline">The Center for Drug Evaluation and Research.</text>
</paragraph>
<paragraph id="HE80219210A504B3497A0C08A2CA49808">
<enum>(2)</enum>
<text>The Center for Biologics Evaluation and Research.</text>
</paragraph>
<paragraph id="H8B634CD8FD2B42F8B54B35F6296B232E">
<enum>(3)</enum>
<text>The Center for Devices and Radiological Health.</text>
</paragraph>
<continuation-text continuation-text-level="subsection">Such positions shall be within the competitive service.</continuation-text>
</subsection>
<subsection id="HFC3A1D1A3B67474990A60DF97F2FF56D">
<enum>(b)</enum>
<header>Compensation</header>
<paragraph id="HFA42DD3C2688424AB7AF255925F633A4">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Notwithstanding any other provision of law, including any requirement with respect to General Schedule pay rates under subchapter III of chapter 53 of title 5, United States Code, and consistent with the requirements of paragraph (2), the Secretary may determine and fix—</text>
<subparagraph id="H17601687CC664C94B559D2F4C324844A">
<enum>(A)</enum>
<text>the annual rate of pay of any individual appointed under subsection (a); and</text>
</subparagraph>
<subparagraph id="H8436EC15AACE4A1EAA0209BCEEF4D1F3" commented="no">
<enum>(B)</enum>
<text>for purposes of retaining qualified employees, the annual rate of pay for any highly qualified scientific, technical, or professional personnel appointed to a position at any of the centers listed under subsection (a) before the date of enactment of this section. </text>
</subparagraph>
</paragraph>
<paragraph id="HC32C8C05D53547F0895A5436E5B24093" commented="no">
<enum>(2)</enum>
<header>Limitation</header>
<text>The annual rate of pay established pursuant to paragraph (1) may not exceed the annual rate of pay of the President. </text>
</paragraph>
</subsection>
<subsection id="H95161749D1474ABF89C12EDFB170339C">
<enum>(c)</enum>
<header>Report</header>
<paragraph id="H41A72B221D9049DB942DB2AB7C117A45">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Not later than September 30, 2021, the Secretary shall submit a report to Congress that examines the extent to which the authority to appoint and retain personnel under this section enhanced the Food and Drug Administration’s ability to meet the agency's critical need for highly qualified individuals for scientific, technical, or professional positions.</text>
</paragraph>
<paragraph id="HC164D6EB288144B08F286ED1C57D37AD">
<enum>(2)</enum>
<header>Recommendations</header>
<text display-inline="yes-display-inline">The report under paragraph (1) shall include the recommendations of the Secretary on—</text>
<subparagraph id="H4F344001C05B48E29F39AF7656F04065">
<enum>(A)</enum>
<text display-inline="yes-display-inline">whether the authority to appoint personnel under this section should be reauthorized; and</text>
</subparagraph>
<subparagraph id="HDD6DD51946D1445AA1DEE2F4E0DE9ACF">
<enum>(B)</enum>
<text display-inline="yes-display-inline">other personnel authorities that would help the Food and Drug Administration to better recruit and retain highly qualified individuals for scientific, technical, or professional positions in the agency’s medical product centers.</text>
</subparagraph>
</paragraph>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="H1FA17D4D626546BEB893F415AFAA9F6F">
<enum>(b)</enum>
<header>Rule of construction</header>
<text display-inline="yes-display-inline">The authority provided by section 714A of the Federal Food, Drug, and Cosmetic Act (as added by subsection (a)) shall not be construed to affect the authority provided under section 714 of such Act. </text>
</subsection>
</section>
</subtitle>
<subtitle id="H1B3AA61CF2BA4D1DAAE218A51CBF8BFE">
<enum>Q</enum>
<header>Exempting from sequestration certain user fees</header>
<section id="H8A97FD8D74C64CEBAAF3422A55329138">
<enum>2301.</enum>
<header>Exempting from sequestration certain user fees of Food and Drug Administration</header>
<text display-inline="no-display-inline">The Balanced Budget and Emergency Deficit Control Act of 1985 is amended—</text>
<paragraph id="H376B7E7D7E4C40F28BA2AF829F2B2FD4">
<enum>(1)</enum>
<text>in section 255(g)(1)(A) (2 U.S.C. 905(g)(1)(A)), by inserting after the item relating to <term>Financial Agent Services</term> the following new item:</text>
<quoted-block display-inline="no-display-inline" id="H53FD77EF908843B386C44890B14F28EB" style="OLC">
<list level="subparagraph">
<list-item>Food and Drug Administration, Salaries and Expenses, but only the portion of appropriations under such account corresponding to fees collected under sections 736, 738, 740, 741, 744B, and 744H of the Federal Food, Drug, and Cosmetic Act (75–9911–0–1–554).</list-item>
</list>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H41383D7024094EC3A35D30C42508B2AA">
<enum>(2)</enum>
<text display-inline="yes-display-inline">in section 256(h) (2 U.S.C. 906(h)), by adding at the end the following new paragraph:</text>
<quoted-block display-inline="no-display-inline" id="HA4BC985025504CE494D7A470C9A0D414" style="OLC">
<paragraph id="HDFC0D78918EB48A8BB1275048E972BDA">
<enum>(5)</enum>
<text display-inline="yes-display-inline">Notwithstanding any other provision of law, this subsection shall not apply with respect to the portion of administrative expenses incurred by the Food and Drug Administration that are funded through fees collected under sections 736, 738, 740, 741, 744B, and 744H of the Federal Food, Drug, and Cosmetic Act.</text>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</section>
</subtitle>
<enum>III</enum>
<header>Delivery</header>
<subtitle id="H7EF843D431F5456FA52529D176E7C4E6">
<enum>A</enum>
<header>Interoperability</header>
<section id="HF290B56142BB4D119833A7D4EC9937FF" section-type="subsequent-section">
<enum>3001.</enum>
<header>Ensuring interoperability of health information technology</header>
<subsection id="HC44ACE66DA584B2EB24E50B1FB30E4B1">
<enum>(a)</enum>
<header>Interoperability standards</header>
<paragraph id="HAAECBD4A3CF24B83A73EE4CF937C966B">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Subtitle A of title XXX of the Public Health Service Act (42 U.S.C. 300jj–11 et seq.) is amended by adding at the end the following new section:</text>
<quoted-block style="OLC" id="H43AC648C462E45F18D387A21927744F5" display-inline="no-display-inline">
<section id="HBC249FBE01DC4479B7C6940F758C6EB3">
<enum>3010.</enum>
<header>Ensuring interoperability of health information technology</header>
<subsection id="HD5F28282D6A74712A3CD3FA69115BDEC">
<enum>(a)</enum>
<header>Interoperability</header>
<text display-inline="yes-display-inline">In order for health information technology to be considered interoperable, such technology must satisfy the following criteria: </text>
<paragraph id="H8803FB2A2FED4D98AE7FC552DB571164">
<enum>(1)</enum>
<header>Secure transfer</header>
<text display-inline="yes-display-inline">The technology allows the secure transfer of all electronically accessible health information to and from any and all health information technology for authorized use under applicable State or Federal law.</text>
</paragraph>
<paragraph id="HBE547DEB986E43F599986DCAB2D92C0D">
<enum>(2)</enum>
<header>Complete Access to Health Information</header>
<text>The technology allows for complete access, exchange, and use of all electronically accessible health information for authorized use under applicable State or Federal law without special effort by the requestor of such health information.</text>
</paragraph>
<paragraph id="H42B49BE2DA914B899C34ADDD560A1D79">
<enum>(3)</enum>
<header>No information blocking</header>
<text display-inline="yes-display-inline">The technology is not configured, set up, or implemented to information block, as defined in section 3010A(d). </text>
</paragraph>
</subsection>
<subsection id="H7ECCB1BECBD8438182B0423D84E5077C">
<enum>(b)</enum>
<header>Categories for interoperability standards</header>
<text>The categories described in this subsection, with respect to standards and the corresponding implementation specifications for determining if health information technology is interoperable, consistent with the criteria described in subsection (a), include at least categories of standards and implementation specifications with respect to the following:</text>
<paragraph id="HCF48308D64364682BDA9672A70371C3C">
<enum>(1)</enum>
<text>Vocabulary and terminology.</text>
</paragraph>
<paragraph id="H925597A5E7924764BC44B1AE040CA732">
<enum>(2)</enum>
<text>Content and structure.</text>
</paragraph>
<paragraph id="HE61F36DC15F44EE0B0C841640489F2C4">
<enum>(3)</enum>
<text>Transport.</text>
</paragraph>
<paragraph id="H84386CBB42D84BE8889E6A30E9FB80BB">
<enum>(4)</enum>
<text>Security.</text>
</paragraph>
<paragraph id="H1996BC595E7A4138AB4DE078E5201E56">
<enum>(5)</enum>
<text>Services.</text>
</paragraph>
<paragraph id="HF5C708CDE8D64106A84D6ED1182FC379">
<enum>(6)</enum>
<text>Querying and requesting health information for access, exchange, and use.</text>
</paragraph>
</subsection>
<subsection id="H92CA442E57A54EA2B9B9374D499648CF">
<enum>(c)</enum>
<header>Allowing for flexibility</header>
<text display-inline="yes-display-inline">A standard and implementation specification, with respect to such standard, that is determined under section 3001(c)(5)(D) to be compatible with baseline standards and implementation specifications (as defined in clause (ii) of such section) shall be treated as in compliance with this section.</text>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H96CDD572C3F84DBFAACFED08CF430F5A">
<enum>(2)</enum>
<header>Guidance</header>
<text>Not later than January 1, 2017, the Secretary of Health and Human Services, in consultation with the National Coordinator of the Office of the National Coordinator for Health Information Technology, shall issue guidance with respect to the implementation of section 3010 of the Public Health Service Act, as added by paragraph (1), including with respect to defining and providing examples of authorized use under applicable State or Federal law of health information.</text>
</paragraph>
</subsection>
<subsection id="HB2A882C505C84119B74B0DE0A4A33059">
<enum>(b)</enum>
<header>Improvements to recommendation process</header>
<paragraph id="HBB89D53DA7D34334990C064A5AF80E93">
<enum>(1)</enum>
<header>HIT Policy Committee to incorporate policies for updates to interoperability standards</header>
<text display-inline="yes-display-inline">Section 3002 of the Public Health Service Act (42 U.S.C. 300jj–12) is amended—</text>
<subparagraph id="H212143B09FBB45DDBBBA3B7E914AD7C3">
<enum>(A)</enum>
<text>in subsection (a)—</text>
<clause id="H688719171F93471FB9A7E1FE49964B4B">
<enum>(i)</enum>
<text>by striking <quote>National Coordinator</quote> and inserting <quote>Secretary, in consultation with the National Coordinator,</quote>; and</text>
</clause>
<clause id="HE38B0E790E914A598768E84344E3A333">
<enum>(ii)</enum>
<text>by adding at the end the following new sentence: <quote>The HIT Policy Committee is authorized only to provide policy and priority recommendations to the Secretary and not authorized to otherwise affect the development or modification of any standard, implementation specification, or certification criterion under this title.</quote>; and </text>
</clause>
</subparagraph>
<subparagraph id="H80CBE59F00CA4D60B13797AC41E688C5">
<enum>(B)</enum>
<text>in subsection (b)(2)—</text>
<clause id="H729E219E82CA46F98F5FD4990F91E17C">
<enum>(i)</enum>
<text>in subparagraph (A), in the first sentence—</text>
<subclause id="HAF68594795D3479990CFD6ADDC111D95">
<enum>(I)</enum>
<text>by striking <quote>The HIT Policy Committee</quote> and inserting <quote>Subject to subparagraph (D), the HIT Policy Committee</quote>; and</text>
</subclause>
<subclause id="H57455A55FE824BFC95388ABBF3D96B23">
<enum>(II)</enum>
<text>by inserting <quote>(including the areas in which modifications and additions to interoperability standards and implementation specifications, with respect to such interoperability standards, under section 3010 are needed for the electronic access, exchange, and use of health information for purposes of adoption of such modifications and additions under section 3004)</quote> after <quote>section 3004</quote>.</text>
</subclause>
</clause>
<clause id="HB41E3FB3BA354698BDCEAD03C18BAF53">
<enum>(ii)</enum>
<text>by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" id="H18E73BA9BFD244A285FB0B8456E5F764" display-inline="no-display-inline">
<subparagraph id="H37CB27F6A5E44A3EA04C422D6EED8031">
<enum>(D)</enum>
<header>Special rule related to interoperability</header>
<text display-inline="yes-display-inline">Any recommendation made by the HIT Policy Committee on or after the date of the enactment of this subparagraph with respect to interoperability of health information technology shall be consistent with the criteria described in subsection (a) of section 3010.</text>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H8F95FFBCF72D42248E93176C692B717B" display-inline="no-display-inline">
<enum>(2)</enum>
<header>Sunset of HIT Standards Committee</header>
<text display-inline="yes-display-inline">Section 3003 of the Public Health Service Act (42 U.S.C. 300jj–13) is amended by adding at the end the following new subsection:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="HDBF64B4BEDB14C84BD05875B627814E0">
<subsection id="HAF9732007D8C4260A89E4076E20598CF">
<enum>(f)</enum>
<header>Termination</header>
<text display-inline="yes-display-inline">The HIT Standards Committee shall terminate on the date that is 90 days after the date of the enactment of this subsection.</text>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H3AAAA7A898AF43F88DCFF89688C0E992">
<enum>(3)</enum>
<header>Standards development organizations</header>
<text>Title XXX of the Public Health Service Act is amended by inserting after section 3003 the following new section:</text>
<quoted-block style="OLC" id="H109CCF298ED0497785F44C6F35313D0B" display-inline="no-display-inline">
<section id="HE10562E3366749778CCE6FB163FAAA34">
<enum>3003A.</enum>
<header>Recommendations for standards through contracts with standards development organizations</header>
<subsection id="H651C33CE04674EBDB4C9F6714AD17398">
<enum>(a)</enum>
<header>Contracts</header>
<text display-inline="yes-display-inline">
</text>
<paragraph id="H8B2E1B604BF641619CA92C7F53148E0B">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">For purposes of activities conducted under this title, the Secretary shall enter into one or more contracts with health care standards development organizations accredited by the American National Standards Institute (or with the American National Standards Institute) to carry out, directly or through contracts with subcontractors, the duties described in subsection (b), as applicable.</text>
</paragraph>
<paragraph id="H0E38060999C14E36BC12131C8A67D1AD">
<enum>(2)</enum>
<header>Timing for first contract</header>
<text>As soon as practicable after the date of the enactment of this section, the Secretary shall enter into the first contracts under paragraph (1).</text>
</paragraph>
<paragraph id="H0374888B83E6490BBD541A8E7319DD3E">
<enum>(3)</enum>
<header>Period of contract</header>
<text>Each contract under paragraph (1) shall be for a period determined necessary by the Secretary, in consultation with the National Coordinator, to carry out the applicable duties described in subsection (b). </text>
</paragraph>
<paragraph id="H9EC44510DB8440A981F93142EE71A250">
<enum>(4)</enum>
<header>Appropriate entities</header>
<text>The Secretary shall ensure the most appropriate entities described in paragraph (1) are selected for each contract under such paragraph.</text>
</paragraph>
</subsection>
<subsection id="H2EE433B8F20F49C4AAC3A144BAFE1222">
<enum>(b)</enum>
<header>Duties</header>
<paragraph id="HFCB9ACD866454B18A134C704084858FF" commented="no">
<enum>(1)</enum>
<header>Initial contract</header>
<text display-inline="yes-display-inline">The Secretary shall initially enter into one or more contracts under subsection (a)(1) with entities described in such subsection, under which the entities—</text>
<subparagraph id="H607AF5A9B54343F08409D86331FCA335" commented="no">
<enum>(A)</enum>
<text>shall recommend to the Secretary—</text>
<clause id="HAB87983DEC8749CB83D20A15FF24872A" commented="no">
<enum>(i)</enum>
<text>for adoption under section 3004, an initial set of interoperability standards and implementation specifications, with respect to such standards, identified or, as appropriate, developed by such entities that are consistent with the criteria described in subsection (a) of section 3010, and with respect to the categories described in subsection (b) of such section; and</text>
</clause>
<clause id="HC84C71B168804E47A1665584D24267FF" commented="no">
<enum>(ii)</enum>
<text>as applicable, for purposes of section 3001(c)(5)(D), methods to test if health information technology is compatible with health information technology that applies baseline standards and implementation specifications (as defined in clause (ii) of such section); and</text>
</clause>
</subparagraph>
<subparagraph id="HC21AE9EF6F484A3E85347F2EF9C9070E" commented="no">
<enum>(B)</enum>
<text>may provide to the Secretary recommendations described in paragraph (2).</text>
</subparagraph>
</paragraph>
<paragraph id="H5BD8780BA8BA44119FAF7ADD6884A64F">
<enum>(2)</enum>
<header>Subsequent contracts</header>
<text display-inline="yes-display-inline">Under each subsequent contract entered into under this section with entities described in subsection (a)(1) pursuant to subsection (c), the entities shall recommend to the Secretary—</text>
<subparagraph id="HB83B8B5210D8438BA995C7EC8460C0B2">
<enum>(A)</enum>
<text>for adoption under section 3004 any standards (including interoperability standards), implementation specifications, and, to the extent necessary, certification criteria (and modifications, including additions, to such standards, specifications, and, to the extent necessary, criteria), which are in accordance with the criteria described in section 3010; and</text>
</subparagraph>
<subparagraph id="H86343E66B221471AAE99F88EC0A3F886">
<enum>(B)</enum>
<text display-inline="yes-display-inline">as applicable, for purposes of section 3001(c)(5)(D), methods to test if health information technology is compatible with baseline standards and implementation specifications (as defined in clause (ii) of such section).</text>
</subparagraph>
</paragraph>
<paragraph id="H7451F0AEABCA421D9BF0600D669BC5AF">
<enum>(3)</enum>
<header>Submission to NIST</header>
<text>Under each contract with an entity under this section, the entity shall submit to the Director of the National Institute of Standards and Technology each recommendation submitted to the Secretary by such entity under this section.</text>
</paragraph>
<paragraph id="H4F6A1C48DD634DFCA9EF875CB1CEFEB0">
<enum>(4)</enum>
<header>Consultation</header>
<text display-inline="yes-display-inline">For the purposes of developing methods to test interoperability standards and implementation specifications with respect to such standards, the entities with a contract under this section may consult with the Director of the National Institute of Standards and Technology.</text>
</paragraph>
</subsection>
<subsection id="H012557D019E7407EB70D6E7C4912EFD4">
<enum>(c)</enum>
<header>Modifications and subsequent contracts</header>
<paragraph id="HCCC5ADA84C214B46953E27A1B71CF0CE">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary, in consultation with the National Coordinator, shall periodically conduct hearings to evaluate and review the standards, implementation specifications, and certification criteria adopted under section 3004 for purposes of determining if modifications, including any additions, are needed with respect to such standards, specifications, and criteria. </text>
</paragraph>
<paragraph id="H2E43D3E442CE4894B49D3FAE5CAD729A">
<enum>(2)</enum>
<header>Contract trigger</header>
<text>Based on the needs for standards, implementation specifications, and certification criteria (and modifications, including additions, to such standards, specifications, and criteria) under this title, as determined by the Secretary, with due consideration to section 3010(b) and in consultation with the National Coordinator, the Secretary shall, as needed, enter into contracts under subsection (a) to carry out the duties described in subsection (b)(2) in addition to any contract entered into to carry out the duties described in subsection (b)(1).</text>
</paragraph>
</subsection>
<subsection id="HE1997E40E47C451B825D27E976D4E654">
<enum>(d)</enum>
<header>Authorization of appropriations</header>
<text display-inline="yes-display-inline">There is authorized to be appropriated $10,000,000 for contracts under subsection (a), to remain available until expended.</text>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H17EE783FE8FC483A9AFEDD8D633677EA">
<enum>(4)</enum>
<header>Modifications to role of the National Coordinator</header>
<text>Section 3001(c)(1)(A) of the Public Health Service Act (42 U.S.C. 300jj–11(c)(1)(A)) is amended by inserting <quote>for recommendations made before the date of the enactment of the 21st Century Cures Act,</quote> before <quote>review and determine</quote>.</text>
</paragraph>
</subsection>
<subsection id="H84319381C4F648A0BD6ECD10C9BA1B0C">
<enum>(c)</enum>
<header>Adoption</header>
<text>Section 3004 of the Public Health Service Act (42 U.S.C. 300jj–14) is amended—</text>
<paragraph id="H818E09D8211F439BA486879BD148A8EF">
<enum>(1)</enum>
<text>in subsection (a)—</text>
<subparagraph id="H9AF8B67B9E6A465BA3301B50265B1DA3">
<enum>(A)</enum>
<text>in paragraph (1), by inserting after <quote>section 3001(c)</quote> the following: <quote>(or, subject to subsection (c), in the case of a standard, implementation specification, or criterion recommended on or after the date of the enactment of the 21st Century Cures Act, after the date of submission of the recommendation to the Secretary under section 3003A)</quote>; and</text>
</subparagraph>
<subparagraph id="HAD4D429E0C344B5EB4FD73003A1182D6">
<enum>(B)</enum>
<text>in paragraph (2)(B), by striking <quote>and the HIT Standards Committee</quote>; </text>
</subparagraph>
</paragraph>
<paragraph id="H2375650C23BA4AC48287885688112869">
<enum>(2)</enum>
<text>in subsection (b)—</text>
<subparagraph id="H92BAA06CFDED4CA98561E28BAC3F5E90">
<enum>(A)</enum>
<text>in paragraph (3), by striking <quote>with the schedule published under section 3003(b)(2)</quote> and inserting <quote>with subsection (d)</quote>; and</text>
</subparagraph>
<subparagraph id="HF1691929D5C84A67B54BEE2B177F46AB">
<enum>(B)</enum>
<text>by adding at the end the following new paragraph:</text>
<quoted-block style="OLC" id="H12399D2FD30242EAA5290D969DED67EE" display-inline="no-display-inline">
<paragraph id="H920EFD6CC0D3499994715D536C57B218">
<enum>(4)</enum>
<header>Limitation</header>
<text display-inline="yes-display-inline">The Secretary may not adopt any policies, priorities, standards, implementation specifications, or certification criteria under this subsection or subsection (a) that are inconsistent with or duplicative of an interoperability standard or implementation specification with respect to such standard adopted under this section, in accordance with subsections (c) and (d). In the case of a standard, specification, or criterion that has been adopted under this section and is inconsistent or duplicative of such an interoperability standard or specification that is subsequently adopted under this section, such interoperability standard or specification shall supercede such other standard, specification, or criterion and such other standard, specification, or criterion shall no longer be considered adopted under this section beginning on the date that such interoperability standard or specification becomes effective.</text>
</paragraph>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</subparagraph>
</paragraph>
<paragraph id="HEBED4D7423934E0CABF23E3240326040">
<enum>(3)</enum>
<text>by adding at the end the following new subsections:</text>
<quoted-block style="OLC" id="H56A068631ED449A7A03D95FD90F3EBA5" display-inline="no-display-inline">
<subsection id="H9A486F5A164448F2BE10CB86932CF3FE" display-inline="no-display-inline">
<enum>(c)</enum>
<header>Adoption of initial interoperability standards and implementation specifications</header>
<text display-inline="yes-display-inline">Notwithstanding the previous subsections of this section, the following shall apply in the case of the initial set of interoperability standards and implementation specifications with respect to such standards recommended under section 3003A:</text>
<paragraph id="H69FF3A79F8D645CF97BA3DD29B299D79">
<enum>(1)</enum>
<header>Review of standards</header>
<text display-inline="yes-display-inline">Not later than 90 days after the date of receipt of recommendations for such interoperability standards and implementation specifications, the Secretary, in consultation with the National Coordinator and representatives of other relevant Federal agencies, such as the National Institute of Standards and Technology, shall jointly review such standards and implementation specifications and shall determine whether or not to propose adoption of such standards and implementation specifications.</text>
</paragraph>
<paragraph id="H27006E77C0AB4B029FCBD0223C8C7AFA">
<enum>(2)</enum>
<header>Determination to adopt</header>
<text>If, subject to subsection (d)(3), the Secretary determines—</text>
<subparagraph id="H71EF8D47A51D4F37B2F294B1E16FD375">
<enum>(A)</enum>
<text>to propose adoption of such standards and implementation specifications, the Secretary shall, by regulation under section 553 of title 5, United States Code, determine whether or not to adopt such standards and implementation specifications; or</text>
</subparagraph>
<subparagraph id="H940A9458AB5C48D283DCC8A82F659145">
<enum>(B)</enum>
<text display-inline="yes-display-inline">not to propose adoption of such standards and implementation specifications, the Secretary shall notify the applicable entity with a contract under section 3003A in writing of such determination and the reasons for not proposing the adoption of the recommendation for such standards and implementation specifications.</text>
</subparagraph>
</paragraph>
<paragraph id="HB3151454F0D6435BA9ABB51FB3E87604">
<enum>(3)</enum>
<header>Publication</header>
<text>The Secretary shall provide for publication in the Federal Register of all determinations made by the Secretary under paragraph (1).</text>
</paragraph>
</subsection>
<subsection id="H10D7B703578246DE9417D195C0BFD8FC">
<enum>(d)</enum>
<header>Rules for adoption</header>
<text display-inline="yes-display-inline">In the case of a standard (including interoperability standard), implementation specification, or certification criterion adopted under this section on or after the date of the enactment of the 21st Century Cures Act, the following shall apply:</text>
<paragraph id="HB1A1BCDEEB1747D1B608D9C09CBA4DB8">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Except as provided in paragraphs (2) and (3), any such standard (including interoperability standard), implementation specification, or certification criterion shall be a standard, specification, or criterion that has been recommended by the entities with which the Secretary has entered into a contract under section 3003A. </text>
</paragraph>
<paragraph id="H47B2BA6A0C7942DDB1EE3DE86B7E6125">
<enum>(2)</enum>
<header>Special rule if no standard, specification, or criterion recommended</header>
<text display-inline="yes-display-inline">If no standard, implementation specification, or, to the extent necessary, certification criterion is recommended under paragraph (1)—</text>
<subparagraph id="HE5B2A61720A8430ABF105582E9BB322A">
<enum>(A)</enum>
<text display-inline="yes-display-inline">in the case of interoperability standards and implementation specifications with respect to such standards, relating to a category described in section 3010(b)—</text>
<clause id="HA65BC87D30D048B6AC38A6B47CEC4AAB">
<enum>(i)</enum>
<text>paragraph (1) shall not apply; and</text>
</clause>
<clause id="HC6A78B10ECB04D73A4A836572BA10CB9">
<enum>(ii)</enum>
<text>paragraph (4) shall apply; or</text>
</clause>
</subparagraph>
<subparagraph id="H615C18229A6343409B506F0EFE549314">
<enum>(B)</enum>
<text>in the case of any other standard, implementation specification, or, to the extent necessary, certification criterion, relating to a policy or priority to carry out this title, as determined by the Secretary, in consultation with the National Coordinator—</text>
<clause id="HF23A293D61734BCF95ABACCB4D5EF609">
<enum>(i)</enum>
<text>paragraph (1) shall not apply; and</text>
</clause>
<clause id="H4638FF21981744F99631878C73181660">
<enum>(ii)</enum>
<text>paragraph (4) shall apply.</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H9D69ADE68B524E3888670E31E264BA41">
<enum>(3)</enum>
<header>Authority to modify implementation specifications</header>
<text>If, following public comment pursuant to subsection (c), the Secretary would propose adoption of interoperability standards recommended under section 3003A but for the implementation specifications, with respect to such standards, so recommended, the Secretary may modify such implementation specifications and adopt such standards and specifications in accordance with subsection (c)(2). </text>
</paragraph>
<paragraph id="HFDAB16E9C8FB446B9066FA42F0AA6AD6">
<enum>(4)</enum>
<header>Effective date</header>
<text display-inline="yes-display-inline">In the case of a standard, implementation specification, or certification criterion for which there is a determination to adopt such standard, implementation specification, or certification criterion, such standard, implementation specification, or certification criterion shall be considered adopted under this section and shall be effective beginning on the date that is 12 months after the date of publication of the final rule to adopt such standard, implementation specification, or certification criterion.</text>
</paragraph>
<paragraph id="HB41CB46843E744DAAFCD495AC349567E">
<enum>(5)</enum>
<header>Assistance to the Secretary</header>
<text display-inline="yes-display-inline">In complying with the requirements of this subsection, the Secretary shall give due consideration to any recommendations of the National Committee on Vital and Health Statistics established under section 306(k), and shall consult with appropriate Federal and State agencies and private organizations. The Secretary shall publish in the Federal Register any recommendation of the National Committee on Vital and Health Statistics regarding the adoption of a standard, implementation specification, or certification criterion under this section. Any standard, implementation specification, or certification criterion adopted pursuant to this paragraph shall be promulgated in accordance with the rulemaking procedures of subchapter III of chapter 5 of title 5, United States Code.</text>
</paragraph>
</subsection>
<subsection id="H7D4445F2EB6E4713B43F2FB8ED23CC30" commented="no">
<enum>(e)</enum>
<header>Allowing for flexibility through compatibility with baseline standards and implementation specifications</header>
<text display-inline="yes-display-inline">For purposes of this title, title XVIII of the Social Security Act, title XIX of such Act, and any other provision of law, a standard and implementation specification, with respect to such standard, that is determined under section 3001(c)(5)(D) to be compatible with baseline standards and implementation specifications (as defined in clause (ii) of such section) shall be treated as if such standard and specification were an interoperability standard and implementation specification, with respect to such interoperability standard, adopted under this section.</text>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="H5BE6D96382764F788316CA3D339A0750">
<enum>(d)</enum>
<header>Reports and notifications</header>
<text display-inline="yes-display-inline">Section 3010 of the Public Health Service Act, as added by subsection (a), is amended by adding at the end the following new subsection:</text>
<quoted-block style="OLC" id="HC577863EB0614151ADD9099603726869" display-inline="no-display-inline">
<subsection id="HBAFFFFE536B74D96881BF70D7A04B839" commented="no">
<enum>(c)</enum>
<header>Dissemination of information</header>
<paragraph id="H1712E9B27E1E41D298FFFA1E064F4427">
<enum>(1)</enum>
<header>Initial summary report</header>
<text>Not later than July 1, 2017, the Secretary, after consultation with relevant stakeholders, shall submit to Congress and provide for publication in the Federal Register and the posting on the Internet website of the Office of the National Coordinator for Health Information Technology a report on the following:</text>
<subparagraph id="H7B2B7285D7E246C99A2AC57AB8B98A01" commented="no">
<enum>(A)</enum>
<text>The initial set of interoperability standards and implementation specifications adopted under section 3004(c).</text>
</subparagraph>
<subparagraph id="H3D04FEFFC81C4D93917E821A0CA26D85">
<enum>(B)</enum>
<text>The strategies for achieving widespread interoperability.</text>
</subparagraph>
<subparagraph id="H5E1E3860A9FD4F80910141420A29B572">
<enum>(C)</enum>
<text>Any barriers that are preventing widespread interoperability.</text>
</subparagraph>
<subparagraph id="H11B1A2885EDB4536A5AF324D0DD6F1FF">
<enum>(D)</enum>
<text display-inline="yes-display-inline">The plan and milestones, including specific steps, to achieve widespread interoperability.</text>
</subparagraph>
</paragraph>
<paragraph id="H5FAFD84A3BD04A7686368CBEDA7FFF66" commented="no">
<enum>(2)</enum>
<header>Ongoing publication of recommendations</header>
<text display-inline="yes-display-inline">The Secretary shall provide for publication in the Federal Register, and the posting on the Internet website of the Office of the National Coordinator for Health Information Technology, of all recommendations made under this section.</text>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="H844903A4E6154CBB8E3F34F25C739675">
<enum>(e)</enum>
<header>Certification and other enforcement provisions</header>
<paragraph id="H0AC51995D9D34DB49F55BB2374FFBC0A">
<enum>(1)</enum>
<header>Certification of qualified electronic health records</header>
<text display-inline="yes-display-inline">
</text>
<subparagraph id="H56856A359FEA4E8E9300B15C52A242C9">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 3007(b) of the Public Health Service Act (42 U.S.C. 300jj–17(b)) is amended by striking <quote>under section 3001(c)(3) to be in compliance with</quote> and all that follows through the period at the end and inserting </text>
<quoted-block style="OLC" id="H5E9CFFAE66DD4EA6A63C9737E3B8C1CD" display-inline="yes-display-inline">
<text display-inline="yes-display-inline">under section 3001(c)(3)—</text>
<paragraph id="H6F7B55C86BDC4EDB94EAA890FF9508E4">
<enum>(1)</enum>
<text display-inline="yes-display-inline">for certifications made before January 1, 2018, to be in compliance with applicable standards adopted under subsections (a) and (b) of section 3004; and</text>
</paragraph>
<paragraph id="H79BBFA5DD23C4566822A96E28582BF27">
<enum>(2)</enum>
<text display-inline="yes-display-inline">for certifications made on or after January 1, 2018, to be in compliance with applicable standards adopted under subsections (a) and (b) of section 3004 and to be interoperable in accordance with section 3010 and in compliance with interoperability standards adopted under section 3004.</text>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subparagraph>
<subparagraph id="HE720C826DFB24FDDAD05FB2B1A412D4D">
<enum>(B)</enum>
<header>Requirements of Secretary</header>
<text display-inline="yes-display-inline">Section 3001(c)(5) of the Public Health Service Act (42 U.S.C. 300jj–11(c)(5)) is amended—</text>
<clause id="H43D8C28C7D824CF5846C5D7425BE4CAA">
<enum>(i)</enum>
<text>in subparagraph (B), by inserting before the period at the end the following: <quote>and, for certifications made on or after January 1, 2018, with respect to health information technology, additional criteria to establish that the technology is interoperable, in accordance with section 3010, and in compliance with interoperability standards and implementation specifications, with respect to such standards, adopted under section 3004</quote>; and</text>
</clause>
<clause id="HCD9EB87D06C7445B894264E3EED7FCBB">
<enum>(ii)</enum>
<text>by adding at the end the following new subparagraphs:</text>
<quoted-block style="OLC" id="H9DCCEA2BDAB846A981551D944B75322C" display-inline="no-display-inline">
<subparagraph id="H13CCCB0C9A1F4ED99512ADCFD29A14A4">
<enum>(C)</enum>
<header>Enforcement; decertifications</header>
<clause id="H5D976206902A445AAE13A513213A7E3F">
<enum>(i)</enum>
<header>Requirements</header>
<text display-inline="yes-display-inline">Under any program kept or recognized under subparagraph (A), the Secretary shall ensure that any vendor of or other entity offering to health care providers (as defined in section 3010A(g)) qualified electronic health records seeking a certification of such records under such program on or after January 1, 2018, shall, as a condition of certification (and maintenance of certification) of such a record under such program—</text>
<subclause id="HC7A1BADE8D634E65B4495C82655B2529">
<enum>(I)</enum>
<text>provide to the Secretary an attestation—</text>
<item id="H52A123F0ABAC4DA48A53BE0D81385CF5" commented="no">
<enum>(aa)</enum>
<text display-inline="yes-display-inline">the entity has implemented interoperability standards and implementation specifications, with respect to such standards, adopted under section 3004 (including through application of subsection (e) of such section);</text>
</item>
<item id="HC459D277702C4017A2FB82A91BEBB3BF">
<enum>(bb)</enum>
<text>that the entity, unless for a legitimate purpose specified by the Secretary, has not taken and will not take any action that constitutes information blocking (as defined in section 3010A(d)), with respect to such qualified electronic health records;</text>
</item>
<item id="H7462FC0DB4874C51AB29DF910A3020F8">
<enum>(cc)</enum>
<text display-inline="yes-display-inline">that includes the pricing information described in clause (iii) for purposes of inclusion under subsection (f) of such information on the Internet website of the Department of Health and Human Services; that such information will be available on a public Internet website of such entity; and that the entity will voluntarily provide such information to customers prior to offering any qualified electronic health records or related product or service (including subsequent updates, add-ons, or additional products or services to be provided during the course of an on-going contract), prospective customers (such as persons who request or receive a quotation or estimate), and other persons who request such information;</text>
</item>
<item id="H0AD76C3624CC4838B1EB7753C0BC99AC">
<enum>(dd)</enum>
<text display-inline="yes-display-inline">that the technology with respect to such records has published application programming interfaces, with respect to health information within such records, for search and indexing, semantic harmonization and vocabulary translation, and user interface applications;</text>
</item>
<item id="HE6B9C4F5DC654651B0A63094AAB55FFE">
<enum>(ee)</enum>
<text>that the entity has successfully and rigorously tested the real world use of the record in the type of setting in which it would be marketed; and</text>
</item>
<item id="H363208E9D870495DB7EC33ACEDB54196">
<enum>(ff)</enum>
<text display-inline="yes-display-inline">that the entity has in place data sharing programs or capabilities based on common data elements through such mechanisms as application programming interfaces without the requirement for vendor-specific interfaces;</text>
</item>
</subclause>
<subclause id="H591800DCA310430B90301B77A368A228">
<enum>(II)</enum>
<text>publish application programming interfaces and associated documentation, with respect to health information within such records, for search and indexing, semantic harmonization and vocabulary translation, and user interface applications; and</text>
</subclause>
<subclause id="H594F9779DC6145A298F26C4D2FDE3934">
<enum>(III)</enum>
<text display-inline="yes-display-inline">demonstrate to the satisfaction of the Secretary that health information from such records are able to be exchanged, accessed, and used through the use of application programming interfaces without special effort, as authorized under applicable law.</text>
</subclause>
</clause>
<clause id="H137C4422CB384DAFA05B0D7E0A86EFFA">
<enum>(ii)</enum>
<header>Decertification</header>
<text display-inline="yes-display-inline">Under any program kept or recognized under subparagraph (A), the Secretary shall ensure that beginning January 1, 2019, any qualified electronic health records that do not satisfy the certification criteria described in subparagraph (B) or with respect to which the vendor or other entity described in clause (i) does not satisfy the requirements under such clause (or is determined to be in violation of the terms of the attestation or other requirements under such clause) shall no longer be considered as certified under such program. </text>
</clause>
<clause id="H8F6B7806312047069FAAC494C1E06DF8">
<enum>(iii)</enum>
<header>Pricing information</header>
<text display-inline="yes-display-inline">For purposes of clause (i)(I)(cc), the pricing information described in this clause, with respect to a vendor of or other entity offering a qualified electronic health record, is the following:</text>
<subclause id="HA0CDC9DD1E234882820AAA89103F8682">
<enum>(I)</enum>
<text display-inline="yes-display-inline">Additional types of costs or fees (whether fixed, recurring, transaction based, or otherwise) imposed by the entity (or any third-party from whom the entity purchases, licenses, or obtains any technology, products, or services in connection with the qualified electronic health record) to purchase, license, implement, maintain, upgrade, use, or otherwise enable and support the use of capabilities to which such record is to be certified under this section; or in connection with any health information generated in the course of using any capability to which the record is to be so certified.</text>
</subclause>
<subclause id="HCA1CF1AB57A847DF943656C5F3626C4C">
<enum>(II)</enum>
<text>Limitations, whether by contract or otherwise, on the use of any capability to which the record is to be certified under this section for any purpose within the scope of the record’s certification; or in connection with any health information generated in the course of using any capability to which the record is to be certified under this section.</text>
</subclause>
<subclause id="HD5C62C3B574246639DA05C4BDA606717">
<enum>(III)</enum>
<text>Limitations, including technical or practical limitations of technology or its capabilities, that could prevent or impair the successful implementation, configuration, customization, maintenance, support, or use of any capabilities to which the record is to be certified under this section; or that could prevent or limit the access, use, exchange, or portability of any health information generated in the course of using any capability to which the record is to be so certified.</text>
</subclause>
</clause>
</subparagraph>
<subparagraph id="H6A80554F712B4D87A2B85B9CD167DAFC">
<enum>(D)</enum>
<header>Flexibility through compatibility</header>
<clause id="H59807B4BD21A40CC8844890A51A593DE">
<enum>(i)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Under any program kept or recognized under subparagraph (A), the Secretary shall provide for a method and process by which a vendor of or other entity offering to health care providers (as defined in section 3010A(g)) qualified electronic health records seeking a certification of such records under such program on or after January 1, 2018, may demonstrate, using such mechanisms as a reference implementation model or other means, that the standards and implementation specifications applied by such entity with respect to such records are compatible with baseline standards and implementation specifications, including by demonstrating such records are able to transmit information that is compatible with qualified electronic health records that would receive such information and that apply the baseline standards and implementation specifications. Such a method and process shall ensure that any such entity using a standard or implementation specification other than a baseline standard or implementation specification demonstrates, through testing, compatibility with the baseline standard and implementation specification with respect to receiving information.</text>
</clause>
<clause id="H917570A593A141A09F94923680DBC820">
<enum>(ii)</enum>
<header>Baseline standards and implementation specifications</header>
<text>For purposes of clause (i), the term <quote>baseline standards and implementation specifications</quote> means the interoperability standards and implementation specifications, with respect to such standards, adopted under section 3004 (without application of subsection (e) of such section).</text>
</clause>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</clause>
</subparagraph>
</paragraph>
<paragraph id="HCA613DB06ECA4CD795892C83DD3D2514">
<enum>(2)</enum>
<header>Additional enforcement provisions under the Public Health Service Act</header>
<text>Subtitle A of title XXX of the Public Health Service Act (42 U.S.C. 300jj–11 et seq.), as amended by subsections (a)(1) and (d), is further amended by adding at the end the following new section:</text>
<quoted-block style="OLC" id="HECC84D52A1494CDBBDB60F67F6683EE7" display-inline="no-display-inline">
<section id="H2853C0D399324A2493E33D1154914D49" commented="no">
<enum>3010A.</enum>
<header>Enforcement mechanisms</header>
<subsection id="HA99747B998954A92B64AA2E98590A242" commented="no">
<enum>(a)</enum>
<header>Inspector General authority</header>
<text display-inline="yes-display-inline">The Inspector General of the Department of Health and Human Services shall have the authority to investigate claims of—</text>
<paragraph id="H86EBEC469B2A469EB39247124D4829EB" commented="no">
<enum>(1)</enum>
<subparagraph id="H45DC52588D00406C8932C0EE43C5CB72" display-inline="yes-display-inline" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">vendors of, or other entities offering to health care providers (as defined in subsection (g)), qualified electronic health records (as defined in section 3000(13)) being in violation of an attestation (whether providing false information at the time of such attestation or by act or practice conducted after such attestation) made under section 3001(c)(5)(C)(i)(I), with respect to the use of such records by a health care provider with respect to items and services furnished under the Medicare program under title XVIII of the Social Security Act or Medicaid program under title XIX of such Act; and</text>
</subparagraph>
<subparagraph id="H2F9BA130C3BC4B238E66BDFA62F7DDA1" indent="up1" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">vendors of, or other entities offering to health care providers (as defined in subsection (g)), health information technology having engaged in information blocking (as defined in subsection (d)), unless for a legitimate purpose specified by the Secretary, with respect to the use of such technology by a health care provider with respect to items and services furnished under such a program; </text>
</subparagraph>
</paragraph>
<paragraph id="H4641DE9B84D44E68BFAD396D691F2939" commented="no">
<enum>(2)</enum>
<text display-inline="yes-display-inline">health care providers having engaged in information blocking (as so defined), with respect to the use of health information technology with respect to items and services furnished under such a program, unless for a legitimate purpose specified by the Secretary; and</text>
</paragraph>
<paragraph id="HF57D5694E6134981BCECBC760BBB1845" commented="no">
<enum>(3)</enum>
<text display-inline="yes-display-inline">health information system providers (such as operators of health information exchanges, clinical data registries, and other systems that facilitate the exchange of information) having engaged in information blocking (as so defined), unless for a legitimate purpose specified by the Secretary, with respect to the use of health information technology with respect to items and services furnished under such a program.</text>
</paragraph>
</subsection>
<subsection id="HF4B986EB9544493DBAACDB006C6F4337" commented="no">
<enum>(b)</enum>
<header>Information sharing provisions</header>
<paragraph id="H4C84D0FA5F3B4BE290F09499346DE07C" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The National Coordinator may serve as a technical consultant to the Inspector General of the Department of Health and Human Services and the Federal Trade Commission for purposes of carrying out this section. As such technical consultant, the National Coordinator may, notwithstanding any other provision of law, share information related to claims or investigations under subsection (a) with the Federal Trade Commission for purposes of such investigations and shall share information with the Inspector General, as required by law.</text>
</paragraph>
<paragraph id="H09334900E6214DEE9929EDA50BBD7E75" commented="no">
<enum>(2)</enum>
<header>Protection from disclosure of information</header>
<text display-inline="yes-display-inline">Any information that is received by the National Coordinator in connection with a claim or suggestion of possible information blocking and that could reasonably be expected to facilitate identification of the source of the information—</text>
<subparagraph id="HA3A309244B4149EC80589E0A7C98FECE" commented="no">
<enum>(A)</enum>
<text>shall not be disclosed by the National Coordinator except as may be necessary to carry out the purpose of this section; and</text>
</subparagraph>
<subparagraph id="HC171390FE18740EB9D98C0DC96C53F6A" commented="no">
<enum>(B)</enum>
<text>shall be exempt from mandatory disclosure under section 552 of title 5, United States Code, as provided by subsection (b)(3) of such section.</text>
</subparagraph>
<continuation-text continuation-text-level="paragraph" commented="no">Such information may be used by the Inspector General of the Department of Health and Human Services or Federal Trade Commission for reporting purposes to the extent that such information could not reasonably be expected to facilitate identification of the source of such information.</continuation-text>
</paragraph>
<paragraph id="H5F2BC953F9F14080A808FF59B04062DE" commented="no">
<enum>(3)</enum>
<header>Non-application of Paperwork Reduction Act</header>
<text display-inline="yes-display-inline">Chapter 35 of title 44, United States Code (commonly referred to as the Paperwork Reduction Act of 1995) shall not apply to the National Coordinator or to the Office of the National Coordinator for Health Information Technology with respect to the collection of complaints relating to claims described in subsection (a).</text>
</paragraph>
<paragraph id="HAA78193472C945E48A977B8AAE4A872F" commented="no">
<enum>(4)</enum>
<header>Standardized process</header>
<text display-inline="yes-display-inline">The National Coordinator shall implement a standardized process for the public to submit reports on claims of—</text>
<subparagraph id="H1793678E3CF7450CACCCB431B377C8CD" commented="no">
<enum>(A)</enum>
<text>health information technology products of vendors (or other entities offering such products to health care providers (as defined in subsection (g)) not being interoperable or resulting in information blocking; or</text>
</subparagraph>
<subparagraph id="H720A4FC6B0B2476DB96E6322C23953AE" commented="no">
<enum>(B)</enum>
<text>actions by such entities, health care providers, or health information system providers that result in such technology not being interoperable or in information blocking with respect to such technology; and</text>
</subparagraph>
<subparagraph id="H512C6246034A45228AD7DDDC2E9C4C8A" commented="no">
<enum>(C)</enum>
<text>any other act described in subsection (a). </text>
</subparagraph>
<continuation-text continuation-text-level="paragraph" commented="no">The standardized process shall provide for the collection of such information as the originating institution, location, type of transaction, system and version, timestamp, terminating institution, locations, system and version, failure notice, and other related information.</continuation-text>
</paragraph>
</subsection>
<subsection id="H61811228215E492CA5805526DDA4991A" commented="no">
<enum>(c)</enum>
<header>Penalty</header>
<paragraph id="HF9707B6437DB448A9A6169349F3B6689" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Any person or entity described in paragraph (1), (2), or (3) of subsection (a) determined to have committed on or after January 1, 2018, an act described in such respective paragraph with respect to the use of a qualified electronic health record or health information technology, as applicable under such respective paragraph, with respect to items and services furnished under the Medicare program under title XVIII of the Social Security Act or the Medicaid program under title XIX of such Act, shall be subject to a civil monetary penalty in such amount as determined appropriate by the Secretary through rulemaking.</text>
</paragraph>
<paragraph id="HA9F8307063B240A28D35C940D22C162B" commented="no">
<enum>(2)</enum>
<header>Application</header>
<text>Subject to paragraph (3), the provisions of section 1128A (other than subsections (a) and (b)) of such Act (42 U.S.C. 1320a–7a) shall apply to a civil money penalty applied under this subsection in the same manner as they apply to a civil money penalty or proceeding under subsection (a) of such section 1128A.</text>
</paragraph>
<paragraph id="H599A8484E17D48788B313E4A5D26AF13" commented="no">
<enum>(3)</enum>
<header>Recovery of funds</header>
<text>Notwithstanding section 3302 of title 31, United States Code, or any other provision of law affecting the crediting of collections, the Inspector General of the Department of Health and Human Services may receive and retain for current use any amounts recovered under this subsection. In addition to amounts otherwise available to the Inspector General, funds received by the Inspector General under this paragraph shall be deposited, as an offsetting collection, to the credit of any appropriation available for purposes of carrying out this subsection and subsection (a) and shall be available without fiscal year limitation and without further appropriation.</text>
</paragraph>
</subsection>
<subsection id="H78EE498F63E04D5B9966FB4234649012" commented="no">
<enum>(d)</enum>
<header>Information blocking</header>
<paragraph id="HB7C3EF639926412FB2C90B0149E0C3DF" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">For purposes of this section and section 3010, subject to paragraph (3), the term <quote>information blocking</quote> means, with respect to the access, use, and exchange of qualified electronic health records and other health information technology, business, technical, and organizational practices, including practices described in paragraph (2), that—</text>
<subparagraph id="H238D4EC878A34814AD58DCED770C5958" commented="no">
<enum>(A)</enum>
<text>prevent or materially discourage the access, exchange, or use of electronic health information; and</text>
</subparagraph>
<subparagraph id="H97611383F78C411EA97171DC124F22D9" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">the actor knows or should know (as defined in section 1128A(i)(7) of the Social Security Act) are likely to interfere with the access, exchange, or use of electronic health information.</text>
</subparagraph>
</paragraph>
<paragraph id="HD9E396F2F80E4988AF004090C51B6CFD" commented="no">
<enum>(2)</enum>
<header>Practices described</header>
<text display-inline="yes-display-inline">For purposes of paragraph (1), the practices described in this paragraph shall include the following:</text>
<subparagraph id="H96BDA771BF9B48BA9643E68526AD095F" commented="no">
<enum>(A)</enum>
<text>Contract terms, policies, or business or organizational practices that restrict authorized use under applicable State or Federal law of electronic health information or restrict the authorized exchange under applicable State or Federal law of such information for treatment and other permitted purposes under such applicable law, including transitions between certified EHR technologies.</text>
</subparagraph>
<subparagraph id="H32089C9F8CE44B3A9CCAAB708D8ABA6C" commented="no">
<enum>(B)</enum>
<text>Charging unreasonable prices or fees (such as for health information exchange, portability, interfaces, and full export of health information) that make accessing, exchanging, or using electronic health information cost prohibitive.</text>
</subparagraph>
<subparagraph id="HA1DD2CE901AB4A238F9D83F31626DFE6" commented="no">
<enum>(C)</enum>
<text>Developing or implementing health information technology in nonstandard ways that are likely to substantially increase the costs, complexity, or burden of sharing electronic health information, especially in cases in which relevant interoperability standards or methods to measure interoperability have been adopted by the Secretary.</text>
</subparagraph>
<subparagraph id="H66270C724B8B483DA61F8E2DC79D2928" commented="no">
<enum>(D)</enum>
<text>Developing or implementing health information technology in ways that are likely to lock in users or electronic health information, such as not allowing for the full export of health information; lead to fraud, waste, or abuse; or impede innovations and advancements in health information access, exchange, and use, including health information technology-enabled care delivery.</text>
</subparagraph>
</paragraph>
<paragraph id="HECB09979EEA4405F9CBBE8E08CD61A19" commented="no">
<enum>(3)</enum>
<header>Exceptions</header>
<subparagraph id="H0590DE6076484A6F818E33E704A30AB8" commented="no">
<enum>(A)</enum>
<header>In general</header>
<text>The term <quote>information blocking</quote> shall not include practices that—</text>
<clause id="H6968F8EC660549A2AABA57C97135E68D" commented="no">
<enum>(i)</enum>
<text>are required by applicable law; or</text>
</clause>
<clause id="H2554CA2874504E5D9B6A60674A20CE5A" commented="no">
<enum>(ii)</enum>
<text>that the Secretary, through regulation, identifies as necessary to protect patient safety, to maintain the privacy or security of individuals’ health information, or to promote competition and consumer welfare.</text>
</clause>
</subparagraph>
<subparagraph id="H65F081002D774BDBA301DA64D0835987" commented="no">
<enum>(B)</enum>
<header>Process</header>
<text>For purposes of subparagraph (A)(ii), not later than 12 months after the date of the enactment of this section, the Secretary shall issue regulations following the notice and comment procedures of section 553 of title 5, United States Code, except that the Secretary may issue the first such regulation as an interim final regulation.</text>
</subparagraph>
<subparagraph id="H476488BF61674350B5EBABB1A838FC80" commented="no">
<enum>(C)</enum>
<header>No enforcement before exceptions identified</header>
<text>The term <quote>information blocking</quote> shall not include any practice or conduct occurring before the date that is 30 days after the date on which the first regulation (as described in subparagraph (B)) is issued under such subparagraph.</text>
</subparagraph>
<subparagraph id="H433DA03D64954135A9556AC148E552D0" commented="no">
<enum>(D)</enum>
<header>Consultation</header>
<text>To the extent that regulations issued under this paragraph define practices that are necessary to promote competition and consumer welfare, the Secretary may consult with the Federal Trade Commission in issuing such regulations.</text>
</subparagraph>
<subparagraph id="H8DFF8F49B9ED4CEC951419B78ACBCA18" commented="no">
<enum>(E)</enum>
<header>Application</header>
<text>The term <quote>information blocking</quote>, with respect to an individual or entity, shall not include an act or practice other than an act or practice committed by such individual or entity. </text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H0EE8F202A2D04531ACC3714D2752B8E9" commented="no">
<enum>(e)</enum>
<header>Treatment of vendors with respect to patient safety organizations</header>
<text display-inline="yes-display-inline">In applying part C of title IX—</text>
<paragraph id="H4EA6B92969144BCB819D450145524641" commented="no">
<enum>(1)</enum>
<text>vendors shall be treated as a provider (as defined in section 921) for purposes of reporting requirements under such part, to the extent that such reports are related to attestation requirements under section 3001(c)(5)(C)(i)(I);</text>
</paragraph>
<paragraph id="H406F6B682E4D407FAB8BA50479755A19" commented="no">
<enum>(2)</enum>
<text>claims of information blocking described in subsection (a) shall be treated as a patient safety activity under such part for purposes of reporting requirements under such part; and</text>
</paragraph>
<paragraph id="H9A69F996F6EB4FF198ED0602CBBD9C4A" commented="no">
<enum>(3)</enum>
<text>health care providers that are not members of patient safety organizations shall be treated in the same manner as health care providers that are such members for purposes of such reporting requirements with respect to claims of information blocking described in subsection (a).</text>
</paragraph>
</subsection>
<subsection id="H024A1713FA5C4C7F994C08E27242810C" commented="no">
<enum>(f)</enum>
<header>Rulemaking and guidance</header>
<paragraph id="H2F4A238111CD4327A463B3241C8470AA" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Not later than 12 months after the date of the enactment of this section, the Secretary, in consultation with the National Coordinator and the Inspector General of the Department of Health and Human Services, shall, through rulemaking, implement the provisions of section 3001 of the 21st Century Cures Act, including amendments made by such section, relating to information blocking.</text>
</paragraph>
<paragraph id="HBD0C2F8C867A4E83A0BDF3B86F9AF915" commented="no">
<enum>(2)</enum>
<header>Non-duplication of penalty structures</header>
<text>In carrying out paragraph (1), in determining the scope of penalties, assessments, or exclusions under such section 3001, including amendments made by such section, relating to information blocking, the Secretary shall ensure to the extent possible that such penalties, assessments, and exclusions do not duplicate penalty, assessment, and exclusion structures that would otherwise apply with respect to information blocking and the type of individual or entity involved as of the day before the date of the enactment of this section.</text>
</paragraph>
<paragraph id="H4A2B1CEC695049438794FC54DF55E2A3" commented="no">
<enum>(3)</enum>
<header>Clarification</header>
<text>In carrying out paragraph (1), the Secretary shall ensure that health care providers are not penalized for actions of vendor of, and other entities offering to such providers, health information technology for the failure of such technology to meet requirements for such technology to be certified under this title.</text>
</paragraph>
<paragraph id="H59043E38C716419AA064815E72BC6983" commented="no">
<enum>(4)</enum>
<header>Guidance relating to HIPAA</header>
<text display-inline="yes-display-inline">Not later than January 1, 2017, the National Coordinator shall publish guidance to clarify the relationship of the provisions of the HIPAA privacy and security law, as defined in section 3009(a)(2) to information blocking, including—</text>
<subparagraph id="H506BC29BB8B045EDB10329CEE5EEFE69" commented="no">
<enum>(A)</enum>
<text>examples of how such provisions may result in information blocking; and</text>
</subparagraph>
<subparagraph id="H6D88AF3020B84464BF068ABEFB3AE697" commented="no">
<enum>(B)</enum>
<text>clarifying that a health care provider (as defined in subsection (g)) who discloses health information as allowed under applicable State and Federal law is not liable for unlawful actions, including breaches that occur in the custody of the recipient unless the disclosure proximately cause the breach.</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="HF2D32B7CFD0F4BE7A71895E7CF53298E" commented="no">
<enum>(g)</enum>
<header>Health care provider defined</header>
<text>For purposes of this section, the term <quote>health care provider</quote> means a provider of services under subsection (u) of section 1861 of the Social Security Act and a supplier under subsection (d) of such section.</text>
</subsection>
<subsection id="H0113F0695FA046BCB82B7C4B2BC20ED4" commented="no">
<enum>(h)</enum>
<header>Authorization of appropriations</header>
<text display-inline="yes-display-inline">In addition to amounts made available under subsection (c)(3), there is authorized to be appropriated $10,000,000 for fiscal year 2017 to carry out subsection (a), to remain available until expended. </text>
</subsection>
</section>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H28B7F50C7CEC4DB0A85B58CB7A66AE22" commented="no">
<enum>(3)</enum>
<header>Postings relating to enforcement on HHS Internet website</header>
<text display-inline="yes-display-inline">Section 3001 of the Public Health Service Act (42 U.S.C. 300jj–11) is amended by adding at the end the following new subsection:</text>
<quoted-block style="OLC" id="H96C7824531DD45FFA3524A6FE97B7541" display-inline="no-display-inline">
<subsection id="H7F7209E314E64309B40F9282687EBE56" commented="no">
<enum>(f)</enum>
<header>Enforcement information posted on HHS Internet website</header>
<paragraph id="H3F111B475BB044CCA4D98378194AAE0C" commented="no">
<enum>(1)</enum>
<header>Pricing information</header>
<text display-inline="yes-display-inline">Not later than January 1, 2019, the National Coordinator shall post the information described in subsection (c)(5)(C)(I)(i)(cc) on the public Internet website of the Office of the National Coordinator for Health Information Technology in a manner that allows for comparison of functionality, price information, and other features among health information technology products that aids in making informed decisions for purchasing such a product.</text>
</paragraph>
<paragraph id="HAC020983111F4A8A9ACC883C684DE60B" commented="no">
<enum>(2)</enum>
<header>Annual posting</header>
<text display-inline="yes-display-inline">For 2019 and each subsequent year, the Secretary shall post on the public Internet website of the Department of Health and Human Services a list of any qualified electronic health records with respect to which certification has been withdrawn under subsection (c)(5)(C)(ii) during such year and the vendor of or other entity offering to health care providers (as defined in section 3010A(g)) such qualified electronic health records.</text>
</paragraph>
<paragraph id="H6ED5C3D3A6254CFC8E878317AE536461" commented="no">
<enum>(3)</enum>
<header>Periodic review</header>
<text display-inline="yes-display-inline">The Secretary shall periodically review and confirm that vendors of and other entities offering to health care providers (as defined in section 3010A(g)) qualified electronic health records have publicly published application programming interfaces and associated documentation as required by subsection (c)(5)(C)(i)(II) for purposes of certification and maintaining certification under any program kept or recognized under subsection (c)(5)(A).</text>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="HA92098F84E624AAF83CDC662C7936A66" commented="no" display-inline="no-display-inline">
<enum>(4)</enum>
<header>Demonstration required for meaningful EHR use under Medicare</header>
<text display-inline="yes-display-inline">
</text>
<subparagraph id="H9FE921A469574B2E8D02150EE017F810" commented="no">
<enum>(A)</enum>
<header>Eligible professionals</header>
<clause id="H1B6B032179D443188BC84E08DBA2B53A" commented="no">
<enum>(i)</enum>
<header>In general</header>
<text>Section 1848(o)(2)(A) of the Social Security Act (42 U.S.C. 1395w–4(o)(2)(A)) is amended by inserting after clause (iii) the following new clause:</text>
<quoted-block style="OLC" id="H5D45639112B84930A8A9FE52B4CCE14D" display-inline="no-display-inline">
<clause id="HAD84C4EE4D09423B803CAB448440811F" commented="no">
<enum>(iv)</enum>
<header>Interoperability</header>
<text display-inline="yes-display-inline">With respect to EHR reporting periods for payment years beginning with 2020, the eligible professional demonstrates to the satisfaction of the Secretary, in accordance with subparagraph (C)(i), that during such period the professional has not taken any action described in subsection (a)(2) of section 3010A of the Public Health Service Act, with respect to the use of any certified EHR technology.</text>
</clause>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</clause>
<clause id="H1BF6A4D9EA7D422484607B349B8DA15B" commented="no">
<enum>(ii)</enum>
<header>Hardship exemption in case of decertified EHR</header>
<text display-inline="yes-display-inline">Subparagraph (B) of section 1848(a)(7) of the Social Security Act (42 U.S.C. 1395w–4(a)(7)) is amended to read as follows: </text>
<quoted-block style="OLC" id="H8A0D1F89B8EB4BA3865A96BA19BF321D" display-inline="no-display-inline">
<subparagraph id="H7CC95A5E4BC84ECAA4C1333C62D4CC90" commented="no">
<enum>(B)</enum>
<header>Significant hardship exception</header>
<text display-inline="yes-display-inline">
</text>
<clause id="H4291E47D1F024479975B95CF0FF4F52E" commented="no">
<enum>(i)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary may, on a case-by-case basis, exempt an eligible professional from the application of the payment adjustment under subparagraph (A) if the Secretary determines, subject to annual renewal, that compliance with the requirement for being a meaningful EHR user would result in a significant hardship, such as in the case of an eligible professional who practices in a rural area without sufficient Internet access.</text>
</clause>
<clause id="H9B418E9A7C744B719FB29BBB0A7DA94E" commented="no">
<enum>(ii)</enum>
<header>Decertification</header>
<text display-inline="yes-display-inline">The Secretary shall exempt an eligible professional from the application of the payment adjustment under subparagraph (A) if the Secretary determines that such professional was determined to not be a meaningful EHR user because the certified EHR technology used by such professional is decertified under section 3001(c)(5)(C) of the Public Health Service Act. An exemption under the previous sentence may be applied to an eligible professional only, subject to clause (iii), during the first payment year with respect to the first EHR reporting period to which such decertification applies.</text>
</clause>
<clause id="H9A284F7D074F45F6AEAE5E822210F058" commented="no">
<enum>(iii)</enum>
<header>Duration of decertification</header>
<subclause id="H03A77555AEAE4504A50C527ADB09B991" commented="no">
<enum>(I)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Notwithstanding clause (iv)(I), in no case shall an exemption by reason of clause (ii) be for a period of less than 12 months.</text>
</subclause>
<subclause id="HBA537953CB664A54997C425D7D189A02" commented="no">
<enum>(II)</enum>
<header>Extension</header>
<text>An exemption under clause (ii) may be extended, on a case-by-case basis, for a period of an additional 12 months subject to the limitation described in clause (iv)(I).</text>
</subclause>
</clause>
<clause id="HCA682126763249F7BDF1744F9AA81937" commented="no">
<enum>(iv)</enum>
<header>Limitation</header>
<subclause id="H15E51DCD20A54A00B182C34D711B17FC" commented="no">
<enum>(I)</enum>
<header>In general</header>
<text>Subject to subclause (II), in no case may an eligible professional be granted an exemption under this subparagraph for more than 5 years.</text>
</subclause>
<subclause id="H8E71639B0A314227BBF00CCBA92A1D56" commented="no">
<enum>(II)</enum>
<header>Exception</header>
<text>Subclause (I) shall not apply to an exemption by reason of clause (ii) to the extent necessary to satisfy clause (iii)(I).</text>
</subclause>
</clause>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</clause>
<clause id="HA1AD84D36B4546BB8667B9EF99770B97" commented="no">
<enum>(iii)</enum>
<header>Further application</header>
<text>Section 1848(o)(2) of the Social Security Act (42 U.S.C. 1395w–4(o)(2)) is amended by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" id="H849C8203BB194C6E86116F5711EB1EEF" display-inline="no-display-inline">
<subparagraph id="H0C75F3ADDFA444C497B636EEB1B79109" commented="no">
<enum>(E)</enum>
<header>Hardship exemption in case of decertified EHR</header>
<text display-inline="yes-display-inline">In the case of certified EHR technology used by an eligible professional that is decertified under section 3001(c)(5)(C), during the first payment year with respect to the first EHR reporting period to which such decertification applies, the Secretary shall not treat the professional as not being a meaningful EHR user solely because the technology used by such professional was so decertified. The treatment of a professional under the previous sentence shall be for a period of at least 12 months and may, on a case-by-case basis, be for a period of an additional 12 months. </text>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</clause>
</subparagraph>
<subparagraph id="HDF4BC2D68C3D4A4DA5CFBD3209F6DBDF" commented="no">
<enum>(B)</enum>
<header>Eligible hospitals</header>
<clause id="HA3F414314C41403F9CCA651B6FA3395C" commented="no">
<enum>(i)</enum>
<header>In general</header>
<text>Section 1886(n)(3)(A) of the Social Security Act (42 U.S.C. 1395ww(n)(3)(A)) is amended by inserting after clause (iii) the following new clause:</text>
<quoted-block style="OLC" id="HEF26F579DF314103B21FF965BA72DEC1" display-inline="no-display-inline">
<clause id="H423BEEB155E94575ADFBF9C2F8923F1E" commented="no">
<enum>(iv)</enum>
<header>Interoperability</header>
<text display-inline="yes-display-inline">With respect to EHR reporting periods for payment years beginning with 2020, the hospital demonstrates to the satisfaction of the Secretary, in accordance with subparagraph (C)(i), that during such period the hospital has not taken any action described in subsection (a)(2) of section 3010A of the Public Health Service Act, with respect to the use of any certified EHR technology.</text>
</clause>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</clause>
<clause id="H700CA3ED4624488C99F496611F3E9F61" commented="no">
<enum>(ii)</enum>
<header>Hardship exemption in case of decertified EHR</header>
<text display-inline="yes-display-inline">Subclause (II) of section 1886(b)(3)(B)(ix) of the Social Security Act (42 U.S.C. 1395ww(b)(3)(B)(ix)) is amended to read as follows: </text>
<quoted-block style="OLC" id="H1595F61480CC4DCBA4ACB6D3712B65CA" display-inline="no-display-inline">
<subclause id="HEBC4D18DE81B41C891504A602ABEA199" commented="no" indent="up1">
<enum>(II)</enum>
<item id="H8C1A79287A524E6DB80438F0EB751110" display-inline="yes-display-inline" commented="no" indent="up1">
<enum>(aa)</enum>
<text display-inline="yes-display-inline">The Secretary may, on a case-by-case basis, exempt a subsection (d) hospital from the application of subclause (I) with respect to a fiscal year if the Secretary determines, subject to annual renewal, that requiring such hospital to be a meaningful EHR user during such fiscal year would result in a significant hardship, such as in the case of a hospital in a rural area without sufficient Internet access.</text>
</item>
<item id="H98F12EBEBDD842AAB8E6ACAA493EFDE6" indent="up1" commented="no">
<enum>(bb)</enum>
<text display-inline="yes-display-inline">The Secretary shall exempt a subsection (d) hospital from the application of subclause (I) with respect to a fiscal year if the Secretary determines that such hospital was determined to not be a meaningful EHR user because the certified EHR technology used by such hospital is decertified under section 3001(c)(5)(C) of the Public Health Service Act. An exemption under the previous sentence may be applied to a subsection (d) hospital only, subject to items (cc) and (dd), during the first payment year with respect to the first EHR reporting period to which such decertification applies.</text>
</item>
<item id="H2FF1971E507B4180908BDAF6736C1AA1" indent="up1" commented="no">
<enum>(cc)</enum>
<text>Notwithstanding item (ee), in no case shall an exemption by reason of item (bb) be for a period of less than 12 months.</text>
</item>
<item id="HDFE556A48B044A32886490B28BAEEE93" indent="up1" commented="no">
<enum>(dd)</enum>
<text>An exemption under item (bb) may, on a case-by-case basis, be extended for a period of an additional 12 months subject to the limitation described in item (ee).</text>
</item>
<item id="H0DEED54088BC4A3497AA7037E8522E47" indent="up1" commented="no">
<enum>(ee)</enum>
<text>Subject to item (ff), in no case may a hospital be granted an exemption under this subclause for more than 5 years.</text>
</item>
<item id="H0B5A13C930794E3BA4A8DC2593622596" indent="up1">
<enum>(ff)</enum>
<text display-inline="yes-display-inline">Item (ee) shall not apply to an exemption by reason of item (bb) to the extent necessary to satisfy item (cc).</text>
</item>
</subclause>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</clause>
</subparagraph>
<subparagraph id="H53DCE634B71D48BBAFC551A9C6328C91" commented="no">
<enum>(C)</enum>
<header>Demonstration required for meaningful EHR use under Medicaid</header>
<text>Section 1903(t)(2) of the Social Security Act (42 U.S.C. 1396b(t)(2)) is amended by adding at the end the following: <quote>An eligible professional shall not qualify as a Medicaid provider under this subsection, with respect to a year beginning with 2020, unless such provider demonstrates to the Secretary, through means such as an attestation, that the provider has not taken any action described in subsection (a)(2) of section 3010A of the Public Health Service Act, with respect to the use of any certified EHR technology.</quote>.</text>
</subparagraph>
</paragraph>
<paragraph id="H6C5799941CF54CBB9769970F751EFAB4">
<enum>(5)</enum>
<header>Guidance</header>
<text display-inline="yes-display-inline">Not later than January 1, 2018, the Secretary of Health and Human Services shall issue guidance to further the voluntary transition of health care providers between different certified EHR technology (as defined in section 3000(1) of the Public Health Service Act (42 U.S.C. 300jj(1)) by removing disincentives to such transition, which may include applying to instances of such a transition the hardship exemption authority under section 1848(a)(7) of the Social Security Act (42 U.S.C. 1395w–4(a)(7)), section 1886(b)(3)(B)(ix) of such Act (42 U.S.C. 1395ww(b)(3)(B)(ix)), and other provisions of law in existence as of the date of the enactment of this Act. In developing such guidance, the Secretary may consult with the relevant Federal agencies.</text>
</paragraph>
</subsection>
<subsection id="HFCADA4B3F26041FBA6DEF33E6152B35E">
<enum>(f)</enum>
<header>Definitions</header>
<paragraph id="H58146C6FBF194E268D42C9D28DE70E23">
<enum>(1)</enum>
<header>Certified EHR technology</header>
<text>Paragraph (1) of section 3000 of the Public Health Service Act (42 U.S.C. 300jj) is amended to read as follows:</text>
<quoted-block style="OLC" id="HB31E29EB68A4464E984EEA48BDC50B06" display-inline="no-display-inline">
<paragraph id="HDA2B9975D5CE4F238FE5AE613667113D">
<enum>(1)</enum>
<header>Certified EHR technology</header>
<text display-inline="yes-display-inline">The term <quote>certified EHR technology</quote> means a qualified electronic health record that is certified pursuant to section 3001(c)(5) as meeting the certification criteria defined in subparagraph (B) of such section that are applicable to the type of record involved (as determined by the Secretary, such as an ambulatory electronic health record for office-based physicians or an inpatient hospital electronic health record for hospitals) including, beginning January 1, 2018, with respect to which the vendor or other entity offering such technology is in compliance with the requirements under section 3001(c)(5)(C)(i).</text>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H727F3AEEE1204A488329A90F83C99042">
<enum>(2)</enum>
<header>Widespread interoperability</header>
<text display-inline="yes-display-inline">Section 3000 of the Public Health Service Act (42 U.S.C. 300jj) is amended by adding at the end the following new paragraph:</text>
<quoted-block style="OLC" id="HF2F9CEA23C1649348ADBD0A84270252B" display-inline="no-display-inline">
<paragraph id="H11DA3A4AC7C3465D951E34E362E88796">
<enum>(15)</enum>
<header>Widespread interoperability</header>
<text display-inline="yes-display-inline">The term <quote>widespread interoperability</quote> means that, on a nationwide basis—</text>
<subparagraph id="HB1897ACFD68641F596D79699433DC1EC">
<enum>(A)</enum>
<text>health information technology is interoperable, in accordance with section 3010; and</text>
</subparagraph>
<subparagraph id="H588A4835B1354E4D9BCEE507EB23DB7C">
<enum>(B)</enum>
<text>such technology is employed by meaningful EHR users under the Medicare program under title XVIII of the Social Security Act and the Medicaid program under title XIX of such Act and by other clinicians and health care providers.</text>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="H84E9E3B96F994DB69E141FB5F0C205C5">
<enum>(g)</enum>
<header>Conforming amendments</header>
<paragraph id="H039EA4E5A10D4097BC96064BDE2B9D5D">
<enum>(1)</enum>
<header>Voluntary use of standards</header>
<text display-inline="yes-display-inline">Section 3006 of the Public Health Service Act (42 U.S.C. 300jj–16) is amended—</text>
<subparagraph id="HDA8F0371B1CB42CE9FE24095BAEC7E67">
<enum>(A)</enum>
<text>in subsection (a)(1), by inserting <quote>, including an interoperability standard or implementation specification, with respect to such interoperability standard, adopted under such section</quote> after <quote>section 3004</quote>.</text>
</subparagraph>
<subparagraph id="H11E5A5B3FDF44726BE7D6B882BC7E461">
<enum>(B)</enum>
<text>in subsection (b), by inserting <quote>, including the interoperability standards and implementation specifications, with respect to such interoperability standards, adopted under such section</quote> after <quote>section 3004</quote>. </text>
</subparagraph>
</paragraph>
<paragraph id="H2A7C1F4CB04E4E91BCCEFD657243DC07">
<enum>(2)</enum>
<header>HIPAA privacy and security law definition correction</header>
<text display-inline="yes-display-inline">Section 3009(a)(2)(A) of the Public Health Service Act (42 U.S.C. 300jj–19(a)(2)(A)) is amended by striking <quote>title IV</quote> and inserting <quote>title XIII</quote>. </text>
</paragraph>
<paragraph id="H677B9F1A210949CD838F074155487B1F">
<enum>(3)</enum>
<header>Coordination of Federal activities</header>
<text>Section 13111 of the HITECH Act is amended—</text>
<subparagraph id="H7B3A97E3A27447FDA2941A0A5E4D775F">
<enum>(A)</enum>
<text>in subsection (a), by inserting before the period at the end the following: <quote>(and, beginning on January 1, 2018, that are also interoperable under section 3010 of such Act and in compliance with interoperability standards and implementation specifications, with respect to such interoperability standards, adopted under section 3004 of such Act )</quote>; and</text>
</subparagraph>
<subparagraph id="H8CAE0E9F069244729A1631FD065FE6C0">
<enum>(B)</enum>
<text>in subsection (b), by inserting <quote>(and, beginning on January 1, 2018, including an interoperability standard or implementation specification, with respect to such interoperability standard, adopted under section 3004 of such Act)</quote> before <quote>the President</quote>.</text>
</subparagraph>
</paragraph>
<paragraph id="HFD221F3D010E48B1B31E46ADA7CE65CD">
<enum>(4)</enum>
<header>Application to private entities</header>
<text>Section 13112 of the HITECH Act is amended by inserting before the period at the end the following: <quote>(and, beginning on January 1, 2018, that are also interoperable under section 3010 of such Act and in compliance with interoperability standards and implementation specifications, with respect to such interoperability standards, adopted under section 3004 of such Act)</quote>.</text>
</paragraph>
<paragraph id="HAD93B9F1158B4DE689F8D9D76E979840" commented="no">
<enum>(5)</enum>
<header>NIST testing</header>
<text>Section 13201 of the HITECH Act (42 U.S.C. 17911) is amended—</text>
<subparagraph id="H7BC8B2AF307B4092A170DD3271C68066" commented="no">
<enum>(A)</enum>
<text>in subsection (a), by inserting <quote>(or, beginning January 1, 2018, in coordination with the entities with contracts under section 3003A, with respect to standards, and implementation specifications under section 3004) </quote> before <quote>, the Director</quote>; and</text>
</subparagraph>
<subparagraph id="H8E754ED9AF604CD09A87467A352E2EB8" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">in subsection (b), by inserting <quote>(or, beginning January 1, 2018, in coordination with the entities with contracts under section 3003A, with respect to standards and implementation specifications under section 3004)</quote> before <quote>, the Director</quote>; and</text>
</subparagraph>
<subparagraph id="H42B53299120549BAB32CAC471B04A559" commented="no">
<enum>(C)</enum>
<text>by adding at the end the following new subsection:</text>
<quoted-block style="OLC" display-inline="no-display-inline" id="H02A5543C0C624A38BAAB37F05F9B890B">
<subsection id="H3B1F27EE6A88495F9DCB180FAFB7F238" commented="no">
<enum>(c)</enum>
<header>Funding</header>
<text display-inline="yes-display-inline">For purposes of carrying out this section, in addition to any other funds made available to carry out this section, there is authorized to be appropriated $15,000,000, to remain available until expended. </text>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subparagraph>
</paragraph>
<paragraph id="H31CEED828E0C4FF798038AE587D4CC09">
<enum>(6)</enum>
<header>Coordination with recommendations for achieving widespread EHR interoperability</header>
<text display-inline="yes-display-inline">Section 106 of the Medicare Access and CHIP Reauthorization Act of 2015 (Public Law 114–10) is amended by striking subsection (b). </text>
<quoted-block style="OLC" id="H8758E2A74736434CA193FB3793DBD4FA" display-inline="no-display-inline">
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="H2354EF58B1114114BA1084F7AA40B219">
<enum>(h)</enum>
<header>Patient engagement and empowerment</header>
<text display-inline="yes-display-inline">It is the sense of Congress that—</text>
<paragraph id="HDC417D747ADA40AEB5F63658425992E5">
<enum>(1)</enum>
<text>if the strategic goals that Congress set forth in the HITECH Act are to be achieved, interoperability is best achieved with individuals and authorized representatives having equal access to the health information of such individuals in electronic format;</text>
</paragraph>
<paragraph id="H744BA38952D3468798955B1EE87B80A1">
<enum>(2)</enum>
<text>patients have the right to the entirety of the health information of such individuals, including such information contained in an electronic health record of such individuals;</text>
</paragraph>
<paragraph id="H3D46B69F89A9476783AFBF7E646B18D8">
<enum>(3)</enum>
<text>such right extends to both structured and unstructured data;</text>
</paragraph>
<paragraph id="HA330175B688E4025A0E1C8DBB5B121F7">
<enum>(4)</enum>
<text>such right extends to authorized representatives of the individual involved, such as care takers of such individual, family members of such individual, and guardians of such individual; and</text>
</paragraph>
<paragraph id="H884D363C84204CADB27071EA6EFDB092">
<enum>(5)</enum>
<text>to further facilitate access of an individual to health information of such individual—</text>
<subparagraph id="H2B86F9D3D2C240089ABC9609B141F232">
<enum>(A)</enum>
<text>health care providers should not have the ability to deny a request of the individual for access to the entirety of such health information of such individual; </text>
</subparagraph>
<subparagraph id="HBBF7A494696F4E98A79F831A99C36E7D">
<enum>(B)</enum>
<text display-inline="yes-display-inline">health care providers do not need the consent of individuals to share personal health information of such individuals with other covered entities, in compliance with the HIPAA privacy regulations promulgated pursuant to section 264(c) of the Health Insurance Portability and Accountability Act of 1996 for the purposes of supporting patient care, except in situations where consent is specifically required under such regulations, such as in cases related to the psychiatric records of the individual involved;</text>
</subparagraph>
<subparagraph id="HDE86EBCB98014BA69580EC07486DC70D">
<enum>(C)</enum>
<text display-inline="yes-display-inline">mechanisms should be utilized that allow for the bidirectional exchange of information through such mechanisms as web portals, appointments, and prescription refills, for the purpose of patients partnering with providers to assist in managing health and care;</text>
</subparagraph>
<subparagraph id="H0E1E420A4D274253BEF5FC66AF7B17B5">
<enum>(D)</enum>
<text>mechanisms described in subparagraph (C) should allow for connecting individuals across the continuum of care; </text>
</subparagraph>
<subparagraph id="HE811195C25204D7A8642A9C5477D5233">
<enum>(E)</enum>
<text>an individual has the right to access the health information of the individual without cost to the individual; </text>
</subparagraph>
<subparagraph id="HBFB58E46CDCF459B87DB840497F4782F">
<enum>(F)</enum>
<text>mechanisms described in subparagraph (C) should allow for data of an individual generated by the individual to be integrated into such platforms as electronic health records; </text>
</subparagraph>
<subparagraph id="H4114BB566A164AB3AD538B30E6312167">
<enum>(G)</enum>
<text>such access should be timely, in accordance with the HIPAA privacy regulations described in subparagraph (B), and take into account communications preferences of the individual involved; </text>
</subparagraph>
<subparagraph id="H803969C4647E4B54811E00287CE7E916">
<enum>(H)</enum>
<text>an individual should have the right to be confident that the data in the electronic health record of the individual pertains to such individual; and</text>
</subparagraph>
<subparagraph id="H52CAF4F881964B22874786581CB2D084">
<enum>(I)</enum>
<text display-inline="yes-display-inline">the right described in subparagraph (H) will promote safety and care coordination for individuals.</text>
</subparagraph>
</paragraph>
</subsection>
</section>
</subtitle>
<subtitle id="HC1B4DF5F14494CBFA2412D3043AAE7EF">
<enum>B</enum>
<header>Telehealth</header>
<section id="HB997E9EB98794313B6617823EAEF2E86" section-type="subsequent-section">
<enum>3021.</enum>
<header>Telehealth services under the Medicare program</header>
<subsection id="HB1844EB4113F4514A40BDF39B4594DAC">
<enum>(a)</enum>
<header>Provision of information by Centers for Medicare & Medicaid Services</header>
<text display-inline="yes-display-inline">Not later than 1 year after the date of the enactment of this Act, the Administrator of the Centers for Medicare & Medicaid Services shall provide to the committees of jurisdiction of the House of Representatives and the Senate information on the following:</text>
<paragraph id="HCA06BA4D281F49D19C76A588BF86306F">
<enum>(1)</enum>
<text display-inline="yes-display-inline">The populations of Medicare beneficiaries, such as those who are dually eligible for the Medicare program under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq.) and the Medicaid program under title XIX of such Act (42 U.S.C. 1396 et seq.) and those with chronic conditions, whose care may be improved most in terms of quality and efficiency by the expansion, in a manner that meets or exceeds the existing in-person standard of care under the Medicare program under title XVIII of such Act, of telehealth services under section 1834(m)(4) of such Act (42 U.S.C. 1395m(m)(4)).</text>
</paragraph>
<paragraph id="H40D343507CBC4767A59023399B02363A">
<enum>(2)</enum>
<text display-inline="yes-display-inline">Activities by the Center for Medicare and Medicaid Innovation which examine the use of telehealth services in models, projects, or initiatives funded through section 1115A of the Social Security Act (42 U.S.C. 1315a).</text>
</paragraph>
<paragraph id="H29FE6BAD4F324A5BAD8E3293E8905B62">
<enum>(3)</enum>
<text display-inline="yes-display-inline">The types of high volume services (and related diagnoses) under such title XVIII which might be suitable to the furnishing of services via telehealth.</text>
</paragraph>
<paragraph id="H53F5340EB0F748249727C6066EFEEC7C">
<enum>(4)</enum>
<text>Barriers that might prevent the expansion of telehealth services under section 1834(m)(4) of the Social Security Act (42 U.S.C. 1395m(m)(4)) beyond such services that are in effect as of the date of the enactment of this Act.</text>
</paragraph>
</subsection>
<subsection id="H8EE8EAFE4C404715A61D21CF9A3E624B">
<enum>(b)</enum>
<header>Provision of information by MedPAC</header>
<text display-inline="yes-display-inline">Not later than March 15, 2017, the Medicare Payment Advisory Commission established under section 1805 of the Social Security Act (42 U.S.C. 1395b–6) shall, using quantitative and qualitative research methods, provide information to the committees of jurisdiction of the House of Representatives and the Senate that identifies—</text>
<paragraph id="HFD0343E19A9146E3BC8A87D4577A94D7">
<enum>(1)</enum>
<text display-inline="yes-display-inline">the telehealth services for which payment can be made, as of the date of the enactment of this Act, under the fee-for-service program under parts A and B of title XVIII of such Act;</text>
</paragraph>
<paragraph id="HD500CC0329704E199416C7AAD34D6198">
<enum>(2)</enum>
<text display-inline="yes-display-inline">the telehealth services for which payment can be made, as of such date, under private health insurance plans;</text>
</paragraph>
<paragraph id="H5B7BB8AB09954CE5A5FF91CF2D7DBB76">
<enum>(3)</enum>
<text display-inline="yes-display-inline">with respect to services identified under paragraph (2) but not under paragraph (1), ways in which payment for such services might be incorporated into such fee-for-service program (including any recommendations for ways to accomplish this incorporation).</text>
</paragraph>
</subsection>
<subsection id="H3901D41623934B508EF9BB8A26BE59FA">
<enum>(c)</enum>
<header>Sense of Congress</header>
<text display-inline="yes-display-inline">It is the sense of Congress that—</text>
<paragraph id="H733BA0D6069C4AC995783305FDBEEDBD">
<enum>(1)</enum>
<text display-inline="yes-display-inline">eligible originating sites should be expanded beyond those originating sites described in section 1834(m)(4)(C) of the Social Security Act (42 U.S.C. 1395m(m)(4)(C)); and</text>
</paragraph>
<paragraph id="H57DFD0F8955E48D880FEC3B13A42251E">
<enum>(2)</enum>
<text>any expansion of telehealth services under the Medicare program should—</text>
<subparagraph id="H6A2DCF062C3E442F8B234A97AFE41748">
<enum>(A)</enum>
<text display-inline="yes-display-inline">recognize that telemedicine is the delivery of safe, effective, quality health care services, by a health care provider, using technology as the mode of care delivery;</text>
</subparagraph>
<subparagraph id="H7E6ED878793B4F8C81EEBA62AF546118">
<enum>(B)</enum>
<text display-inline="yes-display-inline">meet or exceed the conditions of coverage and payment with respect to the Medicare program under title XVIII unless specifically address in subsequent statute, of such Act if the service were furnished in person, including standards of care; and</text>
</subparagraph>
<subparagraph id="H9CFA8C5052124B238C4EEFD79C6C756C">
<enum>(C)</enum>
<text display-inline="yes-display-inline">involve clinically appropriate means to furnish such services.</text>
</subparagraph>
</paragraph>
</subsection>
</section>
</subtitle>
<subtitle id="H0555C8A383ED4169A2F3E1DB61088DBC">
<enum>C</enum>
<header>Encouraging Continuing Medical Education for Physicians</header>
<section id="HC98C7D66C8ED4175820AA41367943573" section-type="subsequent-section" commented="no">
<enum>3041.</enum>
<header>Exempting from manufacturer transparency reporting certain transfers used for educational purposes</header>
<subsection id="H681B217154CD45FDB4137B14E28D7CC0" commented="no">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 1128G(e)(10)(B) of the Social Security Act (42 U.S.C. 1320a–7h(e)(10)(B)) is amended—</text>
<paragraph id="H24C89CB3005F476DBC44727792B43BAC" commented="no">
<enum>(1)</enum>
<text display-inline="yes-display-inline">in clause (iii), by inserting <quote>, including peer-reviewed journals, journal reprints, journal supplements, medical conference reports, and medical textbooks</quote> after <quote>patient use</quote>; and</text>
</paragraph>
<paragraph id="HCEC584D7795C406594D0F3E7CC60D282" commented="no">
<enum>(2)</enum>
<text>by adding at the end the following new clause:</text>
<quoted-block display-inline="no-display-inline" id="H7846AC5D138C496C9CDF0241AE8F2783" style="OLC">
<clause commented="no" id="H329DAA8B3BBD40DB9D692EAAED3192C6">
<enum>(xiii)</enum>
<text display-inline="yes-display-inline">In the case of a covered recipient who is a physician, an indirect payment or transfer of value to the covered recipient—</text>
<subclause id="HDC526168307347748066554AC2712C2A" commented="no">
<enum>(I)</enum>
<text>for speaking at, or preparing educational materials for, an educational event for physicians or other health care professionals that does not commercially promote a covered drug, device, biological, or medical supply; or </text>
</subclause>
<subclause id="HF366F163E7BD41A480F8BEE2B9558DF2" commented="no">
<enum>(II)</enum>
<text>that serves the sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event.</text>
</subclause>
</clause>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="H204D3FE831B5454784395D14487C2068" commented="no">
<enum>(b)</enum>
<header>Effective date</header>
<text display-inline="yes-display-inline">The amendments made by this section shall apply with respect to transfers of value made on or after the date of the enactment of this Act.</text>
</subsection>
</section>
</subtitle>
<subtitle id="H66F72BBC8F214FFAA379109A1AB88D4D">
<enum>D</enum>
<header>Disposable Medical Technologies</header>
<section id="H10A27DFF95264F4DA0E3D82A37577679" section-type="subsequent-section" commented="no">
<enum>3061.</enum>
<header>Treatment of certain items and devices</header>
<subsection id="HAE52C1A1402F4815A483968EF85CF21C" commented="no">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following new subsection:</text>
<quoted-block style="OLC" id="H1DE9D2E4B6DD409FA6465AB03595D2E8" display-inline="no-display-inline">
<subsection id="H5B085C408E4C44EA9E98A334DA66DF74" commented="no">
<enum>(r)</enum>
<header>Payment for certain disposable devices</header>
<paragraph id="H1C55AC3AF39A44928A386D371080BE94" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall make separate payment in the amount established under paragraph (3) to a home health agency for a device described in paragraph (2) when furnished to an individual who receives home health services for which payment is made under section 1895(b).</text>
</paragraph>
<paragraph id="HD696FB42487C4F63844B569A7297F307" commented="no">
<enum>(2)</enum>
<header>Device described</header>
<text display-inline="yes-display-inline">For purposes of paragraph (1), a device described in this paragraph is a disposable device for which, as of January 1, 2015, there is—</text>
<subparagraph id="H7E4981786100401787E80070BFB86A40" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">a Level I Healthcare Common Procedure Coding System (HCPCS) code for which the description for a professional service includes the furnishing of such device; and</text>
</subparagraph>
<subparagraph id="HEA45A4EB6030488C8D549F64BCEC9048" commented="no">
<enum>(B)</enum>
<text>a separate Level I HCPCS code for a professional service that uses durable medical equipment instead of such device.</text>
</subparagraph>
</paragraph>
<paragraph id="HD5D603EC75914B5C89B2FB7C62B6D8E2" commented="no">
<enum>(3)</enum>
<header>Payment amount</header>
<text display-inline="yes-display-inline">The Secretary shall establish the separate payment amount for such a device such that such amount does not exceed the payment that would be made for the HCPCS code described in paragraph (2)(A) under section 1833(t) (relating to payment for covered OPD services).</text>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="H2B0E406A98694058A904DB63BF9E4CF3" commented="no">
<enum>(b)</enum>
<header>Conforming amendment</header>
<text display-inline="yes-display-inline">Section 1861(m)(5) of the Social Security Act (42 U.S.C. 1395x(m)(5)) is amended by inserting <quote>and devices described in section 1834(r)(2)</quote> after <quote>durable medical equipment</quote>.</text>
</subsection>
<subsection id="H61E95A0206E045A1857B204553C96CCA" commented="no">
<enum>(c)</enum>
<header>Effective date</header>
<text display-inline="yes-display-inline">The amendments made by this section shall apply to devices furnished on or after January 1, 2017.</text>
</subsection>
</section>
</subtitle>
<subtitle id="H2CF2CC416F9E4E71933061DD8996C227">
<enum>E</enum>
<header>Local coverage decision reforms</header>
<section id="H57B79DB322F641D4B44FA01BFC9A1090" section-type="subsequent-section" commented="no">
<enum>3081.</enum>
<header>Improvements in the Medicare local coverage determination (LCD) process</header>
<subsection id="H68B56DC37E3F4AF7A04327EF9C16FF1F" commented="no">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 1862(l)(5) of the Social Security Act (42 U.S.C. 1395y(l)(5)) is amended by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" id="HF6D657260AC94C0394A9EDAF70F6CBF7" display-inline="no-display-inline">
<subparagraph id="H8A51B1F3C6ED4A4F9CC58698CE9ADBC5" commented="no">
<enum>(D)</enum>
<header>Local coverage determinations</header>
<text display-inline="yes-display-inline">The Secretary shall require each medicare administrative contractor that develops a local coverage determination to make available on the website of such contractor and on the Medicare website, at least 45 days before the effective date of such determination, the following information:</text>
<clause id="H7DE86024DA9F463E8349C7D4F89D707B" commented="no">
<enum>(i)</enum>
<text display-inline="yes-display-inline">Such determination in its entirety.</text>
</clause>
<clause id="HEE8CEB74C454425EAD84D307CBF2AA05" commented="no">
<enum>(ii)</enum>
<text>Where and when the proposed determination was first made public.</text>
</clause>
<clause id="H06C525CB45754888B5C3406007D76859" commented="no">
<enum>(iii)</enum>
<text>Hyperlinks to the proposed determination and a response to comments submitted to the contractor with respect to such proposed determination.</text>
</clause>
<clause id="H012980A636A2482B8415B2B9B919A297" commented="no">
<enum>(iv)</enum>
<text>A summary of evidence that was considered by the contractor during the development of such determination and a list of the sources of such evidence.</text>
</clause>
<clause id="H26105C5896194FBE92B5C3C84D1F1B5B" commented="no">
<enum>(v)</enum>
<text>An explanation of the rationale that supports such determination.</text>
</clause>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="HA417FAC2FE494A04AF4A143676C99B55" commented="no">
<enum>(b)</enum>
<header>Effective date</header>
<text display-inline="yes-display-inline">The amendment made by subsection (a) shall apply with respect to local coverage determinations that are proposed or revised on or after the date that is 180 days after the date of the enactment of this Act.</text>
</subsection>
</section>
</subtitle>
<subtitle id="H1B1D7ACDFA044136876202294FBC0BD1">
<enum>F</enum>
<header>Medicare Pharmaceutical and Technology Ombudsman</header>
<section id="H7544267E91B44C229D8FD6EE3BFCCCE2" section-type="subsequent-section">
<enum>3101.</enum>
<header>Medicare pharmaceutical and technology ombudsman</header>
<text display-inline="no-display-inline">Section 1808(c) of the Social Security Act (42 U.S.C. 1395b–9(c)) is amended by adding at the end the following new paragraph:</text>
<quoted-block style="OLC" id="H9E87C16E8520446BBF00ECF3076A34B9" display-inline="no-display-inline">
<paragraph id="HF9A9A9B5122A4CE289F6A44F38E8195A">
<enum>(4)</enum>
<header>Pharmaceutical and technology ombudsman</header>
<text display-inline="yes-display-inline">Not later than 12 months after the date of the enactment of this paragraph, the Secretary shall provide for a pharmaceutical and technology ombudsman within the Centers for Medicare & Medicaid Services who shall receive and respond to complaints, grievances, and requests that—</text>
<subparagraph id="HEDE6B18B5213422FA4CA5BA49F30FEF4">
<enum>(A)</enum>
<text display-inline="yes-display-inline">are from entities that manufacture pharmaceutical, biotechnology, medical device, or diagnostic products that are covered or for which coverage is being sought under this title; and</text>
</subparagraph>
<subparagraph id="HD9150ABC5B43433C8144AA66129B8612">
<enum>(B)</enum>
<text>are with respect to coverage, coding, or payment under this title for such products.</text>
</subparagraph>
<continuation-text continuation-text-level="paragraph">The second sentence of paragraph (2) shall apply to this paragraph in the same manner as such sentence applies to paragraph (2).</continuation-text>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
</subtitle>
<subtitle id="HC3C627B58F084BBCBFD3574B830E9740" commented="no">
<enum>G</enum>
<header>Medicare site-of-Service price transparency</header>
<section id="HD932A66C5F7C457AB792AE9F7D644D3A" section-type="subsequent-section" commented="no">
<enum>3121.</enum>
<header>Medicare site-of-Service price transparency</header>
<text display-inline="no-display-inline">Section 1834 of the Social Security Act (42 U.S.C. 1395m), as amended by section 3061, is further amended by adding at the end the following new subsection:</text>
<quoted-block style="OLC" id="H286533D35814439CAAAA9516D954E097" display-inline="no-display-inline">
<subsection id="H0BE2BD48AD94462DBB5C5050AADFBA70" commented="no">
<enum>(s)</enum>
<header>Site-of-Service price transparency</header>
<paragraph id="HFFA6AD7E0A914EE5BE1101DBB76CD8C3" commented="no">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">In order to facilitate price transparency with respect to items and services for which payment may be made either to a hospital outpatient department or to an ambulatory surgical center under this title, the Secretary shall, for 2017 and each year thereafter, make available to the public via a searchable website, with respect to an appropriate number of such items and services—</text>
<subparagraph id="HE3432FB9D37743A9BE4A6A402D79DAAD" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">the estimated payment amount for the item or service under the outpatient department fee schedule under subsection (t) of section 1833 and the ambulatory surgical center payment system under subsection (i) of such section; and</text>
</subparagraph>
<subparagraph id="HA86FAC097C8A4C789026DBAE81F04197" commented="no">
<enum>(B)</enum>
<text>the estimated amount of beneficiary liability applicable to the item or service.</text>
</subparagraph>
</paragraph>
<paragraph id="HC1B83B0CAB0444F9A8DF9ACD3F161B53" commented="no">
<enum>(2)</enum>
<header>Calculation of estimated beneficiary liability</header>
<text display-inline="yes-display-inline">For purposes of paragraph (1)(B), the estimated amount of beneficiary liability, with respect to an item or service, is the amount for such item or service for which an individual who does not have coverage under a medicare supplemental policy certified under section 1882 or any other supplemental insurance coverage is responsible.</text>
</paragraph>
<paragraph id="H2B7FD23A6A9249EFACF1FB81F6C8CEB1" commented="no" display-inline="no-display-inline">
<enum>(3)</enum>
<header>Implementation</header>
<text display-inline="yes-display-inline">In carrying out this subsection, the Secretary— </text>
<subparagraph id="H88B2907823EC47189D4EAFF4C7E75AD5" commented="no">
<enum>(A)</enum>
<text display-inline="yes-display-inline">shall include in the notice described in section 1804(a) a notification of the availability of the estimated amounts made available under paragraph (1); and </text>
</subparagraph>
<subparagraph id="H0C3A10877CEB45AC84012B52EB661E0D" commented="no">
<enum>(B)</enum>
<text display-inline="yes-display-inline">may utilize mechanisms in existence on the date of the enactment of this subsection, such as the portion of the website of the Centers for Medicare & Medicaid Services on which information comparing physician performance is posted (commonly referred to as the Physician Compare website), to make available such estimated amounts under such paragraph.</text>
</subparagraph>
</paragraph>
<paragraph id="H92B4B5C92CDE4B519CD6064ADD9280C1" commented="no">
<enum>(4)</enum>
<header>Funding</header>
<text display-inline="yes-display-inline">For purposes of implementing this subsection, the Secretary shall provide for the transfer, from the Supplemental Medical Insurance Trust Fund under section 1841 to the Centers for Medicare & Medicaid Services Program Management Account, of $6,000,000 for fiscal year 2015, to remain available until expended.</text>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</section>
</subtitle>
<subtitle id="H78B4A5BACD9F468EBAEA860BF595E27C" commented="no">
<enum>H</enum>
<header>Medicare Part D Patient Safety and Drug Abuse Prevention</header>
<section id="H7A8268CBC49A4B72820845A0858B85BA" section-type="subsequent-section">
<enum>3141.</enum>
<header>Programs to prevent prescription drug abuse under Medicare parts C and D</header>
<subsection id="H4D995CFB75F14187ABD1A51FB0A9F64B">
<enum>(a)</enum>
<header>Drug management program for at-Risk beneficiaries</header>
<paragraph id="H94BC1E70B1654A4E86731673AD1B6938">
<enum>(1)</enum>
<header>In general</header>
<text>Section 1860D–4(c) of the Social Security Act (42 U.S.C. 1395w–10(c)) is amended by adding at the end the following:</text>
<quoted-block id="HE25414320E0F4FF2846EFF1F5125F28A" style="OLC">
<paragraph id="HD7EC93C99E73415997CC1A50BC269EEF">
<enum>(5)</enum>
<header>Drug management program for at-risk beneficiaries</header>
<subparagraph id="H5D091D673D5B41FCBAA3E46503E9CBCD">
<enum>(A)</enum>
<header>Authority to establish</header>
<text display-inline="yes-display-inline">A PDP sponsor may establish a drug management program for at-risk beneficiaries under which, subject to subparagraph (B), the PDP sponsor may, in the case of an at-risk beneficiary for prescription drug abuse who is an enrollee in a prescription drug plan of such PDP sponsor, limit such beneficiary’s access to coverage for frequently abused drugs under such plan to frequently abused drugs that are prescribed for such beneficiary by one or more prescribers selected under subparagraph (D), and dispensed for such beneficiary by one or more pharmacies selected under such subparagraph. </text>
</subparagraph>
<subparagraph id="H04337F4C499648F19289E9682E7CC7A3">
<enum>(B)</enum>
<header>Requirement for notices</header>
<clause id="HED7DCE0860DA429BBA0DDC03BB4BF2B6">
<enum>(i)</enum>
<header>In general</header>
<text>A PDP sponsor may not limit the access of an at-risk beneficiary for prescription drug abuse to coverage for frequently abused drugs under a prescription drug plan until such sponsor—</text>
<subclause id="H98F44C24BDDF4CE4B961E3DBCD5A10D9">
<enum>(I)</enum>
<text>provides to the beneficiary an initial notice described in clause (ii) and a second notice described in clause (iii); and</text>
</subclause>
<subclause id="HF9292C0776224C67B997A14CC486B5C6">
<enum>(II)</enum>
<text display-inline="yes-display-inline">verifies with the providers of the beneficiary that the beneficiary is an at-risk beneficiary for prescription drug abuse.</text>
</subclause>
</clause>
<clause commented="no" id="HA28A768C8E4C4C80AF9E230C43F1C707">
<enum>(ii)</enum>
<header>Initial notice</header>
<text display-inline="yes-display-inline">An initial notice described in this clause is a notice that provides to the beneficiary—</text>
<subclause commented="no" id="H017AD389D9ED4B21A0FE3CBDC5B81AF6">
<enum>(I)</enum>
<text>notice that the PDP sponsor has identified the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse;</text>
</subclause>
<subclause commented="no" id="HE0AA79AD315049ED86D656B06C467B10">
<enum>(II)</enum>
<text display-inline="yes-display-inline">information describing all State and Federal public health resources that are designed to address prescription drug abuse to which the beneficiary has access, including mental health services and other counseling services;</text>
</subclause>
<subclause id="H9254B8ED9DB64F53A4FA9E4E2583D971">
<enum>(III)</enum>
<text display-inline="yes-display-inline">notice of, and information about, the right of the beneficiary to appeal such identification under subsection (h) and the option of an automatic escalation to external review;</text>
</subclause>
<subclause id="HDA7F1289C03043F28C1DFD41E17B38E2">
<enum>(IV)</enum>
<text display-inline="yes-display-inline">a request for the beneficiary to submit to the PDP sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the PDP sponsor to select under subparagraph (D) in the case that the beneficiary is identified as an at-risk beneficiary for prescription drug abuse as described in clause (iii)(I);</text>
</subclause>
<subclause id="HF7EE4350FE3F479488182BB84BF76DED">
<enum>(V)</enum>
<text display-inline="yes-display-inline">an explanation of the meaning and consequences of the identification of the beneficiary as potentially being an at-risk beneficiary for prescription drug abuse, including an explanation of the drug management program established by the PDP sponsor pursuant to subparagraph (A);</text>
</subclause>
<subclause id="H5474D0FA02AF432BA074FA5C453EA31A">
<enum>(VI)</enum>
<text display-inline="yes-display-inline">clear instructions that explain how the beneficiary can contact the PDP sponsor in order to submit to the PDP sponsor the preferences described in subclause (IV) and any other communications relating to the drug management program for at-risk beneficiaries established by the PDP sponsor; and</text>
</subclause>
<subclause id="H8FC40C95FE80495AB430077EEBE661D9">
<enum>(VII)</enum>
<text display-inline="yes-display-inline">contact information for other organizations that can provide the beneficiary with assistance regarding such drug management program (similar to the information provided by the Secretary in other standardized notices provided to part D eligible individuals enrolled in prescription drug plans under this part).</text>
</subclause>
</clause>
<clause id="HBDAD4E96BFA54D1799FCA5989001D48B">
<enum>(iii)</enum>
<header>Second notice</header>
<text>A second notice described in this clause is a notice that provides to the beneficiary notice—</text>
<subclause id="HC51C05D86A514847B1267307AFAB61A6">
<enum>(I)</enum>
<text display-inline="yes-display-inline">that the PDP sponsor has identified the beneficiary as an at-risk beneficiary for prescription drug abuse;</text>
</subclause>
<subclause id="H27A1EC4EC2AD4818838F5244CDADB4BD">
<enum>(II)</enum>
<text display-inline="yes-display-inline">that such beneficiary is subject to the requirements of the drug management program for at-risk beneficiaries established by such PDP sponsor for such plan;</text>
</subclause>
<subclause id="HEC5728F276FC4E11A58C5E8E3468EBFA">
<enum>(III)</enum>
<text display-inline="yes-display-inline">of the prescriber (or prescribers) and pharmacy (or pharmacies) selected for such individual under <internal-xref idref="H59ADA7F39D824BDC8ECC9D190C5B3750" legis-path="(4)(D)">subparagraph (D)</internal-xref>;</text>
</subclause>
<subclause id="H8F73287711F94706966FA43DCCF58F0C">
<enum>(IV)</enum>
<text display-inline="yes-display-inline">of, and information about, the beneficiary’s right to appeal such identification under subsection (h) and the option of an automatic escalation to external review;</text>
</subclause>
<subclause commented="no" id="HF64AA375BEB643E89F15FABC1549DBB3">
<enum>(V)</enum>
<text display-inline="yes-display-inline">that the beneficiary can, in the case that the beneficiary has not previously submitted to the PDP sponsor preferences for which prescribers and pharmacies the beneficiary would prefer the PDP sponsor select under subparagraph (D), submit such preferences to the PDP sponsor; and</text>
</subclause>
<subclause id="H741852ACFD5842E59815C53B291C8F64">
<enum>(VI)</enum>
<text display-inline="yes-display-inline">that includes clear instructions that explain how the beneficiary can contact the PDP sponsor.</text>
</subclause>
</clause>
<clause id="H265D39F966624592903C63C0E9E3F73E">
<enum>(iv)</enum>
<header>Timing of notices</header>
<subclause id="H1A01AAA669FD449D9945E1EC09BC522A">
<enum>(I)</enum>
<header>In general</header>
<text>Subject to subclause (II), a second notice described in clause (iii) shall be provided to the beneficiary on a date that is not less than 60 days after an initial notice described in clause (ii) is provided to the beneficiary.</text>
</subclause>
<subclause id="H8883E75AA3594ABA99367ECF2D6A4314">
<enum>(II)</enum>
<header>Exception</header>
<text display-inline="yes-display-inline">In the case that the PDP sponsor, in conjunction with the Secretary, determines that concerns identified through rulemaking by the Secretary regarding the health or safety of the beneficiary or regarding significant drug diversion activities require the PDP sponsor to provide a second notice described in clause (iii) to the beneficiary on a date that is earlier than the date described in subclause (I), the PDP sponsor may provide such second notice on such earlier date.</text>
</subclause>
</clause>
</subparagraph>
<subparagraph id="H60829EE8C7FB47DA92102C01D55C335F">
<enum>(C)</enum>
<header>At-risk beneficiary for prescription drug abuse</header>
<clause id="HB47A177019EC44639685DE825C8DCAF3">
<enum>(i)</enum>
<header>In general</header>
<text>For purposes of this paragraph, the term <quote>at-risk beneficiary for prescription drug abuse</quote> means a part D eligible individual who is not an exempted individual described in clause (ii) and—</text>
<subclause display-inline="no-display-inline" id="H6708F976FA2A41E3BD257A85C1DC991A">
<enum>(I)</enum>
<text display-inline="yes-display-inline">who is identified as such an at-risk beneficiary through the use of clinical guidelines developed by the Secretary in consultation with PDP sponsors and other stakeholders described in section 3141(f)(2)(A) of the 21st Century Cures Act; or</text>
</subclause>
<subclause id="HEC06AB64DCEE46B2BAC2DA8134DD3078">
<enum>(II)</enum>
<text display-inline="yes-display-inline">with respect to whom the PDP sponsor of a prescription drug plan, upon enrolling such individual in such plan, received notice from the Secretary that such individual was identified under this paragraph to be an at-risk beneficiary for prescription drug abuse under the prescription drug plan in which such individual was most recently previously enrolled and such identification has not been terminated under subparagraph (F).</text>
</subclause>
</clause>
<clause id="HB8E02ADD0F88414CBF7596F017D46035">
<enum>(ii)</enum>
<header>Exempted individual described</header>
<text>An exempted individual described in this clause is an individual who—</text>
<subclause id="H53B562F62F7B46F79978511460B8DFE5">
<enum>(I)</enum>
<text display-inline="yes-display-inline">receives hospice care under this title;</text>
</subclause>
<subclause id="H48E1293786204198A069721542DAADDA">
<enum>(II)</enum>
<text>is a resident of a long-term care facility, of an intermediate care facility for the mentally retarded, or of another facility for which frequently abused drugs are dispensed for residents through a contract with a single pharmacy; or</text>
</subclause>
<subclause commented="no" id="H118F7D12A2C34047863244DBDF6C78A4">
<enum>(III)</enum>
<text> the Secretary elects to treat as an exempted individual for purposes of clause (i).</text>
</subclause>
</clause>
</subparagraph>
<subparagraph id="H59ADA7F39D824BDC8ECC9D190C5B3750">
<enum>(D)</enum>
<header>Selection of prescribers and pharmacies</header>
<clause id="H32D1916E2119450E91890E4581299D71">
<enum>(i)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">With respect to each at-risk beneficiary for prescription drug abuse enrolled in a prescription drug plan offered by such sponsor, a PDP sponsor shall, based on the preferences submitted to the PDP sponsor by the beneficiary pursuant to clauses (ii)(IV) and (iii)(V) of subparagraph (B) (except as otherwise provided in this subparagraph), select—</text>
<subclause id="HBC713AE7F19C40FF9C3113EE5BA6C901">
<enum>(I)</enum>
<text display-inline="yes-display-inline">one or more individuals who are authorized to prescribe frequently abused drugs (referred to in this paragraph as <quote>prescribers</quote>) who may write prescriptions for such drugs for such beneficiary; and</text>
</subclause>
<subclause id="HB18EDDDF02574EC49086EBE613A14CDD">
<enum>(II)</enum>
<text>one or more pharmacies that may dispense such drugs to such beneficiary.</text>
</subclause>
</clause>
<clause id="HCCC044711D96481A8802396D76C05E93">
<enum>(ii)</enum>
<header>Reasonable access</header>
<text display-inline="yes-display-inline">In making the selections under this subparagraph—</text>
<subclause id="H0252D2C6141548DFA51BA3C76648587F">
<enum>(I)</enum>
<text> a PDP sponsor shall ensure that the beneficiary continues to have reasonable access to frequently abused drugs (as defined in subparagraph (G)), taking into account geographic location, beneficiary preference, impact on costsharing, and reasonable travel time; and</text>
</subclause>
<subclause id="HED669AF89DD94FD3A59ED5CCD248387E">
<enum>(II)</enum>
<text>a PDP sponsor shall ensure such access (including access to prescribers and pharmacies with respect to frequently abused drugs) in the case of individuals with multiple residences and in the case of natural disasters and similar emergency situations. </text>
</subclause>
</clause>
<clause id="H96DDE1E2A4BF45A1A57D7466D3E0E374">
<enum>(iii)</enum>
<header>Beneficiary preferences</header>
<text>If an at-risk beneficiary for prescription drug abuse submits preferences for which in-network prescribers and pharmacies the beneficiary would prefer the PDP sponsor select in response to a notice under subparagraph (B), the PDP sponsor shall—</text>
<subclause id="HE937BF234564460AAB424791AD155F04">
<enum>(I)</enum>
<text>review such preferences;</text>
</subclause>
<subclause id="H1E435DCCAEBB483DBEB27C7F9473160C">
<enum>(II)</enum>
<text>select or change the selection of prescribers and pharmacies for the beneficiary based on such preferences; and</text>
</subclause>
<subclause id="HCE1F49A0D2324F4698D1BC0D09079DFD">
<enum>(III)</enum>
<text>inform the beneficiary of such selection or change of selection.</text>
</subclause>
</clause>
<clause id="HF14122181A694178AF1266214B8A95AE">
<enum>(iv)</enum>
<header>Exception regarding beneficiary preferences</header>
<text display-inline="yes-display-inline">In the case that the PDP sponsor determines that a change to the selection of prescriber or pharmacy under clause (iii)(II) by the PDP sponsor is contributing or would contribute to prescription drug abuse or drug diversion by the beneficiary, the PDP sponsor may change the selection of prescriber or pharmacy for the beneficiary without regard to the preferences of the beneficiary described in clause (iii).</text>
</clause>
<clause id="HEC83E6E0111E4521958073E85C5388F5">
<enum>(v)</enum>
<header>Confirmation</header>
<text display-inline="yes-display-inline">Before selecting a prescriber (or prescribers) or pharmacy (or pharmacies) under this subparagraph, a PDP sponsor must request and receive confirmation from such a prescriber or pharmacy acknowledging and accepting that the beneficiary involved is in the drug management program for at-risk beneficiaries.</text>
</clause>
</subparagraph>
<subparagraph id="H3D4FE05760EB43DE9381CE0BA73C0E34">
<enum>(E)</enum>
<header>Terminations and appeals</header>
<text display-inline="yes-display-inline">The identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph, a coverage determination made under a drug management program for at-risk beneficiaries, and the selection of prescriber or pharmacy under subparagraph (D) with respect to such individual shall be subject to reconsideration and appeal under subsection (h) and the option of an automatic escalation to external review to the extent provided by the Secretary.</text>
</subparagraph>
<subparagraph id="H8927F8CA0E3E4308B08D0DC83D037955">
<enum>(F)</enum>
<header>Termination of identification</header>
<clause id="H956452DEBF594F4EB53452955BA6DB33">
<enum>(i)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall develop standards for the termination of identification of an individual as an at-risk beneficiary for prescription drug abuse under this paragraph. Under such standards such identification shall terminate as of the earlier of—</text>
<subclause id="HAD415C0A526F4688B8A9CEA9CD3EFAE4">
<enum>(I)</enum>
<text display-inline="yes-display-inline">the date the individual demonstrates that the individual is no longer likely, in the absence of the restrictions under this paragraph, to be an at-risk beneficiary for prescription drug abuse described in subparagraph (C)(i); and</text>
</subclause>
<subclause id="H5434E2A662EE450C9A991D92339B2D3E">
<enum>(II)</enum>
<text>the end of such maximum period of identification as the Secretary may specify.</text>
</subclause>
</clause>
<clause id="H4BCA08025D4D4BB78D0E5535934C83AD">
<enum>(ii)</enum>
<header>Rule of construction</header>
<text display-inline="yes-display-inline">Nothing in clause (i) shall be construed as preventing a plan from identifying an individual as an at-risk beneficiary for prescription drug abuse under subparagraph (C)(i) after such termination on the basis of additional information on drug use occurring after the date of notice of such termination.</text>
</clause>
</subparagraph>
<subparagraph id="HCEF28CFA26F44DB0AF515786BF74B4D3">
<enum>(G)</enum>
<header>Frequently abused drug</header>
<text display-inline="yes-display-inline">For purposes of this subsection, the term <term>frequently abused drug</term> means a drug that is a controlled substance that the Secretary determines to be frequently abused or diverted.</text>
</subparagraph>
<subparagraph id="H6A9FB3956120436396D45041D752681B">
<enum>(H)</enum>
<header>Data disclosure</header>
<text display-inline="yes-display-inline">In the case of an at-risk beneficiary for prescription drug abuse whose access to coverage for frequently abused drugs under a prescription drug plan has been limited by a PDP sponsor under this paragraph, such PDP sponsor shall disclose data, including any necessary individually identifiable health information, in a form and manner specified by the Secretary, about the decision to impose such limitations and the limitations imposed by the sponsor under this part to other PDP sponsors that request such data.</text>
</subparagraph>
<subparagraph id="H6276328D415441F68CB9CD5F4BDA06B3">
<enum>(I)</enum>
<header>Education</header>
<text display-inline="yes-display-inline">The Secretary shall provide education to enrollees in prescription drug plans of PDP sponsors and providers regarding the drug management program for at-risk beneficiaries described in this paragraph, including education—</text>
<clause id="H11B21EE1C98E40A681FD62642C3EF948">
<enum>(i)</enum>
<text>provided by medicare administrative contractors through the improper payment outreach and education program described in section 1874A(h); and</text>
</clause>
<clause id="H9BB8445A961C4BDC875E0D22B152B376">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">through current education efforts (such as State health insurance assistance programs described in subsection (a)(1)(A) of section 119 of the Medicare Improvements for Patients and Providers Act of 2008 (42 U.S.C. 1395b–3 note)) and materials directed toward such enrollees.</text>
</clause>
</subparagraph>
<subparagraph id="H3154E34CD85E47A1B23F1C741E0C5C7D">
<enum>(J)</enum>
<header>Application under MA–PD plans</header>
<text>Pursuant to section 1860D—21(c)(1), the provisions of this paragraph apply under part D to MA organizations offering MA–PD plans to MA eligible individuals in the same manner as such provisions apply under this part to a PDP sponsor offering a prescription drug plan to a part D eligible individual. </text>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H8062A841739244318B3A759DD20CD32A">
<enum>(2)</enum>
<header>Information for consumers</header>
<text display-inline="yes-display-inline">Section 1860D–4(a)(1)(B) of the Social Security Act (42 U.S.C. 1395w–104(a)(1)(B)) is amended by adding at the end the following:</text>
<quoted-block style="OLC" id="HD201B71C853748E1B003C7EC9C0795C3" display-inline="no-display-inline">
<clause id="H85008C5AA5374BF1BA7B588D0A0EA436">
<enum>(v)</enum>
<text display-inline="yes-display-inline">The drug management program for at-risk beneficiaries under subsection (c)(5).</text>
</clause>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="HBEA08D55D5764587801530C97E2EC9E7">
<enum>(b)</enum>
<header>Utilization management programs</header>
<text display-inline="yes-display-inline">Section 1860D–4(c) of the Social Security Act (42 U.S.C. 1395w–104(c)), as amended by subsection (a)(1), is further amended—</text>
<paragraph id="H7809CBCE66D141618E9AC788CF2E0045">
<enum>(1)</enum>
<text display-inline="yes-display-inline">in paragraph (1), by inserting after subparagraph (D) the following new subparagraph:</text>
<quoted-block style="OLC" id="HE09B6AB8E51A4A1083F979222F7E3D8A" display-inline="no-display-inline">
<subparagraph id="H9E9D7A73E14F462086604B3683F5875B">
<enum>(E)</enum>
<text display-inline="yes-display-inline">A utilization management tool to prevent drug abuse (as described in paragraph (6)(A)).</text>
</subparagraph>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H87AA671AC7244753B56E85483CC470E5">
<enum>(2)</enum>
<text display-inline="yes-display-inline">by adding at the end the following new paragraph:</text>
<quoted-block style="OLC" id="H7EBD76A65CB0455BB3ADBFE9225EFD94" display-inline="no-display-inline">
<paragraph id="HD6245AAF0DBB45739EB8D7BC342F85F8">
<enum>(6)</enum>
<header>Utilization management tool to prevent drug abuse</header>
<subparagraph id="H7A7FA149EE0C4413B8F02A84B5A6A156">
<enum>(A)</enum>
<header>In general</header>
<text>A tool described in this paragraph is any of the following:</text>
<clause id="H9412F29BBB74493B926D0ECBC465E6D5">
<enum>(i)</enum>
<text>A utilization tool designed to prevent the abuse of frequently abused drugs by individuals and to prevent the diversion of such drugs at pharmacies.</text>
</clause>
<clause id="HC0EFC0A083E54DF7A8104D5A96CD1330">
<enum>(ii)</enum>
<text>Retrospective utilization review to identify—</text>
<subclause id="H0A01DB3792CF43A38A94C45E1189C006">
<enum>(I)</enum>
<text display-inline="yes-display-inline">individuals that receive frequently abused drugs at a frequency or in amounts that are not clinically appropriate; and</text>
</subclause>
<subclause id="HE3FA71D2BD9C4DBAA41F85463047571C">
<enum>(II)</enum>
<text>providers of services or suppliers that may facilitate the abuse or diversion of frequently abused drugs by beneficiaries.</text>
</subclause>
</clause>
<clause id="HFADD57201DF74B0899519275F8509264">
<enum>(iii)</enum>
<text>Consultation with the contractor described in subparagraph (B) to verify if an individual enrolling in a prescription drug plan offered by a PDP sponsor has been previously identified by another PDP sponsor as an individual described in clause (ii)(I).</text>
</clause>
</subparagraph>
<subparagraph id="H9DC84E7BFFBC4163986D65041ED58B2B">
<enum>(B)</enum>
<header>Reporting</header>
<text>A PDP sponsor offering a prescription drug plan (and an MA organization offering an MA–PD plan) in a State shall submit to the Secretary and the Medicare drug integrity contractor with which the Secretary has entered into a contract under section 1893 with respect to such State a report, on a monthly basis, containing information on—</text>
<clause id="H84A8DDAAA468469BB91DD6DE1223D507">
<enum>(i)</enum>
<text>any provider of services or supplier described in subparagraph (A)(ii)(II) that is identified by such plan sponsor (or organization) during the 30-day period before such report is submitted; and</text>
</clause>
<clause id="H384EA3089BB8498BB6FD1D8077D64F73">
<enum>(ii)</enum>
<text>the name and prescription records of individuals described in paragraph (5)(C).</text>
</clause>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</subsection>
<subsection id="H877A0243ABE247E6A8024089CBA4D485">
<enum>(c)</enum>
<header>Expanding Activities of Medicare Drug Integrity Contractors (MEDICs)</header>
<paragraph id="H0954BD0A2BD64933AB2597CD3C0F530C">
<enum>(1)</enum>
<header>In general</header>
<text>Section 1893 of the Social Security Act (42 U.S.C. 1395ddd) is amended by adding at the end the following new subsection:</text>
<quoted-block display-inline="no-display-inline" id="H9706C4153DB4466EB9E2BA032F70D678" style="OLC">
<subsection id="H4BB00E7CEDA648AEB2036F792517EA25">
<enum>(j)</enum>
<header>Expanding Activities of Medicare Drug Integrity Contractors (MEDICs)</header>
<paragraph id="HCD8B88BCD1BE43188FDA98D08F14C36F">
<enum>(1)</enum>
<header>Access to information</header>
<text display-inline="yes-display-inline">Under contracts entered into under this section with Medicare drug integrity contractors (including any successor entity to a Medicare drug integrity contractor), the Secretary shall authorize such contractors to directly accept prescription and necessary medical records from entities such as pharmacies, prescription drug plans, MA–PD plans, and physicians with respect to an individual in order for such contractors to provide information relevant to the determination of whether such individual is an at-risk beneficiary for prescription drug abuse, as defined in section 1860D–4(c)(5)(C).</text>
</paragraph>
<paragraph commented="no" id="H90EB18D09EF84470BC585B4288443C6B">
<enum>(2)</enum>
<header>Requirement for acknowledgment of referrals</header>
<text display-inline="yes-display-inline">If a PDP sponsor or MA organization refers information to a contractor described in paragraph (1) in order for such contractor to assist in the determination described in such paragraph, the contractor shall—</text>
<subparagraph commented="no" id="HFDEE3629160441F0A02E5B23C405B0C1">
<enum>(A)</enum>
<text>acknowledge to the sponsor or organization receipt of the referral; and</text>
</subparagraph>
<subparagraph commented="no" id="HEB6F0DCDE549457D93DD3224CEBECC31">
<enum>(B)</enum>
<text>in the case that any PDP sponsor or MA organization contacts the contractor requesting to know the determination by the contractor of whether or not an individual has been determined to be an individual described such paragraph, shall inform such sponsor or organization of such determination on a date that is not later than 15 days after the date on which the sponsor or organization contacts the contractor.</text>
</subparagraph>
</paragraph>
<paragraph id="H6C256DDBF92640A4BBC5DEA71F5317B3">
<enum>(3)</enum>
<header>Making data available to other entities</header>
<subparagraph id="HA00F23B724124BD3AE81359AEFF8BE23">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">For purposes of carrying out this subsection, subject to subparagraph (B), the Secretary shall authorize MEDICs to respond to requests for information from PDP sponsors and MA organizations, State prescription drug monitoring programs, and other entities delegated by such sponsors or organizations using available programs and systems in the effort to prevent fraud, waste, and abuse.</text>
</subparagraph>
<subparagraph id="H12B5F141781B4D4497BD73EA8A056757">
<enum>(B)</enum>
<header>HIPAA compliant information only</header>
<text display-inline="yes-display-inline">Information may only be disclosed by a MEDIC under subparagraph (A) if the disclosure of such information is permitted under the Federal regulations (concerning the privacy of individually identifiable health information) promulgated under section 264(c) of the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. 1320d–2 note).</text>
</subparagraph>
</paragraph>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="H276882E609234AEEBC95CB5AFC70AB74">
<enum>(2)</enum>
<header>OIG study and report on effectiveness of MEDICs</header>
<subparagraph id="H38412AA32A574925BF540102BF4506FF">
<enum>(A)</enum>
<header>Study</header>
<text display-inline="yes-display-inline">The Inspector General of the Department of Health and Human Services shall conduct a study on the effectiveness of Medicare drug integrity contractors with which the Secretary of Health and Human Services has entered into a contract under section 1893 of the Social Security Act (42 U.S.C. 1395ddd) in identifying, combating, and preventing fraud under the Medicare program, including under the authority provided under section 1893(j) of the Social Security Act, added by paragraph (1).</text>
</subparagraph>
<subparagraph id="HB3C3B3CC6A614242B3602980C8662152">
<enum>(B)</enum>
<header>Report</header>
<text>Not later than 1 year after the date of the enactment of this Act, the Inspector General shall submit to Congress a report on the study conducted under subparagraph (A). Such report shall include such recommendations for improvements in the effectiveness of such contractors as the Inspector General determines appropriate. </text>
</subparagraph>
</paragraph>
</subsection>
<subsection commented="no" id="HD979BB76AF9A4D5886697F31B2334258">
<enum>(d)</enum>
<header>Treatment of certain complaints for purposes of quality or performance assessment</header>
<text display-inline="yes-display-inline">Section 1860D–42 of the Social Security Act (42 U.S.C. 1395w–152) is amended by adding at the end the following new subsection:</text>
<quoted-block style="OLC" id="H104DBFACE43945F08CB5803A2C9874C9" display-inline="no-display-inline">
<subsection id="HFA1EA50BCD864985ACD3914B25ECB401">
<enum>(d)</enum>
<header>Treatment of certain complaints for purposes of quality or performance assessment</header>
<text display-inline="yes-display-inline">In conducting a quality or performance assessment of a PDP sponsor, the Secretary shall develop or utilize existing screening methods for reviewing and considering complaints that are received from enrollees in a prescription drug plan offered by such PDP sponsor and that are complaints regarding the lack of access by the individual to prescription drugs due to a drug management program for at-risk beneficiaries.</text>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="H4C18ED10846247B9854B159897E3FED7">
<enum>(e)</enum>
<header>Sense of congress regarding use of technology tools To combat fraud</header>
<text display-inline="yes-display-inline">It is the sense of Congress that MA organizations and PDP sponsors should consider using e-prescribing and other health information technology tools to support combating fraud under MA–PD plans and prescription drug plans under parts C and D of the Medicare program.</text>
</subsection>
<subsection id="H4836065D25E640D2B3BB45FEC94E3B66">
<enum>(f)</enum>
<header>Effective date</header>
<paragraph id="H01B44BD23A0A4BDC9BC243179654ED8A">
<enum>(1)</enum>
<header>In general</header>
<text>The amendments made by this section shall apply to prescription drug plans (and MA–PD plans) for plan years beginning more than 1 year after the date of the enactment of this Act. </text>
</paragraph>
<paragraph id="H2C5D2872868B44D3BA9CFF6D3B76B71B">
<enum>(2)</enum>
<header>Stakeholder meetings prior to effective date</header>
<subparagraph id="HF85E4BAE21194E1F9873EE8B02669C4E">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Not later than January 1, 2016, the Secretary of Health and Human Services shall convene stakeholders, including individuals entitled to benefits under part A of title XVIII of the Social Security Act or enrolled under part B of such title of such Act, advocacy groups representing such individuals, physicians, pharmacists, and other clinicians, retail pharmacies, plan sponsors, entities delegated by plan sponsors, and biopharmaceutical manufacturers for input regarding the topics described in subparagraph (B).</text>
</subparagraph>
<subparagraph commented="no" id="HA7021B09294643BF909D40AC8330EC4E">
<enum>(B)</enum>
<header>Topics described</header>
<text display-inline="yes-display-inline">The topics described in this subparagraph are the topics of—</text>
<clause id="H34E623DCFB83477FA2BA446EC8B48336">
<enum>(i)</enum>
<text display-inline="yes-display-inline">the anticipated impact of drug management programs for at-risk beneficiaries under paragraph (5) of section 1860D–4(c) of the Social Security Act (42 U.S.C. 1395w–104(c)) on cost-sharing and ensuring accessibility to prescription drugs for enrollees in prescription drug plans of PDP sponsors, and enrollees in MA–PD plans, who are at-risk beneficiaries for prescription drug abuse (as defined in subparagraph (C) of such paragraph);</text>
</clause>
<clause id="HE6A45B733C104AFD94FF7AA43BFF863D">
<enum>(ii)</enum>
<text>the use of an expedited appeals process under which such an enrollee may appeal an identification of such enrollee as an at-risk beneficiary for prescription drug abuse under such paragraph (similar to the processes established under the Medicare Advantage program under part C of title XVIII of the Social Security Act that allow an automatic escalation to external review of claims submitted under such part);</text>
</clause>
<clause id="H397F21736CF442A7AC46BA50156C02F0">
<enum>(iii)</enum>
<text>the types of enrollees that should be treated as exempted individuals, as described in subparagraph (C)(ii) of such paragraph;</text>
</clause>
<clause id="H40B1AD1311364831BE49F6022D47F8C5">
<enum>(iv)</enum>
<text display-inline="yes-display-inline">the manner in which terms and definitions in such paragraph should be applied, such as the use of clinical appropriateness in determining whether an enrollee is an at-risk beneficiary for prescription drug abuse as defined in subparagraph (C) of such paragraph;</text>
</clause>
<clause id="HDA0733EE7EA04B3E980AE3FBB970BB87">
<enum>(v)</enum>
<text>the information to be included in the notices described in subparagraph (B) of such paragraph and the standardization of such notices; and</text>
</clause>
<clause id="H209E51B556FC4B3DA70AB17EC8C2D3DB">
<enum>(vi)</enum>
<text display-inline="yes-display-inline">with respect to a PDP sponsor (or Medicare Advantage organization) that establishes a drug management program for at-risk beneficiaries under such paragraph, the responsibilities of such PDP sponsor (or organization) with respect to the implementation of such program.</text>
</clause>
</subparagraph>
</paragraph>
</subsection>
<subsection id="H69A5776D6560444EB89E00CD942AEF7A">
<enum>(g)</enum>
<header>Rulemaking</header>
<text display-inline="yes-display-inline">The Secretary of Health and Human Services shall promulgate regulations based on the input gathered pursuant to subsection (f)(2)(A). </text>
</subsection>
</section>
</subtitle>
<enum>IV</enum>
<header>Medicaid, Medicare, and Other Reforms </header>
<subtitle id="H00F2353427184E9A9E528FDB554C6DE3">
<enum>A</enum>
<header>Medicaid and Medicare Reforms</header>
<section id="H60E3FF0FD7924E31AC4859B31CB73EA2">
<enum>4001.</enum>
<header>Limiting Federal Medicaid reimbursement to States for durable medical equipment (DME) to Medicare payment rates</header>
<subsection id="H74B7641B3BBF48DD8C36DEE7AEDFB1C8">
<enum>(a)</enum>
<header>Medicaid reimbursement</header>
<paragraph id="H8E9DCC1F21CB4A40978CE5823CEE6A60">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 1903(i) of the Social Security Act (42 U.S.C. 1396b(i)) is amended—</text>
<subparagraph id="H5103A59A6A864B6D8B14E6A3DD846335">
<enum>(A)</enum>
<text>in paragraph (25), by striking <quote>or</quote> at the end;</text>
</subparagraph>
<subparagraph id="HE4EE673C26824C8E8A36D6E440EE7F5B">
<enum>(B)</enum>
<text>in paragraph (26), by striking the period at the end and inserting <quote>; or</quote>; and</text>
</subparagraph>
<subparagraph id="H78F4E685AA2F45788193F36998D6528D">
<enum>(C)</enum>
<text>by inserting after paragraph (26) the following new paragraph:</text>
<quoted-block id="H2580EAE1057B4CB8A33088AC2BF5596E" style="OLC">
<paragraph id="HFEF9427C4055464ABB9DE8E944CFDB7B">
<enum>(27)</enum>
<text display-inline="yes-display-inline">with respect to any amounts expended by the State on the basis of a fee schedule for items described in section 1861(n), as determined in the aggregate with respect to each class of such items as defined by the Secretary, in excess of the aggregate amount, if any, that would be paid for such items within such class on a fee-for-service basis under the program under part B of title XVIII, including, as applicable, under a competitive acquisition program under section 1847 in an area of the State.</text>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subparagraph>
</paragraph>
<paragraph id="H78B8D0C34ECE4A1DBE9A94432AFAF7E6">
<enum>(2)</enum>
<header>Effective date</header>
<text display-inline="yes-display-inline">The amendments made by this subsection shall be effective with respect to payments for items furnished on or after January 1, 2020.</text>
</paragraph>
</subsection>
<subsection id="H0453C200AEDC412FB74D87635F813AD9">
<enum>(b)</enum>
<header>Medicare ombudsman</header>
<text>Section 1808(c) of the Social Security Act (42 U.S.C. 1395b(c)), as amended by section 3101, is further amended by adding at the end the following new paragraph:</text>
<quoted-block style="OLC" id="HE19D9FC8A93645AE9E8D3EB5364C0548" display-inline="no-display-inline">
<paragraph id="H78B8146E70134D66BE6AC305B698154B">
<enum>(5)</enum>
<header>Monitoring DME reimbursement under Medicaid</header>
<text display-inline="yes-display-inline">The ombudsmen under each of paragraphs (1) and (4) shall evaluate the impact of the competitive acquisition program under section 1847, including as applied under section 1903(i)(27), on beneficiary health status and health outcomes. </text>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
</section>
<section id="HF5C0BB61C90B4A47BBBEFCA11ADFDABE">
<enum>4002.</enum>
<header>Excluding authorized generics from calculation of average manufacturer price</header>
<subsection id="H6E01C65EBF094DC5918A9676E2C2A331">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Subparagraph (C) of section 1927(k)(1) of the Social Security Act (42 U.S.C. 1396r–8(k)(1)) is amended—</text>
<paragraph id="HCB4108026C5E4F1495B4A46130A3C68C">
<enum>(1)</enum>
<text>in the subparagraph heading, by striking <quote><header-in-text level="subparagraph" style="OLC">Inclusion</header-in-text></quote> and inserting <quote><header-in-text level="subparagraph" style="OLC">Exclusion</header-in-text></quote>;</text>
</paragraph>
<paragraph id="H4EC6F5503D5A4EE39BB35634E1DB53E6">
<enum>(2)</enum>
<text>by striking <quote>a new drug application</quote> and inserting <quote>the manufacturer’s new drug application</quote>; and</text>
</paragraph>
<paragraph id="HFE486683812D4F1E9610E4E6DA924249">
<enum>(3)</enum>
<text>by striking <quote>inclusive</quote> and inserting <quote>exclusive</quote>.</text>
</paragraph>
</subsection>
<subsection id="HA0361A66EBEA478ABE9BEE184E3B6CDA">
<enum>(b)</enum>
<header>Effective date</header>
<text>The amendments made by this section take effect on October 1, 2015.</text>
</subsection>
</section>
<section id="HF31E09781B4744DDA3B150AD39B4C256" section-type="subsequent-section">
<enum>4003.</enum>
<header>Medicare payment incentive for the transition from traditional x-ray imaging to digital radiography and other Medicare imaging payment provision</header>
<subsection id="H766F8A0CA7984458A20F5B26070CD72F">
<enum>(a)</enum>
<header>Physician fee schedule</header>
<paragraph id="HBE8B0D1B87E34B4989B629D895347972">
<enum>(1)</enum>
<header>Payment incentive for transition</header>
<subparagraph id="H522C649C7ECD4A158944A1CCF6683CD9">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 1848(b) of the Social Security Act (42 U.S.C. 1395w–4(b)) is amended by adding at the end the following new paragraph:</text>
<quoted-block style="OLC" id="HCFCA275C1E1C438694F7EE66FF3198BC" display-inline="no-display-inline">
<paragraph id="H2660B8BD61524AF4A933559892086E15">
<enum>(9)</enum>
<header>Special rule to incentivize transition from traditional x-ray imaging to digital radiography</header>
<subparagraph id="H62E6B56C0E484290A4837F3CD2648BF2">
<enum>(A)</enum>
<header>Limitation on payment for film x-ray imaging services</header>
<text display-inline="yes-display-inline">In the case of an imaging service (including the imaging portion of a service) that is an X-ray taken using film and that is furnished during 2017 or a subsequent year, the payment amount for the technical component (including the technical component portion of a global service) of such service that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this section) for such year shall be reduced by 20 percent.</text>
</subparagraph>
<subparagraph id="H9D1EF0471037446AB2E02F86CA40FF3E">
<enum>(B)</enum>
<header>Phased-in limitation on payment for computed radiography imaging services</header>
<text>In the case of an imaging service (including the imaging portion of a service) that is an X-ray taken using computed radiography technology—</text>
<clause id="HF8FBC1F7A1D644888215C08276EC8FC7">
<enum>(i)</enum>
<text display-inline="yes-display-inline">in the case of such a service furnished during 2018, 2019, 2020, 2021, or 2022, the payment amount for the technical component (including the technical component portion of a global service) of such service that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this section) for such year shall be reduced by 7 percent; and</text>
</clause>
<clause id="H0D2DDB406ACD47679DEEC94F104E2DC4">
<enum>(ii)</enum>
<text display-inline="yes-display-inline">in the case of such a service furnished during 2023 or a subsequent year, the payment amount for the technical component (including the technical component portion of a global service) of such service that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this section) for such year shall be reduced by 10 percent.</text>
</clause>
</subparagraph>
<subparagraph id="HC0F57DAA5A2944FC953476BB33BB2CE3">
<enum>(C)</enum>
<header>Computed radiography technology defined</header>
<text>For purposes of this paragraph, the term <quote>computed radiography technology</quote> means cassette-based imaging which utilizes an imaging plate to create the image involved.</text>
</subparagraph>
<subparagraph id="HA5799CE1B2574290AD6047AA57410595">
<enum>(D)</enum>
<header>Implementation</header>
<text>In order to implement this paragraph, the Secretary shall adopt appropriate mechanisms which may include use of modifiers. </text>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subparagraph>
<subparagraph id="H4269E85A94AC4B75B0BF06249C09CDC2">
<enum>(B)</enum>
<header>Exemption from budget neutrality</header>
<text>Section 1848(c)(2)(B)(v) of the Social Security Act (42 U.S.C. 1395w–4(c)(2)(B)(v)) is amended by adding at the end the following new subclause:</text>
<quoted-block style="OLC" id="HB0A78EE5056049EEBFA02C65A5BC729F" display-inline="no-display-inline">
<subclause id="H354375322AF54D908F27DCC4FE7C992F">
<enum>(X)</enum>
<header>Reduced expenditures attributable to incentives to transition to digital radiography</header>
<text display-inline="yes-display-inline">Effective for fee schedules established beginning with 2017, reduced expenditures attributable to subparagraph (A) of subsection (b)(9) and effective for fee schedules established beginning with 2018, reduced expenditures attributable to subparagraph (B) of such subsection.</text>
</subclause>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subparagraph>
</paragraph>
<paragraph id="H7471F602E63E45808371EDCC6DAEEE6F">
<enum>(2)</enum>
<header>Elimination of application of multiple procedure payment reduction</header>
<subparagraph id="HB416C244D4B94542965E48FC43AD2E7E">
<enum>(A)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 1848(b)(4) of the Social Security Act (42 U.S.C. 1395w–4(b)(4)) is amended by adding at the end the following new subparagraph: </text>
<quoted-block style="OLC" id="H59D23BE9422D49209C61EA345B36D9CD" display-inline="no-display-inline">
<subparagraph id="H3437898B588F43DF825F25C846609258">
<enum>(E)</enum>
<header>Elimination of application of multiple procedure payment reduction</header>
<clause id="H8A4E945F1B8C4C2F8C58BC657C5D8A88">
<enum>(i)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">For services furnished on or after January 1, 2017, the Secretary shall not apply a multiple procedure payment reduction to the professional component of imaging services unless the Secretary has published as part of a Medicare Physician Fee Schedule Proposed Rule the empirical analysis described in clause (ii) with tables made available on the website of the Centers for Medicare & Medicaid Services. </text>
</clause>
<clause id="H8FC3C19247124FC7930BB7F7DB711B21">
<enum>(ii)</enum>
<header>Empirical analysis described</header>
<text>The empirical analysis described in this clause is an analysis of the Resource-Based Relative Value Scale Data Manager information or other information that is used to determine what, if any, efficiencies exist within the professional component of imaging services when two or more studies are furnished to the same individual on the same day. Such empirical analysis shall include—</text>
<subclause id="H9696BE9E4FF24F05B3E9C97EED4DD05D">
<enum>(I)</enum>
<text>information detailing which physician work activities overlap and the reductions applicable to such overlap;</text>
</subclause>
<subclause id="H6E7571829DCB4EB5B07B002AE07BF41B">
<enum>(II)</enum>
<text>a discussion of the clinical aspects that informed the assignment of the reduction percentages described in subclause (I);</text>
</subclause>
<subclause id="H407383A5699741C8BA06A75D8EA396DC">
<enum>(III)</enum>
<text>to the extent that such reductions are used for proposed payment reductions, an explanation of how the percentage reductions for pre-service, intra-service, and post-service work were determined and calculated;</text>
</subclause>
<subclause id="HAEEDEC52C68646E3A6E9AB336F9F206C">
<enum>(IV)</enum>
<text>other data used to determine a reduction; and</text>
</subclause>
<subclause id="HD038414A21AA4FADAA6577AA5274740D">
<enum>(V)</enum>
<text>a demonstration that the Secretary has consulted with practicing radiologists to gain knowledge of how radiologists interpret studies of multiple body parts on the same individual on the same day.</text>
</subclause>
</clause>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subparagraph>
<subparagraph id="H22A98646E0A843D2BE34104C0738BB63">
<enum>(B)</enum>
<header>Conforming amendment</header>
<text display-inline="yes-display-inline">Section 220(i) of the Protecting Access to Medicare Act of 2014 (42 U.S.C. 1395w–4 note) is repealed.</text>
</subparagraph>
</paragraph>
</subsection>
<subsection id="HD57048944D1E423EBC2F1C387A90D821">
<enum>(b)</enum>
<header>Payment incentive for transition under hospital outpatient prospective payment system</header>
<text>Section 1833(t)(16) of the Social Security Act (42 U.S.C. 1395(t)(16)) is amended by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" id="HF9F8580F115743919A4F504FDCC1EE42" display-inline="no-display-inline">
<subparagraph id="HF97D7D8C4D5E4B859AF97685BC698E8C">
<enum>(F)</enum>
<header>Payment incentive for the transition from traditional x-ray imaging to digital radiography</header>
<text display-inline="yes-display-inline">Notwithstanding the previous provisions of this subsection:</text>
<clause id="H62E65A07E1F540E39387452F96217580">
<enum>(i)</enum>
<header>Limitation on payment for film x-ray imaging services</header>
<text display-inline="yes-display-inline">In the case of an imaging service that is an X-ray taken using film and that is furnished during 2017 or a subsequent year, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 20 percent.</text>
</clause>
<clause id="HAEC589AF7D77427086B3DCDFCBCC9421">
<enum>(ii)</enum>
<header>Phased-in limitation on payment for computed radiography imaging services</header>
<text>In the case of an imaging service that is an X-ray taken using computed radiography technology (as defined in section 1848(b)(9)(C))—</text>
<subclause id="H8EA044E8AEBD40379B18B59D03222D63">
<enum>(I)</enum>
<text display-inline="yes-display-inline">in the case of such a service furnished during 2018, 2019, 2020, 2021, or 2022, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 7 percent; and</text>
</subclause>
<subclause id="H2AAECB04396344A6B0A712F4FD01C11A">
<enum>(II)</enum>
<text display-inline="yes-display-inline">in the case of such a service furnished during 2023 or a subsequent year, the payment amount for such service (including the X-ray component of a packaged service) that would otherwise be determined under this section (without application of this paragraph and before application of any other adjustment under this subsection) for such year shall be reduced by 10 percent.</text>
</subclause>
</clause>
<clause id="H6633FBC476A54D3DA482A30B9E7BD49D">
<enum>(iii)</enum>
<header>Application without regard to budget neutrality</header>
<text>The reductions made under this paragraph—</text>
<subclause id="H5D101693C28E4CC1B64DBB99D6E881B4">
<enum>(I)</enum>
<text>shall not be considered an adjustment under paragraph (2)(E); and</text>
</subclause>
<subclause id="H55AD016289414A75AC6FFB3E6D49CA52">
<enum>(II)</enum>
<text>shall not be implemented in a budget neutral manner.</text>
</subclause>
</clause>
<clause id="HAB6E9DE589614558BFEFB47257552774">
<enum>(iv)</enum>
<header>Implementation</header>
<text display-inline="yes-display-inline">In order to implement this subparagraph, the Secretary shall adopt appropriate mechanisms which may include use of modifiers.</text>
</clause>
</subparagraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
</section>
<section id="HCF4B01696C8147B9803BE1398DCF55FF">
<enum>4004.</enum>
<header>Treatment of infusion drugs furnished through durable medical equipment</header>
<text display-inline="no-display-inline">Section 1842(o)(1) of the Social Security Act (42 U.S.C. 1395u(o)(1)) is amended—</text>
<paragraph id="HC247971B2F874040BF54AD1BF42E5306">
<enum>(1)</enum>
<text display-inline="yes-display-inline">in subparagraph (C), by inserting <quote>(and including a drug or biological described in subparagraph (D)(i) furnished on or after January 1, 2017)</quote> after <quote>2005</quote>; and</text>
</paragraph>
<paragraph id="HF5360B6D7CD34FAF8B705E0B82C29FDA">
<enum>(2)</enum>
<text>in subparagraph (D)—</text>
<subparagraph id="HD4F565AE509C4CDB9CE1734F5B967882">
<enum>(A)</enum>
<text>by striking <quote>infusion drugs</quote> and inserting <quote>infusion drugs or biologicals</quote> each place it appears; and</text>
</subparagraph>
<subparagraph id="H64AD6C612C514EE18B9E2AE3ADC85417">
<enum>(B)</enum>
<text>in clause (i)—</text>
<clause id="H23C79164E5444F5AB9647E41BCA8D1D7">
<enum>(i)</enum>
<text>by striking <quote>2004</quote> and inserting <quote>2004, and before January 1, 2017</quote>; and</text>
</clause>
<clause id="H7CA0E63E6FA44C70BABA7DFFEDBF7735">
<enum>(ii)</enum>
<text>by striking <quote>for such drug</quote>. </text>
</clause>
</subparagraph>
</paragraph>
</section>
<section id="HDD75264A8A78460C81B935AD2F484504" section-type="subsequent-section">
<enum>4005.</enum>
<header>Extension and expansion of prior authorization for power mobility devices (PMDs) and accessories and prior authorization audit limitations</header>
<text display-inline="no-display-inline">Section 1834(a) of the Social Security Act (42 U.S.C. 1395m(a)) is amended—</text>
<paragraph id="H0056569B6DFC4BD2827E269F8EC109FD">
<enum>(1)</enum>
<text>in paragraph (15), by adding at the end the following new subparagraph:</text>
<quoted-block style="OLC" id="H29515B4C6E4044F29CA2D34B199093DC" display-inline="no-display-inline">
<subparagraph id="HAD062B2450FA4E5F9783BEAC3870E4C9">
<enum>(D)</enum>
<header>Limitation on audits after advance determination</header>
<text display-inline="yes-display-inline">A claim for an item that has received a provisional affirmation under an advance determination under this paragraph or a prior authorization under paragraph (23) shall not be subject to review under section 1893(h) but may be subject to audits for potential fraud, inappropriate utilization, changes in billing patterns, or information that could not have been considered during the advance determination (such as proof of item delivery).</text>
</subparagraph>
<after-quoted-block>; and</after-quoted-block>
</quoted-block>
</paragraph>
<paragraph id="HAA38FFB4C5BE48A3BE215719EC838077">
<enum>(2)</enum>
<text>by adding at the end the following new paragraph:</text>
<quoted-block style="OLC" id="H04D54AB6831647D2A02E17B6C16A14E3" display-inline="no-display-inline">
<paragraph id="H8AA708C1AC644459B1E62DFA5B786216">
<enum>(23)</enum>
<header>Prior authorization for power mobility devices (PMDs) and accessories</header>
<text display-inline="yes-display-inline">Not later than 90 days after the date of the enactment of this paragraph, the Secretary shall, using funds provided under paragraph (2) of section 402(a) of the Social Security Amendments of 1967 and other funds available to the Secretary—</text>
<subparagraph id="H0AF10412CA71464283581057B4E15C56">
<enum>(A)</enum>
<text display-inline="yes-display-inline">extend at least through August 31, 2018, the PMD Prior Authorization Demonstration (being conducted under paragraph (1)(J) of such section); </text>
</subparagraph>
<subparagraph id="H1F607AE7A0484268A216893EAC053DD9">
<enum>(B)</enum>
<text>begin to expand, as appropriate, such demonstration to include additional power mobility devices and accessories as part of initial claims for payment under this part for such devices; and </text>
</subparagraph>
<subparagraph id="H4130168C783549D89DE2BCC620773D38">
<enum>(C)</enum>
<text>begin to expand such demonstration to such additional States or geographic areas as may be appropriate.</text>
</subparagraph>
</paragraph>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</paragraph>
</section>
<section id="H922992E4032C4301A14B441E1F478107" section-type="subsequent-section">
<enum>4006.</enum>
<header>Civil monetary penalties for violations related to grants, contracts, and other agreements</header>
<subsection id="H29A2019B67AF4CE792758148124F631C">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Section 1128A of the Social Security Act (42 U.S.C. 1320a–7a) is amended by adding at the end the following new subsection:</text>
<quoted-block style="OLC" id="HA71BB73C8B754972AF8F26E93FD8C846" display-inline="no-display-inline">
<subsection id="H0B7879C31A694A45BC41B936F2BEC4CE">
<enum>(o)</enum>
<text display-inline="yes-display-inline">Any person (including an organization, agency, or other entity, but excluding a program beneficiary, as defined in subsection (r)(4)) that, with respect to a grant, contract, or other agreement for which the Secretary of Health and Human Services provides funding—</text>
<paragraph id="H24B125A6F2324584850277AE5F02CEE5">
<enum>(1)</enum>
<text display-inline="yes-display-inline">knowingly presents or causes to be presented a specified claim (as defined in subsection (r)(6)) under such grant, contract, or other agreement that the person knows or should know is false or fraudulent; </text>
</paragraph>
<paragraph id="H50FFDD2D41B34E4083BF8FFFBF1EA7A6">
<enum>(2)</enum>
<text display-inline="yes-display-inline">knowingly makes, uses, or causes to be made or used any false statement, omission, or misrepresentation of a material fact in any application, proposal, bid, progress report, or other document that is required to be submitted in order to directly or indirectly receive or retain funds provided in whole or in part by such Secretary pursuant to such grant, contract, or other agreement; </text>
</paragraph>
<paragraph id="HE7C00C9602FA4E099FD72F10315C58B2">
<enum>(3)</enum>
<text display-inline="yes-display-inline">knowingly makes, uses, or causes to be made or used, a false record or statement material to a false or fraudulent specified claim under such grant, contract, or other agreement; </text>
</paragraph>
<paragraph id="HE345281F46E24AE9BA46EC7EFCB44A89">
<enum>(4)</enum>
<text display-inline="yes-display-inline">knowingly makes, uses, or causes to be made or used, a false record or statement material to an obligation to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement, or knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay or transmit funds or property to such Secretary with respect to such grant, contract, or other agreement; or </text>
</paragraph>
<paragraph id="H39815DC0343B4A6387352BFB06009AAF">
<enum>(5)</enum>
<text display-inline="yes-display-inline">fails to grant timely access, upon reasonable request (as defined by such Secretary in regulations), to the Inspector General of the Department, for the purpose of audits, investigations, evaluations, or other statutory functions of such Inspector General in matters involving such grants, contracts, or other agreements;</text>
</paragraph>
<continuation-text continuation-text-level="subsection">shall be subject, in addition to any other penalties that may be prescribed by law, to a civil money penalty in cases under paragraph (1), of not more than $10,000 for each specified claim; in cases under paragraph (2), not more than $50,000 for each false statement, omission, or misrepresentation of a material fact; in cases under paragraph (3), not more than $50,000 for each false record or statement; in cases under paragraph (4), not more than $50,000 for each false record or statement or $10,000 for each day that the person knowingly conceals or knowingly and improperly avoids or decreases an obligation to pay; or in cases under paragraph (5), not more than $15,000 for each day of the failure described in such paragraph. In addition, in cases under paragraphs (1) and (3), such a person shall be subject to an assessment of not more than 3 times the amount claimed in the specified claim described in such paragraph in lieu of damages sustained by the United States or a specified State agency because of such specified claim, and in cases under paragraphs (2) and (4), such a person shall be subject to an assessment of not more than 3 times the total amount of the funds described in paragraph (2) or (4), respectively (or, in the case of an obligation to transmit property to the Secretary Health and Human Services described in paragraph (4), of the value of the property described in such paragraph) in lieu of damages sustained by the United States or a specified State agency because of such case. In addition, the Secretary of Health and Human Services may make a determination in the same proceeding to exclude the person from participation in the Federal health care programs (as defined in section 1128B(f)(1)) and to direct the appropriate State agency to exclude the person from participation in any State health care program.</continuation-text>
</subsection>
<subsection id="H35DE5D1605924F50BA4D1B9599BB7BC3">
<enum>(p)</enum>
<text display-inline="yes-display-inline">The provisions of subsections (c), (d), and (g) shall apply to a civil money penalty or assessment under subsection (o) in the same manner as such provisions apply to a penalty, assessment, or proceeding under subsection (a).</text>
</subsection>
<subsection id="HAF945DB8B2544C4ABC8D6DF31590BE82">
<enum>(q)</enum>
<text display-inline="yes-display-inline">With respect to a penalty or assessment under subsection (o), the Inspector General of the Department is authorized to receive, and to retain for current use, such amounts of such penalty or assessment as are necessary to provide reimbursement for the costs of conducting investigations and audits with respect to such subsection and for monitoring compliance plans with respect to such subsection when such penalty or assessment is ordered by a court, voluntarily agreed to by the payor, or otherwise. Funds received by such Inspector General as reimbursement under the preceding sentence shall be deposited to the credit of the appropriations from which initially paid, or to appropriations for similar purposes currently available at the time of deposit, and shall remain available for obligation for 1 year from the date of the deposit of such funds.</text>
</subsection>
<subsection id="H9C121F73F67B4C899B755FD6F4930C27">
<enum>(r)</enum>
<text>For purposes of this subsection and subsections (o), (p), and (q):</text>
<paragraph id="HDCC0BA827EF443F0A0AB4833EF3AACA9">
<enum>(1)</enum>
<text>The term <quote>Department</quote> means the Department of Health and Human Services. </text>
</paragraph>
<paragraph id="HAD5CED61368447489B0A6D44F47858F9" commented="no">
<enum>(2)</enum>
<text display-inline="yes-display-inline">The term <quote>material</quote> means having a natural tendency to influence, or be capable of influencing, the payment or receipt of money or property. </text>
</paragraph>
<paragraph id="H90408077C91041169DF95CBD221C9070">
<enum>(3)</enum>
<text display-inline="yes-display-inline">The term <quote>other agreement</quote> includes a cooperative agreement, scholarship, fellowship, loan, subsidy, payment for a specified use, donation agreement, award, or sub-award (regardless of whether one or more of the persons entering into the agreement is a contractor or sub-contractor).</text>
</paragraph>
<paragraph id="H96B4ACC6D2314203AACCC213E25F5832" commented="no">
<enum>(4)</enum>
<text display-inline="yes-display-inline">The term <quote>program beneficiary</quote> means, in the case of a grant, contract, or other agreement designed to accomplish the objective of awarding or otherwise furnishing benefits or assistance to individuals and for which the Secretary of Health and Human Services provides funding, an individual who applies for, or who receives, such benefits or assistance from such grant, contract, or other agreement. Such term does not include, with respect to such grant, contract, or other agreement, an officer, employee, or agent of a person or entity that receives such grant or that enters into such contract or other agreement.</text>
</paragraph>
<paragraph id="H6A2C82A66EB140AD99F73FE7253FAA4B">
<enum>(5)</enum>
<text>The term <quote>recipient</quote> includes a sub-recipient or subcontractor. </text>
</paragraph>
<paragraph id="HF87C991354ED47FABEFCCF4AE656394B">
<enum>(6)</enum>
<text display-inline="yes-display-inline">The term <quote>specified claim</quote> means any application, request, or demand under a grant, contract, or other agreement for money or property, whether or not the United States or a specified State agency has title to the money or property, that is not a claim (as defined in subsection (i)(2)) and that—</text>
<subparagraph id="H536063C8C69C4B03A9AE781A8B13294A">
<enum>(A)</enum>
<text display-inline="yes-display-inline">is presented or caused to be presented to an officer, employee, or agent of the Department or agency thereof, or of any specified State agency; or </text>
</subparagraph>
<subparagraph id="H48D0A5BD8CFE4002AA9F945EACF470EB">
<enum>(B)</enum>
<text>is made to a contractor, grantee, or any other recipient if the money or property is to be spent or used on the Department’s behalf or to advance a Department program or interest, and if the Department—</text>
<clause id="H3BBF4B88B05E4DA3919C2D17E46A1F17">
<enum>(i)</enum>
<text>provides or has provided any portion of the money or property requested or demanded; or</text>
</clause>
<clause id="H990C35D76E38458F9566972EB30C9BBF">
<enum>(ii)</enum>
<text>will reimburse such contractor, grantee or other recipient for any portion of the money or property which is requested or demanded.</text>
</clause>
</subparagraph>
</paragraph>
<paragraph id="H5EC8AA4559F6439EBDBDC1E821DF5E79">
<enum>(7)</enum>
<text display-inline="yes-display-inline">The term <quote>specified State agency</quote> means an agency of a State government established or designated to administer or supervise the administration of a grant, contract, or other agreement funded in whole or in part by the Secretary of Health and Human Services.</text>
</paragraph>
</subsection>
<subsection id="HCCE2D8CC7C5040E9A043160CFEA078D7">
<enum>(s)</enum>
<text>For purposes of subsection (o), the term <quote>obligation</quote> means an established duty, whether or not fixed, arising from an express or implied contractual, grantor-grantee, or licensor-licensee relationship, for a fee-based or similar relationship, from statute or regulation, or from the retention of any overpayment. </text>
</subsection>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="H292D35BCE6EA4BAB8DC3DFF81A995F56">
<enum>(b)</enum>
<header>Conforming amendments</header>
<text>Section 1128A of the Social Security Act (42 U.S.C. 1320a–7a) is amended—</text>
<paragraph id="H8E52114AC27B4BEE9EDC70B44073B6E9">
<enum>(1)</enum>
<text display-inline="yes-display-inline">in subsection (d)—</text>
<subparagraph id="H663B15A3E11E4FE49382B0EF0E76CA16">
<enum>(A)</enum>
<text>in paragraph (1), by inserting <quote>or specified claims</quote> after <quote>claims</quote>;</text>
</subparagraph>
<subparagraph id="H1F98A22FC2BE4C28B79774D621A55172" commented="no">
<enum>(B)</enum>
<text>in paragraph (2), by inserting <quote>or specified claims</quote> after <quote>claims</quote>;</text>
</subparagraph>
</paragraph>
<paragraph id="HBFC29ECEFB3249BEBDDB9AE00FE819C5">
<enum>(2)</enum>
<text display-inline="yes-display-inline">in subsection (e), by inserting <quote>or specified claim</quote> after <quote>claim</quote>; and</text>
</paragraph>
<paragraph id="H57DB921FA583417F89B3462378A6A153">
<enum>(3)</enum>
<text>in subsection (f)—</text>
<subparagraph id="H47D6C3B210EF47F0865961C38B40B85B">
<enum>(A)</enum>
<text>by inserting <quote>or specified claim (as defined in subsection (r)(6))</quote> after <quote>district where the claim</quote>;</text>
</subparagraph>
<subparagraph id="H44D58A0CA91749AFA703BC39837057FF">
<enum>(B)</enum>
<text>by inserting <quote>(or, with respect to a person described in subsection (o), the person)</quote> after <quote>claimant</quote>; </text>
</subparagraph>
<subparagraph id="HCDF0AC907FFB41BA8A2442E13AC51B62">
<enum>(C)</enum>
<text>by inserting <quote>that are not received by the Inspector General of the Department of Health and Human Services under subsection (q) as reimbursement</quote> after <quote>amounts recovered</quote>; and </text>
</subparagraph>
<subparagraph id="HA35EFF88C89F4028BB102EC924BAB5E1">
<enum>(D)</enum>
<text>by inserting <quote>(or, in the case of a penalty or assessment under subsection (o), by a specified State agency (as defined in subsection (r)(7))</quote> after <quote>or a State agency</quote>.</text>
</subparagraph>
</paragraph>
</subsection>
</section>
</subtitle>
<subtitle id="HB9A36ADAC43A432F9FEDBABB6DC3FE4E">
<enum>B</enum>
<header>Other Reforms</header>
<section id="H83642E38E6214F3FA04AC663D0FCAA4B" section-type="subsequent-section">
<enum>4041.</enum>
<header>SPR drawdown</header>
<subsection id="H471C0A472ADF404BBC4E6F2286EB025D">
<enum>(a)</enum>
<header>Drawdown and sale</header>
<text display-inline="yes-display-inline">Notwithstanding section 161 of the Energy Policy and Conservation Act (42 U.S.C. 6241), except as provided in subsection (b) the Secretary of Energy shall draw down and sell—</text>
<paragraph id="H90336A010F4D42129DB610A631001CAE">
<enum>(1)</enum>
<text>4,000,000 barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2018;</text>
</paragraph>
<paragraph id="H2C3571605C984FC7866B5AF4BEFC2C10">
<enum>(2)</enum>
<text>5,000,000 barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2019;</text>
</paragraph>
<paragraph id="HB63A028AD1D94C9CBD31F5AA82F3988D">
<enum>(3)</enum>
<text>8,000,000 barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2020;</text>
</paragraph>
<paragraph id="HE80D83BDA5304E86874E3A48923A2F96">
<enum>(4)</enum>
<text>8,000,000 barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2021;</text>
</paragraph>
<paragraph id="H0F32526679474CCF891F6686B5C13E37">
<enum>(5)</enum>
<text>10,000,000 barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2022;</text>
</paragraph>
<paragraph id="H4ADBB824C7C24C818646583D4370E1E2">
<enum>(6)</enum>
<text>15,000,000 barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2023;</text>
</paragraph>
<paragraph id="H850B3B97009848729B650352E59B2E5B">
<enum>(7)</enum>
<text>15,000,000 barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2024; and</text>
</paragraph>
<paragraph id="HE64BC87B6F8C434C8562D9765978D6DD">
<enum>(8)</enum>
<text>15,000,000 barrels of crude oil from the Strategic Petroleum Reserve during fiscal year 2025.</text>
</paragraph>
<continuation-text continuation-text-level="subsection">Amounts received for a sale under this subsection shall be deposited in the General Fund of the Treasury during the fiscal year in which the sale occurs.</continuation-text>
</subsection>
<subsection id="H00F82E5077F544E192E2AB736C2DBDAD">
<enum>(b)</enum>
<header>Emergency protection</header>
<text>The Secretary shall not draw down and sell crude oil under this section in amounts that would result in a Strategic Petroleum Reserve that contains an inventory of petroleum products representing less than 90 days of emergency reserves, based on the average daily level of net imports of crude oil and petroleum products in the previous calendar year.</text>
</subsection>
<subsection id="HA11C576A479643EC99D1B719AF61F954">
<enum>(c)</enum>
<header>Proceeds</header>
<text display-inline="yes-display-inline">Proceeds from a sale under this section shall be deposited into the general fund of the Treasury of the United States.</text>
</subsection>
</section>
</subtitle>
<subtitle id="H37C91184B9B941C58846803B43C78B33">
<enum>C</enum>
<header>Miscellaneous</header>
<section commented="no" id="HB85F4964EDE046F58262238914EEC9F2">
<enum>4061.</enum>
<header>Lyme disease and other tick-borne diseases</header>
<subsection id="HFAC2CC0ACACC40BDBB9EEB46EC4C9DE9">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is amended by adding at the end the following new part:</text>
<quoted-block display-inline="no-display-inline" id="H69C899AB9D1742B2834CF31F4BB7E412" style="OLC">
<part commented="no" id="H33DDA1E7497B4E5CBF4B2208F06F4AD3">
<enum>W</enum>
<header>Lyme disease and other tick-borne diseases</header>
<section commented="no" id="HA56463C81AE247619BB185A3839239F5">
<enum>399OO.</enum>
<header>Research</header>
<subsection commented="no" id="H4B14D5BC488B44A99E9C0681B0838B6E">
<enum>(a)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Secretary shall conduct or support epidemiological, basic, translational, and clinical research regarding Lyme disease and other tick-borne diseases.</text>
</subsection>
<subsection commented="no" id="H516749DE3F744B02A671675FEE9E1660">
<enum>(b)</enum>
<header>Biennial reports</header>
<text>The Secretary shall ensure that each biennial report under section 403 includes information on actions undertaken by the National Institutes of Health to carry out subsection (a) with respect to Lyme disease and other tick-borne diseases, including an assessment of the progress made in improving the outcomes of Lyme disease and such other tick-borne diseases.</text>
</subsection>
</section>
<section commented="no" id="H1FCA7CE32A4743F3912F5BDDB3F5B87F">
<enum>399OO–1.</enum>
<header>Working Group</header>
<subsection commented="no" id="H8B4BBA4408AF43E1842029CA5F0FDB57">
<enum>(a)</enum>
<header>Establishment</header>
<text display-inline="yes-display-inline">The Secretary shall establish a permanent working group, to be known as the Interagency Lyme and Tick-Borne Disease Working Group (in this section and section 399OO–2 referred to as the <quote>Working Group</quote>), to review all efforts within the Department of Health and Human Services concerning Lyme disease and other tick-borne diseases to ensure interagency coordination, minimize overlap, and examine research priorities.</text>
</subsection>
<subsection commented="no" id="H4B4A1ED139634BF68D39A34BA5C96381">
<enum>(b)</enum>
<header>Responsibilities</header>
<text>The Working Group shall—</text>
<paragraph commented="no" id="H973FA5884AFD494B8A9B4A0AB76D1FAC">
<enum>(1)</enum>
<text>not later than 24 months after the date of enactment of this part, and every 24 months thereafter, develop or update a summary of—</text>
<subparagraph commented="no" id="H00D22653E2EC4C8282E763DE197A4995">
<enum>(A)</enum>
<text>ongoing Lyme disease and other tick-borne disease research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, duration of illness, intervention, and access to services and supports for individuals with Lyme disease or other tick-borne diseases;</text>
</subparagraph>
<subparagraph commented="no" id="HD3714E9799B74E3BA920167802BDB735">
<enum>(B)</enum>
<text>advances made pursuant to such research;</text>
</subparagraph>
<subparagraph commented="no" id="H312254DD8B574AFFA773BED8CF443F09">
<enum>(C)</enum>
<text display-inline="yes-display-inline">the engagement of the Department of Health and Human Services with persons that participate at the public meetings required by paragraph (5); and</text>
</subparagraph>
<subparagraph commented="no" id="H1200089D8E0045E9A9C4AF25A3C385E2">
<enum>(D)</enum>
<text>the comments received by the Working Group at such public meetings and the Secretary’s response to such comments;</text>
</subparagraph>
</paragraph>
<paragraph commented="no" id="H404260CA383F47998E1527D8D2BD1BA5">
<enum>(2)</enum>
<text>ensure that a broad spectrum of scientific viewpoints is represented in each such summary;</text>
</paragraph>
<paragraph commented="no" id="H9723C1413CB2468CA71906618F2CE708">
<enum>(3)</enum>
<text>monitor Federal activities with respect to Lyme disease and other tick-borne diseases;</text>
</paragraph>
<paragraph commented="no" id="H738F0EFD72884EE7B2E9B736E66C5E80">
<enum>(4)</enum>
<text>make recommendations to the Secretary regarding any appropriate changes to such activities; and</text>
</paragraph>
<paragraph commented="no" id="H83E556AE43C64BE28D0645FA1CB5DA06">
<enum>(5)</enum>
<text>ensure public input by holding annual public meetings that address scientific advances, research questions, surveillance activities, and emerging strains in species of pathogenic organisms.</text>
</paragraph>
</subsection>
<subsection commented="no" id="HF185688E709C40239060E5B49D89FA6C">
<enum>(c)</enum>
<header>Membership</header>
<paragraph commented="no" id="H9A8860032FE14797BB1D8063B9D4152E">
<enum>(1)</enum>
<header>In general</header>
<text display-inline="yes-display-inline">The Working Group shall be composed of a total of 14 members as follows:</text>
<subparagraph commented="no" id="H511D39124EBF4B35BB6BFC17E80888CA">
<enum>(A)</enum>
<header>Federal members</header>
<text>Seven Federal members, consisting of one or more representatives of each of—</text>
<clause commented="no" id="H630D041626764815A054020A8A36CF0C">
<enum>(i)</enum>
<text>the Office of the Assistant Secretary for Health;</text>
</clause>
<clause commented="no" id="HDDB09CA9DA9B4625A8B5B8A95ED9C983">
<enum>(ii)</enum>
<text>the Food and Drug Administration;</text>
</clause>
<clause commented="no" id="H32B963D234BB43B88F3184EED27C075E">
<enum>(iii)</enum>
<text>the Centers for Disease Control and Prevention;</text>
</clause>
<clause commented="no" id="HA6257D1CC5C7456284E5AD93F2486112">
<enum>(iv)</enum>
<text>the National Institutes of Health; and</text>
</clause>
<clause commented="no" id="H8D87830AEDDB404E83AEF96F8C70ECD4">
<enum>(v)</enum>
<text>such other agencies and offices of the Department of Health and Human Services as the Secretary determines appropriate.</text>
</clause>
</subparagraph>
<subparagraph commented="no" id="H30C5EC67F9CD4C599264EE3E2F4FAD23">
<enum>(B)</enum>
<header>Non-Federal public members</header>
<text>Seven non-Federal public members, consisting of representatives of the following categories:</text>
<clause commented="no" id="HD350FE2066194537B601357E5BF10ADB">
<enum>(i)</enum>
<text>Physicians and other medical providers with experience in diagnosing and treating Lyme disease and other tick-borne diseases.</text>
</clause>
<clause commented="no" id="H80A1ACB5609C4266BF7A30FDA620D841">
<enum>(ii)</enum>
<text>Scientists or researchers with expertise.</text>
</clause>
<clause commented="no" id="HFF7CDA079B7E46BD8F241F35B06F8C0C">
<enum>(iii)</enum>
<text>Patients and their family members.</text>
</clause>
<clause commented="no" id="H8016B4F1789A45FABD48A650265415C8">
<enum>(iv)</enum>
<text display-inline="yes-display-inline">Nonprofit organizations that advocate for patients with respect to Lyme disease and other tick-borne diseases.</text>
</clause>
<clause commented="no" id="H68DC44F2AD5549C3AA8B76281B66F4B2">
<enum>(v)</enum>
<text>Other individuals whose expertise is determined by the Secretary to be beneficial to the functioning of the Working Group.</text>
</clause>
</subparagraph>
</paragraph>
<paragraph commented="no" id="H88D3F4A9A18D452E91ED64355ED60F0E">
<enum>(2)</enum>
<header>Appointment</header>
<text>The members of the Working Group shall be appointed by the Secretary, except that of the non-Federal public members under paragraph (1)(B)—</text>
<subparagraph commented="no" id="HC71AE47CC52A4EC2A89618D1B113C1A6">
<enum>(A)</enum>
<text display-inline="yes-display-inline">one shall be appointed by the Speaker of the House of Representatives; and</text>
</subparagraph>
<subparagraph commented="no" id="H2CB074C302204342AFCCC90E30D5C53E">
<enum>(B)</enum>
<text>one shall be appointed by the majority leader of the Senate.</text>
</subparagraph>
</paragraph>
<paragraph commented="no" id="H179CBBAD722543A6A8CFF2DB2F7562E3">
<enum>(3)</enum>
<header>Diversity of scientific perspectives</header>
<text display-inline="yes-display-inline">In making appointments under paragraph (2), the Secretary, the Speaker of the House of Representatives, and the majority leader of the Senate shall ensure that the non-Federal public members of the Working Group represent a diversity of scientific perspectives.</text>
</paragraph>
<paragraph commented="no" id="HA0B77B4FDB61442FA8FBAAE31B13FD43">
<enum>(4)</enum>
<header>Terms</header>
<text>The non-Federal public members of the Working Group shall each be appointed to serve a 4-year term and may be reappointed at the end of such term.</text>
</paragraph>
</subsection>
<subsection commented="no" id="HE0815E95A8224A4A882616CA8BCD49CB">
<enum>(d)</enum>
<header>Meetings</header>
<text>The Working Group shall meet as often as necessary, as determined by the Secretary, but not less than twice each year.</text>
</subsection>
<subsection id="H143F4FF6AD0C4C3E8CFF45125B00B52A">
<enum>(e)</enum>
<header>Applicability of FACA</header>
<text>The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act.</text>
</subsection>
<subsection commented="no" id="H4577073399FA4DC99C1BE8EF444B669E">
<enum>(f)</enum>
<header>Reporting</header>
<text display-inline="yes-display-inline">Not later than 24 months after the date of enactment of this part, and every 24 months thereafter, the Working Group—</text>
<paragraph commented="no" id="H35695C86FF204579A1C6DD2948553641">
<enum>(1)</enum>
<text>shall submit a report on its activities, including an up-to-date summary under subsection (b)(1) and any recommendations under subsection (b)(4), to the Secretary, the Committee on Energy and Commerce of the House of Representatives, and the Committee on Health, Education, Labor and Pensions of the Senate;</text>
</paragraph>
<paragraph commented="no" id="H3935489FDA5343D98336BD956C17402B">
<enum>(2)</enum>
<text>shall make each such report publicly available on the website of the Department of Health and Human Services; and</text>
</paragraph>
<paragraph commented="no" id="H291F724FCDAF44F28ECCB02467546DD4">
<enum>(3)</enum>
<text>shall allow any member of the Working Group to include in any such report minority views.</text>
</paragraph>
</subsection>
</section>
<section commented="no" id="HF73266C2B1FA4441B35126C45CCE517A">
<enum>399OO–2.</enum>
<header>Strategic plan</header>
<text display-inline="no-display-inline">Not later than 3 years after the date of enactment of this section, and every 5 years thereafter, the Secretary shall submit to the Congress a strategic plan, informed by the most recent summary under section 399OO–1(b)(1), for the conduct and support of Lyme disease and tick-borne disease research, including—</text>
<paragraph commented="no" id="H637C4840A3D04B12B96603921837CDEA">
<enum>(1)</enum>
<text>proposed budgetary requirements;</text>
</paragraph>
<paragraph commented="no" id="HB0E24E4658B949858842B43CA2A5F267">
<enum>(2)</enum>
<text display-inline="yes-display-inline">a plan for improving outcomes of Lyme disease and other tick-borne diseases, including progress related to chronic or persistent symptoms and chronic or persistent infection and co-infections;</text>
</paragraph>
<paragraph commented="no" id="H5E7A45A9A8FD43FCA7162FE6A471E9CB">
<enum>(3)</enum>
<text>a plan for improving diagnosis, treatment, and prevention;</text>
</paragraph>
<paragraph commented="no" id="H4DEBAB5A86414645B31AB670B2602CCC">
<enum>(4)</enum>
<text>appropriate benchmarks to measure progress on achieving the improvements described in paragraphs (2) and (3); and</text>
</paragraph>
<paragraph commented="no" id="H7C96DDF9F9A049AC9F0E43CB068B6C20">
<enum>(5)</enum>
<text display-inline="yes-display-inline">a plan to disseminate each summary under section 399OO–1(b)(1) and other relevant information developed by the Working Group to the public, including health care providers, public health departments, and other relevant medical groups.</text>
</paragraph>
</section>
</part>
<after-quoted-block>.</after-quoted-block>
</quoted-block>
</subsection>
<subsection id="HB36E3C89E9264F81A801E89D3BD77C85">
<enum>(b)</enum>
<header>No additional authorization of appropriations</header>
<text>No additional funds are authorized to be appropriated for the purpose of carrying out this section and the amendment made by this section, and this section and such amendment shall be carried out using amounts otherwise available for such purpose.</text>
</subsection>
</section>
</subtitle>