[Congressional Record Volume 161, Number 107 (Friday, July 10, 2015)]
[House]
[Pages H5035-H5082]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
21ST CENTURY CURES ACT
General Leave
Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members may
have 5 legislative days to revise and extend their remarks and to
include extraneous material therein on H.R. 6.
The SPEAKER pro tempore (Mr. Fitzpatrick). Is there objection to the
request of the gentleman from Michigan?
There was no objection.
The SPEAKER pro tempore. Pursuant to House Resolution 350 and rule
XVIII, the Chair declares the House in the Committee of the Whole House
on the state of the Union for the further consideration of the bill,
H.R. 6.
Will the gentlewoman from North Carolina (Ms. Foxx) kindly retake the
chair.
{time} 0916
In the Committee of the Whole
Accordingly, the House resolved itself into the Committee of the
Whole House on the state of the Union for the further consideration of
the bill (H.R. 6) to accelerate the discovery, development, and
delivery of 21st century cures, and for other purposes, with Ms. Foxx
(Acting Chair) in the chair.
The Clerk read the title of the bill.
The Acting CHAIR. When the Committee of the Whole rose on Thursday,
July 9, 2015, all time for general debate had expired.
Pursuant to the rule, the bill shall be considered for amendment
under the 5-minute rule.
In lieu of the amendment in the nature of a substitute recommended by
the Committee on Energy and Commerce, printed in the bill, an amendment
in the nature of a substitute consisting of the text of Rules Committee
Print 114-22 is adopted.
The bill, as amended, shall be considered as the original bill for
the purpose of further amendment under the 5-minute rule and shall be
considered as read.
The text of the bill, as amended, is as follows:
H.R. 6
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``21st
Century Cures Act''.
(b) Table of Contents.--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.
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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.
SEC. 2. NIH AND CURES INNOVATION FUND.
(a) Establishment.--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) In general.--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) Allocation of amounts.--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) Authorized Uses.--
(1) NIH biomedical research.--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
[[Page H5037]]
(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) Cures development.--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) NIH Innovation Fund.--
(1) Coordination.--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) Strategic plan.--
(A) In general.--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) Updates and reviews.--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) Transfer Authority.--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) Definition.--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)).
TITLE I--DISCOVERY
Subtitle A--National Institutes of Health Funding
SEC. 1001. NATIONAL INSTITUTES OF HEALTH REAUTHORIZATION.
Section 402A(a)(1) of the Public Health Service Act (42
U.S.C. 282a(a)(1)) is amended--
(1) in subparagraph (B), by striking at the end ``and'';
(2) in subparagraph (C), by striking at the end the period
and inserting a semicolon; and
(3) by adding at the end the following new subparagraphs:
``(D) $31,811,000,000 for fiscal year 2016;
``(E) $33,331,000,000 for fiscal year 2017; and
``(F) $34,851,000,000 for fiscal year 2018.''.
Subtitle B--National Institutes of Health Planning and Administration
SEC. 1021. NIH RESEARCH STRATEGIC PLAN.
Section 402 of the Public Health Service Act (42 U.S.C.
282) is amended--
(1) in subsection (b), by amending paragraph (5) to read as
follows:
``(5) 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);''; and
(2) by adding at the end the following:
``(m) Research Strategic Plan.--
``(1) Five-year plans for biomedical research strategy.--
``(A) In general.--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--
``(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 National Institutes of
Health can best contribute to the goal of expanding knowledge
on human health in the United States through biomedical
research; and
``(iii) includes objectives for each such strategic focus
area.
``(B) Entities described.--The entities described in this
subparagraph are the directors of the national research
institutes and national centers, researchers, patient
advocacy groups, and industry leaders.
``(2) Use of plan.--The Director of NIH and the directors
of the national research institutes and national centers
shall use the strategic plan--
``(A) to identify research opportunities; and
``(B) to develop individual strategic plans for the
research activities of each of the national research
institutes and national centers that--
``(i) have a common template; and
``(ii) 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.
``(3) Contents of plans.--
``(A) Strategic focus areas.--The strategic focus areas
identified pursuant to paragraph (1)(A)(ii) shall--
``(i) be identified in a manner that--
``(I) considers the return on investment to the United
States public through the investments of the National
Institutes of Health in biomedical research; and
``(II) contributes to expanding knowledge to improve the
United States public's health through biomedical research;
and
``(ii) 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.
``(B) Rare and pediatric diseases and conditions.--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.
``(C) Workforce.--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.
``(4) Initial plan.--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--
``(A) complete the initial strategic plan required by
paragraphs (1) and (2); and
``(B) make such initial strategic plan publicly available
on the website of the National Institutes of Health.
``(5) Review; updates.--
``(A) Progress reviews.--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).
[[Page H5038]]
``(B) Updates.--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--
``(i) conduct a review of the plan, including each
strategic focus area identified under paragraph (2)(B); and
``(ii) update such plan in accordance with this section.''.
SEC. 1022. INCREASING ACCOUNTABILITY AT THE NATIONAL
INSTITUTES OF HEALTH.
(a) Appointment and Terms of Directors of National Research
Institutes and National Centers.--Subsection (a) of section
405 of the Public Health Service Act (42 U.S.C. 284) is
amended to read as follows: ``(a) Appointment; Terms.--
``(1) Appointment.--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.
``(2) Terms.--
``(A) In general.--The term of office of a director of a
national research institute or national center shall be 5
years.
``(B) Removal.--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.
``(C) Reappointment.--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.
``(D) Vacancies.--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.
``(E) Transitional provision.--Each director of a national
research institute or national center serving on the date of
enactment of the 21st Century Cures Act is deemed to be
appointed for a 5-year term under this subsection starting on
such date of enactment.''.
(b) Compensation to Consultants or Individual Scientists.--
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 ``portable structures;'' and all that
follows and inserting ``portable structures.''.
(c) Review of Certain Awards by Directors.--Section 405(b)
of the Public Health Service Act (42 U.S.C. 284(b)) is
amended by adding at the end the following:
``(3) 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 `R-series
grant'), 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--
``(A) shall review and approve the award; and
``(B) shall take into consideration--
``(i) the mission of the national research institute or
national center and the scientific priorities identified in
the strategic plan under section 402(m); and
``(ii) whether other agencies are funding programs or
projects to accomplish the same goal.''.
(d) IOM Study on Duplication in Federal Biomedical
Research.--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--
(1) complete a study on the extent to which biomedical
research conducted or supported by Federal agencies is
duplicative; and
(2) submit a report to the Congress on the results of such
study, including recommendations on how to prevent such
duplication.
SEC. 1023. REDUCING ADMINISTRATIVE BURDENS OF RESEARCHERS.
(a) Plan Preparation and Implementation of Measures To
Reduce Administrative Burdens.--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:
(1) The Scientific Management Review Board.
(2) The National Academy of Sciences.
(3) The 2007 and 2012 Faculty Burden Survey conducted by
The Federal Demonstration Partnership.
(4) Relevant recommendations from the Research Business
Models Working Group.
(b) Report.--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).
SEC. 1024. EXEMPTION FOR THE NATIONAL INSTITUTES OF HEALTH
FROM THE PAPERWORK REDUCTION ACT REQUIREMENTS.
Section 3518(c)(1) of title 44, United States Code, is
amended--
(1) in subparagraph (C), by striking ``; or'' and inserting
a semicolon;
(2) in subparagraph (D), by striking the period at the end
and inserting ``; or''; and
(3) by inserting at the end the following new subparagraph:
``(E) during the conduct of research by the National
Institutes of Health.''.
SEC. 1025. NIH TRAVEL.
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.
SEC. 1026. OTHER TRANSACTIONS AUTHORITY.
Section 480 of the Public Health Service Act (42 U.S.C.
287a) is amended--
(1) in subsection (b), by striking ``the appropriation of
funds as described in subsection (g)'' and inserting ``the
availability of funds as described in subsection (f)'';
(2) in subsection (e)(3), by amending subparagraph (C) to
read as follows:
``(C) Other transactions authority.--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.'';
(3) by striking subsection (f); and
(4) by redesignating subsection (g) as subsection (f).
SEC. 1027. NCATS PHASE IIB RESTRICTION.
Section 479 of the Public Health Service Act (42 U.S.C.
287) is amended--
(1) prior to making the amendments under paragraph (2), by
striking ``IIB'' each place it appears and inserting ``III'';
and
(2) by striking ``IIA'' each place it appears and inserting
``IIB''.
SEC. 1028. HIGH-RISK, HIGH-REWARD RESEARCH.
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:
``SEC. 409K. HIGH-RISK, HIGH-REWARD RESEARCH PROGRAM.
``The director of each national research institute shall,
as appropriate--
``(1) 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
``(2) set aside a specific percentage of funding, to be
determined by the Director of NIH for each national research
institute, for such projects.''.
SEC. 1029. SENSE OF CONGRESS ON INCREASED INCLUSION OF
UNDERREPRESENTED COMMUNITIES IN CLINICAL
TRIALS.
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.
Subtitle C--Supporting Young Emerging Scientists
SEC. 1041. IMPROVEMENT OF LOAN REPAYMENT PROGRAMS OF THE
NATIONAL INSTITUTES OF HEALTH.
(a) In General.--Part G of title IV of the Public Health
Service (42 U.S.C. 288 et seq.) is amended--
(1) by redesignating the second section 487F (42 U.S.C.
288-6; relating to pediatric research loan repayment program)
as section 487G; and
(2) by inserting after section 487G, as so redesignated,
the following:
``SEC. 487H. LOAN REPAYMENT PROGRAM.
``(a) In General.--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.
``(b) Adjustment for Inflation.--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.
``(c) Limitation.--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.
``(d) Applicability of Certain Provisions Regarding
Obligated Service.--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.
``(e) Availability of Appropriations.--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.''.
(b) Update of Other Loan Repayment Programs.--
(1) Section 464z-5(a) of the Public Health Service Act (42
U.S.C.285t-2(a)) is amended--
(A) by striking ``$35,000'' and inserting ``$50,000''; and
(B) by adding at the end the following new sentence:
``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.''.
(2) Section 487A(a) of such Act (42 U.S.C. 288-1(a)) is
amended--
(A) by striking ``$35,000'' and inserting ``$50,000''; and
(B) by adding at the end the following new sentence:
``Subsection (b) of section 487H shall apply with respect to
the maximum amount
[[Page H5039]]
specified in this subsection in the same manner as it applies
to the maximum amount specified in subsection (a) of such
section.''.
(3) Section 487B(a) of such Act (42 U.S.C. 288-2(a)) is
amended--
(A) by striking ``$35,000'' and inserting ``$50,000''; and
(B) by adding at the end the following new sentence:
``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.''.
(4) Section 487C(a)(1) of such Act (42 U.S.C. 288-3(a)(1))
is amended--
(A) by striking ``$35,000'' and inserting ``$50,000''; and
(B) by adding at the end the following new sentence:
``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.''.
(5) Section 487E(a)(1) of such Act (42 U.S.C. 288-5(a)(1))
is amended--
(A) by striking ``$35,000'' and inserting ``$50,000''; and
(B) by adding at the end the following new sentence:
``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.''.
(6) 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--
(A) by striking ``$35,000'' and inserting ``$50,000''; and
(B) by adding at the end the following new sentence:
``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.''.
(7) Section 487G of such Act (42 U.S.C. 288-6, as
redesignated by subsection (a)(1)), is further amended--
(A) in subsection (a)(1), by striking ``$35,000'' and
inserting ``$50,000''; and
(B) in subsection (b), by adding at the end the following
new sentence: ``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.''.
SEC. 1042. REPORT.
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.
Subtitle D--Capstone Grant Program
SEC. 1061. CAPSTONE AWARD.
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:
``SEC. 490. CAPSTONE AWARD.
``(a) In General.--The Secretary may make awards (each of
which, hereafter in this section, referred to as a `Capstone
Award') to support outstanding scientists who have been
funded by the National Institutes of Health.
``(b) Purpose.--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.
``(c) Duration and Amount.--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.
``(d) Limitation.--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.''.
Subtitle E--Promoting Pediatric Research Through the National
Institutes of Health
SEC. 1081. NATIONAL PEDIATRIC RESEARCH NETWORK.
Section 409D(d) of the Public Health Service Act (42 U.S.C.
284h(d)) is amended--
(1) in paragraph (1)--
(A) by striking ``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'' and inserting
``in collaboration with the national research institutes and
national centers that carry out activities involving
pediatric research'';
(B) by striking subparagraph (B);
(C) by striking ``may be comprised of, as appropriate'' and
all that follows through ``the pediatric research consortia''
and inserting ``may be comprised of, as appropriate, the
pediatric research consortia''; and
(D) by striking ``; or'' at the end and inserting a period;
and
(2) in paragraph (1), paragraph (2)(A), the first sentence
of paragraph (2)(E), and paragraph (4), by striking ``may''
each place it appears and inserting ``shall''.
SEC. 1082. GLOBAL PEDIATRIC CLINICAL STUDY NETWORK SENSE OF
CONGRESS.
It is the sense of Congress that--
(1) 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;
(2) 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;
(3) 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
(4) 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.
SEC. 1083. APPROPRIATE AGE GROUPINGS IN CLINICAL RESEARCH.
(a) Input From Experts.--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--
(1) appropriate age groupings to be included in research
studies involving human subjects; and
(2) acceptable scientific justifications for excluding
participants from a range of age groups from human subjects
research studies.
(b) Guidelines.--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--
(1) addressing the consideration of age as an inclusion
variable in research involving human subjects; and
(2) identifying criteria for justifications for any age-
related exclusions in such research.
(c) Public Availability of Findings and Conclusions.--The
Director of the National Institutes of Health shall--
(1) 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
(2) 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.
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.
(a) Standardization.--
(1) In general.--Section 402(j) of the Public Health
Service Act (42 U.S.C. 282(j)) is amended--
(A) by redesignating paragraph (7) as paragraph (8); and
(B) by inserting after paragraph (6) the following:
``(7) Standardization.--The Director of NIH shall--
``(A) ensure that the registry and results data bank is
easily used by the public;
``(B) ensure that entries in the registry and results data
bank are easily compared;
``(C) 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--
``(i) the disease or indication being studied;
``(ii) inclusion criteria such as age, gender, diagnosis or
diagnoses, laboratory values, or imaging results; and
``(iii) exclusion criteria such as specific diagnosis or
diagnoses, laboratory values, or prohibited medications; and
``(D) 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.''.
(2) Conforming amendment.--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.
(b) Consultation.--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).
(c) Applicability.--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).
Subtitle G--Facilitating Collaborative Research
SEC. 1121. CLINICAL TRIAL DATA SYSTEM.
(a) Establishment.--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.
[[Page H5040]]
(b) Application.--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:
(1) 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.
(2) 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).
(3) 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.
(4) 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.
(5) 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.
(6) 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.
(7) Evidence demonstrating a proven track record of--
(A) being a neutral third party in working with medical
product manufacturers, academic institutions, and the Food
and Drug Administration; and
(B) having the ability to protect confidential data.
(8) 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).
(c) Extension, Expansion, Termination.--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.
(d) Study and Report.--
(1) In general.--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).
(2) Study.--The study under paragraph (1) shall--
(A) review the effectiveness of the pilot program
established under subsection (a); and
(B) be designed to formulate recommendations on
improvements to the program.
(3) Report.--The report under paragraph (1) shall contain
at least the following information:
(A) The new discoveries, research inquiries, or clinical
trials that have resulted from accessing clinical trial data
under the pilot program established under subsection (a).
(B) The number of times scientists have accessed such data,
disaggregated by research area and clinical trial phase.
(C) An analysis of whether the program has helped to reduce
adverse events in clinical trials.
(D) 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.
(E) An analysis of privacy and data integrity practices
used in the program.
(e) Definitions.--In this section:
(1) The term ``eligible entity'' means an entity that has
experienced personnel with clinical and other technical
expertise in the biomedical sciences and biomedical ethics
and that is--
(A) 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
(B) 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.
(2) The term ``medical product'' 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.
(3) The term ``qualified clinical trial'' means a clinical
trial sponsored solely by an agency of the Department of
Health and Human Services with respect to a medical product--
(A) that--
(i) 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
(ii) 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
(B) that is an investigational product for which the
original development was discontinued and with respect to
which--
(i) 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
(ii) 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.
(4) The term ``registered user'' means a scientific or
medical researcher who has--
(A) a legitimate biomedical research purpose for accessing
information from the clinical trials data system and has
appropriate qualifications to conduct such research; and
(B) 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.
(5) The term ``Secretary'' means the Secretary of Health
and Human Services.
SEC. 1122. NATIONAL NEUROLOGICAL DISEASES SURVEILLANCE
SYSTEM.
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:
``SEC. 399V-6 SURVEILLANCE OF NEUROLOGICAL DISEASES.
``(a) In General.--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--
``(1) enhance and expand infrastructure and activities to
track the epidemiology of neurological diseases, including
multiple sclerosis and Parkinson's disease; and
``(2) 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.
``(b) Research.--The Secretary shall ensure that the
National Neurological Diseases Surveillance System is
designed in a manner that facilitates further research on
neurological diseases.
``(c) Content.--In carrying out subsection (a), the
Secretary--
``(1) shall provide for the collection and storage of
information on the incidence and prevalence of neurological
diseases in the United States;
``(2) to the extent practicable, shall provide for the
collection and storage of other available information on
neurological diseases, such as information concerning--
``(A) demographics and other information associated or
possibly associated with neurological diseases, such as age,
race, ethnicity, sex, geographic location, and family
history;
``(B) risk factors associated or possibly associated with
neurological diseases, including genetic and environmental
risk factors; and
``(C) diagnosis and progression markers;
``(3) may provide for the collection and storage of
information relevant to analysis on neurological diseases,
such as information concerning--
``(A) the epidemiology of the diseases;
``(B) the natural history of the diseases;
``(C) the prevention of the diseases;
``(D) the detection, management, and treatment approaches
for the diseases; and
``(E) the development of outcomes measures; and
``(4) may address issues identified during the consultation
process under subsection (d).
``(d) Consultation.--In carrying out this section, the
Secretary shall consult with individuals with appropriate
expertise, including--
``(1) epidemiologists with experience in disease
surveillance or registries;
``(2) representatives of national voluntary health
associations that--
``(A) focus on neurological diseases, including multiple
sclerosis and Parkinson's disease; and
``(B) have demonstrated experience in research, care, or
patient services;
``(3) health information technology experts or other
information management specialists;
``(4) clinicians with expertise in neurological diseases;
and
``(5) research scientists with experience conducting
translational research or utilizing surveillance systems for
scientific research purposes.
``(e) Grants.--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.
``(f) Coordination With Other Federal, State, and Local
Agencies.--Subject to subsection (h), the Secretary shall
make information and analysis in the National Neurological
Diseases Surveillance System available, as appropriate--
``(1) 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
``(2) to State and local agencies.
``(g) Public Access.--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.
[[Page H5041]]
``(h) Privacy.--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)).
``(i) Report.--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--
``(1) the development and maintenance of the National
Neurological Diseases Surveillance System;
``(2) the type of information collected and stored in the
System;
``(3) the use and availability of such information,
including guidelines for such use; and
``(4) the use and coordination of databases that collect or
maintain information on neurological diseases.
``(j) Definition.--In this section, the term `national
voluntary health association' means a national nonprofit
organization with chapters, other affiliated organizations,
or networks in States throughout the United States.
``(k) Authorization of Appropriations.--To carry out this
section, there is authorized to be appropriated $5,000,000
for each of fiscal years 2016 through 2020.''.
SEC. 1123. DATA ON NATURAL HISTORY OF DISEASES.
(a) Sense of Congress.--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.
(b) Authority.--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:
``SEC. 229A. DATA ON NATURAL HISTORY OF DISEASES.
``(a) In General.--The Secretary, acting through the
Commissioner of Food and Drugs, may, for the purposes
described in subsection (b)--
``(1) participate in public-private partnerships engaged in
one or more activities specified in subsection (c); and
``(2) award grants to patient advocacy groups or other
organizations determined appropriate by the Secretary.
``(b) Purposes Described.--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.
``(c) Activities of Public-Private Partnerships.--The
activities of public-private partnerships in which the
Secretary may participate for purposes of this section
include--
``(1) cooperating with other entities that sponsor or
maintain disease registries, including disease registries and
disease registry platforms for rare diseases;
``(2) developing or enhancing a secure information
technology system that--
``(A) has the capacity to support data needs across a wide
range of disease studies;
``(B) is easily modified as knowledge is gained during such
studies; and
``(C) is capable of handling increasing amounts of data as
more studies are carried out; and
``(3) providing advice to clinical researchers, patient
advocacy groups, and other entities with respect to--
``(A) the design and conduct of disease studies;
``(B) the modification of any such ongoing studies; and
``(C) addressing associated patient privacy issues.
``(d) Availability of Data on Natural History of
Diseases.--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.
``(e) Confidentiality.--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.
``(f) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $5,000,000 for
each of fiscal years 2016 through 2020.''.
SEC. 1124. ACCESSING, SHARING, AND USING HEALTH DATA FOR
RESEARCH PURPOSES.
(a) In General.--(1) 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:
``PART 4--ACCESSING, SHARING, AND USING HEALTH DATA FOR RESEARCH
PURPOSES
``SEC. 13441. REFERENCES.
``In this part:
``(1) The rule.--References to `the Rule' refer to part 160
or part 164, as appropriate, of title 45, Code of Federal
Regulations (or any successor regulation).
``(2) Part 164.--References to a specified section of `part
164', refer to such specified section of part 164 of title
45, Code of Federal Regulations (or any successor section).
``SEC. 13442. DEFINING HEALTH DATA RESEARCH AS PART OF HEALTH
CARE OPERATIONS.
``(a) In General.--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.
``(b) Modifications to Rules for Disclosures for Health
Care Operations.--In applying section 164.506 of part 164 to
the disclosure of protected health information described in
subsection (a)--
``(1) the Secretary shall revise or clarify the Rule so
that the disclosure may be made by the covered entity to
only--
``(A) another covered entity for health care operations (as
defined in section 164.501 of part 164);
``(B) 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
``(C) 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
``(2) 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).
``(c) Rule of Construction.--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.
``SEC. 13443. TREATING DISCLOSURES OF PROTECTED HEALTH
INFORMATION FOR RESEARCH SIMILARLY TO
DISCLOSURES OF SUCH INFORMATION FOR PUBLIC
HEALTH PURPOSES.
``(a) Remuneration.--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.
``(b) Permitted Uses and Disclosures.--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.
``SEC. 13444. PERMITTING REMOTE ACCESS TO PROTECTED HEALTH
INFORMATION BY RESEARCHERS.
``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--
``(1) appropriate security and privacy safeguards are
maintained by the covered entity and the researcher; and
``(2) the protected health information is not copied or
otherwise retained by the researcher.
``SEC. 13445. ALLOWING ONE-TIME AUTHORIZATION OF USE AND
DISCLOSURE OF PROTECTED HEALTH INFORMATION FOR
RESEARCH PURPOSES.
``(a) In General.--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--
``(1) 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;
``(2) either--
``(A) states that the authorization will expire on a
particular date or on the occurrence of a particular event;
or
``(B) states that the authorization will remain valid
unless and until it is revoked by the individual; and
``(3) provides instruction to the individual on how to
revoke such authorization at any time.
``(b) Revocation of Authorization.--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.''.
(2) 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:
``Part 4--Accessing, Sharing, and Using Health Data for Research
Purposes
``Sec. 13441. References.
``Sec. 13442. Defining health data research as part of
health care operations.
``Sec. 13443. Treating disclosures of protected health
information for research similarly to disclosures of
such information for public health purposes.
``Sec. 13444. Permitting remote access to protected health
information by researchers.
``Sec. 13445. Allowing one-time authorization of use and
disclosure of protected health information for research
purposes.''.
(b) Revision of Regulations.--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).
[[Page H5042]]
Subtitle H--Council for 21st Century Cures
SEC. 1141. COUNCIL FOR 21ST CENTURY CURES.
Title II of the Public Health Service Act (42 U.S.C. 202 et
seq.) is amended by adding at the end the following:
``PART E--COUNCIL FOR 21ST CENTURY CURES
``SEC. 281. ESTABLISHMENT.
``A nonprofit corporation to be known as the Council for
21st Century Cures (referred to in this part as the
`Council') 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 `Executive Director'), appointed by the members of the
Board of Directors. The Council shall not be an agency or
instrumentality of the United States Government.
``SEC. 281A. PURPOSE.
``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.
``SEC. 281B. DUTIES.
``For the purpose described in section 281A, the Council
shall--
``(1) 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;
``(2) undertake communication and dissemination activities;
``(3) publish information on the activities funded under
section 281D;
``(4) establish a strategic agenda for accelerating the
discovery, development, and delivery in the United States of
innovative cures, treatments, and preventive measures for
patients;
``(5) identify gaps and opportunities within and across the
discovery, development, and delivery cycle;
``(6) develop and propose recommendations based on the gaps
and opportunities so identified;
``(7) facilitate the interoperability of the components of
the discovery, development, and delivery cycle;
``(8) propose recommendations that will facilitate
precompetitive collaboration;
``(9) identify opportunities to work with, but not
duplicate the efforts of, nonprofit organizations and other
public-private partnerships; and
``(10) identify opportunities for collaboration with
organizations operating outside of the United States, such as
the Innovative Medicines Initiative of the European Union.
``SEC. 281C. ORGANIZATION; ADMINISTRATION.
``(a) Board of Directors.--
``(1) Establishment.--
``(A) In general.--The Council shall have a Board of
Directors (in this part referred to as the `Board of
Directors'), 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.
``(B) Ex officio members.--The ex officio members of the
Board shall be the following individuals or their designees:
``(i) The Director of the National Institutes of Health.
``(ii) The Commissioner of Food and Drugs.
``(iii) The Administrator of the Centers for Medicare &
Medicaid Services.
``(iv) The heads of five other Federal agencies deemed by
the Secretary to be engaged in biomedical research and
development.
``(C) Appointed members.--The appointed members of the
Board shall consist of 17 individuals, of whom--
``(i) 8 shall be appointed by the Comptroller General of
the United States from a list of nominations submitted by
leading trade associations--
``(I) 4 of whom shall be representatives of the
biopharmaceutical industry;
``(II) 2 of whom shall be representatives of the medical
device industry; and
``(III) 2 of whom shall be representatives of the
information and digital technology industry; and
``(ii) 9 shall be appointed by the Comptroller General of
the United States, after soliciting nominations--
``(I) 2 of whom shall be representatives of academic
researchers;
``(II) 3 of whom shall be representatives of patients;
``(III) 2 of whom shall be representatives of health care
providers; and
``(IV) 2 of whom shall be representatives of health care
plans and insurers.
``(D) Chair.--The Chair of the Board shall be selected by
the members of the Board by majority vote from among the
members of the Board.
``(2) Terms and vacancies.--
``(A) In general.--The term of office of each member of the
Board appointed under paragraph (1)(C) shall be 5 years.
``(B) Vacancy.--Any vacancy in the membership of the
Board--
``(i) shall not affect the power of the remaining members
to execute the duties of the Board; and
``(ii) shall be filled by appointment by the appointed
members described in paragraph (1)(C) by majority vote.
``(C) Partial term.--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.
``(3) Responsibilities.--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--
``(A) are published in the Federal Register and available
for public comment;
``(B) establish policies for the selection and, as
applicable, appointment of--
``(i) the officers, employees, agents, and contractors of
the Council; and
``(ii) the members of any committees of the Council;
``(C) establish policies, including ethical standards, for
the conduct of programs and other activities under section
281D; and
``(D) establish specific duties of the Executive Director.
``(4) Meetings.--
``(A) In general.--The Board of Directors shall--
``(i) meet on a quarterly basis; and
``(ii) submit to Congress, and make publicly available, the
minutes of such meetings.
``(B) Agenda.--The Board of Directors shall, not later than
3 months after the incorporation of the Council--
``(i) issue an agenda (in this part referred to as the
`agenda') outlining how the Council will achieve the purpose
described in section 281A; and
``(ii) annually thereafter, in consultation with the
Executive Director, review and update such agenda.
``(b) Appointment and Incorporation.--Not later than 6
months after the date of enactment of the 21st Century Cures
Act--
``(1) the Comptroller General of the United States shall
appoint the appointed members of the Board of Directors under
subsection (a)(1)(C); and
``(2) 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.
``(c) Nonprofit Status.--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--
``(1) is described in subsection (c)(3) of section 501 of
the Internal Revenue Code of 1986; and
``(2) is, under subsection (a) of such section, exempt from
taxation.
``(d) Executive Director.--The Executive Director shall--
``(1) be the chief executive officer of the Council; and
``(2) subject to the oversight of the Board of Directors,
be responsible for the day-to-day management of the Council.
``SEC. 281D. OPERATIONAL ACTIVITIES AND ASSISTANCE.
``(a) In General.--The Council shall establish a sufficient
operational infrastructure to fulfill the duties specified in
section 281B.
``(b) Private Sector Matching Funds.--The Council may
accept financial or in-kind support from participating
entities or private foundations or organizations when such
support is deemed appropriate.
``SEC. 281E. TERMINATION; REPORT.
``(a) In General.--The Council shall terminate on September
30, 2023.
``(b) Report.--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.
``SEC. 281F. FUNDING.
``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.''.
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.
(a) In General.--Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) is amended--
(1) in subsection (d), by striking ``The Secretary shall
implement'' and all that follows through ``premarket approval
of a drug.''; and
(2) by adding at the end the following new subsections:
``(x) Structured Risk-Benefit Assessment Framework.--
``(1) In general.--The Secretary shall implement a
structured risk-benefit assessment framework in the new drug
approval process--
``(A) to facilitate the balanced consideration of benefits
and risks; and
``(B) 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.
``(2) Rule of construction.--Nothing in paragraph (1) shall
alter the criteria for evaluating an application for
premarket approval of a drug.
``(y) Development and Use of Patient Experience Data To
Enhance Structured Risk-Benefit Assessment Framework.--
``(1) In general.--Not later than two years after the date
of the enactment of this subsection, the Secretary shall
establish and implement processes under which--
``(A) an entity seeking to develop patient experience data
may submit to the Secretary--
``(i) initial research concepts for feedback from the
Secretary; and
``(ii) with respect to patient experience data collected by
the entity, draft guidance documents, completed data, and
summaries and analyses of such data;
[[Page H5043]]
``(B) the Secretary may request such an entity to submit
such documents, data, and summaries and analyses; and
``(C) patient experience data may be developed and used to
enhance the structured risk-benefit assessment framework
under subsection (x).
``(2) Patient experience data.--In this subsection, the
term `patient experience data' 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.''.
(b) Guidance.--
(1) In general.--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--
(A) with respect to draft guidance documents, data, or
summaries and analyses submitted to the Secretary under
paragraph (1)(A) of such subsection, guidance--
(i) specifying the timelines for the review of such
documents, data, or summaries and analyses by the Secretary;
and
(ii) 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;
(B) with respect to the collection and analysis of patient
experience data (as defined in paragraph (2) of such
subsection (y)), guidance on--
(i) methodological considerations for the collection of
patient experience data, which may include structured
approaches to gathering information on--
(I) the experience of a patient living with a particular
disease;
(II) the burden of living with or managing the disease;
(III) the impact of the disease on daily life and long-term
functioning; and
(IV) the effect of current therapeutic options on different
aspects of the disease; and
(ii) the establishment and maintenance of registries
designed to increase understanding of the natural history of
a disease;
(C) 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
(D) methodologies, standards, and potential experimental
designs for patient-reported outcomes.
(2) Timing.--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.
(3) Workshops.--
(A) In general.--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.
(B) Attendees.--A workshop convened under this paragraph
shall include--
(i) patients;
(ii) representatives from patient advocacy organizations,
biopharmaceutical companies, and disease research
foundations;
(iii) representatives of the reviewing divisions of the
Food and Drug Administration; and
(iv) methodological experts with significant expertise in
patient experience data.
(4) Public meeting.--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.
Subtitle B--Qualification and Use of Drug Development Tools
SEC. 2021. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
(a) Findings.--Congress finds the following:
(1) Development of new drugs has become increasingly
challenging and resource intensive.
(2) Development of drug development tools can benefit the
availability of new medical therapies by helping to translate
scientific discoveries into clinical applications.
(3) 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.
(b) Sense of Congress.--It is the sense of Congress that--
(1) Congress should promote and facilitate a collaborative
effort among the biomedical research consortia described in
subsection (a)(3)--
(A) 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;
(B) to coordinate efforts toward developing and qualifying
drug development tools in key therapeutic areas; and
(C) to encourage the development of accessible databases
for collecting relevant drug development tool data for such
purposes; and
(2) 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.
(c) Qualification of Drug Development Tools.--Chapter V of
the Federal Food, Drug, and Cosmetic Act is amended by
inserting after section 506F the following new section:
``SEC. 507. QUALIFICATION OF DRUG DEVELOPMENT TOOLS.
``(a) Process for Qualification.--
``(1) In general.--The Secretary shall establish a process
for the qualification of drug development tools for a
proposed context of use under which--
``(A)(i) a requestor initiates such process by submitting a
letter of intent to the Secretary; and
``(ii) the Secretary accepts or declines to accept such
letter of intent;
``(B)(i) if the Secretary accepts the letter of intent, a
requestor submits a qualification plan to the Secretary; and
``(ii) the Secretary accepts or declines to accept the
qualification plan; and
``(C)(i) if the Secretary accepts the qualification plan,
the requestor submits to the Secretary a full qualification
package;
``(ii) the Secretary determines whether to accept such
qualification package for review; and
``(iii) if the Secretary accepts such qualification package
for review, the Secretary conducts such review in accordance
with this section.
``(2) Acceptance and review of submissions.--
``(A) In general.--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 `qualification submissions').
``(B) Acceptance factors; nonacceptance.--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.
``(C) Prioritization of qualification review.--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--
``(i) 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
``(ii) 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.
``(D) Engagement of external experts.--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).
``(3) Review of full qualification package.--The Secretary
shall--
``(A) conduct a comprehensive review of a full
qualification package accepted under paragraph (1)(C); and
``(B) determine whether the drug development tool at issue
is qualified for its proposed context of use.
``(4) Qualification.--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).
``(b) Effect of Qualification.--
``(1) In general.--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).
``(2) Use of a drug development tool.--Subject to paragraph
(3), a drug development tool qualified under this section may
be used for--
``(A) 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
``(B) 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.
``(3) Rescission or modification.--
``(A) In general.--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.
``(B) Meeting for review.--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.
``(c) Transparency.--
``(1) In general.--Subject to paragraph (3), the Secretary
shall make publicly available, and update on at least a
biannual basis, on the
[[Page H5044]]
Internet website of the Food and Drug Administration the
following:
``(A) Information with respect to each qualification
submission under the qualification process under subsection
(a), including--
``(i) the stage of the review process applicable to the
submission;
``(ii) the date of the most recent change in stage status;
``(iii) whether the external scientific experts were
utilized in the development of a qualification plan or the
review of a full qualification package; and
``(iv) 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.
``(B) The Secretary's formal written determinations in
response to such qualification submissions.
``(C) Any rescissions or modifications under subsection
(b)(3) of a determination to qualify a drug development tool.
``(D) Summary reviews that document conclusions and
recommendations for determinations to qualify drug
development tools under subsection (a).
``(E) A comprehensive list of--
``(i) all drug development tools qualified under subsection
(a); and
``(ii) 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.
``(2) Relation to trade secrets act.--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.
``(3) Applicability.--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.
``(d) Rule of Construction.--Nothing in this section shall
be construed--
``(1) 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
``(2) 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).
``(e) Definitions.--In this section:
``(1) Biomarker.--(A) The term `biomarker' 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
``(B) such term includes a surrogate endpoint.
``(2) Biomedical research consortia.--The term `biomedical
research consortia' 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.
``(3) Clinical outcome assessment.--(A) The term `clinical
outcome assessment' 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
``(B) such term includes a patient-reported outcome.
``(4) Context of use.--The term `context of use' 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.
``(5) Drug development tool.--The term `drug development
tool' includes--
``(A) a biomarker;
``(B) a clinical outcome assessment; and
``(C) any other method, material, or measure that the
Secretary determines aids drug development and regulatory
review for purposes of this section.
``(6) Patient-reported outcome.--The term `patient-reported
outcome' 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.
``(7) Qualification.--The terms `qualification' and
`qualified' 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.
``(8) Requestor.--The term `requestor' 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.
``(9) Surrogate endpoint.--The term `surrogate endpoint'
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--
``(A) is known to predict clinical benefit and could be
used to support traditional approval of a drug or biological
product; or
``(B) 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).
``(f) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section,
$10,000,000 for each of fiscal years 2016 through 2020.''.
(d) Guidance.--
(1) In general.--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--
(A) provides a conceptual framework describing appropriate
standards and scientific approaches to support the
development of biomarkers delineated under the taxonomy
established under paragraph (3);
(B) 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));
(C) with respect to the qualification process under such
section 507--
(i) describes the requirements that entities seeking to
qualify a drug development tool under such section shall
observe when engaging in such process;
(ii) outlines reasonable timeframes for the Secretary's
review of letters, qualification plans, or full qualification
packages submitted under such process; and
(iii) 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
(D) includes such other information as the Secretary
determines appropriate.
(2) Timing.--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.
(3) Taxonomy.--
(A) In general.--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.
(B) Public availability.--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.
(e) Meeting and Report.--
(1) Meeting.--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).
(2) Report.--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--
(A) 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);
(B) 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;
(C) 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
(D) the number of qualification plans and full
qualification packages, respectively, submitted to the
Secretary; and
(3) 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).
SEC. 2022. ACCELERATED APPROVAL DEVELOPMENT PLAN.
(a) In General.--Section 506 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356) is amended by adding the
following subsection:
``(g) Accelerated Approval Development Plan.--
``(1) In general.--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).
``(2) Plan described.--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--
``(A) the surrogate endpoint to be assessed under such
plan;
``(B) the design of the study that will utilize the
surrogate endpoint; and
[[Page H5045]]
``(C) 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.
``(3) Modification; termination.--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--
``(A) the plan as originally agreed upon is no longer
sufficient to demonstrate the safety and effectiveness of the
drug involved; or
``(B) the drug is no longer eligible for accelerated
approval under subsection (c).
``(4) Sponsor consultation.--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.
``(5) Definition.--In this section, the term `accelerated
approval development plan' 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--
``(A) is reasonably likely to predict clinical benefit; and
``(B) is intended to be the basis of the accelerated
approval of a drug in accordance with subsection (c).''.
(b) Technical Amendments.--Section 506 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 356) is amended--
(1) by striking ``(f) Awareness Efforts'' and inserting
``(e) Awareness Efforts''; and
(2) by striking ``(e) Construction'' and inserting ``(f)
Construction''.
Subtitle C--FDA Advancement of Precision Medicine
SEC. 2041. PRECISION MEDICINE GUIDANCE AND OTHER PROGRAMS OF
FOOD AND DRUG ADMINISTRATION.
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:
``Subchapter J--Precision Medicine
``SEC. 591. GENERAL AGENCY GUIDANCE ON PRECISION MEDICINE.
``(a) In General.--The Secretary shall issue and
periodically update guidance to assist sponsors in the
development of a precision drug or biological product. Such
guidance shall--
``(1) define the term `precision drug or biological
product'; and
``(2) address the topics described in subsection (b).
``(b) Certain Issues.--The topics to be addressed by
guidance under subsection (a) are--
``(1) 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;
``(2) recommendations for the design of studies to
demonstrate the validity of a biomarker as a predictor of
drug or biological product response;
``(3) 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;
``(4) the development of companion diagnostics in the
context of a drug development program; and
``(5) 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.
``(c) Date Certain for Initial Guidance.--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.
``SEC. 592. PRECISION MEDICINE REGARDING ORPHAN-DRUG AND
EXPEDITED-APPROVAL PROGRAMS.
``(a) In General.--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--
``(1) 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--
``(A) for a different drug or biological product; or
``(B) for a different indication for such precision drug or
biological product,
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
``(2) 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.
``(b) Rule of Construction.--Nothing in this section shall
be construed to--
``(1) 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
``(2) 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.''.
Subtitle D--Modern Trial Design and Evidence Development
SEC. 2061. BROADER APPLICATION OF BAYESIAN STATISTICS AND
ADAPTIVE TRIAL DESIGNS.
(a) Proposals for Use of Innovative Statistical Methods in
Clinical Protocols for Drugs and Biological Products.--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).
(b) Guidance Addressing Use of Adaptive Trial Designs and
Bayesian Methods.--
(1) In general.--The Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs
(in this subsection referred to as the ``Secretary''),
shall--
(A) update and finalize the draft guidance addressing the
use of adaptive trial design for drugs and biological
products; and
(B) issue draft guidance on the use of Bayesian methods in
the development and regulatory review and approval or
licensure of drugs and biological products.
(2) Contents.--The guidances under paragraph (1) shall
address--
(A) 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));
(B) how sponsors may obtain feedback from the Secretary on
technical issues related to modeling and simulations prior
to--
(i) completion of such modeling or simulations; or
(ii) the submission of resulting information to the
Secretary;
(C) the types of quantitative and qualitative information
that should be submitted for review; and
(D) recommended analysis methodologies.
(3) Public meeting.--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.
(4) Schedule.--The Secretary shall publish--
(A) 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
(B) the guidance required by paragraph (1)(B) not later
than 48 months after the date of the public meeting required
by paragraph (3).
SEC. 2062. UTILIZING EVIDENCE FROM CLINICAL EXPERIENCE.
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:
``SEC. 505F. UTILIZING EVIDENCE FROM CLINICAL EXPERIENCE.
``(a) In General.--The Secretary shall establish a program
to evaluate the potential use of evidence from clinical
experience--
``(1) to help to support the approval of a new indication
for a drug approved under section 505(b); and
``(2) to help to support or satisfy postapproval study
requirements.
``(b) Evidence From Clinical Experience Defined.--In this
section, the term `evidence from clinical experience' 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.
``(c) Program Framework.--
``(1) In general.--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.
``(2) Contents of framework.--The framework shall include
information describing--
``(A) the current sources of data developed through
clinical experience, including ongoing safety surveillance,
registry, claims, and patient-centered outcomes research
activities;
``(B) the gaps in current data collection activities;
``(C) the current standards and methodologies for
collection and analysis of data generated through clinical
experience; and
``(D) the priority areas, remaining challenges, and
potential pilot opportunities that the program established
under this section will address.
``(3) Consultation.--
``(A) In general.--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.
``(B) Process.--The consultation under subparagraph (A) may
be carried out through approaches such as--
``(i) a public-private partnership with the entities
described in such subparagraph in which the Secretary may
participate; or
``(ii) a contract, grant, or other arrangement, as
determined appropriate by the Secretary with
[[Page H5046]]
such a partnership or an independent research organization.
``(d) Program Implementation.--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.
``(e) Guidance for Industry.--The Secretary shall--
``(1) utilize the program established under subsection (a),
its activities, and any subsequent pilots or written reports,
to inform a guidance for industry on--
``(A) 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
``(B) the appropriate standards and methodologies for
collection and analysis of evidence from clinical experience
submitted for such purposes;
``(2) not later than 36 months after the date of enactment
of this section, issue draft guidance for industry as
described in paragraph (1); and
``(3) 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.
``(f) Rule of Construction.--
``(1) 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.
``(2) This section shall not be construed to alter--
``(A) the standards of evidence under--
``(i) subsection (c) or (d) of section 505, including the
substantial evidence standard in such subsection (d); or
``(ii) section 351(a) of the Public Health Service Act; or
``(B) the Secretary's authority to require postapproval
studies or clinical trials, or the standards of evidence
under which studies or trials are evaluated.
``SEC. 505G. COLLECTING EVIDENCE FROM CLINICAL EXPERIENCE
THROUGH TARGETED EXTENSIONS OF THE SENTINEL
SYSTEM.
``(a) In General.--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).
``(b) Pilot Demonstrations.--
``(1) In general.--The Secretary--
``(A) 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--
``(i) generating evidence from clinical experience to
improve characterization or assessment of risks or benefits
of a drug approved under section 505(c);
``(ii) protecting the public health; or
``(iii) advancing patient-centered care; and
``(B) may make strategic linkages with sources of
complementary public health data and infrastructure the
Secretary determines appropriate and necessary.
``(2) Consultation.--In developing the pilot demonstrations
under this subsection, the Secretary shall--
``(A) 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
``(B) develop a framework to promote appropriate
transparency and dialogue about research conducted under
these pilot demonstrations, including by--
``(i) 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;
``(ii) 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
``(iii) 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.
``(3) HIPAA privacy rule; human subject research
regulation.--The Secretary may deem such pilot
demonstrations--
``(A) 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
``(B) outside the scope of `research' as defined in section
46.102(d) of title 45, Code of Federal Regulations (or any
successor regulation).
``(c) Authorization of Appropriations.--There are
authorized to be appropriated to carry out this section
$3,000,000 for each of fiscal years 2016 through 2020.''.
SEC. 2063. STREAMLINED DATA REVIEW PROGRAM.
(a) In General.--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:
``SEC. 505H. STREAMLINED DATA REVIEW PROGRAM.
``(a) In General.--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.
``(b) Eligibility.--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--
``(1) 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;
``(2) 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);
``(3) 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);
``(4) the supplemental application incorporates or
supplements the data submitted in the application for
approval or licensure referred to in paragraph (1); and
``(5) 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.
``(c) Public Availability of Information on Program.--The
Secretary shall post on the public website of the Food and
Drug Administration and update annually--
``(1) the number of applications reviewed under the
streamlined data review program;
``(2) the average time for completion of review under the
streamlined data review program versus other review of
applications for new indications; and
``(3) 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.
``(d) Definitions.--In this section:
``(1) The term `qualified indication' means--
``(A) an indication for the treatment of cancer, as
determined appropriate by the Secretary; or
``(B) such other types of indications as the Secretary
determines to be subject to the streamlined data review
program under this section.
``(2) The term `qualified data summary' means a summary of
clinical data intended to demonstrate safety and
effectiveness with respect to a qualified indication for use
of a drug.''.
(b) Sense of Congress.--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).
(c) Guidance; Regulations.--The Commissioner of Food and
Drugs--
(1) shall--
(A) 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
(B) 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
(2) in addition to issuing guidance under paragraph (1),
may issue such regulations as may be necessary for
implementation of the program.
Subtitle E--Expediting Patient Access
SEC. 2081. SENSE OF CONGRESS.
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)).
SEC. 2082. EXPANDED ACCESS POLICY.
Chapter V of the Federal Food, Drug, and Cosmetic Act is
amended by inserting after section 561 (21 U.S.C. 360bbb) the
following:
``SEC. 561A. EXPANDED ACCESS POLICY REQUIRED FOR
INVESTIGATIONAL DRUGS.
``(a) In General.--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.
``(b) Content of Policy.--A policy described in subsection
(a) shall include making publicly available--
``(1) contact information for the manufacturer or
distributor to facilitate communication about requests
described in subsection (a);
[[Page H5047]]
``(2) procedures for making such requests;
``(3) the general criteria the manufacturer or distributor
will consider or use to approve such requests; and
``(4) the length of time the manufacturer or distributor
anticipates will be necessary to acknowledge receipt of such
requests.
``(c) No Guarantee of Access.--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.
``(d) Revised Policy.--A manufacturer or distributor that
has made a policy publicly available as required by this
section may revise the policy at any time.
``(e) Application.--This section shall apply to a
manufacturer or distributor with respect to an
investigational drug beginning on the later of--
``(1) the date that is 60 days after the date of enactment
of the 21st Century Cures Act; or
``(2) 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.''.
SEC. 2083. FINALIZING DRAFT GUIDANCE ON EXPANDED ACCESS.
(a) In General.--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
``Expanded Access to Investigational Drugs for Treatment
Use--Qs & As'' and dated May 2013.
(b) Contents.--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)).
Subtitle F--Facilitating Responsible Manufacturer Communications
SEC. 2101. FACILITATING DISSEMINATION OF HEALTH CARE ECONOMIC
INFORMATION.
Section 502(a) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352(a)) is amended--
(1) by striking ``(a) If its'' and inserting ``(a)(1) If
its'';
(2) by striking ``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'' and inserting
``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'';
(3) by striking ``directly relates'' and inserting
``relates'';
(4) by striking ``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'' and inserting ``, 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''; and
(5) by striking ``In this paragraph, the term'' and all
that follows and inserting the following:
``(2)(A) For purposes of this paragraph, the term `health
care economic information' 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.
``(B) 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.''.
SEC. 2102. FACILITATING RESPONSIBLE COMMUNICATION OF
SCIENTIFIC AND MEDICAL DEVELOPMENTS.
(a) Guidance.--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.
(b) Definition.--In this section, the terms ``drug'' and
``device'' have the meaning given to such terms in section
201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321).
Subtitle G--Antibiotic Drug Development
SEC. 2121. APPROVAL OF CERTAIN DRUGS FOR USE IN A LIMITED
POPULATION OF PATIENTS.
(a) Purpose.--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.
(b) Approval of Certain Antibacterial and Antifungal
Drugs.--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:
``(z) Approval of Certain Antibacterial and Antifungal
Drugs for Use in a Limited Population of Patients.--
``(1) Process.--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--
``(A) 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;
``(B) shall proceed in accordance with this subsection only
if a written agreement is reached under subparagraph (A);
``(C) shall provide the sponsor with an opportunity to
request meetings under paragraph (2);
``(D) if a written agreement is reached under subparagraph
(A), may approve the drug under this subsection for such
use--
``(i) in a limited population of patients for which there
is an unmet medical need;
``(ii) based on a streamlined development program; and
``(iii) 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
``(E) in approving a drug in accordance with this
subsection, subject to subparagraph (D)(iii), may rely upon--
``(i) traditional endpoints, alternate endpoints, or a
combination of traditional and alternate endpoints, and, as
appropriate, data sets of a limited size; and
``(ii)(I) additional data, including preclinical,
pharmacologic, or pathophysiologic evidence;
``(II) nonclinical susceptibility and pharmacokinetic data;
``(III) data from phase 2 clinical trials; and
``(IV) such other confirmatory evidence as the Secretary
determines appropriate to approve the drug.
``(2) Formal meetings.--
``(A) In general.--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:
``(i) An early consultation meeting.
``(ii) An assessment meeting.
``(iii) A postapproval meeting.
``(B) No altering of goals.--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.
``(C) Breakthrough therapies.--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).
``(3) Labeling requirement.--The labeling of an
antibacterial or antifungal drug approved in accordance with
this subsection shall contain the statement `Limited
Population' 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: `This drug is indicated for use in a
limited and specific population of patients.'.
``(4) Promotional materials.--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).
``(5) Termination of requirements or conditions.--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--
``(A) 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
``(B) 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.
``(6) Relation to other provisions.--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--
``(A) an agreement on the design and size of a clinical
trial pursuant to subparagraphs (B) and (C) of subsection
(b)(5);
``(B) designation and treatment of the drug as a
breakthrough therapy under section 506(a);
``(C) designation and treatment of the drug as a fast track
product under section 506(b); or
``(D) accelerated approval of the drug in accordance with
section 506(c).
``(7) Rule of construction.--Nothing in this subsection
shall be construed--
``(A) to alter the standards of evidence under subsection
(c) or (d) (including the substantial evidence standard in
subsection (d));
[[Page H5048]]
``(B) to waive or otherwise preclude the application of
requirements under subsection (o);
``(C) 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
``(D) 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.
``(8) Effective immediately.--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.
``(9) Definitions.--In this subsection:
``(A) Early consultation meeting.--The term `early
consultation meeting' means a pre-investigational new drug
meeting or an end-of-phase-1 meeting that--
``(i) is conducted to review and reach a written
agreement--
``(I) 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
``(II) 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
``(ii) 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.
``(B) Assessment meeting.--The term `assessment meeting'
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.
``(C) Postapproval meeting.--The term `postapproval
meeting' 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.''.
(c) Guidance.--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).
(d) Conforming Amendments.--
(1) Licensure of certain biological products.--Section
351(j) of the Public Health Service Act (42 U.S.C. 262(j)) is
amended--
(A) by striking ``(j)'' and inserting ``(j)(1)'';
(B) by inserting ``505(z),'' after ``505(p),''; and
(C) by adding at the end the following new paragraph:
``(2) In applying section 505(z) of the Federal Food, Drug,
and Cosmetic Act to the licensure of biological products
under this section--
``(A) 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
``(B) 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.''.
(2) Misbranding.--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:
``(dd) 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.''.
(e) Evaluation.--
(1) Assessment.--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.
(2) Meeting.--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.
(f) Expansion of Program.--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.
(g) Monitoring.--The Public Health Service Act is amended
by inserting after section 317T (42 U.S.C. 247b-22) the
following:
``SEC. 317U. MONITORING ANTIBACTERIAL AND ANTIFUNGAL DRUG USE
AND RESISTANCE.
``(a) Monitoring.--The Secretary shall use an appropriate
monitoring system to monitor--
``(1) 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
``(2) changes in bacterial and fungal resistance to drugs.
``(b) Public Availability of Data.--The Secretary shall
make summaries of the data derived from monitoring under this
section publicly available for the purposes of--
``(1) improving the monitoring of important trends in
antibacterial and antifungal resistance; and
``(2) 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.''.
SEC. 2122. SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA FOR
MICROORGANISMS.
(a) In General.--Section 511 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360a) is amended to read as follows:
``SEC. 511. IDENTIFYING AND UPDATING SUSCEPTIBILITY TEST
INTERPRETIVE CRITERIA FOR MICROORGANISMS.
``(a) Purpose; Identification of Criteria.--
``(1) Purpose.--The purpose of this section is to provide
the Secretary with an expedited, flexible method for--
``(A) 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
``(B) 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.
``(2) In general.--The Secretary shall identify appropriate
susceptibility test interpretive criteria with respect to
antimicrobial drugs--
``(A) 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
``(B) if such criteria are unavailable on such date, on the
date on which such criteria are available for such drug.
``(3) Bases for initial identification.--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--
``(A) preclinical and clinical data, including
pharmacokinetic, pharmacodynamic, and epidemiological data;
``(B) Bayesian and pharmacometric statistical
methodologies; and
``(C) such other evidence and information as the Secretary
considers appropriate.
``(b) Susceptibility Test Interpretive Criteria Website.--
``(1) In general.--Not later than 1 year after the date of
the enactment of the 21st Century Cures Act, 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 `Interpretive Criteria Website').
``(2) Listing of susceptibility test interpretive criteria
standards.--
``(A) In general.--The list described in paragraph (1)
shall consist of any new or updated susceptibility test
interpretive criteria standards that are--
``(i) established by a nationally or internationally
recognized standard development organization that--
``(I) establishes and maintains procedures to address
potential conflicts of interest and ensure transparent
decisionmaking;
``(II) 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
``(III) permits its standards to be made publicly
available, through the National Library of Medicine or
another similar source acceptable to the Secretary; and
``(ii) recognized in whole, or in part, by the Secretary
under subsection (c).
``(B) Other list.--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--
``(i) the Secretary does not recognize, in whole or in
part, an interpretive criteria standard described under
subparagraph (A) otherwise applicable to such a drug;
``(ii) the Secretary withdraws under subsection (c)(1)(B)
recognition of a standard, in whole or in part, otherwise
applicable to such a drug;
``(iii) the Secretary approves an application under section
505 of this Act or section 351 of the
[[Page H5049]]
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
``(iv) because the characteristics of such a drug differ
from other drugs with the same active ingredient, the
interpretive criteria with respect to such drug--
``(I) differ from otherwise applicable interpretive
criteria included in a standard listed under subparagraph (A)
or interpretive criteria otherwise listed under this
subparagraph; and
``(II) are determined by the Secretary to be appropriate
for the drug.
``(C) Required statements of limitations of information.--
The Interpretive Criteria Website shall include the
following:
``(i) A statement that--
``(I) the website provides information about the
susceptibility of bacteria, fungi, or other microorganisms to
a certain drug (or drugs); and
``(II) 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.
``(ii) 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.
``(iii) 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.
``(3) Notice.--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.
``(4) Inapplicability of misbranding provision.--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.
``(5) Trade secrets and confidential information.--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.
``(c) Recognition of Susceptibility Test Interpretive
Criteria From Standard Development Organizations.--
``(1) In general.--Beginning on the date of the
establishment of the Interpretive Criteria Website, and at
least every 6 months thereafter, the Secretary shall--
``(A) 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
``(B) publish on the public website of the Food and Drug
Administration a notice--
``(i) withdrawing recognition of any different
susceptibility test interpretive criteria standard, in whole
or in part;
``(ii) recognizing the new or updated standards;
``(iii) 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
``(iv) making any necessary updates to the lists under
subsection (b)(2).
``(2) Bases for updating interpretive criteria standards.--
In evaluating new or updated susceptibility test interpretive
criteria standards under paragraph (1)(A), the Secretary may
consider--
``(A) 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;
``(B) information provided by interested third parties,
including public comment on the annual compilation of notices
published under paragraph (3);
``(C) any bases used to identify susceptibility test
interpretive criteria under subsection (a)(2); and
``(D) such other information or factors as the Secretary
determines appropriate.
``(3) Annual compilation of notices.--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--
``(A) recognized by the Secretary under this subsection; or
``(B) otherwise listed on the Interpretive Criteria Website
under subsection (b)(2).
``(4) Relation to section 514(c).--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).
``(5) Voluntary use of interpretive criteria.--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).
``(d) Antimicrobial Drug Labeling.--
``(1) Drugs marketed prior to establishment of interpretive
criteria website.--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--
``(A) 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
``(B) may begin distribution of the drug involved upon
receipt by the Secretary of the supplemental application for
such change.
``(2) Drugs marketed subsequent to establishment of
interpretive criteria website.--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.
``(e) Special Condition for Marketing of Antimicrobial
Susceptibility Testing Devices.--
``(1) In general.--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.
``(2) Conditions applicable to antimicrobial susceptibility
testing devices.--The conditions specified in this paragraph
are the following:
``(A) The device is used to make a determination of
susceptibility using susceptibility test interpretive
criteria that are--
``(i) included in a standard recognized by the Secretary
under subsection (c); or
``(ii) otherwise listed on the Interpretive Criteria
Website under subsection (b)(2).
``(B) The labeling of such device prominently and
conspicuously--
``(i) includes a statement that--
``(I) the device provides information about the
susceptibility of bacteria and fungi to certain drugs; and
``(II) 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;
``(ii) 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
``(iii) includes any other statement the Secretary
determines appropriate to adequately convey the limitations
of the data supporting the interpretive criteria described in
subparagraph (A).
``(f) Definitions.--In this section:
``(1) The term `antimicrobial susceptibility testing
device' 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).
``(2) The term `qualified infectious disease product' means
a qualified infectious disease product designated under
section 505E(d).
``(3) The term `susceptibility test interpretive criteria'
means--
``(A) one or more specific numerical values which
characterize the susceptibility of bacteria or other
microorganisms to the drug tested; and
``(B) related categorizations of such susceptibility,
including categorization of the drug as susceptible,
intermediate, resistant, or such other term as the Secretary
determines appropriate.
``(4)(A) The term `antimicrobial drug' means, subject to
subparagraph (B), a systemic antibacterial or antifungal drug
that--
``(i) is intended for human use in the treatment of a
disease or condition caused by a bacterium or fungus;
``(ii) may include a qualified infectious disease product
designated under section 505E(d); and
``(iii) is subject to section 503(b)(1).
``(B) If provided by the Secretary through regulations,
such term may include--
``(i) drugs other than systemic antibacterial and
antifungal drugs; and
``(ii) biological products (as such term is defined in
section 351 of the Public Health Service Act) to the extent
such products exhibit antimicrobial activity.
``(g) Rule of Construction.--Nothing in this section shall
be construed--
``(1) to alter the standards of evidence--
``(A) 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
``(B) with respect to marketing authorization for devices,
under section 510, 513, or 515;
``(2) to apply with respect to any drug, device, or
biological product, in any context other than--
``(A) an antimicrobial drug; or
``(B) 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
``(3) unless specifically stated, to have any effect on
authorities provided under other sections of this Act,
including any regulations issued under such sections.''.
(b) Conforming Amendments.--
(1) Repeal of related authority.--Section 1111 of the Food
and Drug Administration
[[Page H5050]]
Amendments Act of 2007 (42 U.S.C. 247d-5a; relating to
identification of clinically susceptible concentrations of
antimicrobials) is repealed.
(2) Clerical amendment.--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.
(3) Misbranding.--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:
``(ee) If it is an antimicrobial drug and its labeling
fails to conform with the requirements under section
511(d).''.
(4) Recognition of interpretive criteria as device
standard.--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 ``the Secretary shall, by publication in the
Federal Register'' the following: ``(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)''.
(c) Report to Congress.--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.
(d) Requests for Updates to Interpretive Criteria
Website.--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).
(e) No Effect on Health Care Practice.--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.
SEC. 2123. ENCOURAGING THE DEVELOPMENT AND USE OF DISARM
DRUGS.
(a) Additional Payment for DISARM Drugs Under Medicare.--
(1) In general.--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:
``(M)(i) 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--
``(I) include a list of the DISARM drugs for such fiscal
year; and
``(II) 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.
``(ii) Additional payments may not be made for a drug under
this subparagraph--
``(I) 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
``(II) with respect to which payment has ever been made
pursuant to subparagraph (K).
``(iii) For purposes of this subparagraph, the term `DISARM
drug' 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--
``(I) for which there is an unmet medical need; and
``(II) 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.
``(iv) For purposes of clause (iii), the term
`antimicrobial product' means a product that either--
``(I) 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
``(II) meets the definition of a qualified infectious
disease product under section 505E(g) of the Federal Food,
Drug, and Cosmetic Act.
Such determination may be revoked only upon a finding that
the request for such determination contained an untrue
statement of material fact.
``(v) For purposes of this subparagraph, the term `eligible
hospital' 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).
``(vi) 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.
``(vii) As part of the rulemaking referred to in clause (i)
for each fiscal year, the Secretary shall estimate--
``(I) total add-on payments (as defined in subclause (I) of
clause (ix)); and
``(II) total hospital payments (as defined in subclause
(II) of such clause).
``(viii) 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.
``(ix) In this subparagraph:
``(I) The term `total add-on payments' 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).
``(II) The term `total hospital payments' means, with
respect to a fiscal year, the total amount of payments made
under this subsection for all discharges in such fiscal
year.''.
(2) Conforming amendments.--
(A) No duplicative ntap payments.--Section
1886(d)(5)(K)(vi) of the Social Security Act (42 U.S.C.
1395ww(d)(5)(K)(vi)) is amended by inserting ``and if
additional payment has never been made under this subsection
pursuant to subparagraph (M) with respect to the service or
technology'' before the period at the end.
(B) Access to price information.--Section 1927(b)(3)(A) of
the Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)) is
amended--
(i) in clause (ii)--
(I) by striking ``for each'' and inserting ``, for each'';
and
(II) by striking ``and'' at the end;
(ii) in clause (iii)--
(I) in subclause (II), by inserting ``or under section
1886(d) pursuant to paragraph (5)(M) of such section,'' after
``1847A,'';
(II) in the matter following subclause (III), by striking
``or 1881(b)(13)(A)(ii)'' and inserting ``, section
1881(b)(13)(A)(ii), or section 1886(d)(5)(M)''; and
(III) by striking the period at the end and inserting ``;
and''; and
(iii) in clause (iv), by striking the semicolon at the end
and inserting a period.
(b) Study and Report on Removing Barriers to Development of
DISARM Drugs.--
(1) Study.--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--
(A) 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
(B) develop recommendations for actions to be taken in
order to overcome any barriers identified under subparagraph
(A).
(2) Report.--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).
Subtitle H--Vaccine Access, Certainty, and Innovation
SEC. 2141. TIMELY REVIEW OF VACCINES BY THE ADVISORY
COMMITTEE ON IMMUNIZATION PRACTICES.
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:
``(10) Advisory committee on immunization practices.--
``(A) Standard periods of time for making
recommendations.--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.
``(B) Expedited review pursuant to request by sponsor or
manufacturer.--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.
``(C) Expedited review for breakthrough therapies and for
use during public health emergencies.--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.
``(D) Definition.--In this paragraph, the terms `Advisory
Committee on Immunization Practices' and `Advisory Committee'
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.''.
SEC. 2142. REVIEW OF PROCESSES AND CONSISTENCY OF ACIP
RECOMMENDATIONS.
(a) Review.--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.
(b) Considerations.--The review under subsection (a) shall
include assessment of--
(1) the criteria used to evaluate new and existing
vaccines;
(2) 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
(3) the extent to which the processes used by the working
groups of the Advisory Committee on Immunization Practices
are consistent among groups.
(c) Stakeholders.--In carrying out the review under
subsection (a), the Director of the
[[Page H5051]]
Centers for Disease Control and Prevention shall solicit
input from vaccine stakeholders.
(d) Report.--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.
(e) Definition.--In this section, the term ``Advisory
Committee on Immunization Practices'' 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.
SEC. 2143. MEETINGS BETWEEN CDC AND VACCINE DEVELOPERS.
Section 310 of the Public Health Service Act (42 U.S.C.
242o) is amended by adding at the end the following:
``(c)(1) In this subsection, the term `vaccine developer'
means a nongovernmental entity engaged in--
``(A)(i) the development of a vaccine with the intent to
pursue licensing of the vaccine by the Food and Drug
Administration; or
``(ii) the production of a vaccine licensed by the Food and
Drug Administration; and
``(B) vaccine research.
``(2)(A) 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--
``(i) public health needs, epidemiology, and implementation
considerations with regard to a vaccine developer's potential
vaccine profile; and
``(ii) potential implications of such perspectives for the
vaccine developer's vaccine research and development
planning.
``(B) 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--
``(i) the Food and Drug Administration; and
``(ii) the National Vaccine Program.
``(C) 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.
``(3)(A) 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--
``(i) are specified in the request;
``(ii) have been published;
``(iii) have been performed by or are in the possession of
the Centers;
``(iv) 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
``(v) do not contain individually identifiable information.
``(B) 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.
``(4) The Secretary shall promptly notify a vaccine
developer if--
``(A) the Secretary becomes aware of any significant change
to information that was--
``(i) shared by the Secretary with the vaccine developer
during a meeting under paragraph (2); or
``(ii) provided by the Secretary to the vaccine developer
in one or more analyses under paragraph (3); and
``(B) the change to such information may have implications
for the vaccine developer's vaccine research and
development.''.
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.
(a) In General.--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:
``SEC. 505I. EXTENSION OF EXCLUSIVITY PERIODS FOR A DRUG
APPROVED FOR A NEW INDICATION FOR A RARE
DISEASE OR CONDITION.
``(a) Designation.--
``(1) In general.--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--
``(A) 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;
``(B)(i) 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
``(ii) the Secretary approves the application or
supplemental application; and
``(C) 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.
``(2) Revocation of designation.--
``(A) In general.--Except as provided in subparagraph (B),
a designation under paragraph (1) shall not be revoked for
any reason.
``(B) Exception.--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.
``(3) Notification prior to discontinuance of production
for solely commercial reasons.--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.
``(4) Notice to public.--Notice respecting the designation
of a drug under paragraph (1) shall be made available to the
public.
``(b) Extension.--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)--
``(1)(A) the 4-, 5-, and 7\1/2\-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
``(B) 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
``(2)(A) 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
``(B) 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).
``(c) Relation to Pediatric and Qualified Infectious
Disease Product Exclusivity.--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.
``(d) Limitations.--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).
``(e) Definition.--In this section, the term `rare disease
or condition' has the meaning given to such term in section
526(a)(2).''.
(b) Application.--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.
(c) Conforming Amendments.--
(1) Relation to pediatric exclusivity for drugs.--Section
505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a) is amended--
(A) in subsection (b), by adding at the end the following:
``(3) Relation to exclusivity for a drug approved for a new
indication for a rare disease or condition.--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.''; and
(B) in subsection (c), by adding at the end the following:
``(3) Relation to exclusivity for a drug approved for a new
indication for a rare disease or condition.--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.''.
(2) Relation to exclusivity for new qualified infectious
disease products that are drugs.--Subsection (b) of section
505E of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355f) is amended--
(A) by amending the subsection heading to read as follows:
``Relation to Pediatric Exclusivity and Exclusivity for a
Drug Approved for a New Indication for a Rare Disease or
Condition.--''; and
[[Page H5052]]
(B) by striking ``any extension of the period under section
505A'' and inserting ``any extension of the periods under
sections 505A and 505G, as applicable,''.
(3) Relation to pediatric exclusivity for biological
products.--Section 351(m) of the Public Health Service Act
(42 U.S.C. 262(m)) is amended by adding at the end the
following:
``(5) Relation to exclusivity for a biological product
approved for a new indication for a rare disease or
condition.--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.''.
SEC. 2152. REAUTHORIZATION OF RARE PEDIATRIC DISEASE PRIORITY
REVIEW VOUCHER INCENTIVE PROGRAM.
(a) In General.--Section 529 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360ff) is amended--
(1) in subsection (a)--
(A) in paragraph (3), by amending subparagraph (A) to read
as follows:
``(A) 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.''; and
(B) in paragraph (4)--
(i) in subparagraph (E), by striking ``and'' at the end;
(ii) in subparagraph (F), by striking the period at the end
and inserting ``; and''; and
(iii) by adding at the end the following:
``(G) 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).''; and
(2) in subsection (b), by striking paragraph (5) and
inserting the following:
``(5) Termination of authority.--
``(A) In general.--The Secretary may not award any priority
review vouchers under paragraph (1) after December 31, 2018.
``(B) Exception.--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 21st Century Cures Act 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.''.
(b) GAO Study and Report.--
(1) Study.--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:
(A) 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).
(B) Whether the priority review voucher impacted a
sponsor's decision to invest in developing a drug to treat or
prevent a rare pediatric disease.
(C) An analysis of the drugs that utilized such priority
review vouchers, which shall include--
(i) 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);
(ii) whether unmet medical needs were addressed through the
approval of such drugs, including, for each such drug--
(I) if an alternative therapy was previously available to
treat the indication; and
(II) the benefit or advantage the drug provided over
another available therapy;
(iii) the number of patients potentially treated by such
drugs;
(iv) the value of the priority review voucher if
transferred; and
(v) the length of time between the date on which a priority
review voucher was awarded and the date on which it was used.
(D) With respect to the priority review voucher program
under section 529 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360ff)--
(i) 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;
(ii) 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
(iii) alternative approaches to improving such program so
that the program is appropriately targeted toward providing
incentives for the development of clinically important drugs
that--
(I) prevent or treat rare pediatric diseases; and
(II) would likely not otherwise have been developed to
prevent or treat such diseases.
(2) Report.--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).
Subtitle J--Domestic Manufacturing and Export Efficiencies
SEC. 2161. GRANTS FOR STUDYING THE PROCESS OF CONTINUOUS DRUG
MANUFACTURING.
(a) In General.--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.
(b) Definitions.--In this section:
(1) The term ``drug'' has the meaning given to such term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321).
(2) The term ``biological product'' has the meaning given
to such term in section 351(i) of the Public Health Service
Act (42 U.S.C. 262(i)).
(3) The term ``institution of higher education'' has the
meaning given to such term in section 101 of the Higher
Education Act of 1965 (20 U.S.C. 1001).
(c) Authorization of Appropriations.--There is authorized
to be appropriated to carry out this section $5,000,000 for
each of fiscal years 2016 through 2020.
SEC. 2162. RE-EXPORTATION AMONG MEMBERS OF THE EUROPEAN
ECONOMIC AREA.
Section 1003 of the Controlled Substances Import and Export
Act (21 U.S.C. 953) is amended--
(1) in subsection (f)--
(A) in paragraph (5)--
(i) by striking ``(5)'' and inserting ``(5)(A)'';
(ii) by inserting ``, except that the controlled substance
may be exported from the second country to another country
that is a member of the European Economic Area'' before the
period at the end; and
(iii) by adding at the end the following:
``(B) 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--
``(i) 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
``(ii) 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.''; and
(B) in paragraph (6)--
(i) by striking ``(6)'' and inserting ``(6)(A)''; and
(ii) by adding at the end the following:
``(B) 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--
``(i) documentation certifying that such re-exportation has
occurred; and
``(ii) information concerning the consignee, country, and
product.''; and
(2) by adding at the end the following:
``(g) Limitation.--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--
``(1) 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
``(2) 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.''.
Subtitle K--Enhancing Combination Products Review
SEC. 2181. ENHANCING COMBINATION PRODUCTS REVIEW.
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:
``(iii) Not later than 18 months after the date of the
enactment of the 21st Century Cures Act, 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.''.
Subtitle L--Priority Review for Breakthrough Devices
SEC. 2201. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.
(a) In General.--Chapter V of the Federal Food, Drug, and
Cosmetic Act is amended--
(1) in section 515(d)--
(A) by striking paragraph (5); and
(B) by redesignating paragraph (6) as paragraph (5); and
(2) by inserting after section 515A (21 U.S.C. 360e-1) the
following:
``SEC. 515B. PRIORITY REVIEW FOR BREAKTHROUGH DEVICES.
``(a) In General.--In order to provide for more effective
treatment or diagnosis of life-threatening or irreversibly
debilitating human diseases or conditions, the Secretary
shall establish a program to provide priority review for
devices--
[[Page H5053]]
``(1) representing breakthrough technologies;
``(2) for which no approved alternatives exist;
``(3) 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
``(4) the availability of which is in the best interest of
patients.
``(b) Request for Designation.--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).
``(c) Designation Process.--
``(1) In general.--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.
``(2) Review.--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.
``(3) Designation determination.--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).
``(4) Reconsideration.--
``(A) Request for reconsideration.--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)--
``(i) based upon the submission of documents by such
person; or
``(ii) based upon such documents and a meeting or
teleconference.
``(B) Response.--Reconsideration of a designation
determination under this paragraph shall be conducted in
accordance with section 517A(b).
``(5) Withdrawal.--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--
``(A) this section; or
``(B) section 515(d)(5) (as in effect immediately prior to
the enactment of the 21st Century Cures Act).
``(d) Priority Review.--
``(1) Actions.--For purposes of expediting the development
and review of devices designated under subsection (c), the
Secretary shall--
``(A) 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);
``(B) 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;
``(C) adopt an efficient process for timely dispute
resolution;
``(D) provide for interactive communication with the
sponsor of the device during the review process;
``(E) expedite the Secretary's review of manufacturing and
quality systems compliance, as applicable;
``(F) 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;
``(G) 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
``(H) 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).
``(2) Additional actions.--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--
``(A) coordinate with the sponsor regarding early agreement
on a data development plan;
``(B) 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;
``(C) 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
``(D) agree to clinical protocols that the Secretary will
consider binding on the Secretary and the sponsor, subject
to--
``(i) changes agreed to by the sponsor and the Secretary;
``(ii) changes that the Secretary determines are required
to prevent an unreasonable risk to the public health; or
``(iii) the identification of a substantial scientific
issue determined by the Secretary to be essential to the
safety or effectiveness of the device involved.
``(e) Priority Review Guidance.--
``(1) Content.--The Secretary shall issue guidance on the
implementation of this section. Such guidance shall include
the following:
``(A) The process for a person to seek a priority review
designation.
``(B) A template for requests under subsection (b).
``(C) The criteria the Secretary will use in evaluating a
request for priority review.
``(D) 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.
``(2) Process.--Prior to finalizing the guidance under
paragraph (1), the Secretary shall propose such guidance for
public comment.
``(f) Construction.--
``(1) Purpose.--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.
``(2) Construction.--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.''.
(b) Conforming Amendment Related to Designation
Determinations.--Section 517A(a)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360g-1(a)(1)) is amended by
inserting ``a request for designation under section 515B,''
after ``an application under section 515,''.
Subtitle M--Medical Device Regulatory Process Improvements
SEC. 2221. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.
(a) Establishment of Third-Party Quality System Assessment
Program.--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:
``SEC. 524B. THIRD-PARTY QUALITY SYSTEM ASSESSMENT.
``(a) Accreditation and Assessment.--
``(1) In general; certification of device quality system.--
The Secretary shall, in accordance with this section,
establish a third-party quality system assessment program--
``(A) 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;
``(B) 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
``(C) 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:
``(i) A premarket notification.
``(ii) A thirty-day notice.
``(iii) A Special PMA supplement.
``(2) Definitions.--For purposes of this sectionU
``(A) the term `device-related changes' means changes made
by a requestor with respect to in-scope devices, which are--
``(i) changes to a device found to be substantially
equivalent under sections 513(i) and 510(k) to a predicate
device, that--
``(I) would otherwise be subject to a premarket
notification; and
``(II) do not alter--
``(aa) the intended use of the changed device; or
``(bb) the fundamental scientific technology of such
device;
``(ii) manufacturing changes subject to a 30-day notice;
``(iii) changes that qualify for a Special PMA Supplement;
and
``(iv) such other changes relating to the devices or the
device manufacturing process as the Secretary determines
appropriate;
``(B) the term `in-scope device' 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;
``(C) the term `premarket notification' means a premarket
notification under section 510(k);
``(D) the term `quality system' 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);
``(E) the term `requestor' means a device manufacturer that
is seeking certification under this section of a quality
system used by such manufacturer;
``(F) the term `Special PMA' means a Special PMA supplement
under section 814.39(d) of title 21, Code of Federal
Regulations (or any successor regulations); and
``(G) the term `thirty-day notice' means a notice described
in section 515(d)(6).
[[Page H5054]]
``(3) Accreditation process; accreditation renewal.--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.
``(4) Use of accredited parties to conduct assessments.--
``(A) Initiation of assessment services.--
``(i) Date assessments authorized.--Beginning after the
date on which the final guidance is issued under paragraph
(5), an accredited person may conduct an assessment under
this section.
``(ii) Initiation of assessments.--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.
``(B) Compensation.--Compensation for such accredited
persons shall--
``(i) be determined by agreement between the accredited
person and the person who engages the services of the
accredited person; and
``(ii) be paid by the person who engages such services.
``(C) Accredited person selection.--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).
``(5) Guidance; criteria for certification.--
``(A) In general.--The criteria for certification of a
quality system under this section shall be as specified by
the Secretary in guidance issued under this paragraph.
``(B) Contents; criteria.--The guidance under this
paragraph shall include specification of--
``(i) 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
``(ii) criteria for accredited persons to apply for a
waiver of, and exemptions from, the criteria under clause
(i).
``(C) Timeframe for issuing guidance.--The Secretary shall
issue under this paragraph--
``(i) draft guidance not later than 12 months after the
enactment of the 21st Century Cures Act; and
``(ii) final guidance not later than 12 months after
issuance of the draft guidance under clause (i).
``(b) Use of Third-Party Assessment.--
``(1) Assessment summary; certification.--
``(A) Submission of assessment to secretary.--An accredited
person who assesses a requestor's quality system under
subsection (a) shall submit to the Secretary a summary of the
assessment--
``(i) within 30 days of the assessment; and
``(ii) which shall include (as applicable)--
``(I) 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
``(II) any waivers or exemptions from such criteria applied
by the accredited person.
``(B) Treatment of assessments.--Subject to action by the
Secretary under subparagraph (C), with respect to assessments
which include a certification under this section--
``(i) 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
``(ii) the assessment summary and certification of the
quality system of a requestor shall be deemed accepted by the
Secretary on such 30th day.
``(C) Actions by secretary.--
``(i) In general.--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)--
``(I) additional information is needed to support such
certification;
``(II) such assessment or certification is unwarranted; or
``(III) such action with regard to the certification is
otherwise justified according to such factors and criteria as
the Secretary finds appropriate.
``(ii) Acceptance of certification.--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.
``(2) Notifications to secretary by certified requestors or
accredited persons for program evaluation purposes.--
``(A) Annual summary report for device-related changes
otherwise subject to premarket notification.--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--
``(i) describes the changes made to the in-scope device;
and
``(ii) indicates the effective dates of such changes.
``(B) Periodic notification for manufacturing changes
otherwise subject to thirty-day notice.--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--
``(i) describe the changes made; and
``(ii) indicate the effective dates of such changes.
``(C) Periodic notification for device-related changes
otherwise subject to special pma supplement.--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--
``(i) describe the changes made, including a full
explanation of the basis for the changes; and
``(ii) indicate the effective dates of such changes.
``(D) Use of notifications for program evaluation
purposes.--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).
``(c) Duration and Effect of Certification.--A
certification under this section--
``(1) shall remain in effect for a period of 2 years from
the date such certification is accepted by the Secretary,
subject to paragraph (6);
``(2) may be renewed through the process described in
subsection (a)(3);
``(3) 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;
``(4) 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);
``(5) 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
``(6) 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.
``(d) Notice of Revocation.--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.
``(e) Program Evaluation; Sunset.--
``(1) Program evaluation and report.--
``(A) Evaluation.--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--
``(i) 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
``(ii) such other available information and data as the
Secretary determines appropriate.
``(B) Report.--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--
``(i) device submissions beyond those identified in
subsection (a)(1)(C); and
``(ii) device changes beyond those described in subsection
(a)(2)(A).
``(2) Sunset.--This section shall cease to be effective
October 1, 2022.
``(f) Rule of Construction.--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.''.
(b) Conforming Amendments.--
(1) Requirements for premarket approval supplements.--
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 ``, subject to
section 524B'' after ``that affects safety or
effectiveness''.
(2) Requirements for thirty-day notice.--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 ``, subject to section
524B'' after ``the date on which the Secretary receives the
notice''.
(3) Requirements for premarket notification; technical
correction to reference to section 510(k).--Section 510(l) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(l))
is amended by striking ``of this subsection under subsection
(m)'' and inserting ``of subsection (k) under subsection (m)
or section 524B''.
(4) Misbranded devices.--Section 502(t) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 352(t)) is amended by
inserting ``or 524B'' after ``section 519''.
[[Page H5055]]
SEC. 2222. VALID SCIENTIFIC EVIDENCE.
Section 513(a)(3)(B) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c(a)(3)(B)) is amended--
(1) by redesignating clauses (i) and (ii) as subclauses (I)
and (II), respectively;
(2) by striking ``(B) If the Secretary'' and inserting
``(B)(i) If the Secretary''; and
(3) by adding at the end the following:
``(ii) For purposes of clause (i), valid scientific
evidence may include--
``(I) 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;
``(II) studies published in peer-reviewed journals; and
``(III) data collected in countries other than the United
States so long as such data otherwise meet the criteria
specified in this subparagraph.
``(iii) 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--
``(I) 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;
``(II) the Secretary furnishes a written rationale for so
requesting the underlying data together with such request;
and
``(III) 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.''.
SEC. 2223. TRAINING AND OVERSIGHT IN LEAST BURDENSOME
APPROPRIATE MEANS CONCEPT.
(a) In General.--Section 513 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c) is amended by adding at the end
the following:
``(j) Training and Oversight in Least Burdensome
Appropriate Means Concept.--
``(1) Training.--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).
``(2) Guidance documents.--
``(A) Draft updated guidance.--Not later than 12 months
after the date of enactment of the 21st Century Cures Act,
the Secretary shall issue a draft guidance document updating
the October 4, 2002, guidance document entitled `The Least
Burdensome Provision of the FDA Modernization Act of 1997:
Concept and Principles; Final Guidance for FDA and Industry'.
``(B) Meeting of stakeholders.--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.
``(3) Ombudsman audit.--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--
``(A) conduct, or have conducted, an audit of the training
described in paragraph (1); and
``(B) include in such audit interviews with a
representative sample of persons from industry regarding
their experience in the device premarket review process.''.
(b) Additional Information Regarding Premarket
Applications.--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:
``(5)(A) 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.
``(B) For purposes of subparagraph (A), the term
`necessary' 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.
``(C) Nothing in this paragraph alters the standards for
premarket approval of a device.''.
SEC. 2224. RECOGNITION OF STANDARDS.
Section 514(c) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360d(c)) is amended--
(1) in paragraph (1), by inserting after subparagraph (B)
the following new subparagraphs:
``(C)(i) 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.
``(ii) Not later than 60 days after the Secretary receives
such a request, the Secretary shall--
``(I) make a determination to recognize all, part, or none
of the standard that is the subject of the request; and
``(II) 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.
``(iii) The Secretary shall make a response issued under
clause (ii)(II) publicly available, in such manner as the
Secretary determines appropriate.
``(iv) 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).
``(D) 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.''; and
(2) by adding at the end the following new paragraphs:
``(4) Training on use of standards.--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.
``(5) Guidance.--
``(A) Draft guidance.--The Secretary shall publish guidance
identifying the principles for recognizing standards under
this section. In publishing such guidance, the Secretary
shall consider--
``(i) the experience with, and reliance on, a standard by
other Federal regulatory authorities and the device industry;
and
``(ii) whether recognition of a standard will promote
harmonization among regulatory authorities in the regulation
of devices.
``(B) Timing.--The Secretary shall publish--
``(i) draft guidance under subparagraph (A) not later than
12 months after the date of the enactment of the 21st Century
Cures Act; and
``(ii) final guidance not later than 12 months after the
close of the public comment period for the draft guidance
under clause (i).''.
SEC. 2225. EASING REGULATORY BURDEN WITH RESPECT TO CERTAIN
CLASS I AND CLASS II DEVICES.
(a) Class I Devices.--Section 510(l) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360(l)) is amended--
(1) by striking ``A report under subsection (k)'' and
inserting ``(1) A report under subsection (k)''; and
(2) by adding at the end the following new paragraph:
``(2) Not later than 120 days after the date of the
enactment of the 21st Century Cures Act, 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--
``(A) each type of class I device so identified shall be
exempt from the requirement for a report under subsection
(k); and
``(B) the classification regulation applicable to each such
type of device shall be deemed amended to incorporate such
exemption.''.
(b) Class II Devices.--Section 510(m) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360(m)) is amended--
(1) by striking paragraph (1) and inserting the following
new paragraph: ``(1) The Secretary shall--
``(A) not later than 60 days after the date of the
enactment of the 21st Century Cures Act--
``(i) 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
``(ii) provide for a period of not less than 60 days for
public comment beginning on the date of the publication of
such notice; and
``(B) not later than 180 days after the date of the
enactment of 21st Century Cures Act, 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).'';
(2) in paragraph (2)--
(A) by striking ``1 day after the date of the publication
of a list under this subsection,'' and inserting ``1 day
after the date of publication of the final list under
paragraph (1)(B),''; and
(B) by striking ``30-day period'' and inserting ``60-day
period''; and
(3) by adding at the end the following new paragraph:
``(3) Upon the publication of the final list under
paragraph (1)(B)--
``(A) each type of class II device so listed shall be
exempt from the requirement for a report under subsection
(k); and
``(B) the classification regulation applicable to each such
type of device shall be deemed amended to incorporate such
exemption.''.
SEC. 2226. ADVISORY COMMITTEE PROCESS.
(a) Classification Panels.--Paragraph (5) of section 513(b)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360c(b)) is amended--
(1) by striking ``(5)'' and inserting ``(5)(A)''; and
(2) by adding at the end the following:
``(B) When a device is specifically the subject of review
by a classification panel, the Secretary shall--
``(i) ensure that adequate expertise is represented on the
classification panel to assess--
``(I) the disease or condition which the device is intended
to cure, treat, mitigate, prevent, or diagnose; and
``(II) the technology of the device; and
``(ii) 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.
``(C) For purposes of subparagraph (B)(ii), the term
`adequate expertise' means, with respect to the membership of
the classification panel reviewing a premarket submission,
that such membership includes--
``(i) two or more voting members, with a specialty or other
expertise clinically relevant to the device under review; and
``(ii) at least one voting member who is knowledgeable
about the technology of the device.''.
[[Page H5056]]
(b) Panel Review Process.--Section 513(b)(6) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360c(b)(6)) is
amended--
(1) in subparagraph (A)(iii), by inserting before the
period at the end ``, 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''; and
(2) by striking subparagraph (B) and inserting the
following new subparagraph:
``(B)(i) Any meeting of a classification panel for a device
that is specifically the subject of review shall--
``(I) 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
``(II) encourage free and open participation by all
interested persons.
``(ii) Following the initial presentations described in
clause (i), the panel may--
``(I) pose questions to a designated representative
described in subparagraph (A)(iii); and
``(II) consider the responses to such questions in the
panel's review of the device that is specifically the subject
of review by the panel.''.
SEC. 2227. HUMANITARIAN DEVICE EXEMPTION APPLICATION.
(a) In General.--Section 520(m) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j) is amended--
(1) in paragraph (1) by striking ``fewer than 4,000'' and
inserting ``not more than 8,000'';
(2) in paragraph (2)(A) by striking ``fewer than 4,000''
and inserting ``not more than 8,000''; and
(3) in paragraph (6)(A)(ii), by striking ``4,000'' and
inserting ``8,000''
(b) Guidance Document on Probable Benefit.--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
``probable benefit'' 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)).
SEC. 2228. CLIA WAIVER STUDY DESIGN GUIDANCE FOR IN VITRO
DIAGNOSTICS.
(a) Draft Revised Guidance.--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--
(1) revises ``Section V. Demonstrating Insignificant Risk
of an Erroneous Result--`Accuracy' '' of the guidance
entitled ``Recommendations for Clinical Laboratory
Improvement Amendments of 1988 (CLIA) Waiver Applications for
Manufacturers of In Vitro Diagnostic Devices'' and dated
January 30, 2008; and
(2) includes guidance on the appropriate use of comparable
performance between a waived user and a moderately complex
laboratory user to demonstrate accuracy.
(b) Final Revised Guidance.--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.
Subtitle N--Sensible Oversight for Technology Which Advances Regulatory
Efficiency
SEC. 2241. HEALTH SOFTWARE.
Section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321) is amended by adding at the end the following:
``(ss)(1) The term `health software' 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--
``(A) is intended for use for administrative or operational
support or the processing and maintenance of financial
records;
``(B) is intended for use in clinical, laboratory, or
administrative workflow and related recordkeeping;
``(C)(i) 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;
``(ii) utilizes a connectivity software platform,
electronic or electrical hardware, or a physical
communications infrastructure; and
``(iii) is not intended for use--
``(I) in active patient monitoring; or
``(II) in controlling or altering the functions or
parameters of a device that is connected to such software;
``(D) 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;
``(E) 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
``(F) 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.
``(2) The term `accessory' means a product that--
``(A) is intended for use with one or more parent devices;
``(B) is intended to support, supplement, or augment the
performance of one or more parent devices; and
``(C) shall be classified by the Secretary--
``(i) according to its intended use; and
``(ii) independently of any classification of any parent
device with which it is used.''.
SEC. 2242. APPLICABILITY AND INAPPLICABILITY OF REGULATION.
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:
``SEC. 524C. HEALTH SOFTWARE.
``(a) Inapplicability of Regulation to Health Software.--
Except as provided in subsection (b), health software shall
not be subject to regulation under this Act.
``(b) Exception.--
``(1) In general.--Subsection (a) shall not apply with
respect to a software product--
``(A) of a type described in subparagraph (F) of section
201(ss)(1); and
``(B) that the Secretary determines poses a significant
risk to patient safety.
``(2) Considerations.--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:
``(A) The likelihood and severity of patient harm if the
product were to not perform as intended.
``(B) The extent to which the product is intended to
support the clinical judgment of a medical professional.
``(C) Whether there is a reasonable opportunity for a
medical professional to review the basis of the information
or treatment recommendation provided by the product.
``(D) 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).
``(c) Delegation.--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.
``(d) Regulation of Software.--
``(1) In general.--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.
``(2) Issuance by order.--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.
``(3) Areas under review.--The review of existing
regulations and guidance under paragraph (1) may include
review of the following areas:
``(A) Classification of software.
``(B) Standards for development of software.
``(C) Standards for validation and verification of
software.
``(D) Review of software.
``(E) Modifications to software.
``(F) Manufacturing of software.
``(G) Quality systems for software.
``(H) Labeling requirements for software.
``(I) Postmarketing requirements for reporting of adverse
events.
``(4) Process for issuing proposed regulations,
administrative order, and guidance.--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.
``(e) Rule of Construction.--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.''.
SEC. 2243. EXCLUSION FROM DEFINITION OF DEVICE.
Section 201(h) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321) is amended--
(1) in subparagraph (2), by striking ``or'' after ``or
other animals,'';
(2) in subparagraph (3), by striking ``and'' and inserting
``or''; and
(3) by inserting after subparagraph (3) the following:
``(4) not health software (other than software determined
to be a risk to patient safety under section 524B(b)), and''.
Subtitle O--Streamlining Clinical Trials
SEC. 2261. PROTECTION OF HUMAN SUBJECTS IN RESEARCH;
APPLICABILITY OF RULES.
(a) In General.--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).
(b) Avoiding Regulatory Duplication and Unnecessary
Delays.--
(1) In general.--The Secretary shall--
(A) 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--
(i) to reduce regulatory duplication and unnecessary
delays;
[[Page H5057]]
(ii) to modernize such provisions in the context of
multisite and cooperative research projects; and
(iii) to incorporate local considerations, community
values, and mechanisms to protect vulnerable populations; and
(B) ensure that human subject research that is subject to
the HHS Human Subject Regulations or to the FDA Human Subject
Regulations may--
(i) use joint or shared review;
(ii) rely upon the review of--
(I) an independent institutional review board; or
(II) an institutional review board of an entity other than
the sponsor of the research; or
(iii) use similar arrangements to avoid duplication of
effort.
(2) Regulations and guidance.--Not later than 36 months
after the date of enactment of this Act, 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:
(A) Arrangements to avoid duplication described in
paragraph (1)(A)(i), including--
(i) 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;
(ii) the risks and benefits to human subjects;
(iii) standardizing the informed consent and other
processes and legal documents; and
(iv) incorporating community values through the use of
local institutional review boards while continuing to use
central or lead institutional review boards.
(B) Concerns about regulatory and legal liability
contributing to decisions by the sponsors of research to rely
on local institutional review boards for multisite research.
(3) Consultation.--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).
(c) Timing.--The Secretary shall complete the harmonization
described in subsection (a) not later than 36 months after
the date of enactment of this Act.
(d) Progress Report.--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.
(e) Draft NIH Policy.--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 ``Draft NIH Policy on Use
of a Single Institutional Review Board for Multi-Site
Research''.
(f) Definitions.--
(1) Human subject regulations.--In this section:
(A) FDA human subject regulations.--The term ``FDA Human
Subject Regulations'' means the provisions of parts 50, 56,
312, and 812 of title 21, Code of Federal Regulations (or any
successor regulations).
(B) HHS human subject regulations.--The term ``HHS Human
Subject Regulations'' means the provisions of subpart A of
part 46 of title 45, Code of Federal Regulations (or any
successor regulations).
(C) Vulnerable-populations rules.--The term ``vulnerable-
populations rules''--
(i) subject to clause (ii), means the provisions of
subparts B through D of such part 46 (or any successor
regulations); or
(ii) 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).
(2) Other definitions.--In this section:
(A) Institutional review board.--The term ``institutional
review board'' has the meaning that applies to the term
``institutional review board'' under the HHS Human Subject
Regulations.
(B) Lead institutional review board.--The term ``lead
institutional review board'' 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.
SEC. 2262. USE OF NON-LOCAL INSTITUTIONAL REVIEW BOARDS FOR
REVIEW OF INVESTIGATIONAL DEVICE EXEMPTIONS AND
HUMAN DEVICE EXEMPTIONS.
(a) In General.--Section 520 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(j)) is amended--
(1) in subsection (g)(3)--
(A) by striking ``local'' each place it appears; and
(B) in subparagraph (A)(i), by striking ``which has been'';
and
(2) in subsection (m)(4)--
(A) by striking ``local'' each place it appears; and
(B) by striking subparagraph (A) and inserting the
following new subparagraph:
``(A) 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''.
(b) Regulations.--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).
SEC. 2263. ALTERATION OR WAIVER OF INFORMED CONSENT FOR
CLINICAL INVESTIGATIONS.
(a) Devices.--Section 520(g)(3) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended--
(1) in subparagraph (D), by striking ``except where subject
to such conditions as the Secretary may prescribe, the
investigator'' and inserting the following: ``except where,
subject to such conditions as the Secretary may prescribe--
``(i) 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
``(ii) the investigator''; and
(2) in the matter following subparagraph (D), by striking
``subparagraph (D)'' and inserting ``subparagraph (D)(ii)''.
(b) Drugs.--Section 505(i)(4) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking
``except where it is not feasible or it is contrary to the
best interests of such human beings'' and inserting ``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''.
Subtitle P--Improving Scientific Expertise and Outreach at FDA
SEC. 2281. SILVIO O. CONTE SENIOR BIOMEDICAL RESEARCH
SERVICE.
(a) Hiring and Retention Authority.--Section 228 of the
Public Health Service Act (42 U.S.C. 237) is amended--
(1) in the section heading, by inserting ``and biomedical
product assessment'' after ``research'';
(2) in subsection (a)(1), by striking ``Silvio O. Conte
Senior Biomedical Research Service, not to exceed 500
members'' and inserting ``Silvio O. Conte Senior Biomedical
Research and Biomedical Product Assessment Service (in this
section referred to as the `Service'), 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'';
(3) by amending subsection (a)(2) to read as follows:
``(2) 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.'';
(4) in subsection (b)--
(A) in the matter preceding paragraph (1), by striking ``or
clinical research evaluation'' and inserting ``, clinical
research evaluation or biomedical product assessment''; and
(B) in paragraph (1), by inserting ``or a master's level
degree in engineering, bioinformatics, or a related or
emerging field,'' after the comma;
(5) in subsection (d)(2), by striking ``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'' and inserting ``and shall not
exceed the rate payable for the President'';
(6) by striking subsection (e); and
(7) by redesignating subsections (f) and (g) as subsections
(e) and (f), respectively.
(b) Report.--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.
SEC. 2282. ENABLING FDA SCIENTIFIC ENGAGEMENT.
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.
SEC. 2283. REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG
ADMINISTRATION.
(a) Board of Directors.--
(1) Composition and size.--Section 770(d)(1)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379dd(d)(1)(C)) is amended--
(A) by redesignating clause (ii) as clause (iii);
(B) by inserting after clause (i) the following:
``(ii) Additional members.--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
[[Page H5058]]
are established by such amendment) are representatives of the
general pharmaceutical, device, food, cosmetic, and
biotechnology industries.''; and
(C) in clause (iii)(I), as redesignated by subparagraph
(A), by striking ``The ex officio members shall ensure'' and
inserting ``The ex officio members, acting pursuant to clause
(i), and the Board, acting pursuant to clause (ii), shall
ensure''.
(2) Federal employees allowed to serve on board.--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: ``For purposes of this section, the term `employee
of the Federal Government' does not include a `special
Government employee', as that term is defined in section
202(a) of title 18, United States Code.''.
(3) Staggered terms.--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:
``(A) Term.--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--
``(i) 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
``(ii) 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.''.
(b) Executive Director Compensation.--Section 770(g)(2) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379dd(g)(2)) is amended by striking ``but shall not be
greater than the compensation of the Commissioner''.
(c) Separation of Funds.--Section 770(m) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379dd(m)) is amended
by striking ``are held in separate accounts from funds
received from entities under subsection (i)'' and inserting
``are managed as individual programmatic funds under
subsection (i), according to best accounting practices''.
SEC. 2284. COLLECTION OF CERTAIN VOLUNTARY INFORMATION
EXEMPTED FROM PAPERWORK REDUCTION ACT.
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:
``SEC. 708A. COLLECTION OF CERTAIN VOLUNTARY INFORMATION
EXEMPTED FROM PAPERWORK REDUCTION ACT.
``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.''.
SEC. 2285. HIRING AUTHORITY FOR SCIENTIFIC, TECHNICAL, AND
PROFESSIONAL PERSONNEL.
(a) In General.--The Federal Food, Drug, and Cosmetic Act
is amended by inserting after section 714 (21 U.S.C. 379d-3)
the following:
``SEC. 714A. ADDITIONAL HIRING AUTHORITY.
``(a) In General.--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:
``(1) The Center for Drug Evaluation and Research.
``(2) The Center for Biologics Evaluation and Research.
``(3) The Center for Devices and Radiological Health.
Such positions shall be within the competitive service.
``(b) Compensation.--
``(1) In general.--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--
``(A) the annual rate of pay of any individual appointed
under subsection (a); and
``(B) 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.
``(2) Limitation.--The annual rate of pay established
pursuant to paragraph (1) may not exceed the annual rate of
pay of the President.
``(c) Report.--
``(1) In general.--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.
``(2) Recommendations.--The report under paragraph (1)
shall include the recommendations of the Secretary on--
``(A) whether the authority to appoint personnel under this
section should be reauthorized; and
``(B) 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.''.
(b) Rule of Construction.--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.
Subtitle Q--Exempting From Sequestration Certain User Fees
SEC. 2301. EXEMPTING FROM SEQUESTRATION CERTAIN USER FEES OF
FOOD AND DRUG ADMINISTRATION.
The Balanced Budget and Emergency Deficit Control Act of
1985 is amended--
(1) in section 255(g)(1)(A) (2 U.S.C. 905(g)(1)(A)), by
inserting after the item relating to ``Financial Agent
Services'' the following new 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).''; and
(2) in section 256(h) (2 U.S.C. 906(h)), by adding at the
end the following new paragraph:
``(5) 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.''.
TITLE III--DELIVERY
Subtitle A--Interoperability
SEC. 3001. ENSURING INTEROPERABILITY OF HEALTH INFORMATION
TECHNOLOGY.
(a) Interoperability Standards.--
(1) In general.--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:
``SEC. 3010. ENSURING INTEROPERABILITY OF HEALTH INFORMATION
TECHNOLOGY.
``(a) Interoperability.--In order for health information
technology to be considered interoperable, such technology
must satisfy the following criteria:
``(1) Secure transfer.--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.
``(2) Complete access to health information.--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.
``(3) No information blocking.--The technology is not
configured, set up, or implemented to information block, as
defined in section 3010A(d).
``(b) Categories for Interoperability Standards.--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:
``(1) Vocabulary and terminology.
``(2) Content and structure.
``(3) Transport.
``(4) Security.
``(5) Services.
``(6) Querying and requesting health information for
access, exchange, and use.
``(c) Allowing for Flexibility.--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.''.
(2) Guidance.--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.
(b) Improvements to Recommendation Process.--
(1) HIT policy committee to incorporate policies for
updates to interoperability standards.--Section 3002 of the
Public Health Service Act (42 U.S.C. 300jj-12) is amended--
(A) in subsection (a)--
(i) by striking ``National Coordinator'' and inserting
``Secretary, in consultation with the National
Coordinator,''; and
(ii) by adding at the end the following new sentence: ``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.''; and
(B) in subsection (b)(2)--
(i) in subparagraph (A), in the first sentence--
(I) by striking ``The HIT Policy Committee'' and inserting
``Subject to subparagraph (D), the HIT Policy Committee'';
and
(II) by inserting ``(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)'' after ``section 3004''.
[[Page H5059]]
(ii) by adding at the end the following new subparagraph:
``(D) Special rule related to interoperability.--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.''.
(2) Sunset of hit standards committee.--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:
``(f) Termination.--The HIT Standards Committee shall
terminate on the date that is 90 days after the date of the
enactment of this subsection.''.
(3) Standards development organizations.--Title XXX of the
Public Health Service Act is amended by inserting after
section 3003 the following new section:
``SEC. 3003A. RECOMMENDATIONS FOR STANDARDS THROUGH CONTRACTS
WITH STANDARDS DEVELOPMENT ORGANIZATIONS.
``(a) Contracts.--
``(1) In general.--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.
``(2) Timing for first contract.--As soon as practicable
after the date of the enactment of this section, the
Secretary shall enter into the first contracts under
paragraph (1).
``(3) Period of contract.--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).
``(4) Appropriate entities.--The Secretary shall ensure the
most appropriate entities described in paragraph (1) are
selected for each contract under such paragraph.
``(b) Duties.--
``(1) Initial contract.--The Secretary shall initially
enter into one or more contracts under subsection (a)(1) with
entities described in such subsection, under which the
entities--
``(A) shall recommend to the Secretary--
``(i) 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
``(ii) 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
``(B) may provide to the Secretary recommendations
described in paragraph (2).
``(2) Subsequent contracts.--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--
``(A) 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
``(B) 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).
``(3) Submission to nist.--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.
``(4) Consultation.--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.
``(c) Modifications and Subsequent Contracts.--
``(1) In general.--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.
``(2) Contract trigger.--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).
``(d) Authorization of Appropriations.--There is authorized
to be appropriated $10,000,000 for contracts under subsection
(a), to remain available until expended.''.
(4) Modifications to role of the national coordinator.--
Section 3001(c)(1)(A) of the Public Health Service Act (42
U.S.C. 300jj-11(c)(1)(A)) is amended by inserting ``for
recommendations made before the date of the enactment of the
21st Century Cures Act,'' before ``review and determine''.
(c) Adoption.--Section 3004 of the Public Health Service
Act (42 U.S.C. 300jj-14) is amended--
(1) in subsection (a)--
(A) in paragraph (1), by inserting after ``section
3001(c)'' the following: ``(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)''; and
(B) in paragraph (2)(B), by striking ``and the HIT
Standards Committee'';
(2) in subsection (b)--
(A) in paragraph (3), by striking ``with the schedule
published under section 3003(b)(2)'' and inserting ``with
subsection (d)''; and
(B) by adding at the end the following new paragraph:
``(4) Limitation.--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.''; and
(3) by adding at the end the following new subsections:
``(c) Adoption of Initial Interoperability Standards and
Implementation Specifications.--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:
``(1) Review of standards.--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.
``(2) Determination to adopt.--If, subject to subsection
(d)(3), the Secretary determines--
``(A) 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
``(B) 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.
``(3) Publication.--The Secretary shall provide for
publication in the Federal Register of all determinations
made by the Secretary under paragraph (1).
``(d) Rules for Adoption.--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:
``(1) In general.--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.
``(2) Special rule if no standard, specification, or
criterion recommended.--If no standard, implementation
specification, or, to the extent necessary, certification
criterion is recommended under paragraph (1)--
``(A) in the case of interoperability standards and
implementation specifications with respect to such standards,
relating to a category described in section 3010(b)--
``(i) paragraph (1) shall not apply; and
``(ii) paragraph (4) shall apply; or
``(B) 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--
``(i) paragraph (1) shall not apply; and
``(ii) paragraph (4) shall apply.
``(3) Authority to modify implementation specifications.--
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).
``(4) Effective date.--In the case of a standard,
implementation specification, or certification criterion for
which there is a determination to adopt such standard,
implementation
[[Page H5060]]
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.
``(5) Assistance to the secretary.--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.
``(e) Allowing for Flexibility Through Compatibility With
Baseline Standards and Implementation Specifications.--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.''.
(d) Reports and Notifications.--Section 3010 of the Public
Health Service Act, as added by subsection (a), is amended by
adding at the end the following new subsection:
``(c) Dissemination of Information.--
``(1) Initial summary report.--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:
``(A) The initial set of interoperability standards and
implementation specifications adopted under section 3004(c).
``(B) The strategies for achieving widespread
interoperability.
``(C) Any barriers that are preventing widespread
interoperability.
``(D) The plan and milestones, including specific steps, to
achieve widespread interoperability.
``(2) Ongoing publication of recommendations.--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.''.
(e) Certification and Other Enforcement Provisions.--
(1) Certification of qualified electronic health records.--
(A) In general.--Section 3007(b) of the Public Health
Service Act (42 U.S.C. 300jj-17(b)) is amended by striking
``under section 3001(c)(3) to be in compliance with'' and all
that follows through the period at the end and inserting
``under section 3001(c)(3)--
``(1) for certifications made before January 1, 2018, to be
in compliance with applicable standards adopted under
subsections (a) and (b) of section 3004; and
``(2) 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.''.
(B) Requirements of secretary.--Section 3001(c)(5) of the
Public Health Service Act (42 U.S.C. 300jj-11(c)(5)) is
amended--
(i) in subparagraph (B), by inserting before the period at
the end the following: ``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''; and
(ii) by adding at the end the following new subparagraphs:
``(C) Enforcement; decertifications.--
``(i) Requirements.--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--
``(I) provide to the Secretary an attestation--
``(aa) 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);
``(bb) 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;
``(cc) 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;
``(dd) 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;
``(ee) 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
``(ff) 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;
``(II) 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
``(III) 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.
``(ii) Decertification.--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.
``(iii) Pricing information.--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:
``(I) 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.
``(II) 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.
``(III) 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.
``(D) Flexibility through compatibility.--
``(i) In general.--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.
``(ii) Baseline standards and implementation
specifications.--For purposes of clause (i), the term
`baseline standards and implementation specifications' means
the interoperability standards and implementation
specifications, with respect to such standards, adopted under
section 3004 (without application of subsection (e) of such
section).''.
(2) Additional enforcement provisions under the public
health service act.--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:
[[Page H5061]]
``SEC. 3010A. ENFORCEMENT MECHANISMS.
``(a) Inspector General Authority.--The Inspector General
of the Department of Health and Human Services shall have the
authority to investigate claims of--
``(1)(A) 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
``(B) 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;
``(2) 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
``(3) 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.
``(b) Information Sharing Provisions.--
``(1) In general.--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.
``(2) Protection from disclosure of information.--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--
``(A) shall not be disclosed by the National Coordinator
except as may be necessary to carry out the purpose of this
section; and
``(B) shall be exempt from mandatory disclosure under
section 552 of title 5, United States Code, as provided by
subsection (b)(3) of such section.
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.
``(3) Non-application of paperwork reduction act.--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).
``(4) Standardized process.--The National Coordinator shall
implement a standardized process for the public to submit
reports on claims of--
``(A) 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
``(B) 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
``(C) any other act described in subsection (a).
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.
``(c) Penalty.--
``(1) In general.--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.
``(2) Application.--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.
``(3) Recovery of funds.--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.
``(d) Information Blocking.--
``(1) In general.--For purposes of this section and section
3010, subject to paragraph (3), the term `information
blocking' 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--
``(A) prevent or materially discourage the access,
exchange, or use of electronic health information; and
``(B) 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.
``(2) Practices described.--For purposes of paragraph (1),
the practices described in this paragraph shall include the
following:
``(A) 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.
``(B) 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.
``(C) 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.
``(D) 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.
``(3) Exceptions.--
``(A) In general.--The term `information blocking' shall
not include practices that--
``(i) are required by applicable law; or
``(ii) 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.
``(B) Process.--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.
``(C) No enforcement before exceptions identified.--The
term `information blocking' 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.
``(D) Consultation.--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.
``(E) Application.--The term `information blocking', 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.
``(e) Treatment of Vendors With Respect to Patient Safety
Organizations.--In applying part C of title IX--
``(1) 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);
``(2) 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
``(3) 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).
``(f) Rulemaking and Guidance.--
``(1) In general.--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.
``(2) Non-duplication of penalty structures.--In carrying
out paragraph (1), in determining the scope of penalties,
assessments, or exclusions under such section 3001, including
[[Page H5062]]
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.
``(3) Clarification.--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.
``(4) Guidance relating to hipaa.--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--
``(A) examples of how such provisions may result in
information blocking; and
``(B) 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.
``(g) Health Care Provider Defined.--For purposes of this
section, the term `health care provider' 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.
``(h) Authorization of Appropriations.--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.''.
(3) Postings relating to enforcement on hhs internet
website.--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:
``(f) Enforcement Information Posted on HHS Internet
Website.--
``(1) Pricing information.--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.
``(2) Annual posting.--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.
``(3) Periodic review.--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).''.
(4) Demonstration required for meaningful ehr use under
medicare.--
(A) Eligible professionals.--
(i) In general.--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:
``(iv) Interoperability.--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.''.
(ii) Hardship exemption in case of decertified ehr.--
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:
``(B) Significant hardship exception.--
``(i) In general.--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.
``(ii) Decertification.--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.
``(iii) Duration of decertification.--
``(I) In general.--Notwithstanding clause (iv)(I), in no
case shall an exemption by reason of clause (ii) be for a
period of less than 12 months.
``(II) Extension.--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).
``(iv) Limitation.--
``(I) In general.--Subject to subclause (II), in no case
may an eligible professional be granted an exemption under
this subparagraph for more than 5 years.
``(II) Exception.--Subclause (I) shall not apply to an
exemption by reason of clause (ii) to the extent necessary to
satisfy clause (iii)(I).''.
(iii) Further application.--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:
``(E) Hardship exemption in case of decertified ehr.--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.''.
(B) Eligible hospitals.--
(i) In general.--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:
``(iv) Interoperability.--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.''.
(ii) Hardship exemption in case of decertified ehr.--
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:
``(II)(aa) 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.
``(bb) 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.
``(cc) Notwithstanding item (ee), in no case shall an
exemption by reason of item (bb) be for a period of less than
12 months.
``(dd) 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).
``(ee) Subject to item (ff), in no case may a hospital be
granted an exemption under this subclause for more than 5
years.
``(ff) Item (ee) shall not apply to an exemption by reason
of item (bb) to the extent necessary to satisfy item (cc).''.
(C) Demonstration required for meaningful ehr use under
medicaid.--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: ``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.''.
(5) Guidance.--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.
(f) Definitions.--
(1) Certified ehr technology.--Paragraph (1) of section
3000 of the Public Health Service Act (42 U.S.C. 300jj) is
amended to read as follows:
``(1) Certified ehr technology.--The term `certified EHR
technology' 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
[[Page H5063]]
to which the vendor or other entity offering such technology
is in compliance with the requirements under section
3001(c)(5)(C)(i).''.
(2) Widespread interoperability.--Section 3000 of the
Public Health Service Act (42 U.S.C. 300jj) is amended by
adding at the end the following new paragraph:
``(15) Widespread interoperability.--The term `widespread
interoperability' means that, on a nationwide basis--
``(A) health information technology is interoperable, in
accordance with section 3010; and
``(B) 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.''.
(g) Conforming Amendments.--
(1) Voluntary use of standards.--Section 3006 of the Public
Health Service Act (42 U.S.C. 300jj-16) is amended--
(A) in subsection (a)(1), by inserting ``, including an
interoperability standard or implementation specification,
with respect to such interoperability standard, adopted under
such section'' after ``section 3004''.
(B) in subsection (b), by inserting ``, including the
interoperability standards and implementation specifications,
with respect to such interoperability standards, adopted
under such section'' after ``section 3004''.
(2) HIPAA privacy and security law definition correction.--
Section 3009(a)(2)(A) of the Public Health Service Act (42
U.S.C. 300jj-19(a)(2)(A)) is amended by striking ``title IV''
and inserting ``title XIII''.
(3) Coordination of federal activities.--Section 13111 of
the HITECH Act is amended--
(A) in subsection (a), by inserting before the period at
the end the following: ``(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 )''; and
(B) in subsection (b), by inserting ``(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)'' before ``the President''.
(4) Application to private entities.--Section 13112 of the
HITECH Act is amended by inserting before the period at the
end the following: ``(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)''.
(5) NIST testing.--Section 13201 of the HITECH Act (42
U.S.C. 17911) is amended--
(A) in subsection (a), by inserting ``(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)'' before
``, the Director''; and
(B) in subsection (b), by inserting ``(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)'' before
``, the Director''; and
(C) by adding at the end the following new subsection:
``(c) Funding.--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.''.
(6) Coordination with recommendations for achieving
widespread ehr interoperability.--Section 106 of the Medicare
Access and CHIP Reauthorization Act of 2015 (Public Law 114-
10) is amended by striking subsection (b).''.
(h) Patient Engagement and Empowerment.--It is the sense of
Congress that--
(1) 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;
(2) 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;
(3) such right extends to both structured and unstructured
data;
(4) 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
(5) to further facilitate access of an individual to health
information of such individual--
(A) 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;
(B) 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;
(C) 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;
(D) mechanisms described in subparagraph (C) should allow
for connecting individuals across the continuum of care;
(E) an individual has the right to access the health
information of the individual without cost to the individual;
(F) 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;
(G) 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;
(H) 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
(I) the right described in subparagraph (H) will promote
safety and care coordination for individuals.
Subtitle B--Telehealth
SEC. 3021. TELEHEALTH SERVICES UNDER THE MEDICARE PROGRAM.
(a) Provision of Information by Centers for Medicare &
Medicaid Services.--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:
(1) 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)).
(2) 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).
(3) The types of high volume services (and related
diagnoses) under such title XVIII which might be suitable to
the furnishing of services via telehealth.
(4) 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.
(b) Provision of Information by MedPAC.--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--
(1) 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;
(2) the telehealth services for which payment can be made,
as of such date, under private health insurance plans;
(3) 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).
(c) Sense of Congress.--It is the sense of Congress that--
(1) 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
(2) any expansion of telehealth services under the Medicare
program should--
(A) 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;
(B) 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
(C) involve clinically appropriate means to furnish such
services.
Subtitle C--Encouraging Continuing Medical Education for Physicians
SEC. 3041. EXEMPTING FROM MANUFACTURER TRANSPARENCY REPORTING
CERTAIN TRANSFERS USED FOR EDUCATIONAL
PURPOSES.
(a) In General.--Section 1128G(e)(10)(B) of the Social
Security Act (42 U.S.C. 1320a-7h(e)(10)(B)) is amended--
(1) in clause (iii), by inserting ``, including peer-
reviewed journals, journal reprints, journal supplements,
medical conference reports, and medical textbooks'' after
``patient use''; and
(2) by adding at the end the following new clause:
``(xiii) In the case of a covered recipient who is a
physician, an indirect payment or transfer of value to the
covered recipient--
``(I) 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
``(II) 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.''.
[[Page H5064]]
(b) Effective Date.--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.
Subtitle D--Disposable Medical Technologies
SEC. 3061. TREATMENT OF CERTAIN ITEMS AND DEVICES.
(a) In General.--Section 1834 of the Social Security Act
(42 U.S.C. 1395m) is amended by adding at the end the
following new subsection:
``(r) Payment for Certain Disposable Devices.--
``(1) In general.--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).
``(2) Device described.--For purposes of paragraph (1), a
device described in this paragraph is a disposable device for
which, as of January 1, 2015, there is--
``(A) 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
``(B) a separate Level I HCPCS code for a professional
service that uses durable medical equipment instead of such
device.
``(3) Payment amount.--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).''.
(b) Conforming Amendment.--Section 1861(m)(5) of the Social
Security Act (42 U.S.C. 1395x(m)(5)) is amended by inserting
``and devices described in section 1834(r)(2)'' after
``durable medical equipment''.
(c) Effective Date.--The amendments made by this section
shall apply to devices furnished on or after January 1, 2017.
Subtitle E--Local Coverage Decision Reforms
SEC. 3081. IMPROVEMENTS IN THE MEDICARE LOCAL COVERAGE
DETERMINATION (LCD) PROCESS.
(a) In General.--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:
``(D) Local coverage determinations.--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:
``(i) Such determination in its entirety.
``(ii) Where and when the proposed determination was first
made public.
``(iii) Hyperlinks to the proposed determination and a
response to comments submitted to the contractor with respect
to such proposed determination.
``(iv) 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.
``(v) An explanation of the rationale that supports such
determination.''.
(b) Effective Date.--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.
Subtitle F--Medicare Pharmaceutical and Technology Ombudsman
SEC. 3101. MEDICARE PHARMACEUTICAL AND TECHNOLOGY OMBUDSMAN.
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:
``(4) Pharmaceutical and technology ombudsman.--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--
``(A) 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
``(B) are with respect to coverage, coding, or payment
under this title for such products.
The second sentence of paragraph (2) shall apply to this
paragraph in the same manner as such sentence applies to
paragraph (2).''.
Subtitle G--Medicare Site-of-Service Price Transparency
SEC. 3121. MEDICARE SITE-OF-SERVICE PRICE TRANSPARENCY.
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:
``(s) Site-of-Service Price Transparency.--
``(1) In general.--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--
``(A) 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
``(B) the estimated amount of beneficiary liability
applicable to the item or service.
``(2) Calculation of estimated beneficiary liability.--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.
``(3) Implementation.--In carrying out this subsection, the
Secretary--
``(A) 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
``(B) 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.
``(4) Funding.--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.''.
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.
(a) Drug Management Program for At-Risk Beneficiaries.--
(1) In general.--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:
``(5) Drug management program for at-risk beneficiaries.--
``(A) Authority to establish.--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.
``(B) Requirement for notices.--
``(i) In general.--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--
``(I) provides to the beneficiary an initial notice
described in clause (ii) and a second notice described in
clause (iii); and
``(II) verifies with the providers of the beneficiary that
the beneficiary is an at-risk beneficiary for prescription
drug abuse.
``(ii) Initial notice.--An initial notice described in this
clause is a notice that provides to the beneficiary--
``(I) notice that the PDP sponsor has identified the
beneficiary as potentially being an at-risk beneficiary for
prescription drug abuse;
``(II) 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;
``(III) 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;
``(IV) 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);
``(V) 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);
``(VI) 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
``(VII) 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).
``(iii) Second notice.--A second notice described in this
clause is a notice that provides to the beneficiary notice--
``(I) that the PDP sponsor has identified the beneficiary
as an at-risk beneficiary for prescription drug abuse;
``(II) 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;
``(III) of the prescriber (or prescribers) and pharmacy (or
pharmacies) selected for such individual under subparagraph
(D);
``(IV) 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;
``(V) 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
[[Page H5065]]
prefer the PDP sponsor select under subparagraph (D), submit
such preferences to the PDP sponsor; and
``(VI) that includes clear instructions that explain how
the beneficiary can contact the PDP sponsor.
``(iv) Timing of notices.--
``(I) In general.--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.
``(II) Exception.--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.
``(C) At-risk beneficiary for prescription drug abuse.--
``(i) In general.--For purposes of this paragraph, the term
`at-risk beneficiary for prescription drug abuse' means a
part D eligible individual who is not an exempted individual
described in clause (ii) and--
``(I) 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
``(II) 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).
``(ii) Exempted individual described.--An exempted
individual described in this clause is an individual who--
``(I) receives hospice care under this title;
``(II) 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
``(III) the Secretary elects to treat as an exempted
individual for purposes of clause (i).
``(D) Selection of prescribers and pharmacies.--
``(i) In general.--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--
``(I) one or more individuals who are authorized to
prescribe frequently abused drugs (referred to in this
paragraph as `prescribers') who may write prescriptions for
such drugs for such beneficiary; and
``(II) one or more pharmacies that may dispense such drugs
to such beneficiary.
``(ii) Reasonable access.--In making the selections under
this subparagraph--
``(I) 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
``(II) 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.
``(iii) Beneficiary preferences.--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--
``(I) review such preferences;
``(II) select or change the selection of prescribers and
pharmacies for the beneficiary based on such preferences; and
``(III) inform the beneficiary of such selection or change
of selection.
``(iv) Exception regarding beneficiary preferences.--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).
``(v) Confirmation.--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.
``(E) Terminations and appeals.--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.
``(F) Termination of identification.--
``(i) In general.--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--
``(I) 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
``(II) the end of such maximum period of identification as
the Secretary may specify.
``(ii) Rule of construction.--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.
``(G) Frequently abused drug.--For purposes of this
subsection, the term `frequently abused drug' means a drug
that is a controlled substance that the Secretary determines
to be frequently abused or diverted.
``(H) Data disclosure.--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.
``(I) Education.--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--
``(i) provided by medicare administrative contractors
through the improper payment outreach and education program
described in section 1874A(h); and
``(ii) 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.
``(J) Application under ma-pd plans.--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.''.
(2) Information for consumers.--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:
``(v) The drug management program for at-risk beneficiaries
under subsection (c)(5).''.
(b) Utilization Management Programs.--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--
(1) in paragraph (1), by inserting after subparagraph (D)
the following new subparagraph:
``(E) A utilization management tool to prevent drug abuse
(as described in paragraph (6)(A)).''; and
(2) by adding at the end the following new paragraph:
``(6) Utilization management tool to prevent drug abuse.--
``(A) In general.--A tool described in this paragraph is
any of the following:
``(i) A utilization tool designed to prevent the abuse of
frequently abused drugs by individuals and to prevent the
diversion of such drugs at pharmacies.
``(ii) Retrospective utilization review to identify--
``(I) individuals that receive frequently abused drugs at a
frequency or in amounts that are not clinically appropriate;
and
``(II) providers of services or suppliers that may
facilitate the abuse or diversion of frequently abused drugs
by beneficiaries.
``(iii) 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).
``(B) Reporting.--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--
``(i) 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
``(ii) the name and prescription records of individuals
described in paragraph (5)(C).''.
(c) Expanding Activities of Medicare Drug Integrity
Contractors (MEDICs).--
(1) In general.--Section 1893 of the Social Security Act
(42 U.S.C. 1395ddd) is amended by adding at the end the
following new subsection:
``(j) Expanding Activities of Medicare Drug Integrity
Contractors (MEDICs).--
``(1) Access to information.--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
[[Page H5066]]
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).
``(2) Requirement for acknowledgment of referrals.--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--
``(A) acknowledge to the sponsor or organization receipt of
the referral; and
``(B) 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.
``(3) Making data available to other entities.--
``(A) In general.--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.
``(B) HIPAA compliant information only.--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).''.
(2) OIG study and report on effectiveness of medics.--
(A) Study.--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).
(B) Report.--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.
(d) Treatment of Certain Complaints for Purposes of Quality
or Performance Assessment.--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:
``(d) Treatment of Certain Complaints for Purposes of
Quality or Performance Assessment.--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.''.
(e) Sense of Congress Regarding Use of Technology Tools To
Combat Fraud.--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.
(f) Effective Date.--
(1) In general.--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.
(2) Stakeholder meetings prior to effective date.--
(A) In general.--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).
(B) Topics described.--The topics described in this
subparagraph are the topics of--
(i) 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);
(ii) 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);
(iii) the types of enrollees that should be treated as
exempted individuals, as described in subparagraph (C)(ii) of
such paragraph;
(iv) 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;
(v) the information to be included in the notices described
in subparagraph (B) of such paragraph and the standardization
of such notices; and
(vi) 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.
(g) Rulemaking.--The Secretary of Health and Human Services
shall promulgate regulations based on the input gathered
pursuant to subsection (f)(2)(A).
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.
(a) Medicaid Reimbursement.--
(1) In general.--Section 1903(i) of the Social Security Act
(42 U.S.C. 1396b(i)) is amended--
(A) in paragraph (25), by striking ``or'' at the end;
(B) in paragraph (26), by striking the period at the end
and inserting ``; or''; and
(C) by inserting after paragraph (26) the following new
paragraph:
``(27) 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.''.
(2) Effective date.--The amendments made by this subsection
shall be effective with respect to payments for items
furnished on or after January 1, 2020.
(b) Medicare Ombudsman.--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:
``(5) Monitoring dme reimbursement under medicaid.--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.''.
SEC. 4002. EXCLUDING AUTHORIZED GENERICS FROM CALCULATION OF
AVERAGE MANUFACTURER PRICE.
(a) In General.--Subparagraph (C) of section 1927(k)(1) of
the Social Security Act (42 U.S.C. 1396r-8(k)(1)) is
amended--
(1) in the subparagraph heading, by striking ``Inclusion''
and inserting ``Exclusion'';
(2) by striking ``a new drug application'' and inserting
``the manufacturer's new drug application''; and
(3) by striking ``inclusive'' and inserting ``exclusive''.
(b) Effective Date.--The amendments made by this section
take effect on October 1, 2015.
SEC. 4003. MEDICARE PAYMENT INCENTIVE FOR THE TRANSITION FROM
TRADITIONAL X-RAY IMAGING TO DIGITAL
RADIOGRAPHY AND OTHER MEDICARE IMAGING PAYMENT
PROVISION.
(a) Physician Fee Schedule.--
(1) Payment incentive for transition.--
(A) In general.--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:
``(9) Special rule to incentivize transition from
traditional x-ray imaging to digital radiography.--
``(A) Limitation on payment for film x-ray imaging
services.--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.
``(B) Phased-in limitation on payment for computed
radiography imaging services.--In the case of an imaging
service (including the imaging portion of a service) that is
an X-ray taken using computed radiography technology--
``(i) 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
``(ii) 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.
``(C) Computed radiography technology defined.--For
purposes of this paragraph, the term `computed radiography
technology' means
[[Page H5067]]
cassette-based imaging which utilizes an imaging plate to
create the image involved.
``(D) Implementation.--In order to implement this
paragraph, the Secretary shall adopt appropriate mechanisms
which may include use of modifiers.''.
(B) Exemption from budget neutrality.--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:
``(X) Reduced expenditures attributable to incentives to
transition to digital radiography.--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.''.
(2) Elimination of application of multiple procedure
payment reduction.--
(A) In general.--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:
``(E) Elimination of application of multiple procedure
payment reduction.--
``(i) In general.--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.
``(ii) Empirical analysis described.--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--
``(I) information detailing which physician work activities
overlap and the reductions applicable to such overlap;
``(II) a discussion of the clinical aspects that informed
the assignment of the reduction percentages described in
subclause (I);
``(III) 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;
``(IV) other data used to determine a reduction; and
``(V) 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.''.
(B) Conforming amendment.--Section 220(i) of the Protecting
Access to Medicare Act of 2014 (42 U.S.C. 1395w-4 note) is
repealed.
(b) Payment Incentive for Transition Under Hospital
Outpatient Prospective Payment System.--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:
``(F) Payment incentive for the transition from traditional
x-ray imaging to digital radiography.--Notwithstanding the
previous provisions of this subsection:
``(i) Limitation on payment for film x-ray imaging
services.--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.
``(ii) Phased-in limitation on payment for computed
radiography imaging services.--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))--
``(I) 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
``(II) 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.
``(iii) Application without regard to budget neutrality.--
The reductions made under this paragraph--
``(I) shall not be considered an adjustment under paragraph
(2)(E); and
``(II) shall not be implemented in a budget neutral manner.
``(iv) Implementation.--In order to implement this
subparagraph, the Secretary shall adopt appropriate
mechanisms which may include use of modifiers.''.
SEC. 4004. TREATMENT OF INFUSION DRUGS FURNISHED THROUGH
DURABLE MEDICAL EQUIPMENT.
Section 1842(o)(1) of the Social Security Act (42 U.S.C.
1395u(o)(1)) is amended--
(1) in subparagraph (C), by inserting ``(and including a
drug or biological described in subparagraph (D)(i) furnished
on or after January 1, 2017)'' after ``2005''; and
(2) in subparagraph (D)--
(A) by striking ``infusion drugs'' and inserting ``infusion
drugs or biologicals'' each place it appears; and
(B) in clause (i)--
(i) by striking ``2004'' and inserting ``2004, and before
January 1, 2017''; and
(ii) by striking ``for such drug''.
SEC. 4005. EXTENSION AND EXPANSION OF PRIOR AUTHORIZATION FOR
POWER MOBILITY DEVICES (PMDS) AND ACCESSORIES
AND PRIOR AUTHORIZATION AUDIT LIMITATIONS.
Section 1834(a) of the Social Security Act (42 U.S.C.
1395m(a)) is amended--
(1) in paragraph (15), by adding at the end the following
new subparagraph:
``(D) Limitation on audits after advance determination.--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).''; and
(2) by adding at the end the following new paragraph:
``(23) Prior authorization for power mobility devices
(pmds) and accessories.--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--
``(A) extend at least through August 31, 2018, the PMD
Prior Authorization Demonstration (being conducted under
paragraph (1)(J) of such section);
``(B) 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
``(C) begin to expand such demonstration to such additional
States or geographic areas as may be appropriate.''.
SEC. 4006. CIVIL MONETARY PENALTIES FOR VIOLATIONS RELATED TO
GRANTS, CONTRACTS, AND OTHER AGREEMENTS.
(a) In General.--Section 1128A of the Social Security Act
(42 U.S.C. 1320a-7a) is amended by adding at the end the
following new subsection:
``(o) 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--
``(1) 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;
``(2) 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;
``(3) 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;
``(4) 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
``(5) 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;
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
[[Page H5068]]
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.
``(p) 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).
``(q) 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.
``(r) For purposes of this subsection and subsections (o),
(p), and (q):
``(1) The term `Department' means the Department of Health
and Human Services.
``(2) The term `material' means having a natural tendency
to influence, or be capable of influencing, the payment or
receipt of money or property.
``(3) The term `other agreement' 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).
``(4) The term `program beneficiary' 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.
``(5) The term `recipient' includes a sub-recipient or
subcontractor.
``(6) The term `specified claim' 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--
``(A) 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
``(B) 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--
``(i) provides or has provided any portion of the money or
property requested or demanded; or
``(ii) will reimburse such contractor, grantee or other
recipient for any portion of the money or property which is
requested or demanded.
``(7) The term `specified State agency' 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.
``(s) For purposes of subsection (o), the term `obligation'
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.''.
(b) Conforming Amendments.--Section 1128A of the Social
Security Act (42 U.S.C. 1320a-7a) is amended--
(1) in subsection (d)--
(A) in paragraph (1), by inserting ``or specified claims''
after ``claims'';
(B) in paragraph (2), by inserting ``or specified claims''
after ``claims'';
(2) in subsection (e), by inserting ``or specified claim''
after ``claim''; and
(3) in subsection (f)--
(A) by inserting ``or specified claim (as defined in
subsection (r)(6))'' after ``district where the claim'';
(B) by inserting ``(or, with respect to a person described
in subsection (o), the person)'' after ``claimant'';
(C) by inserting ``that are not received by the Inspector
General of the Department of Health and Human Services under
subsection (q) as reimbursement'' after ``amounts
recovered''; and
(D) by inserting ``(or, in the case of a penalty or
assessment under subsection (o), by a specified State agency
(as defined in subsection (r)(7))'' after ``or a State
agency''.
Subtitle B--Other Reforms
SEC. 4041. SPR DRAWDOWN.
(a) Drawdown and Sale.--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--
(1) 4,000,000 barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2018;
(2) 5,000,000 barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2019;
(3) 8,000,000 barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2020;
(4) 8,000,000 barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2021;
(5) 10,000,000 barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2022;
(6) 15,000,000 barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2023;
(7) 15,000,000 barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2024; and
(8) 15,000,000 barrels of crude oil from the Strategic
Petroleum Reserve during fiscal year 2025.
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.
(b) Emergency Protection.--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.
(c) Proceeds.--Proceeds from a sale under this section
shall be deposited into the general fund of the Treasury of
the United States.
Subtitle C--Miscellaneous
SEC. 4061. LYME DISEASE AND OTHER TICK-BORNE DISEASES.
(a) In General.--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:
``PART W--LYME DISEASE AND OTHER TICK-BORNE DISEASES
``SEC. 399OO. RESEARCH.
``(a) In General.--The Secretary shall conduct or support
epidemiological, basic, translational, and clinical research
regarding Lyme disease and other tick-borne diseases.
``(b) Biennial Reports.--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.
``SEC. 399OO-1. WORKING GROUP.
``(a) Establishment.--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 `Working Group'), 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.
``(b) Responsibilities.--The Working Group shall--
``(1) not later than 24 months after the date of enactment
of this part, and every 24 months thereafter, develop or
update a summary of--
``(A) 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;
``(B) advances made pursuant to such research;
``(C) the engagement of the Department of Health and Human
Services with persons that participate at the public meetings
required by paragraph (5); and
``(D) the comments received by the Working Group at such
public meetings and the Secretary's response to such
comments;
``(2) ensure that a broad spectrum of scientific viewpoints
is represented in each such summary;
``(3) monitor Federal activities with respect to Lyme
disease and other tick-borne diseases;
``(4) make recommendations to the Secretary regarding any
appropriate changes to such activities; and
``(5) ensure public input by holding annual public meetings
that address scientific advances, research questions,
surveillance activities, and emerging strains in species of
pathogenic organisms.
``(c) Membership.--
``(1) In general.--The Working Group shall be composed of a
total of 14 members as follows:
``(A) Federal members.--Seven Federal members, consisting
of one or more representatives of each of--
``(i) the Office of the Assistant Secretary for Health;
``(ii) the Food and Drug Administration;
``(iii) the Centers for Disease Control and Prevention;
``(iv) the National Institutes of Health; and
``(v) such other agencies and offices of the Department of
Health and Human Services as the Secretary determines
appropriate.
``(B) Non-federal public members.--Seven non-Federal public
members, consisting of representatives of the following
categories:
``(i) Physicians and other medical providers with
experience in diagnosing and treating Lyme disease and other
tick-borne diseases.
``(ii) Scientists or researchers with expertise.
``(iii) Patients and their family members.
``(iv) Nonprofit organizations that advocate for patients
with respect to Lyme disease and other tick-borne diseases.
``(v) Other individuals whose expertise is determined by
the Secretary to be beneficial to the functioning of the
Working Group.
``(2) Appointment.--The members of the Working Group shall
be appointed by the Secretary, except that of the non-Federal
public members under paragraph (1)(B)--
[[Page H5069]]
``(A) one shall be appointed by the Speaker of the House of
Representatives; and
``(B) one shall be appointed by the majority leader of the
Senate.
``(3) Diversity of scientific perspectives.--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.
``(4) Terms.--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.
``(d) Meetings.--The Working Group shall meet as often as
necessary, as determined by the Secretary, but not less than
twice each year.
``(e) Applicability of FACA.--The Working Group shall be
treated as an advisory committee subject to the Federal
Advisory Committee Act.
``(f) Reporting.--Not later than 24 months after the date
of enactment of this part, and every 24 months thereafter,
the Working Group--
``(1) 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;
``(2) shall make each such report publicly available on the
website of the Department of Health and Human Services; and
``(3) shall allow any member of the Working Group to
include in any such report minority views.
``SEC. 399OO-2. STRATEGIC PLAN.
``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--
``(1) proposed budgetary requirements;
``(2) 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;
``(3) a plan for improving diagnosis, treatment, and
prevention;
``(4) appropriate benchmarks to measure progress on
achieving the improvements described in paragraphs (2) and
(3); and
``(5) 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.''.
(b) No Additional Authorization of Appropriations.--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.
The Acting CHAIR. No further amendment to the bill, as amended, shall
be in order except those printed in House Report 114-193. Each such
further amendment may be offered only in the order printed in the
report, by a Member designated in the report, shall be considered read,
shall be debatable for the time specified in the report equally divided
and controlled by the proponent and an opponent, shall not be subject
to amendment, and shall not be subject to a demand for division of the
question.
Amendment No. 1 Offered by Mr. Brat
The Acting CHAIR. It is now in order to consider amendment No. 1
printed in House Report 114-193.
Mr. BRAT. Madam Chair, I have an amendment at the desk.
The Acting CHAIR. The Clerk will designate the amendment.
The text of the amendment is as follows:
Page 5, beginning on line 6, strike paragraph (1) and
insert the following:
(1) Authorization of appropriations.--There is authorized
to be appropriated to the NIH and Cures Innovation Fund
$1,860,000,000 for each of fiscal years 2016 through 2020.
Page 13, beginning on line 3, strike subsection (f).
The Acting CHAIR. Pursuant to House Resolution 350, the gentleman
from Virginia (Mr. Brat) and a Member opposed each will control 5
minutes.
The Chair recognizes the gentleman from Virginia.
Mr. BRAT. Madam Chair, I yield myself 2 minutes.
I rise to support my amendment against the creation of a new
mandatory program.
Some on the other side have called my amendment a poison pill. I
consider that a compliment. A poison pill was reserved for the man who
brought human reason to Greece. I similarly would like to bring a bit
of reason to bear on the budget process of the United States.
We are currently $127 trillion light on mandatory spending at
present. This means by 2027, all Federal revenues will be spent on only
mandatory programs. This is a disaster.
My children right now are 13 and 16. By the time they are about 30,
we will have zero dollars for running the government because all
dollars will be spent on these mandatory programs.
We all want cures, and I am for the underlying bill--make no
mistake--but in economics, rationality requires that we rank our
preferences in order and fund the best programs. This is one of them.
There is no issue finding $2 billion out of a $3.5 trillion budget,
but currently, there is no discipline up here in this city. We just
fund everything and hand the bill to the next generation.
Every mandatory program starts off with high hopes, but go to the
trustee reports on the major mandatory programs today, and you will
find that they are all insolvent by around 2030 as well.
Today, you will hear all sorts of fancy terminology about pay-fors
and oil reserves and deficits, but don't be fooled. Our annual deficit
spending is about $500 billion right now and on its way to a trillion
in a few more years.
We are off course on every front. We always talk about the children,
but at present, we are handing our children $18 trillion in debt and
another $127 trillion in mandatory programs.
You want the truth? The children are the only group up here on
Capitol Hill without a lobbyist, and that is why they are getting
trashed.
If you want a cure, go to a doctor; but if you want to clean up the
U.S. economy, please consult an economist or two. The numbers in the
story I have given are not in dispute. The only issue is whether we
have the resolve to balance our budgets and leave our children a
brighter day.
I urge a ``yes'' vote on the amendment, and I reserve the balance of
my time.
Mr. UPTON. Madam Chair, I rise in opposition to the amendment.
The Acting CHAIR. The gentleman from Michigan is recognized for 5
minutes.
Mr. UPTON. Madam Chair, I yield myself 1 minute.
Madam Chair, I strongly oppose this amendment because making this
funding discretionary and subject to later appropriations is critically
shortsighted for two reasons.
We thought that this might be a placebo amendment, but yes, it really
is a poison pill that would undermine the victories the Republicans
secured in 21st Century Cures, including transformative regulatory
reforms at FDA and permanent entitlement savings in both Medicare and
Medicaid.
Second, supporting the amendment means voting against the critical
balance that we found to pay for these investments using mandatory
savings in a way that reduces the deficit in working with the
Appropriations Committee.
According to the CBO, this bill will reduce the deficit by some $500-
plus million over the first 10 years, and we conservatively estimate
that it cuts $7 billion in the second decade.
Third, more than 100 organizations have joined together to oppose
this amendment. They represent a cross-section of organizations,
including patient groups, universities, veterans, innovators, and
medical providers.
I would ask my colleagues to vote ``no'' on the Brat amendment, and I
reserve the balance of my time.
Mr. BRAT. Madam Chair, I yield 1 minute to the gentleman from
California (Mr. McClintock).
Mr. McCLINTOCK. Madam Chair, the greatest danger facing our country
is a national debt that now exceeds our entire economy. This year, we
spent $230 billion just to pay interest on that debt.
The CBO warns that, on our current trajectory, interest payments will
exceed our entire defense budget just 8 years from now. Behold the
chaos in Greece, and consider that our Nation is not far behind.
Congress has labored mightily to enact a budget that saves us from
this dismal future, but having set that course, we must stay that
course. The underlying bill makes many worthy changes in law, but it
evades the discipline the budget requires to save our country from the
fate of Greece.
Mr. Brat's amendment places this bill back within the boundaries of
the
[[Page H5070]]
budget without budget gimmickry and can be easily accommodated by
cutting lower priority spending. The question before us is whether we
will fund our priorities responsibly or follow Greece to ruin.
Mr. UPTON. Madam Chair, I yield 1 minute to the gentleman from New
Jersey (Mr. Pallone), my friend and the ranking member of the Energy
and Commerce Committee.
Mr. PALLONE. Madam Chairwoman, if we want to speed the pace of
innovation and development of new treatment and cures, we must increase
funding to NIH.
We all know the numbers. NIH has $8.2 billion less to spend in fiscal
year 2015 than it had in fiscal year 2003, when adjusted for inflation.
That funding erosion has reduced the application success rate, leaving
promising research ideas to languish due to lack of funding. It has
also left many young and midcareer scientists wondering whether they
can support themselves through a career in biomedical research.
The NIH and Cures innovation fund aims to reverse that trajectory by
providing $8.7 in mandatory funding over a 5-year period. Providing
mandatory funding through the innovation fund would ensure that NIH has
increased funding to make critical investments in research that will
help us deliver on the promise of the 21st Century Cures Act, to
accelerate the pace of scientific advancement that leads to life-
improving and lifesaving treatments and cures.
Madam Chairwoman, without this funding stream, H.R. 6, I think, will
be ineffective; and I urge Members to reject the Brat amendment.
I am in strong opposition to the Brat amendment.
Mr. BRAT. Madam Chair, I yield 1 minute to the gentleman from
Pennsylvania (Mr. Perry).
Mr. PERRY. Madam Chair, I support the 21st Century Cures Act
underlying text, and I thank the chairman. It has been masterful work.
And who wouldn't? Who doesn't want to do something in Congress about
these horrific, debilitating diseases that plague our families? We all
do, but targeting additional NIH funding for cures remains critical. We
absolutely all support it, but I don't support how we are paying for
it--because we are not.
Many of us who preach about the problems associated with mandatory
spending have used the same board I use in my townhall meetings. People
have seen this, and they know where we are headed. It is the biggest
driver of future debt.
We are creating more mandatory spending as we speak, and we are
placing the burden of paying for it on people that aren't even alive
yet. It is incredible.
I have championed the need for providing a cure for rare diseases and
the things that plague members of our citizenry since I have been here.
One thing missing from this bill is the legalization of CBD. This act
seems to forget about children with epilepsy and their desperate need
for a cure.
I ask for support of this amendment simply to shift the money from
mandatory to discretionary and force us to make the tough decisions we
came here to make.
Mr. UPTON. Madam Chair, I yield 1 minute to the gentleman from Texas
(Mr. Gene Green), the ranking member on the Health Subcommittee.
Mr. GENE GREEN of Texas. Madam Chair, I thank the chair of the
committee for yielding.
If you like how we are doing research right now, then you need to
support the Brat amendment because we are not funding research
adequately. Everybody says that. That is why there are so many
supporters in the private sector and also 230 cosponsors of this bill.
The sponsor of the amendment called it a poison pill. I don't think
there is anything more appropriate than that for this amendment,
because this bill is intended to save people's lives and to make people
have a better lifestyle. When you take a poison pill, you die. That is
what will happen if we do not do mandatory spending in this bill.
This bill is paid for. You can rail against mandatory spending, but
there are cuts in other parts of the Federal budget that will pay for
this. Don't let anybody delude themselves into thinking that this is
increasing spending.
We are cutting spending while we are trying to redirect it to the NIH
and FDA to have these new therapies and also get them through the
approval process.
Mr. BRAT. Madam Chair, I yield 1 minute to the gentleman from
California (Mr. Issa).
Mr. ISSA. Madam Chair, in this short 1 minute, I will close by
reminding people that Ronald Reagan so notably said: ``Nothing lasts
longer than a temporary government program.''
This is a permanent program that is only paid for in offsets at one-
quarter what it costs, and that is an estimate. If the cost goes up, it
will spend even more.
Understand that we are selling the strategic petroleum reserves to
pay for the vast majority of this 5-year program, and then we are
taking 10 years to pay for the remainder.
This is a gimmick. It is not paid for. Do not be fooled. If you are a
fiscal conservative, you must consider this not a permanent entitlement
and vote for the Brat amendment because, if you don't, what you are
doing is unfairly adding to this debt.
I would vote for this if it was paid for. Madam Chair, it is not paid
for. It is a fraudulent pay-for by any possible means of this body.
Please, vote for the Brat amendment because this is not a pay-for
entitlement.
Mr. BRAT. I yield back the balance of my time.
{time} 0930
Announcement by the Acting Chair
The Acting CHAIR. Members are reminded to refrain from trafficking
the well while another Member is under recognition.
Mr. UPTON. Madam Chair, I yield to the gentleman from Pennsylvania
(Mr. Fattah) for a unanimous consent request.
(Mr. FATTAH asked and was given permission to revise and extend his
remarks.)
Mr. FATTAH. Madam Chair, I rise in favor of the underlying bill and
in opposition to this poison-pill amendment.
Mr. UPTON. Madam Chairman, let me just say to the gentleman from
California, it is paid for. CBO has certified that all of it is paid
for.
Madam Chair, I yield the balance of my time to the gentlewoman from
Indiana (Mrs. Brooks), a member of the committee.
Mrs. BROOKS of Indiana. Madam Chairman, I rise today to voice my
unwavering support for 21st Century Cures and vehement opposition to
the amendment before us.
What the authors of this specific amendment fail to grasp is that
21st Century Cures will actually advance real conservative reforms to
the entitlement system that will reduce the deficit and save our Nation
billions of dollars.
There are real cuts in this bill. CBO has scored it. And since when
are we ignoring CBO?
These reforms didn't happen overnight. This legislation is the result
of well over a year of thoughtful and purposeful negotiations.
Unfortunately, the backers of this amendment cannot see the forest
for the trees. Contrary to the misinformation that led them to craft
it, the innovation fund is not forever on autopilot. It sunsets after 5
years. Those are 5 solid years where we can recruit the top minds to
investigate cures that will change and save lives, yes, the lives of
our children and the next generation.
I urge my colleagues to stand with me in opposition, in addition to
the over 100 groups who are opposed to the Brat amendment, groups of
patient groups, universities, veterans, innovators, medical providers.
Every one of these groups urges Members to vote ``no'' on the Brat
amendment, and I urge my colleagues to do the same.
Mr. UPTON. Madam Chair, I yield back the balance of my time.
The Acting CHAIR. The question is on the amendment offered by the
gentleman from Virginia (Mr. Brat).
The question was taken; and the Acting Chair announced that the noes
appeared to have it.
Mr. BRAT. Madam Chair, I demand a recorded vote.
The Acting CHAIR. Pursuant to clause 6 of rule XVIII, further
proceedings on the amendment offered by the gentleman from Virginia
will be postponed.
[[Page H5071]]
Amendment No. 2 Offered by Mr. Young of Indiana
The Acting CHAIR. It is now in order to consider amendment No. 2
printed in House Report 114-193.
Mr. YOUNG of Indiana. Madam Chairman, I have an amendment at the
desk.
The Acting CHAIR. The Clerk will designate the amendment.
The text of the amendment is as follows:
Page 6, line 19, strike ``409K'' and insert ``409L''.
Page 15, after line 6, insert the following:
SEC. 1002. PRIZE COMPETITIONS.
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:
``SEC. 409K. PRIZE COMPETITIONS FOR IMPROVING HEALTH OUTCOMES
AND REDUCING FEDERAL EXPENDITURES.
``(a) Establishment; Goals.--The Director of NIH shall
establish and implement an Innovation Prizes Program for one
or both of the following goals:
``(1) Identifying and funding areas of biomedical science
that could realize significant advancements through the
creation of a prize competition.
``(2) Improving health outcomes, particularly with respect
to human diseases and conditions for which public and private
investment in research is disproportionately small relative
to Federal Government expenditures on prevention and
treatment activities, thereby reducing Federal expenditures
on health programs.
``(b) Design of Prize Competitions.--Not later than 6
months after the date of enactment of this section, the
Director of NIH shall--
``(1) design prize competitions--
``(A) to cooperate with competitors to realize innovations
to identify and address areas of biomedical science that
could realize significant advancements through the creation
of a prize competition; and
``(B) to award one or more prizes--
``(i) if appropriate, at the beginning of or during the
competitions, to the competitors whose innovations are most
promising or demonstrate progress; and
``(ii) at the end of the competitions, to the competitors
whose innovations prove to be the best solutions;
``(2) ensure that the design of such competitions--
``(A) is realistic, given the amount of funds to be awarded
as prizes;
``(B) does not reflect any bias concerning the type of
innovations which will prove to be the best solutions; and
``(C) allows any person to participate as a competitor
without regard to the person's place of incorporation,
primary place of business, citizenship, and residency, as
applicable; and
``(3) submit to the Congress a report on the design of such
competitions.
``(c) Innovation Prizes Advisory Board.--
``(1) Establishment.--The Director of NIH shall establish
and maintain a board, to be known as the I-Prize Board, to
advise and assist the Director of NIH in carrying out this
section.
``(2) Composition; terms.--
``(A) Composition.--The I-Prize Board shall be composed of
9 voting members as follows:
``(i) The Director of NIH (or the Director's designee).
``(ii) Four members appointed by the Director of NIH.
``(iii) One member appointed by the Speaker of the House of
Representatives.
``(iv) One member appointed by the majority leader of the
Senate.
``(v) One member appointed by the minority leader of the
House of Representatives.
``(vi) One member appointed by the minority leader in the
Senate.
``(B) Inclusion of certain experts.--The members of the I-
Prize Board appointed under clauses (ii) through (vi) of
subparagraph (A) shall, collectively, include medical,
economic, budgetary, innovation, or venture capital experts
from for-profit and not-for-profit private sector entities
with experience in awarding prizes similar to the prizes
under this section.
``(C) Terms.--The appointed members of the I-Prize Board
shall each be appointed for a term of 5 years.
``(D) Appointment of initial members.--The initial
appointed members of the I-Prize Board shall be appointed not
later than 120 days after the date of enactment of this
section.
``(3) Responsibilities.--The I-Prize Board shall be
responsible for advising the Director of NIH by--
``(A) identifying areas of biomedical science that could
realize significant advancements through the creation of a
prize competition;
``(B) making recommendations on establishing the criteria
for prize competitions under this section;
``(C) making recommendations on which business
organizations or other entities have successfully met the
criteria established for the prize competition; and
``(D) gaining insight from researchers, health economists,
academia, and industry on how to conduct prize competitions.
``(d) Restrictions.--
``(1) No financial conflicts of interest.--Any member of
the I-Prize Board, and any officer or employee of the
National Institutes of Health responsible for carrying out
this section, may not personally or substantially participate
in the consideration or determination by the I-Board of any
matter that would directly or predictably effect any
financial interest of--
``(A) the individual or a relative (as such term is defined
in section 109(16) of the Ethics in Government Act of 1978)
of the individual; or
``(B) of any business organization or other entity--
``(i) of which the individual is an officer or employee;
``(ii) with respect to which the individual is negotiating
for employment; or
``(iii) in which the individual has any other financial
interest.
``(2) No awards to competitors likely to reap financial
benefit from innovation.--The Director of NIH may not, with
respect to an innovation, award a prize under this section to
any individual or entity that has a vested financial interest
in any product or procedure that is likely to be developed or
marketed because of such innovation.
``(e) Process of Award.--The full monetary amount of any
prize awarded under this section shall be made available to
the prize winner not later than 90 days after the date of
such award.
``(f) Simulation.--The Director of NIH may--
``(1) award one or more contracts--
``(A) to perform a simulation of the prize competitions to
be conducted under this section, based on the designs
developed under subsection (b); and
``(B) to use the simulation to assess the effectiveness of
the design; and
``(2) not later than 4 months after awarding such one or
more contracts, submit to the Congress a report on the
results of the simulation and assessment.
``(g) Implementation of Prize Competitions.--
``(1) In general.--The Director of NIH may enter into an
agreement with one or more entities described in section
501(c), and exempt from tax under section 501(a), of the
Internal Revenue Code of 1986 to implement prize competitions
based on the designs developed under subsection (b).
``(2) Minimum percentage for prizes.--If the Director of
NIH enters into an agreement under paragraph (1) to provide
funds or other assistance (including in-kind contributions
and testing or other technical support) to an entity to
implement a prize competition under this section--
``(A) not more than 15 percent of such assistance shall be
for administration of the prize competition; and
``(B) not less than 85 percent of such assistance shall be
for activities in direct support of competitors such as
demonstration, testing, education, and prize awards.
``(h) Tracking; Reporting.--The Director of NIH shall--
``(1) collect information on--
``(A) the medical efficacy of innovations funded through
the prize competitions under this section; and
``(B) the actual and potential effect of the innovations on
Federal expenditures; and
``(2) not later than one year after the conclusion of the
prize competitions under this section, and not later than the
end of each of the 4 succeeding years, submit to the Congress
a report on the information collected under paragraph (1).
``(i) Intellectual Property.--
``(1) Prohibition on the government acquiring intellectual
property rights.--The Federal Government may not gain an
interest in intellectual property developed by a participant
in a prize competition under this section without the written
consent of the participant.
``(2) Licenses.--The Federal Government may negotiate a
license for the use of intellectual property developed by a
participant in a prize competition under this section.''.
Page 26, line 11, insert ``, as amended by section 1002 of
this Act,'' after ``et seq.)''
Page 26, line 13, strike ``409K'' and insert ``409L''.
The Acting CHAIR. Pursuant to House Resolution 350, the gentleman
from Indiana (Mr. Young) and a Member opposed each will control 5
minutes.
The Chair recognizes the gentleman from Indiana.
Mr. YOUNG of Indiana. Madam Chair, I want to thank Mr. Upton for his
work on the 21st Century Cures Act, finally making medical
breakthroughs a national priority. With this bill, we will extend the
longevity and improve the lives of millions of Americans now and in the
future. And in the process, we will dramatically reduce the taxpayer
money we spend to treat sick Americans.
With all that in mind, I want to highlight an amendment that my
thoughtful and hard-working colleague, Dr. Harris of Maryland, and I
have worked on, and I urge my colleagues' support. This amendment would
create within NIH a structure for a medical prize program.
The United States is currently spending $632 billion per year through
just one program, Medicare, to cover health services of qualified
beneficiaries. To help lower taxpayer costs as well as
[[Page H5072]]
improve patient outcomes, this amendment will offer modest monetary
rewards to those outside of government who can develop significant
medical breakthroughs.
The medical prize program will encourage scientists and
entrepreneurs, especially those that don't typically receive NIH
grants, to develop cost-saving, life-improving cures for some of the
most debilitating diseases that afflict our young and old.
With those thoughts in mind, I urge your support of the amendment,
and I reserve the balance of my time.
Mr. PALLONE. Madam Chair, I claim time in opposition to the
amendment.
The Acting CHAIR. The gentleman from New Jersey is recognized for 5
minutes.
Mr. PALLONE. Madam Chair, while I appreciate the efforts of the
amendment's sponsors, I cannot support the Young-Harris amendment.
As currently drafted, the amendment threatens to undermine the
independent peer review process that is the bedrock of NIH funding by
injecting politics into the development and implementation of the prize
competition.
The amendment would create an innovation prize advisory board to
assist the NIH Director in carrying out the prize competition that is
composed of nine members, four of which are politically appointed. It
would also take away resources from existing research grant programs
and other research efforts at NIH.
It would require NIH to put money on reserve for the prize
competition, money that would go back into the Treasury instead of
funding research if the prize is not won in a given fiscal year.
While I am not opposed to the potential of setting up a prize-like
system--in fact, NIH already has such authority--I would prefer to work
with the sponsors on the language to find a more appropriate way to
accomplish their goals. Therefore, I would urge my colleagues to vote
``no.''
Mr. UPTON. Will the gentleman yield?
Mr. PALLONE. I yield to the gentleman from Michigan.
Mr. UPTON. I would just like to say as chairman of the committee that
I look forward to working with the gentleman on the language. I think
this is an important amendment. I am going to speak in favor of it on
Mr. Young's time in a moment.
But I just want to pledge that we will work with you on language that
certainly we can all accept, knowing that the goal is a very good one.
Mr. PALLONE. I appreciate that. Thank you.
I reserve the balance of my time.
Mr. YOUNG of Indiana. Madam Chair, I would just add that the purpose
of this amendment, obviously, well received on both sides of the
aisle--perhaps there are particulars we can work on--is to catalyze
more innovation among the thousands, tens of thousands of entrepreneurs
and innovators around this country, really around the world.
If we can get more minds collectively thinking about medical
breakthroughs, about actually curing diseases, as a preventative
measure, we can save significant amounts of money in the long term. We
can dramatically improve lives in the shorter term.
This is a model that opens up Federal Government funding as a reward
for these innovations to our Nation's innovators, our entrepreneurs,
our doers.
Right now, the NIH grant process is suboptimal for a lot of these
individuals. I can speak to one individual. He used to be my neighbor,
Fazni Aziz, of Bloomington, Indiana. He is a Thomas Edison-like figure,
and he used to have a workshop right next to his house. He developed
medical devices on his own and sold them off to larger companies.
Fazni Aziz would not receive an NIH grant. He will never apply for
one. He doesn't have time to apply for one. Would he target a medical
innovation on account of a prize that is offered? Indeed. We have
consulted with him.
So for the people like Fazni Aziz around the world that can help
Americans, we have developed this prize program.
Madam Chair, I yield 1 minute to the gentleman from Michigan (Mr.
Upton), the chairman.
Mr. UPTON. Madam Chair, I do rise in support of this important
amendment that, with Mr. Young and Dr. Harris, would authorize the NIH
to conduct a prize program. The intent of the amendment is, in fact, to
incentivize health innovation by offering competitors the chance to win
a prize for developing breakthroughs. We ought to be encouraging that.
Importantly, individuals who win the prize competition would keep all
of the intellectual property rights. I think that is very important.
So I would ask my colleagues to support the amendment. I look forward
to working with both sides of the aisle to make sure that we can, in
fact, perfect it as we get to the end of the cycle and, ultimately, to
the President's desk.
Mr. PALLONE. Madam Chair, I yield back the balance of my time.
Mr. YOUNG of Indiana. Madam Chair, I yield back the balance of my
time.
The Acting CHAIR. The question is on the amendment offered by the
gentleman from Indiana (Mr. Young).
The amendment was agreed to.
Amendment No. 3 Offered by Ms. Lee
The Acting CHAIR. It is now in order to consider amendment No. 3
printed in House Report 114-193.
Ms. LEE. Madam Chair, I have an amendment at the desk.
The Acting CHAIR. The Clerk will designate the amendment.
The text of the amendment is as follows:
Page 13, strike lines 8 through 13 (and make such
conforming changes as may be necessary).
The Acting CHAIR. Pursuant to House Resolution 350, the gentlewoman
from California (Ms. Lee) and a Member opposed each will control 5
minutes.
The Chair recognizes the gentlewoman from California.
Ms. LEE. Madam Chair, I am very pleased to offer this amendment with
my colleagues, two great women, Representative Jan Schakowsky and
Representative Yvette Clarke.
Our amendment is very simple. It would strike a provision in this
bill that applies to any policy riders included in the annual Labor,
Health and Human Services and Agricultural appropriations bills to the
new National Institutes of Health funds and the Federal Drug
Administration funds included in H.R. 6, the 21st Century Cures Act.
This provision reiterates the current law restrictions on
appropriations bills, like the Hyde amendment, which is restrictive and
discriminatory against low-income women to make their own reproductive
healthcare decisions. Now this would apply to this new fund created for
the NIH in this bill.
Let's be clear what this is really about. It is yet another attempt
to insert abortion restrictions and other inappropriate riders into an
unrelated bill.
This is a bill to increase biomedical innovative research. The 21st
Century Cures Act should have been a noncontroversial, bipartisan
effort. But anti-choice leaders could not help but add this to the bill
after--mind you, after--it had passed out of committee on a bipartisan
vote. It is really outrageous and part of a larger effort to force the
inclusion of these harmful Hyde restrictions in multiple and unrelated
bills.
We know that these dangerous policies disproportionately affect low-
income women and women of color. So our amendment is about removing
these inappropriate and consistent attacks on a woman's right to make
her own healthcare decisions.
I urge my colleagues to vote ``yes'' to protecting a woman's right to
choose.
I reserve the balance of my time.
Mr. UPTON. Madam Chair, I claim time in opposition to the amendment.
The Acting CHAIR. The gentleman from Michigan is recognized for 5
minutes.
Mr. UPTON. Madam Chair, I yield 2 minutes to the gentleman from
Pennsylvania (Mr. Pitts), the chairman of the Health Subcommittee.
Mr. PITTS. Madam Chair, I rise in opposition to the Lee amendment. If
passed, this amendment would allow the National Institutes of Health to
use taxpayer dollars to conduct experiments involving abortion or to
hone abortion techniques.
Let me be clear. The underlying bill simply applies current Federal
health policies that have been approved by both Republican and Democrat
majorities for decades to new funds appropriated in the Cures bill. It
is nothing
[[Page H5073]]
more than the status quo applied to new funding.
There is a reason why these policies are the status quo. Americans do
not want their tax dollars used to destroy unborn lives. A poll
conducted just this January showed 68 percent of Americans oppose
taxpayer funding for abortion.
H.R. 6, the 21st Century Cures Act, is about finding cures and
protecting the health and well-being of Americans. It would be a
terrible injustice if a bill designed to save lives were to become a
conduit for the destruction of the most vulnerable, the voiceless
unborn who are still too young to be heard crying out for help.
I urge all Members to oppose this amendment.
Ms. LEE. Madam Chair, I yield 1 minute to the gentlewoman from
Illinois (Ms. Schakowsky), a cosponsor of this amendment.
Ms. SCHAKOWSKY. Madam Chair, I am proud to join Congresswoman Lee and
Congresswoman Clarke in offering this amendment.
Our amendment would strike the policy riders that were added to the
21st Century Cures Act after it passed unanimously the Energy and
Commerce Committee, 51-0.
{time} 0945
Most notably, our amendment would remove the unnecessary addition of
the Hyde amendment. The Hyde amendment is a discriminatory policy that
denies millions of women the full range of healthcare choices, and it
has no business being included in this legislation.
It is time for us to stop using these bills as a way to discriminate
against women. Going forward, as far as I am concerned, I will not
support any bill that adds such language.
It is time for us to stop taking away health services from low-income
women, from women serving in the military, from Federal employees, and
from every woman who relies on the Federal Government for her health
insurance. All women, regardless of their incomes and what insurance
they have, deserve to make their own health choices.
This harmful provision is unrelated to the goals of this otherwise
bipartisan landmark legislation, and I ask that Members vote in favor
of our amendment.
Mr. UPTON. Madam Chair, I yield 2 minutes to the gentlewoman from
Tennessee (Mrs. Blackburn), the vice chair of the Energy and Commerce
Committee.
Mrs. BLACKBURN. Madam Chairman, I do rise in opposition to this
amendment. I think it is important to realize a couple of things.
The American people have spoken out on this issue. Sixty-eight
percent of all Americans oppose taxpayer dollars being used for
abortions. Seventy-one percent of all millennials oppose this.
What the Lee amendment would do is strip away bipartisan agreements
that we use in appropriations bills. This is not something that is new.
It is not language that is new.
The Hyde amendment and the Hyde language has been around for a very
long time. The Lee amendment would reverse important limitations to
protect these taxpayer dollars.
I have mentioned the opposition to abortion. There is also
prohibition for the use of public funds to advocate for gun control,
limit Federal grants from being awarded to tax cheats. Do we really
want tax cheats being able to get Federal dollars?
It limits extravagant conference spending for public employees. Do we
really want them to be able to waste these dollars? Of course not. Of
course not.
That is why this language is in the bill. I encourage my colleagues
to vote against the Lee amendment.
Ms. LEE. Madam Chair, I yield 1 minute to the gentlewoman from New
York (Ms. Clarke), another cosponsor of this amendment.
Ms. CLARKE of New York. Madam Chair, today I rise in support of the
Lee-Schakowsky-Clarke amendment, and I thank them for their leadership
in advancing this amendment.
H.R. 6, the 21st Century Cures Act, which received unanimous support
from members of the Energy and Commerce Committee, demonstrates that
Democrats and Republicans can work together in an effort to develop
medicines, treatments, and cures that will save lives.
Unfortunately, our bipartisan consensus has been undermined by a
last-minute inclusion of an antichoice provision in this bill. This new
provision, which is a cynical poison pill and lacks germaneness to the
underlying bill, would place restrictions on women's ability to access
health services.
It fails to respect the personal dignity of women by limiting their
healthcare options. It interferes with the private relationship between
a woman and her doctor, and it denies women what I believe is their
fundamental right to have control over their own bodies.
I am deeply concerned that this new provision will only serve as
confirmation for the skeptics, who believe that Members of Congress are
simply unable to work with each other in the public interest.
We have the opportunity to disprove the skeptic by voting for this
amendment and stripping out this provision.
Mr. UPTON. Madam Chair, could I ask how much time is remaining on
each side?
The Acting CHAIR. The gentleman from Michigan has 2 minutes
remaining, and the gentlewoman from California has 1 minute remaining.
Mr. UPTON. Madam Chair, I yield myself such time as I may consume.
Madam Chair, I do rise in opposition to the Lee amendment. The Lee
amendment would strip dozens of important limitations and restrictions
that routinely apply to funding appropriated by Congress with
bipartisan support and through the normal appropriation process.
For example, this amendment would strike limitations that, as has
been noted, would prevent taxpayer dollars from being used to destroy
life. And, frankly, they have been in place since the seventies, going
back to the Henry Hyde days in the House.
The Lee amendment would also strike other commonsense protections
that normally apply to appropriated funds. This includes restrictions
that prevent Federal grants from being awarded to tax cheats.
The Lee amendment would be a vote, should it pass, to allow abuse of
taxpayer funds. So I would urge the House to reject this amendment.
We carefully wrote provisions that the riders that are in place would
apply to each of the years of the NIH funds. And I think that that is
appropriate, that the Lee amendment would undermine that.
So I would urge my colleagues to vote ``no.''
I yield back the balance of my time.
Ms. LEE. I yield 1 minute to the gentlewoman from Colorado (Ms.
DeGette), a leader of this bill and sponsor.
Ms. DeGETTE. Madam Chair, I rise in strong support of the Lee
amendment, which removes completely unnecessary and intrusive policy
riders attached to the funding provisions of the underlying bill after
its unanimous passage from our committee.
At best, these policy riders are immaterial provisions that have no
effect on the policies and activities of the NIH or FDA. Many of them
interfere with researchers and the scientific understanding that can
make us all safer and healthier.
The inclusion of the Hyde amendment, among these riders, is
especially offensive. The last I heard, neither the NIH or the FDA ever
performed abortions. And so Hyde's restrictions remind us that even
bipartisan efforts are not immune from political attacks.
Women consist of more than half the patients in America, and their
healthcare needs should not be insulted and restricted by this
Congress.
I want to thank my colleagues, Congresswomen Lee, Schakowsky, and
Clarke, for introducing this amendment. We should remove these policy
riders and keep 21st Century Cures' focus on the great potential to do
more for patients.
Ms. LEE. I yield back the balance of my time.
The Acting CHAIR. The question is on the amendment offered by the
gentlewoman from California (Ms. Lee).
The question was taken; and the Acting Chair announced that the ayes
appeared to have it.
Mr. UPTON. Madam Chair, I demand a recorded vote.
[[Page H5074]]
The Acting CHAIR. Pursuant to clause 6 of rule XVIII, further
proceedings on the amendment offered by the gentlewoman from California
will be postponed.
Amendment No. 4 Offered by Mr. Castro of Texas
The Acting CHAIR. It is now in order to consider amendment No. 4
printed in House Report 114-193.
Mr. CASTRO of Texas. Madam Chair, I have an amendment at the desk.
The Acting CHAIR. The Clerk will designate the amendment.
The text of the amendment is as follows:
Page 32, line 8, insert before the period the following:
``, including underrepresented individuals in the sciences,
such as women and other minorities''.
The Acting CHAIR. Pursuant to House Resolution 350, the gentleman
from Texas (Mr. Castro) and a Member opposed each will control 5
minutes.
The Chair recognizes the gentleman.
Mr. CASTRO of Texas. Madam Chair, I thank Chairman Upton, Ranking
Member Pallone, and also Congresswoman DeGette for their work on this
bill.
My amendment seeks to ensure that, when the NIH reports on its
retention of young scientists, it includes data specifically related to
women and other underrepresented minority populations in the scientific
community.
Madam Chair, I reserve the balance of my time.
Mr. UPTON. Madam Chair, I claim time in opposition, although I do not
oppose this amendment.
The Acting CHAIR. Without objection, the gentleman from Michigan is
recognized for 5 minutes.
There was no objection.
Mr. UPTON. Madam Chair, we support this amendment. I think that it is
important. It would include underrepresented individuals in the
sciences in the NIH report on efforts to attract, retain, and develop
emerging scientists.
It is important to ensure that the NIH is indeed focused on including
all qualified individuals dedicated to finding cures.
I know no one that is opposed to this amendment. We support it. I
appreciate your hard work on this and look forward to having it be part
of the process as it moves forward.
I yield back the balance of my time.
Mr. CASTRO of Texas. Madam Chair, I yield 1 minute to the gentleman
from New Jersey (Mr. Pallone), the ranking member.
Mr. PALLONE. Madam Chairwoman, this amendment would require the NIH
to report on their specific efforts to attract more women and racial
and ethnic minorities into the biomedical workforce.
It is clear that we must reverse the harmful trend of limited
participation by women and racial and ethnic minorities in the
biomedical workforce.
To remain the world's leader in research, we must encourage the best
and brightest from all populations to pursue biomedical research
careers.
Without robust participation by women and ethnic minorities, we risk
losing our position as having the best biomedical workforce in the
world.
So I urge my colleagues to vote ``yes'' on this amendment.
Mr. CASTRO of Texas. Mr. Chair, I yield 1 minute to the gentlewoman
from Texas (Ms. Jackson Lee).
Ms. JACKSON LEE. Mr. Chair, this gives me an opportunity to not only
thank the gentleman for his very astute amendment, but to thank the
sponsors of this bill, Mr. Pallone, Mr. Green, Ms. DeGette, Mr. Upton,
for all the work that has been done.
Having served a number of years on the House Science Committee, I
want to thank the gentleman from Texas because all we heard very often
was the value of investing in minorities and women as the new cutting
edge of scientific research.
We know that this bill is expansive, but we are delighted with your
emphasis on the recruiting of women and minorities, particularly for
the young emerging scientists, and primarily because they begin to fuel
the next generation of research and the next generation of the solving
of problems, which is the American Cures Act.
So I rise to support the gentleman's amendment and say to you that
the documentation is long, that these individuals will then fill the
laboratories of America and begin to do cutting-edge research to be
able to create a better life for all of us.
I thank the gentleman. I support his amendment.
Mr. CASTRO of Texas. Mr. Chair, I thank Chairman Upton and the
Republicans for their cooperation on this amendment.
I yield back the balance of my time.
The Acting CHAIR (Mr. Hill). The question is on the amendment offered
by the gentleman from Texas (Mr. Castro).
The amendment was agreed to.
Amendment No. 5 Offered by Ms. Slaughter
The Acting CHAIR. It is now in order to consider amendment No. 5
printed in House Report 114-193.
Ms. SLAUGHTER. Mr. Chair, I have an amendment at the desk.
The Acting CHAIR. The Clerk will designate the amendment.
The text of the amendment is as follows:
Page 152, insert after line 9 the following new subsection:
(c) Study and Report on the Impact of Additional Medicare
Payment for DISARM Drugs on Usage Practices and Development
of Resistance.--
(1) Study.--The Director of the Centers for Disease Control
and Prevention shall conduct a study to examine the effects
of the additional payment for DISARM drugs under the Medicare
program provided under subparagraph (M) of section 1886(d)(5)
of the Social Security Act (42 U.S.C. 1395ww(d)(5)), as added
by subsection (a), on--
(A) the usage of DISARM drugs (as defined by clause (iii)
of such subparagraph) by subsection (d) hospitals (as defined
in section 1886(d)(1)(B) of such Act); and
(B) the development of resistance by individuals to such
DISARM drugs.
(2) Report.--Not later than three years after the date of
the enactment of this Act, such Director shall submit to
Congress a report on the study conducted under paragraph (1).
The Acting CHAIR. Pursuant to House Resolution 350, the gentlewoman
from New York (Ms. Slaughter) and a Member opposed each will control 5
minutes.
The Chair recognizes the gentlewoman from New York.
Ms. SLAUGHTER. Mr. Chair, I rise today in support of my amendment
which directs the CDC, the Centers for Disease Control, to study
whether incentivizing the use of new antibiotics, which the underlying
bill does, will lead to antibiotic resistance and cause these
lifesaving drugs to be less effective.
Section 2123 of the 21st Century Cures Act authorizes additional
payments to hospitals for using newly developed antibiotics.
{time} 1000
Of course, the reason we need new antibiotics is that we have
frittered away one of the greatest medical achievements of the 21st
century by overusing the ones that we already have and hastening the
development of bacterial resistance.
I fear that paying hospitals more to use a new generation of
antibiotics will just repeat the cycle of overuse and develop more
drug-resistant superbugs. Quite simply, the taxpayers should not foot
the bill for practices that are making antibiotics less effective.
This amendment directs the CDC to study the effect the bill would
have on drugs that are part of the foundation of modern medicine. I
urge my colleagues, many of whom have expressed their alarm at the rise
of antibiotic resistance, to support the amendment.
I am certainly not alone in my concern about this section of the
bill. I know there are several Members, myself included, who will feel
safer if section 2123 was removed entirely.
A recent report from the United Kingdom review on antimicrobial
resistance, led by brilliant economist Jim O'Neill, noted that
increasing reimbursements for new antibiotics risks undermining ``good
infection control and antibiotic stewardship practices within
hospitals.'' The study required by this amendment will provide valuable
data on the link between efforts to incentivize development of new
antibiotics and the development of resistance to make sure we don't
repeat the cycle.
Mr. Chairman, I want to be clear about what is at stake here.
Worldwide, antibiotic-resistant infections already kill 700,000 people
every year. If we don't act now, by the year 2050, according to Mr.
O'Neill's study, the annual death toll will rise to 10 million a year,
and the costs will be $100 trillion.
The World Health Organization has told us that the very future of
medicine is at stake. Without antibiotics,
[[Page H5075]]
modern medical advances such as joint replacements and organ
transplants would be impossible, and even the routine procedures such
as dental work and caesarean sections would be too risky to perform.
We have to remember that our urgent need for new antibiotics is due
to our widespread misuse and overuse of the current antibiotics that
led to the crisis of antibiotic resistance. We have to cure that before
we use new antibiotics.
Mr. Chairman, 30 to 50 percent of the antibiotics prescribed to
humans are unnecessary, but 80 percent of the antibiotics produced in
the United States are used on industrial farms where they are routinely
fed to healthy animals. It is an absolute recipe for creating
antibiotic resistance. We can't afford to keep using such precious,
live-saving resources so thoughtlessly. The changes in how our current
antibiotics are used are desperately needed.
Unfortunately, my amendment doesn't do what I would really like to
do, which would be to protect eight classes of antibiotics just for use
in human health by not allowing their use on the farm except for sick
animals.
Remember, as I said before, these antibiotics, 80 percent, are fed to
well animals every single day. However, the amendment will ensure that
we can know whether incentives to develop new antibiotics continue the
problem of resistance. Having effective antibiotic for humans is too
important not to get this right.
Mr. Chairman, I urge my colleagues to support the amendment, and I
reserve the balance of my time.
Mr. UPTON. Mr. Chairman, although I am not in opposition to the
amendment, I claim the time.
The Acting CHAIR. Without objection, the gentleman from Michigan is
recognized for 5 minutes.
There was no objection.
Mr. UPTON. Mr. Chairman, we strongly support this amendment, and I
congratulate the gentlewoman for offering it.
Mr. Chairman, I yield 3 minutes to the gentleman from Texas (Mr.
Barton), the former chairman, ranking member, subcommittee chair,
ranking member, and now chairman emeritus and former deputy whip.
(Mr. BARTON asked and was given permission to revise and extend his
remarks.)
Mr. BARTON. Mr. Chairman, I thank the gentleman.
Mr. Chairman, if you look up here at the podium right behind me on
the Republican side, what do you see? Carved into the balustrade is the
word ``liberty.'' If you look on the Democratic side, what do you see?
You see the word ``justice.'' If you look straight down the center
aisle right between them, what do you see? It is ``tolerance.''
Mr. Chairman, the bill that is before us today is a culmination of 4
years of hard work between both political parties and both leaderships
of the Energy and Commerce Committee on both sides of the aisle in
which a lot of tolerance has been exhibited.
Conservatives on the Republican side haven't gotten everything that
we want in this bill, and liberals on the Democratic side haven't
gotten everything they want on this bill, but the work product is a
culmination of an open process that Chairman Upton and subcommittee
Chairman Pitts have put together.
Every member of the committee has been invited to numerous working
groups--probably 10, 15, I don't know--and have been given every
opportunity to have input into what they want and what they don't want.
This bill would become law, and it will stay law. It will become law,
and it will unite the medical research community. There are things in
this bill that I have worked on for 10 years that will help find cures
sooner rather than later.
Mr. Chairman, I had a woman in my office in Texas 4 days ago. Her son
has autism, and he is 11 years old. He is her only child. They
literally don't know what to do. He speaks one word at a time. He
becomes violent.
She has almost given up hope, but we are doing amazing research in
autism. This bill will facilitate and expedite that. I am tired of
telling parents of children: I don't know. I can't help you.
I want to say: Here is what we are doing.
This bill does that.
Now, Mr. Chairman, there is a $2 billion mandatory program for 5
years called the innovation fund. Some of my conservative friends have
said: Oh, we can't vote for the bill because of that program.
What was Medicare part D? It was a mandatory program--$40 billion
that was not offset. Every Republican in the House voted for that--I
might point out every Democrat voted against it--and that was
voluntary. The people could participate or not participate, but it was
mandatory that the Federal Government had to spend the money.
Last year, we voted on a program for veterans, $10 billion. Every
Republican in the House voted for that. It wasn't offset.
Now, I would rather that we have everything discretionary. I wish the
whole Federal budget was discretionary except for Social Security, but
it is not.
The Acting CHAIR. The time of the gentleman has expired.
Mr. UPTON. Mr. Chairman, I yield the gentleman an additional 15
seconds.
Mr. BARTON. Mr. Chairman, let's come together. Let's vote for
something that we can all be proud of so that we can tell the parents
of children with autism that there is hope and there is a future.
Vote ``yes.'' Please vote ``yes.''
Ms. SLAUGHTER. Mr. Chairman, I very much want to thank Mr. Upton for
his graciousness in accepting this, and I look forward to working with
him further on this issue.
Mr. Chairman, I yield the balance of my time to the gentleman from
Texas, Congressman Gene Green.
Mr. GENE GREEN of Texas. Mr. Chairman, I want to thank our ranking
member on the Rules Committee for bringing up this amendment. I support
the amendment.
Mr. Chairman, this bill also includes some great provisions in there
for the next generation of research on antibiotics. Congressman John
Shimkus and I worked on it this session, and previously, over the last
two sessions, Congressman Phil Gingrey and I worked on it.
What this amendment addresses is it is not just a new generation, but
we also need to not overuse what we have. That is a problem in our
country. As I say, I have sinus infections, but those antibiotics won't
help it. We need to make sure we don't overuse.
Mr. Chairman, I am glad our colleague has come up with the amendment,
and I support her amendment.
Ms. SLAUGHTER. Mr. Chair, I yield back the balance of my time.
Mr. UPTON. Mr. Chairman, I yield the balance of my time to the
gentleman from Illinois (Mr. Roskam), a member of the important Ways
and Means Committee.
Mr. ROSKAM. Thank you, Chairman Upton.
Mr. Chairman, my DISARM Act is part of this H.R. 6 Cures Act, and I
thank Chairman Upton and his staff for including it. It is a focal
point of a lot of discussion on both sides of the aisle as it relates
to antibiotics.
Mr. Chairman, there is an incredible health threat that has
manifested itself interestingly and sadly in two important ways near my
constituency in the Chicago area.
Back in December of 2013, 44 patients at Lutheran General Hospital
cultured positive for CRE, which is known as the nightmare bacteria. To
put this in perspective, previously, only 96 cases had been reported to
the CDC before. Nearby, in Algonquin, Illinois, two cases of an
ostensibly drug-resistant tuberculosis were also diagnosed. Now,
according to the CDC, 23,000 patients die annually from this.
What the DISARM Act does--which is embedded in Cures, H.R. 6--is it
gets researchers and scientists back in the business of antibiotic
research and development by modernizing how Medicare views treatments
for infections that are considered to be unmet medical needs.
It reimburses target antibiotics at cost to ensure a functioning
marketplace where the right treatment is used at the right time for the
right patient helping to reinvigorate the pipeline of drugs and
development, and it is a critical piece of the drug resistance puzzle.
Mr. Chairman, I urge passage of Cures, H.R. 6, and I thank Chairman
Upton.
[[Page H5076]]
Mr. UPTON. Mr. Chair, I yield back the balance of my time.
The Acting CHAIR. The question is on the amendment offered by the
gentlewoman from New York (Ms. Slaughter).
The amendment was agreed to.
Amendment No. 6 Offered by Mr. Fitzpatrick
The Acting CHAIR. It is now in order to consider amendment No. 6
printed in House Report 114-193.
Mr. FITZPATRICK. Mr. Chairman, I have an amendment at the desk.
The Acting CHAIR. The Clerk will designate the amendment.
The text of the amendment is as follows:
Page 235, after line 2, insert the following:
Subtitle R--Other Provisions
SEC. 2321. SENSE OF CONGRESS.
It is the sense of the Congress that recording unique
device identifiers at the point-of-care in electronic health
record systems could significantly enhance the availability
of medical device data for postmarket surveillance purposes.
The Acting CHAIR. Pursuant to House Resolution 350, the gentleman
from Pennsylvania (Mr. Fitzpatrick) and a Member opposed each will
control 5 minutes.
The Chair recognizes the gentleman from Pennsylvania.
Mr. FITZPATRICK. Mr. Chairman, I yield myself such time as I may
consume.
Mr. Chairman, first, I want to express my deep appreciation to
Chairman Upton and Ranking Member DeGette on this bill. The funding and
these innovative reforms will save lives, and that is something that
everyone in this Chamber should be proud of. There are a lot of
wonderful provisions in this bill, and we should see those provisions
through.
I am a member, Mr. Chairman, of the Rare Disease Caucus. Like most of
us here, I have met with constituents with incredible stories of
courage and stories of their battle with diseases without treatments.
It would be easy to fall victim to despair, but they don't.
They remain beacons of hope, hope for a treatment and hope for a
world where no one else has to go through what they did. They look to
us to support them and to fight alongside them for these treatments in
lifesaving research, and I am proud to stand with them and to fight for
them.
There is a part of this bill that I believe will do more harm than
good, and that is the part that deals with easing medical device safety
regulations. While we bring our research and treatments into the 21st
century, I think it is equally important we bring our medical device
safety regulations into the 21st century as well.
As part of a 21st century approach to medical devices, the FDA has
established a unique device identification system to adequately
identify medical devices through their distribution and use. These
codes can significantly improve safety and help track down dangerous
recalled products.
Currently, these UDIs are not incorporated into all electronic health
records, which make it difficult to fully achieve the benefits to
patient safety. For example, a claim form might list a procedure like a
routine surgery to remove uterine fibroids, but not note the make or
model of the device used, such as the laparoscopic power morcellator, a
device that the FDA placed a black box warning on, some manufacturers
have recalled, and some insurance companies have stopped covering as a
result of its devastatingly adverse effects on women's health.
It is this tragedy surrounding the power morcellator that has driven
me to action, and it is why I offered eight amendments to the Rules
Committee which would strengthen our safety laws.
This week, I have heard from dozens of these individuals affected by
complications from power morcellation. One doctor from California sent
me a note about how her sister died 9 months after a routine surgery
with a power morcellator. A woman from Massachusetts described her
battle with the cancer that was spread by the morcellator. These
constituents wrote their letters to Members of Congress and copied my
office.
Another constituent in New York lost her sister to cancer spread by
the morcellator and described her sister's tragedy as ``a routine
surgery ending with a death sentence.'' A constituent of mine, a doctor
and a mother of six children, is courageously fighting an aggressive
cancer that was spread by the blades of the device.
What happened, Mr. Chairman, with the power morcellator should never
be allowed to happen again, and I think that we missed an opportunity
with this bill to tackle this problem head-on.
In 2011, the Institute of Medicine found the current, four-decade-old
medical device safety process known as 510(k) inadequate, noting
``510(k) process lacks the legal basis to be a reliable premarket
screen of the safety and effectiveness of moderate-risk devices.''
I wish the bill had addressed this gap that allowed the power
morcellator to slip through and cause unnecessary harm to way too many
families.
{time} 1015
It is time we take our medical device safety regulations into the
21st century. I ask my colleagues to join me in this effort and to
support this amendment of mine today, which is a small but important
step.
I am proud to stand for patient safety. I urge my colleagues to stand
with me and the thousands of others who have been injured or killed by
unsafe medical devices.
Mr. Chairman, I yield to the gentleman from Pennsylvania (Mr. Pitts).
Mr. PITTS. Mr. Chair, I rise today in support of the amendment
offered by Representative Fitzpatrick.
The Fitzpatrick amendment would put forward a sense of Congress that
our healthcare system should find ways to incorporate information from
medical devices into the care of our Nation's patients.
I believe that such information can prove a valuable tool advancing
quality health care in this country, but it must be done carefully to
ensure that the value to patients, healthcare providers, industry, and
the government is realized.
Mr. PALLONE. Mr. Chairman, I rise in opposition, although I do want
to speak in favor of the amendment.
The Acting CHAIR. Without objection, the gentleman from New Jersey is
recognized for 5 minutes.
There was no objection.
Mr. PALLONE. Mr. Chairman, I yield myself such time as I may consume.
Mr. Chairman, the amendment offered today by Congressman Fitzpatrick
expresses a sense of Congress that recording unique device identifiers
within electronic health records could significantly enhance the
availability of medical device data for purposes of postmarket
surveillance.
I have long supported the use of UDIs. In the Food and Drug
Administration Amendment Act of 2007, we required FDA to establish a
unique device identification system; and in the Food and Drug
Administration Safety and Innovation Act of 2012, we required FDA to
promulgate final implementing regulations on how UDIs should be used.
Better integrating the use of UDIs into our health system will lead
to improved medical devices and care across our healthcare system that
will modernize how FDA monitors the safety of medical devices after
they have been approved or cleared, and it will enable FDA and
providers to identify medical devices with a history of safety issues.
It also will facilitate recalls and make it easier for patients to
learn when their medical device, such as a knee implant, is subject to
a recall.
The unique device identifier is one more tool that can help FDA and
our healthcare system improve their monitoring of the safety of medical
devices. Incorporating UDIs into electronic health records will take
time, but it is a worthy goal, and one that I support.
I urge my colleagues to support the amendment offered by Congressman
Fitzpatrick.
I yield back the balance of my time.
Mr. FITZPATRICK. Mr. Chairman, I would like to thank Ranking Member
Pallone and Chairman Pitts for their support of this amendment.
This amendment will, as I said, take a small step toward improving
medical device safety in the United States.
As I said earlier in my remarks, I have seven amendments that did not
make it out of Rules Committee, and I hope to be able to work with the
chairman and the ranking member on those issues as well.
I urge my colleagues to support the amendment, and I yield back the
balance of my time.
[[Page H5077]]
Mr. PASCRELL. Mr. Chair, I rise today in support of the Fitzpatrick
Amendment.
The unique device identifier (UDI) is an extremely important patient-
safety tool, and can help identify safety concerns with devices more
quickly or disprove a suspected problem. I support the inclusion of UDI
in electronic health records, as this amendment encourages. But I have
also been working in the Ways and Means Committee to include the UDI in
Medicare claims.
As is the case with any new medical technology, not all adverse
events are detected in the product's market approval or clearance
processes. However, we can mitigate the impact on patients with a
robust post-market surveillance program.
In 2013 and 2014 alone, the FDA recalled more than 120 medical
devices, but in many cases, the recall occurs only after the devices
have been implanted in or used by hundreds or thousands of patients.
This can result in extensive revision surgeries, severe pain or other
medical problems, and in some cases, even death. In a 2001 device
recall case, Sweden's post-market surveillance program successfully
identified the faulty device after it had been implanted in 30
patients. By contrast, the same device was implanted into 3,000 U.S.
patients before the gravity of the problem was recognized.
The FDA's Sentinel Initiative, which has been very successful in
tracking and evaluating adverse events linked to the use of
pharmaceuticals, relies primarily on data from health insurance claims.
Because claims currently lack information on the specific devices used
in patients' care, Sentinel cannot be expanded to include medical
devices as Congress has directed FDA to do. This is a missed
opportunity.
Patients deserve access to innovative new devices that improve their
health and their lives. And a vote for this amendment tells patients
that we owe it to them and to be able to quickly identify problems with
devices when they arise.
I urge my colleagues to support this amendment.
The Acting CHAIR. The question is on the amendment offered by the
gentleman from Pennsylvania (Mr. Fitzpatrick).
The amendment was agreed to.
Amendment No. 7 Offered by Mr. Polis
The Acting CHAIR. It is now in order to consider amendment No. 7
printed in House Report 114-193.
Mr. POLIS. Mr. Chairman, I have an amendment at the desk.
The Acting CHAIR. The Clerk will designate the amendment.
The text of the amendment is as follows:
Page 235, insert after line 2 the following new subtitle:
Subtitle R--Other Provisions
SEC. 2321. STUDY ON TWO-TIERED APPROVAL PROCESS FOR DEVICES
BY FDA.
(a) In General.--Not later than one year after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall submit to Congress a report assessing the
feasibility, benefits, and risks associated with establishing
an expedited, two-tiered approval process for devices (as
defined in section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321)) that would enable devices to be
lawfully marketed as of the date on which the device has been
shown to be safe--
(1) regardless of whether the device has been shown to be
effective; and
(2) so long as the person submitting the application for
approval of the device has made no false claims with respect
to whether the device is safe or effective.
(b) Included Elements of Report.--The report described in
subsection (a) shall include--
(1) an analysis of the impact of such a process on survival
rates and quality of life measures for seniors and
individuals with disabilities;
(2) an analysis of the impact of such a process on survival
rates and quality of life measures of individuals suffering
from life-threatening or irreversibly debilitating human
diseases or conditions;
(3) an estimation of the impact such a process would have
on national health care costs;
(4) an analysis of the extent to which such a process could
be designed so as to guarantee that patient safety is not
compromised;
(5) an analysis of the extent to which fraudulent or
ineffective devices could be marketed to patients under such
a process and how such risks could be successfully mitigated;
(6) proposals for providing device manufacturers with
incentives to show the effectiveness of devices after the
Secretary of Health and Human Services has approved such
devices to be lawfully marketed under such a system, such
as--
(A) by permitting only limited marketing of a device, the
effectiveness of which has not yet been shown; or
(B) by revoking approval of any device, the effectiveness
of which has not been shown within a specified timeframe; and
(7) recommendations for whether such a process should be
applicable to all devices or to only devices that have been
granted specific designations by the Secretary or been
determined eligible to be approved under specific approval
programs under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.).
The Acting CHAIR. Pursuant to House Resolution 350, the gentleman
from Colorado (Mr. Polis) and a Member opposed each will control 5
minutes.
The Chair recognizes the gentleman from Colorado.
Mr. POLIS. Mr. Chairman, I would like to start by commending Chairman
Upton, Ranking Member Pallone, Ms. DeGette, Mr. Green, and so many
others. I am proud to join as a cosponsor for the 21st Century Cures
Act, which is really a first step to updating our approval process to
help countless Americans gain access to lifesaving drugs and devices.
This bill will save lives. I am proud to support it and send a strong
message that we need to move forward with reform.
But at the same time we are passing this bill, we should start
thinking about what the next step is. Passage of this bill should not
foreclose additional opportunities in the future to improve access to
lifesaving medical device products and lifesaving drugs.
Most importantly, this body can move forward with the next generation
and start the process to help people get access to medical technology
that can help keep people healthy, independent, save lives, and save
money.
It is in that spirit that I put forward my amendment, which would
look at a two-tiered approval process for medical devices, that would
allow devices to come to market once they have demonstrated safety
while the FDA is still reviewing them for efficacy.
This solves a real problem in the world. In the U.S., the cost of
bringing a medical device to market through the approval process is $30
million to $100 million. Those are costs that are then added to
consumers of the medical device. That makes it even more difficult for
niche medical devices that may help rare and unusual conditions because
they are priced prohibitively.
In addition, there is the aspect of the timeline. In the European
market, for instance, if somebody creates a new device to prevent blood
clots, it reaches the market in 7 to 11 months. In the U.S. market,
they are looking at a timeline of 2\1/2\ to 4 years. Think of how many
sufferers might die or have additional health problems simply because
our own government is keeping that lifesaving product off the market,
even though it has been demonstrated as safe.
An additional result is that some medical technology companies are
bypassing the U.S. market altogether when they develop new devices,
which can result in years-long delays for access to U.S. patients and,
in some cases, companies who view the U.S. approval system as too
expensive market their devices exclusively in other nations.
I think it is important to talk about what comes next. I think that
with both devices and drugs, we need to look at the potential for a
two-tiered process that allows a provisional approval and access to the
U.S. market. That doesn't mean that insurance will cover it. That
doesn't mean, clearly, that they can make any health claims with regard
to the efficacy of their product. That is in existing law. But with
regard to the safety being demonstrated, the provisional marketing of
the product in America can save lives and will save lives.
I reserve the balance of my time.
Mr. GENE GREEN of Texas. Mr. Chairman, I claim the time in
opposition.
The Acting CHAIR. The gentleman is recognized for 5 minutes.
Mr. GENE GREEN of Texas. Mr. Chairman, I rise not necessarily in
opposition to the amendment, but concerning the amendment offered by my
colleague, Congressman Polis.
I want to thank the Congressman for his efforts to advance medical
device
[[Page H5078]]
development and would like to work with him on the legislation to
enhance patient access to therapies.
However, I am concerned this amendment as drafted would lower the
approval standard for medical devices and suggest that patients should
be exposed to products that are not proven effective.
The FDA approval is a global gold standard for safety and
effectiveness. While I support efforts to modernize and improve the
standard, safety cannot be evaluated in a vacuum, and patients should
not be offered treatments that have not been studied or proven useful
to their care.
I have great respect for my colleague, Congressman Polis, and
appreciate his commitment to improving our healthcare system. I would
like to work with him forward on that because he was correct in his
statement, this doesn't mean it will be reimbursed. So we are proving a
device is safe but it is not effective. I think there is a way, maybe,
we can still make sure that not only we want it to be safe, but we want
also to solve the problem or have a cure for whatever particular
illness.
Mr. UPTON. Will the gentleman yield?
Mr. GENE GREEN of Texas. I yield to the gentleman from Michigan.
Mr. UPTON. Mr. Chairman, I would like to give my commitment, too. I
would like to work with the gentleman from Colorado. This is an
important issue. I believe it has got merit, but we have got to make
sure that it is designed just the right way.
I want to say it is probably the lateness of the timing of the
amendment when it came forward. It is my understanding the gentleman
may withdraw the amendment--I would appreciate that--and allow us some
time to really get together and see if there might be another day.
Mr. PALLONE. Will the gentleman yield?
Mr. GENE GREEN of Texas. I yield to the gentleman from New Jersey.
Mr. PALLONE. Mr. Chairman, I just want to join with my other
colleagues, Mr. Green and also the chairman, that we do understand the
purpose of the Polis amendment, but we do have problems with it at the
same time. We would like to have a conversation with Mr. Polis about
it. I understand he is going to withdraw it. Then we would follow up
and have a conversation and perhaps a meeting with the FDA as well.
Mr. GENE GREEN of Texas. Mr. Chairman, I reserve the balance of my
time.
Mr. POLIS. Mr. Chairman, I thank both the chair and the ranking
member.
This is a very important discussion to have, both with regard to
devices and also with regard to drugs.
We know that there are treatments that are available overseas. I
represent a district with, by the way, one of the largest veterinary
hospitals in our country, Colorado State University Veterinary Teaching
Hospital, and I can tell you that there are actually treatments,
advance treatments available today for animals with cancer, like
horses, that are not yet approved for humans and are lifesaving.
If we can provide access in a shortened timeframe--I understand that
while medical devices might cost $30 million to $100 million to bring
to market, drugs often cost over $1 billion to bring to market.
There are additional opportunities, by the way, in making sure that,
as part of this provisional process, at least with regard to drugs, the
data can be gathered, too. So it can serve a dual function and might,
at the same time complying with some of the needs or an updating of the
needs of some of the phases of FDA efficacy trials, it can actually be
available through a market-oriented plan where people, consumers who
are fully informed and, of course, to whom no health claims have been
made, can choose to purchase the product, just as they can today, by
the way, but they have to buy it overseas and import it for their own
personal use. I have constituents who do that. But I think we can
facilitate that process.
I deeply appreciate working with the chair and the ranking member of
the committee and the subcommittee with regard to helping to bring
access to lifesaving medical devices and pharmaceutical products to our
shore.
Mr. FITZPATRICK. Will the gentleman yield?
Mr. POLIS. I yield to the gentleman from Pennsylvania.
Mr. FITZPATRICK. Mr. Chairman, I was actually going to rise in
opposition to the amendment, although now it is being withdrawn I see
an opportunity here for, perhaps, us to work together on the medical
device safety issue.
I was going to object and vote against the amendment because it is my
concern that the amendment would actually loosen medical device safety
regulations and permit safe but ineffective devices to get to the
market. I know that this sort of came late in the process. I would have
objected because I had seven amendments before the committee to
strengthen medical device regulations. But since the amendment is being
withdrawn, I would see an opportunity for us perhaps to work together,
take a step back and look at all the FDA regulations on medical device
safety.
Mr. POLIS. Mr. Chairman, I ask unanimous consent to withdraw my
amendment.
The Acting CHAIR. Is there objection to the request of the gentleman
from Colorado?
There was no objection.
Amendment No. 8 Offered by Ms. Jackson Lee
The Acting CHAIR. It is now in order to consider amendment No. 8
printed in House Report 114-193.
Ms. JACKSON LEE. Mr. Chairman, I have an amendment at the desk.
The Acting CHAIR. The Clerk will designate the amendment.
The text of the amendment is as follows:
Page 352, after line 8, insert the following:
SEC. 4062. OUTREACH TO HISTORICALLY BLACK COLLEGES AND
UNIVERSITIES.
The Secretary of Health and Human Services shall conduct
outreach to historically Black colleges and universities,
Hispanic-serving institutions, Native American colleges, and
rural colleges to ensure that health professionals from
underrepresented populations are aware of research
opportunities under this Act.
The Acting CHAIR. Pursuant to House Resolution 350, the gentlewoman
from Texas (Ms. Jackson Lee) and a Member opposed each will control 5
minutes.
The Chair recognizes the gentlewoman from Texas.
Ms. JACKSON LEE. Mr. Chairman, let me add my appreciation to Mr.
Upton, Ms. DeGette, Mr. Pitts, Mr. Pallone, and Mr. Green, and I ask
the simple question: When have we had a historic opportunity on the
floor of the House to have such a major investment--major investment--
in the lives and health of Americans, quality investment involving a
mandatory fund that will open America's labs and put more people in
labs and be able to give people relief on some of the issues that we
have heard discussed today?
I thank Mr. Barton for raising the sadness that comes of parents that
cannot find answers. Many of them are my constituency who have children
with sickle cell, as we have been attempting to research this disease
for many, many years; or the lupus that took advantage of a very active
civic leader and caused the hospitalization for months; or this issue
of triple negative breast cancer that many people are not aware of.
The amendment I have today is to emphasize the importance of outreach
to our Historically Black Colleges, Hispanic-Serving, Indian, Native
American, and rural colleges.
Let me explain for a brief moment the importance of this particular
message.
Physicians are a gateway to the patient. In short, the Jackson Lee
amendment seeks to open up the physician gateway for patients and to
researchers. It is to emphasize STEM education. It is to talk about the
different medical illnesses and how important it is to reach out to
these particular institutions to produce more medical professionals.
According to the Centers for Disease Control and Prevention, sickle
cell trait is common among African Americans and occurs in about 1 in
12. Additionally, race and ethnicity have also been shown to affect the
effectiveness in response to certain drugs.
We need these students from these colleges to be in our labs, to be
physicians, and to welcome minorities into the clinical labs; because
we have evidence to show of the short numbers of individuals who
volunteer for clinicals, and minorities are at the low end.
[[Page H5079]]
{time} 1030
I encourage my colleagues to support the Jackson Lee amendment. Open
the doors of research and patient care through doctors, and open the
doors of solving some of these very difficult diseases.
I reserve the balance of my time.
Mr. UPTON. Mr. Chairman, I claim the time in opposition, although I
support the amendment.
The Acting CHAIR. Without objection, the gentleman from Michigan is
recognized for 5 minutes.
There was no objection.
Mr. UPTON. Mr. Chairman, I yield myself 2 minutes.
I appreciate this amendment. It is a good amendment, and it builds on
what a member of our committee, Bobby Rush, did in the full committee
markup.
It directs the Secretary of HHS to perform outreach to Historically
Black Colleges and Universities, to Hispanic-serving institutions,
Native American colleges, and rural colleges to ensure health
professionals from unrepresented areas are, in fact, aware of research
opportunities under this act. It is a real complement to what was done
before.
Mr. Rush, as I remember, grabbed me on the House floor literally
during our markup process and was very supportive of a number of
amendments through the night. In fact, we worked on those amendments
and included them in the manager's amendment. I offered them the very
next morning, and they were accepted on a voice vote. This is clearly a
bipartisan amendment. It is essential that we include everyone as we
find cures for all.
Ms. Jackson Lee and I have worked together on a number of health-
related issues over the years, on date rape drugs and other issues that
really strike to the heart. So I appreciate her value in adding this
amendment, and I very strongly support it.
Mr. Chairman, I yield 1 minute to the gentleman from Pennsylvania
(Mr. Fattah).
Mr. FATTAH. Mr. Chairman, this is a special day. This is probably the
first day that I would have preferred to have been a member of the
chairman's committee rather than of the Appropriations Committee. The
committee should be congratulated for its great work on this bill, and
I am happy to be an original cosponsor.
I rise in support of the amendment. It is critically important that
we have serious outreach to all of our universities and medical
centers, including African American, Hispanic, Native American
universities, and those in the most rural parts of our country.
I thank the gentleman and Diana DeGette and all of those who worked
on this great piece of legislation.
Ms. JACKSON LEE. Mr. Chairman, how much time is remaining?
The Acting CHAIR. The gentlewoman from Texas has 2\1/2\ minutes
remaining.
Ms. JACKSON LEE. Mr. Chairman, I am delighted to yield 30 seconds to
the gentleman from New Jersey (Mr. Pallone), the distinguished ranking
member of the Energy and Commerce Committee.
Mr. PALLONE. Mr. Chairman, I just want to urge support for this
amendment.
We need to make sure that emerging scientists from all populations
understand Congress' commitment to ensuring that the funding is there
to support our biomedical workforce.
Requiring the Secretary to do outreach to colleges and universities
that educate large numbers of students from underrepresented groups
will ensure that all groups know of our commitment to making sure that
funding is not a barrier to a career in biomedical research.
I urge my colleagues to vote ``yes'' on the Sheila Jackson Lee
amendment.
Ms. JACKSON LEE. In reclaiming my time, Mr. Chairman, I thank Mr.
Upton. I certainly thank Mr. Fattah, Mr. Pallone, and, again, my dear
friend from Texas (Mr. Green) for his great leadership.
Let me indicate that certain medical illnesses have been known to
have a higher prevalence amongst certain demographic groups, including
type 2 diabetes, lupus, sickle cell anemia, triple-negative breast
cancer, and many other forms of diseases impacting our children, ones
with early birth.
So I ask my colleagues again to support this because increased
diversity in research trials could help researchers find better, more
precise ways to fight diseases that disproportionately impact certain
populations and may be important for the safe and effective use of
therapies.
Again, I think this is a historic day, and I join with Mr. Upton to
say that we have been friends. We started with the first bill together,
and all of these Members have come together to put a historic mark on
this Nation to say that we will not take a back step to any nation on
research and on improving the quality of life for all of our citizens.
I must say that this is a historic day as well for minorities. I
thank Mr. Rush for his constant service, and I take note of the fact
that increased in this is the ability to raise the FDA loans that
people might get to $50,000, which will help many minorities. I hold
this chart to show that minorities don't volunteer for clinicals
without the outreach.
Finally, I am delighted to have a letter from United Negro College
Fund President Michael Lomax, who indicates that 25 percent of African
American graduates with degrees in science, technology, engineering,
and math come from our Historically Black Colleges.
They are waiting in line to be a part of these clinicals, to be
doctors and researchers, and we must give them that opportunity. It is
a historic day.
United Negro College Fund, Inc.,
Washington, DC, July 9, 2015.
Hon. Sheila Jackson Lee,
House of Representatives,
Washington, DC.
Dear Representative Jackson Lee: On behalf of UNCF (the
United Negro College Fund), our 37 member private
historically black colleges and universities (HBCUs) and the
students we serve, I write to express our strong support for
your amendment to H.R. 6, the 21st Century Cures Act, which
would require the U.S. Department of Health and Human
Services to increase its outreach to underrepresented health
professionals and researchers regarding federal research
opportunities.
As you know, Historically Black Colleges and Universities
(HBCUs) are making strong contributions to the nation's
scientific, technological, and research workforce. HBCUs
enroll 10 percent of African American undergraduates, but
produce 25 percent of African American graduates with degrees
in science, technology, engineering, and mathematics (STEM)
fields. According to the National Science Foundation (NSF),
ten of the top eleven baccalaureate institutions producing
African American STEM doctorate recipients are HBCUs. Four
HBCU medical institutions supply over 50 percent of African
Americans who receive doctoral degrees in medicine,
dentistry, and the biomedical sciences each year.
Despite these contributions, federal efforts to tap into
this talent pool in the dissemination of federal research
grants at the National Institutes of Health, the NSF, and
other federal science agencies continues to lag behind. Your
amendment will help draw greater attention to the
disproportionately low representation of minority researchers
in U.S. Department of Health and Human Services-supported
biomedical and behavioral research.
We are grateful for your recognition of the vital need to
diversify and strengthen the nation's scientific and research
workforce and thank you for your ongoing advocacy to drive
improvement.
Sincerely,
Michael L. Lomax, Ph.D.,
President and CEO, UNCF.
Ms. JACKSON LEE. I cannot conclude my remarks without saying that
just a few minutes ago, by video, I witnessed the flag of South
Carolina--the rebel flag--being taken down.
I would only say that it is a unifying factor. This bill is a
unifying factor, and it is going to help all of us. I ask my colleagues
to support the Jackson Lee amendment.
Mr. Chair, I have an amendment at the desk. It is listed in the Rule
as Jackson Lee #8.
I wish to thank the Chair and Ranking Member of the Committee on
Rules for making the Jackson Lee Amendment in order.
I thank Energy and Commerce Committee Chairman Upton and Ranking
Member Pallone for their collaborative effort that resulted in this
bipartisan legislation being reported favorably to the House by a vote
of 51-0.
I thank them all for this opportunity to explain the Jackson Lee
Amendment, which makes a good bill even better by ensuring that the
national goals of finding and bringing more cures and treatments to
patients and strengthening the biomedical innovation ecosystem in the
United States is aided by an expanding pool of diverse and talented
medical researchers.
Specifically, the Jackson Lee Amendment provides:
[[Page H5080]]
The Secretary of Health and Human Services shall conduct outreach to
historically Black colleges and universities, Hispanic-serving
institutions, Native American colleges, and rural colleges to ensure
that health professionals from underrepresented populations are aware
of research opportunities under this Act.
Many racial health disparities stem from lack of access to quality
healthcare and proper health awareness.
Unfortunately this means that incidence of disease does not always
match trial populations.
For example, consider that:
1. African-Americans represent 12% of the U.S. population but only 5%
of clinical trial participants.
2. Hispanics make up 16% of the population but only 1% of clinical
trial participants.
3. Sex distribution in cardiovascular device trials is 67% male.
Other significant barriers to diversified clinical trials, which are
the key to sound medical research and the foundation for medical cures
and breakthroughs, as reported by investigators and coordinators are
insurance status, patient inconvenience costs, availability of
transportation, distance to the study site, and patient and family
concerns about risk.
But the most significant barriers limiting clinical participation are
race, age, and sex of participants:
1. Women and minority patients are more difficult to recruit.
2. Women and minority physicians have less experience and are
relatively more costly to engage.
3. Minority patients with limited English proficiency can require
costly translation services.
The first step in engaging women and minorities in clinical trials is
finding them.
Research has shown that minority patients seek physicians of their
own race, so bringing these doctors into trials is critical.
``Physicians are the gateway to the patient''.
There are disturbing statistics on the number of African Americans,
Hispanics and Native Americans pursuing academic qualification and
participating in scientific research.
Many barriers exist that account for the low rate of participation
among diverse communities, including patient fear of experimentation
and lack of understanding or education with regard to the importance of
clinical trials in creating new treatments and cures.
The Jackson Lee Amendment is intended to aid in the necessary effort
to diversify the pool of doctors and medical researchers conducting
clinical trials, and thereby helping to diversify the participants in
the clinical trials.
In short, the Jackson Lee Amendment seeks to open the ``physician
gateway'' to the patient.
The Journal on STEM Education reported in 2011 that only 8.34% of the
STEM doctorates awarded in 2006 were given to URMs, despite making up
approximately 28% of the U.S. population.
Furthermore, GAO noted that while the percentage of underrepresented
minorities nationwide increased from 13% to 19% from 1994 to 2003, the
total number of STEM doctorates awarded to the same group dropped
during this period from 8,335 to 7,310.
In response, the National Institute of General Medical Sciences
(NIGMS) created the Minority Opportunities in Research (MORE) Division
and similar academic intervention programs.
The MORE programs are comprised of four primary components: research
experience, mentoring and advisement, supplemental instruction and
workshops, and financial support.
In 2007, NIGMS' annual budget was $1.9 billion, of which nearly $126
million was spent on its MORE programs.
This amount includes the Minority Biomedical Research Support-
Research Initiative for Scientific Enhancement (MBRS-RISE) program, the
Minority Access to Research Careers (MARC), Post-baccalaureate Research
Education Program (PREP), and the Bridges to the Baccalaureate and
Bridges to the Ph.D. programs.
The amount of funds dedicated to these programs reflects the
commitment by the science and research community to the goals of the
MORE Division in addressing this problem.
Certain medical illnesses have been known to have higher prevalence
in certain demographic groups, including type II diabetes, lupus,
sickle cell anemia, and Triple Negative Breast Cancer for which African
Americans are more than twice as likely to be diagnosed on average.
According to the Centers for Disease Control and Prevention, sickle
cell trait is common among African Americans and occurs in about 1 in
12, and sickle cell disease occurs in about 1 out of every 500 African-
American births, compared to about 1 out of every 36,000 Hispanic-
American births.
Race and ethnicity have also been shown to affect the effectiveness
of and response to certain drugs, such as anti-hypertensive therapies
in the treatment of hypertension in African Americans and anti-
depressants in Hispanics.
Increased diversity in research trials could help researchers find
better, more precise ways to fight diseases that disproportionately
impact certain populations, and may be important for the safe and
effective use of new therapies.
But before we can engage more women and minorities to participate in
clinical trials, we must be able to find them.
And the key to finding minority patients is to find more physicians
from their racial and ethnic groups because research has shown that
physicians are the gateway to the patient.
The Jackson Lee Amendment opens that gateway.
I urge support for the Jackson Lee Amendment.
I yield back the balance of my time.
Mr. UPTON. Mr. Chairman, I yield back the balance of my time.
The Acting CHAIR. The question is on the amendment offered by the
gentlewoman from Texas (Ms. Jackson Lee).
The amendment was agreed to.
Announcement by the Acting Chair
The Acting CHAIR. Pursuant to clause 6 of rule XVIII, proceedings
will now resume on those amendments printed in House Report 114-193 on
which further proceedings were postponed, in the following order:
Amendment No. 1 by Mr. Brat of Virginia.
Amendment No. 3 by Ms. Lee of California.
The Chair will reduce to 2 minutes the minimum time for any
electronic vote after the first vote in this series.
Amendment No. 1 Offered by Mr. Brat
The Acting CHAIR. The unfinished business is the demand for a
recorded vote on the amendment offered by the gentleman from Virginia
(Mr. Brat) on which further proceedings were postponed and on which the
noes prevailed by voice vote.
The Clerk will redesignate the amendment.
The Clerk redesignated the amendment.
Recorded Vote
The Acting CHAIR. A recorded vote has been demanded.
A recorded vote was ordered.
The vote was taken by electronic device, and there were--ayes 141,
noes 281, not voting 11, as follows:
[Roll No. 431]
AYES--141
Abraham
Aderholt
Amash
Amodei
Babin
Barr
Bishop (MI)
Bishop (UT)
Black
Blum
Brady (TX)
Brat
Bridenstine
Brooks (AL)
Buck
Byrne
Carter (GA)
Carter (TX)
Chabot
Chaffetz
Clawson (FL)
Coffman
Collins (GA)
Conaway
Cook
Crawford
Culberson
DeSantis
DesJarlais
Duffy
Duncan (SC)
Duncan (TN)
Emmer (MN)
Farenthold
Fincher
Fleischmann
Fleming
Forbes
Fortenberry
Foxx
Franks (AZ)
Garrett
Gibbs
Gohmert
Goodlatte
Gosar
Gowdy
Graves (GA)
Graves (LA)
Grothman
Hardy
Harris
Hartzler
Heck (NV)
Hensarling
Hice, Jody B.
Holding
Huelskamp
Huizenga (MI)
Hultgren
Hunter
Hurd (TX)
Hurt (VA)
Issa
Jenkins (KS)
Johnson, Sam
Jolly
Jones
Jordan
Joyce
King (IA)
Labrador
LaMalfa
Lamborn
Loudermilk
Love
Lummis
Marchant
Massie
McClintock
Meadows
Messer
Mica
Miller (FL)
Moolenaar
Mooney (WV)
Mulvaney
Newhouse
Noem
Palazzo
Palmer
Paulsen
Pearce
Perry
Poe (TX)
Poliquin
Posey
Price, Tom
Ratcliffe
Renacci
Ribble
Rice (SC)
Rigell
Roby
Rohrabacher
Rokita
Rooney (FL)
Ross
Rothfus
Rouzer
Royce
Russell
Ryan (WI)
Sanford
Schweikert
Scott, Austin
Sensenbrenner
Sessions
Smith (MO)
Smith (NE)
Smith (TX)
Stewart
Stutzman
Thornberry
Tipton
Trott
Walberg
Walker
Walorski
Weber (TX)
Webster (FL)
Wenstrup
Westerman
Westmoreland
Williams
Wilson (SC)
Wittman
Woodall
Yoho
Young (IN)
Zinke
NOES--281
Adams
Aguilar
Allen
Ashford
Barletta
Barton
Beatty
Becerra
Benishek
Bera
Beyer
Bilirakis
Bishop (GA)
Blackburn
Blumenauer
Bonamici
Bost
Boustany
Boyle, Brendan F.
Brady (PA)
Brooks (IN)
Brown (FL)
Brownley (CA)
Buchanan
Bucshon
Burgess
Bustos
Butterfield
Calvert
Capps
Capuano
Cardenas
Carney
Carson (IN)
Cartwright
Castor (FL)
Castro (TX)
Chu, Judy
Cicilline
Clark (MA)
Clarke (NY)
Clay
Cleaver
Clyburn
Cohen
Cole
Collins (NY)
Comstock
Connolly
Conyers
Cooper
Costa
Costello (PA)
Courtney
Cramer
Crenshaw
Crowley
Cuellar
Cummings
Curbelo (FL)
Davis (CA)
Davis, Danny
Davis, Rodney
DeFazio
DeGette
[[Page H5081]]
Delaney
DeLauro
DelBene
Denham
Dent
Deutch
Diaz-Balart
Dingell
Doggett
Dold
Donovan
Doyle, Michael F.
Duckworth
Edwards
Ellison
Ellmers (NC)
Eshoo
Esty
Farr
Fattah
Fitzpatrick
Flores
Foster
Frankel (FL)
Frelinghuysen
Fudge
Gabbard
Gallego
Garamendi
Gibson
Graham
Granger
Grayson
Green, Al
Green, Gene
Griffith
Grijalva
Guinta
Guthrie
Hahn
Hanna
Harper
Hastings
Heck (WA)
Herrera Beutler
Higgins
Hill
Himes
Hinojosa
Honda
Hoyer
Hudson
Huffman
Israel
Jackson Lee
Jeffries
Jenkins (WV)
Johnson (GA)
Johnson (OH)
Johnson, E. B.
Kaptur
Katko
Keating
Kelly (IL)
Kelly (MS)
Kelly (PA)
Kildee
Kilmer
Kind
King (NY)
Kinzinger (IL)
Kirkpatrick
Kline
Knight
Kuster
Lance
Langevin
Larsen (WA)
Larson (CT)
Latta
Lawrence
Lee
Levin
Lewis
Lieu, Ted
Lipinski
LoBiondo
Loebsack
Long
Lowenthal
Lowey
Lucas
Luetkemeyer
Lujan Grisham (NM)
Lujan, Ben Ray (NM)
Lynch
MacArthur
Maloney, Carolyn
Maloney, Sean
Marino
Matsui
McCarthy
McCaul
McCollum
McDermott
McGovern
McHenry
McKinley
McMorris Rodgers
McNerney
McSally
Meehan
Meeks
Meng
Miller (MI)
Moore
Moulton
Mullin
Murphy (FL)
Murphy (PA)
Nadler
Napolitano
Neal
Nolan
Norcross
Nugent
Nunes
O'Rourke
Olson
Pallone
Pascrell
Payne
Pelosi
Perlmutter
Peters
Peterson
Pingree
Pittenger
Pitts
Pocan
Polis
Pompeo
Price (NC)
Quigley
Rangel
Reed
Reichert
Rice (NY)
Richmond
Rogers (AL)
Rogers (KY)
Ros-Lehtinen
Roskam
Roybal-Allard
Ruiz
Ruppersberger
Rush
Ryan (OH)
Sanchez, Linda T.
Sarbanes
Scalise
Schakowsky
Schiff
Schrader
Scott (VA)
Scott, David
Serrano
Sewell (AL)
Sherman
Shimkus
Shuster
Simpson
Sinema
Sires
Slaughter
Smith (NJ)
Smith (WA)
Speier
Stefanik
Stivers
Swalwell (CA)
Takai
Takano
Thompson (CA)
Thompson (MS)
Thompson (PA)
Tiberi
Titus
Tonko
Torres
Tsongas
Turner
Upton
Valadao
Van Hollen
Vargas
Veasey
Vela
Velazquez
Visclosky
Wagner
Walden
Walters, Mimi
Walz
Wasserman Schultz
Waters, Maxine
Watson Coleman
Welch
Whitfield
Wilson (FL)
Womack
Yarmuth
Yoder
Young (AK)
Young (IA)
Zeldin
NOT VOTING--11
Bass
DeSaulnier
Engel
Graves (MO)
Gutierrez
Kennedy
Lofgren
Neugebauer
Roe (TN)
Salmon
Sanchez, Loretta
{time} 1107
Messrs. RICHMOND, MARINO, KNIGHT, HUFFMAN, and RYAN of Ohio changed
their vote from ``aye'' to ``no.''
Mrs. WALORSKI and Mr. TROTT changed their vote from ``no'' to
``aye.''
So the amendment was rejected.
The result of the vote was announced as above recorded.
Amendment No. 3 Offered by Ms. Lee
The Acting CHAIR. The unfinished business is the demand for a
recorded vote on the amendment offered by the gentlewoman from
California (Ms. Lee) on which further proceedings were postponed and on
which the noes prevailed by voice vote.
The Clerk will redesignate the amendment.
The Clerk redesignated the amendment.
Recorded Vote
The Acting CHAIR. A recorded vote has been demanded.
A recorded vote was ordered.
The Acting CHAIR. This will be a 2-minute vote.
The vote was taken by electronic device, and there were--ayes 176,
noes 245, not voting 12, as follows:
[Roll No. 432]
AYES--176
Adams
Aguilar
Ashford
Beatty
Becerra
Bera
Beyer
Bishop (GA)
Blumenauer
Bonamici
Boyle, Brendan F.
Brady (PA)
Brown (FL)
Brownley (CA)
Bustos
Butterfield
Capps
Capuano
Cardenas
Carney
Carson (IN)
Castor (FL)
Castro (TX)
Chu, Judy
Cicilline
Clark (MA)
Clarke (NY)
Clay
Cleaver
Clyburn
Cohen
Connolly
Conyers
Cooper
Costa
Courtney
Crowley
Cummings
Davis (CA)
Davis, Danny
DeFazio
DeGette
Delaney
DeLauro
DelBene
Deutch
Dingell
Doggett
Doyle, Michael F.
Duckworth
Edwards
Ellison
Eshoo
Esty
Farr
Fattah
Foster
Frankel (FL)
Fudge
Gabbard
Gallego
Garamendi
Graham
Grayson
Green, Al
Green, Gene
Grijalva
Hahn
Hastings
Heck (WA)
Higgins
Himes
Hinojosa
Honda
Hoyer
Huffman
Israel
Jackson Lee
Jeffries
Johnson (GA)
Johnson, E. B.
Keating
Kelly (IL)
Kildee
Kilmer
Kind
Kirkpatrick
Kuster
Langevin
Larsen (WA)
Larson (CT)
Lawrence
Lee
Levin
Lewis
Lieu, Ted
Loebsack
Lowenthal
Lowey
Lujan Grisham (NM)
Lujan, Ben Ray (NM)
Lynch
Maloney, Carolyn
Maloney, Sean
Matsui
McCollum
McDermott
McGovern
McNerney
Meeks
Meng
Moore
Moulton
Murphy (FL)
Nadler
Napolitano
Neal
Nolan
Norcross
O'Rourke
Pallone
Pascrell
Payne
Pelosi
Perlmutter
Peters
Pingree
Pocan
Polis
Price (NC)
Quigley
Rangel
Rice (NY)
Richmond
Roybal-Allard
Ruiz
Ruppersberger
Rush
Ryan (OH)
Sanchez, Linda T.
Sarbanes
Schakowsky
Schiff
Schrader
Scott (VA)
Scott, David
Serrano
Sewell (AL)
Sherman
Sinema
Sires
Slaughter
Smith (WA)
Speier
Swalwell (CA)
Takai
Takano
Thompson (CA)
Thompson (MS)
Titus
Tonko
Torres
Tsongas
Van Hollen
Vargas
Veasey
Vela
Velazquez
Visclosky
Walz
Wasserman Schultz
Waters, Maxine
Watson Coleman
Welch
Wilson (FL)
Yarmuth
NOES--245
Abraham
Aderholt
Allen
Amash
Amodei
Babin
Barletta
Barr
Barton
Benishek
Bilirakis
Bishop (MI)
Bishop (UT)
Black
Blackburn
Blum
Bost
Boustany
Brady (TX)
Brat
Bridenstine
Brooks (AL)
Brooks (IN)
Buchanan
Buck
Bucshon
Burgess
Byrne
Calvert
Carter (GA)
Carter (TX)
Cartwright
Chabot
Chaffetz
Clawson (FL)
Coffman
Cole
Collins (GA)
Collins (NY)
Comstock
Conaway
Cook
Costello (PA)
Cramer
Crawford
Crenshaw
Cuellar
Culberson
Curbelo (FL)
Davis, Rodney
Denham
Dent
DeSantis
DesJarlais
Diaz-Balart
Dold
Donovan
Duffy
Duncan (SC)
Duncan (TN)
Ellmers (NC)
Emmer (MN)
Farenthold
Fincher
Fitzpatrick
Fleischmann
Fleming
Flores
Forbes
Fortenberry
Foxx
Franks (AZ)
Frelinghuysen
Garrett
Gibbs
Gibson
Gohmert
Goodlatte
Gosar
Gowdy
Granger
Graves (GA)
Graves (LA)
Griffith
Grothman
Guinta
Guthrie
Hanna
Hardy
Harper
Harris
Hartzler
Heck (NV)
Hensarling
Herrera Beutler
Hice, Jody B.
Hill
Holding
Hudson
Huelskamp
Huizenga (MI)
Hultgren
Hunter
Hurd (TX)
Hurt (VA)
Issa
Jenkins (KS)
Jenkins (WV)
Johnson (OH)
Johnson, Sam
Jolly
Jones
Jordan
Joyce
Kaptur
Katko
Kelly (MS)
Kelly (PA)
King (IA)
King (NY)
Kinzinger (IL)
Kline
Knight
Labrador
LaMalfa
Lamborn
Lance
Latta
Lipinski
LoBiondo
Long
Loudermilk
Love
Lucas
Luetkemeyer
Lummis
MacArthur
Marchant
Marino
Massie
McCarthy
McCaul
McClintock
McHenry
McKinley
McMorris Rodgers
McSally
Meadows
Meehan
Messer
Mica
Miller (FL)
Miller (MI)
Moolenaar
Mooney (WV)
Mullin
Mulvaney
Murphy (PA)
Newhouse
Noem
Nugent
Nunes
Olson
Palazzo
Palmer
Paulsen
Pearce
Perry
Peterson
Pittenger
Pitts
Poe (TX)
Poliquin
Pompeo
Posey
Price, Tom
Ratcliffe
Reed
Reichert
Renacci
Ribble
Rice (SC)
Rigell
Roby
Rogers (AL)
Rogers (KY)
Rohrabacher
Rokita
Ros-Lehtinen
Roskam
Ross
Rothfus
Rouzer
Royce
Russell
Ryan (WI)
Sanford
Scalise
Schweikert
Scott, Austin
Sensenbrenner
Sessions
Shimkus
Shuster
Simpson
Smith (MO)
Smith (NE)
Smith (NJ)
Smith (TX)
Stefanik
Stewart
Stivers
Stutzman
Thompson (PA)
Thornberry
Tiberi
Tipton
Trott
Turner
Upton
Valadao
Wagner
Walberg
Walden
Walker
Walorski
Walters, Mimi
Weber (TX)
Webster (FL)
Wenstrup
Westerman
Westmoreland
Whitfield
Williams
Wilson (SC)
Wittman
Womack
Woodall
Yoder
Yoho
Young (AK)
Young (IA)
Young (IN)
Zeldin
Zinke
NOT VOTING--12
Bass
DeSaulnier
Engel
Graves (MO)
Gutierrez
Kennedy
Lofgren
Neugebauer
Roe (TN)
Rooney (FL)
Salmon
Sanchez, Loretta
Announcement by the Acting Chair
The Acting CHAIR (during the vote). There is 1 minute remaining.
{time} 1115
Mr. GRAYSON changed his vote from ``no'' to ``aye.''
So the amendment was rejected.
The result of the vote was announced as above recorded.
The Acting CHAIR. There being no further amendments, the Committee
rises.
Accordingly, the Committee rose; and the Speaker pro tempore (Mr.
Collins of Georgia) having assumed the chair, Mr. Hill, Acting Chair of
the Committee of the Whole House on the
[[Page H5082]]
state of the Union, reported that that Committee, having had under
consideration the bill (H.R. 6) to accelerate the discovery,
development, and delivery of 21st century cures, and for other
purposes, and, pursuant to House Resolution 350, he reported the bill,
as amended by that resolution, back to the House with sundry further
amendments adopted in the Committee of the Whole.
The SPEAKER pro tempore. Under the rule, the previous question is
ordered.
Is a separate vote demanded on any further amendment reported from
the Committee of the Whole? If not, the Chair will put them en gros.
The amendments were agreed to.
The SPEAKER pro tempore. The question is on the engrossment and third
reading of the bill.
The bill was ordered to be engrossed and read a third time, and was
read the third time.
The SPEAKER pro tempore. The question is on passage of the bill.
The question was taken; and the Speaker pro tempore announced that
the ayes appeared to have it.
Recorded Vote
Mr. UPTON. Mr. Speaker, I demand a recorded vote.
A recorded vote was ordered.
The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, this 5-
minute vote on passage will be followed by a 5-minute vote on approval
of the Journal, if ordered.
The vote was taken by electronic device, and there were--ayes 344,
noes 77, not voting 12, as follows:
[Roll No. 433]
AYES--344
Abraham
Adams
Aderholt
Aguilar
Allen
Amodei
Ashford
Barletta
Barr
Barton
Beatty
Becerra
Benishek
Bera
Beyer
Bilirakis
Bishop (GA)
Bishop (MI)
Blackburn
Blum
Blumenauer
Bonamici
Bost
Boyle, Brendan F.
Brady (PA)
Brady (TX)
Brooks (IN)
Brown (FL)
Brownley (CA)
Buchanan
Bucshon
Burgess
Bustos
Butterfield
Calvert
Capps
Capuano
Cardenas
Carney
Carson (IN)
Carter (GA)
Cartwright
Castor (FL)
Castro (TX)
Chabot
Chaffetz
Chu, Judy
Cicilline
Clark (MA)
Clarke (NY)
Clawson (FL)
Clay
Cleaver
Clyburn
Coffman
Cohen
Cole
Collins (GA)
Collins (NY)
Comstock
Connolly
Conyers
Cook
Cooper
Costa
Costello (PA)
Courtney
Cramer
Crenshaw
Crowley
Cuellar
Cummings
Curbelo (FL)
Davis (CA)
Davis, Danny
Davis, Rodney
DeFazio
DeGette
Delaney
DelBene
Denham
Dent
DeSantis
Deutch
Diaz-Balart
Dingell
Doggett
Dold
Donovan
Doyle, Michael F.
Duckworth
Duncan (SC)
Duncan (TN)
Edwards
Ellison
Ellmers (NC)
Emmer (MN)
Esty
Fattah
Fleischmann
Flores
Fortenberry
Foster
Foxx
Frankel (FL)
Franks (AZ)
Frelinghuysen
Fudge
Gabbard
Gallego
Garamendi
Gibson
Gohmert
Gowdy
Graham
Granger
Graves (LA)
Grayson
Green, Al
Green, Gene
Griffith
Guinta
Guthrie
Hahn
Hanna
Hardy
Harper
Harris
Hastings
Heck (NV)
Heck (WA)
Herrera Beutler
Higgins
Hill
Himes
Hinojosa
Honda
Hoyer
Hudson
Huffman
Huizenga (MI)
Hultgren
Hunter
Hurd (TX)
Hurt (VA)
Israel
Jackson Lee
Jeffries
Jenkins (KS)
Jenkins (WV)
Johnson (GA)
Johnson (OH)
Johnson, E. B.
Jolly
Joyce
Kaptur
Katko
Keating
Kelly (IL)
Kelly (MS)
Kelly (PA)
Kildee
Kilmer
Kind
King (IA)
King (NY)
Kinzinger (IL)
Kirkpatrick
Kline
Knight
Kuster
LaMalfa
Lance
Langevin
Larsen (WA)
Larson (CT)
Latta
Lawrence
Levin
Lewis
Lieu, Ted
Lipinski
LoBiondo
Loebsack
Long
Lowenthal
Lowey
Lucas
Luetkemeyer
Lujan Grisham (NM)
Lujan, Ben Ray (NM)
Lynch
MacArthur
Maloney, Carolyn
Maloney, Sean
Marchant
Marino
Matsui
McCarthy
McCaul
McCollum
McDermott
McGovern
McHenry
McKinley
McMorris Rodgers
McNerney
McSally
Meadows
Meehan
Meeks
Meng
Messer
Mica
Miller (MI)
Moolenaar
Moore
Moulton
Mullin
Murphy (FL)
Murphy (PA)
Napolitano
Neal
Newhouse
Noem
Nolan
Norcross
Nugent
Nunes
O'Rourke
Olson
Pallone
Pascrell
Paulsen
Payne
Pelosi
Perlmutter
Peters
Peterson
Pingree
Pittenger
Pitts
Pocan
Poliquin
Polis
Pompeo
Posey
Price (NC)
Quigley
Rangel
Reed
Reichert
Ribble
Rice (NY)
Richmond
Rigell
Roby
Rogers (AL)
Rogers (KY)
Rohrabacher
Rooney (FL)
Ros-Lehtinen
Roskam
Ross
Rothfus
Rouzer
Roybal-Allard
Royce
Ruiz
Ruppersberger
Rush
Russell
Ryan (OH)
Ryan (WI)
Sanchez, Linda T.
Sarbanes
Scalise
Schakowsky
Schiff
Schrader
Schweikert
Scott (VA)
Scott, Austin
Scott, David
Serrano
Sessions
Sewell (AL)
Sherman
Shimkus
Shuster
Simpson
Sinema
Sires
Slaughter
Smith (NJ)
Smith (WA)
Stefanik
Stivers
Swalwell (CA)
Takai
Takano
Thompson (CA)
Thompson (MS)
Thompson (PA)
Thornberry
Tiberi
Titus
Tonko
Torres
Trott
Tsongas
Turner
Upton
Valadao
Van Hollen
Vargas
Veasey
Vela
Velazquez
Visclosky
Wagner
Walberg
Walden
Walorski
Walters, Mimi
Walz
Wasserman Schultz
Waters, Maxine
Watson Coleman
Webster (FL)
Welch
Whitfield
Wilson (FL)
Wilson (SC)
Womack
Woodall
Yarmuth
Yoder
Yoho
Young (AK)
Young (IA)
Young (IN)
Zeldin
Zinke
NOES--77
Amash
Babin
Black
Boustany
Brat
Bridenstine
Brooks (AL)
Buck
Byrne
Carter (TX)
Conaway
Crawford
Culberson
DeLauro
DesJarlais
Duffy
Eshoo
Farenthold
Farr
Fincher
Fitzpatrick
Fleming
Forbes
Garrett
Gibbs
Goodlatte
Gosar
Graves (GA)
Grijalva
Grothman
Hartzler
Hensarling
Hice, Jody B.
Holding
Huelskamp
Issa
Johnson, Sam
Jones
Jordan
Labrador
Lamborn
Lee
Loudermilk
Love
Lummis
Massie
McClintock
Miller (FL)
Mooney (WV)
Mulvaney
Nadler
Neugebauer
Palazzo
Palmer
Pearce
Perry
Poe (TX)
Price, Tom
Ratcliffe
Renacci
Rice (SC)
Rokita
Sanford
Sensenbrenner
Smith (MO)
Smith (NE)
Smith (TX)
Speier
Stewart
Stutzman
Tipton
Walker
Weber (TX)
Wenstrup
Westerman
Westmoreland
Williams
NOT VOTING--12
Bass
Bishop (UT)
DeSaulnier
Engel
Graves (MO)
Gutierrez
Kennedy
Lofgren
Roe (TN)
Salmon
Sanchez, Loretta
Wittman
Announcement by the Speaker Pro Tempore
The SPEAKER pro tempore (during the vote). There are 2 minutes
remaining.
{time} 1126
So the bill was passed.
The result of the vote was announced as above recorded.
A motion to reconsider was laid on the table.
Personal Explanation
Mr. DeSAULNIER. Mr. Speaker, I regret that I was unable to vote on
Friday, July 10 as I was attending the memorial services of a dear
friend in my congressional district. Had I been present, I would have
cast the following votes: rollcall No. 431: ``no;'' rollcall No. 432:
``aye;'' rollcall No. 433: ``aye.''
personal explanation
Ms. LORETTA SANCHEZ of California. Mr. Speaker, I missed votes on
H.R. 6, the 21st Century Cures Act. Specifically, I missed an amendment
by Rep. Dave Brat (R-VA) (rollcall No. 431), amendment by Rep. Barbara
Lee (D-CA) (rollcall No. 432), and Final Passage of H.R. 6 (rollcall
No. 433). Had I been present, I would have voted ``nay'' on the
amendment by Rep. Dave Brat (R-VA) (rollcall No. 431), ``yea'' on the
amendment by Rep. Barbara Lee (D-CA) (rollcall no. 432), and ``yea'' on
the Final Passage of H.R. 6 (rollcall No. 433).
personal explanation
Mr. GUTIERREZ. Mr. Speaker, I was unavoidably absent in the House
chamber for votes on Friday, July 10, 2015.
Had I been present, I would have voted ``nay'' on rollcall vote 431,
``yea'' on rollcall vote 432, and ``yea'' on rollcall vote 433 in
support of H.R. 6--21st Century Cures Act.
____________________