[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6 Introduced in House (IH)]
114th CONGRESS
1st Session
H. R. 6
To accelerate the discovery, development, and delivery of 21st century
cures, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 19, 2015
Mr. Upton (for himself, Ms. DeGette, Mr. Pitts, Mr. Pallone, and Mr.
Gene Green of Texas) introduced the following bill; which was referred
to the Committee on Energy and Commerce, and in addition to the
Committee on Ways and Means, for a period to be subsequently determined
by the Speaker, in each case for consideration of such provisions as
fall within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To accelerate the discovery, development, and delivery of 21st century
cures, and for other purposes.
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.
TITLE I--DISCOVERY
Subtitle A--National Institutes of Health Funding
Sec. 1001. National Institutes of Health reauthorization.
Sec. 1002. NIH Innovation Fund.
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.
Subtitle C--Supporting Young Emerging Scientists
Sec. 1041. Improvement of loan repayment programs of 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 National Institutes of Health Research and
Data Access
Sec. 1101. Sharing of data generated through NIH-funded research.
Sec. 1102. Standardization of data in Clinical Trial Registry Data Bank
on eligibility for clinical trials.
Subtitle G--Facilitating Collaborative Research
Sec. 1121. Clinical Trial Data System.
Sec. 1122. National neurological diseases surveillance system.
Sec. 1123. Data on natural history of diseases.
Sec. 1124. Accessing, sharing, and using health data for research
purposes.
Subtitle H--Council for 21st Century Cures
Sec. 1141. Council for 21st Century Cures.
TITLE II--DEVELOPMENT
Subtitle A--Patient-Focused Drug Development
Sec. 2001. Development and use of patient experience data to enhance
structured risk-benefit assessment
framework.
Subtitle B--Qualification and Use of Drug Development Tools
Sec. 2021. Qualification of drug development tools.
Sec. 2022. Accelerated approval development plan.
Subtitle C--FDA Advancement of Precision Medicine
Sec. 2041. Precision medicine guidance and other programs of Food and
Drug Administration.
Subtitle D--Modern Trial Design and Evidence Development
Sec. 2061. Broader application of Bayesian statistics and adaptive
trial designs.
Sec. 2062. Utilizing evidence from clinical experience.
Sec. 2063. Streamlined data review program.
Subtitle E--Expediting Patient Access
Sec. 2081. Sense of Congress.
Sec. 2082. Expanded access policy.
Sec. 2083. Finalizing draft guidance on expanded access.
Subtitle F--Facilitating Responsible Manufacturer Communications
Sec. 2101. Facilitating dissemination of health care economic
information.
Sec. 2102. Facilitating responsible communication of scientific and
medical developments.
Subtitle G--Antibiotic Drug Development
Sec. 2121. Approval of certain drugs for use in a limited population of
patients.
Sec. 2122. Susceptibility test interpretive criteria for
microorganisms.
Sec. 2123. Encouraging the development and use of new antimicrobial
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.
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 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 ``; and''; 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.''.
SEC. 1002. NIH INNOVATION FUND.
(a) Use of Innovation Fund.--Section 402(b) of the Public Health
Service Act is amended--
(1) in paragraph (23), by striking at the end ``and'';
(2) in paragraph (24), by striking at the end the period
and inserting ``; and''; and
(3) by inserting after paragraph (24), the following new
paragraph:
``(25) shall, with respect to funds appropriated under
section 402A(e) to the NIH Innovation Fund, allocate such funds
to the national research institutes and national centers for
conducting and supporting innovation fund initiatives
identified under paragraph (3) of such section.''.
(b) Establishment of Innovation Fund.--Section 402A of the Public
Health Service Act is amended--
(1) by redesignating subsection (e) as subsection (f); and
(2) by inserting after subsection (d) the following new
subsection:
``(e) NIH Innovation Fund.--
``(1) Establishment.--For the purpose of allocations under
section 402(b)(25), there is established a fund to be known as
the NIH Innovation Fund. The Director of NIH shall, with
respect to funds appropriated to the NIH Innovation Fund,
allocate such funds to support biomedical research through the
funding of basic, translational, and clinical research.
``(2) Amounts made available to fund.--
``(A) In general.--Subject to subparagraph (B),
there is authorized to be appropriated, and
appropriated, to the NIH Innovation Fund out of any
funds in the Treasury not otherwise appropriated,
$2,000,000,000 for each of fiscal years 2016 through
2020. The amounts appropriated to the Fund by the
preceding sentence shall be in addition to any amounts
otherwise made available to the National Institutes of
Health.
``(B) Availability subject to appropriations.--
Amounts in the Fund shall not be available except to
the extent and in such amounts as are provided in
advance in appropriation Acts.
``(C) Allocation of amounts.--Of the amounts made
available from the NIH Innovation Fund for allocations
under section 402(b)(25) for a fiscal year--
``(i) not less than $500,000,000 shall be
for the Accelerating Advancement Program under
paragraph (5);
``(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 (7);
``(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; and
``(iv) not more than 10 percent of such
amounts (without subtracting the allocation for
the Accelerating Advancement Program) shall be
for intramural research.
``(D) Inapplicability of certain provisions.--
Amounts in the NIH Innovation Fund shall not be subject
to--
``(i) any transfer authority of the
Secretary or the Director of NIH under section
241, subsection (c), subsection (d), or any
other provision of law (other than section
402(b)(25) and this subsection); or
``(ii) the Nonrecurring expenses fund under
section 223 of division G of the Consolidated
Appropriations Act, 2008 (42 U.S.C. 3514a).
``(3) Authorized uses.--Amounts in the NIH Innovation Fund
established under paragraph (1) may be used only to conduct or
support innovative biomedical research through the following:
``(A) Research in which--
``(i) a principal investigator has a
specific project or specific objectives; and
``(ii) funding is tied to pursuit of such
project or objectives.
``(B) Research in which--
``(i) a principal investigator has shown
promise in biomedical research; and
``(ii) funding is not tied to a specific
project or specific objectives.
``(C) Research to be carried out by an early stage
investigator (as defined in paragraph (7)).
``(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
paragraph (5).
``(F) Development and implementation of the
strategic plan under paragraph (6).
``(4) Coordination.--In funding programs and activities
through the NIH Innovation Fund, the Secretary, acting through
the Director of NIH, 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.
``(5) Accelerating advancement program.--The Director of
NIH shall establish a program, to be known as the Accelerating
Advancement Program, under which--
``(A) the Director of NIH partners with national
research institutes and national centers to accomplish
important biomedical research objectives; and
``(B) for every $1 made available by the Director
of NIH 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 Innovation Fund.
``(6) Strategic plan.--
``(A) In general.--The Director of NIH 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 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 shall
review and, as appropriate, update the research
strategic plan under subparagraph (A) not less than
every 18 months.
``(7) Definition.--In this subsection, 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).''.
(c) Supplement, Not Supplant; Prohibition Against Transfer.--Funds
appropriated pursuant to section 402A(e) of the Public Health Service
Act, as inserted by subsection (b)--
(1) shall be used to supplement, not supplant, the funds
otherwise allocated by the National Institutes of Health for
biomedical research; and
(2) notwithstanding any transfer authority in any
appropriation Act, shall not be used for any purpose other than
allocating funds for conducting and supporting innovation fund
initiatives as described in section 402(b)(25) of the Public
Health Service Act, as added by subsection (a).
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
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.
``(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).
``(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) Implementation of Measures To Reduce Administrative Burdens.--
The Director of the National Institutes of Health shall 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) Reports.--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.''.
Subtitle C--Supporting Young Emerging Scientists
SEC. 1041. IMPROVEMENT OF LOAN REPAYMENT PROGRAMS OF 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; 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) in subsection (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 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 487F of such Act (42 U.S.C. 288-6, as added by
section 1002(b) of Public Law 106-310, is amended--
(A) in subsection (a)(1), by striking ``$35,000''
and inserting ``$50,000'';
(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.''; and
(C) by redesignating such section as section 487G.
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 conclusion 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 National Institutes of Health Research and
Data Access
SEC. 1101. SHARING OF DATA GENERATED THROUGH NIH-FUNDED RESEARCH.
Section 402 of the Public Health Service Act (42 U.S.C. 282) is
amended by adding at the end the following:
``(m) Sharing of Data Generated Through NIH-funded Research.--
``(1) Authority.--Subject to paragraph (2), the Director of
NIH may require recipients of the award of an NIH grant or
other financial support, provided that the research is fully
funded through such grant or other support, to share scientific
data generated from research conducted through such support for
research purposes.
``(2) Limitation.--The Director of NIH shall not require
the sharing of data that is inconsistent with applicable law
and policy protecting--
``(A) privacy and confidentiality;
``(B) proprietary interests;
``(C) business confidential information;
``(D) intellectual property rights; and
``(E) other relevant rights.''.
SEC. 1102. 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 shall
include at least--
``(i) the disease or indication being
studied;
``(ii) inclusion criteria such as age,
gender, diagnosis or diagnoses, lab values, or
imaging results; and
``(iii) exclusion criteria such as specific
diagnosis or diagnoses, lab 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.
(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 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 in 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 Secretary shall conduct a study and
issue a report to the Congress, 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
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 a
description, if any, of such burden.
(E) An emphasis 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 subsection (g) of section 201 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331)), a device (as defined in
subsection (h) of such section), 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 was--
(i) 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) 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.
``(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 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 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 to 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 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.--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:
``(a) 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).
``(b) 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 such 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 such 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) shall 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.''.
(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).
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 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
representative 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;
``(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 section 507 of the Federal Food, Drug, and Cosmetic
Act, as added by subsection (c)) can play a valuable role in
helping 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 shall accept or decline to
accept such letter of intent;
``(B)(i) if the Secretary accepts the letter of
intent, a requestor shall submit a qualification plan
to the Secretary; and
``(ii) the Secretary shall accept or decline 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 shall determine whether to
accept such qualification package for review; and
``(iii) if the Secretary accepts such qualification
package for review, conduct 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; non-acceptance.--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 be granted a request for 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 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 to 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) 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.
``(f) 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
(20 U.S.C. 1001)), 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, a statement that
describes 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).''.
(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 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 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 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
``(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 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, as amended
by section 2021, is further 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 support the approval of a new indication for
a drug approved under section 505(b); and
``(2) to help 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 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 in subsection (d),
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 non-specified 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 in 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) Public health exemption.--The Secretary may--
``(A) deem such pilot demonstrations public health
activities, permitting the use and disclosure of
protected health information as described in section
164.512(b)(1)(iii) of title 45, Code of Federal
Regulations (or any successor regulation) and exempted
as a public health activity as described in section
46.101(b)(5) of title 46, Code of Federal Regulations
(or any successor regulation); and
``(B) deem safety surveillance performed at the
request of the Food and Drug Administration or under
such jurisdiction by a sponsor with responsibility for
a drug approved under this section or section 351 of
the Public Health Services Act using the Sentinel
System surveillance infrastructure authorized under
section 505(k), including use of analytic tools and
querying capabilities developed to implement the active
postmarket surveillance system described in this
section, public health activities as described in
section 164.512(b)(1)(iii) of title 45, Code of Federal
Regulations (or any successor regulation) and exempted
as a public health activity as described in section
46.101(b)(5) of title 46, 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 of 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);
``(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 analyses 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 non-misleading 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 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 with the development and
approval of such a drug 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 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));
``(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 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 will 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 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 Amendments Act of 2007 (42 U.S.C. 247d-
5a; relating to identification of clinically susceptible
concentrations of antimicrobials) is repealed.
(2) 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).''.
(3) 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 NEW ANTIMICROBIAL
DRUGS.
(a) Additional Payment for New Antimicrobial 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)(I) Effective for discharges beginning on or after October
1, 2017, the Secretary shall, after notice and opportunity for public
comment (in the publications required by subsection (e)(5) for a fiscal
year or otherwise), provide for additional payment to be made under
this subsection in accordance with the provisions of this subparagraph
with respect to discharges by eligible hospitals that involve new
antimicrobial drugs in the amount, subject to clause (vi), provided for
under section 1847A.
``(II) Additional payments to be made under this subsection shall
be with respect to discharges involving a new antimicrobial drug that
occur during the four-fiscal-year period beginning on which an
inpatient hospital code is issued with respect to the drug.
``(ii) For purposes of this subparagraph, the term `new
antimicrobial 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--
``(I) either--
``(aa) 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
``(bb) meets the definition of a qualified
infectious disease product under section 505E(g) of the
Federal Food, Drug, and Cosmetic Act;
``(II) is intended to treat an infection for which there is
an `unmet medical need'; and
``(III) is intended to treat an infection associated with
high rates of mortality or significant patient morbidity, as
determined in consultation with the infectious disease
professional community.
``(iii) For purposes of this subparagraph, the term `eligible
hospital' means a 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 reporting program 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).
``(iv) The Secretary may only revoke a determination of a product
under this subparagraph as a new antimicrobial drug if the Secretary
finds that the request for such determination contained an untrue
statement of material fact.
``(v) Not later than October 1, 2017, the Secretary shall first
publish in the Federal Register a list of the new antimicrobial drugs.
Each fiscal year thereafter, the Secretary shall publish a list of the
new antimicrobial drugs for such fiscal year as part of the annual
rulemaking under this subsection.
``(vi)(I) The total of the additional payments made under this
subsection pursuant to this subparagraph for discharges in a fiscal
year (as estimated by the Secretary as part of the rulemaking under
this subsection for the fiscal year) may not exceed the applicable
percentage (specified in subclause (II)) of the total program payments
estimated to be made under this subsection for all discharges in such
fiscal year (as calculated by the Secretary as part of the rulemaking
under this subsection for the fiscal year). For purposes of the
preceding sentence, in the case that, with respect to a fiscal year,
such additional payments are made only with respect to discharges
during a portion of such fiscal year, the reference to `all discharges
in such fiscal year' shall be considered a reference to all discharges
during such portion of such fiscal year.
``(II) For purposes of subclause (I), the term `applicable
percentage' means, for fiscal year 2018 and each fiscal year
thereafter, 0.06807 percent.
``(III) If the Secretary estimates before the beginning of a
fiscalyear that the amount of the additional payments under this
subsection pursuant to this subparagraph for the fiscal year (or
portion thereof) as determined under subclause (I) will exceed the
limit established under such subclause, the Secretary shall reduce pro
rata the amount of each of the additional payments under this
subsection pursuant to this subparagraph for such fiscal year (or
portion thereof) in order to ensure that the aggregate additional
payments under this subsection pursuant to this paragraph (as so
estimated) do not exceed such limit.''.
(2) Conforming amendments.--
(A) No duplicative ntap payments.--Section
1886(d)(5)(K)(i) of the Social Security Act (42 U.S.C.
1395ww(d)(5)(K)(i)) is amended by inserting ``and with
respect to which an additional payment is not made
pursuant to subparagraph (M),'' after ``2001,''.
(B) Access to price information.--Section
1927(b)(3)(A)(iii) of the Social Security Act (42
U.S.C. 1396r-8(b)(3)(A)(iii)) is amended--
(i) in subclause (II), by inserting ``, or
under section 1886(d) pursuant to paragraph
(5)(M) of such section,'' after ``1847A,''; and
(ii) in the matter following subclause
(III), by inserting ``or section
1886(d)(5)(M)'' after ``1881(b)(13)(A)(ii)''.
(b) Study and Report on Removing Barriers to Development of New
Antimicrobial Drugs.--
(1) Study.--The Comptroller General of the United States
shall conduct a study to--
(A) identify and examine the barriers that prevent
the development of new antimicrobial drugs, as defined
in section 1886(d)(5)(M)(iii) of the Social Security
Act (42 U.S.C. 1395ww(d)(5)(M)(iii)); and
(B) develop recommendations for actions to be taken
in order to overcome any barriers identified under
subparagraph (A).
(2) Consideration.--In conducting such study, the
Comptroller General shall take into account the perspectives of
the Director of the National Institutes of Health, the
Commissioner of the Food and Drugs, and the Director of the
Centers for Disease Control and Prevention.
(3) 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 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 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 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 120calendar 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 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 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 section 2063, is further amended by inserting after
section 505F of such Act the following:
``SEC. 505G. 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 this subsection
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 subsection (b)(1) to the lengths of the
exclusivity periods after application of pediatric exclusivity,
the 6-month extensions described in subsection (b)(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 subsection (c)(1) to the lengths of the
exclusivity periods after application of pediatric exclusivity,
the 6-month extensions described in subsection (c)(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
(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)(A)--
(i) in subparagraph (E), by striking
``and'';
(ii) in subparagraph (F), by striking the
period 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.--The Secretary may not
award any priority review vouchers under paragraph (1) after
December 31, 2018.''.
(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 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 priority review
voucher 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 towards 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 $5,000,000 for each of fiscal years 2016 through 2020 to
carry out this section.
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.--The Attorney General shall not promulgate nor
enforce any regulation, subregulatory guidance, or enforcement policy
which impedes re-exportation among European Economic Area countries (as
provided in subsection (f)(5)), 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 (as such terms are used in subsection (f)) 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--
``(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 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 (as defined in paragraph (2));
``(B) under which accredited persons shall, as
applicable, certify that a requestor's quality system
meets the criteria 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 of in-scope devices subject to the
device-related changes involved, in lieu of compliance
with the following submission requirements:
``(i) A thirty-day notice (as defined in
paragraph (2)).
``(ii) A Special PMA supplement (as defined
in paragraph (2)).
``(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) manufacturing changes subject to a
30-day notice;
``(ii) changes that qualify for a Special
PMA supplement; and
``(iii) 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 `quality system' means a quality
system described in section 520(f);
``(D) the term `requestor' means a device
manufacturer that is seeking certification under this
section of a quality system used by such manufacturer;
``(E) 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
``(F) the term `thirty-day notice' means a notice
described in section 515(d)(6).
``(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 issuance of the final guidance
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; certification 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 a waiver of and exemptions from the
certification 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 as applicable shall include--
``(I) the accredited person's
certification that the requestor has
satisfied the criteria 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 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 manufacturers
for program evaluation purposes.--
``(A) Periodic notification for manufacturing
changes otherwise subject to thirty-day notice.--A
requestor 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.
``(B) Periodic notification for device-related
changes otherwise subject to special pma supplement.--A
requestor 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.
``(C) Use of notifications for program evaluation
purposes.--Information submitted to the Secretary under
subparagraphs (A) and (B) 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 two 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 the
requestor's conformance with the applicable requirements of
this Act; and
``(6) shall be considered to be revoked if the Secretary
provides written notification to the certified requestor that
its quality system does not satisfy the certification criteria
issued under subsection (a)(5) with respect to the in-scope
devices at issue, such that the applicable submission
requirements specified in subsection (a)(1)(C) must be met for
changes made after receipt of such written notification, with
respect to such devices.
``(d) 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 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 include additional types of submissions and
additional types of changes beyond those identified in
subsection (a)(1)(C), including changes to devices
cleared under section 510(k). At the discretion of the
Secretary, the program may be expanded prior to January
31, 2021.
``(2) Sunset.--This section shall cease to be effective
October 1, 2022.
``(e) 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)(6)(A)(i) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e(d)(6)(A)(i)) is amended by inserting ``,
subject to section 524B,'' after ``that affects safety or
effectiveness''.
(2) Requirements for thirty-day notice.--Section
515(d)(6)(A)(ii) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e(d)(6)(A)(ii)) is amended by inserting ``,
subject to section 524B,'' after ``the date on which the
Secretary receives the notice''.
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) Valid scientific evidence for purposes of
clause (i) may include:
``(I) evidence described in well-documented
case histories, including registry data, that
are collected and monitored under an acceptable
protocol;
``(II) studies published in peer-reviewed
journals; and
``(III) data collected in countries other
than the United States so long as such data
otherwise meets 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 inserting after subsection
(i) 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. 29 360e) is amended by adding at the end the follows:
``(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 subclause (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 the experience
with, and reliance on, a standard by other Federal
regulatory authorities and the device industry, and
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 of 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 contained in the list
published under subparagraph (A).'';
(2) in paragraph (2)--
(A) by striking ``1 day after the date of
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 review by a classification panel of a
premarket submission for a device, the Secretary
shall--
``(i) provide an opportunity for the person
whose premarket submission is subject to panel
review to provide recommendations on the
expertise needed among the voting members of
the panel; and
``(ii) give due consideration to such
recommendations and ensure that adequate
expertise is represented on advisory panels to
assess--
``(I) the disease or condition for
which the device is intended to cure,
treat, mitigate, prevent, or diagnose;
and
``(II) the technology of the
device.
``(D) For purposes of subparagraph (B)(ii), the
term `adequate expertise' means that the membership of
the classification panel reviewing a premarket
submission 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.''.
(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 panel chairperson.''.
(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 classification 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.) is amended by adding at the end the
following:
``SEC. 524B. 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) is 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 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 and the vulnerable-
populations rules as may be necessary--
(i) to reduce regulatory duplication and
unnecessary delays;
(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 12 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 facilitate the broader use of
single, central, or lead institutional review boards. Such
regulations and guidance shall include clarification of
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) standardization of 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
pursuant to 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 towards completing such harmonization.
(d) 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'' subject to clause (ii),
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 the human subjects
involved in research described in subparagraph
(B), 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) Human subject research.--
(A) Except as provided in subparagraph (B), the
term ``human subject research'' means research, as
defined in subpart A of part 46 of title 45, Code of
Federal Regulations (or any successor regulations),
that involves a human subject, as defined in such
subpart A (or any successor regulations); and
(B) In the case of an investigation that is subject
to the provisions of part 50 of title 21, Code of
Federal Regulations (or any successor regulations), the
term ``human subject'' has the meaning given such term
in such part 50, and the term ``human subject
research'' means a clinical investigation as defined in
such part 50.
(3) 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'' after ``evaluation'';
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), 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 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 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.''.
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 the entirety of a patient's data from any and all
health information technology for authorized use under
applicable law.
``(2) Complete access to health data.--The technology
allows access to the entirety of a patient's available data for
authorized use under applicable law without special effort, as
defined by recommendations adopted in accordance with this
section, by the requestor of such data unless such data is not
disclosable under applicable law.
``(3) No information blocking.--The technology is not
configured, set up, or implemented to engage in information
blocking, as defined in section 3010A(f).
``(b) Categories for Interoperability Standards.--The categories
described in this subsection, with respect to standards for determining
if health information technology is interoperable, consistent with the
criteria described in subsection (a), include the following categories
of standards:
``(1) Standards with respect to vocabulary and terminology.
``(2) Standards with respect to content and structure.
``(3) Standards with respect to transport of information.
``(4) Security standards.
``(5) Service standards.''.
(2) Guidance.--Not later than January 1, 2017, the
Secretary of Health and Human Services, through 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 of
health information technology, as described in such section.
(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
under section 3010 are needed for the
electronic exchange and use of health
information for purposes of adoption of
such modifications and additions under
section 3004)'' after ``section 3004''.
(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 CONTRACT WITH
STANDARDS DEVELOPMENT ORGANIZATIONS.
``(a) Contract.--
``(1) In general.--For purposes of activities conducted
under this title, the Secretary shall enter into contracts with
health care standards development organizations accredited by
the American National Standards Institute to carry out 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 contract 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 organizations.--The Secretary shall
ensure the most appropriate organizations described in
paragraph (1) are selected for each contract under paragraph
(1).
``(b) Duties.--
``(1) Initial contract.--Under the initial contract under
subsection (a)(1), the standards development organizations--
``(A) shall provide to the Secretary, in
consultation with the National Coordinator, for
adoption under section 3004, recommendations, in
accordance with section 3010, for interoperability
standards consistent with the criteria described in
subsection (a) of such section and with respect to the
categories described in subsection (b)(1) of such
section; and
``(B) may provide to the Secretary, in consultation
with the National Coordinator, recommendations
described in paragraph (2).
``(2) Subsequent contracts.--Under each subsequent
contract, the organizations shall provide to the Secretary, in
consultation with the National Coordinator, for adoption under
section 3004 recommendations for any standards (including
interoperability criteria), implementation specifications, and
certification criteria (and modifications, including additions
to such standards, specifications, and criteria), which are in
accordance with the policies and priorities developed by the
Secretary, in consultation with the National Coordinator.
``(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
specification, 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, in consultation with the National
Coordinator, the Secretary shall, as needed, enter into
contracts under subsection (a) in addition to the initial
contract.
``(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 onchit.--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, 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), by striking ``and the HIT
Standards Committee'';
(2) in subsection (b), by adding at the end the following
new paragraph:
``(4) Limitation.--The Secretary may not adopt any
standards, implementation specifications, or certification
criteria under this subsection or subsection (a) that are
inconsistent with or duplicative of an interoperability
standard adopted under this section, in accordance with section
3010. 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 that is
subsequently adopted under this section, such interoperability
standard 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
becomes effective.''; and
(3) by adding at the end the following new subsections:
``(c) Adoption of Initial Interoperability Standards.--
Notwithstanding the previous subsections of this section, the following
shall apply in the case of the initial set of interoperability
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, the Secretary, in consultation with
the National Coordinator and representatives of other relevant
Federal agencies, shall jointly review such standards and shall
determine whether or not to propose adoption of such standards.
``(2) Determination to adopt.--If the Secretary
determines--
``(A) to propose adoption of such standards, the
Secretary shall, by regulation under section 553 of
title 5, United States Code, determine whether or not
to adopt such standards; or
``(B) not to propose adoption of such standards,
the Secretary shall notify the National Coordinator and
the standards development organizations under section
3003A in writing of such determination and the reasons
for not proposing the adoption of the recommendation
for such standards.
``(3) Publication.--The Secretary shall provide for
publication in the Federal Register of all determinations made
by the Secretary under paragraph (1).
``(4) Application.--Any standard adopted under this
subsection shall be effective 12 months after the date of
publication of the determination to adopt such standard.
``(c) Rules for Adoption.--In the case of a standard (including
interoperability standard), implementation specification, or
certification criteria 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 paragraph (2), any
such standard (including interoperability standard),
implementation specification, or certification criteria shall
be a standard, specification, or criterion that has been
recommended by the standards development organizations 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 is recommended under
paragraph (1)--
``(A) in the case of interoperability 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 certification
criteria, 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) Effective date.--Any standard, implementation
specification, or certification criterion adopted under this
section shall be effective 12 months after the date of
publication of the final rule to adopt such standard,
implementation specification, or certification criteria.
``(4) Assistance to the secretary.--In complying with the
requirements of this subsection, the Secretary shall rely on
the 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.''.
(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 of a report on the following:
``(A) The initial set of interoperability standards
adopted under section 3004(c).
``(B) The strategies for achieving widespread
interoperability.
``(C) An overview of the extent to which electronic
health records and health information technology
offered as of such date satisfy such initial set.
``(D) Any barriers that are preventing widespread
interoperability.
``(E) The plan and milestones, including specific
steps, to achieve widespread interoperability.
``(2) Follow-up determination and report on widespread
interoperability.--Not later than December 31, 2019, 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 the
following:
``(A) A determination by the Secretary whether the
goal of widespread interoperability has been achieved.
``(B) A list identifying the vendors of, or other
entities offering, qualified electronic health records,
which categorizes such entities, with respect to such
records, as in compliance or not in compliance with the
certification criteria described in section
3001(c)(5)(B)(ii) and with the requirements under
clause (i) of section 3001(c)(5)(C) (including with the
terms of the attestation and other requirements under
such clause).
``(C) Actions that may be taken by entities
identified under subparagraph (B) as not being in
compliance with such criteria and requirements in order
for such entities to become in compliance with such
criteria and requirements.
``(D) Penalties described in section 3010A(d) to
which entities, with respect to such qualified
electronic health records, beginning January 1, 2019,
are subject if such technology and entities are not in
compliance with the certification criteria described in
section 3001(c)(5)(B)(ii) and with the requirements
under clause (i) of section 3001(c)(5)(C),
respectively.
``(3) 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, including by being 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) by amending subparagraph (B) of such
section to read as follows:
``(B) Certification criteria described.--In this
title, the term `certification criteria' means, with
respect to qualified electronic health records--
``(i) for certifications made before
January 1, 2018, criteria to establish that the
records meet standards and implementation
specifications adopted under subsections (a)
and (b) of section 3004 for qualified
electronic health records; and
``(ii) for certifications made on or after
January 1, 2018, criteria described in clause
(i) and criteria to establish that the records
are interoperable, in accordance with section
3010, including by being in compliance with
interoperability standards adopted under
section 3004.''; and
(ii) by adding at the end the following new
subparagraph:
``(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 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) that the entity,
unless for a legitimate purpose
specified by the Secretary, has
not taken any action, including
through any financial,
administrative, or
technological barrier, which
the entity knows or should know
(as defined in section
1128A(i)(7) of the Social
Security Act), is to limit or
restrict the exchange of
information or to prevent or
disincentivize widespread
interoperability between any
providers using such records or
other health information
technology in connection with
such record;
``(bb) on the pricing
information described in clause
(v) for purposes of the portal
created under paragraph (9),
that such information will be
available on a public Web site
of such entity and in marketing
materials, communications
statements, and other
assertions of such entity
related to such record, and
that the entity will
voluntarily provide such
information to customers prior
to providing 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,
estimate, or other similar
marketing or promotional
material), and other persons
who request such information;
``(cc) that the software
with respect to such records
have published application
programming interfaces for
medical records data, search
and indexing, semantic
harmonization and vocabulary
translation, and user interface
applications;
``(dd) that the entity has
successfully tested the use of
the record in the type of
setting in which it would be
marketed;
``(ee) the entity has in
place implementation guidelines
for such record that support
interoperability, consistent
with section 3010; and
``(ff) that the entity has
in place data sharing programs
or capabilities based on common
data elements through
application programming
interfaces without the
requirement for vendor-specific
interfaces;
``(II) publish application
programming interfaces and associated
documentation, with respect to such
records, for medical records data,
search and indexing, semantic
harmonization and vocabulary
translation, and user interface
applications; and
``(III) demonstrate to the
satisfaction of the Secretary that data
from such records is able to be
exchanged through the use of
application programming interfaces and
used in a manner that allows for
exchange and everyday use, as
authorized under applicable law, of
such record.
``(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 section 3001(c)(5)(B)(ii)
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) Annual publication.--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 vendors of or other entities offering
qualified electronic health records with
respect to which certification has been
withdrawn under clause (ii) during such year.
``(iv) Periodic review.--The Secretary
shall periodically review and confirm that
vendors of and other entities offering
qualified electronic health records have
publicly published application programming
interfaces and associated documentation as
required by clause (i)(II) for purposes of
certification and maintaining certification
under any program kept or recognized under
subparagraph (A).
``(v) Pricing information.--For purposes of
clause (i)(I)(bb), 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 data 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 data 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 use, exchange, or portability of
any data generated in the course of
using any capability to which the
record is to be so certified.''.
(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
subsection (a)(1), is further amended by adding at the end the
following new section:
``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) vendors of, or other entities offering, qualified
electronic health records--
``(A) being in violation of an attestation made
under section 3001(c)(5)(C)(i)(I), with respect to the
use of such records by a health care provider under a
specified meaningful use incentive program; and
``(B) having engaged in information blocking (as
defined in subsection (f)), unless for a legitimate
purpose specified by the Secretary, with respect to the
use of such records by a health care provider under
such a program;
``(2) health care providers, with respect to the use of
such records under a specified meaningful use incentive
program, having, unless for a legitimate purpose specified by
the Secretary, engaged in information blocking (as so defined);
``(3) health information system providers described in
subsection (b) having engaged in information blocking (as so
defined), unless for a legitimate purpose specified by the
Secretary, with respect to the use of such records under a
specified meaningful use incentive program; and
``(4) vendors of, or other entities offering, health
information technology (other than technology described in
paragraph (1)), health care providers, with respect to the use
of such technology, and health information system providers,
with respect to such technology, unless for a legitimate
purpose specified by the Secretary, having engaged in
information blocking (as so defined).
``(b) Health Information System Providers.--The Inspector General
of the Department of Health and Human Services shall, in coordination
with the Federal Trade Commission, ensure that health information
system providers (such as operators of health information exchanges and
other systems that facilitate the exchange of information) investigate
claims of information blocking, with respect to the use of such records
under a specified meaningful use incentive program.
``(c) 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) or (b) with the Inspector
General and Federal Trade Commission for purposes of such
investigations.
``(2) Protection from disclosure of information.--Any
information shared by the National Coordinator under paragraph
(1) shall not be subject to the provisions of section 552 of
title 5, United States Code (commonly referred to as the
Freedom of Information Act). Any information acquired pursuant
to paragraph (1) shall be held in confidence and shall not be
disclosed to any person except as may be necessary to carry out
the purposes of subsection (a).
``(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).
``(d) Penalty.--Any person or entity determined to have committed
an act described in paragraph (1), (2), or (3) of subsection (a), in
connection with a specified meaningful use incentive program, shall be
subject to a civil monetary penalty of not more than $10,000 for each
such act. The provisions of section 1128A (other than subsections (a)
and (b)) 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 section 1128A(a).
``(e) Specified Meaningful Use Incentive Program.--For purposes of
this section, the term `specified meaningful use incentive program'
includes the following:
``(1) The incentive payments under subsection (o) of
section 1848 of the Social Security Act (42 U.S.C. 1395w-4) and
adjustments under subsection (a)(7) of such section.
``(2) The incentive payments under subsection (n) of
section 1848 of such Act (42 U.S.C. 1395ww) and adjustments
under subsection (b)(3)(B) of such section.
``(3) The incentive payments and adjustments made under
subsections (l) and (m) of section 1853 of such Act (42 U.S.C.
1395w-23).
``(4) The incentive payment under paragraph (3) of section
1814(l) of such Act (42 U.S.C. 1395f(l)) and adjustment under
paragraph (4) of such section.
``(5) The shared savings program under section 1899 of such
Act (42 U.S.C. 1395jjj).
``(6) The payments to Medicaid providers described in
section 1903(t) of such Act (42 U.S.C. 1396b(t)).
``(f) Information Blocking.--
``(1) In general.--For purposes of this section and section
3010, the term `information blocking' means, with respect to
the use of qualified electronic health records or other health
information technology under a specified meaningful use
incentive program, business, technical, and organizational
practices, including practices described in paragraph (2),
that--
``(A) prevent or materially discourage the exchange
of electronic health information;
``(B) the actor knows or should know (as defined in
section 1128A(i)(7) of the Social Security Act) is
likely to interfere with the exchange or use of
electronic health information; and
``(C) do not serve to protect patient safety,
maintain the privacy and security of individuals'
health information or promote competition and consumer
welfare.
``(2) Practices described.--For purposes of paragraph (1),
the practices described in this paragraph are the following:
``(A) Contract terms, policies, or other business
or organizational practices that restrict individuals'
access to their electronic health information or
restrict the exchange or use of that information for
treatment and other permitted purposes.
``(B) Charging prices or fees (such as for data
exchange, portability, and interfaces) that make
exchanging and using electronic health information cost
prohibitive.
``(C) Developing or implementing health information
technology in non-standard 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 data; lead to fraud, waste, or
abuse; or impede innovations and advancements in health
information exchange and health information technology-
enabled care delivery.
``(g) 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).''.
(3) ONCHIT.--
(A) Portal.--Section 3001(c) of the Public Health
Service Act (42 U.S.C. 300jj-11(c)) is amended by
adding at the end the following new paragraph:
``(9) Portal.--Not later than January 1, 2019, the National
Coordinator shall create a portal to make the information
described in paragraph (5)(C)(I)(i)(bb) available to the public
in a manner that allows for comparison of price information
among health information technology products and that aids in
making informed decisions for purchasing such a product.''.
(B) Information blocking.--Not later than 12 months
after the date of the enactment of this Act, the
National Coordinator shall, through rulemaking,
implement the provisions of this section, and
amendments made by this section, relating to
information blocking.
(C) HIPAA.--Not later than January 1, 2017, the
National Coordinator shall publish guidance to clarify
the relationship of the HIPAA privacy and security law,
as defined in section 3009(a)(2) of the Public Health
Service Act (42 U.S.C. 300jj-19(a)(2)) as such
provisions relate to information blocking (as defined
in section 3010A(f) of such Act, as added by paragraph
(2), including examples of how such provisions may
result in information blocking.
(4) Demonstration required for meaningful ehr use
incentives under medicare.--
(A) Incentives for professionals.--
(i) In general.--Section 1848(o)(2)(C) of
the Social Security Act (42 U.S.C. 1395w-
4(o)(2)(C)) is amended by adding at the end the
following new clause:
``(iii) Interoperability.--With respect to
EHR reporting periods for payment years
beginning with 2018, the means described in
clause (i) specified by the Secretary shall
include a demonstration, through means such as
an attestation, that the professional has not
taken any action described in subsection (a)(2)
of section 3010A of the Public Health Service
Act with respect to which the professional,
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)(B)) 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.--
``(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 that such professional was
determined to not be a meaningful EHR
user because the qualified electronic
health record used by such professional
was 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
subclause (II), during the first
payment year with respect to the first
EHR reporting period to which such
decertification applies.
``(II) Duration.--
``(aa) In general.--In no
case shall an exemption by
reason of this clause be for a
period of less than 12 months.
``(bb) Extension.--An
exemption under this clause may
be extended for a period of an
additional 12 months subject to
the limitation described in
clause (ii).
``(iii) Limitation.--Subject to clause
(ii)(II)(aa), in no case may an eligible
professional be granted an exemption under this
subparagraph for more than 5 years.''.
(B) Incentives for hospitals.--
(i) In general.--Section 1886(o)(1) of the
Social Security Act (42 U.S.C. 1395ww(o)(1)) is
amended--
(I) in subparagraph (A), by
inserting before the period at the end
the following: ``and, for performance
periods for fiscal year 2018 or a
subsequent fiscal year, that provide a
demonstration described in subparagraph
(D) to the Secretary''; and
(II) by adding at the end the
following new subparagraph:
``(D) Demonstration described.--The demonstration
described in this subparagraph is a demonstration,
through means such as an attestation, that the hospital
has not taken any action described in subsection (a)(2)
of section 3010A of the Public Health Service Act with
respect to which the hospital, 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 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 such
hospital was determined to not be a
meaningful EHR user because the
qualified electronic health record used
by such hospital was 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) 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 be extended for a period of an
additional 12 months subject to the
limitation described in item (ee).
``(ee) Subject to item (cc), in no
case may a hospital be granted an
exemption under this subclause for more
than 5 years.''.
(C) Demonstration required for meaningful ehr use
incentives 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 2018, 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 which the provider knows or
should know (as defined in section 1128A(i)(7) of the
Social Security Act) about, with respect to the use of
any certified EHR technology.''.
(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 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 are
interoperable, in accordance with section 3010,
including as measured by the methods adopted under such
section; and
``(B) such records are employed by meaningful EHR
users under the specified meaningful use incentive
programs (as defined in section 3010A(e)) and 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 adopted under section
3004'' after ``section 3004''.
(B) in subsection (b), by inserting ``including the
interoperability standards adopted under section 3004''
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, including by being in
compliance with 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 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, including by
being in compliance with interoperability standards adopted
under section 3004 of such Act)''.
(5) 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 Empowerment.--It is the sense of Congress that--
(1) patients have the right to the entirety of the health
information of such patient, including such information
contained in an electronic health record of such patient;
(2) such right extends to both structured and unstructured
data; and
(3) to further facilitate patient ownership over health
information of such patient--
(A) health care providers should not have the
ability to deny a patient's request for access to the
entirety of such health information of such patient;
and
(B) health care providers do not need the consent
of their patients to share personal health information
of such patients 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 patient.
Subtitle B--Telehealth
SEC. 3021. TELEHEALTH SERVICES UNDER THE MEDICARE PROGRAM.
(a) Provision of Information by Centers for Medicare & Medicaid
Services.--Not later than one 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 and the Medicaid program
under title XIX of such Act 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 procedures codes or 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 one year
after the date of the enactment of this Act, the Medicare Payment
Advisory Commission established under section 1805 of the Social
Security Act (42 U.S.C. 1395b-6) shall, using data from the Medicare
Advantage program under part C of title XVIII of such Act, provide
information to the committees of jurisdiction of the House of
Representatives and the Senate that identifies--
(1) services--
(A) for which payment could not be made, as of the
date of the enactment of this Act, under the fee-for-
service program under parts A and B of such title by
reason of any limitation imposed under section 1834(m)
of such Act (42 U.S.C. 1395m(m)); and
(B) that are services that are recommended by the
Commission to be included as telehealth services for
which payment may be made under the fee-for-service
program under parts A and B of such title; and
(2) barriers to furnishing telehealth services for which
payment may be made under such title XVIII and solutions to
address such barriers.
(c) Sense of Congress.--It is the sense of Congress that--
(1) States should collaborate, through the use of State
health board compacts or other mechanisms, to create common
licensure requirements services in order to facilitate
multistate practices and allow for health care providers to
provide such services across State lines;
(2) health care providers should be appropriately licensed
in the physical location where the patient is receiving
services;
(3) 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
(4) 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.''.
(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) Payment for Durable Medical Items (DMI).--
(1) In general.--Section 1861(s)(2) of the Social Security
Act (42 U.S.C. 1395x(s)(2)) is amended--
(A) in subparagraph (EE), by striking ``and'' at
the end;
(B) in subparagraph (FF), by inserting ``and'' at
the end; and
(C) by adding at the end the following new
subparagraph:
``(GG) a durable medical item that administers a drug
described in section 1927(k)(2)(C) that would otherwise be
self-administered multiple times per day and includes a
disposable component and at least one component that can
withstand repeated use, and supplies used in conjunction with
such item (including the drug administered by such item);''.
(2) Payment.--
(A) Payment amount for dmi.--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 Methodology for Durable Medical Items (DMI).--The
Secretary shall establish a payment methodology for a durable medical
item described in section 1861(s)(2)(GG) and supplies used in
conjunction with such item (other than a drug administered by such
item) such that the estimated average total payment per individual for
such items and supplies does not exceed the estimated average total
payment per individual that would otherwise be made (taking into
account the application of section 1847) for the durable medical
equipment for which it is a substitute and for supplies used in
conjunction with such equipment (other than such a drug) as determined
appropriate by the Secretary.''.
(B) Payment for drug.--Section 1842(o)(1)(D) of the
Social Security Act (42 U.S.C. 1395u(o)(1)(D)) is
amended--
(i) in clause (i), by inserting ``or drugs
administered by a durable medical item covered
under section 1861(s)(2)(GG) on or after
January 1, 2017,'' after ``after January 1,
2004,''; and
(ii) in clause (ii), by striking
``infusion''.
(C) Competitive acquisition.--Section 1847(a)(2) of
the Social Security Act (42 U.S.C. 1395w-3(a)(2)) is
amended by adding at the end the following new
subparagraph:
``(D) Durable medical item.--A durable medical item
and supplies used in conjunction with such item,
described in section 1861(s)(2)(GG).''.
(3) Conforming amendment.--Section 1833(a)(1) of the Social
Security Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) by striking ``and'' before ``(Z)''; and
(B) by inserting before the semicolon at the end
the following: ``, and (AA) with respect to durable
medical items described in section 1861(s)(2)(GG), the
amount paid shall be equal to 80 percent of the lesser
of the actual charge or the amount determined under
section 1834(r)''.
(4) Effective date.--The amendments made by this subsection
shall apply to items furnished on or after January 1, 2017.
(b) Payment for Certain Disposable Devices.--
(1) In general.--Section 1834 of the Social Security Act
(42 U.S.C. 1395m), as amended by subsection (a)(2), is further
amended by adding at the end the following new subsection:
``(s) 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).''.
(2) 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(s)(2)'' after ``durable
medical equipment''.
(3) Effective date.--The amendments made by this subsection
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 in the
coverage database 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) Links 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) regard coverage, coding, or payment under
this title for such products.''.
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) is
amended by adding at the end the following new subsection:
``(r) 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 surgery 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 such items
and services 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 such an 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 existing mechanisms, 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 s(or
pharmacies) elected 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 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 (II), 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 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), 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 drugs described in
subparagraph (G), taking into account
geographic location, beneficiary
preference, impact on cost-sharing, and
reasonable travel time; or
``(II) a PDP sponsor shall ensure
such access to prescribers and
pharmacies in the case of individuals
with multiple residences and in the
case of natural disasters and similar
emergency situations.
``(iii) Beneficiary preferences.--
``(I) In general.--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--
``(aa) review such
preferences;
``(bb) select or change the
selection of prescribers and
pharmacies for the beneficiary
based on such preferences; and
``(cc) inform the
beneficiary of such selection
or change of selection.
``(II) Exception.--In the case that
the PDP sponsor determines that a
change to the selection of prescriber
or pharmacy under item (bb) 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 subclause (I).
``(iv) 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); or
``(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.
``(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,
the Secretary shall authorize such contractors to directly
accept prescription and necessary medical records from entities
such as pharmacies, prescription drug plans, MA-PD plans, and
physicians with respect to an individual in order for such
contractors to provide information relevant to the
determination of whether such individual is an at-risk
beneficiary for prescription drug abuse, as defined in section
1860D-4(c)(5)(C).
``(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 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 impact 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
paragraph (5) of section 1860D-4(c) of the
Social Security Act (42 U.S.C. 1395w-104(c)));
(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).
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