[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5400 Introduced in House (IH)]
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116th CONGRESS
1st Session
H. R. 5400
To establish the ``Biomedical Innovation Fund'', and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 11, 2019
Ms. Clarke of New York (for herself and Mr. Loebsack) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committees on Rules, and the Budget,
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 establish the ``Biomedical Innovation Fund'', 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.
This Act may be cited as the ``National Biomedical Research Act''.
SEC. 2. DEFINITIONS.
In this Act:
(1) Discretionary appropriations.--The term ``discretionary
appropriations'' has the meaning given such term in section 250
of the Balanced Budget and Emergency Deficit Control Act of
1985 (2 U.S.C. 900).
(2) Fund.--The term ``Fund'' means the Biomedical
Innovation Fund established under section 3(a).
(3) Minimum amount.--The term ``minimum amount'', with
respect to the applicable entity and for an applicable fiscal
year--
(A) means the amount equal to the greatest amount
of discretionary appropriations appropriated to such
entity for a fiscal year during the period beginning
with fiscal year 2020 and ending with the fiscal year
before the applicable fiscal year; and
(B) does not include--
(i) any reduction in an appropriation under
a sequestration order issued under the Balanced
Budget and Emergency Deficit Control Act of
1985 (2 U.S.C. 900 et seq.);
(ii) amounts collected by the Secretary of
Health and Human Services under subchapter C of
chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379f et seq.);
(iii) amounts distributed under section
3(c)(2); or
(iv) amounts appropriated under a
supplemental or emergency appropriation Act.
SEC. 3. BIOMEDICAL INNOVATION FUND.
(a) Establishment.--There is established in the Treasury of the
United States a fund to be known as the ``Biomedical Innovation Fund'',
to be administered by the Secretary of the Treasury, consisting of--
(1) the amounts transferred to the Fund under subsection
(b); and
(2) any interest earned on the investment of such amounts
under subsection (d).
(b) Commitment to Biomedical Innovation.--Not later than September
1, 2020, and every year thereafter through 2029, the Secretary of the
Treasury shall transfer $10,000,000,000 from the general fund of the
Treasury into the Fund.
(c) Distribution of Amounts.--
(1) Calculation of annual fund amount.--For fiscal year
2020 and each fiscal year thereafter, not later than 15 days
after the latter of the date of enactment of an appropriation
Act making full fiscal year appropriations for such fiscal year
to the entity described in paragraph (2)(A) and the date of
enactment of an appropriation Act making full fiscal year
appropriations for such fiscal year to the entity described in
paragraph (2)(B), the Secretary of the Treasury shall calculate
the total amount in the Fund that is available to be
distributed for such fiscal year in accordance with paragraph
(2).
(2) Distribution of amounts in the fund.--Subject to the
other provisions of this section, not later than 30 days after
a calculation is made under paragraph (1) for a fiscal year,
the Secretary of the Treasury shall distribute the amount
available to be distributed for such fiscal year to each of the
following entities:
(A) The National Institutes of Health.
(B) The Food and Drug Administration.
(3) Ratio.--The amount that the Secretary of the Treasury
distributes to an entity described in subparagraph (A) or (B)
of paragraph (2) during a fiscal year shall bear the same
relation to the total amount calculated under paragraph (1) for
such fiscal year as the amount of discretionary appropriations
appropriated to such entity for such fiscal year bears to the
total amount of discretionary appropriations appropriated to
the entities described in subparagraphs (A) and (B) of
paragraph (2) for such fiscal year.
(4) Requirements for distribution.--
(A) In general.--The Secretary of the Treasury
shall distribute amounts in the Fund during a fiscal
year in accordance with paragraph (2) only if--
(i) the discretionary appropriations for
the entity described in paragraph (2)(A) is
greater than the applicable minimum amount for
such entity for such fiscal year; and
(ii) the discretionary appropriations for
the entity described in paragraph (2)(B) is
greater than the applicable minimum amount for
such entity for such fiscal year.
(B) Subsequent law impacting distribution.--
(i) Below minimum amount.--If a law is
enacted or becomes effective after amounts are
appropriated to each entity described in
subparagraph (A) or (B) of paragraph (2) for a
fiscal year and such law decreases the amount
appropriated to either such entity for such
fiscal year from an amount that is greater than
the applicable minimum amount to an amount that
is less than or equal to such minimum amount,
any amounts that were distributed by the
Secretary of the Treasury under paragraph (2)
shall remain so distributed for such fiscal
year.
(ii) Above minimum amount.--If a law is
enacted or becomes effective after amounts are
appropriated for a fiscal year to each entity
described in subparagraph (A) or (B) of
paragraph (2) and such law increases the amount
appropriated to either such entity for such
fiscal year from an amount that is less than or
equal to the minimum amount to an amount that
is greater than such minimum amount, and all
other conditions for distribution under this
paragraph are met for the fiscal year, the
amounts in the Fund shall be distributed by the
Secretary of the Treasury under paragraph (2)
for such fiscal year.
(C) Failure to meet requirements.--If the
requirements under subparagraph (A) are not met during
a fiscal year, amounts in the Fund shall--
(i) not be distributed under paragraph (2);
and
(ii) remain in the Fund, earning interest
in accordance with subsection (d), until such
requirements, or the conditions under
subsection (f), are met during a fiscal year.
(5) Allocations.--
(A) In general.--If amounts are distributed under
paragraph (2) during a fiscal year, of the amounts so
distributed--
(i) 20 percent shall become available for
obligation during the fiscal year during which
the distribution is made;
(ii) 20 percent shall become available for
obligation during the first fiscal year after
the fiscal year during which the distribution
is made;
(iii) 20 percent shall become available for
obligation during the second fiscal year after
the fiscal year during which the distribution
is made;
(iv) 20 percent shall become available for
obligation during the third fiscal year after
the fiscal year during which the distribution
is made; and
(v) 20 percent shall become available for
obligation during the fourth fiscal year after
the fiscal year during which the distribution
is made.
(B) Availability of amounts.--Any amounts
distributed under paragraph (2) shall remain available
until expended.
(6) Authorized uses.--Amounts distributed under paragraph
(2) from the Fund shall be used to support--
(A) basic research on the underlying basis for
disease to better address disease prevention,
diagnosis, and treatment;
(B) research that fosters disruptive innovation,
such as--
(i) research on diseases or conditions for
which treatments exist but are inadequate,
including chronic and acute pain;
(ii) research on diseases or conditions for
which there are unmet medical needs;
(iii) research on diseases or conditions
for which treatments exist but the side effect
profiles of such treatments limit therapeutic
potential;
(iv) research on new approaches to
treatment of diseases using drugs, devices, or
therapies that, at the time of distribution
under paragraph (2), are not used or are
underused; or
(v) research conducted by experienced
investigators with a history of productive and
innovative research, such that funding provides
long-term stability for such research and
allows such investigators to take greater
risks, be more adventurous in their lines of
inquiry, or take the time to develop
groundbreaking techniques;
(C) research related to diseases that
disproportionally account for Federal health care
spending, including spending under the Medicare program
under title XVIII of the Social Security Act (42 U.S.C.
1395 et seq.), the Medicaid program under title XIX of
the Social Security Act (42 U.S.C. 1396 et seq.), the
State Children's Health Insurance Program under title
XXI of the Social Security Act (42 U.S.C. 1397aa et
seq.), the TRICARE program under chapter 55 of title
10, United States Code, and hospital care and medical
services furnished by the Department of Veterans
Affairs under chapters 17 and 18 of title 38, United
States Code, such as research relating to--
(i) diseases that disproportionally impact
older individuals;
(ii) degenerative diseases; or
(iii) chronic conditions;
(D) early career scientists, such as through--
(i) awarding research project grants that
support discrete, specified, and circumscribed
projects to be performed by the investigator in
an area representing the specific interests and
competencies of such investigator, to
investigators--
(I) who are within 10 years of
completing a terminal research degree;
or
(II) who are within 10 years of
completing a medical residency;
(ii) awarding grants that support career
development experiences that lead to earlier
research independence; and
(iii) awarding grants that support
innovative training programs that, in addition
to scientific training, provide additional
training to enhance employment opportunities,
including training in management and business,
to--
(I) graduate students;
(II) post-doctoral fellows;
(III) individuals within 10 years
of completing a terminal research
degree; or
(IV) individuals within 10 years of
completing a medical residency;
(E) research efforts that increase the potential
for breakthrough discoveries across a diverse set of
investigators, research groups, and institutions, which
may include supporting--
(i) investigators that are members of
traditionally underrepresented racial and
ethnic groups;
(ii) research groups that are diverse in
size; or
(iii) institutions that increase the
geographic diversity of funding provided by the
National Institutes of Health;
(F) the development, review, and post-market
surveillance of medical products, as determined by the
Secretary of Health and Human Services; and
(G) research to carry out the goals of the strategy
and implementation plan for advancing science to
promote public health and advance innovation in
regulatory decision making developed under section 1124
of the Food and Drug Administration Safety and
Innovation Act (21 U.S.C. 393 note), and other such
research activities to improve the predictability,
consistency, and efficiency of science-based decision
making concerning medical products, including
facilitating the timely introduction of new
technologies and methodologies in a safe and effective
manner as determined by the Secretary of Health and
Human Services.
(7) Interagency transfers.--Amounts distributed from the
Fund under paragraph (2) shall be available through interagency
transfer to support research conducted jointly by the National
Institutes of Health or the Food and Dug Administration and
other Federal agencies.
(d) Investment of Fund Balances.--
(1) In general.--Amounts in the Fund shall be invested in
interest-bearing obligations of the United States in the form
of special-issue securities, paying interest to the Fund at
rates applicable to such securities, and such amounts shall be
redeemable by the Secretary of the Treasury, for purposes of
distribution under subsection (c)(2).
(2) Distributed amounts.--Any amounts that have been
distributed during a fiscal year under subsection (c)(2) shall
not be considered amounts in the Fund for the purpose of this
subsection.
(e) Prohibition.--Amounts in the Fund may not be made available for
any use other than a use described in subsection (c)(6).
(f) Transfer To Reduce the Deficit.--
(1) In general.--Subject to paragraph (2), if amounts in
the Fund are not distributed by the Secretary of the Treasury
under subsection (c)(2) for any 3 consecutive fiscal years, the
Secretary of the Treasury shall transfer all amounts in the
Fund to the general fund of the Treasury for purposes of
reducing the Federal deficit.
(2) Year of distribution.--For purposes of paragraph (1), 3
fiscal years shall not be deemed to be consecutive if during
any of such years the Secretary of the Treasury has transferred
all amounts in the Fund into the general fund of the Treasury
in accordance with such paragraph.
(g) Reports.--
(1) Secretary reports.--
(A) In general.--Not later than November 30, 2021,
and every year thereafter through 2030 the Secretary of
the Treasury shall submit to the Committee on
Appropriations of the Senate, the Committee on
Appropriations of the House of Representatives, and the
authorizing committees a report on the operation of the
Fund during the fiscal year.
(B) Contents.--Each report shall include, for the
fiscal year covered by the report, each of the
following:
(i) A statement of the amounts, and the
source of such amounts, transferred to,
credited to, and deposited into the Fund.
(ii) A description of any amounts
distributed under subsection (c)(2) during the
fiscal year.
(iii) A statement of the balance remaining
in the Fund at the end of the fiscal year.
(iv) A statement of the amounts invested in
interest-bearing obligations of the United
States, and the interest earned on such
investments.
(2) Agency reports.--
(A) Annual reporting.--For each fiscal year in
which amounts are available for obligation under
subsection (c)(5), the Director of the National
Institutes of Health and the Commissioner of Food and
Drugs shall report on the use of such amounts in the
annual budget submission for such fiscal year of the
National Institutes of Health and the Food and Drug
Administration, respectively.
(B) NIH reports.--Section 403(a) of the Public
Health Service Act (42 U.S.C. 283(a)) is amended by
adding at the end the following:
``(7) A summary of the use of funds distributed under
section 3(c)(2)(A) of the National Biomedical Research Act to
the National Institutes of Health from the Biomedical
Innovation Fund, established under section 3(a) of such Act,
including the amounts allocated to each national research
institute and national center, the projects funded by such
amounts, the accomplishments that have resulted from such
amounts, and the goals for future use of such amounts.''.
(C) FDA reports.--For each 3-year period beginning
on the date of enactment of this Act, if amounts are
distributed under subsection (c)(2)(B) to the Food and
Drug Administration for any fiscal year during such 3-
year period, the Commissioner of Food and Drugs shall
submit, to the Committee on Health, Education, Labor,
and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives, a report
that describes the allocation of such amounts within
the Food and Drug Administration, the projects funded
by such amounts, the accomplishments that have resulted
from such amounts, and the goals for future use of such
amounts.
SEC. 4. BUDGETARY PROVISIONS.
(a) Discretionary Spending Limits.--The Office of Management and
Budget shall not include amounts distributed under section 3(c)(2)
during a fiscal year in determining whether there has been a breach of
the discretionary spending limits under the Balanced Budget and
Emergency Deficit Control Act of 1985 (2 U.S.C. 900 et seq.) during the
fiscal year.
(b) Budget Enforcement.--If a bill or joint resolution, or
amendment thereto or conference report thereon, if enacted, would cause
amounts to be distributed under section 3(c)(2), the Chairperson of the
Committee on the Budget of the House of Representatives and Chairperson
of the Committee on the Budget of the Senate shall not include the
budgetary effects of such distribution for purposes of enforcement of
budgetary allocations, aggregates, levels, and limits in the House of
Representatives and the Senate.
SEC. 5. OFFSETS.
It is the sense of the House of Representatives that the amounts
transferred under section 3(b) should be offset completely.
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