I 
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 fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, 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 com-
mittee concerned 
A BILL 
To establish the ‘‘Biomedical Innovation Fund’’, and for 
other purposes. 
Be it enacted by the Senate and House of Representa-
tives 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 mean-
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00001
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
ing 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 Bio-
medical 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 great-
est amount of discretionary appropriations ap-
propriated to such entity for a fiscal year dur-
ing the period beginning with fiscal year 2020 
and ending with the fiscal year before the appli-
cable fiscal year; and 
(B) does not include— 
(i) any reduction in an appropriation 
under a sequestration order issued under 
the Balanced Budget and Emergency Def-
icit Control Act of 1985 (2 U.S.C. 900 et 
seq.); 
(ii) amounts collected by the Secretary 
of Health and Human Services under sub-
chapter C of chapter VII of the Federal 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00002
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
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 there-
after 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 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00003
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
the date of enactment of an appropriation Act mak-
ing 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 Sec-
retary of the Treasury shall calculate the total 
amount in the Fund that is available to be distrib-
uted for such fiscal year in accordance with para-
graph (2). 
(2) DISTRIBUTION
OF
AMOUNTS
IN
THE 
FUND.—Subject to the other provisions of this sec-
tion, not later than 30 days after a calculation is 
made under paragraph (1) for a fiscal year, the Sec-
retary 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 fis-
cal year as the amount of discretionary appropria-
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00004
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
tions appropriated to such entity for such fiscal year 
bears to the total amount of discretionary appropria-
tions appropriated to the entities described in sub-
paragraphs (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 para-
graph (2) only if— 
(i) the discretionary appropriations 
for the entity described in paragraph 
(2)(A) is greater than the applicable min-
imum amount for such entity for such fis-
cal year; and 
(ii) the discretionary appropriations 
for the entity described in paragraph 
(2)(B) is greater than the applicable min-
imum amount for such entity for such fis-
cal year. 
(B) SUBSEQUENT
LAW
IMPACTING
DIS-
TRIBUTION.— 
(i) BELOW MINIMUM AMOUNT.—If a 
law is enacted or becomes effective after 
amounts are appropriated to each entity 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00005
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
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 appli-
cable 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 ei-
ther 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 distrib-
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00006
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
uted 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 inter-
est 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 distrib-
uted 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 dis-
tribution is made; 
(iii) 20 percent shall become available 
for obligation during the second fiscal year 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00007
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
after the fiscal year during which the dis-
tribution is made; 
(iv) 20 percent shall become available 
for obligation during the third fiscal year 
after the fiscal year during which the dis-
tribution is made; and 
(v) 20 percent shall become available 
for obligation during the fourth fiscal year 
after the fiscal year during which the dis-
tribution 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 innova-
tion, such as— 
(i) research on diseases or conditions 
for which treatments exist but are inad-
equate, including chronic and acute pain; 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00008
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
(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 ef-
fect profiles of such treatments limit thera-
peutic potential; 
(iv) research on new approaches to 
treatment of diseases using drugs, devices, 
or therapies that, at the time of distribu-
tion 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 re-
search 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 So-
cial Security Act (42 U.S.C. 1395 et seq.), the 
Medicaid program under title XIX of the Social 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00009
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
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 Af-
fairs under chapters 17 and 18 of title 38, 
United States Code, such as research relating 
to— 
(i) diseases that disproportionally im-
pact 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 cir-
cumscribed 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 de-
gree; or 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00010
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
(II) who are within 10 years of 
completing a medical residency; 
(ii) awarding grants that support ca-
reer development experiences that lead to 
earlier research independence; and 
(iii) awarding grants that support in-
novative training programs that, in addi-
tion to scientific training, provide addi-
tional training to enhance employment op-
portunities, including training in manage-
ment and business, to— 
(I) graduate students; 
(II) post-doctoral fellows; 
(III) individuals within 10 years 
of completing a terminal research de-
gree; or 
(IV) individuals within 10 years 
of completing a medical residency; 
(E) research efforts that increase the po-
tential for breakthrough discoveries across a di-
verse set of investigators, research groups, and 
institutions, which may include supporting— 
(i) investigators that are members of 
traditionally underrepresented racial and 
ethnic groups; 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00011
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
(ii) research groups that are diverse 
in size; or 
(iii) institutions that increase the geo-
graphic diversity of funding provided by 
the National Institutes of Health; 
(F) the development, review, and post-mar-
ket surveillance of medical products, as deter-
mined 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 devel-
oped under section 1124 of the Food and Drug 
Administration Safety and Innovation Act (21 
U.S.C. 393 note), and other such research ac-
tivities to improve the predictability, consist-
ency, and efficiency of science-based decision 
making concerning medical products, including 
facilitating the timely introduction of new tech-
nologies and methodologies in a safe and effec-
tive manner as determined by the Secretary of 
Health and Human Services. 
(7) INTERAGENCY TRANSFERS.—Amounts dis-
tributed from the Fund under paragraph (2) shall 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00012
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
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 redeem-
able 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 Sec-
retary 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 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
the general fund of the Treasury for purposes of re-
ducing 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 Sec-
retary 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 Novem-
ber 30, 2021, and every year thereafter through 
2030 the Secretary of the Treasury shall sub-
mit 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 in-
clude, 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. 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
(ii) A description of any amounts dis-
tributed under subsection (c)(2) during the 
fiscal year. 
(iii) A statement of the balance re-
maining in the Fund at the end of the fis-
cal year. 
(iv) A statement of the amounts in-
vested 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 obliga-
tion under subsection (c)(5), the Director of the 
National Institutes of Health and the Commis-
sioner of Food and Drugs shall report on the 
use of such amounts in the annual budget sub-
mission for such fiscal year of the National In-
stitutes of Health and the Food and Drug Ad-
ministration, 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 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
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 pe-
riod beginning on the date of enactment of this 
Act, if amounts are distributed under sub-
section (c)(2)(B) to the Food and Drug Admin-
istration for any fiscal year during such 3-year 
period, the Commissioner of Food and Drugs 
shall submit, to the Committee on Health, Edu-
cation, Labor, and Pensions of the Senate and 
the Committee on Energy and Commerce of the 
House of Representatives, a report that de-
scribes 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. 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS
SEC. 4. BUDGETARY PROVISIONS. 
(a) DISCRETIONARY SPENDING LIMITS.—The Office 
of Management and Budget shall not include amounts dis-
tributed under section 3(c)(2) during a fiscal year in de-
termining whether there has been a breach of the discre-
tionary 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 reso-
lution, or amendment thereto or conference report there-
on, 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 Chair-
person 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, aggre-
gates, 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 off-
set completely. 
Æ 
VerDate Sep 11 2014 
01:17 Dec 17, 2019
Jkt 099200
PO 00000
Frm 00017
Fmt 6652
Sfmt 6301
E:\BILLS\H5400.IH
H5400
kjohnson on DSK79L0C42 with BILLS