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 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘National Biomedical 

5 Research Act’’. 

6 SEC. 2. DEFINITIONS. 

7 In this Act: 

8 (1) DISCRETIONARY APPROPRIATIONS.—The 

9 term ‘‘discretionary appropriations’’ has the meanVerDate Sep 11 2014 01:17 Dec 17, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5400.IH H5400

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1 ing given such term in section 250 of the Balanced 

2 Budget and Emergency Deficit Control Act of 1985 

3 (2 U.S.C. 900). 

4 (2) FUND.—The term ‘‘Fund’’ means the Bio5 medical Innovation Fund established under section 

6 3(a). 

7 (3) MINIMUM AMOUNT.—The term ‘‘minimum 

8 amount’’, with respect to the applicable entity and 

9 for an applicable fiscal year— 

10 (A) means the amount equal to the great11 est amount of discretionary appropriations ap12 propriated to such entity for a fiscal year dur13 ing the period beginning with fiscal year 2020 

14 and ending with the fiscal year before the appli15 cable fiscal year; and 

16 (B) does not include— 

17 (i) any reduction in an appropriation 

18 under a sequestration order issued under 

19 the Balanced Budget and Emergency Def20 icit Control Act of 1985 (2 U.S.C. 900 et 

21 seq.); 

22 (ii) amounts collected by the Secretary 

23 of Health and Human Services under sub24 chapter C of chapter VII of the Federal 


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1 Food, Drug, and Cosmetic Act (21 U.S.C. 

2 379f et seq.); 

3 (iii) amounts distributed under section 

4 3(c)(2); or 

5 (iv) amounts appropriated under a 

6 supplemental or emergency appropriation 

7 Act. 

8 SEC. 3. BIOMEDICAL INNOVATION FUND. 

9 (a) ESTABLISHMENT.—There is established in the 

10 Treasury of the United States a fund to be known as the 

11 ‘‘Biomedical Innovation Fund’’, to be administered by the 

12 Secretary of the Treasury, consisting of— 

13 (1) the amounts transferred to the Fund under 

14 subsection (b); and 

15 (2) any interest earned on the investment of 

16 such amounts under subsection (d). 

17 (b) COMMITMENT TO BIOMEDICAL INNOVATION.— 

18 Not later than September 1, 2020, and every year there19 after through 2029, the Secretary of the Treasury shall 

20 transfer $10,000,000,000 from the general fund of the 

21 Treasury into the Fund. 

22 (c) DISTRIBUTION OF AMOUNTS.— 

23 (1) CALCULATION OF ANNUAL FUND

24 AMOUNT.—For fiscal year 2020 and each fiscal year 

25 thereafter, not later than 15 days after the latter of 


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1 the date of enactment of an appropriation Act mak2 ing full fiscal year appropriations for such fiscal year 

3 to the entity described in paragraph (2)(A) and the 

4 date of enactment of an appropriation Act making 

5 full fiscal year appropriations for such fiscal year to 

6 the entity described in paragraph (2)(B), the Sec7 retary of the Treasury shall calculate the total 

8 amount in the Fund that is available to be distrib9 uted for such fiscal year in accordance with para10 graph (2). 

11 (2) DISTRIBUTION OF AMOUNTS IN THE

12 FUND.—Subject to the other provisions of this sec13 tion, not later than 30 days after a calculation is 

14 made under paragraph (1) for a fiscal year, the Sec15 retary of the Treasury shall distribute the amount 

16 available to be distributed for such fiscal year to 

17 each of the following entities: 

18 (A) The National Institutes of Health. 

19 (B) The Food and Drug Administration. 

20 (3) RATIO.—The amount that the Secretary of 

21 the Treasury distributes to an entity described in 

22 subparagraph (A) or (B) of paragraph (2) during a 

23 fiscal year shall bear the same relation to the total 

24 amount calculated under paragraph (1) for such fis25 cal year as the amount of discretionary appropriaVerDate Sep 11 2014 01:17 Dec 17, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5400.IH H5400

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1 tions appropriated to such entity for such fiscal year 

2 bears to the total amount of discretionary appropria3 tions appropriated to the entities described in sub4 paragraphs (A) and (B) of paragraph (2) for such 

5 fiscal year. 

6 (4) REQUIREMENTS FOR DISTRIBUTION.— 

7 (A) IN GENERAL.—The Secretary of the 

8 Treasury shall distribute amounts in the Fund 

9 during a fiscal year in accordance with para10 graph (2) only if— 

11 (i) the discretionary appropriations 

12 for the entity described in paragraph 

13 (2)(A) is greater than the applicable min14 imum amount for such entity for such fis15 cal year; and 

16 (ii) the discretionary appropriations 

17 for the entity described in paragraph 

18 (2)(B) is greater than the applicable min19 imum amount for such entity for such fis20 cal year. 

21 (B) SUBSEQUENT LAW IMPACTING DIS22 TRIBUTION.— 

23 (i) BELOW MINIMUM AMOUNT.—If a 

24 law is enacted or becomes effective after 

25 amounts are appropriated to each entity 


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1 described in subparagraph (A) or (B) of 

2 paragraph (2) for a fiscal year and such 

3 law decreases the amount appropriated to 

4 either such entity for such fiscal year from 

5 an amount that is greater than the appli6 cable minimum amount to an amount that 

7 is less than or equal to such minimum 

8 amount, any amounts that were distributed 

9 by the Secretary of the Treasury under 

10 paragraph (2) shall remain so distributed 

11 for such fiscal year. 

12 (ii) ABOVE MINIMUM AMOUNT.—If a 

13 law is enacted or becomes effective after 

14 amounts are appropriated for a fiscal year 

15 to each entity described in subparagraph 

16 (A) or (B) of paragraph (2) and such law 

17 increases the amount appropriated to ei18 ther such entity for such fiscal year from 

19 an amount that is less than or equal to the 

20 minimum amount to an amount that is 

21 greater than such minimum amount, and 

22 all other conditions for distribution under 

23 this paragraph are met for the fiscal year, 

24 the amounts in the Fund shall be distribVerDate Sep 11 2014 01:17 Dec 17, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5400.IH H5400

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1 uted by the Secretary of the Treasury 

2 under paragraph (2) for such fiscal year. 

3 (C) FAILURE TO MEET REQUIREMENTS.— 

4 If the requirements under subparagraph (A) 

5 are not met during a fiscal year, amounts in the 

6 Fund shall— 

7 (i) not be distributed under paragraph 

8 (2); and 

9 (ii) remain in the Fund, earning inter10 est in accordance with subsection (d), until 

11 such requirements, or the conditions under 

12 subsection (f), are met during a fiscal year. 

13 (5) ALLOCATIONS.— 

14 (A) IN GENERAL.—If amounts are distrib15 uted under paragraph (2) during a fiscal year, 

16 of the amounts so distributed— 

17 (i) 20 percent shall become available 

18 for obligation during the fiscal year during 

19 which the distribution is made; 

20 (ii) 20 percent shall become available 

21 for obligation during the first fiscal year 

22 after the fiscal year during which the dis23 tribution is made; 

24 (iii) 20 percent shall become available 

25 for obligation during the second fiscal year 


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1 after the fiscal year during which the dis2 tribution is made; 

3 (iv) 20 percent shall become available 

4 for obligation during the third fiscal year 

5 after the fiscal year during which the dis6 tribution is made; and 

7 (v) 20 percent shall become available 

8 for obligation during the fourth fiscal year 

9 after the fiscal year during which the dis10 tribution is made. 

11 (B) AVAILABILITY OF AMOUNTS.—Any 

12 amounts distributed under paragraph (2) shall 

13 remain available until expended. 

14 (6) AUTHORIZED USES.—Amounts distributed 

15 under paragraph (2) from the Fund shall be used to 

16 support— 

17 (A) basic research on the underlying basis 

18 for disease to better address disease prevention, 

19 diagnosis, and treatment; 

20 (B) research that fosters disruptive innova21 tion, such as— 

22 (i) research on diseases or conditions 

23 for which treatments exist but are inad24 equate, including chronic and acute pain; 


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1 (ii) research on diseases or conditions 

2 for which there are unmet medical needs; 

3 (iii) research on diseases or conditions 

4 for which treatments exist but the side ef5 fect profiles of such treatments limit thera6 peutic potential; 

7 (iv) research on new approaches to 

8 treatment of diseases using drugs, devices, 

9 or therapies that, at the time of distribu10 tion under paragraph (2), are not used or 

11 are underused; or 

12 (v) research conducted by experienced 

13 investigators with a history of productive 

14 and innovative research, such that funding 

15 provides long-term stability for such re16 search and allows such investigators to 

17 take greater risks, be more adventurous in 

18 their lines of inquiry, or take the time to 

19 develop groundbreaking techniques; 

20 (C) research related to diseases that 

21 disproportionally account for Federal health 

22 care spending, including spending under the 

23 Medicare program under title XVIII of the So24 cial Security Act (42 U.S.C. 1395 et seq.), the 

25 Medicaid program under title XIX of the Social 


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1 Security Act (42 U.S.C. 1396 et seq.), the 

2 State Children’s Health Insurance Program 

3 under title XXI of the Social Security Act (42 

4 U.S.C. 1397aa et seq.), the TRICARE program 

5 under chapter 55 of title 10, United States 

6 Code, and hospital care and medical services 

7 furnished by the Department of Veterans Af8 fairs under chapters 17 and 18 of title 38, 

9 United States Code, such as research relating 

10 to— 

11 (i) diseases that disproportionally im12 pact older individuals; 

13 (ii) degenerative diseases; or 

14 (iii) chronic conditions; 

15 (D) early career scientists, such as 

16 through— 

17 (i) awarding research project grants 

18 that support discrete, specified, and cir19 cumscribed projects to be performed by the 

20 investigator in an area representing the 

21 specific interests and competencies of such 

22 investigator, to investigators— 

23 (I) who are within 10 years of 

24 completing a terminal research de25 gree; or 


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1 (II) who are within 10 years of 

2 completing a medical residency; 

3 (ii) awarding grants that support ca4 reer development experiences that lead to 

5 earlier research independence; and 

6 (iii) awarding grants that support in7 novative training programs that, in addi8 tion to scientific training, provide addi9 tional training to enhance employment op10 portunities, including training in manage11 ment and business, to— 

12 (I) graduate students; 

13 (II) post-doctoral fellows; 

14 (III) individuals within 10 years 

15 of completing a terminal research de16 gree; or 

17 (IV) individuals within 10 years 

18 of completing a medical residency; 

19 (E) research efforts that increase the po20 tential for breakthrough discoveries across a di21 verse set of investigators, research groups, and 

22 institutions, which may include supporting— 

23 (i) investigators that are members of 

24 traditionally underrepresented racial and 

25 ethnic groups; 


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1 (ii) research groups that are diverse 

2 in size; or 

3 (iii) institutions that increase the geo4 graphic diversity of funding provided by 

5 the National Institutes of Health; 

6 (F) the development, review, and post-mar7 ket surveillance of medical products, as deter8 mined by the Secretary of Health and Human 

9 Services; and 

10 (G) research to carry out the goals of the 

11 strategy and implementation plan for advancing 

12 science to promote public health and advance 

13 innovation in regulatory decision making devel14 oped under section 1124 of the Food and Drug 

15 Administration Safety and Innovation Act (21 

16 U.S.C. 393 note), and other such research ac17 tivities to improve the predictability, consist18 ency, and efficiency of science-based decision 

19 making concerning medical products, including 

20 facilitating the timely introduction of new tech21 nologies and methodologies in a safe and effec22 tive manner as determined by the Secretary of 

23 Health and Human Services. 

24 (7) INTERAGENCY TRANSFERS.—Amounts dis25 tributed from the Fund under paragraph (2) shall 


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1 be available through interagency transfer to support 

2 research conducted jointly by the National Institutes 

3 of Health or the Food and Dug Administration and 

4 other Federal agencies. 

5 (d) INVESTMENT OF FUND BALANCES.— 

6 (1) IN GENERAL.—Amounts in the Fund shall 

7 be invested in interest-bearing obligations of the 

8 United States in the form of special-issue securities, 

9 paying interest to the Fund at rates applicable to 

10 such securities, and such amounts shall be redeem11 able by the Secretary of the Treasury, for purposes 

12 of distribution under subsection (c)(2). 

13 (2) DISTRIBUTED AMOUNTS.—Any amounts 

14 that have been distributed during a fiscal year under 

15 subsection (c)(2) shall not be considered amounts in 

16 the Fund for the purpose of this subsection. 

17 (e) PROHIBITION.—Amounts in the Fund may not be 

18 made available for any use other than a use described in 

19 subsection (c)(6). 

20 (f) TRANSFER TO REDUCE THE DEFICIT.— 

21 (1) IN GENERAL.—Subject to paragraph (2), if 

22 amounts in the Fund are not distributed by the Sec23 retary of the Treasury under subsection (c)(2) for 

24 any 3 consecutive fiscal years, the Secretary of the 

25 Treasury shall transfer all amounts in the Fund to 


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1 the general fund of the Treasury for purposes of re2 ducing the Federal deficit. 

3 (2) YEAR OF DISTRIBUTION.—For purposes of 

4 paragraph (1), 3 fiscal years shall not be deemed to 

5 be consecutive if during any of such years the Sec6 retary of the Treasury has transferred all amounts 

7 in the Fund into the general fund of the Treasury 

8 in accordance with such paragraph. 

9 (g) REPORTS.— 

10 (1) SECRETARY REPORTS.— 

11 (A) IN GENERAL.—Not later than Novem12 ber 30, 2021, and every year thereafter through 

13 2030 the Secretary of the Treasury shall sub14 mit to the Committee on Appropriations of the 

15 Senate, the Committee on Appropriations of the 

16 House of Representatives, and the authorizing 

17 committees a report on the operation of the 

18 Fund during the fiscal year. 

19 (B) CONTENTS.—Each report shall in20 clude, for the fiscal year covered by the report, 

21 each of the following: 

22 (i) A statement of the amounts, and 

23 the source of such amounts, transferred to, 

24 credited to, and deposited into the Fund. 


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1 (ii) A description of any amounts dis2 tributed under subsection (c)(2) during the 

3 fiscal year. 

4 (iii) A statement of the balance re5 maining in the Fund at the end of the fis6 cal year. 

7 (iv) A statement of the amounts in8 vested in interest-bearing obligations of the 

9 United States, and the interest earned on 

10 such investments. 

11 (2) AGENCY REPORTS.— 

12 (A) ANNUAL REPORTING.—For each fiscal 

13 year in which amounts are available for obliga14 tion under subsection (c)(5), the Director of the 

15 National Institutes of Health and the Commis16 sioner of Food and Drugs shall report on the 

17 use of such amounts in the annual budget sub18 mission for such fiscal year of the National In19 stitutes of Health and the Food and Drug Ad20 ministration, respectively. 

21 (B) NIH REPORTS.—Section 403(a) of the 

22 Public Health Service Act (42 U.S.C. 283(a)) is 

23 amended by adding at the end the following: 

24 ‘‘(7) A summary of the use of funds distributed 

25 under section 3(c)(2)(A) of the National Biomedical 


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1 Research Act to the National Institutes of Health 

2 from the Biomedical Innovation Fund, established 

3 under section 3(a) of such Act, including the 

4 amounts allocated to each national research institute 

5 and national center, the projects funded by such 

6 amounts, the accomplishments that have resulted 

7 from such amounts, and the goals for future use of 

8 such amounts.’’. 

9 (C) FDA REPORTS.—For each 3-year pe10 riod beginning on the date of enactment of this 

11 Act, if amounts are distributed under sub12 section (c)(2)(B) to the Food and Drug Admin13 istration for any fiscal year during such 3-year 

14 period, the Commissioner of Food and Drugs 

15 shall submit, to the Committee on Health, Edu16 cation, Labor, and Pensions of the Senate and 

17 the Committee on Energy and Commerce of the 

18 House of Representatives, a report that de19 scribes the allocation of such amounts within 

20 the Food and Drug Administration, the projects 

21 funded by such amounts, the accomplishments 

22 that have resulted from such amounts, and the 

23 goals for future use of such amounts. 


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1 SEC. 4. BUDGETARY PROVISIONS. 

2 (a) DISCRETIONARY SPENDING LIMITS.—The Office 

3 of Management and Budget shall not include amounts dis4 tributed under section 3(c)(2) during a fiscal year in de5 termining whether there has been a breach of the discre6 tionary spending limits under the Balanced Budget and 

7 Emergency Deficit Control Act of 1985 (2 U.S.C. 900 et 

8 seq.) during the fiscal year. 

9 (b) BUDGET ENFORCEMENT.—If a bill or joint reso10 lution, or amendment thereto or conference report there11 on, if enacted, would cause amounts to be distributed 

12 under section 3(c)(2), the Chairperson of the Committee 

13 on the Budget of the House of Representatives and Chair14 person of the Committee on the Budget of the Senate shall 

15 not include the budgetary effects of such distribution for 

16 purposes of enforcement of budgetary allocations, aggre17 gates, levels, and limits in the House of Representatives 

18 and the Senate. 

19 SEC. 5. OFFSETS. 

20 It is the sense of the House of Representatives that 

21 the amounts transferred under section 3(b) should be off22 set completely. 

Æ 


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