National Biomedical Research Act

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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘National Biomedical 4 Research Act’’. 5 SEC. 2. DEFINITIONS. 6 In this Act: 7 (1) DISCRETIONARY APPROPRIATIONS.—The 8 term ‘‘discretionary appropriations’’ has the mean- 9 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 2 •HR 5400 IH ing given such term in section 250 of the Balanced 1 Budget and Emergency Deficit Control Act of 1985 2 (2 U.S.C. 900). 3 (2) FUND.—The term ‘‘Fund’’ means the Bio- 4 medical Innovation Fund established under section 5 3(a). 6 (3) MINIMUM AMOUNT.—The term ‘‘minimum 7 amount’’, with respect to the applicable entity and 8 for an applicable fiscal year— 9 (A) means the amount equal to the great- 10 est amount of discretionary appropriations ap- 11 propriated to such entity for a fiscal year dur- 12 ing the period beginning with fiscal year 2020 13 and ending with the fiscal year before the appli- 14 cable fiscal year; and 15 (B) does not include— 16 (i) any reduction in an appropriation 17 under a sequestration order issued under 18 the Balanced Budget and Emergency Def- 19 icit Control Act of 1985 (2 U.S.C. 900 et 20 seq.); 21 (ii) amounts collected by the Secretary 22 of Health and Human Services under sub- 23 chapter C of chapter VII of the Federal 24 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 3 •HR 5400 IH Food, Drug, and Cosmetic Act (21 U.S.C. 1 379f et seq.); 2 (iii) amounts distributed under section 3 3(c)(2); or 4 (iv) amounts appropriated under a 5 supplemental or emergency appropriation 6 Act. 7 SEC. 3. BIOMEDICAL INNOVATION FUND. 8 (a) ESTABLISHMENT.—There is established in the 9 Treasury of the United States a fund to be known as the 10 ‘‘Biomedical Innovation Fund’’, to be administered by the 11 Secretary of the Treasury, consisting of— 12 (1) the amounts transferred to the Fund under 13 subsection (b); and 14 (2) any interest earned on the investment of 15 such amounts under subsection (d). 16 (b) COMMITMENT TO BIOMEDICAL INNOVATION.— 17 Not later than September 1, 2020, and every year there- 18 after through 2029, the Secretary of the Treasury shall 19 transfer $10,000,000,000 from the general fund of the 20 Treasury into the Fund. 21 (c) DISTRIBUTION OF AMOUNTS.— 22 (1) CALCULATION OF ANNUAL FUND 23 AMOUNT.—For fiscal year 2020 and each fiscal year 24 thereafter, not later than 15 days after the latter of 25 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 4 •HR 5400 IH the date of enactment of an appropriation Act mak- 1 ing full fiscal year appropriations for such fiscal year 2 to the entity described in paragraph (2)(A) and the 3 date of enactment of an appropriation Act making 4 full fiscal year appropriations for such fiscal year to 5 the entity described in paragraph (2)(B), the Sec- 6 retary of the Treasury shall calculate the total 7 amount in the Fund that is available to be distrib- 8 uted for such fiscal year in accordance with para- 9 graph (2). 10 (2) DISTRIBUTION OF AMOUNTS IN THE 11 FUND.—Subject to the other provisions of this sec- 12 tion, not later than 30 days after a calculation is 13 made under paragraph (1) for a fiscal year, the Sec- 14 retary of the Treasury shall distribute the amount 15 available to be distributed for such fiscal year to 16 each of the following entities: 17 (A) The National Institutes of Health. 18 (B) The Food and Drug Administration. 19 (3) RATIO.—The amount that the Secretary of 20 the Treasury distributes to an entity described in 21 subparagraph (A) or (B) of paragraph (2) during a 22 fiscal year shall bear the same relation to the total 23 amount calculated under paragraph (1) for such fis- 24 cal year as the amount of discretionary appropria- 25 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 5 •HR 5400 IH tions appropriated to such entity for such fiscal year 1 bears to the total amount of discretionary appropria- 2 tions appropriated to the entities described in sub- 3 paragraphs (A) and (B) of paragraph (2) for such 4 fiscal year. 5 (4) REQUIREMENTS FOR DISTRIBUTION.— 6 (A) IN GENERAL.—The Secretary of the 7 Treasury shall distribute amounts in the Fund 8 during a fiscal year in accordance with para- 9 graph (2) only if— 10 (i) the discretionary appropriations 11 for the entity described in paragraph 12 (2)(A) is greater than the applicable min- 13 imum amount for such entity for such fis- 14 cal year; and 15 (ii) the discretionary appropriations 16 for the entity described in paragraph 17 (2)(B) is greater than the applicable min- 18 imum amount for such entity for such fis- 19 cal year. 20 (B) SUBSEQUENT LAW IMPACTING DIS- 21 TRIBUTION.— 22 (i) BELOW MINIMUM AMOUNT.—If a 23 law is enacted or becomes effective after 24 amounts are appropriated to each entity 25 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 6 •HR 5400 IH described in subparagraph (A) or (B) of 1 paragraph (2) for a fiscal year and such 2 law decreases the amount appropriated to 3 either such entity for such fiscal year from 4 an amount that is greater than the appli- 5 cable minimum amount to an amount that 6 is less than or equal to such minimum 7 amount, any amounts that were distributed 8 by the Secretary of the Treasury under 9 paragraph (2) shall remain so distributed 10 for such fiscal year. 11 (ii) ABOVE MINIMUM AMOUNT.—If a 12 law is enacted or becomes effective after 13 amounts are appropriated for a fiscal year 14 to each entity described in subparagraph 15 (A) or (B) of paragraph (2) and such law 16 increases the amount appropriated to ei- 17 ther such entity for such fiscal year from 18 an amount that is less than or equal to the 19 minimum amount to an amount that is 20 greater than such minimum amount, and 21 all other conditions for distribution under 22 this paragraph are met for the fiscal year, 23 the amounts in the Fund shall be distrib- 24 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 7 •HR 5400 IH uted by the Secretary of the Treasury 1 under paragraph (2) for such fiscal year. 2 (C) FAILURE TO MEET REQUIREMENTS.— 3 If the requirements under subparagraph (A) 4 are not met during a fiscal year, amounts in the 5 Fund shall— 6 (i) not be distributed under paragraph 7 (2); and 8 (ii) remain in the Fund, earning inter- 9 est in accordance with subsection (d), until 10 such requirements, or the conditions under 11 subsection (f), are met during a fiscal year. 12 (5) ALLOCATIONS.— 13 (A) IN GENERAL.—If amounts are distrib- 14 uted under paragraph (2) during a fiscal year, 15 of the amounts so distributed— 16 (i) 20 percent shall become available 17 for obligation during the fiscal year during 18 which the distribution is made; 19 (ii) 20 percent shall become available 20 for obligation during the first fiscal year 21 after the fiscal year during which the dis- 22 tribution is made; 23 (iii) 20 percent shall become available 24 for obligation during the second fiscal year 25 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 8 •HR 5400 IH after the fiscal year during which the dis- 1 tribution is made; 2 (iv) 20 percent shall become available 3 for obligation during the third fiscal year 4 after the fiscal year during which the dis- 5 tribution is made; and 6 (v) 20 percent shall become available 7 for obligation during the fourth fiscal year 8 after the fiscal year during which the dis- 9 tribution is made. 10 (B) AVAILABILITY OF AMOUNTS.—Any 11 amounts distributed under paragraph (2) shall 12 remain available until expended. 13 (6) AUTHORIZED USES.—Amounts distributed 14 under paragraph (2) from the Fund shall be used to 15 support— 16 (A) basic research on the underlying basis 17 for disease to better address disease prevention, 18 diagnosis, and treatment; 19 (B) research that fosters disruptive innova- 20 tion, such as— 21 (i) research on diseases or conditions 22 for which treatments exist but are inad- 23 equate, including chronic and acute pain; 24 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 9 •HR 5400 IH (ii) research on diseases or conditions 1 for which there are unmet medical needs; 2 (iii) research on diseases or conditions 3 for which treatments exist but the side ef- 4 fect profiles of such treatments limit thera- 5 peutic potential; 6 (iv) research on new approaches to 7 treatment of diseases using drugs, devices, 8 or therapies that, at the time of distribu- 9 tion under paragraph (2), are not used or 10 are underused; or 11 (v) research conducted by experienced 12 investigators with a history of productive 13 and innovative research, such that funding 14 provides long-term stability for such re- 15 search and allows such investigators to 16 take greater risks, be more adventurous in 17 their lines of inquiry, or take the time to 18 develop groundbreaking techniques; 19 (C) research related to diseases that 20 disproportionally account for Federal health 21 care spending, including spending under the 22 Medicare program under title XVIII of the So- 23 cial Security Act (42 U.S.C. 1395 et seq.), the 24 Medicaid program under title XIX of the Social 25 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 10 •HR 5400 IH Security Act (42 U.S.C. 1396 et seq.), the 1 State Children’s Health Insurance Program 2 under title XXI of the Social Security Act (42 3 U.S.C. 1397aa et seq.), the TRICARE program 4 under chapter 55 of title 10, United States 5 Code, and hospital care and medical services 6 furnished by the Department of Veterans Af- 7 fairs under chapters 17 and 18 of title 38, 8 United States Code, such as research relating 9 to— 10 (i) diseases that disproportionally im- 11 pact older individuals; 12 (ii) degenerative diseases; or 13 (iii) chronic conditions; 14 (D) early career scientists, such as 15 through— 16 (i) awarding research project grants 17 that support discrete, specified, and cir- 18 cumscribed projects to be performed by the 19 investigator in an area representing the 20 specific interests and competencies of such 21 investigator, to investigators— 22 (I) who are within 10 years of 23 completing a terminal research de- 24 gree; or 25 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 11 •HR 5400 IH (II) who are within 10 years of 1 completing a medical residency; 2 (ii) awarding grants that support ca- 3 reer development experiences that lead to 4 earlier research independence; and 5 (iii) awarding grants that support in- 6 novative training programs that, in addi- 7 tion to scientific training, provide addi- 8 tional training to enhance employment op- 9 portunities, including training in manage- 10 ment and business, to— 11 (I) graduate students; 12 (II) post-doctoral fellows; 13 (III) individuals within 10 years 14 of completing a terminal research de- 15 gree; or 16 (IV) individuals within 10 years 17 of completing a medical residency; 18 (E) research efforts that increase the po- 19 tential for breakthrough discoveries across a di- 20 verse set of investigators, research groups, and 21 institutions, which may include supporting— 22 (i) investigators that are members of 23 traditionally underrepresented racial and 24 ethnic groups; 25 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 12 •HR 5400 IH (ii) research groups that are diverse 1 in size; or 2 (iii) institutions that increase the geo- 3 graphic diversity of funding provided by 4 the National Institutes of Health; 5 (F) the development, review, and post-mar- 6 ket surveillance of medical products, as deter- 7 mined by the Secretary of Health and Human 8 Services; and 9 (G) research to carry out the goals of the 10 strategy and implementation plan for advancing 11 science to promote public health and advance 12 innovation in regulatory decision making devel- 13 oped under section 1124 of the Food and Drug 14 Administration Safety and Innovation Act (21 15 U.S.C. 393 note), and other such research ac- 16 tivities to improve the predictability, consist- 17 ency, and efficiency of science-based decision 18 making concerning medical products, including 19 facilitating the timely introduction of new tech- 20 nologies and methodologies in a safe and effec- 21 tive manner as determined by the Secretary of 22 Health and Human Services. 23 (7) INTERAGENCY TRANSFERS.—Amounts dis- 24 tributed from the Fund under paragraph (2) shall 25 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 13 •HR 5400 IH be available through interagency transfer to support 1 research conducted jointly by the National Institutes 2 of Health or the Food and Dug Administration and 3 other Federal agencies. 4 (d) INVESTMENT OF FUND BALANCES.— 5 (1) IN GENERAL.—Amounts in the Fund shall 6 be invested in interest-bearing obligations of the 7 United States in the form of special-issue securities, 8 paying interest to the Fund at rates applicable to 9 such securities, and such amounts shall be redeem- 10 able by the Secretary of the Treasury, for purposes 11 of distribution under subsection (c) [Text truncated for display. 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