II 114th CONGRESS 2d Session S. 2624 IN THE SENATE OF THE UNITED STATES March 3, 2016 Ms. Warren (for herself, Mrs. Murray , Ms. Mikulski , Mr. Sanders , Mr. Casey , Mr. Franken , Mr. Bennet , Mr. Whitehouse , Ms. Baldwin , and Mr. Murphy ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To establish the “Biomedical Innovation Fund”, and for other purposes.

1. Short title This Act may be cited as the National Biomedical Research Act . 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 2016 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. 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, 2016, and every year thereafter through 2025, the Secretary of the Treasury shall transfer $5,000,000,000 from the general fund of the Treasury into the Fund. (c) Distribution of amounts (1) Calculation of annual fund amount For fiscal year 2017 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) the execution of the Precision Medicine Initiative, which may include— (i) basic research on the underlying basis for diseases to better address disease prevention, diagnosis, and treatment; (ii) a diverse national research cohort with a goal of enrolling 1,000,000 participants in the United States to study topics including how genes, the environment, lifestyle, and diet contribute to health, disease, and wellness; and (iii) the development and use of the information technology to leverage existing or future research cohorts and clinical networks, support secure data exchange with the consent of participants, and allow researchers to access data generated from the cohorts; (B) the execution of the Brain Research through Advancing Innovative Neu­ro­tech­nol­o­gies Initiative (commonly known as the BRAIN Initiative ), which may include efforts to— (i) develop and apply technology to help scientists understand the brain; (ii) support interdisciplinary and multi-institute research collaborations, including coordination with privately funded efforts to advance the understanding of the human brain and improve the diagnosis and treatment of nervous system disorders and injuries; and (iii) facilitate comprehensive analysis, integration across platforms of large-scale research and health data, and broad distribution sharing of experimental and data analysis tools; (C) the execution of the Cancer Moonshot Initiative, which may include— (i) cancer clinical trials with a focus on genetics and immunotherapy; (ii) research on cancer biology; (iii) facilitating information and data exchange and transparency between and within research and treatment communities to accelerate the pace of scientific advancement; and (iv) supporting the development of entities, such as a virtual center of excellence, to leverage the combined skills of regulatory scientists and reviewers; (D) 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; (E) 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; (F) 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; (G) 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; (H) the development, review, and post-market surveillance of medical products, as determined by the Secretary of Health and Human Services; and (I) research to carry out the goals of the strategy and implementation plan for advancing science to promote public health and advance innovation in regulatory decisionmaking 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 decisionmaking 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. (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, 2017, and every year thereafter through 2026, 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. 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. 5. Offsets It is the sense of the Senate that the amounts transferred under section 3(b) should be offset completely.