[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2624 Introduced in Senate (IS)]

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114th CONGRESS
  2d Session
                                S. 2624

    To establish the ``Biomedical Innovation Fund'', and for other 
                               purposes.


_______________________________________________________________________


                   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.

    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 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.

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, 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.

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 Senate that the amounts transferred under 
section 3(b) should be offset completely.
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