[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4494 Introduced in House (IH)]

113th CONGRESS
  2d Session
                                H. R. 4494

To launch a national strategy to support regenerative medicine through 
    funding for research and commercial development of regenerative 
  medicine products and development of a regulatory environment that 
 enables rapid approval of safe and effective products, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 28, 2014

  Ms. DeGette (for herself and Mr. Paulsen) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To launch a national strategy to support regenerative medicine through 
    funding for research and commercial development of regenerative 
  medicine products and development of a regulatory environment that 
 enables rapid approval of safe and effective products, 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; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Regenerative 
Medicine Promotion Act of 2014''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Findings.
Sec. 3. Report on ongoing Federal programs and activities regarding 
                            regenerative medicine.
Sec. 4. Establishment of Regenerative Medicine Coordinating Council.
Sec. 5. Grants for basic or preclinical research into regenerative 
                            medicine.
Sec. 6. Grants for development of drugs, biological products, medical 
                            devices, and biomaterials for use in 
                            regenerative medicine.
Sec. 7. Supporting innovation in regenerative medicine through cures 
                            acceleration network.
Sec. 8. Funding for Food and Drug Administration research.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) Regenerative medicine has the potential to treat many 
        chronic diseases, promote economic growth, and reduce health 
        care spending in the United States.
            (2) Regenerative medicine products have already 
        successfully treated numerous health conditions, and have the 
        potential to provide cures, treatments, and diagnostics for a 
        range of diseases and disabilities including diabetes, spinal 
        cord injury, heart disease, stroke, and various forms of 
        cancer.
            (3) A United States national strategy on regenerative 
        medicine is critical to ensure that this technology fulfills 
        its potential to cure and treat diseases and disabilities, 
        reduce overall health spending, and promote economic growth.
            (4) The Department of Defense has stated that regenerative 
        medicine has the potential to treat many battlefield injuries 
        such as burns, that it has the potential to heal wounds without 
        scarring, and that it has the potential to be used for 
        traumatic brain injury and other forms of trauma, craniofacial 
        reconstruction, limb reconstruction, regeneration, and 
        transplantation.
            (5) The Department of Health and Human Services and the 
        Multi-Agency Tissue Engineering Science Interagency Working 
        Group have endorsed a national initiative to support research 
        and product development in regenerative medicine.
            (6) The Department of Health and Human Services has said 
        the potential benefits of regenerative medicine in improved 
        health care and economic savings are enormous. States that have 
        invested in regenerative medicine have experienced economic 
        growth and see future growth potential, including an increase 
        in biotech employment, payroll increases, and proportional 
        impacts on tax receipts.

SEC. 3. REPORT ON ONGOING FEDERAL PROGRAMS AND ACTIVITIES REGARDING 
              REGENERATIVE MEDICINE.

    Not later than 180 days after the date of the enactment of this 
Act, the Comptroller General of the United States shall provide for the 
completion, and submission to the Congress, of a report identifying all 
ongoing Federal programs and activities regarding regenerative 
medicine.

SEC. 4. ESTABLISHMENT OF REGENERATIVE MEDICINE COORDINATING COUNCIL.

    (a) Establishment.--The Secretary of Health and Human Services 
shall establish, within six months of the enactment of this Act, in the 
Office of the Secretary, a Regenerative Medicine Coordinating Council 
(in this section referred to as the ``Council'').
    (b) Composition.--The Council shall be composed of the following:
            (1) The Secretary of Commerce.
            (2) The Secretary of Defense.
            (3) The Secretary of Health and Human Services.
            (4) The Secretary of the Treasury.
            (5) The Secretary of Veterans Affairs.
            (6) The Administrator of the Agency for Healthcare Research 
        and Quality.
            (7) The Administrator of the Centers for Medicare & 
        Medicaid Services.
            (8) The Commissioner of Food and Drugs.
            (9) The Director of the National Institutes of Health.
            (10) The Director of the National Institutes of Standards 
        and Technology.
            (11) The members appointed by the Secretary under 
        subsection (d).
    (c) Chair.--The Secretary of Health and Human Services shall be the 
Chair of the Council.
    (d) Members Appointed by Secretary.--The Secretary shall appoint at 
least 5 persons to serve as members of the Council under subsection 
(b)(11). The members of the Council appointed under the preceding 
sentence shall include persons with expertise in third-party payment, 
regenerative medicine researchers from academic institutions, patient 
advocates, persons with expertise in drug discovery, persons with 
expertise in drug development, persons with expertise in basic 
research, persons with expertise in translational research, persons 
with expertise in medical device development, persons with expertise in 
biomaterials, clinicians, and persons with expertise in clinical 
research.
    (e) Functions.--The Council shall--
            (1) consult with, and provide information to, the Secretary 
        of Health and Human Services for purposes of implementing any 
        recommendations in the report required by section 3;
            (2) prepare, and keep up-to-date, a national strategy to 
        support research into regenerative medicine and the development 
        of drugs, biological products, medical devices, and 
        biomaterials for use in regenerative medicine;
            (3) prepare a plan specifying priorities for research into 
        regenerative medicine;
            (4) not later than 1 year after the date of the enactment 
        of this Act, establish priorities for the award of grants under 
        sections 5 and 6 (relating to grants for basic or preclinical 
        research into regenerative medicine and for development of 
        drugs, biological products, medical devices, and biomaterials 
        for use in regenerative medicine, respectively);
            (5) identify sources of funding for research into 
        regenerative medicine;
            (6) identify areas where such funding is inadequate;
            (7) make recommendations regarding Federal regulatory, 
        reimbursement, tax, and other policies that will support 
        development and marketing of regenerative medicine products;
            (8) facilitate development of consensus standards regarding 
        scientific issues critical to regulatory approval of 
        regenerative medicine products; and
            (9) determine the need for establishing centers of 
        excellence or consortia to further advance regenerative 
        medicine.
    (f) Transparency; Reporting Requirements.--
            (1) Transparency.--The Council shall adopt procedures to 
        ensure the receipt of public input, such as holding public 
        stakeholder meetings or creating advisory boards.
            (2) Annual reports.--The Council shall submit an annual 
        report on its activities to the Congress, the Director of the 
        National Institutes of Health, and the Commissioner of Food and 
        Drugs. Each such report shall--
                    (A) provide details on progress in meeting goals 
                identified by the Council for regenerative medicine;
                    (B) make recommendations regarding funding, 
                regulatory, or other policies to achieve regenerative 
                medicine goals identified by the Council;
                    (C) identify all regenerative medicine products 
                currently on the market and those in development;
                    (D) identify regenerative medicine research and 
                technological advances and discoveries that occurred in 
                the previous year; and
                    (E) assess the impact of regenerative medicine on 
                the Nation's economy, including with respect to--
                            (i) the number of people employed in 
                        companies or research institutions working in 
                        regenerative medicine;
                            (ii) the number of companies pursuing 
                        regenerative medicine products;
                            (iii) increases in tax revenues; and
                            (iv) the impact on national health 
                        spending.

SEC. 5. GRANTS FOR BASIC OR PRECLINICAL RESEARCH INTO REGENERATIVE 
              MEDICINE.

    (a) Grants for Basic or Preclinical Research.--The Secretary may 
make grants to eligible entities for the purpose of funding basic or 
preclinical research into regenerative medicine.
    (b) Conditions.--The Secretary may make a grant under this section 
for research only if--
            (1) the research is carried out directly by the grant 
        recipient;
            (2) the research is partly funded by one or more private 
        entities; and
            (3) the amount of the grant does not exceed the total 
        amount provided for the research by private entities (other 
        than the grant recipient itself).
    (c) Terms and Conditions.--A grant under this section may be made 
on such terms and conditions as the Secretary determines appropriate.
    (d) Priority.--In awarding grants under this section, the Secretary 
shall take into consideration the priorities established by the 
Regenerative Medicine Coordinating Council under section 4(e).
    (e) Definitions.--In this section:
            (1) The term ``eligible entity'' means a nonprofit entity 
        or an institution of higher education.
            (2) The term ``institution of higher education'' has the 
        meaning given that term in section 101 of the Higher Education 
        Act of 1965 (20 U.S.C. 1001).
            (3) The term ``nonprofit entity'' means an entity that--
                    (A) is described in section 501(c)(3) of the 
                Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3)); 
                and
                    (B) is exempt from tax under section 501(a) of the 
                Internal Revenue Code of 1986 (26 U.S.C. 501(a)).
            (4) The term ``Secretary'' means the Secretary of Health 
        and Human Services, acting through the Director of the National 
        Institutes of Health.

SEC. 6. GRANTS FOR DEVELOPMENT OF DRUGS, BIOLOGICAL PRODUCTS, MEDICAL 
              DEVICES, AND BIOMATERIALS FOR USE IN REGENERATIVE 
              MEDICINE.

    (a) Grants for Drug Development.--The Secretary may make grants to 
eligible entities for the purpose of funding projects that have as 
their aim--
            (1) the research and development of drugs, biological 
        products, medical devices, and biomaterials for use in 
        regenerative medicine; and
            (2) the making of an investigational new drug application 
        with respect to such drugs or biological products, or the 
        making of an investigational device exemption application with 
        respect to such devices, by not later than the end of the 4-
        year period beginning on the date on which such grant is made.
    (b) Terms and Conditions.--A grant under this section may be made 
on such terms and conditions as the Secretary determines appropriate.
    (c) Priority.--In awarding grants under this section, the Secretary 
shall take into consideration the priorities established by the 
Regenerative Medicine Coordinating Council under section 4(e).
    (d) Definitions.--In this section:
            (1) The term ``biological product'' has the meaning given 
        the term in section 351(i) of the Public Health Service Act (42 
        U.S.C. 262(i)).
            (2) The terms ``drug'' and ``medical device'' have the 
        meanings given to the terms ``drug'' and ``device'', 
        respectively, in section 201 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 321).
            (3) The term ``eligible entity'' means a collaborative 
        partnership including--
                    (A) a qualified nonprofit entity or an institution 
                of higher education; and
                    (B) a for-profit entity.
            (4) The term ``institution of higher education'' has the 
        meaning given that term in section 101 of the Higher Education 
        Act of 1965 (20 U.S.C. 1001).
            (5) The term ``investigational new drug application'' means 
        an investigational new drug application that is made to the 
        Food and Drug Administration under section 505(i) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 505(i)).
            (6) The term ``investigational device exemption 
        application'' means an application for an investigational 
        device exemption that is made to the Food and Drug 
        Administration under section 520(g) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360j(g)).
            (7) The term ``qualified nonprofit entity'' means an entity 
        that--
                    (A) is described in section 501(c)(3) of the 
                Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3)); 
                and
                    (B) is exempt from tax under section 501(a) of the 
                Internal Revenue Code of 1986 (26 U.S.C. 501(a)).
            (8) The term ``Secretary'' means the Secretary of Health 
        and Human Services, acting through the Director of the National 
        Institutes of Health.

SEC. 7. SUPPORTING INNOVATION IN REGENERATIVE MEDICINE THROUGH CURES 
              ACCELERATION NETWORK.

    Section 480 of the Public Health Service Act (42 U.S.C. 287a) is 
amended--
            (1) in subsection (d), by adding at the end the following:
            ``(7) Collaboration.--With respect to activities of the 
        Board relating to medical products and behavioral therapies for 
        use in regenerative medicine, the Board shall collaborate with 
        the Regenerative Medicine Coordinating Council.''; and
            (2) in subsection (e)(3), by adding at the end the 
        following:
                    ``(D) The cures acceleration awards with respect to 
                products and therapies for use in regenerative 
                medicine.--The Director of NIH may, without regard to 
                subparagraphs (A), (B), and (C), provide assistance 
                under paragraph (1) with respect to medical products 
                and behavioral therapies for use in regenerative 
                medicine, including assistance--
                            ``(i) to perform clinical trials under a 
                        protocol approved by the Commissioner of Food 
                        and Drugs or studies which use good 
                        manufacturing practice or good laboratory 
                        practice procedures and the data from which are 
                        intended for inclusion in an investigational 
                        new drug application or an investigational 
                        device exemption application; or
                            ``(ii) to perform basic research or 
                        preclinical studies in regenerative medicine 
                        the data from which are not intended for 
                        inclusion in an investigational new drug 
                        application or an investigational device 
                        exemption application.''.

SEC. 8. FUNDING FOR FOOD AND DRUG ADMINISTRATION RESEARCH.

    (a) Grants.--The Secretary may--
            (1) conduct, support, or collaborate in regulatory research 
        for the purpose of assisting the Food and Drug Administration 
        to perform its functions with respect to regenerative medicine; 
        or
            (2) make grants to fund regulatory research for such 
        purpose.
    (b) Definitions.--In this section:
            (1) The term ``regulatory research'' means research 
        regarding development, evaluation, and availability of new or 
        improved tools, methods, standards, and applied science that 
        support a better understanding and improved evaluation of 
        product safety, quality, effectiveness, and manufacturing 
        throughout the product life cycle.
            (2) The term ``Secretary'' means the Secretary of Health 
        and Human Services, acting through the Commissioner of Food and 
        Drugs.
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