HR 1862 IHCommentsClose CommentsPermalink

112th CONGRESSCommentsClose CommentsPermalink

1st SessionCommentsClose CommentsPermalink

H. R. 1862CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

IN THE HOUSE OF REPRESENTATIVESCommentsClose CommentsPermalink

May 12, 2011CommentsClose CommentsPermalink

Mr. BILBRAY (for himself, Ms. DEGETTE, Mr. DENT, Mr. GERLACH, Mr. HOLT, Ms. FUDGE, Mr. BUTTERFIELD, and Mr. LANGEVIN) introduced the following bill; which was referred to the Committee on Energy and CommerceCommentsClose CommentsPermalink

A BILLCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,CommentsClose CommentsPermalink

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

(a) Short Title- This Act may be cited as the ‘Regenerative Medicine Promotion Act of 2011’.CommentsClose CommentsPermalink





(b) Table of Contents- The table of contents of this Act is as follows:CommentsClose CommentsPermalink





Sec. 1. Short title; table of contents.CommentsClose CommentsPermalink





Sec. 2. Findings.CommentsClose CommentsPermalink





Sec. 3. Report on ongoing Federal programs and activities regarding regenerative medicine.CommentsClose CommentsPermalink





Sec. 4. Establishment of regenerative medicine coordinating council.CommentsClose CommentsPermalink





Sec. 5. Grants for basic or preclinical research into regenerative medicine.CommentsClose CommentsPermalink





Sec. 6. Grants for development of drugs, biological products, medical devices, and biomaterials for use in regenerative medicine.CommentsClose CommentsPermalink





Sec. 7. Supporting innovation in regenerative medicine through cures acceleration network.CommentsClose CommentsPermalink





Sec. 8. Funding for food and drug administration research.CommentsClose CommentsPermalink

SEC. 2. FINDINGS.

Congress finds the following:CommentsClose CommentsPermalink





(1) Regenerative medicine has the potential to treat many chronic diseases, promote economic growth, and reduce health care spending in the United States.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

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’).CommentsClose CommentsPermalink





(b) Composition- The Council shall be composed of the following:CommentsClose CommentsPermalink





(1) The Secretary of Commerce.CommentsClose CommentsPermalink





(2) The Secretary of Defense.CommentsClose CommentsPermalink





(3) The Secretary of Health and Human Services.CommentsClose CommentsPermalink





(4) The Secretary of the Treasury.CommentsClose CommentsPermalink





(5) The Secretary of Veterans Affairs.CommentsClose CommentsPermalink





(6) The Administrator of the Agency for Healthcare Research and Quality.CommentsClose CommentsPermalink





(7) The Administrator of the Centers for Medicare & Medicaid Services.CommentsClose CommentsPermalink





(8) The Commissioner of Food and Drugs.CommentsClose CommentsPermalink





(9) The Director of the National Institutes of Health.CommentsClose CommentsPermalink





(10) The Director of the National Institutes of Standards and Technology.CommentsClose CommentsPermalink





(11) The members appointed by the Secretary under subsection (d).CommentsClose CommentsPermalink





(c) Chair- The Secretary of Health and Human Services shall be the Chair of the Council.CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(e) Functions- The Council shall--CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(3) prepare a plan specifying priorities for research into regenerative medicine;CommentsClose CommentsPermalink





(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);CommentsClose CommentsPermalink





(5) identify sources of funding for research into regenerative medicine;CommentsClose CommentsPermalink





(6) identify areas where such funding is inadequate;CommentsClose CommentsPermalink





(7) make recommendations regarding Federal regulatory, reimbursement, tax, and other policies that will support development and marketing of regenerative medicine products;CommentsClose CommentsPermalink





(8) facilitate development of consensus standards regarding scientific issues critical to regulatory approval of regenerative medicine products; andCommentsClose CommentsPermalink





(9) determine the need for establishing centers of excellence or consortia to further advance regenerative medicine.CommentsClose CommentsPermalink





(f) Transparency; Reporting Requirements-CommentsClose CommentsPermalink





(1) TRANSPARENCY- The Council shall adopt procedures to ensure the receipt of public input, such as holding public stakeholder meetings or creating advisory boards.CommentsClose CommentsPermalink





(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--CommentsClose CommentsPermalink





(A) provide details on progress in meeting goals identified by the Council for regenerative medicine;CommentsClose CommentsPermalink





(B) make recommendations regarding funding, regulatory, or other policies to achieve regenerative medicine goals identified by the Council;CommentsClose CommentsPermalink





(C) identify all regenerative medicine products currently on the market and those in development;CommentsClose CommentsPermalink





(D) identify regenerative medicine research and technological advances and discoveries that occurred in the previous year; andCommentsClose CommentsPermalink





(E) assess the impact of regenerative medicine on the Nation’s economy, including with respect to--CommentsClose CommentsPermalink





(i) the number of people employed in companies or research institutions working in regenerative medicine;CommentsClose CommentsPermalink





(ii) the number of companies pursuing regenerative medicine products;CommentsClose CommentsPermalink





(iii) increases in tax revenues; andCommentsClose CommentsPermalink





(iv) the impact on national health spending.CommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink





(b) Conditions- The Secretary may make a grant under this section for research only if--CommentsClose CommentsPermalink





(1) the research is carried out directly by the grant recipient;CommentsClose CommentsPermalink





(2) the research is partly funded by one or more private entities; andCommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(c) Terms and Conditions- A grant under this section may be made on such terms and conditions as the Secretary determines appropriate.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(e) Definitions- In this section:CommentsClose CommentsPermalink





(1) The term ‘eligible entity’ means a nonprofit entity or an institution of higher education.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(3) The term ‘nonprofit entity’ means an entity that--CommentsClose CommentsPermalink





(A) is described in section 501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3)); andCommentsClose CommentsPermalink





(B) is exempt from tax under section 501(a) of the Internal Revenue Code of 1986 (26 U.S.C. 501(a)).CommentsClose CommentsPermalink





(4) The term ‘Secretary’ means the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health.CommentsClose CommentsPermalink

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--CommentsClose CommentsPermalink





(1) the research and development of drugs, biological products, medical devices, and biomaterials for use in regenerative medicine; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(b) Terms and Conditions- A grant under this section may be made on such terms and conditions as the Secretary determines appropriate.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(d) Definitions- In this section:CommentsClose CommentsPermalink





(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)).CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(3) The term ‘eligible entity’ means a collaborative partnership including--CommentsClose CommentsPermalink





(A) a qualified nonprofit entity or an institution of higher education; andCommentsClose CommentsPermalink





(B) a for-profit entity.CommentsClose CommentsPermalink





(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).CommentsClose CommentsPermalink





(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)).CommentsClose CommentsPermalink





(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)).CommentsClose CommentsPermalink





(7) The term ‘qualified nonprofit entity’ means an entity that--CommentsClose CommentsPermalink





(A) is described in section 501(c)(3) of the Internal Revenue Code of 1986 (26 U.S.C. 501(c)(3)); andCommentsClose CommentsPermalink





(B) is exempt from tax under section 501(a) of the Internal Revenue Code of 1986 (26 U.S.C. 501(a)).CommentsClose CommentsPermalink





(8) The term ‘Secretary’ means the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health.CommentsClose CommentsPermalink

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

Section 402C of the Public Health Service Act (42 U.S.C. 282d) is amended--CommentsClose CommentsPermalink





(1) in subsection (d), by adding at the end the following:CommentsClose CommentsPermalink





‘(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.’; andCommentsClose CommentsPermalink





(2) in subsection (e)(3), by adding at the end the following:CommentsClose CommentsPermalink





‘(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--CommentsClose CommentsPermalink





‘(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; orCommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink

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

(a) Grants- The Secretary may--CommentsClose CommentsPermalink





(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; orCommentsClose CommentsPermalink





(2) make grants to fund regulatory research for such purpose.CommentsClose CommentsPermalink





(b) Definitions- In this section:CommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink





(2) The term ‘Secretary’ means the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs.CommentsClose CommentsPermalink