I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Regenerative Medicine Promotion Act of 2014’’. 


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1 (b) TABLE OF CONTENTS.—The table of contents of 

2 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. 

3 SEC. 2. FINDINGS. 

4 Congress finds the following: 

5 (1) Regenerative medicine has the potential to 

6 treat many chronic diseases, promote economic 

7 growth, and reduce health care spending in the 

8 United States. 

9 (2) Regenerative medicine products have al10 ready successfully treated numerous health condi11 tions, and have the potential to provide cures, treat12 ments, and diagnostics for a range of diseases and 

13 disabilities including diabetes, spinal cord injury, 

14 heart disease, stroke, and various forms of cancer. 

15 (3) A United States national strategy on regen16 erative medicine is critical to ensure that this tech17 nology fulfills its potential to cure and treat diseases 

18 and disabilities, reduce overall health spending, and 

19 promote economic growth. 


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1 (4) The Department of Defense has stated that 

2 regenerative medicine has the potential to treat 

3 many battlefield injuries such as burns, that it has 

4 the potential to heal wounds without scarring, and 

5 that it has the potential to be used for traumatic 

6 brain injury and other forms of trauma, craniofacial 

7 reconstruction, limb reconstruction, regeneration, 

8 and transplantation. 

9 (5) The Department of Health and Human 

10 Services and the Multi-Agency Tissue Engineering 

11 Science Interagency Working Group have endorsed a 

12 national initiative to support research and product 

13 development in regenerative medicine. 

14 (6) The Department of Health and Human 

15 Services has said the potential benefits of regenera16 tive medicine in improved health care and economic 

17 savings are enormous. States that have invested in 

18 regenerative medicine have experienced economic 

19 growth and see future growth potential, including an 

20 increase in biotech employment, payroll increases, 

21 and proportional impacts on tax receipts. 


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1 SEC. 3. REPORT ON ONGOING FEDERAL PROGRAMS AND 

2 ACTIVITIES REGARDING REGENERATIVE 

3 MEDICINE. 

4 Not later than 180 days after the date of the enact5 ment of this Act, the Comptroller General of the United 

6 States shall provide for the completion, and submission 

7 to the Congress, of a report identifying all ongoing Federal 

8 programs and activities regarding regenerative medicine. 

9 SEC. 4. ESTABLISHMENT OF REGENERATIVE MEDICINE CO10 ORDINATING COUNCIL. 

11 (a) ESTABLISHMENT.—The Secretary of Health and 

12 Human Services shall establish, within six months of the 

13 enactment of this Act, in the Office of the Secretary, a 

14 Regenerative Medicine Coordinating Council (in this sec15 tion referred to as the ‘‘Council’’). 

16 (b) COMPOSITION.—The Council shall be composed 

17 of the following: 

18 (1) The Secretary of Commerce. 

19 (2) The Secretary of Defense. 

20 (3) The Secretary of Health and Human Serv21 ices. 

22 (4) The Secretary of the Treasury. 

23 (5) The Secretary of Veterans Affairs. 

24 (6) The Administrator of the Agency for 

25 Healthcare Research and Quality. 


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1 (7) The Administrator of the Centers for Medi2 care & Medicaid Services. 

3 (8) The Commissioner of Food and Drugs. 

4 (9) The Director of the National Institutes of 

5 Health. 

6 (10) The Director of the National Institutes of 

7 Standards and Technology. 

8 (11) The members appointed by the Secretary 

9 under subsection (d). 

10 (c) CHAIR.—The Secretary of Health and Human 

11 Services shall be the Chair of the Council. 

12 (d) MEMBERS APPOINTED BY SECRETARY.—The 

13 Secretary shall appoint at least 5 persons to serve as mem14 bers of the Council under subsection (b)(11). The mem15 bers of the Council appointed under the preceding sen16 tence shall include persons with expertise in third-party 

17 payment, regenerative medicine researchers from aca18 demic institutions, patient advocates, persons with exper19 tise in drug discovery, persons with expertise in drug de20 velopment, persons with expertise in basic research, per21 sons with expertise in translational research, persons with 

22 expertise in medical device development, persons with ex23 pertise in biomaterials, clinicians, and persons with exper24 tise in clinical research. 

25 (e) FUNCTIONS.—The Council shall— 


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1 (1) consult with, and provide information to, 

2 the Secretary of Health and Human Services for 

3 purposes of implementing any recommendations in 

4 the report required by section 3; 

5 (2) prepare, and keep up-to-date, a national 

6 strategy to support research into regenerative medi7 cine and the development of drugs, biological prod8 ucts, medical devices, and biomaterials for use in re9 generative medicine; 

10 (3) prepare a plan specifying priorities for re11 search into regenerative medicine; 

12 (4) not later than 1 year after the date of the 

13 enactment of this Act, establish priorities for the 

14 award of grants under sections 5 and 6 (relating to 

15 grants for basic or preclinical research into regen16 erative medicine and for development of drugs, bio17 logical products, medical devices, and biomaterials 

18 for use in regenerative medicine, respectively); 

19 (5) identify sources of funding for research into 

20 regenerative medicine; 

21 (6) identify areas where such funding is inad22 equate; 

23 (7) make recommendations regarding Federal 

24 regulatory, reimbursement, tax, and other policies 


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1 that will support development and marketing of re2 generative medicine products; 

3 (8) facilitate development of consensus stand4 ards regarding scientific issues critical to regulatory 

5 approval of regenerative medicine products; and 

6 (9) determine the need for establishing centers 

7 of excellence or consortia to further advance regen8 erative medicine. 

9 (f) TRANSPARENCY; REPORTING REQUIREMENTS.— 

10 (1) TRANSPARENCY.—The Council shall adopt 

11 procedures to ensure the receipt of public input, 

12 such as holding public stakeholder meetings or cre13 ating advisory boards. 

14 (2) ANNUAL REPORTS.—The Council shall sub15 mit an annual report on its activities to the Con16 gress, the Director of the National Institutes of 

17 Health, and the Commissioner of Food and Drugs. 

18 Each such report shall— 

19 (A) provide details on progress in meeting 

20 goals identified by the Council for regenerative 

21 medicine; 

22 (B) make recommendations regarding 

23 funding, regulatory, or other policies to achieve 

24 regenerative medicine goals identified by the 

25 Council; 


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1 (C) identify all regenerative medicine prod2 ucts currently on the market and those in devel3 opment; 

4 (D) identify regenerative medicine research 

5 and technological advances and discoveries that 

6 occurred in the previous year; and 

7 (E) assess the impact of regenerative medi8 cine on the Nation’s economy, including with 

9 respect to— 

10 (i) the number of people employed in 

11 companies or research institutions working 

12 in regenerative medicine; 

13 (ii) the number of companies pursuing 

14 regenerative medicine products; 

15 (iii) increases in tax revenues; and 

16 (iv) the impact on national health 

17 spending. 

18 SEC. 5. GRANTS FOR BASIC OR PRECLINICAL RESEARCH 

19 INTO REGENERATIVE MEDICINE. 

20 (a) GRANTS FOR BASIC OR PRECLINICAL RE21 SEARCH.—The Secretary may make grants to eligible enti22 ties for the purpose of funding basic or preclinical research 

23 into regenerative medicine. 

24 (b) CONDITIONS.—The Secretary may make a grant 

25 under this section for research only if— 


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1 (1) the research is carried out directly by the 

2 grant recipient; 

3 (2) the research is partly funded by one or 

4 more private entities; and 

5 (3) the amount of the grant does not exceed the 

6 total amount provided for the research by private 

7 entities (other than the grant recipient itself). 

8 (c) TERMS AND CONDITIONS.—A grant under this 

9 section may be made on such terms and conditions as the 

10 Secretary determines appropriate. 

11 (d) PRIORITY.—In awarding grants under this sec12 tion, the Secretary shall take into consideration the prior13 ities established by the Regenerative Medicine Coordi14 nating Council under section 4(e). 

15 (e) DEFINITIONS.—In this section: 

16 (1) The term ‘‘eligible entity’’ means a non17 profit entity or an institution of higher education. 

18 (2) The term ‘‘institution of higher education’’ 

19 has the meaning given that term in section 101 of 

20 the Higher Education Act of 1965 (20 U.S.C. 

21 1001). 

22 (3) The term ‘‘nonprofit entity’’ means an enti23 ty that— 


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1 (A) is described in section 501(c)(3) of the 

2 Internal Revenue Code of 1986 (26 U.S.C. 

3 501(c)(3)); and 

4 (B) is exempt from tax under section 

5 501(a) of the Internal Revenue Code of 1986 

6 (26 U.S.C. 501(a)). 

7 (4) The term ‘‘Secretary’’ means the Secretary 

8 of Health and Human Services, acting through the 

9 Director of the National Institutes of Health. 

10 SEC. 6. GRANTS FOR DEVELOPMENT OF DRUGS, BIOLOGI11 CAL PRODUCTS, MEDICAL DEVICES, AND BIO12 MATERIALS FOR USE IN REGENERATIVE 

13 MEDICINE. 

14 (a) GRANTS FOR DRUG DEVELOPMENT.—The Sec15 retary may make grants to eligible entities for the purpose 

16 of funding projects that have as their aim— 

17 (1) the research and development of drugs, bio18 logical products, medical devices, and biomaterials 

19 for use in regenerative medicine; and 

20 (2) the making of an investigational new drug 

21 application with respect to such drugs or biological 

22 products, or the making of an investigational device 

23 exemption application with respect to such devices, 

24 by not later than the end of the 4-year period begin25 ning on the date on which such grant is made. 


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1 (b) TERMS AND CONDITIONS.—A grant under this 

2 section may be made on such terms and conditions as the 

3 Secretary determines appropriate. 

4 (c) PRIORITY.—In awarding grants under this sec5 tion, the Secretary shall take into consideration the prior6 ities established by the Regenerative Medicine Coordi7 nating Council under section 4(e). 

8 (d) DEFINITIONS.—In this section: 

9 (1) The term ‘‘biological product’’ has the 

10 meaning given the term in section 351(i) of the Pub11 lic Health Service Act (42 U.S.C. 262(i)). 

12 (2) The terms ‘‘drug’’ and ‘‘medical device’’ 

13 have the meanings given to the terms ‘‘drug’’ and 

14 ‘‘device’’, respectively, in section 201 of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 321). 

16 (3) The term ‘‘eligible entity’’ means a collabo17 rative partnership including— 

18 (A) a qualified nonprofit entity or an insti19 tution of higher education; and 

20 (B) a for-profit entity. 

21 (4) The term ‘‘institution of higher education’’ 

22 has the meaning given that term in section 101 of 

23 the Higher Education Act of 1965 (20 U.S.C. 

24 1001). 


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1 (5) The term ‘‘investigational new drug applica2 tion’’ means an investigational new drug application 

3 that is made to the Food and Drug Administration 

4 under section 505(i) of the Federal Food, Drug, and 

5 Cosmetic Act (21 U.S.C. 505(i)). 

6 (6) The term ‘‘investigational device exemption 

7 application’’ means an application for an investiga8 tional device exemption that is made to the Food 

9 and Drug Administration under section 520(g) of 

10 the Federal Food, Drug, and Cosmetic Act (21 

11 U.S.C. 360j(g)). 

12 (7) The term ‘‘qualified nonprofit entity’’ 

13 means an entity that— 

14 (A) is described in section 501(c)(3) of the 

15 Internal Revenue Code of 1986 (26 U.S.C. 

16 501(c)(3)); and 

17 (B) is exempt from tax under section 

18 501(a) of the Internal Revenue Code of 1986 

19 (26 U.S.C. 501(a)). 

20 (8) The term ‘‘Secretary’’ means the Secretary 

21 of Health and Human Services, acting through the 

22 Director of the National Institutes of Health. 


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1 SEC. 7. SUPPORTING INNOVATION IN REGENERATIVE MED2 ICINE THROUGH CURES ACCELERATION NET3 WORK. 

4 Section 480 of the Public Health Service Act (42 

5 U.S.C. 287a) is amended— 

6 (1) in subsection (d), by adding at the end the 

7 following: 

8 ‘‘(7) COLLABORATION.—With respect to activi9 ties of the Board relating to medical products and 

10 behavioral therapies for use in regenerative medi11 cine, the Board shall collaborate with the Regenera12 tive Medicine Coordinating Council.’’; and 

13 (2) in subsection (e)(3), by adding at the end 

14 the following: 

15 ‘‘(D) THE CURES ACCELERATION AWARDS

16 WITH RESPECT TO PRODUCTS AND THERAPIES

17 FOR USE IN REGENERATIVE MEDICINE.—The 

18 Director of NIH may, without regard to sub19 paragraphs (A), (B), and (C), provide assist20 ance under paragraph (1) with respect to med21 ical products and behavioral therapies for use in 

22 regenerative medicine, including assistance— 

23 ‘‘(i) to perform clinical trials under a 

24 protocol approved by the Commissioner of 

25 Food and Drugs or studies which use good 

26 manufacturing practice or good laboratory 


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1 practice procedures and the data from 

2 which are intended for inclusion in an in3 vestigational new drug application or an 

4 investigational device exemption applica5 tion; or 

6 ‘‘(ii) to perform basic research or pre7 clinical studies in regenerative medicine the 

8 data from which are not intended for inclu9 sion in an investigational new drug appli10 cation or an investigational device exemp11 tion application.’’. 

12 SEC. 8. FUNDING FOR FOOD AND DRUG ADMINISTRATION 

13 RESEARCH. 

14 (a) GRANTS.—The Secretary may— 

15 (1) conduct, support, or collaborate in regu16 latory research for the purpose of assisting the Food 

17 and Drug Administration to perform its functions 

18 with respect to regenerative medicine; or 

19 (2) make grants to fund regulatory research for 

20 such purpose. 

21 (b) DEFINITIONS.—In this section: 

22 (1) The term ‘‘regulatory research’’ means re23 search regarding development, evaluation, and avail24 ability of new or improved tools, methods, standards, 

25 and applied science that support a better underVerDate Mar 15 2010 02:09 Apr 29, 2014 Jkt 039200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\H4494.IH H4494

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1 standing and improved evaluation of product safety, 

2 quality, effectiveness, and manufacturing throughout 

3 the product life cycle. 

4 (2) The term ‘‘Secretary’’ means the Secretary 

5 of Health and Human Services, acting through the 

6 Commissioner of Food and Drugs. 

Æ 


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