I 

111TH CONGRESS 

2D SESSION H. R. 6173 

To provide for a Federal initiative to support regenerative medicine through 

increased 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 

SEPTEMBER 22, 2010 

Mr. CASTLE (for himself and Ms. DEGETTE) introduced the following bill; 

which was referred to the Committee on Energy and Commerce 

A BILL 

To provide for a Federal initiative to support regenerative 

medicine through increased 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 2010’’. 


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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 and promote economic 

7 growth in the United States. 

8 (2) Regenerative medicine has the potential to 

9 provide cures, treatments and diagnostics for a 

10 range of diseases and disabilities including diabetes, 

11 spinal cord injury, heart disease, stroke, and various 

12 forms of cancer. 

13 (3) The Department of Defense has stated that 

14 regenerative medicine has the potential to treat 

15 many battlefield injuries such as burns, that it has 

16 the potential to heal wounds without scarring, and 

17 that it has the potential to be used for craniofacial 

18 reconstruction, limb reconstruction, regeneration, 

19 and transplantation. 


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1 (4) The Department of Health and Human 

2 Services and the Multi-Agency Tissue Engineering 

3 Science Interagency Working Group have endorsed a 

4 national initiative to support research and product 

5 development in regenerative medicine. 

6 (5) The Department of Health and Human 

7 Services has said the potential benefits of regenera8 tive medicine in improved health care and economic 

9 savings are enormous. States that have invested in 

10 regenerative medicine have experienced economic 

11 growth and see future growth potential, including an 

12 increase in biotech employment, payroll increases, 

13 and proportional impacts on tax receipts. 

14 SEC. 3. REPORT ON ONGOING FEDERAL PROGRAMS AND 

15 ACTIVITIES REGARDING REGENERATIVE 

16 MEDICINE. 

17 Not later than 90 days after the date of the enact18 ment of this Act, the Secretary of Health and Human 

19 Services shall provide for the completion, and submission 

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

21 programs and activities regarding regenerative medicine. 

22 SEC. 4. ESTABLISHMENT OF REGENERATIVE MEDICINE CO23 ORDINATING COUNCIL. 

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

25 Human Services shall establish, in the Office of the SecVerDate Mar 15 2010 06:05 Sep 23, 2010 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6173.IH H6173

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1 retary, a Regenerative Medicine Coordinating Council (in 

2 this section referred to as the ‘‘Council’’). 

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

4 of the following: 

5 (1) The Secretary of Commerce. 

6 (2) The Secretary of Defense. 

7 (3) The Secretary of Health and Human Serv8 ices. 

9 (4) The Secretary of the Treasury. 

10 (5) The Secretary of Veterans Affairs. 

11 (6) The Administrator of the Agency for 

12 Healthcare Research and Quality. 

13 (7) The Administrator of the Centers for Medi14 care & Medicaid Services. 

15 (8) The Commissioner of Food and Drugs. 

16 (9) The Director of the National Institutes of 

17 Health. 

18 (10) The Director of the National Institutes of 

19 Standards and Technology. 

20 (11) Such other members as may be appointed 

21 by the Secretary. 

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

23 Services shall be the Chair of the Council. 

24 (d) MEMBERS APPOINTED BY SECRETARY.—The 

25 members of the Council appointed by the Secretary under 


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1 subsection (b)(11) shall include insurers, persons from 

2 academic institutions, patient advocates, persons with ex3 pertise in drug discovery, persons with expertise in drug 

4 development, persons with expertise in basic research, per5 sons with expertise in translational research, persons with 

6 expertise in medical device development, persons with ex7 pertise in biomaterials, and person with expertise in clin8 ical research. 

9 (e) FUNCTIONS.—The Council shall— 

10 (1) consult with and provide information to the 

11 Secretary of Health and Human Services for pur12 poses of preparing the report required by section 3; 

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

14 strategy for the promotion of research into regenera15 tive medicine and the development of drugs, biologi16 cal products, medical devices, and biomaterials for 

17 use in regenerative medicine; 

18 (3) prepare a plan specifying priorities for re19 search into regenerative medicine; 

20 (4) not later than 120 days after the date of 

21 the enactment of this Act, establish priorities for the 

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

23 grants for basic or preclinical research into regen24 erative medicine and for development of drugs, bioVerDate Mar 15 2010 06:05 Sep 23, 2010 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H6173.IH H6173

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1 logical products, medical devices, and biomaterials 

2 for use in regenerative medicine, respectively); 

3 (5) identify sources of funding for research into 

4 regenerative medicine; 

5 (6) identify areas where such funding is inad6 equate; 

7 (7) make recommendations regarding Federal 

8 regulatory, reimbursement, and other policies that 

9 will support development and marketing of regenera10 tive medicine products; 

11 (8) develop consensus standards regarding sci12 entific issues critical to regulatory approval of regen13 erative medicine products; and 

14 (9) determine the need for establishing centers 

15 of excellence or consortia to further advance regen16 erative medicine. 

17 (f) TRANSPARENCY; REPORTING REQUIREMENTS.— 

18 (1) TRANSPARENCY.—The Council shall adopt 

19 procedures to ensure the receipt of public input, 

20 such as holding public stakeholder meetings or cre21 ating advisory boards. 

22 (2) ANNUAL REPORTS.—The Council shall sub23 mit an annual report on its activities to the Con24 gress, the Director of the National Institutes of 


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1 Health, and the Commissioner of Food and Drugs. 

2 Each such report shall— 

3 (A) provide details on progress in meeting 

4 goals identified by the Council for regenerative 

5 medicine; 

6 (B) identify regenerative medicine products 

7 currently on the market and those in develop8 ment; 

9 (C) identify regenerative medicine research 

10 and technological advances and discoveries that 

11 occurred in the previous year; and 

12 (D) assess the impact of regenerative med13 icine on the Nation’s economy, including with 

14 respect to— 

15 (i) the number of people employed in 

16 companies or research institutions working 

17 in regenerative medicine; 

18 (ii) the number of companies pursuing 

19 regenerative medicine products; and 

20 (iii) increases in tax revenues. 

21 SEC. 5. GRANTS FOR BASIC OR PRECLINICAL RESEARCH 

22 INTO REGENERATIVE MEDICINE. 

23 (a) GRANTS FOR BASIC OR PRECLINICAL RE24 SEARCH.—The Secretary may make grants to eligible entiVerDate Mar 15 2010 06:05 Sep 23, 2010 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H6173.IH H6173

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1 ties for the purpose of funding basic or preclinical research 

2 into regenerative medicine. 

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

4 under this section for research only if— 

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

6 grant recipient; 

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

8 more private entities; and 

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

10 total amount provided for the research by private 

11 entities (other than the grant recipient itself). 

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

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

14 Secretary determines appropriate. 

15 (d) PRIORITY.—In awarding grants under this sec16 tion, the Secretary shall take into consideration the prior17 ities established by the Regenerative Medicine Coordi18 nating Council under section 4(e). 

19 (e) DEFINITIONS.—In this section: 

20 (1) The term ‘‘eligible entity’’ means a non21 profit entity or an institution of higher education. 

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

23 has the meaning given that term in section 101 of 

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

25 1001). 


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1 (3) The term ‘‘nonprofit entity’’ means an enti2 ty that— 

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

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

5 501(c)(3)); and 

6 (B) is exempt from tax under section 

7 501(a) of the Internal Revenue Code of 1986 

8 (26 U.S.C. 501(a)). 

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

10 of Health and Human Services, acting through the 

11 Director of the National Institutes of Health. 

12 (f) AUTHORIZATION OF APPROPRIATIONS.—To carry 

13 out this section, there is authorized to be appropriated 

14 $100,000,000 for the period of fiscal years 2011 though 

15 2016. 

16 SEC. 6. GRANTS FOR DEVELOPMENT OF DRUGS, BIOLOGI17 CAL PRODUCTS, MEDICAL DEVICES, AND BIO18 MATERIALS FOR USE IN REGENERATIVE 

19 MEDICINE. 

20 (a) GRANTS FOR DRUG DEVELOPMENT.—The Sec21 retary may make grants to eligible entities for the purpose 

22 of funding projects that have as their aim— 

23 (1) the research and development of drugs, bio24 logical products, medical devices, and biomaterials 

25 for use in regenerative medicine; and 


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1 (2) the making of an investigational new drug 

2 application with respect to such drugs or biological 

3 products, or the making of an investigational device 

4 exemption application with respect to such devices, 

5 by not later than the end of the 4-year period begin6 ning on the date on which such grant is made. 

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

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

9 Secretary determines appropriate. 

10 (c) PRIORITY.—In awarding grants under this sec11 tion, the Secretary shall take into consideration the prior12 ities established by the Regenerative Medicine Coordi13 nating Council under section 4(e). 

14 (d) DEFINITIONS.—In this section: 

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

16 meaning given the term in section 351(i) of the Pub17 lic Health Service Act (42 U.S.C. 262(i)). 

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

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

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

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

22 (3) The term ‘‘eligible entity’’ means a collabo23 rative partnership including— 

24 (A) a qualified nonprofit entity or an insti25 tution of higher education; and 


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1 (B) a for-profit entity. 

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

3 has the meaning given that term in section 101 of 

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

5 1001). 

6 (5) The term ‘‘investigational new drug applica7 tion’’ means an investigational new drug application 

8 that is made to the Food and Drug Administration 

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

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

11 (6) The term ‘‘investigational device exemption 

12 application’’ means an application for an investiga13 tional device exemption that is made to the Food 

14 and Drug Administration under section 520(g) of 

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

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

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

18 means an entity that— 

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

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

21 501(c)(3)); and 

22 (B) is exempt from tax under section 

23 501(a) of the Internal Revenue Code of 1986 

24 (26 U.S.C. 501(a)). 


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

2 of Health and Human Services, acting through the 

3 Director of the National Institutes of Health. 

4 (e) AUTHORIZATION OF APPROPRIATIONS.—To carry 

5 out this section, there is authorized to be appropriated 

6 $100,000,000 for the period of fiscal years 2011 though 

7 2016. 

8 SEC. 7. SUPPORTING INNOVATION IN REGENERATIVE MED9 ICINE THROUGH CURES ACCELERATION NET10 WORK. 

11 Section 402C of the Public Health Service Act (42 

12 U.S.C. 282d) is amended— 

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

14 following: 

15 ‘‘(7) COLLABORATION.—With respect to activi16 ties of the Board relating to medical products and 

17 behavioral therapies for use in regenerative medi18 cine, the Board shall collaborate with the Regenera19 tive Medicine Coordinating Council.’’; 

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

21 the following: 

22 ‘‘(D) THE CURES ACCELERATION AWARDS

23 WITH RESPECT TO PRODUCTS AND THERAPIES

24 FOR USE IN REGENERATIVE MEDICINE.—The 

25 Director of NIH may, without regard to subVerDate Mar 15 2010 06:05 Sep 23, 2010 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H6173.IH H6173

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1 paragraphs (A), (B), and (C), provide assist2 ance under paragraph (1) with respect to med3 ical products and behavioral therapies for use in 

4 regenerative medicine, including assistance— 

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

6 protocol approved by the Commissioner of 

7 Food and Drugs or studies which use good 

8 manufacturing practice or good laboratory 

9 practice procedures and the data from 

10 which are intended for inclusion in an in11 vestigational new drug application or an 

12 investigational device exemption applica13 tion; or 

14 ‘‘(ii) to perform basic research or pre15 clinical studies in regenerative medicine the 

16 data from which are not intended for inclu17 sion in an investigational new drug appli18 cation or an investigational device exemp19 tion application.’’; and 

20 (3) in subsection (g)— 

21 (A) in paragraph (2), by striking ‘‘para22 graph (1)’’ and inserting ‘‘paragraph (1) or 

23 (2)’’; 

24 (B) by redesignating paragraph (2) as 

25 paragraph (3); and 


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1 (C) by inserting after paragraph (1) the 

2 following: 

3 ‘‘(2) REGENERATIVE MEDICINE.—For providing 

4 assistance under subsection (e)(1) with respect to 

5 medical products and behavioral therapies for use in 

6 regenerative medicine, in addition to amounts au7 thorized to be appropriated by paragraph (1), there 

8 are authorized to be appropriated $100,000,000 for 

9 each of fiscal years 2011 through 2015.’’. 

10 SEC. 8. FUNDING FOR FOOD AND DRUG ADMINISTRATION 

11 RESEARCH. 

12 (a) GRANTS.—The Secretary may— 

13 (1) conduct, support, or collaborate in regu14 latory research for the purpose of assisting the Food 

15 and Drug Administration to perform its functions 

16 with respect to regenerative medicine; or 

17 (2) make grants to fund regulatory research for 

18 such purpose. 

19 (b) DEFINITIONS.—In this section: 

20 (1) The term ‘‘regulatory research’’ means re21 search regarding development, evaluation, and avail22 ability of new or improved tools, methods, standards, 

23 and applied science that support a better under24 standing and improved evaluation of product safety, 


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1 quality, effectiveness, and manufacturing throughout 

2 the product life cycle. 

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

4 of Health and Human Services, acting through the 

5 Commissioner of Food and Drugs. 

6 (c) AUTHORIZATION OF APPROPRIATIONS.—To carry 

7 out this section, there are authorized to be appropriated 

8 $25,000,000 for fiscal year 2011 and $125,000,000 for 

9 the period of fiscal years 2012 though 2016. 

Æ 


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