I 

111TH CONGRESS 

1ST SESSION H. R. 872 

To amend the Public Health Service Act to provide for human embryonic 

stem cell research, to direct the National Institutes of Health to issue 

guidelines for such stem cell research, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

FEBRUARY 4, 2009 

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

which was referred to the Committee on Energy and Commerce 

A BILL 

To amend the Public Health Service Act to provide for 

human embryonic stem cell research, to direct the National Institutes of Health to issue guidelines for such 

stem cell research, 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. 

4 This Act may be cited as the ‘‘Stem Cell Research 

5 Improvement Act of 2009’’. 


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1 SEC. 2. HUMAN EMBRYONIC STEM CELL RESEARCH. 

2 Part H of title IV of the Public Health Service Act 

3 (42 U.S.C. 289 et seq.) is amended by inserting after sec4 tion 498C the following: 

5 ‘‘SEC. 498D. HUMAN EMBRYONIC STEM CELL RESEARCH. 

6 ‘‘(a) IN GENERAL.—Notwithstanding any other pro7 vision of law (including any regulation or guidance), the 

8 Secretary shall conduct and support research that utilizes 

9 human embryonic stem cells (regardless of the date on 

10 which the stem cells were derived from a human embryo). 

11 ‘‘(b) ETHICAL REQUIREMENTS.—Human embryonic 

12 stem cells shall be eligible for use in any research con13 ducted or supported by the Secretary if the cells meet each 

14 of the following: 

15 ‘‘(1) The stem cells were derived from human 

16 embryos that have been donated from in vitro fer17 tilization clinics, were created for the purposes of 

18 fertility treatment, and were in excess of the clinical 

19 need of the individuals seeking such treatment. 

20 ‘‘(2) Prior to the consideration of embryo dona21 tion and through consultation with the individuals 

22 seeking fertility treatment, it was determined that 

23 the embryos would never be implanted in a woman 

24 and would otherwise be discarded. 

25 ‘‘(3) The individuals seeking fertility treatment 

26 donated the embryos with written informed consent 


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1 and without receiving any financial or other induce2 ments to make the donation.’’. 

3 SEC. 3. GUIDELINES ON RESEARCH INVOLVING HUMAN 

4 STEM CELLS. 

5 Part H of title IV of the Public Health Service Act 

6 (42 U.S.C. 289 et seq.) is further amended by inserting 

7 after section 498D, as inserted by this Act, the following: 

8 ‘‘SEC. 498E. GUIDELINES ON RESEARCH INVOLVING HUMAN 

9 STEM CELLS. 

10 ‘‘(a) IN GENERAL.—Not later than 90 days after the 

11 date of the enactment of this section, the Director of 

12 NIH— 

13 ‘‘(1) shall issue guidelines on research involving 

14 human embryonic stem cells; and 

15 ‘‘(2) may issue guidelines on research involving 

16 other human stem cells, as determined to be scientif17 ically warranted by the Director of NIH. 

18 ‘‘(b) UPDATES.— 

19 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

20 the Director of NIH shall review and, as appro21 priate, update the guidelines issued under para22 graphs (1) and (2) of subsection (a) when the Direc23 tor determines that such updates are scientifically 

24 warranted. The Director of NIH may determine the 

25 extent to which such an update applies to ongoing 


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1 National Institutes of Health conducted- or sup2 ported-research. 

3 ‘‘(2) FREQUENCY OF UPDATES.—The first up4 date required under paragraph (1), with respect to 

5 guidelines issued under paragraph (1) or (2) of sub6 section (a), shall be made not later than the last day 

7 of the three-year period beginning on the date such 

8 respective guidelines are issued and each subsequent 

9 update to such respective guidelines shall be made 

10 not later than the last day of each subsequent three11 year period. 

12 ‘‘(c) CONSIDERATION OF OTHER GUIDELINES.—In 

13 developing and updating the guidelines under this section, 

14 the Director of NIH shall, as appropriate, take into con15 sideration guidelines on human stem cell research devel16 oped by nationally and internationally recognized scientific 

17 organizations. 

18 ‘‘(d) APPLICATION OF GUIDELINES TO RESEARCH.— 

19 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

20 research that is conducted or supported by the Na21 tional Institutes of Health on or after the effective 

22 date of the applicable guidelines under subsection 

23 (a) shall comply with such guidelines. 

24 ‘‘(2) EXCEPTION FOR CELLS DERIVED BEFORE

25 THE EFFECTIVE DATE OF THE GUIDELINES.—The 


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1 Director of NIH shall determine the extent to which 

2 the guidelines under this section shall apply to re3 search described in paragraph (1) that uses human 

4 stem cells derived before the effective date of such 

5 guidelines. 

6 ‘‘(e) PUBLIC DISCLOSURE.—The Director of NIH 

7 shall publish the guidelines issued and updated under this 

8 section on the public website of the National Institutes 

9 of Health.’’. 

10 SEC. 4. REPORTING REQUIREMENTS. 

11 Section 403(a)(5) of the Public Health Service Act 

12 (42 U.S.C. 283(a)(5)) is amended— 

13 (1) by redesignating subparagraph (L) as (M); 

14 and 

15 (2) by inserting the following: 

16 ‘‘(L) Human stem cells.’’. 

17 SEC. 5. SENSE OF CONGRESS. 

18 It is the sense of the Congress that— 

19 (1) in developing, updating, and implementing 

20 the guidelines under section 498E of the Public 

21 Health Service Act, as added by section 3, the Di22 rector of the National Institutes of Health should 

23 consult with the Commissioner of Food and Drugs; 

24 (2) any research using human stem cells, irre25 spective of whether such research is federally fundVerDate Nov 24 2008 00:13 Feb 07, 2009 Jkt 079200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H872.IH H872

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1 ed, should comply with the guidelines under section 

2 498E; and 

3 (3) the Commissioner of Food and Drugs 

4 should keep the Director of the National Institutes 

5 of Health informed of the types of human stem cell 

6 and related research that would facilitate the evalua7 tion of the safety or effectiveness of drugs, devices, 

8 and biological products. 

Æ 


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