I 111th CONGRESS 1st Session H. R. 872 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.

Short title

This Act may be cited as the Stem Cell Research Improvement Act of 2009.

2.

Human embryonic stem cell research

Part H of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is amended by inserting after section 498C the following:

498D.

Human embryonic stem cell research

(a)

In General

Notwithstanding any other provision of law (including any regulation or guidance), the Secretary shall conduct and support research that utilizes human embryonic stem cells (regardless of the date on which the stem cells were derived from a human embryo). (b)

Ethical Requirements

Human embryonic stem cells shall be eligible for use in any research conducted or supported by the Secretary if the cells meet each of the following: (1)The stem cells were derived from human embryos that have been donated from in vitro fertilization clinics, were created for the purposes of fertility treatment, and were in excess of the clinical need of the individuals seeking such treatment. (2)Prior to the consideration of embryo donation and through consultation with the individuals seeking fertility treatment, it was determined that the embryos would never be implanted in a woman and would otherwise be discarded. (3)The individuals seeking fertility treatment donated the embryos with written informed consent and without receiving any financial or other inducements to make the donation.

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3.

Guidelines on research involving human stem cells

Part H of title IV of the Public Health Service Act (42 U.S.C. 289 et seq.) is further amended by inserting after section 498D, as inserted by this Act, the following:

498E.

Guidelines on research involving human stem cells

(a)

In general

Not later than 90 days after the date of the enactment of this section, the Director of NIH— (1)shall issue guidelines on research involving human embryonic stem cells; and (2)may issue guidelines on research involving other human stem cells, as determined to be scientifically warranted by the Director of NIH. (b)

Updates

(1)

In general

Subject to paragraph (2), the Director of NIH shall review and, as appropriate, update the guidelines issued under paragraphs (1) and (2) of subsection (a) when the Director determines that such updates are scientifically warranted. The Director of NIH may determine the extent to which such an update applies to ongoing National Institutes of Health conducted- or supported-research. (2)

Frequency of updates

The first update required under paragraph (1), with respect to guidelines issued under paragraph (1) or (2) of subsection (a), shall be made not later than the last day of the three-year period beginning on the date such respective guidelines are issued and each subsequent update to such respective guidelines shall be made not later than the last day of each subsequent three-year period. (c)

Consideration of other guidelines

In developing and updating the guidelines under this section, the Director of NIH shall, as appropriate, take into consideration guidelines on human stem cell research developed by nationally and internationally recognized scientific organizations. (d)

Application of guidelines to research

(1)

In general

Subject to paragraph (2), research that is conducted or supported by the National Institutes of Health on or after the effective date of the applicable guidelines under subsection (a) shall comply with such guidelines. (2)

Exception for cells derived before the effective date of the guidelines

The Director of NIH shall determine the extent to which the guidelines under this section shall apply to research described in paragraph (1) that uses human stem cells derived before the effective date of such guidelines. (e)

Public disclosure

The Director of NIH shall publish the guidelines issued and updated under this section on the public website of the National Institutes of Health.

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4.

Reporting requirements

Section 403(a)(5) of the Public Health Service Act (42 U.S.C. 283(a)(5)) is amended— (1)by redesignating subparagraph (L) as (M); and (2)by inserting the following: (L)Human stem cells. .

5.

Sense of Congress

It is the sense of the Congress that— (1)in developing, updating, and implementing the guidelines under section 498E of the Public Health Service Act, as added by section 3, the Director of the National Institutes of Health should consult with the Commissioner of Food and Drugs; (2)any research using human stem cells, irrespective of whether such research is federally funded, should comply with the guidelines under section 498E; and (3)the Commissioner of Food and Drugs should keep the Director of the National Institutes of Health informed of the types of human stem cell and related research that would facilitate the evaluation of the safety or effectiveness of drugs, devices, and biological products.