HR 872 IHCommentsClose CommentsPermalink

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.CommentsClose CommentsPermalink

February 4, 2009CommentsClose CommentsPermalink

Ms. DEGETTE (for herself and Mr. CASTLE) introduced the following bill; which was referred to the Committee on Energy and CommerceCommentsClose CommentsPermalink

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.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.

This Act may be cited as the ‘Stem Cell Research Improvement Act of 2009’.CommentsClose CommentsPermalink

SEC. 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:CommentsClose CommentsPermalink

‘SEC. 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).CommentsClose CommentsPermalink





‘(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:CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink

SEC. 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:CommentsClose CommentsPermalink

‘SEC. 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--CommentsClose CommentsPermalink





‘(1) shall issue guidelines on research involving human embryonic stem cells; andCommentsClose CommentsPermalink





‘(2) may issue guidelines on research involving other human stem cells, as determined to be scientifically warranted by the Director of NIH.CommentsClose CommentsPermalink





‘(b) Updates-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(d) Application of Guidelines to Research-CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.CommentsClose CommentsPermalink





‘(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.’.CommentsClose CommentsPermalink

SEC. 4. REPORTING REQUIREMENTS.

Section 403(a)(5) of the Public Health Service Act (42 U.S.C. 283(a)(5)) is amended--CommentsClose CommentsPermalink





(1) by redesignating subparagraph (L) as (M); andCommentsClose CommentsPermalink





(2) by inserting the following:CommentsClose CommentsPermalink





‘(L) Human stem cells.’.CommentsClose CommentsPermalink

SEC. 5. SENSE OF CONGRESS.

It is the sense of the Congress that--CommentsClose CommentsPermalink





(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;CommentsClose CommentsPermalink





(2) any research using human stem cells, irrespective of whether such research is federally funded, should comply with the guidelines under section 498E; andCommentsClose CommentsPermalink





(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.CommentsClose CommentsPermalink