[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7141 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 7141

 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

                           September 26, 2008

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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Stem Cell Research Enhancement Act 
of 2008''.

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:

``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).
    ``(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.''.

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:

``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--
            ``(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 first 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.''.

SEC. 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.''.

SEC. 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.
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