text: 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.
target: Stem Cell Research Enhancement Act of 2008 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to 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. Limits such research to stem cells that meet the following requirements: (1) the stem cells were derived from human embryos donated from in vitro fertilization clinics, were created for the purposes of fertility treatment, and were in excess of the needs of the individuals seeking such treatment; (2) prior to donation, it was determined that the embryos would never be implanted in a woman and would otherwise be discarded; and (3) the individuals seeking fertility treatment donated the embryos with written informed consent and received no financial or other inducements.
  
  Requires the Director of the National Institutes of Health (NIH) to issue guidelines on research involving human embryonic stem cells. Authorizes the Director to issue guidelines on research involving other human stem cells, as scientifically warranted. Provides for updates of guidelines under this Act. Directs the Secretary to take into consideration guidelines on human stem cell research developed by nationally- and internationally- recognized scientific organizations.
  
  Requires NIH research to comply with guidelines under this Act.
  
  Requires the Director to: (1) determine the extent to which the guidelines under this Act apply to research on human embryonic stem cells derived before the effective date of such guidelines; and (2) include in its biennial report to Congress a summary of research activities on human stem cells.
feat_title: 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.