and without receiving any financial or other induce-
ments 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 scientif-
ically warranted by the Director of NIH. 
‘‘(b) UPDATES.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Director of NIH shall review and, as appro-
priate, update the guidelines issued under para-
graphs (1) and (2) of subsection (a) when the Direc-
tor determines that such updates are scientifically 
warranted. The Director of NIH may determine the 
extent to which such an update applies to ongoing 
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National Institutes of Health conducted- or sup-
ported-research. 
‘‘(2) FREQUENCY OF UPDATES.—The first up-
date required under paragraph (1), with respect to 
guidelines issued under paragraph (1) or (2) of sub-
section (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 con-
sideration guidelines on human stem cell research devel-
oped by nationally- and internationally-recognized sci-
entific 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 effec-
tive date of the applicable guidelines under sub-
section (a) shall comply with such guidelines. 
‘‘(2) EXCEPTION FOR CELLS DERIVED BEFORE 
THE EFFECTIVE DATE OF THE GUIDELINES.—The 
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Director of NIH shall determine the extent to which 
the guidelines under this section shall apply to re-
search 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 Di-
rector of the National Institutes of Health should 
consult with the Commissioner of Food and Drugs; 
(2) any research using human stem cells, irre-
spective of whether such research is federally fund-
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ed, 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 evalua-
tion of the safety or effectiveness of drugs, devices, 
and biological products. 
Æ 
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