‘‘(1) the creation of a human embryo for re-
search purposes; 
‘‘(2) the destruction of or discarding of, or risk 
of injury to, a living human embryo; or 
‘‘(3) the use of any stem cell, the derivation or 
provision of which would be inconsistent with the 
standards established in paragraph (1) or (2). 
‘‘(b) GUIDELINES.—Not later than 90 days after the 
date of the enactment of this section, the Secretary, after 
consultation with the Director of NIH, shall issue final 
guidelines implementing subsection (a) to ensure that any 
research (including any clinical trial) supported under 
subsection (a)— 
‘‘(1) is clearly consistent with the standards es-
tablished in subsection (a) if conducted using human 
cells, as demonstrated by animal trials or other sub-
stantial evidence; and 
‘‘(2) is prioritized in terms of potential for 
near-term clinical benefit in human patients, as indi-
cated by substantial evidence from basic research or 
by substantial clinical evidence which may include 
but is not limited to— 
‘‘(A) evidence of improvement in one or 
more human patients suffering from illness or 
injury, as documented in reports by professional 
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medical or scientific associations or in peer-re-
viewed medical or scientific literature; or 
‘‘(B) approval for use in human trials by 
the Food and Drug Administration. 
‘‘(c) DEFINITIONS.—In this section: 
‘‘(1) HUMAN EMBRYO.—The term ‘human em-
bryo’ includes any organism, not protected as a 
human subject under part 46 of title 45, Code of 
Federal Regulations, as of the date of the enactment 
of this section, that is derived by fertilization, par-
thenogenesis, cloning, or any other means from one 
or more human gametes or human diploid cells. 
‘‘(2) RISK OF INJURY.—The term ‘risk of in-
jury’ means subjecting a human embryo to risk of 
injury or death greater than that allowed for re-
search on fetuses in utero under section 46.204(b) 
of title 45, Code of Federal Regulations (or any suc-
cessor regulation), or section 498(b) of this Act.’’. 
(b) PRIORITY SETTING; REPORTS.—Section 492 of 
the Public Health Service Act (42 U.S.C. 289a) is amend-
ed by adding at the end the following: 
‘‘(d)(1) With respect to human stem cell research, the 
Secretary, acting through the Director of NIH, shall give 
priority to conducting or supporting research in accord-
ance with section 409K. 
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‘‘(2) At the end of fiscal year 2016 and each subse-
quent fiscal year, the Secretary shall submit to the Con-
gress a report outlining the number of research proposals 
under section 409K that were peer reviewed, a summary 
and detailed list of all such research proposals that were 
not funded, and an explanation of why the proposals did 
not merit funding. The reports under this paragraph shall 
be in addition to the reporting on stem cell research in-
cluded in the biennial report required by section 403.’’. 
(c) BIENNIAL REPORTS.—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 sub-
paragraph (M); and 
(2) by inserting after subparagraph (K) the fol-
lowing: 
‘‘(L) Stem cells.’’. 
Æ 
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