Notice: National Institutes of Health Guidelines for Human Stem Cell 
Research

Federal Register: February 23, 2010 (Volume 75, Number 35)             
                  Page 8085-8086

Agency:  DEPARTMENT OF HEALTH AND HUMAN SERVICES
         National Institutes of Health

 
SUMMARY: The National Institutes of Health (NIH) is requesting public 
comment on a revision to the definition of human embryonic stem cells 
(hESCs) in the ``National Institutes of Health Guidelines for Human 
Stem Cell Research'' (Guidelines).
    On July 7, 2009, NIH issued Guidelines (http://
edocket.access.gpo.gov/2009/pdf/E9-15954.pdf) to implement Executive 
Order 13505, as it pertains to NIH-funded stem cell research, to 
establish policy and procedures under which the NIH will fund such 
research, and help ensure that NIH-funded research in this area is 
ethically responsible, scientifically worthy, and conducted in 
accordance with applicable law.
    In Section II of the final Guidelines, hESCs are defined as: ``For 
the purpose of these Guidelines, `human embryonic stem cells (hESCs)' 
are cells that are derived from the inner cell mass of blastocyst stage 
human embryos, are capable of dividing without differentiating for a 
prolonged period in culture, and are known to develop into cells and 
tissues of the three primary germ layers.''
    This definition had the unintended consequence of excluding certain 
hESCs which may otherwise be appropriate for Federal funding. For 
example, the current definition excludes hESCs from an embryo which 
fails to develop to the blastocyst stage.
    Therefore, the NIH proposes replacing the current definition of 
hESCs in Section II with the following: ``For the purpose of these 
Guidelines, `human embryonic stem cells (hESCs)' are pluripotent cells 
that are derived from

[[Page 8086]]

early stage human embryos, up to and including the blastocyst stage, 
are capable of dividing without differentiating for a prolonged period 
in culture, and are known to develop into cells and tissues of the 
three primary germ layers.''
    This proposed change in no way alters the rigorous ethical 
standards set forth in the Guidelines.

DATES: Written comments on this proposed change must be received by NIH 
on or before March 25, 2010 in order to be considered.

ADDRESSES: Public comments may be may be entered at: http://
hescregapp.od.nih.gov/comments/add.htm.
    Comments may also be mailed to: NIH Stem Cell Guidelines, MSC 7997, 
9000 Rockville Pike, Bethesda, Maryland 20892-7997. Comments will be 
made publicly available. Personally identifiable information (except 
for organizational affiliations) will be removed prior to making 
comments publicly available.

    Dated: February 16, 2010.
Francis S. Collins,
Director, National Institutes of Health.
[FR Doc. 2010-3527 Filed 2-19-10; 4:15 pm]
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