[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Notices]
[Pages 8085-8086]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-3527]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institutes of Health Guidelines for Human Stem Cell
Research
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
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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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