National Institutes of Health Guidelines for Human Stem Cell Research, 8085-8086 [2010-3527]
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Federal Register / Vol. 75, No. 35 / Tuesday, February 23, 2010 / Notices
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Dated: February 16, 2010.
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Dated: February 16, 2010.
Jennifer Spaeth,
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Committee Policy.
National Institutes of Health
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Date: March 12, 2010.
Time: 3:30 p.m. to 5 p.m.
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Committee Policy.
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hereby given of the following meetings.
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as amended. The grant applications and
the discussions could disclose
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would constitute a clearly unwarranted
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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 (https://
edocket.access.gpo.gov/2009/pdf/E915954.pdf) to implement Executive
Order 13505, as it pertains to NIHfunded 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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8086
Federal Register / Vol. 75, No. 35 / Tuesday, February 23, 2010 / Notices
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: https://
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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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0085]
Preventive Controls for Fresh Produce;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice; request for comments.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
opening of a docket to obtain
information about current practices and
conditions for the production and
packing of fresh produce. FDA is
establishing this docket in order to
provide an opportunity for interested
parties to provide information and share
views that will inform the development
of safety standards for fresh produce at
the farm and packing house and
strategies and cooperative efforts to
ensure compliance.
DATES: Submit electronic or written
comments by May 24, 2010.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
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Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Michelle A. Smith, Center for Food
Safety and Applied Nutrition (HFS–
317), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 301–436–2024.
SUPPLEMENTARY INFORMATION:
I. Background
On March 19, 2009, President Barack
Obama established a new Food Safety
Working Group (FSWG), chaired by the
Secretaries of the Department of Health
and Human Services and the
Department of Agriculture. In
announcing creation of the FSWG, the
President said the group would advise
him on how to upgrade U.S. food safety
laws for the 21st century, foster
coordination of food safety efforts
throughout the Government, and ensure
laws are being adequately enforced to
keep the American people safe from
foodborne illness (Ref. 1).
On July 1, 2009, the FSWG
recommended a new public healthfocused approach to food safety based
on three core principles: (1) Prioritizing
prevention; (2) strengthening
surveillance and enforcement; and (3)
improving response and recovery (Ref.
1). The FSWG announced steps to be
taken by FDA and other Federal
agencies to achieve these goals.
With regard to fresh produce, the
FSWG announced that FDA would issue
‘‘commodity-specific draft guidance on
preventive controls that industry can
implement to reduce the risk of
microbial contamination in the
production and distribution of tomatoes,
melons, and leafy greens’’ (Ref. 1). The
FSWG also announced that FDA, over
the next 2 years, would ‘‘seek public
comment and work to require adoption
of these approaches through regulation’’
(Ref. 1).
On August 3, 2009, FDA made
available draft guidances to industry for
leafy greens, melons, and tomatoes
(Refs. 3 through 5). FDA is now
establishing a docket in order to provide
an opportunity for interested parties to
provide information and share views
that will inform the development of: (1)
Safety standards for fresh produce at the
farm and packing house and (2)
strategies and cooperative efforts to
ensure compliance.
II. Request for Comments and
Information
We are requesting comments that will
inform the development of: (1) Safety
standards for fresh produce at the farm
and packing house and (2) strategies and
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cooperative efforts to ensure
compliance. In particular, we welcome
input on any of these general categories:
• Role of the good agricultural
practice guidelines entitled ‘‘Guide to
Minimize Microbial Food Safety
Hazards for Fresh Fruits and Vegetables’’
(GAPs Guide, Ref. 6);
• Standards for domestic and foreign
growers and packers;
• Identification and prioritization of
risk factors;
• Environmental assessment of
hazards and possible pathways of
contamination;
• The impact of scale of growing
operations on the nature and degree of
possible food safety hazards;
• Methods to tailor preventive
controls to particular hazards and
conditions affecting an operation;
• Possible approaches to tailoring
preventive controls to the scale of an
operation so that the controls achieve an
appropriate level of food safety
protection and are feasible for a wide
range of large and small operations;
• Coordination of produce food safety
practices and sustainable and/or organic
production methods;
• Coordination of produce food safety
practices and environmental and/or
conservation goals or practices;
• Coordination of produce food safety
practices and Federal, State, local and
tribal government statutes and
regulations;
• Microbial testing;
• Post-harvest operations and the role
of the current good manufacturing
practices in 21 CFR part 110;
• Records and other documentation
that would be useful to industry and
regulators in ensuring the safety of fresh
produce; and
• Strategies to enhance compliance.
The agency will consider information
submitted to the docket in developing
safety standards for fresh produce.
Comments previously submitted to the
Division of Dockets Management for the
following dockets will also be
considered by FDA and do not need to
be resubmitted:
• ‘‘Draft Guidance for Industry: Guide
to Minimize Microbial Food Safety
Hazards of Tomatoes; Availability’’ (74
FR 38438, August 3, 2009; Docket No.
FDA–2009–D–0346);
• ‘‘Draft Guidance for Industry: Guide
to Minimize Microbial Food Safety
Hazards of Melons’’ (74 FR 38437,
August 3, 2009; Docket No. FDA–2009–
D–0347);
• ‘‘Draft Guidance for Industry: Guide
to Minimize Microbial Food Safety
Hazards of Leafy Greens; Availability’’
(74 FR 38439, August 3, 2009; Docket
No. FDA–2009–D–0348); and
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]]>Agencies
[Federal Register Volume 75, Number 35 (Tuesday, February 23, 2010)]
[Notices]
[Pages 8085-8086]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3527]
-----------------------------------------------------------------------
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 (https://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: https://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]
BILLING CODE 4140-01-P
