National Cancer Institute; Notice of Closed Meetings, 11422-11423 [08-906]
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Federal Register / Vol. 73, No. 42 / Monday, March 3, 2008 / Notices
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For example, HRSA is interested in
the public’s assessment of the likely
impact if OPTN policies concerning
issues such as membership designation
to receive organs, the retrieval of organs,
allocation of organs, data collection and
reporting, and OPTN policy compliance
oversight were extended to vascularized
composite allograft transplants. HRSA
seeks feedback concerning whether
regulation under the OPTN final rule
would be effective in addressing special
safety and allocation issues presented
by vascularized composite allograft
transplants as the field grows. Further,
HRSA is interested in the public’s
assessment as to whether the clinical
aspects of transplants of such
vascularized composite allografts are
more analogous to transplants of organs,
as defined currently by the final rule,
than to conventional tissue
transplantation without surgical
revascularization.
Presently, it is HRSA’s understanding
that these transplants of vascularized
composite allografts are done by
individual arrangements with local
organ procurement organizations
(OPOs) to allow retrieval of the needed
structure during routine deceased donor
organ retrievals. However, some of these
vascularized composite allografts, e.g.,
testes, ovaries, or other endocrine
glands, may come from living donors.
HRSA is interested in perceived
vulnerabilities concerning the current
regulatory status of such transplants and
the potential benefits of subjecting such
transplants to the oversight of the OPTN
and HRSA under the final rule.
The Definition of Human Organs Under
Section 301 of NOTA
HRSA is also seeking feedback as to
whether it should explore rulemaking to
add vascularized composite allografts to
the definition of human organs covered
by section 301 of NOTA, as well as the
potential consequences of such an
action. Section 301 prohibits the
purchase, sale, or other exchange for
valuable consideration of human organs
for transplantation. Although the statute
lists covered human organs, the
Secretary is authorized to add to this list
through rulemaking. ‘‘Human organ,’’ as
defined by NOTA and modified by the
Secretary, means ‘‘the human (including
fetal) kidney, liver, heart, lung,
pancreas, bone marrow, cornea, eye,
bone, skin, and intestine, including the
esophagus, stomach, small and/or large
intestine, or any portion of the
gastrointestinal tract.’’ Adding to the
definition of human organs covered by
section 301 would make transfers of
organs meeting the statute’s
requirements subject to its criminal
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sanctions. If, after receiving public
comments, HRSA is persuaded that a
change to this definition may be
appropriate, HRSA may initiate
rulemaking setting forth a more specific
set of proposals.
Defining Vascularized Composite
Allografts
To assist the Secretary in the event
that he proposes, through rulemaking, to
add vascularized composite allografts to
the definition of organs covered by the
final rule and/or to the definition of
human organs governed by section 301
of NOTA, HRSA seeks feedback from
stakeholders and from the public as to
how such allografts should be defined.
HRSA has identified two potential
approaches.
Under the first approach, a regulatory
definition could be broad, describing
the features of the allografts without
listing particular body parts. Under such
an approach, the definition might
extend to transplants of body parts that
are not known to have been performed
clinically to date, or even to body parts
whose transplantation has not yet been
envisioned. HRSA is interested in what
elements would need to be included in
such a definition in order to be broad
enough to cover the universe of
intended body parts, but narrow enough
to put the public on notice as to which
parts meet the regulatory definitions of
organs. Shared characteristics that might
be included in a regulatory definition
could include some or all of the
following: (1) A vascularized allograft
containing multiple tissue types; (2)
recovered from a human donor as an
anatomical/structural unit; (3)
transplanted into a human recipient as
an anatomical/structural unit; (4)
minimally manipulated, as defined by
FDA in Title 21 CFR 1271.3(f); (5) for
homologous use as defined by FDA in
Title 21 CFR 1271.3(c); (6) not combined
with another article such as a device; (7)
used fresh and not cryopreserved; (8)
susceptible to ischemia and, therefore,
only stored temporarily (e.g., cold
storage in preservation medium and
intended for implantation into a
recipient within hours of the recovery);
and (9) susceptible to allograft rejection
which requires immunosuppression that
may increase infectious disease risk to
the recipient. HRSA seeks feedback
from the public as to whether some or
all of these characteristics describe
vascularized composite allografts,
which would be included in the
definition of organ. HRSA invites
feedback on such an approach as well
as the particular characteristics listed
here and invites suggestions concerning
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the advisability of including any
additional characteristics.
Under a second alternative, HRSA
could propose a definition that lists
specific body parts to be added to the
definition of organs (e.g., face, hand,
etc.). HRSA seeks feedback as to the
feasibility of creating such a definition,
which body parts should be included in
such a definition, and whether such a
definition would necessarily exclude
certain body parts for which
transplantation might be possible, but
has not been performed to date (either
in the United States or internationally).
Following this comment period and
meeting, if HRSA decides to proceed
with rulemaking to include vascularized
composite allografts in the definition of
organ, this decision will be written and
published as a Notice of Proposed
Rulemaking.
Dated: February 20, 2008.
Elizabeth M. Duke,
Administrator.
[FR Doc. E8–3994 Filed 2–29–08; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel,
Innovations in Cancer Sample Preparation.
Date: March 20, 2008.
Time: 8 a.m. to 8 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Sherwood Githens, PhD,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
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Federal Register / Vol. 73, No. 42 / Monday, March 3, 2008 / Notices
Executive Blvd., Room 8053, Bethesda, MD
20892, 301/435–1822, githenss@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel, Antibody
Array for Cancer Detection.
Date: March 26–27, 2008.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: Sherwood Githens, PhD,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Blvd., Room 8053, Bethesda, MD
20892, 301/435–1822, githenss@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel, Cancer
Stem Cells.
Date: March 27, 2008.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6116
Executive Boulevard, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Irina Gordienko, PhD,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
6116 Executive Blvd., Room 7073, Bethesda,
MD 20892, 301–594–1566,
gordienkoiv@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel, Portable
Energy Balance Review Panel (PEBRP).
Date: April 2, 2008.
Time: 8 a.m. to 3 p.m.
Agenda: To review and evaluate contract
proposals.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: C. Michael Kerwin, PhD,
MPH, Scientific Review Officer, Special
Review and Logistics Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 6116 Executive Blvd., Rm.
8057, Bethesda, MD 20892–8329, 301–496–
7421, kerwinm@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel, A webbased tailored health behavior intervention
for African American colon cancer.
Date: April 2, 2008.
Open: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Bethesda Marriott Suites, 6711
Democracy Boulevard, Bethesda, MD 20817.
Contact Person: C. Michael Kerwin, PhD,
MPH, Scientific Review Officer, Special
Review and Logistics Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 6116 Executive Blvd., Rm.
8057, Bethesda, MD 20892–8329, 301–496–
7421, kerwinm@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel,
Development of Clinical Mass Spectrometric
Immunoassays.
Date: April 3, 2008.
Time: 11 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
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Place: National Institutes of Health, 6116
Executive Boulevard, CR 6008, Rockville, MD
20852 (Telephone Conference Call).
Contact Person: Sherwood Githens, PhD,
Scientific Review Officer, Special Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Blvd., Room 8053, Bethesda, MD
20892, 301/435–1822, githenss@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel, Network
for Translational Research: Optical Imaging
(NTROI).
Date: June 2–3, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington DC North—
Gaithersburg, 620 Perry Parkway,
Gaithersburg, MD 20877.
Contact Person: Kenneth L. Bielat, PhD,
Scientific Review Officer, Special Review
Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Boulevard, Room 7147, Bethesda,
MD 20892–8329, 301–496–7576,
bielatk@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel, Cancer
Prevention Research.
Date: June 17–18, 2008.
Time: 7 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance M Street Hotel, 1143
New Hampshire Avenue, NW., Washington,
DC 20037.
Contact Person: Irina Gordienko, PhD,
Scientific Review Officer, Scientific Review
and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH,
6166 Executive Blvd., Rm. 7073, Bethesda,
MD 20892, 301–594–1566,
gordienkoiv@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: February 21, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 08–906 Filed 2–29–08: 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Amended
Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Cancer
Institute Special Emphasis Panel, April
7, 2008, 8 a.m. to April 7, 5 p.m.,
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Gaithersburg Hilton, 620 Perry Parkway,
Gaithersburg, MD, 20877 which was
published in the Federal Register on
February 15, 2008, 73FR8886–8887.
This notice is amended to change the
name from ‘‘Biosensors for Early Cancer
Detection & Risk Assessment/Novel &
Improved Methods to Measure Cancer
Epigenetic Biomarkers’’ to ‘‘Biosensors/
Cancer Epigenetic Biomarkers’’. The
meeting is closed to the public.
Dated: February 25, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 08–908 Filed 2–29–08; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of
Closing Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
mended (5 U.S.C. Appendix 2), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended.
The grant applications and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Eye Institute
Special Emphasis Panel, NEI Cooperative
Agreement Review.
Date: March 6, 2008.
Time: 9 a.m. to 11 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5635
Fishers Lane, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Houmam H. Araj, PHD,
Scientific Review Administrator, Division of
Extramural Research, National Eye Institute,
NIH, 5635 Fishers Lane, Suite 1300,
Bethesda, MD 20892–9602, 301–451–2020,
Haraj@mail.nih.gov.
This notice is being published less than 15
days prior to the meetings due to the timing
limitations impose by the review and funding
cycle.
Name of Committee: National Eye Institute
Special Emphasis Panel, NEI Cooperative
Agreement Review.
Date: March 20, 2008.
Time: 12 p.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
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Agencies
[Federal Register Volume 73, Number 42 (Monday, March 3, 2008)]
[Notices]
[Pages 11422-11423]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-906]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice is hereby given of the following
meetings.
The meetings will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and/or contract proposals
and the discussions could disclose confidential trade secrets or
commercial property such as patentable material, and personal
information concerning individuals associated with the grant
applications and/or contract proposals, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Cancer Institute Special Emphasis
Panel, Innovations in Cancer Sample Preparation.
Date: March 20, 2008.
Time: 8 a.m. to 8 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda Marriott Suites, 6711 Democracy Boulevard,
Bethesda, MD 20817.
Contact Person: Sherwood Githens, PhD, Scientific Review
Officer, Special Review and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116
[[Page 11423]]
Executive Blvd., Room 8053, Bethesda, MD 20892, 301/435-1822,
githenss@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel, Antibody Array for Cancer Detection.
Date: March 26-27, 2008.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate contract proposals.
Place: Bethesda Marriott Suites, 6711 Democracy Boulevard,
Bethesda, MD 20817.
Contact Person: Sherwood Githens, PhD, Scientific Review
Officer, Special Review and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116 Executive Blvd., Room
8053, Bethesda, MD 20892, 301/435-1822, githenss@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel, Cancer Stem Cells.
Date: March 27, 2008.
Time: 1 p.m. to 5 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, 6116 Executive Boulevard,
Rockville, MD 20892 (Telephone Conference Call).
Contact Person: Irina Gordienko, PhD, Scientific Review Officer,
Special Review and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH, 6116 Executive Blvd.,
Room 7073, Bethesda, MD 20892, 301-594-1566,
gordienkoiv@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel, Portable Energy Balance Review Panel (PEBRP).
Date: April 2, 2008.
Time: 8 a.m. to 3 p.m.
Agenda: To review and evaluate contract proposals.
Place: Bethesda Marriott Suites, 6711 Democracy Boulevard,
Bethesda, MD 20817.
Contact Person: C. Michael Kerwin, PhD, MPH, Scientific Review
Officer, Special Review and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH, 6116 Executive Blvd.,
Rm. 8057, Bethesda, MD 20892-8329, 301-496-7421,
kerwinm@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel, A web-based tailored health behavior intervention for African
American colon cancer.
Date: April 2, 2008.
Open: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Bethesda Marriott Suites, 6711 Democracy Boulevard,
Bethesda, MD 20817.
Contact Person: C. Michael Kerwin, PhD, MPH, Scientific Review
Officer, Special Review and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH, 6116 Executive Blvd.,
Rm. 8057, Bethesda, MD 20892-8329, 301-496-7421,
kerwinm@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel, Development of Clinical Mass Spectrometric Immunoassays.
Date: April 3, 2008.
Time: 11 a.m. to 5 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, 6116 Executive Boulevard,
CR 6008, Rockville, MD 20852 (Telephone Conference Call).
Contact Person: Sherwood Githens, PhD, Scientific Review
Officer, Special Review and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116 Executive Blvd., Room
8053, Bethesda, MD 20892, 301/435-1822, githenss@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel, Network for Translational Research: Optical Imaging (NTROI).
Date: June 2-3, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Washington DC North--Gaithersburg, 620 Perry
Parkway, Gaithersburg, MD 20877.
Contact Person: Kenneth L. Bielat, PhD, Scientific Review
Officer, Special Review Logistics Branch, Division of Extramural
Activities, National Cancer Institute, 6116 Executive Boulevard,
Room 7147, Bethesda, MD 20892-8329, 301-496-7576,
bielatk@mail.nih.gov.
Name of Committee: National Cancer Institute Special Emphasis
Panel, Cancer Prevention Research.
Date: June 17-18, 2008.
Time: 7 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Renaissance M Street Hotel, 1143 New Hampshire Avenue,
NW., Washington, DC 20037.
Contact Person: Irina Gordienko, PhD, Scientific Review Officer,
Scientific Review and Logistics Branch, Division of Extramural
Activities, National Cancer Institute, NIH, 6166 Executive Blvd.,
Rm. 7073, Bethesda, MD 20892, 301-594-1566,
gordienkoiv@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.392,
Cancer Construction; 93.393, Cancer Cause and Prevention Research;
93.394, Cancer Detection and Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology Research; 93.397, Cancer
Centers Support; 93.398, Cancer Research Manpower; 93.399, Cancer
Control, National Institutes of Health, HHS)
Dated: February 21, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 08-906 Filed 2-29-08: 8:45 am]
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