Center for Scientific Review; Notice of Closed Meetings, 71134-71135 [2010-29361]
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71134
Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting 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
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 Institute of
General Medical Sciences Special Emphasis
Panel; Conference Grants Review.
Date: December 13, 2010.
Time: 1 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Room
3AN–12F, Bethesda, MD 20814.
Contact Person: Helen R. Sunshine, PhD,
Chief, Office of Scientific Review, National
Institute of General Medical Sciences,
National Institutes of Health, Natcher
Building, Room 3AN–12F, Bethesda, MD
20892, 301–594–2881, sunshinh@nigms.nih.
gov.
Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
Dated: November 16, 2010.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jlentini on DSKJ8SOYB1PROD with NOTICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
17:49 Nov 19, 2010
Jkt 223001
Name of Committee: National Cancer
Institute Initial Review Group, Subcommittee
J—Population and Patient-Oriented Training.
Date: February 24, 2011.
Time: 7:45 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Westin Alexandria, 400 Courthouse
Square, Alexandria, VA 22314.
Contact Person: ILDA M. Mckenna, PhD,
Scientific Review Officer, Research Training
Review Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Boulevard, Room 8111, Bethesda,
MD 20892, 301–496–7481,
mckennai@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: November 16, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–29362 Filed 11–19–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
[FR Doc. 2010–29359 Filed 11–19–10; 8:45 am]
VerDate Mar<15>2010
The meeting 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
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.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting 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
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
PO 00000
Frm 00068
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would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Initial Review Group; Subcommittee
A—Cancer Centers.
Date: December 9–10, 2010.
Time: 8 a.m. to 12 p.m.
Agenda: To reveiw and evaluate grant
applications.
Place: Residence Inn Bethesda, 735
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Gail J. Bryant, MD,
Medical Officer, Resources and Training
Review Branch, Division of Extramural
Activities, National Cancer Institute, 6116
Executive Blvd., Room 8107, MSC 8328,
Bethesda, MD 20892–8328, (301) 402–0801,
gb30t@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: November 16, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–29363 Filed 11–19–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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
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: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Neurodegenerative Disease and
Anterior Eye Disorders.
Date: December 9–10, 2010.
Time: 8 a.m. to 8 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
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Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Notices
Contact Person: Suzan Nadi, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217B,
MSC 7846, Bethesda, MD 20892, 301–435–
1259, nadis@csr.nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group; Biomaterials and Biointerfaces Study
Section.
Date: January 5–6, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Steven J Zullo, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5146,
MSC 7849, Bethesda, MD 20892, 301–435–
2810, zullost@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 16, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–29361 Filed 11–19–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0586]
Hoffmann-La Roche Inc.; Withdrawal of
Approval of a New Drug Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new drug application
(NDA) for ACCUTANE (isotretinoin)
Capsules held by Hoffmann-La Roche
Inc., 340 Kingsland St., Nutley, NJ
07110–1199. Hoffmann-La Roche Inc.
notified the Agency in writing that the
drug product was no longer marketed
and requested that the approval of the
application be withdrawn.
DATES: Effective Date: November 22,
2010.
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
HoffmannLa Roche Inc. has requested that FDA
withdraw approval of NDA 18–662,
ACCUTANE (isotretinoin) Capsules,
under the process in § 314.150(c) (21
CFR 314.150(c)), stating that the drug
product is no longer marketed.
Hoffmann-La Roche Inc. has also, by its
request, waived its opportunity for a
hearing. Withdrawal of approval of an
application under § 314.150(c) is
without prejudice to refiling.
Therefore, under section 505(e) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 355(e)) and
under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner of Food
and Drugs, approval of NDA 18–662,
ACCUTANE (isotretinoin) Capsules, and
all amendments and supplements
thereto, is hereby withdrawn, effective
November 22, 2010. Introduction or
delivery for introduction into interstate
commerce of a product without an
approved application violates sections
301(a) and (d) of the FD&C Act (21
U.S.C. 331(a) and (d)). ACCUTANE
(isotretinoin) Capsules that are in
inventory on the date that this notice
becomes effective (see the DATES
section) may continue to be dispensed
until the inventories have been depleted
or the drug product has reached its
expiration date or otherwise become
violative, whichever occurs first.
In the Federal Register of July 7, 2010
(75 FR 39024), FDA issued a notice
announcing its determination that
ACCUTANE (isotretinoin) Capsules
were not withdrawn from sale for
reasons of safety or effectiveness, and
isotretinoin continues to be marketed
under approved abbreviated new drug
applications (ANDAs). The holders of
ANDAs for isotretinoin are subject to an
approved risk evaluation and mitigation
strategy (REMS) under section 505–1 of
the FD&C Act (21 U.S.C. 355–1), and the
REMS, known as the iPLEDGE program,
remains in effect.
SUPPLEMENTARY INFORMATION:
Dated: November 2, 2010.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2010–29348 Filed 11–19–10; 8:45 am]
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ADVISORY COUNCIL ON HISTORIC
PRESERVATION
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
VerDate Mar<15>2010
17:49 Nov 19, 2010
Jkt 223001
Notice of Meeting; Advisory Council on
Historic Preservation
Advisory Council on Historic
Preservation.
ACTION: Notice of meeting.
AGENCY:
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71135
Notice is hereby given that
the Advisory Council on Historic
Preservation (ACHP) will meet
Thursday, December 2, 2010. The
meeting will be held in Room MO9 of
the Old Post Office Building, 1100
Pennsylvania Ave, NW., Washington,
DC at 9 a.m.
The ACHP was established by the
National Historic Preservation Act of
1966 (16 U.S.C. 470 et seq.) to advise the
President and Congress on national
historic preservation policy and to
comment upon Federal, federally
assisted, and federally licensed
undertakings having an effect upon
properties listed in or eligible for
inclusion in the National Register of
Historic Places. The ACHP’s members
are the Architect of the Capitol; the
Secretaries of the Interior, Agriculture,
Defense, Housing and Urban
Development, Commerce, Education,
Veterans Affairs, and Transportation;
the Administrator of the General
Services Administration; the Chairman
of the National Trust for Historic
Preservation; the President of the
National Conference of State Historic
Preservation Officers; a Governor; a
Mayor; a Native American; and eight
non-Federal members appointed by the
President.
SUMMARY:
Call to Order—9 a.m.
I. Chairman’s Welcome
II. Chairman’s Report
III. Executive Director’s Report
IV. Native American Activities
A. Native American Program Report
1. HUD Delegation of Tribal
Consultation Responsibilities
2. DOI–DoD–ACHP Memorandum of
Understanding on Consultation
with Native Hawaiians
B. Native American Advisory Group
V. Strategic Planning: Next Steps
VI. Sustainability and Historic
Preservation Task Force
VII. Preservation Initiatives Committee
A. America’s Great Outdoors Initiative
and Historic Preservation
B. Economic Benefits Study
C. Legislation
VIII. Federal Agency Programs
Committee
A. Historic Preservation and Energy
Development Working Group
B. National Trust Section 106 Report
C. Section 106 Update
IX. Communications, Education, and
Outreach Committee
A. Engaging Youth in Historic
Preservation
B. New Directions for ACHP Awards
Programs
X. New Business
XI. Adjourn
Note: The meetings of the ACHP are open
to the public.
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Agencies
[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Notices]
[Pages 71134-71135]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29361]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), 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 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: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Neurodegenerative Disease and Anterior Eye
Disorders.
Date: December 9-10, 2010.
Time: 8 a.m. to 8 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
[[Page 71135]]
Contact Person: Suzan Nadi, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5217B, MSC 7846, Bethesda, MD 20892, 301-435-
1259, nadis@csr.nih.gov.
Name of Committee: Bioengineering Sciences & Technologies
Integrated Review Group; Biomaterials and Biointerfaces Study
Section.
Date: January 5-6, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Steven J Zullo, PhD, Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 5146, MSC 7849, Bethesda, MD 20892, 301-435-
2810, zullost@csr.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: November 16, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2010-29361 Filed 11-19-10; 8:45 am]
BILLING CODE 4140-01-P