Center for Scientific Review; Notice of Closed Meetings, 72808-72809 [E8-28031]
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72808
Federal Register / Vol. 73, No. 231 / Monday, December 1, 2008 / Notices
Participation of Human Subjects in
Research Is Discontinued.’’ FDA
believes the interpretation provided in
its guidance is consistent with that
provided in OHRP’s draft guidance
document.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
II. The Paperwork Reduction Act of
1995
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
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.
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information
under the investigational new drug
regulation have been approved under
OMB Control No. 0910–0014. The
collections of information under the
investigational device exemptions
regulation have been approved under
OMB Control No. 0910–0078.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
IV. Electronic Access
rwilkins on PROD1PC63 with NOTICES
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/oc/gcp/
guidance.html or https://www.fda.gov/
ohrms/dockets/default.htm.
Dated: November 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–28387 Filed 11–28–08; 8:45 am]
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National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Name of Committee: Center for Scientific
Review Special Emphasis Panel Neural
Degeneration, Biophysics and Differentiation.
Date: December 8, 2008.
Time: 11 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Mary Custer, PhD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4148,
MSC 7850, Bethesda, MD 20892–7850, (301)
435–1164, custerm@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Cartilage/
Musculoskeletal Soft Tissue Biology and
Mechanics.
Date: December 8, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: John P. Holden, PhD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4211,
MSC 7814, Bethesda, MD 20892, 301–496–
8551, hoIdenjo@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Member
Conflict: Chemoprevention.
Date: December 8, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
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Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Zhiqiang Zou, MD, PhD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6190,
MSC 7804, Bethesda, MD 20892, 301–451–
0132, zouzhiq@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Member
Conflict: Oncology.
Date: December 9, 2008.
Time: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Mary Bell, PhD., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 6188, MSC 7804, Bethesda, MD
20892, 301–451–8754, bellmar@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel LIRR and
RIBT Member Conflicts.
Date: December 16–17, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: George M. Barnas, PhD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2180,
MSC 7818, Bethesda, MD 20892, 301–435–
0696, barnasg@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel
Neurogenetics, Neurodevelopment and
Neurological Disorders.
Date: December 17, 2008.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Vilen A. Movsesyan, PhD.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040M,
MSC 7806, Bethesda, MD 20892,
301–402–7278, movsesyanv@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)
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Federal Register / Vol. 73, No. 231 / Monday, December 1, 2008 / Notices
Dated: November 19, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–28031 Filed 11–28–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Amended Notice of
Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Child Health and Human Development
Special Emphasis Panel, December 8,
2008, 8 a.m. to December 8, 2008, 5
p.m., Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814 which
was published in the Federal Register
on November 13, 2008, 72 FR 67189.
The meeting location has been
changed from the Hyatt Regency
Bethesda, Bethesda, Maryland to the
National Institutes of Health, 6100
Executive Boulevard, Room 5B01,
Bethesda, Maryland. The meeting is
closed to the public.
Dated: November 21, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–28395 Filed 11–28–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
rwilkins on PROD1PC63 with NOTICES
National Library of Medicine; Notice of
Meeting
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
meeting.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The portions of the meeting devoted
to the review and evaluation of journals
for potential indexing by the National
Library of Medicine will be closed to the
public in accordance with the
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provisions set forth in section
552b(c)(9)(B), Title 5 U.S.C., as
amended. Premature disclosure of the
titles of the journals as potential titles to
be indexed by the National Library of
Medicine, the discussions, and the
presence of individuals associated with
these publications could significantly
frustrate the review and evaluation of
individual journals.
Name of Committee: Literature Selection
Technical Review Committee.
Date: February 26–27, 2009.
Open: February 26, 2009, 9 a.m. to 11 a.m.
Agenda: Administrative reports and
program discussion.
Place: National Library of Medicine,
Building 38, Board Room, 2nd Floor, 8600
Rockville Pike, Bethesda, MD 20894.
Closed: February 26, 2009, 11 a.m. to 5
p.m.
Agenda: To review and evaluate journals
as potential titles to be indexed by the
National Library of Medicine.
Place: National Library of Medicine,
Building 38, Board Room, 2nd Floor, 8600
Rockville Pike, Bethesda, MD 20894.
Closed: February 27, 2009, 8:30 a.m. to 2
p.m.
Agenda: To review and evaluate journals
as potential titles to be indexed by the
National Library of Medicine.
Place: National Library of Medicine,
Building 38, Board Room, 2nd Floor, 8600
Rockville Pike, Bethesda, MD 20894.
Contact Person: Sheldon Kotzin, MLS,
Associate Director, Division of Library
Operations, National Library of Medicine,
8600 Rockville Pike, Bldg 38/Room 2W06,
Bethesda, MD 20894, 301–496–692,
Sheldon_Kotzin@nlm.nih.gov.
Any interested person may file written
comments with the Committee by forwarding
the statement to the Contact Person listed on
this Notice. The statement should include the
name, address, telephone number and, when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
into the building by non-government
employees. Persons without a government ID
will need to show a photo ID and sign in at
the security desk upon entering the building.
(Catalogue of Federal Domestic Assistance
Program No. 93.879, Medical Library
Assistance, National Institutes of Health, 1–
IHS)
Dated: November 20, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy, NIH.
[FR Doc. E8–28204 Filed 11–28–08; 8:45 am]
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72809
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Substance Abuse and
Mental Health Services Administration
(SAMHSA) will publish a summary of
information collection requests under
OMB review, in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1243.
Proposed Project: GPRA Client
Outcomes for the Substance Abuse
and Mental Health Services
Administration (SAMHSA)—(OMB
No. 0930–0208)—Revision
SAMHSA’s Center for Substance
Abuse Treatment (CSAT) is responsible
for collecting data from discretionary
services grants and contracts where
client outcomes are to be assessed at
three points (intake, discharge, and
post-intake). SAMHSA’s CSAT-funded
projects are required to submit these
data as a contingency of their award.
The analysis of the data also will help
determine whether the goal of reducing
health and social costs of drug use to the
public is being achieved.
The primary purpose of this data
collection activity is to meet the
reporting requirements of the
Government Performance and Results
Act (GPRA) by allowing SAMHSA to
quantify the effects and
accomplishments of SAMHSA’s CSAT
programs.
CSAT requests approval to increase
the number of questions in the
instrument due to the agency’s need for
additional information from its
programs to satisfy reporting needs. The
additional information needed is the
following:
• Co-Occurring disorders screening—
Over the years, CSAT has focused
attention on co-occurring disorders and
has established programs designed
specifically for persons with both
mental health and substance abuse
problems. CSAT wants to make sure
that all clients are screened regardless of
the types of program they enter in order
to get the treatment they need. CSAT
has not had a formal way of assessing
whether all programs screen clients for
co-occurring disorders and
consequently, these mental health
problems potentially go untreated.
CSAT will be able to monitor if clients
are screened and for those who screen
E:\FR\FM\01DEN1.SGM
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Agencies
[Federal Register Volume 73, Number 231 (Monday, December 1, 2008)]
[Notices]
[Pages 72808-72809]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28031]
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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. 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 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 Neural Degeneration, Biophysics and Differentiation.
Date: December 8, 2008.
Time: 11 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Mary Custer, PhD., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4148, MSC 7850, Bethesda, MD 20892-7850, (301)
435-1164, custerm@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific Review Special Emphasis
Panel Cartilage/Musculoskeletal Soft Tissue Biology and Mechanics.
Date: December 8, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: John P. Holden, PhD., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4211, MSC 7814, Bethesda, MD 20892, 301-496-
8551, hoIdenjo@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific Review Special Emphasis
Panel Member Conflict: Chemoprevention.
Date: December 8, 2008.
Time: 1 p.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Zhiqiang Zou, MD, PhD., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6190, MSC 7804, Bethesda, MD
20892, 301-451-0132, zouzhiq@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific Review Special Emphasis
Panel Member Conflict: Oncology.
Date: December 9, 2008.
Time: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Mary Bell, PhD., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 6188, MSC 7804, Bethesda, MD 20892, 301-451-
8754, bellmar@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific Review Special Emphasis
Panel LIRR and RIBT Member Conflicts.
Date: December 16-17, 2008.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant applications
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: George M. Barnas, PhD., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2180, MSC 7818, Bethesda, MD
20892, 301-435-0696, barnasg@csr.nih.gov.
Name of Committee: Center for Scientific Review Special Emphasis
Panel Neurogenetics, Neurodevelopment and Neurological Disorders.
Date: December 17, 2008.
Time: 2 p.m. to 4 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Vilen A. Movsesyan, PhD., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040M, MSC 7806, Bethesda, MD
20892, 301-402-7278, movsesyanv@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)
[[Page 72809]]
Dated: November 19, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. E8-28031 Filed 11-28-08; 8:45 am]
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