National Institute of Mental Health Notice of Closed Meetings, 55928-55929 [2011-23093]
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Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
substantial equivalence (sections 905(j)
and 910 of the FD&C Act, as amended
by the Tobacco Control Act (21 U.S.C.
387e(j) and 387j)). In this draft guidance,
FDA provides responses to questions
related to the submission of 905(j)
(substantial equivalence) reports in
specific scenarios, including questions
on whether changes to packaging and
labeling and changes to additive
specifications should be submitted in a
905(j) report to the Center for Tobacco
Products. The draft guidance also
provides information about discussing
submissions.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on ‘‘Demonstrating the Substantial
Equivalence of a New Tobacco Product:
Responses to Frequently Asked
Questions.’’ It does not create or confer
any rights for or on any person and does
not operate to bind FDA or the public.
An alternative approach may be used if
such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
An electronic version of the draft
guidance document is available on the
Internet at https://www.regulations.gov
and https://www.fda.gov/
TobaccoProducts/GuidanceCompliance
RegulatoryInformation/default.htm.
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IV. Paperwork Reduction Act of 1995
This draft guidance refers to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 in sections 905(j) and 910
of the FD&C Act, as amended by the
Tobacco Control Act have been
approved under OMB control number
0910–0673; the collections of
information in 21 CFR part 25 have been
approved under OMB control number
0910–0322.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. It is no longer necessary to
send two copies of mailed comments.
Identify comments with the docket
number found in brackets in the
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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.
Dated: September 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23100 Filed 9–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
Food and Drug Administration Health
Professional Organizations
Conference
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public conference.
The Food and Drug Administration
(FDA) is announcing a conference for
representatives of Health Professional
Organizations. Dr. Margaret Hamburg,
Commissioner of the Food and Drugs,
and Dr. Janet Woodcock, Director of
FDA’s Center for Drug Evaluation and
Research have been invited to speak
about their visions of the relationship
between the Agency and the health
professional community. Other topics
on the agenda include Risk Evaluation
and Mitigation Strategies and the
Unapproved Drugs Initiative.
Date and Time: The conference will
be held on October 31, 2011, from 8 a.m.
to 1:30 p.m.
Location: The conference will be held
at the FDA White Oak Campus, 10903
New Hampshire Ave., Building 31
Conference Center, the Great Room (rm.
1503), Silver Spring, MD 20993–0002.
Contact Person: For further
information contact Janelle Derbis,
Office of Special Health Issues, 10903
New Hampshire Ave., Silver Spring, MD
20993, 312–596–6516, Fax: 312–886–
1682, Janelle.Derbis@fda.hhs.gov.
Registration: Register at https://
www.cvent.com/d/fcq7vv/4W by
October 7, 2011. Please include the
name and title of the person attending,
the name of the organization, address,
and telephone number. There is no
registration fee for this conference. Early
registration is suggested because space
is limited. We request that organizations
limit the number of representatives to
two. For further registration
information, call 1–866–318–4357.
SUPPLEMENTARY INFORMATION: The aim of
the conference is to further the public
health mission of the FDA through
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training, collaboration, and structured
discussion between health professional
organizations and FDA staff. The Office
of Special Health Issues serves as a
liaison between the FDA Centers and
the public on matters that involve
medical product safety and also acts as
the public’s link to information about
the medical product approval process.
The topics of discussion for this
conference will include three separate
panels that will highlight examples
where FDA and health professional
organizations collaborate to further
public health. The goal of the panel
presentations is to exchange ideas,
highlight the value of FDA and health
professional organizations working
together, and encourage collaboration to
promote public health. A list of
concurrent breakout session topics is
included in the agenda to facilitate
informal discussion on how FDA and
health professional organizations can
collaborate more effectively. Please
indicate during your registration the
topics of greatest interest to you for the
breakout session.
If you need special accommodations
due to a disability, please contact
Janelle Derbis at least 7 days in advance.
Dated: September 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–23101 Filed 9–8–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health
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: National Institute of
Mental Health Special Emphasis Panel;
Conflicts and Eating Disorders.
Date: October 4, 2011.
Time: 3 p.m. to 5 p.m.
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Federal Register / Vol. 76, No. 175 / Friday, September 9, 2011 / Notices
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Francois Boller, MD, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6142, MSC 9606,
Bethesda, MD 20892–9606, 301–443–1513,
bollerf@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Translational Research for the Development
of Novel Interventions for Mental Disorders.
Date: October 4, 2011.
Time: 12:30 p.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Francois Boller, MD, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6142, MSC 9606,
Bethesda, MD 20892–9606, 301–443–1513,
bollerf@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
Services Conflicts.
Date: October 14, 2011.
Time: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Melrose Hotel, 2430 Pennsylvania
Ave., NW., Washington, DC 20037.
Contact Person: Marina Broitman, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6153, MSC 9608,
Bethesda, MD 20892–9608, 301–402–8152,
mbroitma@mail.nih.gov.
Name of Committee: National Institute of
Mental Health Special Emphasis Panel;
NIMH Pathway to Independence (K99)
Review.
Date: October 18, 2011.
Time: 12 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Megan Libbey, PhD,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center,
6001 Executive Blvd., Room 6148, MSC 9609,
Rockville, MD 20852–9609, 301–402–6807,
libbeym@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.242, Mental Health Research
Grants; 93.281, Scientist Development
Award, Scientist Development Award for
Clinicians, and Research Scientist Award;
93.282, Mental Health National Research
Service Awards for Research Training,
National Institutes of Health, HHS)
VerDate Mar<15>2010
16:58 Sep 08, 2011
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Dated: September 1, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–23093 Filed 9–8–11; 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: Oncology 2—
Translational Clinical Integrated Review
Group; Basic Mechanisms of Cancer
Therapeutics Study Section.
Date: September 26–27, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Kabuki, 1625 Post Street, San
Francisco, CA 94115.
Contact Person: Lambratu Rahman Sesay,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, 301–451–
3493, rahman-sesayl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Cancer
Therapeutics AREA Grant Applications.
Date: September 27–28, 2011.
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: Denise R Shaw, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6158,
MSC 7804, Bethesda, MD 20892, 301–435–
0198, shawdeni@csr.nih.gov.
Name of Committee: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group; Medical Imaging
Study Section.
Date: October 2–3, 2011.
Time: 7 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
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55929
Place: Washington Plaza Hotel, 10 Thomas
Circle, NW., Washington, DC 20005.
Contact Person: Xiang-Ning Li, MD, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5112,
MSC 7854, Bethesda, MD 20892, 301–435–
1744, lixiang@csr.nih.gov.
Name of Committee: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group; Biomedical
Imaging Technology B Study Section.
Date: October 3–4, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Plaza Hotel, 10 Thomas
Circle, NW., Washington, DC 20005.
Contact Person: Lee Rosen, PhD, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5116, MSC 7854, Bethesda, MD
20892, (301) 435–1171, rosenl@csr.nih.gov.
Name of Committee: Surgical Sciences,
Biomedical Imaging and Bioengineering
Integrated Review Group; Clinical Molecular
Imaging and Probe Development.
Date: October 3–4, 2011.
Time: 7 p.m. to 1 p.m.
Agenda: To review and evaluate grant
applications.
Place: Washington Plaza Hotel, 10 Thomas
Circle, NW., Washington, DC 20005.
Contact Person: Eileen W Bradley, DSC,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5100,
MSC 7854, Bethesda, MD 20892, (301) 435–
1179, bradleye@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Synthetic
and Biological Chemistry B.
Date: October 4, 2011.
Time: 11 a.m. to 12 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: Mike Radtke, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4176,
MSC 7806, Bethesda, MD 20892, 301–435–
1728, radtkem@csr.nih.gov.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Macromolecular Structure
and Function A Study Section.
Date: October 6–7, 2011.
Time: 8 a.m. to 12 p.m.
Agenda: To review and evaluate grant
applications.
Place: George Washington University Inn,
824 New Hampshire Ave., NW., Washington,
DC 20037.
Contact Person: David R. Jollie, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4150,
MSC 7806, Bethesda, MD 20892, (301) 435–
1722, jollieda@csr.nih.gov.
Name of Committee: Cardiovascular and
Respiratory Sciences Integrated Review
Group; Cardiac Contractility, Hypertrophy,
and Failure Study Section.
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]]>Agencies
[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Pages 55928-55929]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23093]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health 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: National Institute of Mental Health Special
Emphasis Panel; Conflicts and Eating Disorders.
Date: October 4, 2011.
Time: 3 p.m. to 5 p.m.
[[Page 55929]]
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Francois Boller, MD, PhD, Scientific Review
Officer, Division of Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room
6142, MSC 9606, Bethesda, MD 20892-9606, 301-443-1513,
bollerf@mail.nih.gov.
Name of Committee: National Institute of Mental Health Special
Emphasis Panel; Translational Research for the Development of Novel
Interventions for Mental Disorders.
Date: October 4, 2011.
Time: 12:30 p.m. to 3 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Francois Boller, MD, PhD, Scientific Review
Officer, Division of Extramural Activities, National Institute of
Mental Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room
6142, MSC 9606, Bethesda, MD 20892-9606, 301-443-1513,
bollerf@mail.nih.gov.
Name of Committee: National Institute of Mental Health Special
Emphasis Panel; Services Conflicts.
Date: October 14, 2011.
Time: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant applications.
Place: Melrose Hotel, 2430 Pennsylvania Ave., NW., Washington,
DC 20037.
Contact Person: Marina Broitman, PhD, Scientific Review Officer,
Division of Extramural Activities, National Institute of Mental
Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6153,
MSC 9608, Bethesda, MD 20892-9608, 301-402-8152,
mbroitma@mail.nih.gov.
Name of Committee: National Institute of Mental Health Special
Emphasis Panel; NIMH Pathway to Independence (K99) Review.
Date: October 18, 2011.
Time: 12 p.m. to 4 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD 20852, (Telephone Conference
Call).
Contact Person: Megan Libbey, PhD, Scientific Review Officer,
Division of Extramural Activities, National Institute of Mental
Health, NIH, Neuroscience Center, 6001 Executive Blvd., Room 6148,
MSC 9609, Rockville, MD 20852-9609, 301-402-6807,
libbeym@mail.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.242,
Mental Health Research Grants; 93.281, Scientist Development Award,
Scientist Development Award for Clinicians, and Research Scientist
Award; 93.282, Mental Health National Research Service Awards for
Research Training, National Institutes of Health, HHS)
Dated: September 1, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-23093 Filed 9-8-11; 8:45 am]
BILLING CODE 4140-01-P
