National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting, 735 [2012-31631]
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Federal Register / Vol. 78, No. 3 / Friday, January 4, 2013 / Notices
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Kalyani Bhatt, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
ACRHD@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
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cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee link, or call the advisory
committee information line to learn
about possible modifications before
coming to the meeting.
Agenda: On March 4, 2013, during the
morning session, the committee will
discuss new drug application (NDA)
022506, gabapentin 600 milligram (mg)
tablets, submitted by Depomed, Inc., for
the proposed indication of treatment of
moderate to severe vasomotor symptoms
due to menopause.
During the afternoon session, the
committee will discuss NDA 204516,
paroxetine mesylate 7.5 mg capsules,
submitted by Noven Therapeutics, LLC,
for the proposed indication of treatment
of moderate to severe vasomotor
symptoms associated with menopause.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
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person on or before February 15, 2013.
Oral presentations from the public will
be scheduled between approximately
10:30 a.m. to 11 a.m. and 3:30 p.m. to
4 p.m. Those individuals interested in
making formal oral presentations should
notify the contact person and submit a
brief statement of the general nature of
the evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before February 7, 2013. Time
allotted for each presentation may be
limited. If the number of registrants
requesting to speak is greater than can
be reasonably accommodated during the
scheduled open public hearing sessions,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing sessions. The contact
person will notify interested persons
regarding their request to speak by
February 8, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Kalyani
Bhatt at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: December 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–31675 Filed 1–3–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
PO 00000
Frm 00047
Fmt 4703
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735
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
Allergy and Infectious Diseases Special
Emphasis Panel U.S.-China Program for
Biomedical Collaborative Research (R01)—2.
Date: January 24–25, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Room 3139, Bethesda, MD
20892, (Telephone Conference Call).
Contact Person: Barney Duane Price, Ph.D.,
Scientific Review Officer, Scientific Review
Program, DHHS/NIH/NIAID/DEA, Room
3139, 6700B Rockledge Drive, MSC 7616,
Bethesda, MD 20892–7616, 301–451–2592,
pricebd@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
Dated: December 28, 2012.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2012–31631 Filed 1–3–13; 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.
E:\FR\FM\04JAN1.SGM
04JAN1
Agencies
[Federal Register Volume 78, Number 3 (Friday, January 4, 2013)]
[Notices]
[Page 735]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-31631]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; 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 Allergy and Infectious
Diseases Special Emphasis Panel U.S.-China Program for Biomedical
Collaborative Research (R01)--2.
Date: January 24-25, 2013.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6700B Rockledge Drive,
Room 3139, Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Barney Duane Price, Ph.D., Scientific Review
Officer, Scientific Review Program, DHHS/NIH/NIAID/DEA, Room 3139,
6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892-7616, 301-451-
2592, pricebd@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.855,
Allergy, Immunology, and Transplantation Research; 93.856,
Microbiology and Infectious Diseases Research, National Institutes
of Health, HHS)
Dated: December 28, 2012.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2012-31631 Filed 1-3-13; 8:45 am]
BILLING CODE 4140-01-P