National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings, 71349-71350 [2011-29748]
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Federal Register / Vol. 76, No. 222 / Thursday, November 17, 2011 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0805]
Dermatologic and Ophthalmic Drugs
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
jlentini on DSK4TPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Dermatologic
and Ophthalmic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on February 27, 2012, from 9 a.m.
to 5 p.m.
Addresses: FDA is opening a docket
for public comment on this meeting.
The docket number is FDA–2011–N–
0805. The docket will open for public
comment on November 17, 2011. The
docket will close on March 5, 2012.
Interested persons may submit
electronic or written comments
regarding this meeting. Submit
electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments received will be posted
without change, including any personal
information provided. Submit a single
copy of electronic comments or a paper
copy 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 meeting
notice. Received comments may be seen
in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday. Comments received on
or before February 10, 2012, will be
provided to the committee before the
meeting.
Location: Hilton Washington DC/
Silver Spring (scheduled to be renamed
in January 2012 to DoubleTree by Hilton
Hotel Washington DC/Silver Spring),
8727 Colesville Rd., Silver Spring, MD.
The hotel phone number is (301) 589–
5200.
Contact Person: Yvette Waples, Center
for Drug Evaluation and Research, Food
and Drug Administration, 10903 New
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Hampshire Ave., Bldg. 31, rm. 2417,
Silver Spring, MD 20993–0002, (301)
796–9001, Fax: (301) 847–8533, email:
DODAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–(800)
741–8138 (301) 443–0572 in the
Washington, DC area), and follow the
prompts to the desired center or product
area. Please call the Information Line for
up-to-date information on this meeting.
A notice in the Federal Register about
last minute modifications that impact a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice. Therefore, you should
always check the Agency’s Web site and
call the appropriate advisory committee
hot line/phone line to learn about
possible modifications before coming to
the meeting.
Agenda: The committee will be asked
to comment on the following topics
related to the use of ophthalmic drug
products (products intended for use in
the eye): (1) Appropriate types of
clinical evidence for developing antiinflammatory drugs for the treatment of
postoperative inflammation and
reduction of ocular (eye) pain in
patients who have undergone ocular
surgery. This will include a discussion
of the definition and scope of this
indication as well as the types of
clinical trials needed to support
approval; and (2) appropriateness of
marketing a single bottle of ophthalmic
product for use in both eyes for
postsurgical indications as it relates to
the potential risk for infection. FDA’s
Center for Drug Evaluation and Research
would like the advisory committee to
provide advice on the potential risk and
approaches to mitigating that risk,
including limits to fill size where
appropriate.
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 link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see the ADDRESSES section of
this document) on or before February
10, 2012, will be provided to the
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71349
committee. Oral presentations from the
public will be scheduled between
approximately 11 a.m. and 12 noon.
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 2, 2012. 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 session,
FDA may conduct a lottery to determine
the speakers for the scheduled open
public hearing session. The contact
person will notify interested persons
regarding their request to speak by
February 3, 2012.
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 Yvette
Waples 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/Advisory
Committees/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: November 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–29682 Filed 11–16–11; 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
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.
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71350
Federal Register / Vol. 76, No. 222 / Thursday, November 17, 2011 / Notices
jlentini on DSK4TPTVN1PROD with NOTICES
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
Allergy and Infectious Diseases Special
Emphasis Panel, NIAID Investigator Initiated
Program Project Applications.
Date: December 1, 2011.
Time: 2 p.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Vasundhara Varthakavi,
Ph.D., DVM, Scientific Review Officer,
Scientific Review Program, DEA/NIAID/NIH/
DHHS, Room 2217, 6700–B Rockledge Drive,
Bethesda, MD 20892–7616, (301) 496–2550,
varthakaviv@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, NIAID Resource—Related
Research Projects.
Date: December 12, 2011.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Vasundhara Varthakavi,
Ph.D., DVM, Scientific Review Officer,
Scientific Review Program, DEA/NIAID/NIH/
DHHS, Room 2217, 6700–B Rockledge Drive,
Bethesda, MD 20892–7616, (301) 496–2550,
varthakaviv@niaid.nih.gov.
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel, Functional Genomics
Research Program.
Date: December 20, 2011.
Time: 11 a.m. to 5 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6700B
Rockledge Drive, Bethesda, MD 20817,
(Telephone Conference Call).
Contact Person: Lynn Rust, Ph.D.,
Scientific Review Officer, Scientific Review
Program, Division of Extramural Activities,
NIAID/NIH/DHHS, 6700B Rockledge Drive,
MSC 7616, Bethesda, MD 20892, (301) 402–
3938, lr228v@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)
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Dated: November 10, 2011.
Anna Snouffer
Deputy Director, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–29748 Filed 11–16–11; 8:45 am]
National Eye Institute; Notice of Closed
Meetings
BILLING CODE 4140–01–P
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, MBRS Score Meeting.
Date: December 9, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Palamor Dupont Circle, NW.,
2121 P Street, Washington, DC 20037.
Contact Person: Lisa Dunbar, Ph.D.,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN12, Bethesda, MD
20892, (301) 594–2849,
dunbarl@mail.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 9, 2011.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
National Institutes of Health
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 Eye Institute
Special Emphasis Panel, NEI Pediatric Vision
Science Grant Applications.
Date: November 28, 2011.
Time: 1 p.m. to 2 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NEI,
5635 Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
Contact Person: Anne E. Schaffner, Ph.D.,
Chief, Scientific Review Officer, Division of
Extramural Research, National Eye Institute,
National Institutes of Health, 5635 Fishers
Lane, Suite 1300, MSC 9300, (301) 451–2020,
aes@nei.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: National Eye Institute
Special Emphasis Panel, NEI Clinical
Applications.
Date: December 2, 2011.
Time: 1:30 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, NEI,
5635 Fishers Lane, Rockville, MD 20892,
(Telephone Conference Call).
Contact Person: Anne E. Schaffner, Ph.D.,
Chief, Scientific Review Officer, Division of
Extramural Research, National Eye Institute,
National Institutes of Health, 5635 Fishers
Lane, Suite 1300, MSC 9300, (301) 451–2020,
aes@nei.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
[FR Doc. 2011–29747 Filed 11–16–11; 8:45 am]
Dated: November 9, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
BILLING CODE 4140–01–P
[FR Doc. 2011–29745 Filed 11–16–11; 8:45 am]
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]]>Agencies
[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Notices]
[Pages 71349-71350]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-29748]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Institute of Allergy and Infectious Diseases; 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.
[[Page 71350]]
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 Allergy and Infectious
Diseases Special Emphasis Panel, NIAID Investigator Initiated
Program Project Applications.
Date: December 1, 2011.
Time: 2 p.m. to 6 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6700B Rockledge Drive,
Bethesda, MD 20817, (Telephone Conference Call).
Contact Person: Vasundhara Varthakavi, Ph.D., DVM, Scientific
Review Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, Room
2217, 6700-B Rockledge Drive, Bethesda, MD 20892-7616, (301) 496-
2550, varthakaviv@niaid.nih.gov.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel, NIAID Resource--Related Research
Projects.
Date: December 12, 2011.
Time: 11 a.m. to 2 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6700B Rockledge Drive,
Bethesda, MD 20817, (Telephone Conference Call).
Contact Person: Vasundhara Varthakavi, Ph.D., DVM, Scientific
Review Officer, Scientific Review Program, DEA/NIAID/NIH/DHHS, Room
2217, 6700-B Rockledge Drive, Bethesda, MD 20892-7616, (301) 496-
2550, varthakaviv@niaid.nih.gov.
Name of Committee: National Institute of Allergy and Infectious
Diseases Special Emphasis Panel, Functional Genomics Research
Program.
Date: December 20, 2011.
Time: 11 a.m. to 5 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institutes of Health, 6700B Rockledge Drive,
Bethesda, MD 20817, (Telephone Conference Call).
Contact Person: Lynn Rust, Ph.D., Scientific Review Officer,
Scientific Review Program, Division of Extramural Activities, NIAID/
NIH/DHHS, 6700B Rockledge Drive, MSC 7616, Bethesda, MD 20892, (301)
402-3938, lr228v@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: November 10, 2011.
Anna Snouffer
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-29748 Filed 11-16-11; 8:45 am]
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