Vaccines and Related Biological Products Advisory Committee; Notice of Meeting, 59729-59730 [2010-24253]
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srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices
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: Fungai Chanetsa, MPH,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3135,
MSC 7770, Bethesda, MD 20892, 301–408–
9436, fungai.chanetsa@nih.hhs.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: AIDS/HIV Innovative Research
Applications.
Date: November 16–18, 2010.
Time: 8 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Kenneth A Roebuck, PhD,
PhD, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5106,
MSC 7852, Bethesda, MD 20892, (301) 435–
1166, roebuckk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Genes, Genomes, and Genetics.
Date: November 17, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Mayflower Hotel, 1127
Connecticut Avenue, NW., Washington, DC
20036.
Contact Person: Maria DeBernardi, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6158,
MSC 7892, Bethesda, MD 20892, 301–435–
1355, debernardima@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Fellowship:
Technology Development.
Date: November 17–18, 2010.
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: Alessandra M. Bini, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5142,
MSC 7840, Bethesda, MD 20892, 301–435–
1024, binia@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Special
Topics: Bioanalytical and Imaging
Technologies.
Date: November 17–18, 2010.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Vonda K. Smith, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
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Health, 6701 Rockledge Drive, Room 6188,
MSC 7892, Bethesda, MD 20892, 301–435–
1789, smithvo@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Arthritis, Connective Tissue and
Skin Special Emphasis Panel.
Date: November 17, 2010.
Time: 2:30 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: Jean D. Sipe, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4106,
MSC 7814, Bethesda, MD 20892, 301–435–
1743, sipej@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; ODCS
Member Conflicts.
Date: November 17, 2010.
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: Priscilla B. Chen, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4104,
MSC 7814, Bethesda, MD 20892, (301) 435–
1787, chenp@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Fellowship:
Genes, Genomes, and Genetics.
Date: November 18–19, 2010.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications,
Place: Hyatt at Fisherman’s Wharf, 555
North Point Street, San Francisco, CA 94133.
Contact Person: Michael A. Marino, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2216,
MSC 7890, Bethesda, MD 20892, (301) 435–
0601, marinomi@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–10–
082: Shared Instrumentation: S10 Flow
Cytometry Review.
Date: November 18–19, 2010.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Baltimore Harborplace
Hotel, 202 East Pratt Street, Baltimore, MD
21202.
Contact Person: Jonathan Arias, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5170,
MSC 7840, Bethesda, MD 20892, 301–435–
2406, ariasj@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Small
Business: Respiratory Sciences.
Date: November 18–19, 2010.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
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59729
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Ghenima Dirami, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4122,
MSC 7814, Bethesda, MD 20892, 301–594–
1321, diramig@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: September 22, 2010.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2010–24279 Filed 9–27–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Vaccines and Related Biological
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). At least one portion of the
meeting will be closed to the public.
Name of Committee: Vaccines and
Related Biological Products 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 November 16, 2010, from 9 a.m.
to approximately 4 p.m. and on
November 17, 2010, from 8:30 a.m. to
approximately 1:15 p.m.
Location: Hilton Silver Spring Hotel,
Maryland Ballroom, 8727 Colesville Rd.,
Silver Spring, MD 20910.
Contact Person: Donald W. Jehn or
Denise Royster, Food and Drug
Administration, Center for Biologics
Evaluation and Research (HFM–71),
Food and Drug Administration, 1401
Rockville, Pike, Rockville, MD 20852,
301–827–0314, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512391. Please call the Information
Line for up-to-date information on this
meeting. A notice in the Federal
E:\FR\FM\28SEN1.SGM
28SEN1
srobinson on DSKHWCL6B1PROD with NOTICES
59730
Federal Register / Vol. 75, No. 187 / Tuesday, September 28, 2010 / Notices
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: On November 16, 2010, the
committee will meet in open session to
review and discuss the pathway to
licensure for protective antigen-based
anthrax vaccines for a post-exposure
prophylaxis indication using the animal
rule. On November 17, 2010, the
committee will meet in open session to
review and discuss the effectiveness of
vaccinating males and females with
Gardasil manufactured by Merck & Co.
for the prevention of anal dysplasia and
anal cancer.
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: On November 16, 2010,
from 9 a.m. until approximately 11:45
a.m. and from 2 p.m. until
approximately 4 p.m. and on November
17, 2010, the meeting is open to the
public. 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 person on or before
November 10, 2010. Oral presentations
from the public will be scheduled
between approximately 2:15 p.m. and
2:45 p.m. on November 16, 2010, and
between approximately 11:45 a.m. and
12:15 p.m. on November 17, 2010.
Those desiring to make 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
November 2, 2010. 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
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15:22 Sep 27, 2010
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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 November 3, 2010.
Closed Committee Deliberations: On
November 16, 2010, between 12 p.m.
and approximately 2 p.m., the meeting
will be closed to permit discussion and
review of trade secret and/or
confidential commercial information (5
U.S.C. 552b(c)(4)). The committee will
hear firms discuss protocols they
propose to use for the pathway to
licensure for protective antigen-based
anthrax vaccines for a post-exposure
prophylaxis indication using the animal
rule.
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 Donald W.
Jehn or Denise Royster 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/About
AdvisoryCommittees/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: September 23, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2010–24253 Filed 9–27–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0001]
Joint Meeting of the Anesthetic and
Life Support Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
PO 00000
Frm 00052
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(FDA). The meeting will be open to the
public.
Name of Committees: Anesthetic and
Life Support Drugs Advisory Committee
and the Drug Safety and Risk
Management Advisory Committee.
General Function of the Committees:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on October 21, 2010, from 8:30
a.m. to 4:30 p.m. and on October 22,
2010, from 8:30 a.m. to 4 p.m.
Location: Hilton Washington DC
North/Gaithersburg, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD. The
hotel telephone number is 301–977–
8900.
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:
kalyani.bhatt@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), codes
3014512529 and 3014512535. 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 discuss
considerations for the design of
postmarketing studies for new drug
applications (NDAs) 22–272, OxyContin
(oxycodone hydrochloride controlledrelease) Tablets, manufactured by
Purdue Pharma, Inc., and NDA 22–321,
EMBEDA (morphine sulfate extendedrelease with a sequestered naltrexone
hydrochloride inner core) Capsules,
manufactured by Alpharma
Pharmaceuticals, LLC and King
Pharmaceuticals Research &
Development, Inc., approved for the
management of moderate to severe pain
when a continuous, around-the-clock
opioid analgesic is needed for an
extended period of time. The
postmarketing studies are intended to be
epidemiological or observational studies
that will assess the known serious risks
of these products and whether productspecific properties which are intended
to discourage misuse and abuse actually
result in a decrease in the risks of
misuse and abuse, and their
E:\FR\FM\28SEN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 187 (Tuesday, September 28, 2010)]
[Notices]
[Pages 59729-59730]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-24253]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0001]
Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). At least one
portion of the meeting will be closed to the public.
Name of Committee: Vaccines and Related Biological Products
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 November 16, 2010, from
9 a.m. to approximately 4 p.m. and on November 17, 2010, from 8:30 a.m.
to approximately 1:15 p.m.
Location: Hilton Silver Spring Hotel, Maryland Ballroom, 8727
Colesville Rd., Silver Spring, MD 20910.
Contact Person: Donald W. Jehn or Denise Royster, Food and Drug
Administration, Center for Biologics Evaluation and Research (HFM-71),
Food and Drug Administration, 1401 Rockville, Pike, Rockville, MD
20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), code 3014512391.
Please call the Information Line for up-to-date information on this
meeting. A notice in the Federal
[[Page 59730]]
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: On November 16, 2010, the committee will meet in open
session to review and discuss the pathway to licensure for protective
antigen-based anthrax vaccines for a post-exposure prophylaxis
indication using the animal rule. On November 17, 2010, the committee
will meet in open session to review and discuss the effectiveness of
vaccinating males and females with Gardasil manufactured by Merck & Co.
for the prevention of anal dysplasia and anal cancer.
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: On November 16, 2010, from 9 a.m. until approximately
11:45 a.m. and from 2 p.m. until approximately 4 p.m. and on November
17, 2010, the meeting is open to the public. 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 person on or before November 10, 2010. Oral presentations from
the public will be scheduled between approximately 2:15 p.m. and 2:45
p.m. on November 16, 2010, and between approximately 11:45 a.m. and
12:15 p.m. on November 17, 2010. Those desiring to make 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 November 2, 2010. 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 November
3, 2010.
Closed Committee Deliberations: On November 16, 2010, between 12
p.m. and approximately 2 p.m., the meeting will be closed to permit
discussion and review of trade secret and/or confidential commercial
information (5 U.S.C. 552b(c)(4)). The committee will hear firms
discuss protocols they propose to use for the pathway to licensure for
protective antigen-based anthrax vaccines for a post-exposure
prophylaxis indication using the animal rule.
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 Donald W. Jehn or
Denise Royster 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: September 23, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-24253 Filed 9-27-10; 8:45 am]
BILLING CODE 4160-01-S
