Antiviral Drugs Advisory Committee; Notice of Meeting, 62418-62419 [2011-25976]
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62418
Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices
comments and suggestions submitted
within 60 days of this publication.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Robert Sargis,
Reports Clearance Officer.
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
[FR Doc. 2011–25947 Filed 10–6–11; 8:45 am]
BILLING CODE 4184–01–P
Antiviral Drugs Advisory Committee;
Notice of Meeting
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
ACTION:
Food and Drug Administration
[Docket No. FDA–2010–N–0646]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Tobacco Products, Exemptions From
Substantial Equivalence
Requirements; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of September 12, 2011 (76 FR
56200). The document announced that
an information collection had been
approved by the Office of Management
and Budget (OMB). The document was
published with an incorrect expiration
date. This document corrects that error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 3208,
Silver Spring, MD 20993–0002, 301–
796–9148.
In FR Doc.
2011–23184, appearing on page 56200,
in the Federal Register of Monday,
September 12, 2011, the following
correction is made:
1. On page 56200, in the first column,
under the SUPPLEMENTARY INFORMATION
section, the sentence ‘‘The approval
expires on August 14, 2014.’’ is
corrected to read ‘‘The approval expires
on August 31, 2014.’’
jlentini on DSK4TPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: October 3, 2011.
David Dorsey,
Acting Associate Commissioner for Policy and
Planning.
[FR Doc. 2011–25967 Filed 10–6–11; 8:45 am]
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Food and Drug Administration,
HHS.
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: Antiviral 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 December 14, 2011, from 8 a.m.
to 5 p.m. and on December 15, 2011,
from 8 a.m. to 1 p.m.
Location: FDA White Oak Campus,
Building 31, the Great Room, White Oak
Conference Center (rm. 1503), 10903
New Hampshire Ave., Silver Spring, MD
20993–0002. Information regarding
special accommodations due to a
disability, visitor parking and
transportation may be accessed at:
https://www.fda.gov/Advisory
Committees/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: Paul Tran, 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, e-mail:
AVAC@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: On December 14 and 15,
2011, the committee will discuss
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pathways for the development of drugs
intended to treat variola virus infection
(smallpox) in the event of an outbreak,
including the use of animal models of
other orthopoxviruses (the group of
viruses that includes smallpox) as
potential evidence of efficacy.
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. Written
submissions may be made to the contact
person on or before November 30, 2011.
Oral presentations from the public will
be scheduled between approximately 3
p.m. and 4 p.m. on December 14, 2011.
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 November 21, 2011. 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 22, 2011.
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 Paul Tran 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.
E:\FR\FM\07OCN1.SGM
07OCN1
Federal Register / Vol. 76, No. 195 / Friday, October 7, 2011 / Notices
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.)
Dated: October 4, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–25976 Filed 10–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0002]
General and Plastic Surgery Devices
Panel of the Medical Devices 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: General and
Plastic Surgery Devices Panel of the
Medical Devices 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 December 1, 2011, from 8 a.m.
to 6 p.m.
Location: Hilton Washington, DC
North/Gaithersburg, Salons A, B, C and
D, 620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Avena Russell, Food
and Drug Administration, Center for
Devices and Radiological Health, 10903
New Hampshire Ave., Bldg. 66, rm.
1535, Silver Spring, MD 20993–0002,
301–796–3805,
Avena.Russell@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
VerDate Mar<15>2010
16:33 Oct 06, 2011
Jkt 226001
possible modifications before coming to
the meeting.
Agenda: On December 1, 2011, the
committee will discuss, make
recommendations, and vote on
information related to the premarket
approval application, sponsored by
Contura, Inc., for AQUAMID, a new
material (polyacrylamide) for use as a
dermal filler for aesthetic treatment of
wrinkles in the face. The AQUAMID
dermal filler is intended for use in midto-deep sub-dermal implantation for the
aesthetic treatment of moderate to
severe facial wrinkles and folds, such as
the nasolabial folds. 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. Written
submissions may be made to the contact
person on or before November 22, 2011.
Oral presentations from the public will
be scheduled between approximately 1
p.m. and 2 p.m., immediately following
lunch. 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 November 14, 2011. 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 15, 2011.
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
PO 00000
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Fmt 4703
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62419
disabilities or special needs. If you
require special accommodations due to
a disability, please contact AnnMarie
Williams, Conference Management
Staff, 301–796–5966, 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: October 4, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–25969 Filed 10–6–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0695]
Science of Abuse Liability
Assessment; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug Administration
(FDA) is announcing a public workshop
to discuss the science of abuse liability
assessment. The Controlled Substance
Staff (CSS) in FDA’s Center for Drug
Evaluation and Research, Office of the
Center Director; the National Institute
on Drug Abuse (NIDA) at the National
Institutes of Health; and the College on
Problems of Drug Dependence (CPDD) at
the Temple University School of
Medicine are cosponsoring the 1-day
workshop.
Date and Time: The public workshop
will be held on Thursday, November 10,
2011, from 8 a.m. to 5 p.m.
Location: The public workshop will
be held at The Legacy Hotel and
Meeting Centre, 1775 Rockville Pike,
Rockville, MD 20852, 301–881–2300,
accessible on the Metro Red Line,
Twinbrook Station.
Contact Person: Ellen B. Geller,
CPDD, Temple University School of
Medicine, 3400 North Broad Street,
Philadelphia, PA 19140, 215–707–5307,
e-mail: ebgeller@temple.edu; or Corinne
P. Moody, Center for Drug Evaluation
and Research, Food and Drug
E:\FR\FM\07OCN1.SGM
07OCN1
]]>Agencies
[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Notices]
[Pages 62418-62419]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25976]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0002]
Antiviral Drugs 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). The meeting will
be open to the public.
Name of Committee: Antiviral 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 December 14, 2011, from
8 a.m. to 5 p.m. and on December 15, 2011, from 8 a.m. to 1 p.m.
Location: FDA White Oak Campus, Building 31, the Great Room, White
Oak Conference Center (rm. 1503), 10903 New Hampshire Ave., Silver
Spring, MD 20993-0002. 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: Paul Tran, 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, e-
mail: AVAC@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: On December 14 and 15, 2011, the committee will discuss
pathways for the development of drugs intended to treat variola virus
infection (smallpox) in the event of an outbreak, including the use of
animal models of other orthopoxviruses (the group of viruses that
includes smallpox) as potential evidence of efficacy.
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.
Written submissions may be made to the contact person on or before
November 30, 2011. Oral presentations from the public will be scheduled
between approximately 3 p.m. and 4 p.m. on December 14, 2011. 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
November 21, 2011. 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 22,
2011.
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 Paul Tran 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.
[[Page 62419]]
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.)
Dated: October 4, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-25976 Filed 10-6-11; 8:45 am]
BILLING CODE 4160-01-P
