Antiviral Drugs Advisory Committee; Notice of Meeting, 38211-38212 [E9-18355]
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Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6200,
MSC 7804, (For courier delivery, use MD
20817), Bethesda, MD 20892. 301–435–1715.
nga@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: July 27, 2009.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–18360 Filed 7–30–09; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Arthritis Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
PWALKER on DSK8KYBLC1PROD 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: Arthritis
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 September 16, 2009, from 8:30 a.m.
to 3:15 p.m.
Location: Holiday Inn, The Ballrooms,
Two Montgomery Village Ave.,
Gaithersburg, MD. The hotel telephone
number is 301–948–8900.
Contact Person: Nicole Vesely, Center
for Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane (for express delivery,
5630 Fishers Lane, rm. 1093), Rockville,
MD 20857, 301–827–6793, FAX: 301–
827–6776, e-mail:
nicole.vesely@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572 in the
Washington, DC area), code
3014512532. 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
VerDate Nov<24>2008
16:38 Jul 30, 2009
Jkt 217001
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
biologics license application (BLA) 12–
5338, clostridial collagenase, Auxilium
Pharmaceuticals, Inc., for the proposed
treatment of advanced Dupuytren’s
disease. Dupuytren’s disease is a
condition in which the tendons of the
hand that help move the fingers of the
hand become thickened and scarred.
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 September 1, 2009.
Oral presentations from the public will
be scheduled between approximately
12:45 p.m. to 1:45 p.m. 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 August 24, 2009. 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 August 25, 2009.
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 Nicole
PO 00000
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Fmt 4703
Sfmt 4703
38211
Vesely 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: July 23, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–18356 Filed 7–30–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
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 October 8, 2009, from 8 a.m. to
5 p.m.
Location: The Inn and Conference
Center, University of Maryland
University College (UMUC), 3501
University Blvd. East, Adelphi, Md. The
hotel telephone number is 301–985–
7300.
Contact Person: Paul Tran, Center for
Drug Evaluation and Research (HFD–
21), Food and Drug Administration,
5600 Fishers Lane, (for express delivery,
5630 Fishers Lane, Rm. 1093) Rockville,
MD 20857, 301–827–7001, fax: 301–
827–6776, e-mail:
paul.tran@fda.hhs.gov, or FDA
Advisory Committee Information Line,
1–800–741–8138 (301–443–0572) in the
Washington, DC area, code 3014512531.
Please call the Information Line for upto-date information on this meeting. A
notice in the Federal Register about last
minute modifications that impact a
E:\FR\FM\31JYN1.SGM
31JYN1
PWALKER on DSK8KYBLC1PROD with NOTICES
38212
Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices
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
an efficacy supplement for new drug
application (NDA) 022–128, maraviroc
300 milligram tablets, Pfizer, Inc.,
proposing a new indication for the
treatment of antiretroviral-naive patients
with chemokine (c-c motif) receptor 5
(CCR5—tropic human
immunodeficiency virus (HIV).
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 September 24, 2009.
Oral presentations from the public will
be scheduled between approximately 11
a.m. and 12 noon. 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 September 16, 2009. 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
September 17, 2009.
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
VerDate Nov<24>2008
16:38 Jul 30, 2009
Jkt 217001
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/
AdvisoryCommitttees/
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: July 21, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–18355 Filed 7–30–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Agency Information Collection
Activities: Foreign Assembler’s
Declaration (With Endorsement by
Importer)
AGENCY: U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 30–Day notice and request for
comments; Extension of an existing
information collection: 1651–0031.
SUMMARY: U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act: Foreign Assembler’s
Declaration (with Endorsement by
Importer). This is a proposed extension
of an information collection that was
previously approved. CBP is proposing
that this information collection be
extended with no change to the burden
hours. This document is published to
obtain comments from the public and
affected agencies. This proposed
information collection was previously
published in the Federal Register (74
FR 28712) on June 17, 2009, allowing
for a 60-day comment period. This
notice allows for an additional 30 days
for public comments. This process is
conducted in accordance with 5 CFR
1320.10.
DATES: Written comments should be
received on or before August 31, 2009.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the OMB Desk Officer for Customs
and Border Protection, Department of
Homeland Security, and sent via
electronic mail to
oira_submission@omb.eop.gov or faxed
to (202) 395–5806.
SUPPLEMENTARY INFORMATION: U.S.
Customs and Border Protection (CBP)
encourages the general public and
affected Federal agencies to submit
written comments and suggestions on
proposed and/or continuing information
collection requests pursuant to the
Paperwork Reduction Act (Pub. L. 104–
13). Your comments should address one
of the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency/component,
including whether the information will
have practical utility;
(2) Evaluate the accuracy of the
agencies/components estimate of the
burden of The proposed collection of
information, including the validity of
the methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collections of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
techniques or other forms of
information.
Title: Foreign Assembler’s Declaration
(with Endorsement by Importer).
OMB Number: 1651–0031.
Form Number: None.
Abstract: The Foreign Assembler’s
Declaration with Importer’s
Endorsement is used by CBP to
substantiate a claim for duty free
treatment of U.S. fabricated components
sent abroad for assembly and
subsequently returned to the United
States.
Current Actions: There are no changes
to the information collection. This
submission is being made to extend the
expiration date.
Type of Review: Extension (without
change).
Affected Public: Businesses.
Estimated Number of Respondents:
2,730.
Estimated Annual Burden per
Respondent: 110.77 hours.
Estimated Total Annual Burden
Hours: 302,402.
E:\FR\FM\31JYN1.SGM
31JYN1
Agencies
[Federal Register Volume 74, Number 146 (Friday, July 31, 2009)]
[Notices]
[Pages 38211-38212]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-18355]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0664]
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 October 8, 2009, from 8
a.m. to 5 p.m.
Location: The Inn and Conference Center, University of Maryland
University College (UMUC), 3501 University Blvd. East, Adelphi, Md. The
hotel telephone number is 301-985-7300.
Contact Person: Paul Tran, Center for Drug Evaluation and Research
(HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express
delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 301-827-
7001, fax: 301-827-6776, e-mail: paul.tran@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572) in the
Washington, DC area, code 3014512531. 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
[[Page 38212]]
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 an efficacy supplement for new
drug application (NDA) 022-128, maraviroc 300 milligram tablets,
Pfizer, Inc., proposing a new indication for the treatment of
antiretroviral-naive patients with chemokine (c-c motif) receptor 5
(CCR5--tropic human immunodeficiency virus (HIV).
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
September 24, 2009. Oral presentations from the public will be
scheduled between approximately 11 a.m. and 12 noon. 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 September 16, 2009. 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 September 17, 2009.
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/AdvisoryCommitttees/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: July 21, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-18355 Filed 7-30-09; 8:45 am]
BILLING CODE 4160-01-S