Document ID: FDA-2009-N-0664-0066
Agency: fda
Document Type: Notice
Title: Antiviral Drugs Advisory Committee; Notice of Meeting
Posted Date: 2009-07-31T04:00Z

[Federal Register: July 31, 2009 (Volume 74, Number 146)]
[Notices]               
[Page 38211-38212]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31jy09-81]                         

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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.

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    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 http://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 http://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