[Federal Register: February 7, 2007 (Volume 72, Number 25)]
[Notices]
[Page 5724]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07fe07-105]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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 April 24, 2007, from 8
a.m. to 4 p.m.
Location: Food and Drug Administration, Center for Drug Evaluation
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers
Lane, Rockville, MD.
Contact Person: Cicely Reese, 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: cicely.reese@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.
Agenda: The committee will discuss new drug application (NDA) 022-
128, maraviroc 300 milligram tablets, Pfizer, Inc., proposed for the
treatment of antiretroviral-experienced 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 1 business day 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on
the year 2007 and 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
April 3, 2007. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 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 March 26, 2007. 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 March 27,
2007.
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 adisability, please contact Cicely Reese at least
7 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app 2).
Dated: February 1, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-1900 Filed 2-6-07; 8:45 am]
BILLING CODE 4160-01-S