[Federal Register: July 12, 2007 (Volume 72, Number 133)]
[Notices]
[Page 38086-38087]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12jy07-64]
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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). At least one
portion of the meeting will be closed 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 September 5, 2007, from
8 a.m. to 4 p.m. and on September 6, 2007, from 9 a.m. to 1 p.m.
Location: On September 5, 2007, the committee will meet at the
Hilton Washington DC/Silver Spring, The Ballrooms, 8727 Colesville Rd.,
Silver Spring, MD. The hotel telephone number is 301-589-5200. On
September 6, 2007, the committee will meet in closed session at FDA,
White Oak Headquarters, rm. 2046, 10903 New Hampshire Ave., Silver
Spring, 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. 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 September 5, 2007, the committee will discuss new drug
application (NDA) 22-145, raltegravir potassium, integrase inhibitor
400 milligram tablets, Merck & Co., Inc., for the treatment of Human
Immunodeficiency Virus-1 (HIV-1) infection in combination with other
[[Page 38087]]
antiretroviral agents in treatment-experienced patients with evidence
of HIV-1 replication despite ongoing antiretroviral therapy. On
September 6, 2007, the meeting will be closed to permit discussion and
review of trade secret and/or confidential information.
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://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: On September 5, 2007, from 8 a.m. to 4 p.m., 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 August 21, 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 August 14, 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 August 13, 2007.
Closed Committee Deliberations: On September 6, 2007, from 9 a.m.
to 1 p.m., the meeting will be closed to permit discussion and review
of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
The committee will be asked to provide feedback on a Phase 3 protocol
in the development of a new indication.
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: July 5, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-13560 Filed 7-11-07; 8:45 am]
BILLING CODE 4160-01-S