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. 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 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://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 a disability, 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. |
