[Federal Register: September 15, 2005 (Volume 70, Number 178)]
[Notices]
[Page 54560-54561]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se05-43]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Nonprescription 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: Nonprescription 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 20, 2005, from 8
a.m. to 5:30 p.m., and on October 21, 2005, from 8 a.m. to 12 noon.
Location: Holiday Inn Washington Silver Spring, The Ballrooms, 8777
Georgia Ave., Silver Spring, MD. The hotel telephone number is 301-589-
0800.
Contact Person: Darrell Lyons, Center for Drug Evaluation and
Research (HFD-021), Food and Drug Administration, 5600 Fishers Lane
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD
20857, 301-827-6760, FAX: 301-827-6778, e-mail: lyonsd@cder.fda.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 3014512541. Please call the
Information Line for up-to-date information on this meeting.
Agenda: The committee will discuss the benefits and risks of
antiseptic products marketed for consumer use (e.g., antibacterial
hand-washes and body-washes). The discussion will include topics such
as the efficacy of antiseptics intended for use by consumers and
potential risks to the individual and the general population from using
these products. The background material will become available no later
than the day before the meeting and will be posted under the
Nonprescription Drugs Advisory Committee (NDAC) on FDA's Web site 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 2005
and scroll down to NDAC).
Procedure: On October 20, 2005, from 8 a.m. to 5:30 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 by
October 13, 2005. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on October 20, 2005. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before
October 13, 2005, 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.
Closed Committee Deliberations: On October 21, 2005, from 8 a.m. to
12 noon, the meeting will be closed to permit discussion and review of
trade secret and/or confidential information (5 U.S.C. 552b(c)(4)).
Persons attending FDA's advisory committee meetings are advised
that the
[[Page 54561]]
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 LaNise Giles at 301-
827-7001, 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: September 8, 2005.
Scott Gottlieb,
Deputy Commissioner for Policy.
[FR Doc. 05-18366 Filed 9-14-05; 8:45 am]
BILLING CODE 4160-01-S