[Federal Register: March 30, 2004 (Volume 69, Number 61)]
[Notices]
[Page 16582]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr04-79]
[[Page 16582]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Nonprescription Drugs Advisory Committee and the Dermatologic and
Ophthalmic 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: Nonprescription Drugs Advisory Committee and the
Dermatologic and Ophthalmic 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 May 6, 2004, from 8 a.m.
to 5:30 p.m. and May 7, 2004, from 8 a.m. to 11 a.m.
Location: Center for Drug Evaluation and Research Advisory
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
Contact Person: Karen Templeton-Somers or Kimberly Littleton
Topper, 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, e-mail:
topperk@cder.fda.gov or somersk@cder.fda.gov., or FDA Advisory Committee
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC
area), codes 3014512541 or 3014512534. Please call the Information Line
for up-to-date information on this meeting. The background materials
for this meeting will become available no later than 1 business day
before the meeting and will be posted 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 2004 and scroll down to the
Nonprescription Drugs Advisory Committee or the Dermatologic and
Ophthalmic Drugs Advisory Committee).
Agenda: On both days, the committee will discuss efficacy and
labeling issues for over-the-counter drug products used in the
treatment of tinea pedis (interdigital) in patients 12 years of age and
over.
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 by April 23,
2004. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on May 6, 2004. Time allotted for each
presentation may be limited. Those desiring to make formal oral
presentations should notify the contact person before April 23, 2004,
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.
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 Karen Templeton-
Somers or Kimberly Littleton Topper 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: March 22, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-6974 Filed 3-29-04; 8:45 am]
BILLING CODE 4160-01-S