[Federal Register Volume 69, Number 78 (Thursday, April 22, 2004)]
[Notices]
[Pages 21838-21839]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9070]


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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; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    The Food and Drug Administration (FDA) is announcing an amendment 
to the notice of meeting of the Nonprescription Drugs Advisory 
Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee. 
This meeting was announced in the Federal Register of March 30, 2004 
(69 FR 16582). The amendment is being made to reflect changes in the 
introductory paragraph and in the following portions of the document: 
Date and Time, Location, Agenda, and Procedure; and to add a portion 
entitled ``Closed Committee Deliberations.'' There are no other 
changes.

FOR FURTHER INFORMATION CONTACT: Dornette Spell-LeSane 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 
[email protected] or [email protected], 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.

SUPPLEMENTARY INFORMATION: In the Federal Register of March 30, 2004, 
FDA announced that a meeting of the Nonprescription Drugs Advisory 
Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee 
would be held on May 6 and May 7, 2004. On page 16582, in the first and 
second columns, the introductory paragraph, Date and Time, Location, 
Agenda, and Procedure portions of the meeting notice are amended; and a 
portion entitled ``Closed Committee Deliberations'' is added to read as 
follows:
    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.
    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 3:30 p.m.
    Location: 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., the committee will meet at the Center for Drug 
Evaluation and Research Advisory Committee Conference Room (rm. 1066), 
5630 Fishers Lane, Rockville, MD. On May 7, 2004, from 11 a.m. to 3:30 
p.m., the two committees will meet separately at two locations. The 
Nonprescription Drugs Advisory Committee will remain at the previously 
listed location for its separate meeting. The Dermatologic and 
Ophthalmic Drugs Advisory Committee will meet at the Food and Drug 
Administration, Parklawn Building, Chesapeake Conference Room, third 
floor, 5600 Fishers Lane, Rockville, MD for its separate meeting.
    Agenda: 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., the committee will discuss efficacy and 
labeling issues for over-the-counter drug products used in the 
treatment of tinea pedis (interdigital)

[[Page 21839]]

in patients 12 years of age and over. On May 7, 2004, from 11 a.m. to 
12 noon, each separate committee meeting will be open to the public, 
unless public participation does not last that long. From 12 noon to 
3:30 p.m., each separate committee meeting will be closed to permit 
discussion and review of trade secret and/or confidential information.
    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. On May 7, 2004, oral 
presentations from the public will be scheduled for each separate 
committee between approximately 11 a.m. and 12 noon. 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 presentations.
    Closed Committee Deliberations: On May 7, 2004, from 12 noon to 
3:30 p.m., the committee meetings will be closed to permit discussion 
and review of trade secret and/or confidential information (5 U.S.C. 
552b (c)(4)).
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2).

    Dated: April 15, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-9070 Filed 4-21-04; 8:45 am]
BILLING CODE 4160-01-S