[Federal Register: October 16, 2002 (Volume 67, Number 200)]
[Page 63933]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 63933]]



Food and Drug Administration

Dermatologic and Ophthalmic Drugs Advisory Committee; Notice of 

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). The meeting will 
be open to the public.
    Name of Committee: Dermatologic and Ophthalmic Drugs Advisory 
    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 November 4, 2002, from 
8:30 a.m. to 5:30 p.m. and November 5, 2002, from 8 a.m. to 1 p.m.
    Location: Holiday Inn, Versailles Ballroom, 8120 Wisconsin Ave., 
Bethesda, MD.
    Contact Person: Karen M. Templeton-Somers, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7001, e-mail: 
SomersK@cder.fda.gov, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), code 12534. 
Please call the Information Line for up-to-date information on this 
    Agenda: On both the days, committee will make recommendations for 
the development of a proposed draft guidance concerning the development 
of products for mild to moderate acne vulgaris. Issues to be considered 
include: (1) The evidence for effectiveness; (2) appropriate outcome 
measures and their analyses; (3) possible acceptable indications such 
as inflammatory, noninflammatory or just mild to moderate acne 
vulgaris; and (4) means for conveying evidence for effectiveness in the 
label to enhance its usefulness for clinicians and patients. Time will 
be included in the agenda for the pharmaceutical industry to present 
their views on the development of the draft guidance. Please register 
to present (see Contact Person) by October 18, 2002.
    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 October 18, 
2002. Oral presentations from the public will be scheduled between 
approximately 8:45 a.m. and 9:15 a.m. on November 4, 2002, and between 
approximately 8:15 a.m. and 8:45 a.m. on November 5, 2002. Time 
allotted for each presentation may be limited. If you wish to make a 
brief statement during the open public hearing, please contact the 
Executive Secretary (see Contact Person), by October 18, 2002.
    You will be asked to submit a brief summary of your planned 
statement and provide information on how we may contact you before the 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 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: October 9, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-26330 Filed 10-15-02; 8:45 am]