[Federal Register Volume 63, Number 182 (Monday, September 21, 1998)]
[Notices]
[Page 50250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25107]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Joint Meeting of the Advisory Committee for Pharmaceutical 
Science 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 Committees: Advisory Committee for Pharmaceutical Science 
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 October 23, 1998, 8:30 
a.m. to 5 p.m.
    Location: Advisory Committee Conference Room, rm. 1066, 5630 
Fishers Lane, Rockville, MD 20852.
    Contact Person: Kimberly L. Topper or Tracy Riley, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7001, or e-mail 
``T[email protected]'', or FDA Advisory Committee Information Line, 
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12539. 
Please call the Information Line for up-to-date information on this 
meeting.
    Agenda: The committees will discuss: (1) The draft guidance 
entitled ``Topical Dermatological Drug Product NDA's and ANDA's--In 
Vivo Bioavailability, Bioequivalence, In Vitro Release and Associated 
Studies;'' (2) public comments received on the draft guidance; and (3) 
additional 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 October 5, 
1998. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before October 5, 1998, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 11, 1998.
Sharon Smith Holston,
Acting Commissioner of Food and Drugs.
[FR Doc. 98-25107 Filed 9-18-98; 8:45 am]
BILLING CODE 4160-01-F