[Federal Register: October 19, 2000 (Volume 65, Number 203)]
[Page 62722-62723]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


    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: 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 November 17, 2000, from 
8:30 a.m. to 12:30 p.m.

[[Page 62723]]

    Location: Quality Suites, Potomac Ballroom, 3 Research Ct., 
Rockville, MD.
    Contact Person: Nancy Chamberlin or Jaime Henriquez, 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, or e-mail: CHAMBERLINN@cder.fda.gov, 
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code 12539 and 12534. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: On November 17, 2000, the committees will discuss the 
current status of, and future plans for, the draft FDA guidance 
entitled ``A Guidance for Industry, Topical Dermatological Drug Product 
NDA's and ANDA's--In Vivo Bioavailability, Bioequivalence, In Vitro 
Release, and Associated Studies;'' see the FDA internet web address 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/2481dft.pdf under the heading of 
``Biopharmaceutics Draft Guidances.'' A proposed research program for 
addressing scientific issues related to this guidance will also be 
    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 November 6, 
2000. Oral presentations from the public will be scheduled between 
approximately 11:15 a.m. to 12:15 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 6, 2000, 
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: October 11, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-26898 Filed 10-18-00; 8:45 am]