[Federal Register Volume 65, Number 141 (Friday, July 21, 2000)]
[Notices]
[Page 45384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18457]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


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: 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 September 18 and 19, 
2000, 8:30 a.m. to 5 p.m.
    Location: Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact: Kimberly L. Topper, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7001, 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 meeting.
    Agenda: On September 18 and 19, 2000, the committee will discuss 
two new drug applications (NDA's): NDA 18-662, Accutane 
(isotretinoin) capsules, Hoffmann-LaRoche, Inc., for severe 
recalcitrant nodular acne; and NDA 21-177, (new formulation) 
isotretinoin capsules, Hoffmann-LaRoche, Inc., for severe recalcitrant 
nodular acne.
    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 September 7, 
2000. 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 September 7, 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: July 11, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-18457 Filed 7-20-00; 8:45 am]
BILLING CODE 4160-01-F