[Federal Register: December 19, 2003 (Volume 68, Number 244)]
[Page 70815-70816]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Joint Meeting of the Drug Safety and Risk Management Advisory 
Committee 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 Committees: Drug Safety and Risk Management Advisory 
Committee 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 February 26 and 27, 
2004, from 8 a.m. to 5 p.m.
    Location: Hilton, The Ballrooms, 620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Shalini Jain, 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: jains@cder.fda.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), codes 3014512535 or 3014512534. Please call the Information Line 
for up-to-date information on this meeting.
    The background materials for this meeting will become available no 
later than 1 business day before the meeting and will be posted at: 
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2003 and 

scroll down to either the Drug Safety and Risk Management Advisory 
Committee or the Dermatologic and Ophthalmic Drugs Advisory Committee 
    Agenda: The committee will discuss the following topics: (1) The 
effectiveness of the isotretinoin risk management program for the 
prevention of fetal exposure to ACCUTANE and its generic equivalents, 
and (2) consider whether changes to this isotretinoin risk management 
program would be appropriate.
    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 February 16, 
2004. Oral presentations from the public will be scheduled between 
approximately 11 a.m. and 12 noon on February 26, 2004, and between 
approximately 8:30 a.m. and 9:30 a.m. on February 27, 2004. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
February 16, 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 presentation.
    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 Shalini Jain 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).

[[Page 70816]]

    Dated: December 15, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-31385 Filed 12-18-03; 8:45 am]