[Federal Register: December 19, 2003 (Volume 68, Number 244)]
[Notices]
[Page 70815-70816]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19de03-76]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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: 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
meetings.)
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
outlets.
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]
BILLING CODE 4160-01-S