[Federal Register: February 17, 2005 (Volume 70, Number 32)]
[Notices]
[Page 8104]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17fe05-43]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory
Committee and the Nonprescription 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: Dermatologic and Ophthalmic Drugs Advisory
Committee and the Nonprescription Drugs Advisory Committee.
General Function of the Committees: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on March 24, 2005, from 8
a.m. to 5:30 p.m.
Location: Hilton Washington DC North/Gaithersburg, The Ballrooms,
620 Perry Pkwy., Gaithersburg, MD.
Contact Person: Teresa A. Watkins, 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, FAX: 301-827-6801, or email: watkinst@cder.fda.gov, or
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 3014512534 or 3014512541. Please call
the Information Line for up-to-date information on this meeting.
Agenda: The committee will discuss what should be the necessary and
sufficient safety database in order to evaluate the prescription (Rx)
to over-the-counter (OTC) switch of topical corticosteroids, especially
the database to evaluate the potential for hypothalamic, pituitary,
adrenal (HPA) and growth suppression and other systemic and local
adverse events.
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 March 17,
2005. 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 March 17, 2005, 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 LaNise Giles at 301-
827-7001, 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).
Dated: February 10, 2005.
Sheila Dearybury Walcoff,
Assistant Commissioner for External Relations.
[FR Doc. 05-3055 Filed 2-16-05; 8:45 am]
BILLING CODE 4160-01-S