05-3055. 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.

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: [phone], or email: [e-mail], 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.