[Federal Register Volume 63, Number 43 (Thursday, March 5, 1998)] [Notices] [Page 10919] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-5630] ----------------------------------------------------------------------- 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). At least one portion of the meeting will be closed 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 regulatory issues. Date and Time: The meeting will be held on March 19 and 20, 1998, 8:30 a.m. to 5:30 p.m. Location: Holiday Inn, Walker Room, Two Montgomery Village Ave., Gaithersburg, MD. Contact Person: Tracy Riley or Angie Whitacre, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455, 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 Agenda: On March 19, 1998, the committee will discuss generic topical dermatologicals draft guidance. On March 20, 1998, the committee will participate in a scientific discussion of clinical trial design questions for products intended for the treatment of psoriasis. Procedure: On March 19, 1998, from 8:30 a.m. to 1 p.m., and on March 20, 1998, from 8:30 a.m. to 5:30 p.m., the meeting is open to the public. Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions should be made to the contact person by March 11, 1998. Oral presentations from the public will be scheduled between approximately 8:30 a.m. and 9 a.m., on March 19 and 20, 1998. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 13, 1998, 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. Closed Committee Deliberations: On March 19, 1998, from 1 p.m. to 5:30 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552b(c)(4)). This portion of the meeting will be closed to permit discussion on pending investigational new drug applications issues. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: February 25, 1998. Michael A. Friedman, Deputy Commissioner for Operations. [FR Doc. 98-5630 Filed 3-4-98; 8:45 am] BILLING CODE 4160-01-F