[Federal Register Volume 63, Number 17 (Tuesday, January 27, 1998)] [Notices] [Page 3907] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-2022] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Medical Imaging 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: Medical Imaging 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 February 9, 1998, 8 a.m. to 5 p.m. Location: Holiday Inn, Versailles Ballrooms I and II, 8120 Wisconsin Ave., Bethesda, MD. Contact Person: Leander B. Madoo, Center for Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-5455, or FDA Advisory Committee Information Line, 1-80-741-8138 (301-443-0572 in the Washington, DC area), code 12540. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss the safety and efficacy of new drug application (NDA) 20-887 AcuTectTM, Diatide, Inc., a radiopharmaceutical agent for the detection and localization of acute venous thrombosis. Procedure: On February 9, 1998, from 8 a.m. to 1 p.m. and from 2 p.m. to 5 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 may be made to the contact person by February 2, 1998. Oral presentations from the public will be scheduled between approximately 8:30 a.m. and 9:30 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 2, 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 February 9, 1998, from 1 p.m. to 2 p.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information relating to NDA 20-887 AcuTectTM (5 U.S.C. 552b(c)(4)). FDA regrets that it was unable to publish this notice 15 days prior to the February 9, 1998, Medical Imaging Drugs Advisory Committee meeting. Because the agency believes there is some urgency to bring this issue to public discussion and qualified members of the Medical Imaging Drugs Advisory Committee were available at this time, the Commissioner concluded that it was in the public interest to hold this meeting even if there was not sufficient time for the customary 15-day public notice. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 22, 1998. Michael A. Friedman, Deputy Commissioner for Operations. [FR Doc. 98-2022 Filed 1-23-98; 11:47 am] BILLING CODE 4160-01-F