[Federal Register Volume 63, Number 46 (Tuesday, March 10, 1998)] [Notices] [Page 11685] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-6210] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Biological Response Modifiers 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: Biological Response Modifiers 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 24, 1998, 8:30 a.m. to 5 p.m. Location: DoubleTree Hotel, 1750 Rockville Pike, Rockville, MD. Contact Person: Gail M. Dapolito or Rosanna L. Harvey, Center for Biologics Evaluation and Research (HFM-21), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443- 0572 in the Washington, DC area), code 12389. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss CellPro Inc.'s CeprateSC System for use in processing autologous peripheral blood stem cells. The committee will also hear short briefings on research programs in the Laboratory of Cellular Immunology and the Laboratory of Developmental Biology. Procedure: On March 24, 1998, from 8:30 a.m. to 1:30 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 may be made to the contact person by March 17, 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 March 17, 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 24, 1998, from 1:30 p.m. to 3:45 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 discuss current investigational new drug application submissions under FDA review. On March 24, 1998, from 3:45 p.m. to 5 p.m., the meeting will be closed to review data of a personal nature where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). This portion of the meeting will be closed to permit discussion of this information. FDA regrets that it was unable to publish this notice 15 days prior to the March 24, 1998, Biological Response Modifiers Advisory Committee meeting. Because the agency believes there is some urgency to bring these issues to public discussion and qualified members of the Biological Response Modifiers 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: March 5, 1998. Michael A. Friedman, Deputy Commision for Operations. [FR Doc. 98-6210 Filed 3-6-98; 12:21 pam] BILLING CODE 4160-01-F