[Federal Register Volume 63, Number 124 (Monday, June 29, 1998)] [Notices] [Page 35238] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-17146] ----------------------------------------------------------------------- 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's regulatory issues. Date and Time: The meeting will be held on July 30, 1998, 8 a.m. to 6 p.m. Location: Bethesda Holiday Inn, Versailles Ballrooms I and II, 8120 Wisconsin Ave., Bethesda, MD. Contact Person: Gail M. Dapolito or Rosanna L. Harvey, Center for Biologics Evaluation and Research (HFM-211), 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: (1) Biologics license application 97-0509, Amgen Inc.'s Stemgen(ancestim); (2) the report from the December 17, 1997, meeting of the Xenotransplantation Subcommittee; and (3) the research programs in the Laboratory of Immunology and the Laboratory of Molecular Immunology, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research. An indication is sought, in combination with Neupogen (filgrastim), for use in mobilization of peripheral blood progenitor cells. Procedure: On July 30, 1998, from 8 a.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 July 20, 1998. Oral presentations from the public will be scheduled between approximately 8 a.m. and 9 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before July 20, 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 July 30, 1998, from 5 p.m. to 6 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss confidential information relevant to the scientific site visit report of the Laboratory of Immunology and the Laboratory of Molecular Immunology, Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 18, 1998. Michael A. Friedman, Deputy Commissioner for Operations. [FR Doc. 98-17146 Filed 6-26-98; 8:45 am] BILLING CODE 4160-01-F