[Federal Register: April 20, 1998 (Volume 63, Number 75)] [Notices] [Page 19501] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr20ap98-85] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Antiviral 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: Antiviral 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 May 4, 1998, 8:30 a.m to 5 p.m.; on May 5, 1998, 8 a.m. to 5 p.m.; and on May 6, 1998, 7:30 a.m. to 5 p.m. Location: Gaithersburg Hilton, Ballroom, 620 Perry Pkwy., Gaithersburg, MD. Contact Person: Rhonda W. Stover or John B. Schupp, 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 12531. Please call the Information Line for up-to-date information on this meeting. Agenda: On May 4, 1998, the committee will discuss new drug application (NDA) 20-903, IntronA/Rebetol, (interferon alfa- 2b, recombinant/ribavirin, Schering Corp.) for the treatment of chronic hepatitis C. On May 5, 1998, the committee will discuss NDA 50-752, Priftin (rifapentine, Hoechst Marion Roussel, Inc.) for the treatment of pulmonary tuberculosis. On May 6, 1998, the committee will discuss NDA 20-871, NTZTM (nitazoxanide, UNIMED Pharmaceuticals, Inc.) for the treatment of diarrhea associated with cryptosporidiosis in acquired immune deficiency syndrome (AIDS) patients. Procedure: On May 4, 1998, from 8:30 a.m. to 5 p.m.; on May 5, 1998, from 8 a.m. to 10:30 a.m. and from 12 m. to 5 p.m.; and on May 6, 1998, from 9 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 April 27, 1998. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 m. on May 4 and May 6, 1998. On May 5, 1998, 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 April 27, 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 May 5, 1998, from 10:30 a.m. to 12 m., the meeting will be closed for a presentation of confidential material (5 U.S.C. 552(b)(2) and (b)(5)). On May 6, 1998, from 7:30 a.m. to 9 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential information (5 U.S.C. 552(b)(4)). The selected NDA's will be discussed. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 14, 1998. Michael A. Friedman, Deputy Commissioner for Operations. [FR Doc. 98-10311 Filed 4-17-98; 8:45 am] BILLING CODE 4160-01-F