[Federal Register Volume 63, Number 246 (Wednesday, December 23, 1998)] [Notices] [Pages 71144-71145] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 98-33915] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cardiovascular and Renal 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). The meeting will be open to the public. Name of Committee: Cardiovascular and Renal Drugs 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 January 28, 1999, 9 a.m. to 5:30 p.m. and January 29, 1999, 8:30 a.m. to 4:30 p.m. Location: National Institutes of Health, Natcher Conference Center, 45 Center Dr., Bethesda, MD. Contact Person: Joan C. Standaert, Center for Drug Evaluation and Research (HFD-110), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 419-259-6211, or John M. Treacy (HFD-21), 301-827- 7001, or FDA Advisory Committee Information Line, 1-800-741-8138 (301- 443-0572 in the Washington, DC area), code 12533. Please call the Information Line for up-to-date information on this meeting. Agenda: On January 28, 1999, the committee will discuss new drug application (NDA) 20-931, TikosynTM Capsules (dofetilide), Pfizer Pharmaceuticals Production Corp., Ltd., for maintenance of normal sinus rhythm with associated symptomatic relief in patients with supraventricular arrhythmias, e.g., atrial flutter, atrial fibrillation, and paroxsysmal supraventricular tachycardia; and conversion of atrial fibrillation and flutter to normal sinus rhythm. On January 29, 1999, the committee will discuss NDA 20-920, NatrecorInjection (nesiritide), Scios, Inc., for short term treatment of congestive heart failure. Procedure: 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 January 18, 1999. Oral presentations from the public will be scheduled between approximately 9 a.m. and 10 a.m. on January 28, 1999. [[Page 71145]] Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before January 18, 1999, 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. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 16, 1998. Michael A. Friedman, Deputy Commissioner for Operations. [FR Doc. 98-33915 Filed 12-22-98; 8:45 am] BILLING CODE 4160-01-F