Meetings: Drug Abuse Advisory Committee,
[Federal Register: April 8, 1998 (Volume 63, Number 67)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Drug Abuse Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
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: Drug Abuse 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 April 27, 1998, 1:30 p.m. to 5 p.m. and April 28, 1998, 8:30 a.m. to 5:30 p.m.
Location: Holiday Inn, Two Montgomery Village Ave., Gaithersburg, MD.
Contact Person: Karen M. Templeton-Somers, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-4090, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12535. Please call the Information Line for up-to-date information on this meeting.
Agenda: On April 27, 1998, the committee will discuss and review trade secret and/or confidential information. On April 28, 1998, the committee will: (1) Discuss the scientific evidence for initiating a scheduling action for ULTRAM‹Register› (tramadol hydrochloride), R. W. Johnson Pharmaceutical Research Institute, under the Controlled Substances Act; (2) evaluate the effectiveness of the independent steering committee in detecting, moderating, and preventing the physical
dependence and abuse of ULTRAM‹Register›; and (3) suggest improvements for surveillance of misuse.
Procedure: On April 28, 1998, from 8:30 a.m. to 5:30 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 April 17, 1998. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. on April 28, 1998. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before April 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 April 27, 1998, from 1:30 p.m. to 5 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)). The investigational new drug application (IND) and Phase I and Phase II drug products in process will be presented, and recent action on selected new drug applications (NDA's) will be discussed. This portion of the meeting will be closed to permit discussion of this information.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Dated: April 1, 1998. Michael A. Friedman, Deputy Commissioner for Operations.
[FR Doc. 98-9102Filed4-7-98; 8:45 am]
BILLING CODE 4160-01-F