[Federal Register: February 7, 2002 (Volume 67, Number 26)] [Notices] [Page 5830] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr07fe02-68] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Gastrointestinal 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: Gastrointestinal 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 March 19, 2002, from 8 a.m. to 5:30 p.m. Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver Spring, MD. Contact Person: Thomas H. Perez, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-6758, e-mail: PerezT@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12538. Please call the Information Line for up-to-date information on this meeting. Agenda: The committee will discuss standards in study designs of clinical trials testing the efficacy and safety of chemopreventive agents that are being developed to gain FDA approval in reducing the risk of sporadic colorectal adenomatous polyps and sporadic colorectal cancer. 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 March 11, 2002. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before March 11, 2002, 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. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Thomas H. Perez at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 31, 2002. Linda A. Suydam, Senior Associate Commissioner. [FR Doc. 02-2951 Filed 2-6-02; 8:45 am] BILLING CODE 4160-01-S