[Federal Register: June 15, 2004 (Volume 69, Number 114)]
[Notices]               
[Page 33392-33393]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15jn04-50]                         

-----------------------------------------------------------------------

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 July 14, 2004, from 8:30 
a.m. to 5 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Thomas H. Perez, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for

[[Page 33393]]

express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 
301-827-6758, FAX: 301-827-6776, or e-mail: PerezT@cder.fda.gov. Please 
call the FDA Advisory Information Line at 1-800-741-8138 (301-443-0572 
in the Washington, DC area), code 3014512538, for up-to-date 
information on this meeting.
    Agenda: The committee will discuss the efficacy and safety of new 
drug application (NDA) 21-200, ZELNORM (tegaserod maleate), 
for the proposed indication of the treatment of patients with chronic 
constipation and relief of associated symptoms of straining, hard or 
lumpy stools, and infrequent defecation.
    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 July 6, 2004. 
Oral presentations from the public will be scheduled between 
approximately 1:30 p.m. and 2:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before July 6, 2004, 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 notify 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: June 7, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-13430 Filed 6-14-04; 8:45 am]

BILLING CODE 4160-01-S