[Federal Register: May 29, 2003 (Volume 68, Number 103)]
[Page 32061]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 June 25 and 26, 2003, 
from 8:30 a.m. to 5 p.m.
    Location: Marriott Washingtonian Center, The Ballrooms, 9751 
Washingtonian Blvd., Gaithersburg, MD, 301-590-0044.
    Contact Person: Thomas H. Perez, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for 
express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 
301-827-6758, or 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: On June 25, 2003, the committee will discuss new drug 
application (NDA) 21-597, SEROSTIM (somatropin), Serono, Inc., for the 
treatment of short bowel syndrome in patients receiving specialized 
nutritional support. SEROSTIM therapy should be used in conjunction 
with optimal management of short bowel syndrome. On June 26, 2003, the 
committee will discuss NDA 21-525, PHOTOFRIN (porfirmer sodium), Axcan 
Scandipharm, Inc. Photodynamic therapy with PHOTOFRIN is indicated for 
the ablation of high-grade dysplasia in Barrett's esophagus among 
patients who refuse esophagectomy and who are in overall good health.
    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 June 16, 2003. 
Oral presentations from the public will be scheduled between 1 p.m. and 
2 p.m. on both days. Time allotted for each presentation may be 
limited. Those desiring to make formal oral presentations should notify 
the contact person before June 16, 2003, 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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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: May 22, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-13318 Filed 5-28-03; 8:45 am]