[Federal Register: May 29, 2003 (Volume 68, Number 103)]
[Notices]
[Page 32061]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29my03-100]
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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.
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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
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: May 22, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-13318 Filed 5-28-03; 8:45 am]
BILLING CODE 4160-01-S