[Federal Register: February 19, 2003 (Volume 68, Number 33)]
[Page 8029-8030]
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). At least one 
portion of the meeting will be closed 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 6, 2003, from 8:30 
a.m. to 5 p.m.
    Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD, 301-948-8900.
    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 March 6, 2003, the committee will discuss new drug 
application 21-549, EMEND (aprepitant) Capsules, Merck & Co., Inc., for 
the following indication: ``EMEND, in combination with other antiemetic 
agents, is indicated for the prevention of acute and delayed nausea and 
vomiting associated with initial and repeat courses of highly 
emetogenic cancer chemotherapy, including high-dose cisplatin.''
    Background material for this meeting will be available 1 business 
day before the meeting on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
    Procedure: On March 6, 2003, from 8:30 a.m. to 4 p.m., the meeting 
is open to the public. Interested persons may

[[Page 8030]]

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 February 26, 2003. Oral presentations from the public 
will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before February 26, 
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.
    Closed Committee Deliberations: On March 6, 2003, from 4 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)).
    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: February 11, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-4002 Filed 2-18-03; 8:45 am]