[Federal Register Volume 70, Number 128 (Wednesday, July 6, 2005)]
[Notices]
[Pages 38967-38968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-13206]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Peripheral and Central Nervous System 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: Peripheral and Central Nervous System 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 August 4, 2005, from 8 
a.m. to 5 p.m.
    Location: Center for Drug Evaluation and Research (CDER) Advisory 
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Anuja Patel, 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, 
301-827-7001, FAX: 301-827-6776, e-mail: [email protected], or FDA 
Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 3014512543. Please call the Information 
Line for up-to-date information on this meeting. When available, 
background materials for this meeting will be posted 1 business day 
prior to the meeting on the FDA Web site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2005 and scroll down to 
Peripheral and Central Nervous System Drugs Advisory Committee).
    Agenda: The committee will discuss new drug application (NDA) 21-
645, proposed trade name MT100 (naproxen sodium and metoclopramide 
hydrochloride) Tablets, Pozen, Inc., for the proposed indication of 
acute treatment of migraine headache with or without aura.
    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 22, 2005. 
Oral presentations from the public will be scheduled between 
approximately 1

[[Page 38968]]

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 July 22, 2005, 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 John Lauttman at 
301-827-7001, 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 23, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-13206 Filed 7-5-05; 8:45 am]
BILLING CODE 4160-01-S