[Federal Register: September 15, 2003 (Volume 68, Number 178)]
[Notices]               
[Page 53982-53983]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15se03-84]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Peripheral and Central Nervous System Drugs Advisory Committee; 
Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Peripheral and Central 
Nervous System Drugs Advisory Committee. This meeting was announced in 
the Federal Register of August 4, 2003, (68 FR 45827). The amendment is 
being made to reflect a change in the Agenda portion of the document. 
There are no other changes.

FOR FURTHER INFORMATION CONTACT: 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, or e-mail: 
patelA@cder.fda.gov, or FDA Advisory Committee Information Line, 1-800-
741-8138 (301-443-0572 in the Washington, DC area), code 12543. Please 
call the Information Line for up-to-date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 4, 2003, 
FDA announced that a meeting of the Peripheral and Central Nervous 
System Drugs Advisory Committee will be held on September 24 and 25, 
2003. On page 45827, in the third column, the Agenda portion of the 
meeting is amended to read as follows:
    Agenda: On September 24, 2003, the committee will discuss new drug

[[Page 53983]]

application (NDA) 21-487, memantine hydrochloride, Forest Laboratories, 
Inc., indicated for the treatment of moderate to severe dementia of the 
Alzheimer's type. On September 25, 2003, the committee will discuss 
supplementary new drug application 20-717 /S-008 Provigil (modafinil) 
Tablets, Cephalon, Inc., indicated for use to improve wakefulness in 
patients with excessive sleepiness associated with disorders of sleep 
and wakefulness.
    This notice is given under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: September 8, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-23333 Filed 9-12-03; 8:45 am]

BILLING CODE 4160-01-S