03-23333. Peripheral and Central Nervous System Drugs Advisory Committee; Amendment of Notice

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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: [phone], or e-mail: [e-mail], 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 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.