[Federal Register: December 27, 1999 (Volume 64, Number 247)]
[Notices]               
[Page 72355]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de99-81]                         

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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 January 27 and 28, 2000, 
8 a.m. to 5 p.m.
    Location: Hilton, Salons A, B, and C, 620 Perry Pkwy., 
Gaithersburg, MD.
    Contact Person: Sandra L. Titus, 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, or e-mail TITUSS@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.
    Agenda: On January 27, 2000, the committee will consider the safety 
and efficacy of new drug application (NDA) 20-914, Promem<SUP>TM</SUP> 
(metrifonate, Bayer Corp., Pharmaceutical Division), proposed to treat 
mild to moderate dementia of the Alzheimer's type. On January 28, 2000, 
the committee will consider the safety and efficacy of NDA 21-120, 
Novantrone<Register> (mitoxantrone, Immunex Corp.) proposed to treat 
secondary progressive multiple sclerosis, including progressive 
relapsing disease.
    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 January 20, 
2000. Oral presentations from the public will be scheduled between 
approximately 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 January 20, 2000, 
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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 16, 1999.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 99-33395 Filed 12-23-99; 8:45 am]
BILLING CODE 4160-01-F