[Federal Register Volume 66, Number 31 (Wednesday, February 14, 2001)]
[Notices]
[Pages 10304-10305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3665]


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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 March 13, 14, and 15, 
2001, 8 a.m. to 5 p.m.
    Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact: Sandra L. Titus or Lauren W. Parcover, 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: [email protected], 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 March 13, 2001, the committee will discuss drug 
development for individuals with mild cognitive impairment (MCI). In 
the

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recent literature there has been a discussion of an entity referred to 
as MCI. While MCI is considered by some to be a distinct clinical 
entity, others consider that the majority of patients diagnosed with 
MCI have an early form of Alzheimer's Disease. It is critical for 
regulatory purposes that the issues surrounding this diagnosis are 
fully explored. Toward that end the committee will listen to speakers 
and discuss the following and other related questions:
    1. Can MCI be clearly defined in a clinical setting?
    2. Are there valid criteria for the diagnosis of MCI?
    3. Can MCI be distinguished from Alzheimer's Disease and other 
causes of dementia?
    4. What outcome measures are appropriate to use in clinical drug 
trials conducted in MCI?
    5. Should clinical drug trials in MCI incorporate any special 
features in their design?
    On March 14, 2001, the committee will discuss drug development for 
individuals with vascular dementia. While vascular dementia is 
considered by some to be a distinct entity others do not agree that it 
can be easily distinguished from Alzheimer's Disease and/or other 
dementias. It is critical for regulatory purposes that the issues 
surrounding this diagnosis are fully explored. Toward that end the 
committee will listen to presentations and then discuss the following 
and other related questions:
    1. Can vascular dementia be clearly defined in a clinical setting?
    2. Are there valid criteria for the diagnosis of vascular dementia?
    3. Can vascular dementia be distinguished from Alzheimer's Disease 
and other causes of dementia?
    4. What outcome measures are appropriate to use in clinical drug 
trials conducted in vascular dementia?
    5. Should clinical drug trials in vascular dementia incorporate any 
special features in their design?
    FDA will provide a background position paper on MCI and on vascular 
dementia prior to each meeting. When the background material becomes 
available, it will be posted under the Peripheral and Central Nervous 
Systems Drugs Advisory Committee Docket site at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm. (Click on the year 2001 and scroll down to 
the Peripheral and Central Nervous Systems Drugs meetings.)
    On March 15, 2001, the committee will consider the safety and 
efficacy of new drug application (NDA) 21-196, Xyrem (sodium 
oxybate, Orphan Medical, Inc.), proposed to reduce the incidence of 
cataplexy and to improve the symptom of daytime sleepiness for persons 
with narcolepsy. A main focus of the deliberations will be on risk 
management issues.
    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 March 1, 2001. 
On March 13 and 14, 2001, oral presentations from the public will be 
scheduled between approximately 10:30 a.m. and 12:30 p.m. Time allotted 
for each presentation may be limited. On March 15, 2001, oral 
presentations from the public will be scheduled between approximately 1 
p.m. and 1:30 p.m. Those desiring to make formal oral presentations 
should notify the contact person before March 1, 2001, 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: February 6, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-3665 Filed 2-13-01; 8:45 am]
BILLING CODE 4160-01-S