[Federal Register Volume 66, Number 49 (Tuesday, March 13, 2001)]
[Notices]
[Pages 14588-14589]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6241]


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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 a meeting of the Peripheral and Central 
Nervous System Drugs Advisory Committee. This meeting was announced in 
the Federal Register of February 14, 2001 (66 FR 10304). The amendment 
is being made to cancel the entire session on March 15, 2001. This 
meeting is open to the public. There are no other changes.

FOR FURTHER INFORMATION CONTACT: 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, 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.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 14, 2001 
(66 FR 10304), FDA announced that a meeting of the Peripheral and 
Central Nervous System Drugs Advisory Committee would be held on March 
13, 14, and 15, 2001. On page 10304, beginning in the last column, the 
Date and Time, Agenda, and Procedure portions of this meeting are 
amended to read as follows:
    Date and Time: The meeting will be held on March 13 and 14, 2001, 8 
a.m. to 5 p.m.
    Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Agenda: On March 13, 2001, the committee will discuss drug 
development for individuals with mild cognitive impairment (MCI). In 
the 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 
System 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 System Drugs meetings.)

[[Page 14589]]

    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. 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: March 7, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-6241 Filed 3-8-01; 4:21 pm]
BILLING CODE 4160-01-S