[Federal Register Volume 67, Number 202 (Friday, October 18, 2002)]
[Notices]
[Page 64400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26613]


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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 November 18 and 19, 
2002, from 8 a.m. to 5 p.m.
    Location: Holiday Inn, The Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Sandra 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 [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 November 18, 2002, the committee will discuss the role 
of brain imaging as an outcome measure in phase 3 trials of putative 
therapeutic drugs for Alzheimer's disease; the discussions will not 
focus on specific drugs or on specific applications to the agency. The 
agency is considering whether brain imaging modalities can be utilized 
as surrogate markers; that is, as primary outcomes in definitive 
clinical trials to measure drug effect in lieu of clinical outcomes. 
The committee will specifically discuss the following issues in 
reference to each imaging modality:
    1. How is the surrogate imaging modality best validated?
    2. If one uses an imaging modality to support a disease-modifying 
effect claim, how does one establish that such an effect occurs?
    3. Has any surrogate imaging modality been validated at the present 
time?
    4. Even if no surrogate imaging modality has currently been 
validated, is it appropriate to use one or more such modalities as 
primary or ancillary outcome measures of efficacy in phase 3 clinical 
trials?
    On November 19, 2002, the committee will consider a supplemental 
new drug application (NDA) 20-306 for F-18 fluorodeoxyglucose (FDG) 
positron emission tomography (PET) imaging proposed to diagnose and/or 
identify progression of Alzheimer's disease and other forms of 
dementia. This application is based on published multi-center 
controlled clinical trials, additional information provided by some of 
the literature authors, and other supportive literature. Considerations 
will include the relevance of current practice, knowledge of 
Alzheimer's disease process, and clinical trial design to establish 
clinical usefulness of F-18 FDG PET in Alzheimer's disease. (Downstate 
Medical Center, Peoria, IL, is the sponsor of the new drug application. 
The Academy of Molecular Imaging provided the literature references and 
the literature summary that formed the basis of the supplemental NDA.)
    The background material will become available no later than the day 
before the meeting and 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 2002 and 
scroll down to the Peripheral and Central Nervous Systems Drugs 
Advisory Committee meetings.)
    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 November 6, 
2002. Oral presentations from the public will be scheduled between 
approximately 11 a.m. and noon each day. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 6, 2002, 
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.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
outlets.
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Sandra Titus at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 10, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-26613 Filed 10-17-02; 8:45 am]
BILLING CODE 4160-01-S