[Federal Register: November 18, 2002 (Volume 67, Number 222)]


[Page 69534-69535]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]




Food and Drug Administration


Peripheral and Central Nervous System Drugs Advisory Committee; 

Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 October 18, 2002 (67 FR 64400). The amendment is being made 

to reflect a change in the Date and Time and Agenda portions of the 

meeting. The meeting was originally scheduled for November 18 and 19, 

2002. However, due to administrative complications, the discussions on 

November 19, 2002, will be postponed until a later date. There are no 

other changes.


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 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 October 18, 2002 


[[Page 69535]]

FR 64400), FDA announced that a meeting of the Peripheral and Central 

Nervous System Drugs Advisory Committee would be held on November 18 

and 19, 2002. On page 64400, in the second column, the Date and Time 

and Agenda portions of the meeting are amended to read as follows:

    Date and Time: The meeting will be held on November 18, 2002, from 

8 a.m. to 5 p.m.

    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 


    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 


    Notice of this meeting is given under the Federal Advisory 

Committee Act (5 U.S.C. app. 2).

    Dated: November 13, 2002.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning, and Legislation.

[FR Doc. 02-29294 Filed 11-14-02; 1:54 pm]