[Federal Register Volume 66, Number 214 (Monday, November 5, 2001)]
[Notices]
[Pages 55943-55944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-27643]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0489]


Draft FDA Guidance on the Establishment and Operation of Clinical 
Trial Data Monitoring Committees; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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    The Food and Drug Administration (FDA), Center for Biologics 
Evaluation and Research (CBER), Center for Drug Evaluation and Research 
(CDER), and Center for Devices and Radiological Health (CDRH), is 
announcing the following public meeting: Draft FDA Guidance on the 
Establishment and Operation of Clinical Trial Data Monitoring 
Committees (DMCs). The topics to be discussed are addressed in the 
draft entitled ``Guidance for Clinical Trial Sponsors On the 
Establishment and Operation of Data Monitoring Committee.'' These 
topics include: The history of DMCs, the types of clinical trials in 
which DMCs are most important, DMC membership and operations, 
independence of DMCs, and the regulatory requirements relevant to DMCs.
    Date and Time: The meeting will be held on November 27, 2001, from 
9 a.m. to 5 p.m.
    Location: The meeting will be held at The Hyatt Regency Bethesda, 
One Bethesda Metro Center, Bethesda, MD 20814.
    Contact: Melanie Whelan, Center for Biologics Evaluation and 
Research (HFM-40), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448, 301-827-3841, FAX 301-827-3843, or e-mail:
    [email protected].
    Registration: Send registration information (including name, title, 
firm name, address, telephone, and fax number), to Melanie Whelan 
(address above) by November 20, 2001. We encourage early registration 
because seating is limited. There is no registration fee.
    If you need special accommodations due to a disability, please 
contact Melanie Whelan at least 7 days in advance.

SUPPLEMENTARY INFORMATION: This meeting will provide a forum for all 
members of the public to express their opinions and suggestions on the 
draft entitled ``Guidance for Clinical Trial Sponsors On the 
Establishment and Operation of Data Monitoring Committees.'' The draft 
guidance is intended to address scientific, ethical, and practical 
issues related to the establishment and operation of DMCs for clinical 
trials. The meeting will be of primary interest to sponsors of clinical 
trials evaluating FDA-regulated products. The objectives of the meeting 
are to: (1) Present the material in the draft guidance document and (2) 
solicit

[[Page 55944]]

your comments and recommendations on the draft guidance document. The 
draft guidance will be announced in the Federal Register for public 
comment and posted on the Internet at
http://www.fda.gov/cber/guidelines.htm.
    Transcripts: Transcripts of the meeting may be requested in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, 
approximately 15 working days after the meeting at a cost of 10 cents 
per page. The public meeting transcript will also be available on the 
Internet at 
http://www.fda.gov/cber/minutes/workshop-min.htm.

    Dated: October 30, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-27643 Filed 11-02-01; 8:45 am]
BILLING CODE 4160-01-S