[Federal Register: November 5, 2001 (Volume 66, Number 214)]
[Notices]
[Page 55943-55944]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05no01-57]
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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:
Whelan@cber.fda.gov.
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 The draft
guidance is intended to address scientific, ethical, and practical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