[Federal Register: March 28, 2006 (Volume 71, Number 59)]
[Notices]
[Page 15421-15422]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr06-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D-0489] (formerly Docket No. 01D-0489)
Guidance for Clinical Trial Sponsors: Establishment and Operation
of Clinical Trial Data Monitoring Committees; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Clinical Trial
Sponsors: Establishment and Operation of Clinical Trial Data Monitoring
Committees'' dated March 2006. The guidance is intended to assist
sponsors of clinical trials in determining when a data monitoring
committee (DMC) is needed for study monitoring, and how such committees
should operate. The guidance announced in this notice finalizes the
draft guidance entitled ``Guidance for Clinical Trial Sponsors on the
Establishment and Operation of Clinical Trial Data Monitoring
Committees'' dated November 2001.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Training, and Manufacturers Assistance
(HFM-40), Center for Biologics Evaluation and Research (CBER), Food and
Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448; the
Drug Information Branch (HFD-210), Center for Drug Evaluation and
Research (CDER), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857; or the Division of Small Manufacturers,
International, and Consumer Assistance (HFZ-220), Center for Devices
and Radiological Health, Food and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850. Send one self-addressed adhesive label to
assist the office in processing your requests. The guidance may also be
obtained by mail by calling CBER at 1-800-835-4709 or 301-827-1800; or
the CDRH Facts-On-Demand system at 1-800-899-0381 or 301-827-0111. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210; Robert Temple,
[[Page 15422]]
Center for Drug Evaluation and Research (HFD-40), 5600 Fishers Lane,
Rockville, MD 20857, 301-594-6758; or Joanne Less, Center for Devices
and Radiological Health (HFZ-403) 9200 Corporate Blvd., Rockville, MD
20850, 301-594-1190.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Clinical Trial Sponsors: Establishment and Operation of
Clinical Trial Data Monitoring Committees'' dated March 2006. The
guidance is intended to assist sponsors of clinical trials in
determining when a DMC is needed for study monitoring, and how such
committees should operate. The guidance addresses the roles,
responsibilities, and operating procedures of DMCs.
In the Federal Register of November 20, 2001 (66 FR 58151), FDA
announced the availability of the draft guidance entitled ``Guidance
for Clinical Trial Sponsors on the Establishment and Operation of
Clinical Trial Data Monitoring Committees'' dated November 2001. FDA
received a number of comments on the draft guidance and considered
those comments carefully as the guidance was finalized. The final
guidance also incorporates editorial and clarifying changes.
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance were approved under OMB
control number 0910-0581.
III. Comments
Interested persons may, at any time, submit written or electronic
comments to the Division of Dockets Management (see ADDRESSES)
regarding this guidance. Submit a single copy of electronic comments or
two paper copies of any mailed comments, except that individuals may
submit one paper copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. A copy of the
guidance and received comments are available for public examination in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm, http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance.htm, http://www.fda.gov/cdrh, or http://www.fda.gov/ohrms/
ov/ohrms/
dockets/default.htm.
Dated: March 17, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-4428 Filed 3-28-06; 8:45 am]
BILLING CODE 4160-01-S