[Federal Register Volume 71, Number 59 (Tuesday, March 28, 2006)]
[Notices]
[Pages 15421-15422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4428]


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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draft guidance entitled ``Guidance for Clinical Trial Sponsors on the 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://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://www.fda.gov/cber/guidelines.htm, http://www.fda.gov/cder/guidance.htm, http://www.fda.gov/cdrh, or 
http://www.fda.gov/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