[Federal Register Volume 71, Number 51 (Thursday, March 16, 2006)]
[Notices]
[Pages 13605-13606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3785]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0103]


Guidance for Industry on Using a Centralized IRB Process in 
Multicenter Clinical Trials; 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 guidance for industry entitled ``Using a Centralized 
IRB Process in Multicenter Clinical Trials.'' The guidance is intended 
to assist sponsors, institutions, institutional review boards (IRBs), 
and clinical investigators involved in multicenter clinical research in 
meeting the requirements of FDA regulations by

[[Page 13606]]

facilitating the use of a centralized IRB review process.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information (HFD-240), Center for Drug Evaluation 
and Research, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, or 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 guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 301-827-1800. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.

FOR FURTHER INFORMATION CONTACT:
    Nancy Stanisic, Center for Drug Evaluation and Research (HFD-1), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-827-1660, or
    Steve Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration,1401 Rockville Pike, suite 200N, 
Rockville, MD 20852-1448, 301-827-6210, or
    David Lepay, Good Clinical Practice Program, Office of Science and 
Health Coordination (HF-34), 5600 Fishers Lane, Rockville, MD 20857, 
301-827-3340.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 28, 2005 (70 FR 15635), FDA 
published a notice announcing the availability of a draft guidance 
entitled ``Using a Centralized IRB Process in Multicenter Clinical 
Trials.'' The notice gave interested persons an opportunity to submit 
comments by May 27, 2005. The agency received only a small number of 
comments, and we carefully considered the received comments as we 
finalized the draft guidance. Other than minor editorial changes and 
some clarifications, no substantive changes were made to the draft 
guidance.
    This guidance is intended to assist sponsors, institutions, IRBs, 
and clinical investigators involved in multicenter clinical research in 
meeting the requirements of 21 CFR part 56 by facilitating the use of a 
centralized IRB review process. The guidance does the following: (1) 
Describes the roles of the participants in a centralized IRB review 
process, (2) offers guidance on how a centralized IRB review process 
might consider the concerns and attitudes of the various communities 
participating in a multicenter clinical trial, (3) makes 
recommendations about documenting agreements between a central IRB and 
the IRBs at institutions involved in the centralized IRB review process 
concerning the responsibilities of a central IRB and each institution's 
IRB, and (4) discusses IRB procedures for implementing a centralized 
review process. Finally, the guidance recommends how to ensure 
effective IRB review for clinical trial sites not already affiliated 
with an IRB. This guidance applies to clinical investigations conducted 
under 21 CFR part 312 (investigational new drug application or IND 
regulations).
    This level 1 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. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance. Submit 
a single copy of electronic comments or two paper copies, 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. 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.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.fda.gov/cder/guidance/index.htm. http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 7, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3785 Filed 3-15-06; 8:45 am]
BILLING CODE 4160-01-S