[Federal Register: March 16, 2006 (Volume 71, Number 51)]
[Notices]
[Page 13605-13606]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16mr06-53]
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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published a notice announcing the availability of a draft guidance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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cber/guidelines.htm., or http://www.fda.gov/ohrms/dockets/default.htm.
ets/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