[Federal Register: March 28, 2005 (Volume 70, Number 58)]
[Notices]               
[Page 15635-15636]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr05-51]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0103]

 
Draft Guidance for Industry on Using a Centralized Institutional 
Review Boards 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availability of a draft guidance for industry entitled ``Using a 
Centralized IRB Process in Multicenter Clinical Trials.'' The draft 
guidance is intended to assist sponsors, institutions, institutional 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's 
regulations by facilitating the use of a centralized IRB review 
process.

DATES: Submit written or electronic comments on the draft guidance by 
May 27, 2005. General comments on agency guidance documents are welcome 
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, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448. Send one self-addressed adhesive label to assist that 
office in processing your requests.
    Submit written comments on the draft guidance to the Division of 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. See the SUPPLEMENTARY 

INFORMATION section for electronic access to the draft guidance 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, Rockville, MD 
20852-1448, 301-827-6210, 301-827-7975; or
    Dave Lepay, Good Clinical Practice Program, Office of Science and 
Health Coordination (HF-34), Office of the Commissioner, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-3340.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Using a Centralized IRB Review 
Process in Multicenter Clinical Trials.'' The draft 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 draft guidance: (1) Describes the roles of the 
participants in a centralized IRB review process; (2) offers guidance 
on how a centralized IRB review process might address local aspects of 
IRB review; (3) makes recommendations about documenting agreements 
between a central IRB and the IRBs at institutions involved in the 
centralized IRB review process concerning their respective 
responsibilities; and (4) makes recommendations concerning written 
procedures for implementing a centralized review process. Finally, the 
draft guidance discusses using a central IRB at clinical trial sites 
not already affiliated with an IRB.
    This draft guidance applies to clinical investigations conducted 
under 21 CFR part 312 (investigational new drug application or IND 
regulations).
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft 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 draft guidance. 
Two copies of any mailed comments are to be submitted, 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 draft guidance and received comments are available for 
public examination in the Dockets Management Branch between 9 a.m. and 
4 p.m., Monday through Friday.

[[Page 15636]]

III. Electronic Access

    Persons with access to the Internet may obtain the draft 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.


    Dated: March 17, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-5977 Filed 3-25-05; 8:45 am]

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