[Federal Register Volume 74, Number 133 (Tuesday, July 14, 2009)]
[Notices]
[Page 34025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-16703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0312]


Guidance for Institutional Review Boards, Frequently Asked 
Questions--Institutional Review Board Registration; 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 entitled ``Guidance for Institutional Review 
Boards (IRBs), Frequently Asked Questions -- IRB Registration.'' This 
guidance is intended to assist IRBs in complying with the new 
requirement for IRB registration. This new rule requires each IRB in 
the United States that reviews FDA-regulated research to register using 
an Internet-based registration system that is maintained by the 
Department of Health and Human Services (HHS). This registration system 
is a modification of the one currently used by the Office for Human 
Research Protections (OHRP) for registration of IRBs that are 
designated by institutions under Federalwide Assurances (FWAs). OHRP 
has issued a similar rule requiring IRBs designated by institutions 
under FWAs to register or update their registration information using 
this modified system.

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

ADDRESSES: Submit written comments on this 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.regulations.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Jean Toth-Allen, Office of Science and 
Health Coordination/Good Clinical Practice Program (HF-34), Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
1585.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance document for IRBs 
entitled, ``Guidance for Institutional Review Boards (IRBs), Frequently 
Asked Questions -- IRB Registration.'' This guidance is intended to 
assist IRBs in complying with the new requirement for IRB registration 
under amended 21 CFR 56.106, which is effective July 14, 2009. 
Registration will be accomplished through a modified version of the 
Internet-based registration system used by OHRP for registration of 
IRBs that are designated by institutions under FWAs. This guidance 
document addresses basic information, such as why FDA issued the new 
rule, which IRBs are subject to the new regulation, the type of 
information to be provided when registering, and implications of non-
compliance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance is being issued as 
a level 1 guidance for immediate implementation in accordance with 21 
CFR 10.115(g). Prior public participation is not feasible and FDA 
believes the guidance is necessary to help IRBs better understand their 
responsibilities under the new registration rule, which will go into 
effect on July 14, 2009.

II. The Paperwork Reduction Act of 1995

    This guidance refers to a previously approved collection of 
information required by the FDA new final rule on registration 
requirements. This collection of information is 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 collection of information in 21 
CFR 56.106(b) has been approved under 0990-0279.

III. Comments

    Interested persons may submit written or electronic comments 
regarding this document to the Division of Dockets Management (see 
ADDRESSES). 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. Received comments may be 
seen 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 
either http://www.fda.gov/oc/gcp/draft.html or http://www.fda.gov/ohrms/dockets/default.htm

    Dated: July 9, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-16703 Filed 7-13-09; 8:45 am]
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