[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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