Document ID: FDA-2010-N-0418-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Institutional Review Boards
Posted Date: 2010-12-15T05:00Z

[Federal Register Volume 75, Number 240 (Wednesday, December 15, 2010)]
[Notices]
[Page 78252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31389]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0418]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Institutional Review 
Boards

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by January 
14, 2011.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0130. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850,. 301-796-3792. 
Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Institutional Review Boards--OMB Control Number 0910-0130--Extension

    When reviewing clinical research studies regulated by FDA, 
institutional review boards (IRBs) are required to create and maintain 
records describing their operations, and make the records available for 
FDA inspection when requested. These records include: Written 
procedures describing the structure and membership of the IRB and the 
methods that the IRB will use in performing its functions; the research 
protocols, informed consent documents, progress reports, and reports of 
injuries to subjects submitted by investigators to the IRB; minutes of 
meetings showing attendance, votes and decisions made by the IRB, the 
number of votes on each decision for, against, and abstaining, the 
basis for requiring changes in or disapproving research; records of 
continuing review activities; copies of all correspondence between 
investigators and the IRB; statement of significant new findings 
provided to subjects of the research; and a list of IRB members by 
name, showing each member's earned degrees, representative capacity, 
and experience in sufficient detail to describe each member's 
contributions to the IRB's deliberations, and any employment 
relationship between each member and the IRB's institution. This 
information is used by FDA in conducting audit inspections of IRBs to 
determine whether IRBs and clinical investigators are providing 
adequate protections to human subjects participating in clinical 
research.
    In the Federal Register of August 17, 2010 (75 FR 50766), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received regarding the 
information collection.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                           Annual
                           21 CFR section                               Number of      frequency per     Total annual      Hours per       Total hours
                                                                      recordkeepers    recordkeeping       records        recordkeeper
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56.115.............................................................            2,500             14.6           36,500              100        3,650,000
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    Total..........................................................  ...............  ...............  ...............  ...............        3,650,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The recordkeeping requirement burden is based on the following: The 
burden for each of the paragraphs under 21 CFR 56.115 has been 
considered as one estimated burden. FDA estimates that there are 
approximately 2,500 IRBs. The IRBs meet on an average of 14.6 times 
annually. The agency estimates that approximately 100 hours of person-
time per meeting are required to meet the requirements of the 
regulation.

    Dated: December 8, 2010.
Leslie Kux,
Acting Assistant, Commissioner for Policy.
[FR Doc. 2010-31389 Filed 12-14-10; 8:45 am]
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