Document ID: FDA-2013-N-1163-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Institutional
Review Boards
Posted Date: 2014-03-04T05:00Z

[Federal Register Volume 79, Number 42 (Tuesday, March 4, 2014)]
[Notices]
[Pages 12202-12203]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04707]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1163]

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 April 
3, 2014.

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 emailed 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@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--21 CFR 56.115--(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: (1) Written 
procedures describing the structure and membership of the IRB and the 
methods that the IRB will use in performing its functions; (2) the 
research protocols, informed consent documents, progress reports, and 
reports of injuries to subjects submitted by investigators to the IRB; 
(3) 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; (4) records of continuing

[[Page 12203]]

review activities; copies of all correspondence between investigators 
and the IRB; (5) statement of significant new findings provided to 
subjects of the research; and (6) 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.
    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.
    In the Federal Register of October 1, 2013 (78 FR 60286), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

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

    Dated: February 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04707 Filed 3-3-14; 8:45 am]
BILLING CODE 4160-01-P