
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)]
[Notices]
[Pages 19056-19057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08327]


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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 or we) 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 (PRA).

DATES: Fax written comments on the collection of information by May 25, 
2017.

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: For specific questions for FDA related 
to this document, contact JonnaLynn Capezzuto, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-3794.

SUPPLEMENTARY INFORMATION: 

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: 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.
    The recordkeeping requirement burden is based on the following: The 
burden for the paragraphs under 21 CFR 56.115 has been considered as 
one

[[Page 19057]]

estimated burden. This burden estimate assumes that there are 
approximately 2,520 IRBs, that each IRB meets on an average of 14.6 
times annually, and that approximately 100 hours of person-time per 
meeting are required to meet the requirements of the regulation.
    In the Federal Register of November 1, 2016 (81 FR 75826), we 
published a 60-day notice requesting public comment on the proposed 
extension of this collection of information. No comments were received 
in response to the notice.
    FDA estimates the burden of this collection as follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                       Average burden
           21 CFR part 56; subpart D; records and reports               Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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56.115.............................................................           2,520             14.6           36,792              100        3,679,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: April 19, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-08327 Filed 4-24-17; 8:45 am]
 BILLING CODE 4164-01-P


