[Federal Register Volume 72, Number 196 (Thursday, October 11, 2007)]
[Notices]
[Pages 57948-57949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-20063]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0241]


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 
November 13, 2007.

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: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0130.

FOR FURTHER INFORMATION CONTACT: Karen L. Nelson, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-4816.

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: 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 June 28, 2007 (72 FR 35492), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. 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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                                                              No. of         Annual Frequency       Total Annual
                    21 CFR Section                        Recordkeepers      per Recordkeeping        Records       Hours per  Record     Total Hours
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56.115                                                              5,000                  14.6             73,000                100          7,300,000
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Total                                                                                                                                          7,300,000
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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 5,000 IRBs. The IRBs meet 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.


[[Page 57949]]


    Dated: October 4, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20063 Filed 10-10-07; 8:45 am]
BILLING CODE 4160-01-S