[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Pages 35492-35493]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12496]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0241]
Agency Information Collection Activities; Proposed Collection;
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 an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the recordkeeping requirements
for institutional review boards (IRBs).
DATES: Submit written or electronic comments on the collection of
information by August 27, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1482.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each
[[Page 35493]]
proposed collection of information, including each proposed extension
of an existing collection of information, before submitting the
collection to OMB for approval. To comply with this requirement, FDA is
publishing notice of the proposed collection of information set forth
in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Institutional Review Boards--21 CFR 56.115 (OMB Control Number 0910-
0130)--Extension
When reviewing clinical research studies regulated by FDA, 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.
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 of Total Annual Hours per
21 CFR Section Recordkeepers Recordkeeping Records Recordkeeper 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 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: June 21, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-12496 Filed 6-27-07; 8:45 am]
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