[Federal Register Volume 63, Number 17 (Tuesday, January 27, 1998)]
[Notices]
[Pages 3902-3903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1944]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0535]
Agency Information Collection Activities: Institutional Review
Boards: Proposed Collection; Comment Request
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 FDA's protection of human
subjects recordkeeping and reporting requirements for institutional
review boards (IRB's). IRB's are groups composed of members of varying
backgrounds which are charged with reviewing the ethics and risk/
benefit aspects of clinical studies involving human subjects to assure
that the rights and welfare of human subjects are adequately protected.
DATES: Submit written comments on the collection of information by
March 30, 1998.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: JonnaLynn P. Capezzuto, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4659.
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 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 listed below.
[[Page 3903]]
With respect to the following collection of information, FDA
invites comments on: (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 Part 56.115)--(OMB Control
Number 0910-0130)--Extension
When reviewing clinical research studies regulated by FDA, IRB's
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 which 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 review activities; (5) copies of all correspondence between
investigators and the IRB; (6) statements of significant new findings
provided to subjects of the research; (7) 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 the FDA in conducting audit inspections of IRB's
to determine whether IRB's 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 Burden1
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Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Recordkeeper
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56.115 2,000 14.6 10,000 65 131,400
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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
formula: Approximately 2,000 IRB's review FDA-regulated research
involving human subjects annually. The burden for each of the
paragraphs under 21 CFR 56.115 has been considered as one for purposes
of estimating the burden. Each paragraph cannot reasonably be
segregated from one another because all are interrelated. FDA has about
2,000 IRB's in its inventory. The 2,000 IRB's meet on an average of
14.6 times annually. The mean number of IRB meetings per year was
derived from a study conducted by the agency and published by the
Office of Planning and Evaluation. The agency estimates that
approximately 4.5 hours of person time per meeting are required to
transcribe and type the minutes of the meeting, to maintain records of
continuing review activities, copies of all correspondence between the
IRB and investigators, member records, and written IRB procedures which
are approximately five pages per IRB.
Dated: January 20, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-1944 Filed 1-26-98; 8:45 am]
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