[Federal Register: March 17, 2004 (Volume 69, Number 52)]
[Page 12700]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0114]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Institutional Review Boards

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


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 May 17, 2004.

ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: Karen L. Nelson, Office of Management
Programs (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 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 Part 56.115)--(OMB Control Number

    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 the following: (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; records of continuing
review activities; (4) 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
    FDA estimates the burden of this collection of information as

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
                                                             Annual Frequency of                                    Hours per
          CFR Section             No. of Recordkeepers          Recordkeeping          Total Annual Records       Recordkeeper           Total Hours
56.115                                            5,000                       14.6                    73,000                  4.5                328,500
Total                           .......................  ..........................  .......................  ....................               328,500
\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 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; and to
make copies of all correspondence between the IRB and investigative
member records, and written IRB procedures that are approximately five
pages per IRB.

    Dated: March 9, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5991 Filed 3-16-04; 8:45 am]