[Federal Register Volume 69, Number 52 (Wednesday, March 17, 2004)]
[Notices]
[Page 12700]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5991]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

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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 May 17, 2004.

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: 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 
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 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 
research.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
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                                                             Annual Frequency of                                    Hours per
          CFR Section             No. of Recordkeepers          Recordkeeping          Total Annual Records       Recordkeeper           Total Hours
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56.115                                            5,000                       14.6                    73,000                  4.5                328,500
Total                           .......................  ..........................  .......................  ....................               328,500
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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 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]
BILLING CODE 4160-01-S