[Federal Register Volume 66, Number 62 (Friday, March 30, 2001)]
[Notices]
[Pages 17427-17428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7839]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0132]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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[[Page 17428]]

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 that 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 or electronic comments on the collection of 
information by May 29, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
via the Internet at http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. Submit written comments on the collection of 
information to the Dockets Management Branch (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 Information 
Resources Management (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: (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--Section 56.115 (21 CFR 56.115) (OMB 
Control No. 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: 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 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 Burden\1\
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                                                    Annual Frequency per
    21 CFR Section        No. of Recordkeepers          Recordkeeping         Total Annual Records     Hours per Recordkeeper          Total Hours
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56.115                                    2,000                      14.6                    29,200                       4.5                   131,400
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Total                                                                                                                                           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 Sec. 56.115 has been considered as one estimated 
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 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 23, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-7839 Filed 3-29-01; 8:45 am]
BILLING CODE 4160-01-S