[Federal Register Volume 66, Number 122 (Monday, June 25, 2001)]
[Notices]
[Page 33711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-15781]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0132]


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by July 
25, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Institutional Review Boards (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 which 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 IRBs 
deliberations, and any employment relationship between each member and 
the IRBs 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.
    In the Federal Register of March 30, 2001 (66 FR 17427), the agency 
requested comments on the proposed collection of information. There 
were no comments received.
    FDA estimates the burden of this collection of information as 
follows:

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
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 21 CFR         No. of         Annual Frequency      Total Annual          Hours per
 Section     Recordkeepers     per Recordkeeping        Records          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 IRBs review FDA-regulated research 
involving human subjects annually. The burden for each of the 
paragraphs under Sec. 56.115 has been considered as one for the purpose 
of estimating the burden. Each paragraph cannot reasonably be 
segregated from one another because all are interrelated. FDA has about 
2,000 IRBs in its inventory. The 2,000 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 
investigator's member records, and written IRB procedures which are 
approximately five pages per IRB.
    In the Federal Register of June 9, 1998 (63 FR 31502), the agency 
requested comments on the proposed collections of information. No 
significant comments were received.

    Dated: June 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-15781 Filed 6-22-01; 8:45 am]
BILLING CODE 4160-01-S