[Federal Register: July 22, 2004 (Volume 69, Number 140)]
[Page 43852-43853]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2004N-0114]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Institutional Review 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
23, 2004.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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: 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, 
institutional review boards (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 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

[[Page 43853]]

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 IRBs to 
determine whether IRBs and clinical investigators are providing 
adequate protections to human subjects participating in clinical 
    In the Federal Register of March 17, 2004 (69 FR 12700), the agency 
requested comments on the proposed collection of information. FDA 
received one comment. The comment strongly disagreed with the estimate 
of the time required to transcribe and type the minutes of IRB 
meetings, to maintain records of continuing review activities, and to 
make copies of all correspondence between the IRB and investigative 
member records and of written IRB procedures. The comment explained 
that the burden estimate should include the time required to keep 
membership lists current, distribute educational materials to members, 
orient new members, instruct researchers and their staffs about IRB 
requirements, provide information to institutions, attend IRB meetings, 
transcribe discussions, incorporate all revisions into typed minutes 
and into the official IRB correspondence that is issued to 
investigators, collate materials, stamp, file, keypunch database entry, 
and other responsibilities. FDA has considered the comment and has 
revised the burden estimate to 100 hours.
    FDA estimates the burden of this collection of information as 

                                                   Table 1.--Estimated Annual Recordkeeping Burden\1\
                                                                   Annual Frequency of      Total Annual
               21 CFR Section                No. of Recordkeepers     Recordkeeping           Records        Hours per Recordkeeper      Total Hours
56.115                                                   5,000                   14.6             73,000                     100            7,300,000
Total                                        ....................  ...................  ...................  ......................         7,300,000
\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 100 hours of person-
time per meeting are required to meet requirements of the regulation.

    Dated: July 15, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-16628 Filed 7-21-04; 8:45 am]