[Federal Register: July 22, 2004 (Volume 69, Number 140)]
[Notices]
[Page 43852-43853]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jy04-77]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0114]
Agency Information Collection Activities; Submission for Office
of Management and Budget 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 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
research.
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
follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
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Annual Frequency of Total Annual
21 CFR Section No. of Recordkeepers Recordkeeping Records Hours per Recordkeeper Total Hours
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56.115 5,000 14.6 73,000 100 7,300,000
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Total .................... ................... ................... ...................... 7,300,000
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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 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]
BILLING CODE 4160-01-S