[Federal Register Volume 69, Number 137 (Monday, July 19, 2004)]
[Notices]
[Pages 43003-43004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16316]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request; Evaluation of National
Cancer Institute's Central Institutional Review Board To Improve Cancer
Clinical Trials System
SUMMARY: In compliance with the requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the National Cancer Institute
(NCI), the National Institutes of Health (NIH) will publish periodic
summaries of proposed projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
Proposed Collection: Title: Evaluation of National Cancer
Institute's Central Institutional Review Board To Improve Cancer
Clinical Trials System. Type of Information Collection Request: NEW.
Need and Use of Information Collection: This study will evaluate the
success of the Central Institutional Review Board (CIRB), a pilot
project designed to streamline the protocol activation process by
conducting human subject protection reviews that can be utilized by
local Institutional Review Boards (IRBs) for facilitated approval of
multi-institutional, NCI-sponsored phase III clinical trails. This
evaluation includes two surveys that will be made available online to
minimize respondent burden. The CIRB Survey will assess acceptance
level and satisfaction of local IRB chairs, coordinators, and principal
investigators with the CIRB. The Cooperative Group Staff survey will
assess the opinions and experiences of the operations and regulations
staff of the nine Clinical Trials Cooperative Groups about CIRB
operations, office processes, and procedures. The findings will provide
valuable information concerning whether the CIRB is meeting its
intended goals and will provide recommendations for change and further
study. Frequency of Response: Once. Affected Public: Registered members
of the CIRB and Clinical Trials Cooperative Group staff. Type of
Respondents: IRB chairs, IRB coordinators, principal investigators, and
the operations and regulations staff of Clinical Trials Cooperative
Groups. The annualized cost to respondents is estimated at $5,500.
There are no Capital Costs to report. There are no Operating or
Maintenance Costs to report. Estimated Number of Respondents: 279.
Estimated Number of Responses per Respondent: 1. Average Burden per
Response: 0.50 Hours. Estimated Total Annual Burden Hours Requested:
139.50.
The total burden estimate per respondent is shown below:
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Estimated
Estimated total
Estimated number of Average annual
Type of respondents number of responses burden per burden
respondents per response hours
respondent requested
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IRB chairs, IRB coordinators, principal investigators.......... 225 1 0.50 112.50
Clinical Trials Cooperative Group operations and regulations 54 1 0.50 27
staff.........................................................
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Total...................................................... ........... .......... .......... 139.50
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Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility; (2) the
accuracy of the agency'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 those who are able to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Bryce B. Reeve, Ph.D, Outcomes Research Branch,
ARP, DCCPS, National Cancer Institute, 6130 Executive Blvd. MSC 7344,
Bethesda, MD 20892-7344. Phone: (301) 594-6574, e-mail:
[email protected].
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 60-days
of this publication.
Dated: July 12, 2004.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 04-16316 Filed 7-16-04; 8:45 am]
BILLING CODE 4140-01-M