[Federal Register Volume 70, Number 91 (Thursday, May 12, 2005)]
[Notices]
[Pages 25092-25093]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-9510]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; Comment Request; Evaluation of 
National Cancer Institute's Central Institutional Review Board To 
Improve Cancer Clinical Trials System

    Summary: Under the provisions of Section 3507(a)(1)(D) of the 
Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), 
the National Institutes of Health has submitted to the Office of 
Management and Budget (OMB) a request to review and approve the 
information collection listed below. This proposed information 
collection was previously published in the Federal Register on July 19, 
2004 on page 43003 and allowed 60 days for public comment. No public 
comments were received. The purpose of this notice is to allow an 
additional 30 days for public comment. The National Institutes of 
Health may not conduct or sponsor, and the respondent is not required 
to respond to, an information collection that has been extended, 
revised, or implemented on or after October 1, 1995, unless it displays 
a currently valid OMB control number.
    Proposed Collection: Title: Evaluation of National Cancer 
Institute's Central Institutional Review Board to Improve Cancer 
Clinical Trials System. Type of

[[Page 25093]]

Information Collection Request: NEW. Need and Use of Information 
Collection: This study will evaluate the effectiveness 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 (IRB) for facilitated approval of multi-institutional, NCI-
sponsored Phase 3 clinical trials. 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.

                                 Table 1.--Total Burden Estimate Per Respondent
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                                                                     Estimated                       Estimated
                                                     Estimated       number of    Average burden   total annual
               Type of respondent                    number of     responses per   per  response    burden hour
                                                    respondents     respondent                        request
----------------------------------------------------------------------------------------------------------------
IRB Chairs, IRB Coordinators, principal                      225               1            0.50          112.50
 investigators..................................
Clinical Trials Cooperative Group operations and              54               1            0.50              27
 regulations staff..............................
                                                 -----------------
    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 on 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.
    Direct Comments to OMB: Written comments and/or suggestions 
regarding the items contained in this notice, especially regarding the 
estimated public burden and associated response time, should be 
directed to the: Office of Management and Budget, Office of Regulatory 
Affairs, New Executive Office Building, Room 10235, Washington, DC 
20503, Attention: Desk Officer for NIH. To request more information on 
the proposed project or to obtain a copy of the data collection plans 
and instruments, contact Bryce B. Reeve, PhD, 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 30 days 
of this publication.

    Dated: May 1, 2005.
Rachelle Ragland-Greene,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 05-9510 Filed 5-11-05; 8:45 am]
BILLING CODE 4101-01-P