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Submission for OMB Review; Comment Request; NIH NCI Central Institutional Review Board (CIRB) Initiative (NCI)

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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 (NIH), 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 August 16, 2010 (75 FR 49938) and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow 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 Start Printed Page 70269displays a currently valid OMB control number.

Proposed Collection: Title: NIH NCI Central Institutional Review Board (CIRB). Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: The CIRB was created to reduce the administrative burden on local IRBs and investigators while protecting human research participants. To accomplish this, the CIRB uses several information collection tools to ensure that CIRB operations occur with high level of reviewer and board member satisfaction and is absent of conflicts of interest with the protocols under review. Tools utilized to accomplish this include the new member packets which are completed once a new member joins the CIRB to provide background information on workflow and processes of CIRB operations as well as a non-disclosure agreement. A conflict of interest form is completed occasionally or each time the reviewer is requested to serve as a reviewer for a study. CIRB helpdesk surveys measure satisfaction of helpdesk users and is conducted occasionally or each time the person contacts the helpdesk. Frequency of Response: Once, except for the SAE Reviewer Worksheet. Affected Public: Includes the Federal Government, business or other for-profits and not-for-profit institutions. Type of Respondents: Respondents include any customer who contacts the CIRB Helpdesk, institutional review board members and CIRB review participants. The annual reporting burden is estimated at 2209 hours (see Table 1 below for the estimated time burden). The total burden has decreased slightly as a result of corrected calculations from what was published in the 60-Day Federal Register Notice. The average annual cost to the government over a 12-month period is approximately $153,574 per year for a six year contract. This includes total annualized capital/start up costs of $25,108 and operating costs of $150,637.

Table 1—Estimates of Annual Burden Hours

Type of respondentsSurvey instrumentNumber of respondentsFrequency of responseAverage time per response (min/hr)Annual burden hours
Participants/Board MembersCIRB Helpdesk Survey (Attachment 1)1,500110/60 (.17 hour)250
ParticipantsNCI CIRB Institution Enrollment Worksheet (Attachment 2A)3013.5 hours105
ParticipantsIRB Staff at Signatory Institution's IRB (Attachment 2B)65110/60 (.17 hour)11
ParticipantsInvestigator at Signatory Institution (Attachment 2C)65110/60 (.17 hour)11
ParticipantsResearch Staff at Signatory Institution (Attachment 2D)65110/60 (.17 hour)11
ParticipantsInvestigator at Affiliate Institution (Attachment 2E)65110/60 (.17 hour)11
ParticipantsResearch Staff at Affiliate Institution (Attachment 2F)65110/60 (.17 hour)11
ParticipantsIRB at Signatory Institution (Attachment 2G)65110/60 (.17 hour)11
ParticipantsComponent Institution at Signatory Institution (Attachment 2H)65110/60 (.17 hour)11
ParticipantsIRB at Affiliate Institution (Attachment 2I)65110/60 (.17 hour)11
ParticipantsInstitution Affiliate Institution without an IRB (Attachment 2J)65110/60 (.17 hour)11
ParticipantsRequest for 30-Day Access Form (Attachment 2K)50110/60 (.17 hour)8
ParticipantsFacilitated Review (FR) Acceptance Form (Attachment 2L)1,450110/60 (.17 hour)242
ParticipantsStudy Review Responsibility Transfer Form (Attachment 2M)120110/60 (.17 hour)20
Board MembersCIRB New Board Member Biographical Sketch Form (Attachment 3B)16130/60 (.5 hour)8
Board MembersCIRB New Board Member Contact Information Form (Attachment 3C)16115/60 (.25 hour)4
Board MembersCIRB New Board Member W-9 (Attachment 3D)16115/60 (.25 hour)4
Board MembersCIRB New Board Member Non-Disclosure Agreement (NDA) (Attachment 3E)16115/60 (.25 hour)4
Board MembersDirect Deposit Form (Attachment 4)16115/60 (.25 hour)4
ParticipantsNCI Adult CIRB Application (Attachment 5A)15012 hours300
ParticipantsNCI Pediatric CIRB Application (Attachment 5B)6212 hours124
ParticipantsAdult/Pediatric CIRB Application—Ancillary Studies (Attachment 5C)1012 hours20
ParticipantsSummary of CIRB Application Revisions (Attachment 5D)20130/60 (.5 hour)10
ParticipantsAdult/Pediatric CIRB Application for Continuing Review (Attachment 5E)23011 hour230
Board MembersAdult CIRB Reviewer Findings—Initial Review of Cooperative Group Protocol (Attachment 6A)2014 hours80
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Board MembersPediatric CIRB Reviewer Findings—Initial Review of Cooperative Group Protocol (Attachment 6B)1214 hours48
Board MembersAdult CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attachment 6C)2511 hour25
Board MembersPediatric CIRB Reviewer Findings Cooperative Group Response to CIRB Review (Attachment 6D)7011 hour70
Board MembersAdult CIRB Reviewer Findings Amendment Cooperative Group Protocol (Attachment 6E)13011.5 hours195
Board MembersPediatric CIRB Reviewer Findings Amendment to Cooperative Group Protocol (Attachment 6F)5011.5 hours75
Board MembersAdult CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attachment 6G)1501.5 hour75
Board MembersPediatric CIRB Reviewer Findings Continuing Review of Cooperative Group Protocol (Attachment 6H)1101.5 hour55
Board MembersCIRB Reviewer Form (Attachment 6I)2012 hours40
Board MembersCIRB Statistical Reviewer Form (Attachment 6J)2012 hours40
Board MembersCIRB SAE Reviewer Worksheet (Attachment 6K)101530/60 (.5 hour)75

Request for Comments: Written comments and/or suggestions from the public and affected agencies should address one or more of the following points: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) Evaluate 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) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are 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 item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the Attention: NIH Desk Officer, Office of Management and Budget, at or by fax to 202-395-6974. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Jeanne Adler, Division of Cancer Treatment and Diagnosis or call non-toll-free number 301-594-0083 or e-mail your request, including your address to:

Comments Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.

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Dated: November 10, 2010.

Vivian Horovitch-Kelley,

NCI Project Clearance Liaison, National Institutes of Health.

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[FR Doc. 2010-28883 Filed 11-16-10; 8:45 am]