[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Notices]
[Pages 70268-70270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


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

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 (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

[[Page 70269]]

displays 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of     Frequency of    Average time per response    Annual burden
           Type of respondents                     Survey instrument           respondents      response               (min/hr)                hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Participants/Board Members...............  CIRB Helpdesk Survey (Attachment           1,500               1  10/60 (.17 hour)...........             250
                                            1).
Participants.............................  NCI CIRB Institution Enrollment               30               1  3.5 hours..................             105
                                            Worksheet (Attachment 2A).
Participants.............................  IRB Staff at Signatory                        65               1  10/60 (.17 hour)...........              11
                                            Institution's IRB (Attachment
                                            2B).
Participants.............................  Investigator at Signatory                     65               1  10/60 (.17 hour)...........              11
                                            Institution (Attachment 2C).
Participants.............................  Research Staff at Signatory                   65               1  10/60 (.17 hour)...........              11
                                            Institution (Attachment 2D).
Participants.............................  Investigator at Affiliate                     65               1  10/60 (.17 hour)...........              11
                                            Institution (Attachment 2E).
Participants.............................  Research Staff at Affiliate                   65               1  10/60 (.17 hour)...........              11
                                            Institution (Attachment 2F).
Participants.............................  IRB at Signatory Institution                  65               1  10/60 (.17 hour)...........              11
                                            (Attachment 2G).
Participants.............................  Component Institution at                      65               1  10/60 (.17 hour)...........              11
                                            Signatory Institution
                                            (Attachment 2H).
Participants.............................  IRB at Affiliate Institution                  65               1  10/60 (.17 hour)...........              11
                                            (Attachment 2I).
Participants.............................  Institution Affiliate                         65               1  10/60 (.17 hour)...........              11
                                            Institution without an IRB
                                            (Attachment 2J).
Participants.............................  Request for 30-Day Access Form                50               1  10/60 (.17 hour)...........               8
                                            (Attachment 2K).
Participants.............................  Facilitated Review (FR)                    1,450               1  10/60 (.17 hour)...........             242
                                            Acceptance Form (Attachment 2L).
Participants.............................  Study Review Responsibility                  120               1  10/60 (.17 hour)...........              20
                                            Transfer Form (Attachment 2M).
Board Members............................  CIRB New Board Member                         16               1  30/60 (.5 hour)............               8
                                            Biographical Sketch Form
                                            (Attachment 3B).
Board Members............................  CIRB New Board Member Contact                 16               1  15/60 (.25 hour)...........               4
                                            Information Form (Attachment
                                            3C).
Board Members............................  CIRB New Board Member W-9                     16               1  15/60 (.25 hour)...........               4
                                            (Attachment 3D).
Board Members............................  CIRB New Board Member Non-                    16               1  15/60 (.25 hour)...........               4
                                            Disclosure Agreement (NDA)
                                            (Attachment 3E).
Board Members............................  Direct Deposit Form (Attachment               16               1  15/60 (.25 hour)...........               4
                                            4).
Participants.............................  NCI Adult CIRB Application                   150               1  2 hours....................             300
                                            (Attachment 5A).
Participants.............................  NCI Pediatric CIRB Application                62               1  2 hours....................             124
                                            (Attachment 5B).
Participants.............................  Adult/Pediatric CIRB                          10               1  2 hours....................              20
                                            Application--Ancillary Studies
                                            (Attachment 5C).
Participants.............................  Summary of CIRB Application                   20               1  30/60 (.5 hour)............              10
                                            Revisions (Attachment 5D).
Participants.............................  Adult/Pediatric CIRB Application             230               1  1 hour.....................             230
                                            for Continuing Review
                                            (Attachment 5E).
Board Members............................  Adult CIRB Reviewer Findings--                20               1  4 hours....................              80
                                            Initial Review of Cooperative
                                            Group Protocol (Attachment 6A).

[[Page 70270]]

 
Board Members............................  Pediatric CIRB Reviewer                       12               1  4 hours....................              48
                                            Findings--Initial Review of
                                            Cooperative Group Protocol
                                            (Attachment 6B).
Board Members............................  Adult CIRB Reviewer Findings                  25               1  1 hour.....................              25
                                            Cooperative Group Response to
                                            CIRB Review (Attachment 6C).
Board Members............................  Pediatric CIRB Reviewer Findings              70               1  1 hour.....................              70
                                            Cooperative Group Response to
                                            CIRB Review (Attachment 6D).
Board Members............................  Adult CIRB Reviewer Findings                 130               1  1.5 hours..................             195
                                            Amendment Cooperative Group
                                            Protocol (Attachment 6E).
Board Members............................  Pediatric CIRB Reviewer Findings              50               1  1.5 hours..................              75
                                            Amendment to Cooperative Group
                                            Protocol (Attachment 6F).
Board Members............................  Adult CIRB Reviewer Findings                 150               1  .5 hour....................              75
                                            Continuing Review of
                                            Cooperative Group Protocol
                                            (Attachment 6G).
Board Members............................  Pediatric CIRB Reviewer Findings             110               1  .5 hour....................              55
                                            Continuing Review of
                                            Cooperative Group Protocol
                                            (Attachment 6H).
Board Members............................  CIRB Reviewer Form (Attachment                20               1  2 hours....................              40
                                            6I).
Board Members............................  CIRB Statistical Reviewer Form                20               1  2 hours....................              40
                                            (Attachment 6J).
Board Members............................  CIRB SAE Reviewer Worksheet                   10              15  30/60 (.5 hour)............              75
                                            (Attachment 6K).
                                                                            ----------------------------------------------------------------------------
    Total................................  ................................           4,904  ..............  ...........................           2,209
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 [email protected] 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: 
[email protected].
    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.

    Dated: November 10, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-28883 Filed 11-16-10; 8:45 am]
BILLING CODE 4140-01-P