[Federal Register Volume 75, Number 157 (Monday, August 16, 2010)]
[Notices]
[Pages 49938-49940]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-20167]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; NIH NCI Central 
Institutional Review Board (CIRB) Initiative (NCI)

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: 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 2221 hours (see Table below for the estimated 
time burden). 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 A.12-1--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                        1500                 1  10/60 (.17 hour).........               255
                                          (Attachment 1).
Participants...........................  NCI CIRB Institution                          30                 1  3.5 hours................               105
                                          Enrollment 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).

[[Page 49939]]

 
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).........                 9
                                          (Attachment 2K).
Participants...........................  Facilitated Review (FR)                     1450                 1  10/60 (.17 hour).........               247
                                          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                           16                 1  15/60 (.25 hour).........                 4
                                          (Attachment 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                         230                 1  1 hour...................               230
                                          Application for Continuing
                                          Review (Attachment 5E).
Board Members..........................  Adult CIRB Reviewer Findings--                20                 1  4 hours..................                80
                                          Initial Review of Cooperative
                                          Group Protocol (Attachment
                                          6A).
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                       70                 1  1 hour...................                70
                                          Findings 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                       50                 1  1.5 hours................                75
                                          Findings 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                      110                 1  .5 hour..................                55
                                          Findings 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..............................  ..............................  ................  ................  .........................              2221
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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

[[Page 49940]]

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.

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 Michael Montello, Pharm. D., CTEP, 6130 Executive 
Blvd., Rockville, MD 20852. At non-toll-free number 301-435-9206 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 60 days 
of the date of this publication.

    Dated: August 9, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-20167 Filed 8-13-10; 8:45 am]
BILLING CODE 4140-01-P