[Federal Register Volume 78, Number 163 (Thursday, August 22, 2013)]
[Notices]
[Pages 52204-52206]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20415]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-day 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), 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.
    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 function 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 to respond, including the 
use of appropriate automated, electronic, mechanical, or other 
technological collection techniques or other forms of information 
technology.
    To Submit Comments and for Further Information: To obtain a copy of 
the data collection plans and instruments, submit comments in writing, 
or request more information on the proposed project, contact: CAPT 
Michael Montello, Pharm. D., MBA, Cancer Therapy Evaluation Program, 
Operations and Informatics Branch, 9609 Medical Center Drive, 
Rockville, MD 20850 or call non-toll-free number (240) 276-6080 or 
Email your request, including your address to: [email protected]. 
Formal requests for additional plans and instruments must be requested 
in writing.
    Comment 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.
    Proposed Collection: NIH NCI Central Institutional Review Board 
(CIRB) Initiative (NCI), 0925-0625, Revision, National Cancer Institute 
(NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: The National Cancer 
Institute (NCI) Central Institutional Review Board (CIRB) provides a 
centralized approach to human subject protection and provides a cost 
efficient approach avoiding duplication of effort at each institution. 
The CIRB provides the services of a fully constituted IRB and provides 
a comprehensive and efficient mechanism to meet regulatory requirements 
pertaining to human subject protections including: Initial reviews, 
continuing reviews, review of amendments, and adverse events. The 
Initiative consists of three central IRBs: Adult CIRB--late phase 
emphasis, Adult CIRB--early phase emphasis, and Pediatric CIRB. CIRB 
membership includes oncology physicians, surgeons, nurses, patient 
advocates, ethicists, statisticians, pharmacists, attorneys and other 
health professionals. The benefits of the CIRB Initiative reaches 
research participants, investigators and research staff, Institutional 
Review Boards (IRB), and Institutions. Benefits include: Study 
participants having dedicated review of NCI-sponsored trials for 
participant protections, access to more trials more quickly and access 
to trials for rare diseases, accrual to trials begin more rapidly, ease 
of opening trials, elimination of need to submit study materials to 
local IRBs, and elimination of the need for a full board review. The 
benefits to the National Clinical Trials Network and Experimental 
Therapy-Clinical Trials Network include a cost efficient approach that 
avoids duplication of efforts at each institution. A variety of 
information collection tools are needed to support NCI's CIRB 
activities which include: Worksheets, forms and a survey that is 
provided to all customers contacting the CIRB helpdesk.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 2,199.

[[Page 52205]]



                                                            Estimates of Annual Burden Hours
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                                                                                                           Frequency of   Average burden
                   Form name                               Type of respondents               Number of     responses per   per response    Total annual
                                                                                            respondents     respondent      (in hours)     burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
CIRB Customer Satisfaction Survey..............  Participants/Board Members.............            1500               1           10/60             250
Request for 30 Day Web site Access Form........  Participants...........................              25               1           10/60               4
Authorization Agreement and Division of          Participants...........................             340               1           30/60             170
 Responsibilities between the NCI CIRB and
 Signatory Institution.
NCI CIRB Signatory Enrollment Form.............  Participants...........................              40               1               4             160
IRB Staff at Signatory Institution's IRB.......  Participants...........................              25               1           10/60               4
Investigator at Signatory Institution..........  Participants...........................              65               1           10/60              11
Research Staff at Signatory Institution........  Participants...........................              65               1           10/60              11
Investigator at Affiliate Institution with an    Participants...........................              25               1           10/60               4
 IRB.
Research Staff at Affiliate Institution with an  Participants...........................              25               1           10/60               4
 IRB.
Investigator at Affiliate Institution without    Participants...........................              25               1           10/60               4
 an IRB.
Research Staff at Affiliate Institution without  Participants...........................              25               1           10/60               4
 an IRB.
Institutional Contact for Signatory Institution  Participants...........................              65               1           10/60              11
IRB at Signatory Institution...................  Participants...........................              25               1           10/60               4
Component Institution at Signatory Institution.  Participants...........................              65               1           10/60              11
IRB at Affiliate Institution...................  Participants...........................              25               1           10/60               4
Affiliate Institution without an IRB...........  Participants...........................              25               1           10/60               4
Facilitated Review Acceptance Form.............  Participants...........................             300               1           10/60              50
Study Review Responsibility Transfer Form......  Participants...........................              80               1           10/60              13
Annual Signatory Institution Worksheet About     Participants...........................             120               1           20/60              40
 Local Context.
Annual Principal Investigator Worksheet About    Participants...........................             120               1           20/60              40
 Local Context.
Study-Specific Worksheet About Local Context...  Participants...........................             220               1           20/60              73
Study Closure or Transfer of Study Review        Participants...........................             120               1           10/60              20
 Responsibility Form.
Potential Unanticipated Problem or Serious or    Participants...........................             120               1           15/60              30
 Continuing Noncompliance Reporting Form.
Add or Remove Signatory and/or Component         Participants...........................             120               1           10/60              20
 Institution Personnel.
Add or Remove Affiliate Institution Personnel..  Participants...........................             120               1           10/60              20
Add or Remove Component Institution............  Participants...........................             120               1           10/60              20
Add or Remove Affiliate Institution............  Participants...........................             120               1           10/60              20
One Time Study Roll Over Worksheet.............  Participants...........................             120               1           10/60              20
Change of Signatory Institution PI Form........  Participants...........................             120               1           10/60              20
CIRB Board Member Biographical Sketch Form.....  Board Members..........................              25               1           15/60            6.25
CIRB Board Member Contact Information Form.....  Board Members..........................              25               1           10/60               4
CIRB Board Member W-9..........................  Board Members..........................              25               1           15/60               6
CIRB Board Member Non-Disclosure Agreement       Board Members..........................              25               1           10/60               4
 (NDA).
CIRB Direct Deposit Form.......................  Board Members..........................              25               1           15/60               6
NCI Adult/Pediatric CIRB Application for         Participants...........................              25               1               2              50
 Treatment Studies.
NCI Adult/Pediatric CIRB Application for         Participants...........................              10               1               2              20
 Ancillary Studies.
NCI Adult/Pediatric CIRB Application for         Participants...........................              80               1               1              80
 Continuing Review.
Summary of CIRB Application Revisions..........  Participants...........................              20               1           30/60              10
Locally-Developed Material Submission Form.....  Participants...........................              15               1           15/60               4
Application Request to Review Translated         Participants...........................              15               1           15/60               4
 Documents.
Adult Initial Review of Cooperative Group        Board Members..........................              15               1               4              60
 Protocol.
Pediatric Initial Review of Cooperative Group    Board Members..........................              15               1               4              60
 Protocol.
Adult Continuing Review of Cooperative Group     Board Members..........................             130               1               1             130
 Protocol.
Pediatric Continuing Review of Cooperative       Board Members..........................              70               1               1              70
 Group Protocol.
Adult Amendment of Cooperative Group Protocol..  Board Members..........................              10               1               2              20
Pediatric Amendment of Cooperative Group         Board Members..........................              10               1               2              20
 Protocol.
Adult Cooperative Group Response to CIRB Review  Participants...........................              15               1               1              15
Pediatric Cooperative Group Response to CIRB     Participants...........................              10               1               1              10
 Review.
Adult Pharmacist's Review of a Cooperative       Board Members..........................              10               1               2              20
 Group Study.
Pediatric Pharmacist's Review of a Cooperative   Board Members..........................              20               1               2              40
 Group Study.
CIRB Statistical Reviewer Form.................  Board Members..........................              30               1           30/60              15
Determination of Unanticipated Problem (UP) and/ Board Members..........................              40               1           10/60               7
 or Serious or Continuing Noncompliance (SCN).
Adult Expedited Amendment Review...............  Board Members..........................             350               1           30/60             175

[[Page 52206]]

 
Ped Expedited Amendment Review.................  Board Members..........................             150               1           30/60              75
Adult Expedited Continuing Review..............  Board Members..........................             120               1           30/60              60
Ped Expedited Continuing Review................  Board Members..........................              70               1           30/60              35
Adult Expedited Study Closure..................  Board Members..........................              20               1           20/60               7
Ped Expedited Study Closure....................  Board Members..........................              20               1           20/60               7
Adult Expedited Study Chair Response to          Board Members..........................             350               1           15/60              88
 Required Mod.
Ped Expedited Study Chair Response to Required   Board Members..........................             150               1           15/60              38
 Mod.
Reviewer Worksheet of Translated Documents.....  Board Members..........................              15               1           15/60               4
Reviewer Advertisement Checklist...............  Board Members..........................              10               1           20/60               3
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    Dated: August 15, 2013.
Vivian Horovitch-Kelley,
Program Analyst, National Institutes of Health.
[FR Doc. 2013-20415 Filed 8-21-13; 8:45 am]
BILLING CODE 4140-01-P