[Federal Register Volume 78, Number 223 (Tuesday, November 19, 2013)]
[Notices]
[Pages 69426-69428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27556]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day 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 Institutes of Health (NIH), has 
submitted to the Office of Management and Budget (OMB) a request for 
review and approval of the information collection listed below. This 
proposed information collection was previously published in the Federal 
Register on August 22, 2013, Vol. 78, P. 52204 and allowed 60-days for 
public comment. There were no public comments received. The purpose of 
this notice is to allow an additional 30 days for public comment. The 
National Cancer Institute (NCI), 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.
    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: Office of Management and Budget, Office of Regulatory 
Affairs, [email protected] or by fax to 202-395-6974, 
Attention: NIH Desk Officer.
    Comment 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.

FOR FURTHER INFORMATION: To obtain a copy of the data collection plans 
and instruments 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.
    Proposed Collection: NIH NCI Central Institutional Review Board 
(CIRB) Initiative (NCI), 0925-0625, Expiration Date 1/31/2014, 
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.

                                                            Estimates of Annual Burden Hours
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                                                                                                                              Average
                                                                                             Number of     Frequency of     burden per     Total annual
                  Form name                               Type of respondents               respondents    responses per   response  (in   burden hours
                                                                                                            respondent        hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
CIRB Customer Satisfaction Survey...........  Participants/Board Members................           1,500               1           10/60             250
Request for 30 Day Website 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

[[Page 69427]]

 
Investigator at Affiliate Institution with    Participants..............................              25               1           10/60               4
 an IRB.
Research Staff at Affiliate Institution with  Participants..............................              25               1           10/60               4
 an IRB.
Investigator at Affiliate Institution         Participants..............................              25               1           10/60               4
 without an IRB.
Research Staff at Affiliate Institution       Participants..............................              25               1           10/60               4
 without an IRB.
Institutional Contact for Signatory           Participants..............................              65               1           10/60              11
 Institution.
IRB at Signatory Institution................  Participants..............................              25               1           10/60               4
Component Institution at Signatory            Participants..............................              65               1           10/60              11
 Institution.
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       Participants..............................             120               1           20/60              40
 About 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    Participants..............................             120               1           15/60              30
 or Continuing Noncompliance Reporting Form.
Add or Remove Signatory and/or Component      Participants..............................             120               1           10/60              20
 Institution Personnel.
Add or Remove Affiliate Institution           Participants..............................             120               1           10/60              20
 Personnel.
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       Board Members.............................              15               1               4              60
 Group 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          Board Members.............................              10               1               2              20
 Protocol.
Pediatric Amendment of Cooperative Group      Board Members.............................              10               1               2              20
 Protocol.
Adult Cooperative Group Response to CIRB      Participants..............................              15               1               1              15
 Review.
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            Board Members.............................              20               1               2              40
 Cooperative Group Study.
CIRB Statistical Reviewer Form..............  Board Members.............................              30               1           30/60              15
Determination of Unanticipated Problem (UP)   Board Members.............................              40               1           10/60               7
 and/or Serious or Continuing Noncompliance
 (SCN).
Adult Expedited Amendment Review............  Board Members.............................             350               1           30/60             175
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

[[Page 69428]]

 
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         Board Members.............................             150               1           15/60              38
 Required 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: November 7, 2013.
Vivian Horovitch-Kelley,
Program Analyst, National Institutes of Health.
[FR Doc. 2013-27556 Filed 11-18-13; 8:45 am]
BILLING CODE 4140-01-P