[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
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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