[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)
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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