[Federal Register Volume 75, Number 221 (Wednesday, November 17, 2010)]
[Notices]
[Pages 70268-70270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-28883]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 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 Cancer Institute (NCI), the
National Institutes of Health (NIH), has submitted to the Office of
Management and Budget (OMB) a request to review and approve the
information collection listed below. This proposed information
collection was previously published in the Federal Register on August
16, 2010 (75 FR 49938) and allowed 60-days for public comment. No
public comments were received. The purpose of this notice is to allow
30 days for public comment. The 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
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displays a currently valid OMB control number.
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 2209 hours (see Table 1 below for the estimated
time burden). The total burden has decreased slightly as a result of
corrected calculations from what was published in the 60-Day Federal
Register Notice. 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 1--Estimates of Annual Burden Hours
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Number of Frequency of Average time per response Annual burden
Type of respondents Survey instrument respondents response (min/hr) hours
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Participants/Board Members............... CIRB Helpdesk Survey (Attachment 1,500 1 10/60 (.17 hour)........... 250
1).
Participants............................. NCI CIRB Institution Enrollment 30 1 3.5 hours.................. 105
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).
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)........... 8
(Attachment 2K).
Participants............................. Facilitated Review (FR) 1,450 1 10/60 (.17 hour)........... 242
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 (Attachment 16 1 15/60 (.25 hour)........... 4
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 Application 230 1 1 hour..................... 230
for Continuing Review
(Attachment 5E).
Board Members............................ Adult CIRB Reviewer Findings-- 20 1 4 hours.................... 80
Initial Review of Cooperative
Group Protocol (Attachment 6A).
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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 Findings 70 1 1 hour..................... 70
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 Findings 50 1 1.5 hours.................. 75
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 Findings 110 1 .5 hour.................... 55
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).
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Total................................ ................................ 4,904 .............. ........................... 2,209
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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 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.
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 Attention: NIH Desk Officer, Office of Management and
Budget, at [email protected] or by fax to 202-395-6974. To
request more information on the proposed project or to obtain a copy of
the data collection plans and instruments, contact Jeanne Adler,
Division of Cancer Treatment and Diagnosis or call non-toll-free number
301-594-0083 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 30 days
of the date of this publication.
Dated: November 10, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-28883 Filed 11-16-10; 8:45 am]
BILLING CODE 4140-01-P