[Federal Register Volume 75, Number 209 (Friday, October 29, 2010)]
[Notices]
[Pages 66767-66769]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-27330]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Cancer Trials Support
Unit (CTSU) Public Use Forms and Customer Satisfaction Surveys (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 July 13,
2010 (75 FR 39950) and allowed 60-days for public comment. There have
been no public comments. Additionally, the 30-day Federal Register was
published on September 13, 2010. The purpose of this notice is to allow
an additional 30 days for public comment to the revisions. 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 displays a currently valid OMB control number.
Proposed Collection: Title: Cancer Trial Support Unit (CTSU). Type
of Information Collection Request: Existing Collection in Use Without
an OMB Number. Need and Use of Information Collection: CTSU collects
annual surveys of customer satisfaction for clinical site staff using
the CTSU Help Desk and the CTSU Web site. An ongoing user satisfaction
survey is in place for the Oncology Patient Enrollment Network (OPEN).
User satisfaction surveys are compiled as part of the project quality
assurance activities and used to direct improvements to processes and
technology. In addition, the CTSU collects standardized forms to
process site regulatory information, changes to membership, patient
enrollment data, and routing information for case report forms. This
questionnaire adheres to The Public Health Service Act, Section 413 (42
U.S.C. 285a-2) authorizes CTEP to establish and support programs to
facilitate the participation of qualified investigators on CTEP-
supported studies, and to institute programs that minimize redundancy
among grant and contract holders, thereby reducing overall cost of
maintaining a robust treatment trials program. Based on a conversation
with the Office of Management and Budget on October 17, 2010, the
burden table has been revised to take into account future submissions
of a generic data transmittal forms (see Attachment 1gg in the Table
below). It was agreed that the generic forms will be finalized and
submitted in the future as non-substantive change requests for OMB
clearance as needed. Frequency of Response: The help desk and Web site
survey are collected annually. The OPEN survey is ongoing. The form
submissions vary depending on the purpose of the form and the activity
of the local site. Affected Public: CTSU's target audience is staff
members at clinical sites and CTEP-supported programs. Respondent and
burden estimates are listed in the Table below. The annualized burden
is estimated to be 34,802 hours and the annualized cost to respondents
is estimated to be $946, 601. There are no Capital Costs, Operating
Costs, and/or Maintenance Costs to report.
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Use metrics/ Estimated time Estimated
month-- respond complete (minutes/ response usage/annual
(minutes) hours) burden hours
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Regulatory/Roster
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1a................................... CTSU IRB/Regulatory Approval 9,000 2 0.03 12.00 3,600
Transmittal Form.
1b................................... CTSU IRB Certification Form...... 8,500 10 0.17 12.00 17,000
1c................................... CTSU Acknowledgement Form........ 500 5 0.08 12.00 500
1d................................... Optional Form 1--Withdrawal from 50 5 0.08 12.00 50
Protocol Participation Form.
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Roster Forms
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1e................................... CTSU Roster Update Form.......... 50 2-4 0.07 12.00 40
1f................................... CTSU Radiation Therapy Facilities 20 30 0.50 12.00 120
Inventory Form.
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Drug shipment
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1g................................... CTSU IBCSG Drug Accountability 11 5-10 0.17 12.00 22
Form.
1h................................... CTSU IBCSG Transfer of 3 20 0.33 12.00 12
Investigational Agent Form.
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Data Management
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1i................................... Site Initiated Data Update Form 100 5-10 0.17 12.00 200
(generic).
1j................................... N0147 CTSU Data Transmittal Form. 1000 5-10 0.17 12.00 2,000
1k................................... Site Intimated Data Update Form 75 5-10 0.17 12.00 150
(DUF), Protocol: NCCTG N0147*.
1l................................... TAILORX/PACCT 1 CTSU Data 2100 5-10 0.17 12.00 4,200
Transmittal Form.
1m................................... Data Clarification Form.......... 650 15-20 0.33 12.00 2,600
1n................................... Unsolicited Data Modification 75 5-10 0.17 12.00 150
Form (UDM), Protocol: TAILORx/
PACCT1.
1o................................... Z4032 CTSU Data Transmittal Form. 50 5-10 0.17 12.00 100
1p................................... Z1031 CTSU Data Transmittal Form. 50 5-10 0.17 12.00 100
1q................................... Z1041 CTSU Data Transmittal Form. 50 5-10 0.17 12.00 100
1r................................... Z6051 CTSU Data Transmittal Form. 75 5-10 0.17 12.00 150
1s................................... RTOG 0834 CTSU Data Transmittal 60 5-10 0.17 12.00 120
Form*.
1t................................... CTSU 7868 Data Transmittal Form.. 50 5-10 0.17 12.00 100
1u................................... Site Initiated Data Update Form, 10 5-10 0.17 12.00 20
protocol 7868.
1v................................... MC0845(8233) CTSU Data 50 5-10 0.17 12.00 100
Transmittal*.
1w................................... 8121 CTSU Data Transmittal Form*. 100 5-10 0.17 12.00 200
1x................................... Site Initiated Data Update Form, 10 5-10 0.17 12.00 20
Protocol 8121.
1y................................... USMCI 8214/Z6091: CTSU Data 50 5-10 0.17 12.00 100
Transmittal.
*In Development..................
1z................................... USMCI 8214/Z6091 Crossover 5 5-10 0.17 12.00 10
Request/Checklist Transmittal
Form.
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Patient Enrollment
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1aa.................................. CTSU Patient Enrollment 600 5-10 0.17 12.00 1,200
Transmittal Form.
1bb.................................. CTSU P2C Enrollment Transmittal 30 5-10 0.17 12.00 60
Form.
1cc.................................. CTSU Transfer Form............... 40 5-10 0.17 12.00 80
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Administrative
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1dd.................................. CTSU System Account Request Form. 50 15-20 0.33 12.00 200
1ee.................................. CTSU Request for Clinical 35 10 0.17 12.00 70
Brochure.
1ff.................................. CTSU Supply Request Form......... 130 5-10 0.17 12.00 260
1gg.................................. CTSU Generic Data Transmittal 500 5-10 0.17 12.00 1000.00
Form.
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Surveys/Web Forms
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2.................................... CTSU Web Site Customer 250 10-15 0.2500 1.00 63
Satisfaction Survey.
3.................................... CTSU Helpdesk Customer 300 10-15 0.2500 1.00 75
Satisfaction Survey.
4.................................... CTSU OPEN Survey................. 120 10-15 0.2500 1.00 30
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Annual Totals
21,770........................... .............. .............. .............. .............. 34,802
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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 Michael Montello,
Pharm. D., CTEP, 6130 Executive Blvd., Rockville, MD 20852, call non-
toll-free number 301-435-9206 or e-mail your request, including your
address to: [email protected].
[[Page 66769]]
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: October 21, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-27330 Filed 10-28-10; 8:45 am]
BILLING CODE 4140-01-P