[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-- <greek-   for site to       burden       Frequency of    Total annual
              Attach No.                  Section/form or survey title      i> 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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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[[Page 66768]]

 
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
                                                                         -------------------------------------------------------------------------------
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 <a href="/cdn-cgi/l/email-protection#85caccd7c4daf6f0e7e8ecf6f6eceaebc5eae8e7abe0eaf5abe2eaf3"><span class="__cf_email__" data-cfemail="226d6b70637d5157404f4b51514b4d4c624d4f400c474d520c454d54">[email protected]</span></a> 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: <a href="/cdn-cgi/l/email-protection#066b696872636a6a696b466b676f6a28686f6e28616970"><span class="__cf_email__" data-cfemail="9ff2f0f1ebfaf3f3f0f2dff2fef6f3b1f1f6f7b1f8f0e9">[email protected]</span></a>.

[[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


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