[Federal Register Volume 75, Number 133 (Tuesday, July 13, 2010)]
[Notices]
[Pages 39950-39952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-17038]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; Comment Request; Cancer Trials Support Unit 
(CTSU) Public Use Forms and Customer Satisfaction Surveys (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), the 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.
    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 are 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

[[Page 39951]]

studies, and to institute programs that minimize redundancy among grant 
and contract holders, thereby reducing overall cost of maintaining a 
robust treatment trials program.
    Frequency of Response: The help desk and web site survey are 
collected annually. The OPEN survey is ongoing. Submission of forms 
varies 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 27,861 hours and the annualized cost to respondents is 
estimated to be $757,828. There are no Capital Costs, Operating Costs, 
and/or Maintenance Costs to report.

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                                                                                          Estimated time     Estimated
                                                                          Use metrics/      for site to       burden       Frequency of    Total annual
               Attach No.                 Section/form or survey title  month--     complete        (minutes/       response      usage/annual
                                                                             respond         (minutes)        hours)                       burden hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
    1a..................................  CTSU IRB/Regulatory Approval            9,000                2          0.03             12.00           3,240
                                           Transmittal Form.
    1b..................................  CTSU IRB Certification Form.            8,500               10          0.17             12.00          17,340
    1c..................................  CTSU Acknowledgement Form...              500                5          0.08             12.00             480
    1d..................................  Optional Form 1--Withdrawal                10                5          0.08             12.00              10
                                           from Protocol Participation
                                           Form.
Roster Forms:
    1e..................................  CTSU Roster Update Form.....               50              2-4          0.07             12.00              42
    1f..................................  CTSU Radiation Therapy                     20               30          0.50             12.00             120
                                           Facilities Inventory Form.
Drug shipment:
    1g..................................  CTSU IBCSG Drug                            11             5-10          0.17             12.00              22
                                           Accountability Form.
    1h..................................  CTSU IBCSG Transfer of                      3               20          0.33             12.00              12
                                           Investigational Agent Form.
Data Management:
    1i..................................  Site Initiated Data Update                 10             5-10          0.17             12.00              20
                                           Form (generic).
    1j..................................  N0147 CTSU Data Transmittal               330             5-10          0.17             12.00             673
                                           Form.
    1k..................................  Site Intimated Data Update                 30             5-10          0.17             12.00              61
                                           Form (DUF), Protocol: NCCTG
                                           N0147*.
    1l..................................  TAILORX/PACCT 1 CTSU Data                1200             5-10          0.17             12.00           2,448
                                           Transmittal Form.
    1m..................................  Data Clarification Form.....              144            15-20          0.33             12.00             570
    1n..................................  Unsolicited Data                           30             5-10          0.17             12.00              61
                                           Modification Form (UDM),
                                           Protocol:TAILORx/PACCT1.
    1o..................................  Z4032 CTSU Data Transmittal                58             5-10          0.17             12.00             118
                                           Form.
    1p..................................  Z1031 CTSU Data Transmittal                54             5-10          0.17             12.00             110
                                           Form.
    1q..................................  Z1041 CTSU Data Transmittal                48             5-10          0.17             12.00              98
                                           Form.
    1r..................................  Z6051 CTSU Data Transmittal                12             5-10          0.17             12.00              24
                                           Form.
    1s..................................  RTOG 0834 CTSU Data                        60             5-10          0.17             12.00             122
                                           Transmittal Form*.
    1t..................................  CTSU 7868 Data Transmittal                 30             5-10          0.17             12.00              61
                                           Form.
    1u..................................  Site Initiated Data Update                 10             5-10          0.17             12.00              20
                                           Form, protocol 7868.
    1v..................................  MC0845(8233) CTSU Data                     40             5-10          0.17             12.00              82
                                           Transmittal*.
    1w..................................  8121 CTSU Data Transmittal                 40             5-10          0.17             12.00              82
                                           Form*.
    1x..................................  Site Initiated Data Update                 10             5-10          0.17             12.00              20
                                           Form, Protocol 8121.
    1y..................................  USMCI 8214/Z6091: CTSU Data                50             5-10          0.17             12.00             102
                                           Transmittal *In Development.
    1z..................................  USMCI 8214/Z6091 Crossover                  5             5-10          0.17             12.00              10
                                           Request/Checklist
                                           Transmittal Form.
Patient Enrollment:
    1aa.................................  CTSU Patient Enrollment                   600             5-10          0.17             12.00           1,224
                                           Transmittal Form.
    1bb.................................  CTSU P2C Enrollment                        30             5-10          0.17             12.00              61
                                           Transmittal Form.
    1cc.................................  CTSU Transfer Form..........               40             5-10          0.17             12.00              82
Administrative:

[[Page 39952]]

 
    1dd.................................  CTSU System Account Request                10            15-20          0.33             12.00              40
                                           Form.
    1ee.................................  CTSU Request for Clinical                  35               10          0.17             12.00              71
                                           Brochure.
    1ff.................................  CTSU Supply Request Form....              130             5-10          0.17             12.00             265
Surveys/Web Forms:
    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   ..............  ..............  ..............          27,861
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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.

FOR FURTHER INFORMATION CONTACT: 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. At non-toll-free number 301-435-9206 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 60 days 
of the date of this publication.

    Dated: July 7, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-17038 Filed 7-12-10; 8:45 am]
BILLING CODE 4140-01-P