[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]
-----------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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