[Federal Register Volume 75, Number 176 (Monday, September 13, 2010)]
[Notices]
[Pages 55586-55587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22710]
[[Page 55586]]
-----------------------------------------------------------------------
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. The purpose of this notice is to allow an
additional 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 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[dash]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. 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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Use metrics/ Estimated
month- Estimated time for site burden Frequency of Total annual
Attach No. Section/form or survey title to complete minutes (minutes/ response usage/annual
respond 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*.
[[Page 55587]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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.
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. all 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 30 days
of the date of this publication.
Dated: September 7, 2010.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2010-22710 Filed 9-10-10; 8:45 am]
BILLING CODE 4140-01-P