[Federal Register Volume 78, Number 223 (Tuesday, November 19, 2013)]
[Notices]
[Pages 69428-69429]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-27554]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request: Cancer Trials
Support Unit (CTSU) (NCI)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH), has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on August 30, 2013, Vol. 78, p. 53763 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 Cancer Institute (NCI), 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.
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: Office of Management and Budget, Office of Regulatory
Affairs, [email protected] or by fax to 202-395-6974,
Attention: NIH Desk Officer.
Comment 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.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments or request more information on the
proposed project contact: Michael Montello, Cancer Therapy Evaluation
Program, Division of Cancer Treatment and Diagnosis, 9609 Medical
Center Drive, Rockville, MD 20850 or call non-toll-free number 240-276-
6080 or Email your request, including your address to:
[email protected]. Formal requests for additional plans and
instruments must be requested in writing.
Proposed Collection: Cancer Trials Support Unit (CTSU) (NCI), 0925-
0624, Expiration Date 12/31/2013, REVISION, National Cancer Institute
(NCI), National Institutes of Health (NIH).
Need and Use of Information Collection: The Cancer Therapy
Evaluation Program (CTEP) establishes and supports 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. Currently guided by the
efforts of the Clinical Trials Working Group (CTWG) and the Institute
of Medicine (IOM) recommendations to revitalize the Cooperative Group
program, CTEP has funded the Cancer Trials Support Unit (CTSU). The
CTSU collects standardized forms to process site regulatory
information, changes to membership, patient enrollment data, and
routing information for case report forms. In addition, CTSU collects
annual surveys of customer satisfaction for clinical site staff using
the CTSU Help Desk, the CTSU Web site, and the Protocol and Information
Office (PIO). 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.
Additionally, there are three surveys that collect information about
health professional's interests in clinical trial, potential issues
with opening and accruing to a clinical trial and reasons for low
accrual.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 25,205.
Estimated Annualized Burden Hours
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Average
Type of Number of Number of burden per Total annual
Form name respondent respondents responses per response (in burden hour
respondent hours)
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CTSU IRB/Regulatory Approval Health Care 9,000 12 2/60 3,600
Transmittal Form. Practitioner.
CTSU IRB Certification Form... Health Care 8,500 12 10/60 17,000
Practitioner.
CTSU Acknowledgement.......... Health Care 500 12 5/60 500
Practitioner.
Withdrawal from Protocol Health Care 50 12 5/60 50
Participation Form. Practitioner.
Site Addition................. Health Care 25 12 5/60 25
Practitioner.
CTSU Roster Update Form....... Health Care 50 12 4/60 40
Practitioner.
CTSU Radiation Therapy Health Care 20 12 30/60 120
Facilities Inventory Form. Practitioner.
[[Page 69429]]
CTSU IBCSG Drug Accountability Health Care 11 12 10/60 22
Form. Practitioner.
CTSU IBCSG Transfer of Health Care 3 12 20/60 12
Investigational Agent Form. Practitioner.
Site Initiated Data Update Health Care 10 12 10/60 20
Form. Practitioner.
Data Clarification Form....... Health Care 341 12 20/60 1,364
Practitioner.
RTOG 0834 CTSU Data Health Care 60 12 10/60 120
Transmittal Form. Practitioner.
MC0845(8233) CTSU Data Health Care 50 12 10/60 100
Transmittal. Practitioner.
CTSU Generic Data Transmittal Health Care 500 12 10/60 1,000
Form. Practitioner.
CTSU Patient Enrollment Health Care 200 12 10/60 400
Transmittal Form. Practitioner.
CTSU P2C Enrollment Health Care 15 12 10/60 30
Transmittal Form. Practitioner.
CTSU Transfer Form............ Health Care 20 12 10/60 40
Practitioner.
CTSU System Account Request Health Care 20 12 20/60 80
Form. Practitioner.
CTSU Request for Clinical Health Care 75 12 10/60 150
Brochure. Practitioner.
CTSU Supply Request Form...... Health Care 75 12 10/60 150
Practitioner.
CTSU Web Site Customer Health Care 275 1 15/60 69
Satisfaction Survey. Practitioner.
CTSU Helpdesk Customer Health Care 325 1 15/60 81
Satisfaction Survey. Practitioner.
CTSU OPEN Survey.............. Health Care 60 1 15/60 15
Practitioner.
PIO Customer Satisfaction Health Care 100 1 5/60 8
Survey. Practitioner.
Concept Clinical Trial Survey. Health Care 500 1 5/60 42
Practitioner.
Prospective Clinical Trial Health Care 1,000 1 5/60 83
Survey. Practitioner.
Low Accrual Clinical Trial Health Care 1,000 1 5/60 83
Survey. Practitioner.
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Dated: November 7, 2013.
Vivian Horovitch-Kelley,
NCI Project Clearance Liaison, National Institutes of Health.
[FR Doc. 2013-27554 Filed 11-18-13; 8:45 am]
BILLING CODE 4140-01-P