```

[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
```