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 Department of Health and Human Services National Institutes of Health
 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. Additionally, the 30-day 
                        **Federal Register**
                         was published on September 13, 2010. The purpose of this notice is to allow an additional 30 days for public comment to the revisions. 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-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. Based on a conversation with the Office of Management and Budget on October 17, 2010, the burden table has been revised to take into account future submissions of a generic data transmittal forms (
                        *see*
                         Attachment 1gg in the Table below). It was agreed that the generic forms will be finalized and submitted in the future as non-substantive change requests for OMB clearance as needed. 
                        *Frequency of Response:*
                         The help desk and Web site survey are collected annually. The OPEN survey is ongoing. The form submissions vary 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 34,802 hours and the annualized cost to respondents is estimated to be $946, 601. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report. Attach
                             No.
Section/form or survey title
Use metrics/
                             month— 
                             # respond
Estimated
                             time for 
                             site to 
                             complete 
                             (minutes)
Estimated
                             burden 
                             (minutes/ 
                             hours)
Frequency of
                             response
Total annual
                             usage/annual 
                             burden hours**Regulatory/Roster**1a
CTSU IRB/Regulatory Approval Transmittal Form
9,000
2
0.03
12.00
3,6001b
CTSU IRB Certification Form
8,500
10
0.17
12.00
17,0001c
CTSU Acknowledgement Form
500
5
0.08
12.00
5001d
Optional Form 1—Withdrawal from Protocol Participation Form
50
5
0.08
12.00
50**Roster Forms**1e
CTSU Roster Update Form
50
2-4
0.07
12.00
401f
CTSU Radiation Therapy Facilities Inventory Form
20
30
0.50
12.00
120**Drug shipment**( print page 66768)1g
CTSU IBCSG Drug Accountability Form
11
5-10
0.17
12.00
221h
CTSU IBCSG Transfer of Investigational Agent Form
3
20
0.33
12.00
12**Data Management**1i
Site Initiated Data Update Form (generic)
100
5-10
0.17
12.00
2001j
N0147 CTSU Data Transmittal Form
1000
5-10
0.17
12.00
2,0001k
Site Intimated Data Update Form (DUF), Protocol: NCCTG N0147*
75
5-10
0.17
12.00
1501l
TAILORX/PACCT 1 CTSU Data Transmittal Form
2100
5-10
0.17
12.00
4,2001m
Data Clarification Form
650
15-20
0.33
12.00
2,6001n
Unsolicited Data Modification Form (UDM), Protocol: TAILORx/PACCT1
75
5-10
0.17
12.00
1501o
Z4032 CTSU Data Transmittal Form
50
5-10
0.17
12.00
1001p
Z1031 CTSU Data Transmittal Form
50
5-10
0.17
12.00
1001q
Z1041 CTSU Data Transmittal Form
50
5-10
0.17
12.00
1001r
Z6051 CTSU Data Transmittal Form
75
5-10
0.17
12.00
1501s
RTOG 0834 CTSU Data Transmittal Form*
60
5-10
0.17
12.00
1201t
CTSU 7868 Data Transmittal Form
50
5-10
0.17
12.00
1001u
Site Initiated Data Update Form, protocol 7868
10
5-10
0.17
12.00
201v
MC0845(8233) CTSU Data Transmittal*
50
5-10
0.17
12.00
1001w
8121 CTSU Data Transmittal Form*
100
5-10
0.17
12.00
2001x
Site Initiated Data Update Form, Protocol 8121
10
5-10
0.17
12.00
201y
USMCI 8214/Z6091: CTSU Data Transmittal
                             *In Development
50
5-10
0.17
12.00
1001z
USMCI 8214/Z6091 Crossover Request/Checklist Transmittal Form
5
5-10
0.17
12.00
10**Patient Enrollment**1aa
CTSU Patient Enrollment Transmittal Form
600
5-10
0.17
12.00
1,2001bb
CTSU P2C Enrollment Transmittal Form
30
5-10
0.17
12.00
601cc
CTSU Transfer Form
40
5-10
0.17
12.00
80**Administrative**1dd
CTSU System Account Request Form
50
15-20
0.33
12.00
2001ee
CTSU Request for Clinical Brochure
35
10
0.17
12.00
701ff
CTSU Supply Request Form
130
5-10
0.17
12.00
2601gg
CTSU Generic Data Transmittal Form
500
5-10
0.17
12.00
1000.00**Surveys/Web Forms**2
CTSU Web Site Customer Satisfaction Survey
250
10-15
0.2500
1.00
633
CTSU Helpdesk Customer Satisfaction Survey
300
10-15
0.2500
1.00
754
CTSU OPEN Survey
120
10-15
0.2500
1.00
30**Annual Totals**21,770




34,802
 *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 
                    *OIRA_submission@omb.eop.gov*
                     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, call non-toll-free number 301-435-9206 or e-mail your request, including your address to: 
                    *montellom@mail.nih.gov.*( print page 66769) *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: October 21, 2010. Vivian Horovitch-Kelley, NCI Project Clearance Liaison, National Institutes of Health.


[FR Doc. 2010-27330 Filed 10-28-10; 8:45 am] BILLING CODE 4140-01-P