Proposed Collection; 60-Day Comment Request; Cancer Trials Support Unit (National Cancer Institute)

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health

Proposed Collection; 60-Day Comment Request; Cancer Trials Support Unit (National Cancer Institute)

AGENCY:

National Institutes of Health.

ACTION:

Notice.

SUMMARY:

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

DATES:

Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication.

FOR FURTHER INFORMATION CONTACT:

To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Michael Montello, Pharm. D., Cancer Therapy Evaluation Program (CTEP), 9609 Medical Center Drive, MSC 9742, Rockville, MD 20850 or call non-toll-free number 240-276-6080 or Email your request, including your address to:

montellom@mail.nih.gov.

Formal requests for additional plans and instruments must be requested in writing.

SUPPLEMENTARY INFORMATION:

Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires: Written comments and/or suggestions from the public and affected agencies are invited to address one or more of the following points: (1) 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) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to 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.

Proposed Collection Title:

Cancer Trials Support Unit (CTSU) (NCI), 0925-0624, EXTENSION, 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.

OMB approval for an extension to the existing approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 25,204.

Estimated Annualized Burden Hours

Form name

Type of respondent

Number of

respondents

Number of

responses per

respondent

Average

burden per

response

(in hours)

Total annual

burden hour

CTSU IRB/Regulatory Approval Transmittal Form

Health Care Practitioner

9,000

12

2/60

3,600

CTSU IRB Certification Form

Health Care Practitioner

8,500

12

10/60

17,000

CTSU Acknowledgement Form

Health Care Practitioner

500

12

5/60

500

Withdrawal from Protocol Participation Form

Health Care Practitioner

50

12

5/60

50

Site Addition

Health Care Practitioner

25

12

5/60

25

CTSU Roster Update Form

Health Care Practitioner

50

12

4/60

40

CTSU Radiation Therapy Facilities Inventory Form

Health Care Practitioner

20

12

30/60

120

CTSU IBCSG Drug Accountability Form

Health Care Practitioner

11

12

10/60

22

CTSU IBCSG Transfer of Investigational Agent Form

Health Care Practitioner

3

12

20/60

12

Site Initiated Data Update Form

Health Care Practitioner

10

12

10/60

20

Data Clarification Form

Health Care Practitioner

341

12

20/60

1,364

RTOG 0834 CTSU Data Transmittal Form

Health Care Practitioner

60

12

10/60

120

MC0845(8233) CTSU Data Transmittal

Health Care Practitioner

50

12

10/60

100

CTSU Generic Data Transmittal Form

Health Care Practitioner

500

12

10/60

1,000

CTSU Patient Enrollment Transmittal Form

Health Care Practitioner

200

12

10/60

400

CTSU P2C Enrollment Transmittal Form

Health Care Practitioner

15

12

10/60

30

CTSU Transfer Form

Health Care Practitioner

20

12

10/60

40

CTSU System Account Request Form

Health Care Practitioner

20

12

20/60

80

CTSU Request for Clinical Brochure

Health Care Practitioner

75

12

10/60

150

CTSU Supply Request Form

Health Care Practitioner

75

12

10/60

150

CTSU Web Site Customer Satisfaction Survey

Health Care Practitioner

275

1

15/60

69

CTSU Helpdesk Customer Satisfaction Survey

Health Care Practitioner

325

1

15/60

81

CTSU OPEN Survey

Health Care Practitioner

60

1

15/60

15

PIO Customer Satisfaction Survey

Health Care Practitioner

100

1

5/60

8

Concept Clinical Trial Survey

Health Care Practitioner

500

1

5/60

42

Prospective Clinical Trial Survey

Health Care Practitioner

1,000

1

5/60

83

Low Accrual Clinical Trial Survey

Health Care Practitioner

1,000

1

5/60

83

Annualized Totals

22,785

237,560

25,204

Dated: November 10, 2016.

Karla Bailey,

Project Clearance Liaison, National Cancer Institute, National Institutes of Health.

[FR Doc. 2016-28004 Filed 11-21-16; 8:45 am]

BILLING CODE 4140-01-P