Proposed Collection; 60-Day Comment Request; Cancer Trials Support Unit (National Cancer Institute), 83856-83857 [2016-28004]

Download as PDF 83856 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Estimated number of respondents Estimated number of responses per respondent Average time per response (in hours) Estimated total annual burden hours Data collection activity Type of respondents APR ............................... IRLCW ........................... Principal Investigator (MD or PhD) ..................... Principal Investigator (MD or PhD degree) or Research Coordinator (RN, BA, MA degree) or Regulatory Staff (BA degree). Principal Investigator (MD or PhD degree) or Research Coordinator (RN, BA, MA degree) or Regulatory Staff (BA degree). 20 250 1 1 2 2 40 500 250 1 1 250 .............................................................................. 520 520 ........................ 790 CRLCW .......................... Total ........................ Dated: November 16, 2016. Lawrence A. Tabak, Deputy Director, National Institutes of Health. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health 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. 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: [FR Doc. 2016–28140 Filed 11–21–16; 8:45 am] BILLING CODE 4140–01–P Proposed Collection; 60-Day Comment Request; Cancer Trials Support Unit (National Cancer Institute) National Institutes of Health. Notice. AGENCY: ACTION: 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. SUMMARY: 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., FOR FURTHER INFORMATION CONTACT: 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). sradovich on DSK3GMQ082PROD with NOTICES ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Number of responses per respondent Average burden per response (in hours) Total annual burden hour Form name Type of respondent CTSU IRB/Regulatory Approval Transmittal Form. CTSU IRB Certification Form ......................... CTSU Acknowledgement Form ...................... Withdrawal from Protocol Participation Form Health Care Practitioner ..... 9,000 12 2/60 3,600 Health Care Practitioner ..... Health Care Practitioner ..... Health Care Practitioner ..... 8,500 500 50 12 12 12 10/60 5/60 5/60 17,000 500 50 VerDate Sep<11>2014 16:52 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\22NON1.SGM 22NON1 83857 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of respondents Average burden per response (in hours) Number of responses per respondent Total annual burden hour Form name Type of respondent Site Addition .................................................... CTSU Roster Update Form ............................ CTSU Radiation Therapy Facilities Inventory Form. CTSU IBCSG Drug Accountability Form ........ CTSU IBCSG Transfer of Investigational Agent Form. Site Initiated Data Update Form ..................... Data Clarification Form ................................... RTOG 0834 CTSU Data Transmittal Form .... MC0845(8233) CTSU Data Transmittal ......... CTSU Generic Data Transmittal Form ........... CTSU Patient Enrollment Transmittal Form ... CTSU P2C Enrollment Transmittal Form ....... CTSU Transfer Form ...................................... CTSU System Account Request Form ........... CTSU Request for Clinical Brochure .............. CTSU Supply Request Form .......................... CTSU Web Site Customer Satisfaction Survey. CTSU Helpdesk Customer Satisfaction Survey. CTSU OPEN Survey ....................................... PIO Customer Satisfaction Survey ................. Concept Clinical Trial Survey ......................... Prospective Clinical Trial Survey .................... Low Accrual Clinical Trial Survey ................... Health Care Practitioner ..... Health Care Practitioner ..... Health Care Practitioner ..... 25 50 20 12 12 12 5/60 4/60 30/60 25 40 120 Health Care Practitioner ..... Health Care Practitioner ..... 11 3 12 12 10/60 20/60 22 12 ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... ..... 10 341 60 50 500 200 15 20 20 75 75 275 12 12 12 12 12 12 12 12 12 12 12 1 10/60 20/60 10/60 10/60 10/60 10/60 10/60 10/60 20/60 10/60 10/60 15/60 20 1,364 120 100 1,000 400 30 40 80 150 150 69 Health Care Practitioner ..... 325 1 15/60 81 ..... ..... ..... ..... ..... 60 100 500 1,000 1,000 1 1 1 1 1 15/60 5/60 5/60 5/60 5/60 15 8 42 83 83 ............................................. 22,785 237,560 ........................ 25,204 Annualized Totals .................................... 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health sradovich on DSK3GMQ082PROD with NOTICES National Institute on Deafness and Other Communication Disorders; Notice of Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Deafness and Other Communication Disorders Advisory Council. The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. VerDate Sep<11>2014 16:52 Nov 21, 2016 Jkt 241001 Health Health Health Health Health Health Health Health Health Health Health Health Health Health Health Health Health Care Care Care Care Care Care Care Care Care Care Care Care Care Care Care Care Care Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner Practitioner The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Deafness and Other Communication Disorders Advisory Council. Date: January 27, 2017. Closed: 8:30 a.m. to 9:40 a.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health, Building 31, Conference Room 6, 31 Center Drive, Bethesda, MD 20892. Open: 9:40 a.m. to 2:00 p.m. Agenda: Staff reports on divisional, programmatic, and special activities. Place: National Institutes of Health, Building 31, Conference Room 6, 31 Center Drive, Bethesda, MD 20892. Contact Person: Craig A. Jordan, Ph.D., Director, Division of Extramural Activities, NIDCD, NIH, Room 8345, MSC 9670, 6001 PO 00000 Frm 00061 Fmt 4703 Sfmt 9990 Executive Blvd., Bethesda, MD 20892–9670, 301–496–8693, jordanc@nidcd.nih.gov. Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their visit. Information is also available on the Institute’s/Center’s home page: http:// www.nidcd.nih.gov/about/Pages/AdvisoryGroups-and-Review-Committees.aspx, where an agenda and any additional information for the meeting will be posted when available. (Catalogue of Federal Domestic Assistance Program Nos. 93.173, Biological Research Related to Deafness and Communicative Disorders, National Institutes of Health, HHS) Dated: November 16, 2016. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2016–27998 Filed 11–21–16; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\22NON1.SGM 22NON1

Agencies

[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Pages 83856-83857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28004]


-----------------------------------------------------------------------

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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
                Form name                                Type of respondent                  Number of     responses per   per response    Total annual
                                                                                            respondents     respondent      (in hours)      burden hour
--------------------------------------------------------------------------------------------------------------------------------------------------------
CTSU IRB/Regulatory Approval Transmittal   Health Care Practitioner.....................           9,000              12            2/60           3,600
 Form.
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     Health Care Practitioner.....................              50              12            5/60              50
 Form.

[[Page 83857]]

 
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          Health Care Practitioner.....................              20              12           30/60             120
 Inventory Form.
CTSU IBCSG Drug Accountability Form......  Health Care Practitioner.....................              11              12           10/60              22
CTSU IBCSG Transfer of Investigational     Health Care Practitioner.....................               3              12           20/60              12
 Agent Form.
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        Health Care Practitioner.....................             275               1           15/60              69
 Survey.
CTSU Helpdesk Customer Satisfaction        Health Care Practitioner.....................             325               1           15/60              81
 Survey.
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