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