Proposed Collection; 60-Day Comment Request; Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys (NCI), 78053-78056 [2023-25022]
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78053
Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices
amended, notice is hereby given of the
following meeting.
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
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR–22–
233: Time-Sensitive Opportunities for Health
Research.
Date: December 8, 2023.
Time: 11:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Wenjuan Wang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 3154,
Bethesda, MD 20892, (301) 480–8667,
wangw22@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: November 8, 2023.
Patricia B. Hansberger,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–25072 Filed 11–13–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Cancer Therapy Evaluation
Program (CTEP) Branch and Support
Contracts Forms and Surveys (NCI)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
Branch and Support Contracts Forms
and Surveys (NCI), 0925–0753,
Expiration Date 03/31/2026, REVISION,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: This is a request for OMB to
approve the revised information
collection, Cancer Therapy Evaluation
Program (CTEP) Support Contracts
Forms and Survey. It includes
modifications to OMB-approved forms
for the CTSU and CIRB and the addition
of new forms for the CTSU, CIRB, and
CTEP. The National Cancer Institute
(NCI) CTEP and the Division of Cancer
Prevention (DCP) fund an extensive
national program of cancer research,
sponsoring clinical trials in cancer
prevention, symptom management, and
treatment for qualified clinical
investigators. As part of this effort,
CTEP implements programs to register
clinical site investigators and clinical
site staff and to oversee the conduct of
research at the clinical sites. CTEP and
DCP also oversee two support programs,
the NCI Central Institutional Review
Board (CIRB) and the Cancer Trial
Support Unit (CTSU). The combined
systems and processes for initiating and
managing clinical trials are termed the
Clinical Oncology Research Enterprise
(CORE) and represent an integrated set
of information systems and processes
that support investigator registration,
trial oversight, patient enrollment, and
clinical data collection. The information
collected is required to ensure
compliance with applicable federal
regulations governing the conduct of
human subjects’ research (45 CFR 46
and 21 CRF 50), and when CTEP acts as
the Investigational New Drug (IND)
holder (Food and Drug Administration
(FDA) regulations pertaining to the
sponsor of clinical trials and the
selection of qualified investigators
under 21 CRF 312.53). Survey
collections assess satisfaction and
provide feedback to guide
improvements with processes and
technology.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
162,831 hours.
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 proposed
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, Cancer
Therapy Evaluation Program—DCTD,
National Cancer Institute, 9609 Medical
Center Drive, Rockville, Maryland
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
Therapy Evaluation Program (CTEP)
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
Form name
Type of respondent
CTSU IRB/Regulatory Approval Transmittal Form
(Attachment A01).
CTSU IRB Certification Form (Attachment A02) ..
Health Care Practitioner
2444
12
2/60
978
Health Care Practitioner
2444
12
10/60
4888
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78054
Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total annual
burden hours
Form name
Type of respondent
Withdrawal from Protocol Participation Form (Attachment A03).
Site Addition Form (Attachment A04) ...................
CTSU Request for Clinical Brochure (Attachment
A06).
CTSU Supply Request Form (Attachment A07) ..
RTOG 0834 CTSU Data Transmittal Form (Attachment A10).
CTSU Patient Enrollment Transmittal Form (Attachment A15).
CTSU Transfer Form (Attachment A16) ...............
CTSU OPEN Rave Request Form (Attachment
A18).
CTSU LPO Form Creation (Attachment A19) ......
CTSU Site Form Creation and PDF (Attachment
A20).
CTSU PDF Signature Form (Attachment A21) ....
CTSU CLASS Course Setup Request Form (Attachment A22).
CTSU LPO Approval of Early Closure Form (Attachment A23).
International DTL Signing (Attachment 24) ..........
NCI CIRB AA & DOR between the NCI CIRB
and Signatory Institution (Attachment B01).
NCI CIRB Signatory Enrollment Form (Attachment B02).
CIRB Board Member Application (Attachment
B03).
CIRB Member COI Screening Worksheet (Attachment B08).
CIRB COI Screening for CIRB meetings (Attachment B09).
CIRB IR Application (Attachment B10) ................
CIRB IR Application for Exempt Studies (Attachment B11).
CIRB Amendment Review Application (Attachment B12).
CIRB Ancillary Studies Application (Attachment
B13).
CIRB Continuing Review Application (Attachment
B14).
Adult IR of Cooperative Group Protocol (Attachment B15).
Pediatric IR of Cooperative Group Protocol (Attachment B16).
Adult Continuing Review of Cooperative Group
Protocol (Attachment B17) Protocol.
Adult Amendment of Cooperative Group Protocol
(Attachment B19).
Pediatric Amendment of Cooperative Group Protocol (Attachment B20).
Pharmacist’s Review of a Cooperative Group
Study (Attachment B21).
Adult Expedited Amendment Review (Attachment
B23).
Pediatric Expedited Amendment Review (Attachment B24).
Adult Expedited Continuing Review (Attachment
B25).
Pediatric Expedited Continuing Review (Attachment B26).
Adult Cooperative Group Response to CIRB Review (Attachment B27).
Pediatric Cooperative Group Response to CIRB
Review (Attachment B28).
Adult Expedited Study Chair Response to Required Modifications (Attachment B29).
Reviewer Worksheet—Determination of UP or
SCN (Attachment B31).
Health Care Practitioner
279
1
10/60
47
Health Care Practitioner
Health Care Practitioner
80
360
12
1
10/60
10/60
160
60
Health Care Practitioner
Health Care Practitioner
90
30
12
2
10/60
5/60
180
5
Health Care Practitioner
12
12
10/60
24
Health Care Practitioner
Health Care Practitioner
360
30
2
21
10/60
10/60
120
105
Health Care Practitioner
Health Care Practitioner
5
400
2
10
120/60
30/60
20
2000
Health Care Practitioner
Health Care Practitioner
400
10
10
2
10/60
20/60
667
7
Health Care Practitioner
2444
6
20/60
4888
Health Care Practitioner
Participants ...................
29
50
1
1
10/60
15/60
5
13
Participants ...................
50
1
15/60
13
Board Member ..............
100
1
30/60
50
Board Members ............
100
1
15/60
25
Board Members ............
72
1
15/60
18
Health Care Practitioner
Health Care Practitioner
80
4
1
1
60/60
30/60
80
2
Health Care Practitioner
400
1
15/60
100
Health Care Practitioner
1
1
60/60
1
Health Care Practitioner
400
1
15/60
100
Board Members ............
65
1
180/60
195
Board Members ............
15
1
180/60
45
Board Members ............
275
1
60/60
275
Board Members ............
40
1
120/60
80
Board Members ............
25
1
120/60
50
Board Members ............
50
1
120/60
100
Board Members ............
348
1
30/60
174
Board Members ............
140
1
30/60
70
Board Members ............
140
1
30/60
70
Board Members ............
36
1
30/60
18
Health Care Practitioner
30
1
60/60
30
Health Care Practitioner
5
1
60/60
5
Board Members ............
40
1
30/60
20
Board Members ............
400
1
10/60
67
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14NON1
78055
Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Average
burden per
response
(in hours)
Number of
responses per
respondent
Number of
respondents
Total annual
burden hours
Form name
Type of respondent
Reviewer Worksheet—CIRB Statistical Reviewer
Form (Attachment B32).
CIRB Application for Translated Documents (Attachment B33).
Reviewer Worksheet of Translated Documents
(Attachment B34).
Reviewer Worksheet of Recruitment Material (Attachment B35).
Reviewer Worksheet Expedited Study Closure
Review (Attachment B36).
Reviewer Worksheet of Expedited IR (Attachment B38).
Annual Signatory Institution Worksheet About
Local Context (Attachment B40).
Annual Principal Investigator Worksheet About
Local Context (Attachment B41).
Study-Specific Worksheet About Local Context
(Attachment B42).
Study Closure or Transfer of Study Review Responsibility (Attachment B43).
Unanticipated Problem or Serious or Continuing
Noncompliance Reporting Form (Attachment
B44).
Change of Signatory Institution PI Form (Attachment B45).
Request Waiver of Assent Form (Attachment
B46).
CIRB Waiver of Consent Request Supplemental
Form (Attachment B47).
Review Worksheet CIRB Review for Inclusion of
Incarcerated Participants (Attachment B48).
Notification of Incarcerated Participant Form (Attachment B49).
Final Video Submission Posting Form (Attachment B50).
Unanticipated Problem or Serious or Continuing
Noncompliance Application (Attachment B52).
CIRB Customer Satisfaction Survey (Attachment
C04).
Follow-up Survey (Communication Audit) (Attachment C05).
CIRB Board Member Annual Assessment Survey
(Attachment C07).
Audit Scheduling Form (Attachment D01) ............
Preliminary Audit Finding Form (Attachment D02)
Audit Maintenance Form (Attachment D03) .........
Final Audit finding Report Form (Attachment
D04).
Follow-up Form (Attachment D05) .......................
Roster Maintenance Form (Attachment D06) ......
Final Report and CAPA Request Form (Attachment D07).
NCI/DCTD/CTEP FDA Form 1572 for Annual
Submission (Attachment E01).
NCI/DCTD/CTE Biosketch (Attachment E02) ......
Board Members ............
100
1
15/60
25
Health Care Practitioner
100
1
30/60
50
Board Members ............
100
1
15/60
25
Board Members ............
20
1
15/60
5
Board Members ............
20
1
15/60
5
Board Members ............
5
1
30/60
3
Health Care Practitioner
400
1
40/60
267
Health Care Practitioner
1800
1
20/60
600
Health Care Practitioner
4800
1
15/60
1200
Health Care Practitioner
1680
1
15/60
420
Health Care Practitioner
360
1
20/60
120
Health Care Practitioner
120
1
20/60
40
Health Care Practitioner
35
1
20/60
12
Health Care Practitioner
20
1
15/60
5
Board Members ............
20
1
60/60
20
Health Care Practitioner
20
1
20/60
7
Health Care Practitioner
80
1
15/60
20
Health Care Practitioner
20
1
30/60
10
Participants ...................
600
1
15/60
150
Participants/ ..................
Board Members ............
Board Members ............
300
1
15/60
75
60
1
15/60
15
Health
Health
Health
Health
Practitioner
Practitioner
Practitioner
Practitioner
229
229
158
110
5
5
5
11
21/60
10/60
9/60
1098/60
401
191
119
22143
Health Care Practitioner
Health Care Practitioner
Health Care Practitioner
44
7
3
7
1
9
27/60
18/60
1800/60
139
2
810
Physician ......................
26,500
1
15/60
6625
Physician; Health Care
Practioner.
Physician; Health Care
Practioner.
Physician ......................
48,000
1
120/60
96000
48,000
1
15/60
12000
24,000
1
10/60
4000
1,000
1
60/60
1000
ISS Form ...............................................................
Basic Study Information Form (Attachment TBD)
Health Care Practitioner, Other.
Physician ......................
Health Care Practioner
2,100
140
1
1
15/60
20/60
525
47
Totals .............................................................
.......................................
173,463
253,510
........................
162,831
NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03).
NCI/DCTD/CTEP Agent Shipment Form (ASF)
(Attachment E04).
NINT Registration Form? ......................................
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Care
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78056
Federal Register / Vol. 88, No. 218 / Tuesday, November 14, 2023 / Notices
Dated: November 8, 2023.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2023–25022 Filed 11–13–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meeting
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meetings 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 purpose of this
meeting is to evaluate requests for
preclinical development resources for
potential new therapeutics for the
treatment of cancer. The outcome of the
evaluation will provide information to
internal NCI committees that will
decide whether NCI should support
requests and make available contract
resources for development of the
potential therapeutic to improve the
treatment of various forms of cancer.
The research proposals and the
discussions could disclose confidential
trade secrets or commercial property
such as patentable material, and
personal information concerning
individuals associated with the
proposed research projects, the
disclosure of which would constitute a
clearly unwarranted invasion of
personal privacy.
khammond on DSKJM1Z7X2PROD with NOTICES
Name of Committee: National Cancer
Institute Special Emphasis Panel; OCT2023
Cycle 45 NExT SEP Committee Meeting.
Date: December 12, 2023.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To evaluate the NCI Experimental
Therapeutics Program Portfolio.
Place: National Institutes of Health, 9000
Rockville Pike, Building 31, Room 3A44,
Bethesda, Maryland 20892 (Virtual Meeting).
Contact Persons: Barbara Mroczkowski,
Ph.D., Executive Secretary, Discovery
Experimental Therapeutics Program,
National Cancer Institute, NIH, 31 Center
Drive, Room 3A44, Bethesda, Maryland
20892, 301–496–4291, mroczkoskib@
mail.nih.gov.
Toby Hecht, Ph.D., Executive Secretary,
Development Experimental Therapeutics
Program, National Cancer Institute, NIH,
9609 Medical Center Drive, Room 3W110,
Rockville, Maryland 20850, 240–276–5683,
toby.hecht2@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
Dated: November 8, 2023.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–25069 Filed 11–13–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2010–1066]
Recreational Boating Safety Projects,
Programs, and Activities Funded
Under Provisions of the Infrastructure
Investment and Jobs Act; Fiscal Year
2023
ACTION:
Notice.
The Coast Guard is publishing
this notice to satisfy a requirement of
the Infrastructure Investment and Jobs
Act that requires a detailed accounting
of the projects, programs, and activities
funded under the national recreational
boating safety program provision of the
Act be published annually in the
Federal Register. This notice specifies
the funding amounts the Coast Guard
has committed, obligated, or expended
during fiscal year 2023, as of September
30, 2023.
FOR FURTHER INFORMATION CONTACT: For
questions on this notice please contact
Mr. Jeff Decker, U.S. Coast Guard,
Regulations Development Manager,
(202) 372–1507 or mailto: RBSInfo@
uscg.mil.
SUMMARY:
SUPPLEMENTARY INFORMATION:
Background and Purpose
Since 1998, Congress has passed a
series of laws providing funding for
projects, programs, and activities
funded under the national recreational
boating safety program, which is
administered by the U.S. Coast Guard.
On November 15, 2021, the
Infrastructure Investment and Jobs Act
(Pub. L. 117–58, Sec. 28001) set aside
funding for Coast Guard administration,
which for fiscal year 2023 was $13.835
million. Of that, not less than $2.1
million shall be made available to
ensure compliance with chapter 43 of
title 46, U.S. Code, and not more than
$1.5 million is available to conduct by
grant or contract a survey of levels of
recreational boating participation and
related matters in the United States.
These funds are available to the
Secretary from the Sport Fish
Restoration and Boating Trust Fund
(Trust Fund) established under 26
U.S.C. 9504(a) for payment of Coast
Guard expenses for personnel and
activities directly related to
coordinating and carrying out the
national recreational boating safety
program. Amounts made available
under this subsection remain available
during the two succeeding fiscal years.
Any amount that is unexpended or
unobligated at the end of the three-year
period during which it is available shall
be withdrawn by the Secretary and
allocated to the States in addition to any
other amounts available for allocation in
the fiscal year in which they are
withdrawn or the following fiscal year.
Use of these funds requires
compliance with standard Federal
contracting rules with associated lead
and processing times resulting in a lag
time between available funds and
spending. The total amount of funding
transferred to the Coast Guard from the
Trust Fund, and committed, obligated,
and/or expended during fiscal year 2023
for each project is shown below.
Specific Accounting of Funds
The total amount of funding
transferred to the Coast Guard from the
Sport Fish Restoration and Boating
Trust Fund and committed, obligated,
and/or expended during fiscal year 2023
for each project is shown in the chart
below.
Project
Description
46 U.S.C. 43 Compliance: Inspection Program/Boat
Testing Program.
46 U.S.C. 43 Compliance: Staff Salaries .....................
Provided for continuance of the national recreational boat compliance
inspection program, which began in January 2001.
Provided for 3 personnel to oversee manufacturer compliance with 46
U.S.C. 43 requirements.
Provided for travel by employees of the Boating Safety Division to
oversee manufacturer compliance with 46 U.S.C. 43 requirements.
46 U.S.C. 43 Compliance: Staff Travel ........................
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Cost
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558,743
66,009
]]>Agencies
[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Notices]
[Pages 78053-78056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25022]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Cancer Therapy
Evaluation Program (CTEP) Branch and Support Contracts Forms and
Surveys (NCI)
AGENCY: National Institutes of Health, HHS.
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 proposed 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, Cancer Therapy Evaluation Program--DCTD, National Cancer
Institute, 9609 Medical Center Drive, Rockville, Maryland 20850 or call
non-toll-free number (240) 276-6080 or email your request, including
your address to: [email protected]. 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 Therapy Evaluation Program (CTEP)
Branch and Support Contracts Forms and Surveys (NCI), 0925-0753,
Expiration Date 03/31/2026, REVISION, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information Collection: This is a request for OMB
to approve the revised information collection, Cancer Therapy
Evaluation Program (CTEP) Support Contracts Forms and Survey. It
includes modifications to OMB-approved forms for the CTSU and CIRB and
the addition of new forms for the CTSU, CIRB, and CTEP. The National
Cancer Institute (NCI) CTEP and the Division of Cancer Prevention (DCP)
fund an extensive national program of cancer research, sponsoring
clinical trials in cancer prevention, symptom management, and treatment
for qualified clinical investigators. As part of this effort, CTEP
implements programs to register clinical site investigators and
clinical site staff and to oversee the conduct of research at the
clinical sites. CTEP and DCP also oversee two support programs, the NCI
Central Institutional Review Board (CIRB) and the Cancer Trial Support
Unit (CTSU). The combined systems and processes for initiating and
managing clinical trials are termed the Clinical Oncology Research
Enterprise (CORE) and represent an integrated set of information
systems and processes that support investigator registration, trial
oversight, patient enrollment, and clinical data collection. The
information collected is required to ensure compliance with applicable
federal regulations governing the conduct of human subjects' research
(45 CFR 46 and 21 CRF 50), and when CTEP acts as the Investigational
New Drug (IND) holder (Food and Drug Administration (FDA) regulations
pertaining to the sponsor of clinical trials and the selection of
qualified investigators under 21 CRF 312.53). Survey collections assess
satisfaction and provide feedback to guide improvements with processes
and technology.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 162,831 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Form name respondent respondents responses per response (in burden hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
CTSU IRB/Regulatory Approval Health Care 2444 12 2/60 978
Transmittal Form (Attachment Practitioner.
A01).
CTSU IRB Certification Form Health Care 2444 12 10/60 4888
(Attachment A02). Practitioner.
[[Page 78054]]
Withdrawal from Protocol Health Care 279 1 10/60 47
Participation Form Practitioner.
(Attachment A03).
Site Addition Form (Attachment Health Care 80 12 10/60 160
A04). Practitioner.
CTSU Request for Clinical Health Care 360 1 10/60 60
Brochure (Attachment A06). Practitioner.
CTSU Supply Request Form Health Care 90 12 10/60 180
(Attachment A07). Practitioner.
RTOG 0834 CTSU Data Health Care 30 2 5/60 5
Transmittal Form (Attachment Practitioner.
A10).
CTSU Patient Enrollment Health Care 12 12 10/60 24
Transmittal Form (Attachment Practitioner.
A15).
CTSU Transfer Form (Attachment Health Care 360 2 10/60 120
A16). Practitioner.
CTSU OPEN Rave Request Form Health Care 30 21 10/60 105
(Attachment A18). Practitioner.
CTSU LPO Form Creation Health Care 5 2 120/60 20
(Attachment A19). Practitioner.
CTSU Site Form Creation and Health Care 400 10 30/60 2000
PDF (Attachment A20). Practitioner.
CTSU PDF Signature Form Health Care 400 10 10/60 667
(Attachment A21). Practitioner.
CTSU CLASS Course Setup Health Care 10 2 20/60 7
Request Form (Attachment A22). Practitioner.
CTSU LPO Approval of Early Health Care 2444 6 20/60 4888
Closure Form (Attachment A23). Practitioner.
International DTL Signing Health Care 29 1 10/60 5
(Attachment 24). Practitioner.
NCI CIRB AA & DOR between the Participants.... 50 1 15/60 13
NCI CIRB and Signatory
Institution (Attachment B01).
NCI CIRB Signatory Enrollment Participants.... 50 1 15/60 13
Form (Attachment B02).
CIRB Board Member Application Board Member.... 100 1 30/60 50
(Attachment B03).
CIRB Member COI Screening Board Members... 100 1 15/60 25
Worksheet (Attachment B08).
CIRB COI Screening for CIRB Board Members... 72 1 15/60 18
meetings (Attachment B09).
CIRB IR Application Health Care 80 1 60/60 80
(Attachment B10). Practitioner.
CIRB IR Application for Exempt Health Care 4 1 30/60 2
Studies (Attachment B11). Practitioner.
CIRB Amendment Review Health Care 400 1 15/60 100
Application (Attachment B12). Practitioner.
CIRB Ancillary Studies Health Care 1 1 60/60 1
Application (Attachment B13). Practitioner.
CIRB Continuing Review Health Care 400 1 15/60 100
Application (Attachment B14). Practitioner.
Adult IR of Cooperative Group Board Members... 65 1 180/60 195
Protocol (Attachment B15).
Pediatric IR of Cooperative Board Members... 15 1 180/60 45
Group Protocol (Attachment
B16).
Adult Continuing Review of Board Members... 275 1 60/60 275
Cooperative Group Protocol
(Attachment B17) Protocol.
Adult Amendment of Cooperative Board Members... 40 1 120/60 80
Group Protocol (Attachment
B19).
Pediatric Amendment of Board Members... 25 1 120/60 50
Cooperative Group Protocol
(Attachment B20).
Pharmacist's Review of a Board Members... 50 1 120/60 100
Cooperative Group Study
(Attachment B21).
Adult Expedited Amendment Board Members... 348 1 30/60 174
Review (Attachment B23).
Pediatric Expedited Amendment Board Members... 140 1 30/60 70
Review (Attachment B24).
Adult Expedited Continuing Board Members... 140 1 30/60 70
Review (Attachment B25).
Pediatric Expedited Continuing Board Members... 36 1 30/60 18
Review (Attachment B26).
Adult Cooperative Group Health Care 30 1 60/60 30
Response to CIRB Review Practitioner.
(Attachment B27).
Pediatric Cooperative Group Health Care 5 1 60/60 5
Response to CIRB Review Practitioner.
(Attachment B28).
Adult Expedited Study Chair Board Members... 40 1 30/60 20
Response to Required
Modifications (Attachment
B29).
Reviewer Worksheet-- Board Members... 400 1 10/60 67
Determination of UP or SCN
(Attachment B31).
[[Page 78055]]
Reviewer Worksheet--CIRB Board Members... 100 1 15/60 25
Statistical Reviewer Form
(Attachment B32).
CIRB Application for Health Care 100 1 30/60 50
Translated Documents Practitioner.
(Attachment B33).
Reviewer Worksheet of Board Members... 100 1 15/60 25
Translated Documents
(Attachment B34).
Reviewer Worksheet of Board Members... 20 1 15/60 5
Recruitment Material
(Attachment B35).
Reviewer Worksheet Expedited Board Members... 20 1 15/60 5
Study Closure Review
(Attachment B36).
Reviewer Worksheet of Board Members... 5 1 30/60 3
Expedited IR (Attachment B38).
Annual Signatory Institution Health Care 400 1 40/60 267
Worksheet About Local Context Practitioner.
(Attachment B40).
Annual Principal Investigator Health Care 1800 1 20/60 600
Worksheet About Local Context Practitioner.
(Attachment B41).
Study-Specific Worksheet About Health Care 4800 1 15/60 1200
Local Context (Attachment Practitioner.
B42).
Study Closure or Transfer of Health Care 1680 1 15/60 420
Study Review Responsibility Practitioner.
(Attachment B43).
Unanticipated Problem or Health Care 360 1 20/60 120
Serious or Continuing Practitioner.
Noncompliance Reporting Form
(Attachment B44).
Change of Signatory Health Care 120 1 20/60 40
Institution PI Form Practitioner.
(Attachment B45).
Request Waiver of Assent Form Health Care 35 1 20/60 12
(Attachment B46). Practitioner.
CIRB Waiver of Consent Request Health Care 20 1 15/60 5
Supplemental Form (Attachment Practitioner.
B47).
Review Worksheet CIRB Review Board Members... 20 1 60/60 20
for Inclusion of Incarcerated
Participants (Attachment B48).
Notification of Incarcerated Health Care 20 1 20/60 7
Participant Form (Attachment Practitioner.
B49).
Final Video Submission Posting Health Care 80 1 15/60 20
Form (Attachment B50). Practitioner.
Unanticipated Problem or Health Care 20 1 30/60 10
Serious or Continuing Practitioner.
Noncompliance Application
(Attachment B52).
CIRB Customer Satisfaction Participants.... 600 1 15/60 150
Survey (Attachment C04).
Follow-up Survey Participants/... 300 1 15/60 75
(Communication Audit) Board Members...
(Attachment C05).
CIRB Board Member Annual Board Members... 60 1 15/60 15
Assessment Survey (Attachment
C07).
Audit Scheduling Form Health Care 229 5 21/60 401
(Attachment D01). Practitioner.
Preliminary Audit Finding Form Health Care 229 5 10/60 191
(Attachment D02). Practitioner.
Audit Maintenance Form Health Care 158 5 9/60 119
(Attachment D03). Practitioner.
Final Audit finding Report Health Care 110 11 1098/60 22143
Form (Attachment D04). Practitioner.
Follow-up Form (Attachment Health Care 44 7 27/60 139
D05). Practitioner.
Roster Maintenance Form Health Care 7 1 18/60 2
(Attachment D06). Practitioner.
Final Report and CAPA Request Health Care 3 9 1800/60 810
Form (Attachment D07). Practitioner.
NCI/DCTD/CTEP FDA Form 1572 Physician....... 26,500 1 15/60 6625
for Annual Submission
(Attachment E01).
NCI/DCTD/CTE Biosketch Physician; 48,000 1 120/60 96000
(Attachment E02). Health Care
Practioner.
NCI/DCTD/CTEP Financial Physician; 48,000 1 15/60 12000
Disclosure Form (Attachment Health Care
E03). Practioner.
NCI/DCTD/CTEP Agent Shipment Physician....... 24,000 1 10/60 4000
Form (ASF) (Attachment E04).
NINT Registration Form?....... Health Care 1,000 1 60/60 1000
Practitioner,
Other.
ISS Form...................... Physician....... 2,100 1 15/60 525
Basic Study Information Form Health Care 140 1 20/60 47
(Attachment TBD). Practioner.
---------------------------------------------------------------
Totals.................... ................ 173,463 253,510 .............. 162,831
----------------------------------------------------------------------------------------------------------------
[[Page 78056]]
Dated: November 8, 2023.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2023-25022 Filed 11-13-23; 8:45 am]
BILLING CODE 4140-01-P
