Notice2023-25022
Proposed Collection; 60-Day Comment Request; Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys (NCI)
Primary source
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Published
November 14, 2023
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 218 (Tuesday, November 14, 2023)</title>
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[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Notices]
[Pages 78053-78056]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-25022]
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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.
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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: <a href="/cdn-cgi/l/email-protection#5d3032332938313132301d303c343173333435733a322b"><span class="__cf_email__" data-cfemail="2d4042435948414142406d404c444103434445034a425b">[email protected]</span></a>. 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
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Average
Type of Number of Number of burden per Total annual
Form name respondent respondents responses per response (in burden hours
respondent hours)
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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.
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Totals.................... ................ 173,463 253,510 .............. 162,831
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[[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
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