Submission for OMB Review; 30-Day Comment Request; Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys (NCI); Correction
| Published date | 25 March 2024 |
| Record Number | 2024-06233 |
| Citation | 89 FR 20667 |
| Court | National Institutes Of Health |
| Section | Notices |
Federal Register, Volume 89 Issue 58 (Monday, March 25, 2024)
[Federal Register Volume 89, Number 58 (Monday, March 25, 2024)]
[Notices]
[Pages 20667-20670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06233]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request; Cancer Therapy
Evaluation Program (CTEP) Branch and Support Contracts Forms and
Surveys (NCI); Correction
AGENCY: National Institutes of Health, HHS.
ACTION: Notice; correction.
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SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the National Cancer Institute (NCI) has submitted to the
Office of Management and Budget (OMB) a request for review and approval
of the information collection listed below.
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.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to https://www.reginfo.gov/public/do/PRAMain. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or using the search function.
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: This proposed information collection was
previously published in the Federal Register on March 8, 2024, page
16776 (89 FR 16776) and allowed 60 days for public comment. No public
comments were received. The purpose of this notice is to allow an
additional 30 days for public comment. The National Cancer Institute
(NCI), National Institutes of Health, may not conduct or sponsor, and
the respondent is not required to respond to, an information collection
that has been extended, revised, or implemented on or after October 1,
1995, unless it displays a currently valid OMB control number.
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, the National Institutes of Health (NIH) has submitted to
the Office of Management and Budget (OMB) a request for review and
approval of the information collection listed below.
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 CFF 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 CFR 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 162,836 hours.
[[Page 20668]]
Estimated Annualized Burden Hours
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Number of Average burden
Form name Type of Number of responses per per response Total annual
respondent respondents respondent (in hours) burden hours
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CTSU IRB/Regulatory Approval Health Care 2,444 12 2/60 978
Transmittal Form (Attachment Practitioner.
A01).
CTSU IRB Certification Form Health Care 2,444 12 10/60 4,888
(Attachment A02). Practitioner.
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 2,000
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 2,444 6 20/60 4,888
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).
[[Page 20669]]
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).
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 1,800 1 20/60 600
Worksheet About Local Context Practitioner.
(Attachment B41).
Study-Specific Worksheet About Health Care 4,800 1 15/60 1,200
Local Context (Attachment Practitioner.
B42).
Study Closure or Transfer of Health Care 1,680 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).
PIO Customer Satisfaction Health Care 60 1 5/60 5
Survey (Attachment C08). Practitioner.
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 1,098/60 22,143
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 1,800/60 810
Form (Attachment D07). Practitioner.
NCI/DCTD/CTEP FDA Form 1572 Physician....... 26,500 1 15/60 6,625
for Annual Submission
(Attachment E01).
NCI/DCTD/CTE Biosketch Physician; 48,000 1 120/60 96,000
(Attachment E02). Health Care
Practioner.
NCI/DCTD/CTEP Financial Physician; 48,000 1 15/60 12,000
Disclosure Form (Attachment Health Care
E03). Practioner.
NCI/DCTD/CTEP Agent Shipment Physician....... 24,000 1 10/60 4,000
Form (ASF) (Attachment E04).
NINT Registration Form?....... Health Care 1,000 1 60/60 1,000
Practitioner,
Other.
ISS Form...................... Physician....... 2,100 1 15/60 525
[[Page 20670]]
Basic Study Information Form Health Care 140 1 20/60 47
(Attachment TBD). Practioner.
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Totals.................... ................ 173,523 253,570 .............. 162,836
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Dated: March 20, 2024.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2024-06233 Filed 3-22-24; 8:45 am]
BILLING CODE 4140-01-P
