Notice2022-18853
Submission for OMB Review; 30-Day Comment Request Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys (National Cancer Institute)
Primary source
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Published
September 1, 2022
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
In compliance with 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.
Full Text
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<title>Federal Register, Volume 87 Issue 169 (Thursday, September 1, 2022)</title>
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[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Notices]
[Pages 53752-53754]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18853]
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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 (National Cancer Institute)
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: In compliance with 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.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 30-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 <a href="http://www.reginfo.gov/public/do/PRAMain">www.reginfo.gov/public/do/PRAMain</a>. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by 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, Division of Cancer
Treatment and Diagnosis, National Cancer Institute, 9609 Medical Center
Drive, Bethesda, Maryland 20892 or call non-toll-free number (240) 276-
6080 or email your request, including your address to:
<a href="/cdn-cgi/l/email-protection#e78a888993828b8b888aa78a868e8bc9898e8fc9808891"><span class="__cf_email__" data-cfemail="aac7c5c4decfc6c6c5c7eac7cbc3c684c4c3c284cdc5dc">[email protected]</span></a>. Formal requests for additional plans and
instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: This proposed information collection was
published in the Federal Register on May 31, 2022 (Vol. 87, No. 104, P.
32427) 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 (NIH), 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 Office of Management and
Budget (OMB) control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, NIH has submitted to OMB a request for review and approval
of the information collection listed below.
Proposed Collection: Cancer Therapy Evaluation Program (CTEP)
Support Contracts Forms and Survey (NCI) (0925-0753), Expiration Date
05/31/2024, REVISION, National Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information Collection: This revision removes one
form, adds one new form, revises three forms, and includes an updated
Privacy Impact Assessment. The National Cancer Institute (NCI) Cancer
Therapy Evaluation Program (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 represents an integrated set of information
systems and processes which 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 (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 is 151,769 hours.
Estimated Annualized Burden Hours
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Average Total
Number of Number of burden per annual
Form name Type of respondent respondents responses per response burden
respondent (in hours) 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 (Attachment Practitioner.
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 Transmittal Health Care 12 76 10/60 152
Form (Attachment A10). Practitioner.
[[Page 53753]]
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 Health Care 400 10 30/60 2,000
(Attachment A20). Practitioner.
CTSU Electronic Signature Form Health Care 400 10 10/60 667
(Attachment A21). Practitioner.
CTSU CLASS Course Setup Form Health Care 10 2 20/60 7
(Attachment A22). Practitioner.
NCI CIRB AA & DOR between the NCI Participants....... 50 1 15/60 13
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 (Attachment Health Care 80 1 60/60 80
B10). Practitioner.
CIRB IR Application for Exempt Health Care 4 1 30/60 2
Studies (Attachment B11). Practitioner.
CIRB Amendment Review Application Health Care 400 1 15/60 100
(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 Group Board Members...... 15 1 180/60 45
Protocol (Attachment B16).
Adult Continuing Review of Board Members...... 275 1 60/60 275
Cooperative Group Protocol
(Attachment B17).
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 Review Board Members...... 348 1 30/60 174
(Attachment B23).
Pediatric Expedited Amendment Board Members...... 140 1 30/60 70
Review (Attachment B24).
Adult Expedited Continuing Review Board Members...... 140 1 30/60 70
(Attachment B25).
Pediatric Expedited Continuing Board Members...... 36 1 30/60 18
Review (Attachment B26).
Adult Cooperative Group Response Health Care 30 1 60/60 30
to CIRB Review (Attachment B27). Practitioner.
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--Determination Board Members...... 400 1 10/60 67
of UP or SCN (Attachment B31).
Reviewer Worksheet--CIRB Board Members...... 100 1 15/60 25
Statistical Reviewer Form
(Attachment B32).
CIRB Application for Translated Health Care 100 1 30/60 50
Documents (Attachment B33). Practitioner.
Reviewer Worksheet of Translated Board Members...... 100 1 15/60 25
Documents (Attachment B34).
Reviewer Worksheet of Recruitment Board Members...... 20 1 15/60 5
Material (Attachment B35).
Reviewer Worksheet Expedited Board Members...... 20 1 15/60 5
Study Closure Review (Attachment
B36).
Reviewer Worksheet of Expedited Board Members...... 5 1 30/60 3
IR (Attachment B38).
Annual Signatory Institution Health Care 400 1 40/60 267
Worksheet About Local Context Practitioner.
(Attachment B40).
[[Page 53754]]
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 B42). Practitioner.
Study Closure or Transfer of Health Care 1,680 1 15/60 420
Study Review Responsibility Practitioner.
(Attachment B43).
Unanticipated Problem or Serious Health Care 360 1 20/60 120
or Continuing Noncompliance Practitioner.
Reporting Form (Attachment B44).
Change of Signatory Institution Health Care 120 1 20/60 40
PI Form (Attachment B45). Practitioner.
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 for Board Members...... 20 1 60/60 20
Inclusion of Incarcerated
Participants (Attachment B48).
Notification of Incarcerated Health Care 20 1 20/60 7
Participant Form (Attachment Practitioner.
B49).
CTSU OPEN Survey (Attachment C03) Health Care 10 1 15/60 3
Practitioner.
CIRB Customer Satisfaction Survey Participants....... 600 1 15/60 150
(Attachment C04).
Follow-up Survey (Communication Participants/...... 300 1 15/60 75
Audit) (Attachment C05). Board Members......
CIRB Board Member Annual Board Members...... 60 1 15/60 15
Assessment Survey (Attachment
C07).
PIO Customer Satisfaction Survey Health Care 60 1 5/60 5
(Attachment C08). Practitioner.
Audit Scheduling Form (Attachment Health Care 152 5 21/60 266
D01). Practitioner.
Preliminary Audit Finding Form Health Care 152 5 10/60 127
(Attachment D02). Practitioner.
Audit Maintenance Form Health Care 152 5 9/60 114
(Attachment D03). Practitioner.
Final Audit finding Report Form Health Care 75 11 1,098/60 15,098
(Attachment D04). Practitioner.
Follow-up Form (Attachment D05).. Health Care 75 7 27/60 236
Practitioner.
Roster Maintenance Form Health Care 5 1 18/60 2
(Attachment D06). Practitioner.
Final Report and CAPA Request Health Care 12 9 1,800/60 3,240
Form (Attachment D07). Practitioner.
NCI/DCTD/CTEP FDA Form 1572 for Physician.......... 26,500 1 15/60 6,625
Annual Submission (Attachment
E01).
NCI/DCTD/CTE Biosketch Physician; Health 48,000 1 120/60 96,000
(Attachment E02). Care Practitioner.
NCI/DCTD/CTEP Financial Physician; Health 48,000 1 15/60 12,000
Disclosure Form (Attachment E03). Care Practitioner.
NCI/DCTD/CTEP Agent Shipment Form Physician.......... 24,000 1 10/60 4,000
(ASF) (Attachment E04).
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Totals....................... ................... 167,545 235,510 ........... 151,769
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Dated: August 26, 2022.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2022-18853 Filed 8-31-22; 8:45 am]
BILLING CODE 4140-01-P
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