Notice2022-11510
Proposed Collection; 60-Day Comment Request; Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys (NCI)
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Published
May 31, 2022
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 87 Issue 104 (Tuesday, May 31, 2022)</title>
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[Federal Register Volume 87, Number 104 (Tuesday, May 31, 2022)]
[Notices]
[Pages 32427-32430]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-11510]
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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#9cf1f3f2e8f9f0f0f3f1dcf1fdf5f0b2f2f5f4b2fbf3ea"><span class="__cf_email__" data-cfemail="b0dddfdec4d5dcdcdfddf0ddd1d9dc9eded9d89ed7dfc6">[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 minimizes 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 05/31/2024, 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. This
revision removes one form (A17 CTSU System Access Request Form), adds
one new form (A22 CLASS Course Setup Request Form), revises three forms
(A18 CTSU Open Rave Request Form; B41 Annual Principal Investigator
Worksheet about Local Context; B47 CIRB Waiver of Consent Request
Supplemental Form), 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 is 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 subject's 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 151,769 hours.
[[Page 32428]]
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 12 76 10/60 152
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 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 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).
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 32429]]
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 (B49). Practitioner.
CTSU OPEN Survey (Attachment Health Care 10 1 15/60 3
C03). Practitioner.
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 152 5 21/60 266
(Attachment 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 Health Care 75 11 1,098/60 15,098
Form (Attachment D04). Practitioner.
Follow-up Form (Attachment Health Care 75 7 27/60 236
D05). 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 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
Practitioner.
NCI/DCTD/CTEP Financial Physician; 48,000 1 15/60 12,000
Disclosure Form (Attachment Health Care
E03). Practitioner.
NCI/DCTD/CTEP Agent Shipment Physician....... 24,000 1 10/60 4,000
Form (ASF) (Attachment E04).
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Totals.................... ................ 167,545 235,510 .............. 151,769
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[[Page 32430]]
Dated: May 24, 2022.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2022-11510 Filed 5-27-22; 8:45 am]
BILLING CODE 4140-01-P
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