[Federal Register Volume 89, Number 47 (Friday, March 8, 2024)]
[Notices]
[Pages 16776-16779]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04943]


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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)

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, 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 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 November 14, 2023, page 
78053 (88 FR 78053) 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,

[[Page 16777]]

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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                                                                     Number of    Average burden
           Form name             Type of respondent   Number of    responses per   per response    Total annual
                                                     respondents    respondent      (in hours)     burden hours
----------------------------------------------------------------------------------------------------------------
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                  30               2            5/60               5
 Form (Attachment A10).           Practitioner.
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 PDF  Health Care                 400              10           30/60           2,000
 (Attachment A20).                Practitioner.
CTSU PDF Signature Form          Health Care                 400              10           10/60             667
 (Attachment A21).                Practitioner.
CTSU CLASS Course Setup Request  Health Care                  10               2           20/60               7
 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 (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            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.

[[Page 16778]]

 
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).
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            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 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).
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         Health Care                 360               1           20/60             120
 Serious or Continuing            Practitioner.
 Noncompliance 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     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).

[[Page 16779]]

 
Follow-up Survey (Communication  Participants/Board          300               1           15/60              75
 Audit) (Attachment C05).         Members.
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 Form  Health Care                 110              11        1,098/60          22,143
 (Attachment D04).                Practitioner.
Follow-up Form (Attachment D05)  Health Care                  44               7           27/60             139
                                  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 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 Practioner.
NCI/DCTD/CTEP Financial          Physician; Health        48,000               1           15/60          12,000
 Disclosure Form (Attachment      Care Practioner.
 E03).
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
Basic Study Information Form     Health Care                 140               1           20/60              47
 (Attachment TBD).                Practioner.
                                                    ------------------------------------------------------------
    Totals.....................  ..................      173,463         253,510  ..............         162,831
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    Dated: March 5, 2024.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2024-04943 Filed 3-7-24; 8:45 am]
BILLING CODE 4140-01-P