[Federal Register Volume 88, Number 218 (Tuesday, November 14, 2023)]
[Notices]
[Pages 78053-78056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25022]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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: [email protected]. 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
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                     Type of         Number of       Number of      burden per     Total annual
           Form name               respondent       respondents    responses per   response (in    burden hours
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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.
                                                 ---------------------------------------------------------------
    Totals....................  ................         173,463         253,510  ..............         162,831
----------------------------------------------------------------------------------------------------------------



[[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