[Federal Register Volume 87, Number 104 (Tuesday, May 31, 2022)]
[Notices]
[Pages 32427-32430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-11510]


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

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 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
----------------------------------------------------------------------------------------------------------------
                                                                     Number of    Average burden
           Form name                 Type of         Number of     responses per   per response    Total annual
                                   respondent       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              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).
                                                 ---------------------------------------------------------------
    Totals....................  ................         167,545         235,510  ..............         151,769
----------------------------------------------------------------------------------------------------------------



[[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