[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Notices]
[Pages 63561-63564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22265]


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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 (National Cancer Institute)

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 propose 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, Pharm. D., Cancer Therapy Evaluation Program (CTEP), 9609 
Medical Center Drive, MSC 9742, Rockville, MD 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

[[Page 63562]]

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: CTEP Support Contract Forms and Surveys 
(NCI), 0925-0753 Expiration Date 07/31/2021, REVISION, National Cancer 
Institute (NCI), National Institutes of Health (NIH).
    Need and Use of Information Collection: 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 subjects research (45 CFR 46 and 21 CRF 50), and when 
CTEP acts as the Investigational New Drug (IND) holder, 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 151,716.

                                        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                2,444              12            2/60             978
 Transmittal Form (Attach.       Practitioner.
 A01).
CTSU IRB Certification Form     Health Care                2,444              12           10/60           4,888
 (Attach. A02).                  Practitioner.
Withdrawal from Protocol        Health Care                  279               1           10/60              47
 Participation Form (Attach.     Practitioner.
 A03).
Site Addition Form (Attach.     Health Care                   80              12           10/60             160
 A04).                           Practitioner.
CTSU Request for Clinical       Health Care                  360               1           10/60              60
 Brochure (Attach. A06).         Practitioner.
CTSU Supply Request Form        Health Care                   90              12           10/60             180
 (Attach. A07).                  Practitioner.
RTOG 0834 CTSU Data             Health Care                   12              76           10/60             152
 Transmittal Form (Attach.       Practitioner.
 A10).
CTSU Patient Enrollment         Health Care                   12              12           10/60              24
 Transmittal Form (Attach.       Practitioner.
 A15).
CTSU Transfer Form (Attach.     Health Care                  360               2           10/60             120
 A16).                           Practitioner.
CTSU System Access Request      Health Care                  180               1           10/60              30
 Form (Attach. A17).             Practitioner.
CTSU OPEN Rave Request Form     Health Care                   30              21           10/60             105
 (Attach. A18).                  Practitioner.
CTSU LPO Form Creation          Health Care                    5               2          120/60              20
 (Attach. A19).                  Practitioner.
CTSU Site Form Creation and     Health Care                  400              10           30/60           2,000
 PDF (Attach. A20).              Practitioner.
CTSU PDF Signature Form         Health Care                  400              10           10/60             667
 (Attach. A21).                  Practitioner.
NCI CIRB AA & DOR between the   Participants....              50               1           15/60              13
 NCI CIRB and Signatory
 Institution (Attach. B01).
NCI CIRB Signatory Enrollment   Participants....              50               1           15/60              13
 Form (Attach. B02).
CIRB Board Member Application   Board Member....             100               1           30/60              50
 (Attach. B03).
CIRB Member COI Screening       Board Members...             100               1           15/60              25
 Worksheet (Attach. B08).
CIRB COI Screening for CIRB     Board Members...              72               1           15/60              18
 meetings (Attach. B09).
CIRB IR Application (Attach.    Health Care                   80               1               1              80
 B10).                           Practitioner.
CIRB IR Application for Exempt  Health Care                    4               1           30/60               2
 Studies (Attach. B11).          Practitioner.
CIRB Amendment Review           Health Care                  400               1           15/60             100
 Application (Attach. B12).      Practitioner.
CIRB Ancillary Studies          Health Care                    1               1               1               1
 Application (Attach. B13).      Practitioner.
CIRB Continuing Review          Health Care                  400               1           15/60             100
 Application (Attach. B14).      Practitioner.
Adult IR of Cooperative Group   Board Members...              65               1          180/60             195
 Protocol (Attach. B15).
Pediatric IR of Cooperative     Board Members...              15               1          180/60              45
 Group Protocol (Attach. B16).

[[Page 63563]]

 
NCI Adult/Pediatric Continuing  Board Members...             275               1               1             275
 Review of Cooperative Group
 Protocol (Attach. B17).
Adult Amendment of Cooperative  Board Members...              40               1          120/60              80
 Group Protocol (Attach. B19).
Pediatric Amendment of          Board Members...              25               1          120/60              50
 Cooperative Group Protocol
 (Attach. B20).
Pharmacist's Review of a        Board Members...              50               1          120/60             100
 Cooperative Group Study
 (Attach. B21).
Adult Expedited Amendment       Board Members...             348               1           30/60             174
 Review (Attach. B23).
Pediatric Expedited Amendment   Board Members...             140               1           30/60              70
 Review (Attach. B24).
Adult Expedited Continuing      Board Members...             140               1           30/60              70
 Review (Attach. B25).
Pediatric Expedited Continuing  Board Members...              36               1           30/60              18
 Review (Attach. B26).
Adult Cooperative Group         Health Care                   30               1               1              30
 Response to CIRB Review         Practitioner.
 (Attach. B27).
Pediatric Cooperative Group     Health Care                    5               1               1               5
 Response to CIRB Review         Practitioner.
 (Attach. B28).
Adult Expedited Study Chair     Board Members...              40               1           30/60              20
 Response to Required
 Modifications (Attach. B29).
Reviewer Worksheet-             Board Members...             400               1           10/60              67
 Determination of UP or SCN
 (Attach. B31).
Reviewer Worksheet -CIRB        Board Members...             100               1           15/60              25
 Statistical Reviewer Form
 (Attach. B32).
CIRB Application for            Health Care                  100               1           30/60              50
 Translated Documents (Attach.   Practitioner.
 B33).
Reviewer Worksheet of           Board Members...             100               1           15/60              25
 Translated Documents (Attach.
 B34).
Reviewer Worksheet of           Board Members...              20               1           15/60               5
 Recruitment Material (Attach.
 B35).
Reviewer Worksheet Expedited    Board Members...              20               1           15/60               5
 Study Closure Review (Attach.
 B36).
Reviewer Worksheet of           Board Members...               5               1           30/60               3
 Expedited IR (Attach. B38).
Annual Signatory Institution    Health Care                  400               1           40/60             267
 Worksheet About Local Context   Practitioner.
 (Attach. B40).
Annual Principal Investigator   Health Care                1,800               1           20/60             600
 Worksheet About Local Context   Practitioner.
 (Attach. B41).
Study-Specific Worksheet About  Health Care                4,800               1           15/60           1,200
 Local Context (Attach. B42).    Practitioner.
Study Closure or Transfer of    Health Care                1,680               1           15/60             344
 Study Review Resp. (Attach.     Practitioner.
 B43).
Unanticipated Problem or        Health Care                  360               1           20/60             120
 Serious or Continuing           Practitioner.
 Noncompliance Reporting Form
 (Attach. (B44).
Change of Signatory             Health Care                  120               1           20/60              40
 Institution PI Form (Attach.    Practitioner.
 B45).
Request Waiver of Assent Form   Health Care                   35               1           20/60              12
 (Attach. 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               1              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 (Attach. C03)  Health Care                   10               1           15/60               3
                                 Practitioner.
CIRB Customer Satisfaction      Participants....             600               1           15/60             150
 Survey (Attach. C04).
Follow-up Survey                Participants/                300               1           15/60              75
 (Communication Audit)           Board Members.
 (Attach. C05).
CIRB Board Member Annual        Board Members...              60               1           15/60              15
 Assessment Survey (Attach.
 C07).
PIO Customer Satisfaction       Health Care                   60               1            5/60               5
 Survey (Attach. C08).           Practitioner.
Audit Scheduling Form (Attach.  Group/CTMS Users             152               5           21/60             266
 D01).
Preliminary Audit Findings      Auditor.........             152               5           10/60             127
 Form (Attach. D02).
Audit Maintenance Form          Group/CTMS Users             152               5            9/60             114
 (Attach. D03).
Final Audit Finding Report      Group/CTMS Users              75              11        1,098/60          15,098
 Form (Attach. D04).
Follow-up Form (Attach. D05)..  Group/CTMS Users              75               7           27/60             236
Roster Maintenance Form         CTMS Users......               5               1           18/60               2
 (Attach. D06).

[[Page 63564]]

 
Final Report and CAPA Request   CTMS Users......              12               9        1,800/60           3,240
 Form (Attach. D07).
NCI/DCTD/CTEP FDA Form 1572     Physician.......          26,500               1           15/60           6,625
 for Annual Submission
 (Attach. E01).
NCI/DCTD/CTE Biosketch          Physician;                48,000               1          120/60          96,000
 (Attach. E02).                  Health Care
                                 Practitioner.
NCI/DCTD/CTEP Financial         Physician;                48,000               1           15/60          12,000
 Disclosure Form (Attach. E03).  Health Care
                                 Practitioner.
NCI/DCTD/CTEP Agent Shipment    Physician.......          24,000               1           10/60           4,000
 Form (ASF) (Attach. E04).
                               ---------------------------------------------------------------------------------
    Totals....................  ................         167,715             276  ..............         151,716
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    Dated: October 1, 2020.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2020-22265 Filed 10-7-20; 8:45 am]
BILLING CODE 4140-01-P