[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9524-9526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03046]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; 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 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.

DATES: Comments regarding this information collection are best assured 
of having their full effect if received within 30 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 by using the search function.

FOR FURTHER INFORMATION 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: <a href="/cdn-cgi/l/email-protection#610c0e0f15040d0d0e0c210c00080d4f0f08094f060e17"><span class="__cf_email__" data-cfemail="8de0e2e3f9e8e1e1e2e0cde0ece4e1a3e3e4e5a3eae2fb">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on October 8, 2020, page 
63565 (Vol. 85, No. 196, FR 63565) and allowed 60 days for public 
comment. No public comments were received. 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: CTEP Support Contract Forms and Surveys 
(NCI), OMB #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 151,792.

                                        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 System Access Request      Health Care                  180               1           10/60              30
 Form (Attachment A17).          Practitioner.
CTSU OPEN Rave Request Form     Health Care                   30              21           10/60             105
 (Attachment A18).               Practitioner.

[[Page 9525]]

 
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.
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).
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).

[[Page 9526]]

 
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....................  ................         167,715         235,670  ..............         151,792
----------------------------------------------------------------------------------------------------------------


    Dated: February 1, 2021.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2021-03046 Filed 2-12-21; 8:45 am]
BILLING CODE 4140-01-P


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