[Federal Register Volume 83, Number 35 (Wednesday, February 21, 2018)]
[Notices]
[Pages 7483-7487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03471]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-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 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

[[Page 7484]]

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., Shanda Finnigan, MPH, RN, CCRC, or Jacquelyn 
Goldberg, JD, 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 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 
0925-0753 Expiration Date 06/30/2020 ICR Type: 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). Information is also 
collected through surveys to assess satisfaction, provide feedback to 
guide improvements with processes and technology, and assess health 
professional's interests in clinical trials.
    To increase efficiencies, reduce administrative burden and cost, 
CTEP has requested consolidation of their current OMB submission. 
Consolidation is justified because although the various branches and 
contracts are responsible for distinct services, the processes that 
support the NCI and participating clinical sites efforts are 
intertwined. This revision of the previous submission includes changes 
to the NCI CIRB and CTSU form collections and integrates the Clinical 
Trials Monitoring Branch (CTMB) and Pharmaceutical Management Branch 
(PMB) form collections related to site audit and clinical investigator 
and key clinical site staff registration.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 68,855.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             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 Transmittal Form    Health Care Practitioner...............           2,444              12            2/60             978
 (Attachment A01).
CTSU IRB Certification Form (Attachment A02)...  Health Care Practitioner...............           2,444              12           10/60           4,888
Withdrawal from Protocol Participation Form      Health Care Practitioner...............             279               1           10/60              47
 (Attachment A03).
Site Addition Form (Attachment A04)............  Health Care Practitioner...............              80              12           10/60             160
CTSU Roster Update Form (Attachment A05).......  Health Care Practitioner...............             600               1            5/60              50
CTSU Request for Clinical Brochure (Attachment   Health Care Practitioner...............             360               1           10/60              60
 A06).
CTSU Supply Request Form (Attachment A07)......  Health Care Practitioner...............              90              12           10/60             180
Site Initiated Data Update Form (Attachment      Health Care Practitioner...............               2              12           10/60               4
 A08).
Data Clarification Form (Attachment A09).......  Health Care Practitioner...............             150              24           10/60             600
RTOG 0834 CTSU Data Transmittal Form             Health Care Practitioner...............              12              76           10/60             152
 (Attachment A10).
CTSU Generic Data Transmittal Form (Attachment   Health Care Practitioner...............               5              12           10/60              10
 A12).
CTSU Patient Enrollment Transmittal Form         Health Care Practitioner...............              12              12           10/60              24
 (Attachment A15).
CTSU Transfer Form (Attachment A16)............  Health Care Practitioner...............             360               2           10/60             120

[[Page 7485]]

 
CTSU System Access Request Form (Attachment      Health Care Practitioner...............             180               1           20/60              60
 A17).
CTSU OPEN Rave Request Form (Attachment A18)...  Health Care Practitioner...............              30              21           10/60             105
CTSU LPO Form Creation (Attachment A19)........  Health Care Practitioner...............               5               2          120/60              20
CTSU Site Form Creation and PDF (Attachment      Health Care Practitioner...............             400              10           30/60           2,000
 A20).
CTSU PDF Signature Form (Attachment A21).......  Health Care Practitioner...............             400              10           10/60             667
NCI CIRB AA & DOR between the NCI CIRB and       Participants...........................              50               1           15/60              13
 Signatory Institution (Attachment B01).
NCI CIRB Signatory Enrollment Form (Attachment   Participants...........................              50               1           15/60              13
 B02).
CIRB Board Member Application (Attachment B03).  Board Member...........................             100               1           30/60              50
CIRB Member COI Screening Worksheet (Attachment  Board Members..........................             100               1           15/60              25
 B08).
CIRB COI Screening for CIRB meetings             Board Members..........................              72               1           15/60              18
 (Attachment B09).
CIRB IR Application (Attachment B10)...........  Health Care Practitioner...............              80               1           60/60              80
CIRB IR Application for Exempt Studies           Health Care Practitioner...............               4               1           30/60               2
 (Attachment B11).
CIRB Amendment Review Application (Attachment    Health Care Practitioner...............             400               1           15/60             100
 B12).
CIRB Ancillary Studies Application (Attachment   Health Care Practitioner...............               1               1           60/60               1
 B13).
CIRB Continuing Review Application (Attachment   Health Care Practitioner...............             400               1           15/60             100
 B14).
Adult IR of Cooperative Group Protocol           Board Members..........................              65               1          180/60             195
 (Attachment B15).
Pediatric IR of Cooperative Group Protocol       Board Members..........................              15               1          180/60              45
 (Attachment B16).
NCI Adult/Pediatric Continuing Review of         Board Members..........................             275               1           60/60             275
 Cooperative Group Protocol (Attachment B17).
Adult Amendment of Cooperative Group Protocol    Board Members..........................              40               1          120/60              80
 (Attachment B19).
Pediatric Amendment of Cooperative Group         Board Members..........................              25               1          120/60              50
 Protocol (Attachment B20).
Pharmacist's Review of a Cooperative Group       Board Members..........................              50               1          120/60             100
 Study (Attachment B21).
Adult Expedited Amendment Review (Attachment     Board Members..........................             348               1           30/60             174
 B23).
Pediatric Expedited Amendment Review             Board Members..........................             140               1           30/60              70
 (Attachment B24).
Adult Expedited Continuing Review (Attachment    Board Members..........................             140               1           30/60              70
 B25).
Pediatric Expedited Continuing Review            Board Members..........................              36               1           30/60              18
 (Attachment B26).
Adult Cooperative Group Response to CIRB Review  Health Care Practitioner...............              30               1           60/60              30
 (Attachment B27).
Pediatric Cooperative Group Response to CIRB     Health Care Practitioner...............               5               1           60/60               5
 Review (Attachment B28).
Adult Expedited Study Chair Response to          Board Members..........................              40               1           30/60              20
 Required Modifications(Attachment B29).
Reviewer Worksheet- Determination of UP or SCN   Board Members..........................             400               1           10/60              67
 (Attachment B31).
Reviewer Worksheet -CIRB Statistical Reviewer    Board Members..........................             100               1           15/60              25
 Form (Attachment B32).
CIRB Application for Translated Documents        Health Care Practitioner...............             100               1           30/60              50
 (Attachment B33).
Reviewer Worksheet of Translated Documents       Board Members..........................             100               1           15/60              25
 (Attachment B34).

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Reviewer Worksheet of Recruitment Material       Board Members..........................              20               1           15/60               5
 (Attachment B35).
Reviewer Worksheet Expedited Study Closure       Board Members..........................              20               1           15/60               5
 Review (Attachment B36).
Reviewer Worksheet of Expedited IR (Attachment   Board Members..........................               5               1           30/60               3
 B38).
Annual Signatory Institution Worksheet About     Health Care Practitioner...............             400               1           40/60             267
 Local Context (Attachment B40).
Annual Principal Investigator Worksheet About    Health Care Practitioner...............           1,800               1           20/60             600
 Local Context (Attachment B41).
Study-Specific Worksheet About Local Context     Health Care Practitioner...............           4,800               1           20/60           1,600
 (Attachment B42).
Study Closure or Transfer of Study Review        Health Care Practitioner...............           1,680               1           20/60             560
 Responsibility(Attachment B43).
Unanticipated Problem or Serious or Continuing   Health Care Practitioner...............             360               1           20/60             120
 Noncompliance Reporting Form (Attachment (B44).
Change of Signatory Institution PI Form          Health Care Practitioner...............             120               1           20/60              40
 (Attachment B45).
Request Waiver of Assent Form (Attachment B46).  .......................................              60               1           20/60              20
CTSU OPEN Survey (Attachment C03)..............  Health Care Practitioner...............              60               1           15/60              15
CIRB Customer Satisfaction Survey (Attachment    Participants...........................             600               1           15/60             150
 C04).
Follow-up Survey (Communication Audit)           Participants/Board Members.............             300               1           15/60              75
 (Attachment C05).
CIRB Board Member Annual Assessment Survey       Board Members..........................              60               1           15/60              15
 (Attachment C07).
PIO Customer Satisfaction Survey (Attachment     Health Care Practitioner...............              60               1            5/60               5
 C08).
Concept Clinical Trial Survey (Attachment C09).  Health Care Practitioner...............             500               1            5/60              42
Prospective Clinical Trial Survey (Attachment    Health Care Practitioner...............           1,000               1            1/60              17
 C10).
Low Accrual Clinical Trial Survey (Attachment    Health Care Practitioner...............           1,000               1            1/60              17
 C11).
Audit Scheduling Form (Attachment D01).........  Group/CTMS Users.......................             152               5           21/60             266
Preliminary Audit Findings Form (Attachment      Auditor................................             152               5           10/60             127
 D02).
Audit Maintenance Form (Attachment D03)........  Group/CTMS Users.......................             152               5            9/60             114
Final Audit Finding Report Form (Attachment      Group/CTMS Users.......................              75              11        1,098/60          15,098
 D04).
Follow-up Form (Attachment D05)................  Group/CTMS Users.......................              75               7           27/60             236
Roster Maintenance Form (Attachment D06).......  CTMS Users.............................               5               1           18/60               2
Final Report and CAPA Request Form (Attachment   CTMS Users.............................              12               9        1,800/60           3,240
 D07).
NCI/DCTD/CTEP FDA Form 1572 for Annual           Physician..............................          23,000               1            8/60           3,067
 Submission(Attachment E01).
NCI/DCTD/CTE Biosketch (Attachment E02)........  Physician; Health Care Practitioner....          33,000               1           47/60          25,850
NCI/DCTD/CTEP Financial Disclosure Form          Physician; Health Care Practitioner....          33,000               1            5/60           2,750
 (Attachment E03).
NCI/DCTD/CTEP Agent Shipment Form (ASF)          Physician..............................          23,000               1            7/60           2,683
 (Attachment E04).
                                                                                         ---------------------------------------------------------------
    Totals.....................................  .......................................         136,487         207,989  ..............          68,855
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[[Page 7487]]

    Dated: January 23, 2018.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2018-03471 Filed 2-20-18; 8:45 am]
 BILLING CODE 4140-01-P