[Federal Register Volume 83, Number 82 (Friday, April 27, 2018)]
[Notices]
[Pages 18576-18579]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08902]


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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/or suggestions regarding the item(s) 
contained in this notice, especially regarding the estimated public 
burden and associated response time, should be directed to the: Office 
of Management and Budget, Office of Regulatory Affairs, 
[email protected] or by fax to 202-395-6974, Attention: Desk 
Officer for NIH.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the data collection plans and 
instruments, contact: Michael Montello, Pharm.D., Shanda Finnigan, MPH, 
RN, CCRC or Jacquelyn Goldberg, JD, Cancer Therapy Evaluation Program, 
Division of Cancer Treatment and Diagnosis, 9609 Medical Center Drive, 
Rockville, MD 20850 or call non-toll-free number (240-276-6080) or 
email your request, including your address to: [email protected].

SUPPLEMENTARY INFORMATION: This proposed information collection was 
previously published in the Federal Register on February 21, 2018, page 
7483 (83 FR 7483) 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: CTEP Branch and Support Contracts Forms and 
Surveys, 0925-0753 Expiration Date 06/30/2020, 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

[[Page 18577]]

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 112,798.

                                        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 Roster Update Form         Health Care                  600               1            5/60              50
 (Attachment A05).               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.
Site Initiated Data Update      Health Care                    2              12           10/60               4
 Form (Attachment A08).          Practitioner.
Data Clarification Form         Health Care                  150              24           10/60             600
 (Attachment A09).               Practitioner.
RTOG 0834 CTSU Data             Health Care                   12              76           10/60             152
 Transmittal Form (Attachment    Practitioner.
 A10).
CTSU Generic Data Transmittal   Health Care                    5              12           10/60              10
 Form (Attachment A12).          Practitioner.
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           20/60              60
 Form (Attachment A17).          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           2,000
 PDF (Attachment A20).           Practitioner.
CTSU PDF 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.                    Practitioner.
(Attachment B13)..............
CIRB Continuing Review          Health Care                  400               1           15/60             100
 Application.                    Practitioner.
(Attachment B14)..............
Adult IR of Cooperative Group   Board Members...              65               1          180/60             195
 Protocol (Attachment B15).

[[Page 18578]]

 
Pediatric IR of Cooperative     Board Members...              15               1          180/60              45
 Group Protocol (Attachment
 B16).
NCI Adult/Pediatric Continuing  Board Members...             275               1           60/60             275
 Review of 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           20/60           1,600
 Local Context (Attachment       Practitioner.
 B42).
Study Closure or Transfer of    Health Care                1,680               1           20/60             560
 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   ................              60               1           20/60              20
 (Attachment B46).
CTSU OPEN Survey (Attachment    Health Care                   60               1           15/60              15
 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.
Concept Clinical Trial Survey   Health Care                  500               1            5/60              42
 (Attachment C09).               Practitioner.
Prospective Clinical Trial      Health Care                1,000               1            1/60              17
 Survey (Attachment C10).        Practitioner.
Low Accrual Clinical Trial      Health Care                1,000               1            1/60              17
 Survey (Attachment C11).        Practitioner.

[[Page 18579]]

 
Audit Scheduling Form           Group/CTMS Users             152               5           21/60             266
 (Attachment D01).
Preliminary Audit Findings      Auditor.........             152               5           10/60             127
 Form (Attachment D02).
Audit Maintenance Form          Group/CTMS Users             152               5            9/60             114
 (Attachment D03).
Final Audit Finding Report      Group/CTMS Users              75              11        1,098/60          15,098
 Form (Attachment D04).
Follow-up Form (Attachment      Group/CTMS Users              75               7           27/60             236
 D05).
Roster Maintenance Form         CTMS Users......               5               1           18/60               2
 (Attachment D06).
Final Report and CAPA Request   CTMS Users......              12               9        1,800/60            3240
 Form (Attachment D07).
NCI/DCTD/CTEP FDA Form 1572     Physician.......          23,000               1           15/60           5,750
 for Annual Submission
 (Attachment E01).
NCI/DCTD/CTE Biosketch          Physician;                33,000               1          120/60          66,000
 (Attachment E02).               Health Care
                                 Practitioner.
NCI/DCTD/CTEP Financial         Physician;                33,000               1            5/60           2,750
 Disclosure Form (Attachment     Health Care
 E03).                           Practitioner.
NCI/DCTD/CTEP Agent Shipment    Physician.......          23,000               1           10/60           3,833
 Form (ASF) (Attachment E04).
                                                 ---------------------------------------------------------------
    Totals....................  ................         136,487         207,989  ..............         112,838
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    Dated: April 12, 2018.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2018-08902 Filed 4-26-18; 8:45 am]
 BILLING CODE 4140-01-P