[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Pages 12618-12621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-04253]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Submission for OMB Review; 30-Day Comment Request; CTEP Support 
Contracts Forms and Surveys, NCI, NIH

AGENCY: National Institutes of Health, HHS.

ACTION: Notice.

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[[Page 12619]]

    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. This proposed information 
collection was previously published in the Federal Register on December 
13, 2016, page 89955 (81 FR 89955) and allowed 60 days for public 
comment. No public comments were received. The purpose of this notice 
is to allow an additional 30 days for public comment.

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., 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].
    Proposed Collection: CTEP Support Contracts Forms and Surveys, NCI, 
0925-New, 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 and DCP oversee two support programs, the 
NCI Central Institutional Review Board (CIRB) and the Cancer Trial 
Support Unit (CTSU). The purpose of the support programs is to increase 
efficiency and minimizing burden. The NCI CIRB provides trial oversight 
satisfying the requirements of 45 CFR part 45 and 21 CFR part 56 for 
review of NCI supported studies. The CTSU provides program and systems 
support for regulatory document collection, membership, data management 
and patient enrollment. The two programs use integrated systems and 
processes for managing participant information and documentation of 
regulatory review.
    To meet the responsibilities of each program, information is 
collected from the sites for purposes of membership, enrollment, 
opening of IRB approved studies, documenting IRB review, regulatory 
approval (for sites not using the CIRB), patient enrollment, and 
routing of case report forms.
    Several surveys are collected to assess satisfaction and provide 
feedback to guide improvements with processes and technology. Other 
Surveys have been developed to assess health professional's interests 
in clinical trials.
    OMB approval is requested for 3 years. There are no costs to 
respondents other than their time. The total estimated annualized 
burden hours are 15,525.

           CTSU and NCI CIRB Forms and CTSU, CIRB and CTEP Surveys--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.
 A1).
CTSU IRB Certification Form     Health Care                2,444              12           10/60           4,888
 (Attachment A2).                Practitioner.
Withdrawal from Protocol        Health Care                  279               1           10/60              47
 Participation Form              Practitioner.
 (Attachment A3).
Site Addition Form (Attachment  Health Care                   80              12           10/60             160
 A4).                            Practitioner.
CTSU Roster Update Form         Health Care                  600               1            5/60              50
 (Attachment A5).                Practitioner.
CTSU Request for Clinical       Health Care                  360               1           10/60              60
 Brochure (Attachment A6).       Practitioner.
CTSU Supply Request Form        Health Care                   90              12           10/60             180
 (Attachment A7).                Practitioner.
Site Initiated Data Update      Health Care                    2              12           10/60               4
 Form (Attachment A8).           Practitioner.
Data Clarification Form         Health Care                  150              24           10/60             600
 (Attachment A9).                Practitioner.
RTOG 0834 CTSU Data             Health Care                   12              76           10/60             152
 Transmittal Form (Attachment    Practitioner.
 A10).
MC0845(8233) CTSU Data          Health Care                    5              12           10/60              10
 Transmittal (Attachment A11).   Practitioner.
CTSU Generic Data Transmittal   Health Care                    5              12           10/60              10
 Form (Attachment A12).          Practitioner.
TAILORx--PACCT1--Data           Health Care                  161              96           10/60            2576
 Transmittal Form (Attachment    Practitioner.
 A13).
Unsolicited Data Modification   Health Care                   30              12           10/60              60
 Form: Protocol: TAILORx/PACCT-  Practitioner.
 1 (Attachment 14).
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.

[[Page 12620]]

 
NCI CIRB AA & DOR between the   Participants....              50               1           15/60              13
 NCI CIRB and Signatory
 Institution (Attachment B1).
NCI CIRB Signatory Enrollment   Participants....              50               1           15/60              13
 Form (Attachment B2).
CIRB Board Member Biographical  Board Member....              25               1           15/60               6
 Sketch Form (Attachment B3).
CIRB Board Member Contact       Board Member....              25               1           10/60               4
 Information Form (Attachment
 B4).
CIRB Board Member NDA           Board Member....              25               1           10/60               4
 (Attachment B6).
CIRB Direct Deposit Form        Board Member....              25               1           15/60               6
 (Attachment B7).
CIRB Member COI Screening       Board Members...              12               1           30/60               6
 Worksheet (Attachment B8).
CIRB COI Screening for CIRB     Board Members...              72               1           15/60              18
 meetings (Attachment B9).
CIRB IR Application             Health Care                   80               1               1              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               1               1
 Application (Attachment B13).   Practitioner.
CIRB Continuing Review          Health Care                  400               1           30/60             200
 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               1             275
 Cooperative Group Protocol
 (Attachment B17) Protocol.
Pediatric Continuing Review of  Board Members...             130               1               1             130
 Cooperative Group Protocol
 (Attachment B18).
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...              10               1          120/60              20
 Cooperative Group Study
 (Attachment B21).
CPC Pharmacist's Review of      Board Members...              20               1          120/60              40
 Cooperative Group Study
 (Attachment B22).
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               1              30
 Response to CIRB Review         Practitioner.
 (Attachment B27).
Pediatric Cooperative Group     Health Care                    5               1               1               5
 Response to CIRB Review         Practitioner.
 (Attachment B28).
Adult Expedited Study Chair     Board Members...              40               1           15/60              10
 Response to Required Mod
 (Attachment B29).
Pediatric Expedited Study       Board Members...              40               1           15/60              10
 Chair Response to Required
 Mod (Attachment B30).
Reviewer Worksheet--            Board Members...             360               1           10/60              61
 Determination of UP or SCN
 (Attachment B31).
Reviewer Worksheet--CIRB        Board Members...             100               1               1             100
 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).

[[Page 12621]]

 
Reviewer Worksheet Expedited    Board Members...              20               1           15/60               5
 Study Closure Review
 (Attachment B36).
Reviewer Worksheet Expedited    Board Members...               5               1           30/60               3
 Review of Study Chair
 Response to CIRB-Required
 Modifications (Attachment
 B37).
Reviewer Worksheet of           Board Members...               5               1           30/60               3
 Expedited IR (Attachment B38).
Reviewer Worksheet--CPC--       Board Members...              40               1           15/60              10
 Determination of UP or SCN
 (Attachment B39).
Annual Signatory Institution    Health Care                  400               1           40/60             267
 Worksheet About Local Context   Practitioner.
 (Attachment B40).
Annual Principal Investigator   Health Care                 1800               1           20/60             600
 Worksheet About Local Context   Practitioner.
 (Attachment B41).
Study-Specific Worksheet About  Health Care                 4800               1           20/60            1600
 Local Context (Attachment       Practitioner.
 B42).
Study Closure or Transfer of    Health Care                 1680               1           15/60             420
 Study Review Responsibility     Practitioner.
 Form (Attachment B43).
UP or SCN Reporting Form        Health Care                  360               1           20/60             120
 (Attachment B44).               Practitioner.
Change of SI PI Form            Health Care                  120               1           15/60              30
 (Attachment B45).               Practitioner.
CTSU Website Customer           Health Care                  275               1           15/60              69
 Satisfaction Survey             Practitioner.
 (Attachment C1).
CTSU Help Desk Customer         Health Care                  325               1           15/60              81
 Satisfaction Survey             Practitioner.
 (Attachment C2).
CTSU OPEN Survey (Attachment    Health Care                   60               1           15/60              15
 C3).                            Practitioner.
CIRB Customer Satisfaction      Participants....             600               1           15/60             150
 Survey (Attachment C4)
 Satisfaction Survey
 (Attachment C4).
Follow-up Survey                Participants/                300               1           15/60              75
 (Communication Audit)           Board Members.
 (Attachment C5).
Website Focus Groups,           Participants/                 18               1               1              18
 Communication Project           Board Members.
 (Attachment C6 A-D).
CIRB Board Member Annual        Board Members...              60               1           20/60              20
 Assessment Survey (Attachment
 C7).
PIO Customer Satisfaction       Health Care                   60               1            5/60               5
 Survey (Attachment C8).         Practitioner.
Concept Clinical Trial Survey   Health Care                  500               1            5/60              42
 (Attachment C9).                Practitioner.
Prospective Clinical Trial      Health Care                 1000               1            1/60              17
 Survey (Attachment C10).        Practitioner.
Low Accrual Clinical Trial      Health Care                 1000               1            1/60              17
 Survey (Attachment C11).        Practitioner.
ETCTN PI Survey (Attachment     Physician.......              75               1           15/60              19
 12).
ETCTN RS Survey (Attachment     Health Care                  175               1           15/60              44
 13).                            Practitioner.
                                                 ---------------------------------------------------------------
    Totals....................  ................          24,100         100,337  ..............          15,525
----------------------------------------------------------------------------------------------------------------


    Dated: February 15, 2017.
Karla Bailey,
PRA OMB Liaison, Office of Management Policy and Compliance, National 
Cancer Institute (NCI) National Institutes of Health (NIH).
[FR Doc. 2017-04253 Filed 3-3-17; 8:45 am]
 BILLING CODE 4140-01-P