[Federal Register Volume 81, Number 239 (Tuesday, December 13, 2016)]
[Notices]
[Pages 89955-89957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29767]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Proposed Collection; 60-Day Comment Request; CTEP Support 
Contracts Forms and Surveys (National Cancer Institute)

AGENCY: National Institutes of Health, Department of Health and Human 
Services.

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 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 minimizes the burden of the collection of

[[Page 89956]]

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 Contracts Forms and 
Surveys, 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 45 and 21 CFR 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 15,531.

                                        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.               Practitioner.
CTSU IRB Certification Form...  Health Care                2,444              12           10/60           4,888
                                 Practitioner.
Withdrawal from Protocol        Health Care                  279               1           10/60              47
 Participation Form.             Practitioner.
Site Addition Form............  Health Care                   80              12           10/60             160
                                 Practitioner.
CTSU Roster Update Form.......  Health Care                  600               1            5/60              50
                                 Practitioner.
CTSU Request for Clinical       Health Care                  360               1           10/60              60
 Brochure.                       Practitioner.
CTSU Supply Request Form......  Health Care                   90              12           10/60             180
                                 Practitioner.
Site Initiated Data Update      Health Care                    2              12           10/60               4
 Form.                           Practitioner.
Data Clarification Form.......  Health Care                  150              24           10/60             600
                                 Practitioner.
RTOG 0834 CTSU Data             Health Care                   12              76           10/60             152
 Transmittal Form.               Practitioner.
MC0845(8233) CTSU Data          Health Care                    5              12           10/60              10
 Transmittal.                    Practitioner.
CTSU Generic Data Transmittal   Health Care                    5              12           10/60              10
 Form.                           Practitioner.
TAILORx_PACCT1_Data             Health Care                  161              96           10/60           2,576
 Transmittal Form.               Practitioner.
Unsolicited Data Modification   Health Care                   30              12           10/60              60
 Form: Protocol: TAILORx/PACCT-  Practitioner.
 1.
CTSU Patient Enrollment         Health Care                   12              12           10/60              24
 Transmittal Form.               Practitioner.
CTSU Transfer Form............  Health Care                  360               2           10/60             120
                                 Practitioner.
CTSU System Access Request      Health Care                  180               1           20/60              60
 Form.                           Practitioner.
NCI CIRB AA & DOR between the   Participants....              50               1           15/60              13
 NCI CIRB and Signatory
 Institution.
NCI CIRB Signatory Enrollment   Participants....              50               1           15/60              13
 Form.
CIRB Board Member Biographical  Board Member....              25               1           15/60               6
 Sketch Form.
CIRB Board Member Contact       Board Member....              25               1           10/60               4
 Information Form.
CIRB Board Member W-9.........  Board Member....              25               1           15/60               6
CIRB Board Member NDA.........  Board Member....              25               1           10/60               4
CIRB Direct Deposit Form......  Board Member....              25               1           15/60               6
CIRB Member COI Screening       Board Members...              12               1           30/60               6
 Worksheet.
CIRB COI Screening for CIRB     Board Members...              72               1           15/60              18
 meetings.
CIRB IR Application...........  Health Care                   80               1           60/60              80
                                 Practitioner.
CIRB IR Application for Exempt  Health Care                    4               1           30/60               2
 Studies.                        Practitioner.
CIRB Amendment Review           Health Care                  400               1           15/60             100
 Application.                    Practitioner.
CIRB Ancillary Studies          Health Care                    1               1           60/60               1
 Application.                    Practitioner.
CIRB Continuing Review          Health Care                  400               1           30/60             200
 Application.                    Practitioner.
Adult IR of Cooperative Group   Board Members...              65               1          180/60             195
 Protocol.
Pediatric IR of Cooperative     Board Members...              15               1          180/60              45
 Group Protocol.
Adult Continuing Review of      Board Members...             275               1           60/60             275
 Cooperative Group Protocol.
Pediatric Continuing Review of  Board Members...             130               1           60/60             130
 Cooperative Group Protocol.
Adult Amendment of Cooperative  Board Members...              40               1          120/60              80
 Group Protocol.
Pediatric Amendment of          Board Members...              25               1          120/60              50
 Cooperative Group Protocol.
Pharmacist's Review of a        Board Members...              10               1          120/60              20
 Cooperative Group Study.
CPC Pharmacist's Review of      Board Members...              20               1          120/60              40
 Cooperative Group Study.
Adult Expedited Amendment       Board Members...             348               1           30/60             174
 Review.

[[Page 89957]]

 
Pediatric Expedited Amendment   Board Members...             140               1           30/60              70
 Review.
Adult Expedited Continuing      Board Members...             140               1           30/60              70
 Review.
Pediatric Expedited Continuing  Board Members...              36               1           30/60              18
 Review.
Adult Cooperative Group         Health Care                   30               1           60/60              30
 Response to CIRB Review.        Practitioner.
Pediatric Cooperative Group     Health Care                    5               1           60/60               5
 Response to CIRB Review.        Practitioner.
Adult Expedited Study Chair     Board Members...              40               1           15/60              10
 Response to Required Mod.
Pediatric Expedited Study       Board Members...              40               1           15/60              10
 Chair Response to Required
 Mod.
Reviewer Worksheet--            Board Members...             360               1           10/60              61
 Determination of UP or SCN.
Reviewer Worksheet--CIRB        Board Members...             100               1           60/60             100
 Statistical Reviewer Form.
CIRB Application for            Health Care                  100               1           30/60              50
 Translated Documents.           Practitioner.
Reviewer Worksheet of           Board Members...             100               1           15/60              25
 Translated Documents.
Reviewer Worksheet of           Board Members...              20               1           15/60               5
 Recruitment Material.
Reviewer Worksheet Expedited    Board Members...              20               1           15/60               5
 Study Closure Review.
Reviewer Worksheet Expedited    Board Members...               5               1           30/60               3
 Review of Study Chair
 Response to CIRB--Required
 Modifications.
Reviewer Worksheet of           Board Members...               5               1           30/60               3
 Expedited IR.
Reviewer Worksheet--CPC--       Board Members...              40               1           15/60              10
 Determination of UP or SCN.
Annual Signatory Institution    Health Care                  400               1           40/60             267
 Worksheet About Local Context.  Practitioner.
Annual Principal Investigator   Health Care                1,800               1           20/60             600
 Worksheet About Local Context.  Practitioner.
Study-Specific Worksheet About  Health Care                4,800               1           20/60           1,600
 Local Context.                  Practitioner.
Study Closure or Transfer of    Health Care                1,680               1           15/60             420
 Study Review Responsibility     Practitioner.
 Form.
UP or SCN Reporting Form......  Health Care                  360               1           20/60             120
                                 Practitioner.
Change of SI PI Form..........  Health Care                  120               1           15/60              30
                                 Practitioner.
CTSU Web site Customer          Health Care                  275               1           15/60              69
 Satisfaction Survey.            Practitioner.
CTSU Help Desk Customer         Health Care                  325               1           15/60              81
 Satisfaction Survey.            Practitioner.
CTSU OPEN Survey..............  Health Care                   60               1           15/60              15
                                 Practitioner.
CIRB Customer Satisfaction      Participants....             600               1           15/60             150
 Survey.
Follow-up Survey                Participants/                300               1           15/60              75
 (Communication Audit).          Board Members.
Web site Focus Groups,          Participants/                 18               1           60/60              18
 Communication Project.          Board Members.
CIRB Board Member Annual        Board Members...              60               1           20/60              20
 Assessment Survey.
PIO Customer Satisfaction       Health Care                   60               1            5/60               5
 Survey.                         Practitioner.
Concept Clinical Trial Survey.  Health Care                  500               1            5/60              42
                                 Practitioner.
Prospective Clinical Trial      Health Care                1,000               1            1/60              17
 Survey.                         Practitioner.
Low Accrual Clinical Trial      Health Care                1,000               1            1/60              17
 Survey.                         Practitioner.
ETCTN PI Survey...............  Physician.......              75               1           15/60              19
ETCTN RS Survey...............  Health Care                  175               1           15/60              44
                                 Practitioner.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Totals....................  ................          24,125         100,362  ..............          15,531
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    Dated: December 1, 2016.
Karla Bailey,
Project Clearance Liaison, National Cancer Institute, National 
Institutes of Health.
[FR Doc. 2016-29767 Filed 12-12-16; 8:45 am]
 BILLING CODE 4140-01-P