[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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