Proposed Collection; 60-Day Comment Request; CTEP Branch and Support Contracts Forms and Surveys (National Cancer Institute), 7483-7487 [2018-03471]
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Federal Register / Vol. 83, No. 35 / Wednesday, February 21, 2018 / Notices
The estimated respondent count per
year is approximately 3,000 families and
1,000 professionals.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total
burden hours
F2F HIC Feedback Survey ..................................................
F2F HIC Grant Recipient Activity ........................................
4,000
51
1
1
4,000
51
0.15
89
600
4,539
Total ..............................................................................
4,051
........................
4,051
........................
5,139
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions; (2) the accuracy of the
estimated burden; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Amy McNulty,
Acting Director, Division of the Executive
Secretariat.
[FR Doc. 2018–03455 Filed 2–20–18; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Eye Institute; Notice of Closed
Meetings
daltland on DSKBBV9HB2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Eye Institute
Special Emphasis Panel; NEI Mentored
Career Development Award and Pathways to
Independence Applications (K).
Date: March 13, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: The William F. Bolger Center, 9600
Newbridge Drive, Potomac, MD 20854.
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Contact Person: Jeanette M. Hosseini,
Ph.D., Scientific Review Officer, Division of
Extramural Research, National Eye Institute,
National Institutes of Health, 5635 Fishers
Lane, Suite 1300, Bethesda, MD 20892, 301–
451–2020, jeanetteh@mail.nih.gov.
Name of Committee: National Eye Institute
Special Emphasis Panel; NEI Clinical,
Epidemiological and Secondary Data
Analysis Applications.
Date: March 22, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Brian Hoshaw, Ph.D.,
Scientific Review Officer, Division of
Extramural Research, National Eye Institute,
National Institutes of Health, 5635 Fishers
Lane, Suite 1300, Rockville, MD 20892, 301–
451–2020, hoshawb@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.867, Vision Research,
National Institutes of Health, HHS)
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Nursing Research Special Emphasis Panel;
NINR Centers Meeting.
Date: March 5–6, 2018.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Washington/Rockville, 1750
Rockville Pike, Rockville, MD 20852.
Contact Person: Weiqun Li, MD, Scientific
Review Officer, National Institute of Nursing
Research, National Institutes of Health, 6701
Democracy Blvd., Suite 710, Bethesda, MD
20892, (301) 594–5966, wli@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.361, Nursing Research,
National Institutes of Health, HHS)
Dated: February 15, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
Dated: February 15, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–03475 Filed 2–20–18; 8:45 am]
[FR Doc. 2018–03473 Filed 2–20–18; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Nursing Research;
Notice to Close Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
PO 00000
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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.
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
SUMMARY:
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Federal Register / Vol. 83, No. 35 / Wednesday, February 21, 2018 / Notices
of having their full effect if received
within 60 days of the date of this
publication.
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-tollfree number 240–276–6080 or Email
your request, including your address to:
ctsuconstact@westat.com. Formal
requests for additional plans and
instruments must be requested in
writing.
FOR FURTHER INFORMATION CONTACT:
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
SUPPLEMENTARY INFORMATION:
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.
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
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total annual
burden hours
daltland on DSKBBV9HB2PROD with NOTICES
Form name
Type of respondent
CTSU
IRB/Regulatory
Approval
Transmittal Form (Attachment A01).
CTSU IRB Certification Form (Attachment A02).
Withdrawal from Protocol Participation Form (Attachment A03).
Site Addition Form (Attachment A04)
CTSU Roster Update Form (Attachment A05).
CTSU Request for Clinical Brochure
(Attachment A06).
CTSU Supply Request Form (Attachment A07).
Site Initiated Data Update Form (Attachment A08).
Data Clarification Form (Attachment
A09).
RTOG 0834 CTSU Data Transmittal
Form (Attachment A10).
CTSU Generic Data Transmittal
Form (Attachment A12).
CTSU Patient Enrollment Transmittal
Form (Attachment A15).
CTSU Transfer Form (Attachment
A16).
Health Care Practitioner ..................
2,444
12
2/60
978
Health Care Practitioner ..................
2,444
12
10/60
4,888
Health Care Practitioner ..................
279
1
10/60
47
Health Care Practitioner ..................
Health Care Practitioner ..................
80
600
12
1
10/60
5/60
160
50
Health Care Practitioner ..................
360
1
10/60
60
Health Care Practitioner ..................
90
12
10/60
180
Health Care Practitioner ..................
2
12
10/60
4
Health Care Practitioner ..................
150
24
10/60
600
Health Care Practitioner ..................
12
76
10/60
152
Health Care Practitioner ..................
5
12
10/60
10
Health Care Practitioner ..................
12
12
10/60
24
Health Care Practitioner ..................
360
2
10/60
120
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Federal Register / Vol. 83, No. 35 / Wednesday, February 21, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total annual
burden hours
daltland on DSKBBV9HB2PROD with NOTICES
Form name
Type of respondent
CTSU System Access Request Form
(Attachment A17).
CTSU OPEN Rave Request Form
(Attachment A18).
CTSU LPO Form Creation (Attachment A19).
CTSU Site Form Creation and PDF
(Attachment A20).
CTSU PDF Signature Form (Attachment A21).
NCI CIRB AA & DOR between the
NCI CIRB and Signatory Institution
(Attachment B01).
NCI CIRB Signatory Enrollment Form
(Attachment B02).
CIRB Board Member Application (Attachment B03).
CIRB Member COI Screening Worksheet (Attachment B08).
CIRB COI Screening for CIRB meetings (Attachment B09).
CIRB IR Application (Attachment
B10).
CIRB IR Application for Exempt
Studies (Attachment B11).
CIRB Amendment Review Application (Attachment B12).
CIRB Ancillary Studies Application
(Attachment B13).
CIRB Continuing Review Application
(Attachment B14).
Adult IR of Cooperative Group Protocol (Attachment B15).
Pediatric IR of Cooperative Group
Protocol (Attachment B16).
NCI Adult/Pediatric Continuing Review of Cooperative Group Protocol (Attachment B17).
Adult Amendment of Cooperative
Group Protocol (Attachment B19).
Pediatric Amendment of Cooperative
Group Protocol (Attachment B20).
Pharmacist’s Review of a Cooperative Group Study (Attachment B21).
Adult Expedited Amendment Review
(Attachment B23).
Pediatric Expedited Amendment Review (Attachment B24).
Adult Expedited Continuing Review
(Attachment B25).
Pediatric Expedited Continuing Review (Attachment B26).
Adult Cooperative Group Response
to CIRB Review (Attachment B27).
Pediatric Cooperative Group Response to CIRB Review (Attachment B28).
Adult Expedited Study Chair Response to Required Modifications(Attachment B29).
Reviewer Worksheet- Determination
of UP or SCN (Attachment B31).
Reviewer Worksheet -CIRB Statistical Reviewer Form (Attachment
B32).
CIRB Application for Translated Documents (Attachment B33).
Reviewer Worksheet of Translated
Documents (Attachment B34).
Health Care Practitioner ..................
180
1
20/60
60
Health Care Practitioner ..................
30
21
10/60
105
Health Care Practitioner ..................
5
2
120/60
20
Health Care Practitioner ..................
400
10
30/60
2,000
Health Care Practitioner ..................
400
10
10/60
667
Participants ......................................
50
1
15/60
13
Participants ......................................
50
1
15/60
13
Board Member .................................
100
1
30/60
50
Board Members ...............................
100
1
15/60
25
Board Members ...............................
72
1
15/60
18
Health Care Practitioner ..................
80
1
60/60
80
Health Care Practitioner ..................
4
1
30/60
2
Health Care Practitioner ..................
400
1
15/60
100
Health Care Practitioner ..................
1
1
60/60
1
Health Care Practitioner ..................
400
1
15/60
100
Board Members ...............................
65
1
180/60
195
Board Members ...............................
15
1
180/60
45
Board Members ...............................
275
1
60/60
275
Board Members ...............................
40
1
120/60
80
Board Members ...............................
25
1
120/60
50
Board Members ...............................
50
1
120/60
100
Board Members ...............................
348
1
30/60
174
Board Members ...............................
140
1
30/60
70
Board Members ...............................
140
1
30/60
70
Board Members ...............................
36
1
30/60
18
Health Care Practitioner ..................
30
1
60/60
30
Health Care Practitioner ..................
5
1
60/60
5
Board Members ...............................
40
1
30/60
20
Board Members ...............................
400
1
10/60
67
Board Members ...............................
100
1
15/60
25
Health Care Practitioner ..................
100
1
30/60
50
Board Members ...............................
100
1
15/60
25
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Federal Register / Vol. 83, No. 35 / Wednesday, February 21, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total annual
burden hours
daltland on DSKBBV9HB2PROD with NOTICES
Form name
Type of respondent
Reviewer Worksheet of Recruitment
Material (Attachment B35).
Reviewer
Worksheet
Expedited
Study Closure Review (Attachment
B36).
Reviewer Worksheet of Expedited IR
(Attachment B38).
Annual Signatory Institution Worksheet About Local Context (Attachment B40).
Annual Principal Investigator Worksheet About Local Context (Attachment B41).
Study-Specific
Worksheet
About
Local Context (Attachment B42).
Study Closure or Transfer of Study
Review Responsibility(Attachment
B43).
Unanticipated Problem or Serious or
Continuing Noncompliance Reporting Form (Attachment (B44).
Change of Signatory Institution PI
Form (Attachment B45).
Request Waiver of Assent Form (Attachment B46).
CTSU OPEN Survey (Attachment
C03).
CIRB Customer Satisfaction Survey
(Attachment C04).
Follow-up Survey (Communication
Audit) (Attachment C05).
CIRB Board Member Annual Assessment Survey (Attachment C07).
PIO Customer Satisfaction Survey
(Attachment C08).
Concept Clinical Trial Survey (Attachment C09).
Prospective Clinical Trial Survey (Attachment C10).
Low Accrual Clinical Trial Survey (Attachment C11).
Audit Scheduling Form (Attachment
D01).
Preliminary Audit Findings Form (Attachment D02).
Audit Maintenance Form (Attachment
D03).
Final Audit Finding Report Form (Attachment D04).
Follow-up Form (Attachment D05) ....
Roster Maintenance Form (Attachment D06).
Final Report and CAPA Request
Form (Attachment D07).
NCI/DCTD/CTEP FDA Form 1572 for
Annual
Submission(Attachment
E01).
NCI/DCTD/CTE Biosketch (Attachment E02).
NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03).
NCI/DCTD/CTEP Agent Shipment
Form (ASF) (Attachment E04).
Board Members ...............................
20
1
15/60
5
Board Members ...............................
20
1
15/60
5
Board Members ...............................
5
1
30/60
3
Health Care Practitioner ..................
400
1
40/60
267
Health Care Practitioner ..................
1,800
1
20/60
600
Health Care Practitioner ..................
4,800
1
20/60
1,600
Health Care Practitioner ..................
1,680
1
20/60
560
Health Care Practitioner ..................
360
1
20/60
120
Health Care Practitioner ..................
120
1
20/60
40
..........................................................
60
1
20/60
20
Health Care Practitioner ..................
60
1
15/60
15
Participants ......................................
600
1
15/60
150
Participants/Board Members ...........
300
1
15/60
75
Board Members ...............................
60
1
15/60
15
Health Care Practitioner ..................
60
1
5/60
5
Health Care Practitioner ..................
500
1
5/60
42
Health Care Practitioner ..................
1,000
1
1/60
17
Health Care Practitioner ..................
1,000
1
1/60
17
Group/CTMS Users .........................
152
5
21/60
266
Auditor ..............................................
152
5
10/60
127
Group/CTMS Users .........................
152
5
9/60
114
Group/CTMS Users .........................
75
11
1,098/60
15,098
Group/CTMS Users .........................
CTMS Users ....................................
75
5
7
1
27/60
18/60
236
2
CTMS Users ....................................
12
9
1,800/60
3,240
Physician ..........................................
23,000
1
8/60
3,067
Physician; Health Care Practitioner
33,000
1
47/60
25,850
Physician; Health Care Practitioner
33,000
1
5/60
2,750
Physician ..........................................
23,000
1
7/60
2,683
..........................................................
136,487
207,989
........................
68,855
Totals ..........................................
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21FEN1
Federal Register / Vol. 83, No. 35 / Wednesday, February 21, 2018 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
A Strategic Roadmap for Establishing
New Approaches To Evaluate the
Safety of Chemicals and Medical
Products in the United States;
Availability of Report
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
The Interagency Coordinating
Committee on the Validation of
Alternative Methods (ICCVAM)
coordinated the development of a
strategic roadmap for establishing new
approaches to evaluate the safety of
chemicals and medical products in the
United States. This document, prepared
with support from the National
Toxicology Program Interagency Center
for the Evaluation of Alternative
Toxicological Methods (NICEATM), is
now available.
ADDRESSES: The report is available at
https://ntp.niehs.nih.gov/go/natlstrategy.
FOR FURTHER INFORMATION CONTACT: Dr.
Warren Casey, Director, NICEATM;
email: warren.casey@nih.gov; telephone:
(984) 287–3118.
SUPPLEMENTARY INFORMATION:
Background: Scientific and
technological advances in toxicology
can significantly improve and protect
public health. However, a national
strategy is required to ensure the safe,
effective, and timely implementation of
human-based, predictive approaches in
toxicity testing.
The goal of the U.S. Strategic
Roadmap is to realize the vision set
forth in the seminal National Research
Council report ‘‘Toxicity Testing in the
21st Century: A Vision and a Strategy.’’
This 2007 report envisioned using
human-based assays and model
information to provide a more efficient,
predictive, and economic system for
assessing the effects of chemicals on
human health.
The U.S. Strategic Roadmap was
developed with participation from the
16 ICCVAM member agencies and
multiple interagency workgroups, as
well as input from a broad range of
stakeholder groups. It describes a new
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:57 Feb 20, 2018
Jkt 244001
framework that will enable
development, establish confidence in,
and ensure use of new approaches to
toxicity testing that improve human
health relevance and reduce or
eliminate the need for testing in
animals.
Summary of Report Contents: The
successful development and
implementation of new approaches to
toxicity testing will require coordinated
efforts that address three strategic goals:
• Connect end users with developers of
new approach methodologies
• Foster the use of efficient, flexible,
and robust practices to establish
confidence in new methods
• Encourage the adoption and use of
new methods and approaches by
federal agencies and regulated
industries
Implementation of the roadmap goals,
already underway in specific testing
areas, will include key elements needed
for advancement of alternative methods.
Availability of Report: The report is
available at https://ntp.niehs.nih.gov/
go/natl-strategy.
Background Information on ICCVAM
and NICEATM: ICCVAM is an
interagency committee composed of
representatives from 16 federal
regulatory and research agencies that
require, use, generate, or disseminate
toxicological and safety testing
information. ICCVAM conducts
technical evaluations of new, revised,
and alternative safety testing methods
and integrated testing strategies with
regulatory applicability and promotes
the scientific validation and regulatory
acceptance of testing methods that more
accurately assess the safety and hazards
of chemicals and products and replace,
reduce, or refine (enhance animal wellbeing and lessen or avoid pain and
distress) animal use.
The ICCVAM Authorization Act of
2000 (42 U.S.C. 285l–3) establishes
ICCVAM as a permanent interagency
committee of the National Institute of
Environmental Health Sciences and
provides the authority for ICCVAM
involvement in activities relevant to the
development of alternative test
methods. ICCVAM acts to ensure that
new and revised test methods are
validated to meet the needs of federal
agencies, increase the efficiency and
effectiveness and federal agency test
method review, and optimize utilization
of scientific expertise outside the federal
government. Additional information
about ICCVAM can be found at https://
ntp.niehs.nih.gov/go/iccvam.
NICEATM administers ICCVAM,
provides scientific and operational
support for ICCVAM-related activities,
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7487
and conducts and publishes analyses
and evaluations of data from new,
revised, and alternative testing
approaches. NICEATM and ICCVAM
work collaboratively to evaluate new
and improved testing approaches
applicable to the needs of U.S. federal
agencies. NICEATM and ICCVAM
welcome the public nomination of new,
revised, and alternative testing
approaches for validation studies and
technical evaluations. Additional
information about NICEATM can be
found at https://ntp.niehs.nih.gov/go/
niceatm.
Dated: February 9, 2018.
Brian Berridge,
Associate Director, National Toxicology
Program.
[FR Doc. 2018–03476 Filed 2–20–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Neurological
Disorders and Stroke: Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Neurological Disorders and Stroke Initial
Review Group; Neurological Sciences and
Disorders K; NSD–K Review Meeting.
Date: March 2, 2018.
Time: 1:00 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Shanta Rajaram, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, NINDS/NIH/DHHS, Neuroscience
Center, 6001 Executive Blvd., Suite 3208,
MSC 9529, Bethesda, MD 20892–9529, 301–
435–6033, rajarams@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
E:\FR\FM\21FEN1.SGM
21FEN1
]]>Agencies
[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.
-----------------------------------------------------------------------
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).
[[Page 7486]]
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[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
