Submission for OMB Review; 30-Day Comment Request, 18576-18579 [2018-08902]
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Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices
biospecimen inventories must register
for an account.
Information will be collected from
those wishing to create an account,
sufficient to identify them as unique
Users. Those submitting or requesting
data and/or biospecimen inventories
will be required to provide additional
supporting information to ensure proper
use and security of NICHD DASH study
data and biospecimen inventories. The
information collected is limited to the
essential data required to ensure the
management of Users in NICHD DASH
is efficient and the sharing of data and
All the data collected from use of
NICHD DASH except for information
provided in the annual progress reports
are for the purposes of internal
administrative management of NICHD
DASH. Information gathered through
the annual progress reports may be used
in publications describing performance
of the DASH system.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
204.
biospecimens among investigators is
effective. The primary uses of the
information collected from Users by
NICHD will be to:
• Communicate with the Users with
regards to their data submission, data
requests and biospecimen requests
• Monitor data submissions, data
requests and biospecimen requests
• Notify interested recipients of updates
to data and biospecimen inventories
stored in NICHD DASH
• Help NICHD understand the use of
NICHD DASH study data and
biospecimen inventories by the
research community
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of form
Frequency of
response
Average time
per response
(in hours)
Total annual
burden hour
User Registration .............................................................................................
Data and Biospecimen Inventory Submission .................................................
Data Request ...................................................................................................
Biospecimen Request ......................................................................................
Data Use Annual Progress Report ..................................................................
Biospecimen Use Annual Progress Report .....................................................
Institutional Certification Template ..................................................................
200
36
60
36
60
36
36
1
1
1
1
1
1
1
5/60
2
1
1
10/60
10/60
5/60
17
72
60
36
10
6
3
Total ..........................................................................................................
200
200
........................
204
Dated: April 17, 2018.
Jennifer M. Guimond,
Project Clearance Liaison, Eunice Kennedy
Shriver, National Institute of Child Health
and Human Development, National Institutes
of Health.
[FR Doc. 2018–08901 Filed 4–26–18; 8:45 am]
BILLING CODE 4140–01–P
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.
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.
daltland on DSKBBV9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:18 Apr 26, 2018
Jkt 244001
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,
OIRA_submission@omb.eop.gov 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: ctsucontact@
westat.com.
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,
ADDRESSES:
PO 00000
Frm 00076
Fmt 4703
Sfmt 4703
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
E:\FR\FM\27APN1.SGM
27APN1
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Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices
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
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) ..........
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).
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 ....
Health Care Practitioner ....
80
600
360
12
1
1
10/60
5/60
10/60
160
50
60
Health Care Practitioner ....
90
12
10/60
180
Health Care Practitioner ....
2
12
10/60
4
Health Care Practitioner ....
Health Care Practitioner ....
150
12
24
76
10/60
10/60
600
152
Health Care Practitioner ....
5
12
10/60
10
Health Care Practitioner ....
12
12
10/60
24
Health Care Practitioner ....
Health Care Practitioner ....
360
180
2
1
10/60
20/60
120
60
Health Care Practitioner ....
30
21
10/60
105
Health Care Practitioner ....
Health Care Practitioner ....
5
400
2
10
120/60
30/60
20
2,000
Health Care Practitioner ....
Participants ........................
400
50
10
1
10/60
15/60
667
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 ....
Health Care Practitioner ....
80
4
1
1
60/60
30/60
80
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
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E:\FR\FM\27APN1.SGM
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18578
Federal Register / Vol. 83, No. 82 / Friday, April 27, 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
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).
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).
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
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 ....
Participants ........................
60
600
1
1
15/60
15/60
15
150
Participants/Board Members.
Board Members .................
300
1
15/60
75
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
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E:\FR\FM\27APN1.SGM
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18579
Federal Register / Vol. 83, No. 82 / Friday, April 27, 2018 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
annual
burden
hours
Form name
Type of respondent
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)
Group/CTMS Users ...........
Auditor ...............................
152
152
5
5
21/60
10/60
266
127
Group/CTMS Users ...........
Group/CTMS Users ...........
152
75
5
11
9/60
1,098/60
114
15,098
Group/CTMS Users ...........
CTMS Users ......................
CTMS Users ......................
75
5
12
7
1
9
27/60
18/60
1,800/60
236
2
3240
Physician ...........................
23,000
1
15/60
5,750
Physician; Health Care
Practitioner.
Physician; Health Care
Practitioner.
Physician ...........................
33,000
1
120/60
66,000
33,000
1
5/60
2,750
23,000
1
10/60
3,833
............................................
136,487
207,989
........................
112,838
NCI/DCTD/CTEP Financial Disclosure Form
(Attachment E03).
NCI/DCTD/CTEP Agent Shipment Form
(ASF) (Attachment E04).
Totals ........................................................
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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: Center for Scientific
Review Special Emphasis Panel; Metabolic
Reprogramming to Improve Immunotherapy.
Date: May 22, 2018.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
VerDate Sep<11>2014
19:43 Apr 26, 2018
Jkt 244001
Contact Person: Malaya Chatterjee, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6192,
MSC 7804, Bethesda, MD 20892, (301) 806–
2515, chatterm@csr.nih.gov.
Name of Committee: Immunology
Integrated Review Group; Cellular and
Molecular Immunology—B Study Section.
Date: May 23–24, 2018.
Time: 8:30 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Double Tree by Hilton Washington/
Silver Spring, 8727 Colesville Road, Silver
Spring, MD 20910.
Contact Person: Betty Hayden, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4206,
MSC 7812, Bethesda, MD 20892, 301–435–
1223, haydenb@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Bioengineering Sciences and Technologies:
AREA Review.
Date: May 24, 2018.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: David Filpula, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6181,
MSC 7892, Bethesda, MD 20892, 301–435–
2902, filpuladr@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
PO 00000
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Fmt 4703
Sfmt 4703
Dated: April 23, 2018.
Sylvia L. Neal,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–08843 Filed 4–26–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed 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
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AIDS and
Related Research Special Topics.
Date: April 26, 2018.
Time: 1:30 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
E:\FR\FM\27APN1.SGM
27APN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
