Submission for OMB Review; 30-Day Comment Request; CTEP Branch and Support Contracts Forms and Surveys (National Cancer Institute), 9524-9526 [2021-03046]
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9524
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
Bethesda, MD 20892, (301) 402–4128,
mark.vosvick@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)
Dated: February 9, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–03019 Filed 2–12–21; 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.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
SUMMARY:
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).
Survey collections assess satisfaction
and provide feedback to guide
improvements with processes and
technology.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
151,792.
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Michael Montello, Pharm. D., 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:
montellom@mail.nih.gov.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on October 8, 2020, page 63565
(Vol. 85, No. 196, FR 63565) 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 Title: CTEP
Support Contract Forms and Surveys
(NCI), OMB #0925–0753 Expiration Date
07/31/2021, REVISION, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The National Cancer
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden
per response
(in hours)
Total
annual
burden
hours
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 Request for Clinical Brochure (Attachment
A06).
CTSU Supply Request Form (Attachment A07) ..
RTOG 0834 CTSU Data Transmittal Form (Attachment A10).
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).
Health Care Practitioner
2,444
12
2/60
978
Health Care Practitioner
Health Care Practitioner
2,444
279
12
1
10/60
10/60
4,888
47
Health Care Practitioner
Health Care Practitioner
80
360
12
1
10/60
10/60
160
60
Health Care Practitioner
Health Care Practitioner
90
12
12
76
10/60
10/60
180
152
Health Care Practitioner
12
12
10/60
24
Health Care Practitioner
Health Care Practitioner
360
180
2
1
10/60
10/60
120
30
Health Care Practitioner
30
21
10/60
105
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17:04 Feb 12, 2021
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Number of
respondents
Number of
responses per
respondent
Form name
Sfmt 4703
E:\FR\FM\16FEN1.SGM
16FEN1
9525
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Total
annual
burden
hours
Type of
respondent
CTSU LPO Form Creation (Attachment A19) ......
CTSU Site Form Creation (Attachment A20) .......
CTSU Electronic 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).
Adult 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).
Health Care Practitioner
Health Care Practitioner
Health Care Practitioner
5
400
400
2
10
10
120/60
30/60
10/60
20
2,000
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
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
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
15/60
1,200
VerDate Sep<11>2014
17:04 Feb 12, 2021
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Frm 00049
Fmt 4703
Number of
respondents
Average
burden
per response
(in hours)
Form name
Sfmt 4703
E:\FR\FM\16FEN1.SGM
16FEN1
9526
Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Total
annual
burden
hours
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).
CIRB Waiver of Consent Request Supplemental
Form (Attachment B47).
Review Worksheet CIRB Review for Inclusion of
Incarcerated Participants (Attachment B48).
Notification of Incarcerated Participant Form
(B49).
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).
Audit Scheduling Form (Attachment D01) ............
Preliminary Audit Finding 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) ......
Health Care Practitioner
1,680
1
15/60
420
Health Care Practitioner
360
1
20/60
120
Health Care Practitioner
120
1
20/60
40
Health Care Practitioner
35
1
20/60
12
Health Care Practitioner
20
1
15/60
5
Board Members ............
20
1
60/60
20
Health Care Practitioner
20
1
20/60
7
Health Care Practitioner
Participants ...................
10
600
1
1
15/60
15/60
3
150
Participants/Board
Members.
Board Members ............
300
1
15/60
75
60
1
15/60
15
Health Care Practitioner
60
1
5/60
5
Practitioner
Practitioner
Practitioner
Practitioner
152
152
152
75
5
5
5
11
21/60
10/60
9/60
1,098/60
266
127
114
15,098
Health Care Practitioner
Health Care Practitioner
Health Care Practitioner
75
5
12
7
1
9
27/60
18/60
1,800/60
236
2
3,240
Physician ......................
26,500
1
15/60
6,625
Physician; Health Care
Practitioner.
Physician; Health Care
Practitioner.
Physician ......................
48,000
1
120/60
96,000
48,000
1
15/60
12,000
24,000
1
10/60
4,000
.......................................
167,715
235,670
........................
151,792
NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03).
NCI/DCTD/CTEP Agent Shipment Form (ASF)
(Attachment E04).
Totals .............................................................
Dated: February 1, 2021.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2021–03046 Filed 2–12–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
khammond on DSKJM1Z7X2PROD with NOTICES
Average
burden
per response
(in hours)
Type of
respondent
Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given that the
Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
Center for Substance Abuse Prevention’s
(CSAP) Drug Testing Advisory Board
VerDate Sep<11>2014
17:04 Feb 12, 2021
Jkt 253001
Health
Health
Health
Health
Care
Care
Care
Care
Number of
respondents
Number of
responses per
respondent
Form name
(DTAB) will convene via web
conference on March 2nd, 2021, from
10:00 a.m. EST to 4:30 p.m. EST, and
March 3rd, 2021, from 10:00 a.m. EST
to 4:30 p.m. EST.
The board will meet in open-session
March 2nd, 2021, from 10:00 a.m. EST
to 2:00 p.m. EST to discuss the
Mandatory Guidelines for Federal
Workplace Drug Testing Programs with
updates from the Department of
Transportation, the Nuclear Regulatory
Commission, and the Department of
Defense. Other discussion topics
include an update on marijuana studies
and efforts as well as the Employee
Assistance Program (EAP) Toolkit. The
board will meet in closed-session on
March 2nd, 2021, from 2:15 p.m. EST to
4:30 p.m. EST, and March 3rd, 2021,
from 10:00 a.m. EST to 4:30 p.m. EST,
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
to discuss confidential issues
surrounding the proposed Mandatory
Guidelines for Federal Workplace Drug
Testing Programs (hair), the Federal
Drug-Free Workplace Programs and
emerging issues, updates on the
revisions of the Urine and Oral Fluid
Mandatory Guidelines and the
Biomarker Table, preliminary and
unpublished studies from the Johns
Hopkins University Behavioral
Pharmacology Research Unit (BPRU),
and cannabidiol (CBD) information from
FDA. Therefore, the March 2nd, 2021,
from 2:15 p.m. EST to 4:30 p.m. EST,
and the March 3rd, 2021, from 10:00
a.m. EST to 4:30 p.m. EST, meetings are
closed to the public, as determined by
the Assistant Secretary for Mental
Health and Substance Use, SAMHSA, in
accordance with 5 U.S.C. 552b(c)(4) and
E:\FR\FM\16FEN1.SGM
16FEN1
]]>Agencies
[Federal Register Volume 86, Number 29 (Tuesday, February 16, 2021)]
[Notices]
[Pages 9524-9526]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03046]
-----------------------------------------------------------------------
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 recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under 30-day Review--
Open for Public Comments'' or by using the search function.
FOR FURTHER INFORMATION 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].
SUPPLEMENTARY INFORMATION: This proposed information collection was
previously published in the Federal Register on October 8, 2020, page
63565 (Vol. 85, No. 196, FR 63565) 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 Title: CTEP Support Contract Forms and Surveys
(NCI), OMB #0925-0753 Expiration Date 07/31/2021, 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). Survey collections assess
satisfaction and provide feedback to guide improvements with processes
and technology.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 151,792.
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 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.
RTOG 0834 CTSU Data Health Care 12 76 10/60 152
Transmittal Form (Attachment Practitioner.
A10).
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 10/60 30
Form (Attachment A17). Practitioner.
CTSU OPEN Rave Request Form Health Care 30 21 10/60 105
(Attachment A18). Practitioner.
[[Page 9525]]
CTSU LPO Form Creation Health Care 5 2 120/60 20
(Attachment A19). Practitioner.
CTSU Site Form Creation Health Care 400 10 30/60 2,000
(Attachment A20). Practitioner.
CTSU Electronic 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 (Attachment B13). Practitioner.
CIRB Continuing Review Health Care 400 1 15/60 100
Application (Attachment B14). Practitioner.
Adult IR of Cooperative Group Board Members... 65 1 180/60 195
Protocol (Attachment B15).
Pediatric IR of Cooperative Board Members... 15 1 180/60 45
Group Protocol (Attachment
B16).
Adult Continuing Review of Board Members... 275 1 60/60 275
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 15/60 1,200
Local Context (Attachment Practitioner.
B42).
[[Page 9526]]
Study Closure or Transfer of Health Care 1,680 1 15/60 420
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 Health Care 35 1 20/60 12
(Attachment B46). Practitioner.
CIRB Waiver of Consent Request Health Care 20 1 15/60 5
Supplemental Form (Attachment Practitioner.
B47).
Review Worksheet CIRB Review Board Members... 20 1 60/60 20
for Inclusion of Incarcerated
Participants (Attachment B48).
Notification of Incarcerated Health Care 20 1 20/60 7
Participant Form (B49). Practitioner.
CTSU OPEN Survey (Attachment Health Care 10 1 15/60 3
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.
Audit Scheduling Form Health Care 152 5 21/60 266
(Attachment D01). Practitioner.
Preliminary Audit Finding Form Health Care 152 5 10/60 127
(Attachment D02). Practitioner.
Audit Maintenance Form Health Care 152 5 9/60 114
(Attachment D03). Practitioner.
Final Audit finding Report Health Care 75 11 1,098/60 15,098
Form (Attachment D04). Practitioner.
Follow-up Form (Attachment Health Care 75 7 27/60 236
D05). Practitioner.
Roster Maintenance Form Health Care 5 1 18/60 2
(Attachment D06). Practitioner.
Final Report and CAPA Request Health Care 12 9 1,800/60 3,240
Form (Attachment D07). Practitioner.
NCI/DCTD/CTEP FDA Form 1572 Physician....... 26,500 1 15/60 6,625
for Annual Submission
(Attachment E01).
NCI/DCTD/CTE Biosketch Physician; 48,000 1 120/60 96,000
(Attachment E02). Health Care
Practitioner.
NCI/DCTD/CTEP Financial Physician; 48,000 1 15/60 12,000
Disclosure Form (Attachment Health Care
E03). Practitioner.
NCI/DCTD/CTEP Agent Shipment Physician....... 24,000 1 10/60 4,000
Form (ASF) (Attachment E04).
---------------------------------------------------------------
Totals.................... ................ 167,715 235,670 .............. 151,792
----------------------------------------------------------------------------------------------------------------
Dated: February 1, 2021.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2021-03046 Filed 2-12-21; 8:45 am]
BILLING CODE 4140-01-P
