Submission for OMB Review; 30-Day Comment Request Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys (National Cancer Institute), 53752-53754 [2022-18853]
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53752
Federal Register / Vol. 87, No. 169 / Thursday, September 1, 2022 / Notices
Boulevard, Rockville, MD 20852 (Virtual
Meeting).
Contact Person: Aileen Schulte, Ph.D.,
Scientific Review Officer, Division of
Extramural Activities, National Institute of
Mental Health, National Institutes of Health,
Neuroscience Center, 6001 Executive Blvd.,
Room 6136, MSC 9606, Bethesda, MD 20852,
301–443–1225, aschulte@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program No. 93.242, Mental Health Research
Grants, National Institutes of Health, HHS)
Dated: August 29, 2022.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–18955 Filed 8–31–22; 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 Cancer Therapy
Evaluation Program (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
notice to www.reginfo.gov/public/do/
SUMMARY:
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: 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, Cancer
Therapy Evaluation Program, Division
of Cancer Treatment and Diagnosis,
National Cancer Institute, 9609 Medical
Center Drive, Bethesda, Maryland 20892
or call non-toll-free number (240) 276–
6080 or email your request, including
your address to: montellom@
mail.nih.gov. Formal requests for
additional plans and instruments must
be requested in writing.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
published in the Federal Register on
May 31, 2022 (Vol. 87, No. 104, P.
32427) and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The National Cancer Institute
(NCI), National Institutes of Health
(NIH), 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
Office of Management and Budget
(OMB) control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, NIH has
submitted to OMB a request for review
and approval of the information
collection listed below.
Proposed Collection: Cancer Therapy
Evaluation Program (CTEP) Support
Contracts Forms and Survey (NCI)
(0925–0753), Expiration Date 05/31/
2024, REVISION, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: This revision removes one
form, adds one new form, revises three
forms, and includes an updated Privacy
Impact Assessment. 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 are 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
(Food and Drug Administration (FDA)
regulations pertaining to the sponsor of
clinical trials and the selection of
qualified investigators (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 is
151,769 hours.
jspears on DSK121TN23PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
annual
burden
hours
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 Request for Clinical Brochure (Attachment
A06).
CTSU Supply Request Form (Attachment A07) ........
RTOG 0834 CTSU Data Transmittal Form (Attachment A10).
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
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53753
Federal Register / Vol. 87, No. 169 / Thursday, September 1, 2022 / Notices
jspears on DSK121TN23PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent
CTSU Patient Enrollment Transmittal Form (Attachment A15).
CTSU Transfer Form (Attachment A16) ....................
CTSU OPEN Rave Request Form (Attachment A18)
CTSU LPO Form Creation (Attachment A19) ...........
CTSU Site Form Creation (Attachment A20) ............
CTSU Electronic Signature Form (Attachment A21)
CTSU CLASS Course Setup Form (Attachment
A22).
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).
Health Care Practitioner ..
VerDate Sep<11>2014
17:15 Aug 31, 2022
Jkt 256001
PO 00000
Number of
responses per
respondent
Number of
respondents
Form name
Average
burden per
response
(in hours)
Total
annual
burden
hours
12
12
10/60
24
..
..
..
..
..
..
360
30
5
400
400
10
2
21
2
10
10
2
10/60
10/60
120/60
30/60
10/60
20/60
120
105
20
2,000
667
7
Participants ......................
50
1
15/60
13
Participants ......................
50
1
15/60
13
Board Member ................
Board Members ...............
100
100
1
1
30/60
15/60
50
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 ..
Health Care Practitioner ..
1
400
1
1
60/60
15/60
1
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
Health
Health
Health
Health
Health
Care
Care
Care
Care
Care
Care
Frm 00044
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
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E:\FR\FM\01SEN1.SGM
01SEN1
53754
Federal Register / Vol. 87, No. 169 / Thursday, September 1, 2022 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
respondents
Average
burden per
response
(in hours)
Total
annual
burden
hours
Type of respondent
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) ..
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 (Attachment 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 ..
1,800
1
20/60
600
Health Care Practitioner ..
4,800
1
15/60
1,200
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 ..
Health Care Practitioner ..
35
20
1
1
20/60
15/60
12
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
Health
Health
Health
Health
Health
Health
Health
..
..
..
..
..
..
..
..
60
152
152
152
75
75
5
12
1
5
5
5
11
7
1
9
5/60
21/60
10/60
9/60
1,098/60
27/60
18/60
1,800/60
5
266
127
114
15,098
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
..........................................
167,545
235,510
....................
151,769
NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03).
NCI/DCTD/CTEP Agent Shipment Form (ASF) (Attachment E04).
Totals ..................................................................
Dated: August 26, 2022.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2022–18853 Filed 8–31–22; 8:45 am]
BILLING CODE 4140–01–P
Care
Care
Care
Care
Care
Care
Care
Care
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
Practitioner
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
SUPPLEMENTARY INFORMATION:
The Department of Health and
Human Services (HHS) notifies federal
agencies of the laboratories and
Instrumented Initial Testing Facilities
(IITFs) currently certified to meet the
17:15 Aug 31, 2022
Jkt 256001
FOR FURTHER INFORMATION CONTACT:
Anastasia Donovan, Division of
Workplace Programs, SAMHSA/CSAP,
5600 Fishers Lane, Room 16N06B,
Rockville, Maryland 20857; 240–276–
2600 (voice); Anastasia.Donovan@
samhsa.hhs.gov (email).
SUMMARY:
VerDate Sep<11>2014
standards of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs using Urine or Oral Fluid
(Mandatory Guidelines).
Current List of HHS-Certified
Laboratories and Instrumented Initial
Testing Facilities Which Meet Minimum
Standards To Engage in Urine and Oral
Fluid Drug Testing for Federal
Agencies
AGENCY:
jspears on DSK121TN23PROD with NOTICES
Number of
responses per
respondent
Form name
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
In
accordance with Section 9.19 of the
Mandatory Guidelines, a notice listing
all currently HHS-certified laboratories
and IITFs is published in the Federal
Register during the first week of each
month. If any laboratory or IITF
certification is suspended or revoked,
the laboratory or IITF will be omitted
E:\FR\FM\01SEN1.SGM
01SEN1
]]>Agencies
[Federal Register Volume 87, Number 169 (Thursday, September 1, 2022)]
[Notices]
[Pages 53752-53754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18853]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day Comment Request Cancer Therapy
Evaluation Program (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: 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, Cancer Therapy Evaluation Program, Division of Cancer
Treatment and Diagnosis, National Cancer Institute, 9609 Medical Center
Drive, Bethesda, Maryland 20892 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: This proposed information collection was
published in the Federal Register on May 31, 2022 (Vol. 87, No. 104, P.
32427) and allowed 60 days for public comment. No public comments were
received. The purpose of this notice is to allow an additional 30 days
for public comment. The National Cancer Institute (NCI), National
Institutes of Health (NIH), 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 Office of Management and
Budget (OMB) control number.
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction
Act of 1995, NIH has submitted to OMB a request for review and approval
of the information collection listed below.
Proposed Collection: Cancer Therapy Evaluation Program (CTEP)
Support Contracts Forms and Survey (NCI) (0925-0753), Expiration Date
05/31/2024, REVISION, National Cancer Institute (NCI), National
Institutes of Health (NIH).
Need and Use of Information Collection: This revision removes one
form, adds one new form, revises three forms, and includes an updated
Privacy Impact Assessment. 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 are 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 (Food and Drug Administration (FDA) regulations
pertaining to the sponsor of clinical trials and the selection of
qualified investigators (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 is 151,769 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average Total
Number of Number of burden per annual
Form name Type of respondent respondents responses per response burden
respondent (in hours) 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 (Attachment Practitioner.
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 Transmittal Health Care 12 76 10/60 152
Form (Attachment A10). Practitioner.
[[Page 53753]]
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 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 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.
CTSU CLASS Course Setup Form Health Care 10 2 20/60 7
(Attachment A22). Practitioner.
NCI CIRB AA & DOR between the NCI Participants....... 50 1 15/60 13
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 (Attachment Health Care 80 1 60/60 80
B10). Practitioner.
CIRB IR Application for Exempt Health Care 4 1 30/60 2
Studies (Attachment B11). Practitioner.
CIRB Amendment Review Application Health Care 400 1 15/60 100
(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 Group Board Members...... 15 1 180/60 45
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 Review Board Members...... 348 1 30/60 174
(Attachment B23).
Pediatric Expedited Amendment Board Members...... 140 1 30/60 70
Review (Attachment B24).
Adult Expedited Continuing Review Board Members...... 140 1 30/60 70
(Attachment B25).
Pediatric Expedited Continuing Board Members...... 36 1 30/60 18
Review (Attachment B26).
Adult Cooperative Group Response Health Care 30 1 60/60 30
to CIRB Review (Attachment B27). Practitioner.
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--Determination Board Members...... 400 1 10/60 67
of UP or SCN (Attachment B31).
Reviewer Worksheet--CIRB Board Members...... 100 1 15/60 25
Statistical Reviewer Form
(Attachment B32).
CIRB Application for Translated Health Care 100 1 30/60 50
Documents (Attachment B33). Practitioner.
Reviewer Worksheet of Translated Board Members...... 100 1 15/60 25
Documents (Attachment B34).
Reviewer Worksheet of Recruitment Board Members...... 20 1 15/60 5
Material (Attachment B35).
Reviewer Worksheet Expedited Board Members...... 20 1 15/60 5
Study Closure Review (Attachment
B36).
Reviewer Worksheet of Expedited Board Members...... 5 1 30/60 3
IR (Attachment B38).
Annual Signatory Institution Health Care 400 1 40/60 267
Worksheet About Local Context Practitioner.
(Attachment B40).
[[Page 53754]]
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 B42). Practitioner.
Study Closure or Transfer of Health Care 1,680 1 15/60 420
Study Review Responsibility Practitioner.
(Attachment B43).
Unanticipated Problem or Serious Health Care 360 1 20/60 120
or Continuing Noncompliance Practitioner.
Reporting Form (Attachment B44).
Change of Signatory Institution Health Care 120 1 20/60 40
PI Form (Attachment B45). Practitioner.
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 for Board Members...... 20 1 60/60 20
Inclusion of Incarcerated
Participants (Attachment B48).
Notification of Incarcerated Health Care 20 1 20/60 7
Participant Form (Attachment Practitioner.
B49).
CTSU OPEN Survey (Attachment C03) Health Care 10 1 15/60 3
Practitioner.
CIRB Customer Satisfaction Survey Participants....... 600 1 15/60 150
(Attachment C04).
Follow-up Survey (Communication Participants/...... 300 1 15/60 75
Audit) (Attachment C05). Board Members......
CIRB Board Member Annual Board Members...... 60 1 15/60 15
Assessment Survey (Attachment
C07).
PIO Customer Satisfaction Survey Health Care 60 1 5/60 5
(Attachment C08). Practitioner.
Audit Scheduling Form (Attachment Health Care 152 5 21/60 266
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 Form Health Care 75 11 1,098/60 15,098
(Attachment D04). Practitioner.
Follow-up Form (Attachment D05).. Health Care 75 7 27/60 236
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 for Physician.......... 26,500 1 15/60 6,625
Annual Submission (Attachment
E01).
NCI/DCTD/CTE Biosketch Physician; Health 48,000 1 120/60 96,000
(Attachment E02). Care Practitioner.
NCI/DCTD/CTEP Financial Physician; Health 48,000 1 15/60 12,000
Disclosure Form (Attachment E03). Care Practitioner.
NCI/DCTD/CTEP Agent Shipment Form Physician.......... 24,000 1 10/60 4,000
(ASF) (Attachment E04).
---------------------------------------------------------
Totals....................... ................... 167,545 235,510 ........... 151,769
----------------------------------------------------------------------------------------------------------------
Dated: August 26, 2022.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2022-18853 Filed 8-31-22; 8:45 am]
BILLING CODE 4140-01-P
