Submission for OMB Review; 30-Day Comment Request; Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys (NCI); Correction, 20667-20670 [2024-06233]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 58 / Monday, March 25, 2024 / Notices
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 Inherited
Disease Research Access Committee.
Date: May 10, 2024.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Radisson Plaza Lord Baltimore, 20
West Baltimore Street, Hanover, Suite B,
Baltimore, MD 21201 (Hybrid Meeting).
Contact Person: Barbara J. Thomas, Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Human Genome Research
Institute, National Institutes of Health, 6700B
Rockledge Drive, MSC 6908, Bethesda, MD
20892, 301–402–0838, barbara.thomas@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.172, Human Genome
Research, National Institutes of Health, HHS)
Dated: March 20, 2024.
Melanie J. Pantoja,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2024–06240 Filed 3–22–24; 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 (NCI); Correction
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice; correction.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the National
Cancer Institute (NCI) has submitted to
the Office of Management and Budget
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:08 Mar 22, 2024
Jkt 262001
(OMB) a request for review and
approval of the information collection
listed below.
Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
DATES:
Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to https://www.reginfo.gov/
public/do/PRAMain. Find this
particular information collection by
selecting ‘‘Currently under 30-day
Review—Open for Public Comments’’ or
using the search function.
ADDRESSES:
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—DCTD,
National Cancer Institute, 9609 Medical
Center Drive, Rockville, Maryland
20850 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.
FOR FURTHER INFORMATION CONTACT:
This
proposed information collection was
previously published in the Federal
Register on March 8, 2024, page 16776
(89 FR 16776) 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, 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.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
20667
Proposed Collection Title: Cancer
Therapy Evaluation Program (CTEP)
Branch and Support Contracts Forms
and Surveys (NCI), 0925–0753,
Expiration Date 03/31/2026, REVISION,
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information
Collection: This is a request for OMB to
approve the revised information
collection, Cancer Therapy Evaluation
Program (CTEP) Support Contracts
Forms and Survey. It includes
modifications to OMB-approved forms
for the CTSU and CIRB and the addition
of new forms for the CTSU, CIRB, and
CTEP. The National Cancer Institute
(NCI) 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 represent an integrated set
of information systems and processes
that 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 CFF 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
under 21 CFR 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
162,836 hours.
E:\FR\FM\25MRN1.SGM
25MRN1
20668
Federal Register / Vol. 89, No. 58 / Monday, March 25, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
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).
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 and PDF (Attachment
A20).
CTSU PDF Signature Form (Attachment A21) ....
CTSU CLASS Course Setup Request Form (Attachment A22).
CTSU LPO Approval of Early Closure Form (Attachment A23).
International DTL Signing (Attachment 24) ..........
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) Protocol.
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).
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
30
12
2
10/60
5/60
180
5
Health Care Practitioner
12
12
10/60
24
Health Care Practitioner
Health Care Practitioner
360
30
2
21
10/60
10/60
120
105
Health Care Practitioner
Health Care Practitioner
5
400
2
10
120/60
30/60
20
2,000
Health Care Practitioner
Health Care Practitioner
400
10
10
2
10/60
20/60
667
7
Health Care Practitioner
2,444
6
20/60
4,888
Health Care Practitioner
Participants ...................
29
50
1
1
10/60
15/60
5
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
VerDate Sep<11>2014
18:08 Mar 22, 2024
Jkt 262001
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
E:\FR\FM\25MRN1.SGM
25MRN1
20669
Federal Register / Vol. 89, No. 58 / Monday, March 25, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in hours)
Total annual
burden hours
Form name
Type of respondent
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).
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).
Final Video Submission Posting Form (Attachment B50).
Unanticipated Problem or Serious or Continuing
Noncompliance Application (Attachment B52).
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) ......
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
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
80
1
15/60
20
Health Care Practitioner
20
1
30/60
10
Participants ...................
600
1
15/60
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
229
229
158
110
5
5
5
11
21/60
10/60
9/60
1,098/60
401
191
119
22,143
Health Care Practitioner
Health Care Practitioner
Health Care Practitioner
44
7
3
7
1
9
27/60
18/60
1,800/60
139
2
810
Physician ......................
26,500
1
15/60
6,625
Physician; Health Care
Practioner.
Physician; Health Care
Practioner.
Physician ......................
48,000
1
120/60
96,000
48,000
1
15/60
12,000
24,000
1
10/60
4,000
Health Care Practitioner, Other.
Physician ......................
1,000
1
60/60
1,000
2,100
1
15/60
525
NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03).
NCI/DCTD/CTEP Agent Shipment Form (ASF)
(Attachment E04).
NINT Registration Form? ......................................
ISS Form ...............................................................
VerDate Sep<11>2014
18:08 Mar 22, 2024
Jkt 262001
Health
Health
Health
Health
PO 00000
Care
Care
Care
Care
Frm 00041
Fmt 4703
Sfmt 4703
E:\FR\FM\25MRN1.SGM
25MRN1
20670
Federal Register / Vol. 89, No. 58 / Monday, March 25, 2024 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name
Basic Study Information Form (Attachment TBD)
Health Care Practioner
Totals .............................................................
Dated: March 20, 2024.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2024–06233 Filed 3–22–24; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended for the review, discussion,
and evaluation of individual grant
applications conducted by the National
Institute On Aging, including
consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, NIA Board of Scientific Council,
NIA.
Date: May 29–31, 2024.
Closed: May 29, 2024, 8:00 a.m. to 8:45
a.m.
Agenda: To review and evaluate executive
Session; Opening Remarks, (Richard J.
Hodes, M.D., NIA Director, and Luigi
Ferrucci, M.D., Ph.D., Scientific Director,
NIA); Board Business, (Andrea LaCroix,
Ph.D., Chairperson, and Holly M. BrownBorg, Ph.D., Incoming Chairperson).
Place: National Institute on Aging,
Biomedical Research Center, 3C211/Virtual,
251 Bayview Blvd., Baltimore, MD 21224
(Hybrid).
VerDate Sep<11>2014
18:08 Mar 22, 2024
Number of
respondents
Type of respondent
Jkt 262001
.......................................
Frm 00042
Fmt 4703
Sfmt 4703
Total annual
burden hours
140
1
20/60
47
173,523
253,570
........................
162,836
Open: May 29, 2024, 8:45 a.m. to 9:45 a.m.
Agenda: Bias in the Review Process
Presentation (Marie Bernard, M.D., Chief
Officer for Scientific Workforce Diversity,
NIH).
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Open: May 29, 2024, 9:45 a.m. to 10:00
a.m.
Agenda: Break.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Open: May 29, 2024, 10:00 a.m. to 10:15
a.m.
Agenda: LBN Overview (Susan Resnick,
Ph.D., Laboratory Chief, Senior Investigator,
LBN).
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Open: May 29, 2024, 10:15 a.m. to 10:30
a.m.
Agenda: Discussion.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Open: May 29, 2024, 10:30 a.m. to 11:00
a.m.
Agenda: A historical perspective on BABS
brain and cognitive aging studies: Setting the
stage for the future (Susan Resnick, Ph.D.,
Laboratory Chief, Senior Investigator, LBN).
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Open: May 29, 2024, 11:00 a.m. to 11:30
a.m.
Agenda: Discussion.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Closed: May 29, 2024, 11:30 a.m. to 11:45
a.m.
Agenda: To review and evaluate Dr.
Resnick meets individually and privately
with BSC members.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Open: May 29, 2024, 11:45 a.m. to 12:00
p.m.
Agenda: Break.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Closed: May 29, 2024, 12:00 p.m. to 1:30
p.m.
Agenda: To review and evaluate executive
Session Luncheon.
Place: National Institute on Aging,
Biomedical Research Center, 3A519/Virtual,
PO 00000
Average
burden per
response
(in hours)
Number of
responses per
respondent
251 Bayview Blvd., Baltimore, MD 21224
(Hybrid).
Open: May 29, 2024, 1:30 p.m. to 2:00 p.m.
Agenda: Integrating omics and
neuroimaging to identify ADRD risk factors,
biomarkers, and therapeutic targets (Keenan
Walker, Ph.D., NIH Distinguished Scholar,
Tenure-Track Investigator, LBN).
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Open: May 29, 2024, 2:00 p.m. to 2:30 p.m.
Agenda: Discussion.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Open: May 29, 2024, 2:30 p.m. to 3:00 p.m.
Agenda: Target discovery, preclinical
validation, and clinical translation of novel
Alzheimer’s therapies (Madhav Thambisetty,
M.D., Ph.D., Senior Investigator (Clinical),
LBN).
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Open: May 29, 2024, 3:00 p.m. to 3:30 p.m.
Agenda: Discussion.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Open: May 29, 2024, 3:30 p.m. to 3:45 p.m.
Agenda: Break.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Open: May 29, 2024, 3:45 p.m. to 4:00 p.m.
Agenda: Drs. Walker and Thambisetty meet
individually and privately with BSC
members.
Place: National Institute on Aging,
Biomedical Research Center, 251 Bayview
Blvd., Baltimore, MD 21224 (Hybrid).
Closed: May 29, 2024, 4:00 p.m. to 5:30
p.m.
Agenda: To review and evaluate executive
Session (Biomedical Research Center, 3rd
Floor, Room 3C211/Virtual).
Place: National Institute on Aging,
Biomedical Research Center, 3C211/Virtual,
251 Bayview Blvd., Baltimore, MD 21224
(Hybrid).
Closed: May 29, 2024, 5:30 p.m. to 5:30
p.m.
Agenda: To review and evaluate adjourn.
Place: National Institute on Aging,
Biomedical Research Center, 3C211/Virtual,
251 Bayview Blvd., Baltimore, MD 21224
(Hybrid).
Closed: May 30, 2024, 8:00 a.m. to 8:30
a.m.
Agenda: To review and evaluate executive
Session—Opening Remarks, (Richard J.
Hodes, M.D., NIA Director, and Luigi
Ferrucci, M.D., Ph.D., Scientific Director,
E:\FR\FM\25MRN1.SGM
25MRN1
]]>Agencies
[Federal Register Volume 89, Number 58 (Monday, March 25, 2024)]
[Notices]
[Pages 20667-20670]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06233]
-----------------------------------------------------------------------
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 (NCI); Correction
AGENCY: National Institutes of Health, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the National Cancer Institute (NCI) 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 60 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 https://www.reginfo.gov/public/do/PRAMain. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or 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--DCTD, National Cancer
Institute, 9609 Medical Center Drive, Rockville, Maryland 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: This proposed information collection was
previously published in the Federal Register on March 8, 2024, page
16776 (89 FR 16776) 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, 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: Cancer Therapy Evaluation Program (CTEP)
Branch and Support Contracts Forms and Surveys (NCI), 0925-0753,
Expiration Date 03/31/2026, REVISION, National Cancer Institute (NCI),
National Institutes of Health (NIH).
Need and Use of Information Collection: This is a request for OMB
to approve the revised information collection, Cancer Therapy
Evaluation Program (CTEP) Support Contracts Forms and Survey. It
includes modifications to OMB-approved forms for the CTSU and CIRB and
the addition of new forms for the CTSU, CIRB, and CTEP. The National
Cancer Institute (NCI) 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 represent an integrated set of information
systems and processes that 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 CFF 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 under 21 CFR 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 162,836 hours.
[[Page 20668]]
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 30 2 5/60 5
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 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.
CTSU CLASS Course Setup Health Care 10 2 20/60 7
Request Form (Attachment A22). Practitioner.
CTSU LPO Approval of Early Health Care 2,444 6 20/60 4,888
Closure Form (Attachment A23). Practitioner.
International DTL Signing Health Care 29 1 10/60 5
(Attachment 24). 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) Protocol.
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).
[[Page 20669]]
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).
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 (Attachment Practitioner.
B49).
Final Video Submission Posting Health Care 80 1 15/60 20
Form (Attachment B50). Practitioner.
Unanticipated Problem or Health Care 20 1 30/60 10
Serious or Continuing Practitioner.
Noncompliance Application
(Attachment B52).
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 229 5 21/60 401
(Attachment D01). Practitioner.
Preliminary Audit Finding Form Health Care 229 5 10/60 191
(Attachment D02). Practitioner.
Audit Maintenance Form Health Care 158 5 9/60 119
(Attachment D03). Practitioner.
Final Audit finding Report Health Care 110 11 1,098/60 22,143
Form (Attachment D04). Practitioner.
Follow-up Form (Attachment Health Care 44 7 27/60 139
D05). Practitioner.
Roster Maintenance Form Health Care 7 1 18/60 2
(Attachment D06). Practitioner.
Final Report and CAPA Request Health Care 3 9 1,800/60 810
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
Practioner.
NCI/DCTD/CTEP Financial Physician; 48,000 1 15/60 12,000
Disclosure Form (Attachment Health Care
E03). Practioner.
NCI/DCTD/CTEP Agent Shipment Physician....... 24,000 1 10/60 4,000
Form (ASF) (Attachment E04).
NINT Registration Form?....... Health Care 1,000 1 60/60 1,000
Practitioner,
Other.
ISS Form...................... Physician....... 2,100 1 15/60 525
[[Page 20670]]
Basic Study Information Form Health Care 140 1 20/60 47
(Attachment TBD). Practioner.
---------------------------------------------------------------------------------
Totals.................... ................ 173,523 253,570 .............. 162,836
----------------------------------------------------------------------------------------------------------------
Dated: March 20, 2024.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2024-06233 Filed 3-22-24; 8:45 am]
BILLING CODE 4140-01-P
