Proposed Collection; 60-Day Comment Request; Cancer Therapy Evaluation Program (CTEP) Branch and Support Contracts Forms and Surveys (National Cancer Institute), 63561-63564 [2020-22265]
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Federal Register / Vol. 85, No. 196 / Thursday, October 8, 2020 / Notices
biologics/biologics-guidances, or https://
www.regulations.gov.
Dated: October 2, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
Michael Warren
Thomas J. Engels,
Administrator.
[FR Doc. 2020–22276 Filed 10–7–20; 8:45 am]
BILLING CODE 4165–15–P
[FR Doc. 2020–22228 Filed 10–7–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Health Resources and Services
Administration
Meeting on the Advisory Commission
on Childhood Vaccines; Correction
Senior Executive Service Performance
Review Board
AGENCY:
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA, an operating division
of HHS, is publishing a list of persons
who may be named to serve on the
Performance Review Board that oversees
the evaluation of performance
appraisals for Senior Executive Service
members within HRSA for the Fiscal
Year 2021 and 2022 review period.
FOR FURTHER INFORMATION CONTACT:
Georgia Lyons, HRSA, Executive
Resources, Office of Human Resources,
5600 Fishers Lane, Rm 12N06C,
Rockville, Maryland 20857, or (301)
443–4618.
SUPPLEMENTARY INFORMATION: Title 5,
U.S.C. Section 4314(c)(4) of the Civil
Service Reform Act of 1978, Public Law
95–454, requires that the appointment
of Performance Review Board Members
be published in the Federal Register.
The following persons may be named to
serve on the HRSA Performance Review
Board:
Onyekachukwu Anaedozie
Leslie Atkinson
Cynthia Baugh
Tonya Bowers
Adriane Burton
Tina Cheatham
Laura Cheever
Natasha Coulouris
Cheryl Dammons
Elizabeth DeVoss
Diana Espinosa
Catherine Ganey
Alexandra Garcia
Heather Hauck
Laura Kavanagh
Martin Kramer
Torey Mack
James Macrae
Susan Monarez
Thomas Morris
Luis Padilla
Wendy Ponton
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SUMMARY:
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Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice; correction.
The original Federal Register
Notice announcing the December 2020
Advisory Commission on Childhood
Vaccines (ACCV) meeting indicated that
this meeting would be held on
December 3, 2020, and December 4,
2020. This meeting is not being
conducted over two days, and instead
will only take place on December 3,
2020.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Annie Herzog, Program Analyst,
Division of Injury Compensation
Programs (DICP), HRSA, in one of three
ways: (1) Send a request to the following
address: Annie Herzog, Program
Analyst, DICP, HRSA, 5600 Fishers
Lane, 08N186B, Rockville, Maryland
20857; (2) call (301) 443–6593; or (3)
send an email to ACCV@hrsa.gov.
SUPPLEMENTARY INFORMATION: The ACCV
will hold a public meeting on December
3, 2020, at 10:00 a.m. Eastern Time. The
meeting will be held via Adobe Connect
and telephone conference. The public
can join the meeting by:
1. (Audio Portion) Calling the
conference phone number 888–790–
1734 and providing the following
information:
Leader Name: Ms. Tamara Overby.
Passcode: 4177683.
2. (Visual Portion) Connecting to the
ACCV Adobe Connect Meeting using the
following URL: https://
hrsa.connectsolutions.com/accv/.
Participants should call and connect 15
minutes prior to the meeting in order for
logistics to be set up. If you have never
attended an Adobe Connect meeting,
please test your connection using the
following URL: https://
hrsa.connectsolutions.com/common/
help/en/support/meeting_test.htm and
get a quick overview by following URL:
https://www.adobe.com/go/connectpro_
overview.
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Meeting times could change. For the
latest information regarding the
meeting, including start time and the
agenda, please access the ACCV
website: https://www.hrsa.gov/
advisorycommittees/childhoodvaccines/
index.html.
This meeting will only take place on
December 3, 2020, and is not being
conducted over 2 days (December 3–4,
2020), as stated previously in Federal
Register notice 2019–28294 (85 FR 112,
published on January 2, 2020, page 112–
113).
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–22209 Filed 10–7–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-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
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCI) will
publish periodic summaries of propose
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Michael Montello, Pharm. D.,
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: montellom@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
SUMMARY:
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Federal Register / Vol. 85, No. 196 / Thursday, October 8, 2020 / Notices
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond, including
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology.
Proposed Collection Title: CTEP
Support Contract Forms and Surveys
(NCI), 0925–0753 Expiration Date 07/
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
151,716.
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
khammond on DSKJM1Z7X2PROD 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
(Attach. A01).
CTSU IRB Certification Form (Attach. A02) .........
Withdrawal from Protocol Participation Form (Attach. A03).
Site Addition Form (Attach. A04) ..........................
CTSU Request for Clinical Brochure (Attach.
A06).
CTSU Supply Request Form (Attach. A07) .........
RTOG 0834 CTSU Data Transmittal Form (Attach. A10).
CTSU Patient Enrollment Transmittal Form (Attach. A15).
CTSU Transfer Form (Attach. A16) ......................
CTSU System Access Request Form (Attach.
A17).
CTSU OPEN Rave Request Form (Attach. A18)
CTSU LPO Form Creation (Attach. A19) .............
CTSU Site Form Creation and PDF (Attach. A20)
CTSU PDF Signature Form (Attach. A21) ...........
NCI CIRB AA & DOR between the NCI CIRB
and Signatory Institution (Attach. B01).
NCI CIRB Signatory Enrollment Form (Attach.
B02).
CIRB Board Member Application (Attach. B03) ...
CIRB Member COI Screening Worksheet (Attach. B08).
CIRB COI Screening for CIRB meetings (Attach.
B09).
CIRB IR Application (Attach. B10) .......................
CIRB IR Application for Exempt Studies (Attach.
B11).
CIRB Amendment Review Application (Attach.
B12).
CIRB Ancillary Studies Application (Attach. B13)
CIRB Continuing Review Application (Attach.
B14).
Adult IR of Cooperative Group Protocol (Attach.
B15).
Pediatric IR of Cooperative Group Protocol (Attach. B16).
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
Health Care Practitioner
Health Care Practitioner
Health Care Practitioner
Participants ...................
30
5
400
400
50
21
2
10
10
1
10/60
120/60
30/60
10/60
15/60
105
20
2,000
667
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
1
30/60
80
2
Health Care Practitioner
400
1
15/60
100
Health Care Practitioner
Health Care Practitioner
1
400
1
1
1
15/60
1
100
Board Members ............
65
1
180/60
195
Board Members ............
15
1
180/60
45
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Federal Register / Vol. 85, No. 196 / Thursday, October 8, 2020 / 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
NCI Adult/Pediatric Continuing Review of Cooperative Group Protocol (Attach. B17).
Adult Amendment of Cooperative Group Protocol
(Attach. B19).
Pediatric Amendment of Cooperative Group Protocol (Attach. B20).
Pharmacist’s Review of a Cooperative Group
Study (Attach. B21).
Adult Expedited Amendment Review (Attach.
B23).
Pediatric Expedited Amendment Review (Attach.
B24).
Adult Expedited Continuing Review (Attach. B25)
Pediatric Expedited Continuing Review (Attach.
B26).
Adult Cooperative Group Response to CIRB Review (Attach. B27).
Pediatric Cooperative Group Response to CIRB
Review (Attach. B28).
Adult Expedited Study Chair Response to Required Modifications (Attach. B29).
Reviewer Worksheet- Determination of UP or
SCN (Attach. B31).
Reviewer Worksheet -CIRB Statistical Reviewer
Form (Attach. B32).
CIRB Application for Translated Documents (Attach. B33).
Reviewer Worksheet of Translated Documents
(Attach. B34).
Reviewer Worksheet of Recruitment Material (Attach. B35).
Reviewer Worksheet Expedited Study Closure
Review (Attach. B36).
Reviewer Worksheet of Expedited IR (Attach.
B38).
Annual Signatory Institution Worksheet About
Local Context (Attach. B40).
Annual Principal Investigator Worksheet About
Local Context (Attach. B41).
Study-Specific Worksheet About Local Context
(Attach. B42).
Study Closure or Transfer of Study Review
Resp. (Attach. B43).
Unanticipated Problem or Serious or Continuing
Noncompliance Reporting Form (Attach. (B44).
Change of Signatory Institution PI Form (Attach.
B45).
Request Waiver of Assent Form (Attach. 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 (Attach. C03) ......................
CIRB Customer Satisfaction Survey (Attach.
C04).
Follow-up Survey (Communication Audit) (Attach.
C05).
CIRB Board Member Annual Assessment Survey
(Attach. C07).
PIO Customer Satisfaction Survey (Attach. C08)
Audit Scheduling Form (Attach. D01) ...................
Preliminary Audit Findings Form (Attach. D02) ....
Audit Maintenance Form (Attach. D03) ................
Final Audit Finding Report Form (Attach. D04) ....
Follow-up Form (Attach. D05) ..............................
Roster Maintenance Form (Attach. D06) .............
Board Members ............
275
1
1
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 ............
Board Members ............
140
36
1
1
30/60
30/60
70
18
Health Care Practitioner
30
1
1
30
Health Care Practitioner
5
1
1
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
Health Care Practitioner
1,680
1
15/60
344
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
1
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
Group/CTMS Users ......
Auditor ..........................
Group/CTMS Users ......
Group/CTMS Users ......
Group/CTMS Users ......
CTMS Users .................
60
152
152
152
75
75
5
1
5
5
5
11
7
1
5/60
21/60
10/60
9/60
1,098/60
27/60
18/60
5
266
127
114
15,098
236
2
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Federal Register / Vol. 85, No. 196 / Thursday, October 8, 2020 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total annual
burden hours
Type of respondent
Final Report and CAPA Request Form (Attach.
D07).
NCI/DCTD/CTEP FDA Form 1572 for Annual
Submission (Attach. E01).
NCI/DCTD/CTE Biosketch (Attach. E02) .............
CTMS Users .................
12
9
1,800/60
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
276
........................
151,716
NCI/DCTD/CTEP Financial Disclosure Form (Attach. E03).
NCI/DCTD/CTEP Agent Shipment Form (ASF)
(Attach. E04).
Totals .............................................................
Dated: October 1, 2020.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2020–22265 Filed 10–7–20; 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
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.
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
respondents
Form name
Name of Committee: Digestive, Kidney and
Urological Systems Integrated Review Group;
Systemic Injury by Environmental Exposure.
Date: November 5–6, 2020.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Yunshang Piao, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 6184,
Bethesda, MD 20892, (301) 402–8402,
piaoy3@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
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Fellowships: Musculoskeletal, Rehabilitation
and Skin Sciences.
Date: November 5–6, 2020.
Time: 9:00 a.m. to 11:00 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Chi-Wing Chow, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4110,
Bethesda, MD 20892, (301) 402–3912,
chowc2@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Oncology.
Date: November 5–6, 2020.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Reigh-Yi Lin, Ph.D.;
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Rm. 4152,
MSC 7846, Bethesda, MD 20892, (301) 827–
6009, lin.reigh-yi@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Renal and Urological Sciences.
Date: November 5, 2020.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Santanu Banerjee, Ph.D.;
Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 2106,
Bethesda, MD 20892, (301) 496–0000,
banerjees5@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Bacterial Pathogenesis.
Date: November 5, 2020.
Time: 9:30 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
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Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Richard G Kostriken,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3192,
MSC 7808, Bethesda, MD 20892, 240–519–
7808, kostrikr@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Molecular Genetics, Genetic
Variation, Genetic/Macromolecular Evolution
and Prokaryotic Cell Biology.
Date: November 5, 2020.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Methode Bacanamwo,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 2200,
Bethesda, MD 20892, 301–827–7088,
methode.bacanamwo@nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel RFA Panel:
The Neuropathological Basis for Chemo
Brain.
Date: November 5, 2020.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Wei-Qin Zhao, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5181,
MSC 7846, Bethesda, MD 20892–7846, 301–
827–7238, zhaow@csr.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)
E:\FR\FM\08OCN1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 196 (Thursday, October 8, 2020)]
[Notices]
[Pages 63561-63564]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22265]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-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 requirement of the Paperwork Reduction
Act of 1995 to provide opportunity for public comment on proposed data
collection projects, the National Cancer Institute (NCI) will publish
periodic summaries of propose projects to be submitted to the Office of
Management and Budget (OMB) for review and approval.
DATES: Comments regarding this information collection are best assured
of having their full effect if received within 60 days of the date of
this publication.
FOR FURTHER INFORMATION CONTACT: To obtain a copy of the data
collection plans and instruments, submit comments in writing, or
request more information on the proposed project, contact: Michael
Montello, Pharm. D., Cancer Therapy Evaluation Program (CTEP), 9609
Medical Center Drive, MSC 9742, Rockville, MD 20850 or call non-toll-
free number 240-276-6080 or email your request, including your address
to: [email protected]. Formal requests for additional plans and
instruments must be requested in writing.
SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
[[Page 63562]]
comments and/or suggestions from the public and affected agencies are
invited to address one or more of the following points: (1) Whether the
proposed collection of information is necessary for the proper
performance of the function of the agency, including whether the
information will have practical utility; (2) The accuracy of the
agency's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) Ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) Ways to minimize the burden of the
collection of information on those who are to respond, including the
use of appropriate automated, electronic, mechanical, or other
technological collection techniques or other forms of information
technology.
Proposed Collection Title: CTEP Support Contract Forms and Surveys
(NCI), 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 151,716.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total annual
Form name respondent respondents responses per response (in burden hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
CTSU IRB/Regulatory Approval Health Care 2,444 12 2/60 978
Transmittal Form (Attach. Practitioner.
A01).
CTSU IRB Certification Form Health Care 2,444 12 10/60 4,888
(Attach. A02). Practitioner.
Withdrawal from Protocol Health Care 279 1 10/60 47
Participation Form (Attach. Practitioner.
A03).
Site Addition Form (Attach. Health Care 80 12 10/60 160
A04). Practitioner.
CTSU Request for Clinical Health Care 360 1 10/60 60
Brochure (Attach. A06). Practitioner.
CTSU Supply Request Form Health Care 90 12 10/60 180
(Attach. A07). Practitioner.
RTOG 0834 CTSU Data Health Care 12 76 10/60 152
Transmittal Form (Attach. Practitioner.
A10).
CTSU Patient Enrollment Health Care 12 12 10/60 24
Transmittal Form (Attach. Practitioner.
A15).
CTSU Transfer Form (Attach. Health Care 360 2 10/60 120
A16). Practitioner.
CTSU System Access Request Health Care 180 1 10/60 30
Form (Attach. A17). Practitioner.
CTSU OPEN Rave Request Form Health Care 30 21 10/60 105
(Attach. A18). Practitioner.
CTSU LPO Form Creation Health Care 5 2 120/60 20
(Attach. A19). Practitioner.
CTSU Site Form Creation and Health Care 400 10 30/60 2,000
PDF (Attach. A20). Practitioner.
CTSU PDF Signature Form Health Care 400 10 10/60 667
(Attach. A21). Practitioner.
NCI CIRB AA & DOR between the Participants.... 50 1 15/60 13
NCI CIRB and Signatory
Institution (Attach. B01).
NCI CIRB Signatory Enrollment Participants.... 50 1 15/60 13
Form (Attach. B02).
CIRB Board Member Application Board Member.... 100 1 30/60 50
(Attach. B03).
CIRB Member COI Screening Board Members... 100 1 15/60 25
Worksheet (Attach. B08).
CIRB COI Screening for CIRB Board Members... 72 1 15/60 18
meetings (Attach. B09).
CIRB IR Application (Attach. Health Care 80 1 1 80
B10). Practitioner.
CIRB IR Application for Exempt Health Care 4 1 30/60 2
Studies (Attach. B11). Practitioner.
CIRB Amendment Review Health Care 400 1 15/60 100
Application (Attach. B12). Practitioner.
CIRB Ancillary Studies Health Care 1 1 1 1
Application (Attach. B13). Practitioner.
CIRB Continuing Review Health Care 400 1 15/60 100
Application (Attach. B14). Practitioner.
Adult IR of Cooperative Group Board Members... 65 1 180/60 195
Protocol (Attach. B15).
Pediatric IR of Cooperative Board Members... 15 1 180/60 45
Group Protocol (Attach. B16).
[[Page 63563]]
NCI Adult/Pediatric Continuing Board Members... 275 1 1 275
Review of Cooperative Group
Protocol (Attach. B17).
Adult Amendment of Cooperative Board Members... 40 1 120/60 80
Group Protocol (Attach. B19).
Pediatric Amendment of Board Members... 25 1 120/60 50
Cooperative Group Protocol
(Attach. B20).
Pharmacist's Review of a Board Members... 50 1 120/60 100
Cooperative Group Study
(Attach. B21).
Adult Expedited Amendment Board Members... 348 1 30/60 174
Review (Attach. B23).
Pediatric Expedited Amendment Board Members... 140 1 30/60 70
Review (Attach. B24).
Adult Expedited Continuing Board Members... 140 1 30/60 70
Review (Attach. B25).
Pediatric Expedited Continuing Board Members... 36 1 30/60 18
Review (Attach. B26).
Adult Cooperative Group Health Care 30 1 1 30
Response to CIRB Review Practitioner.
(Attach. B27).
Pediatric Cooperative Group Health Care 5 1 1 5
Response to CIRB Review Practitioner.
(Attach. B28).
Adult Expedited Study Chair Board Members... 40 1 30/60 20
Response to Required
Modifications (Attach. B29).
Reviewer Worksheet- Board Members... 400 1 10/60 67
Determination of UP or SCN
(Attach. B31).
Reviewer Worksheet -CIRB Board Members... 100 1 15/60 25
Statistical Reviewer Form
(Attach. B32).
CIRB Application for Health Care 100 1 30/60 50
Translated Documents (Attach. Practitioner.
B33).
Reviewer Worksheet of Board Members... 100 1 15/60 25
Translated Documents (Attach.
B34).
Reviewer Worksheet of Board Members... 20 1 15/60 5
Recruitment Material (Attach.
B35).
Reviewer Worksheet Expedited Board Members... 20 1 15/60 5
Study Closure Review (Attach.
B36).
Reviewer Worksheet of Board Members... 5 1 30/60 3
Expedited IR (Attach. B38).
Annual Signatory Institution Health Care 400 1 40/60 267
Worksheet About Local Context Practitioner.
(Attach. B40).
Annual Principal Investigator Health Care 1,800 1 20/60 600
Worksheet About Local Context Practitioner.
(Attach. B41).
Study-Specific Worksheet About Health Care 4,800 1 15/60 1,200
Local Context (Attach. B42). Practitioner.
Study Closure or Transfer of Health Care 1,680 1 15/60 344
Study Review Resp. (Attach. Practitioner.
B43).
Unanticipated Problem or Health Care 360 1 20/60 120
Serious or Continuing Practitioner.
Noncompliance Reporting Form
(Attach. (B44).
Change of Signatory Health Care 120 1 20/60 40
Institution PI Form (Attach. Practitioner.
B45).
Request Waiver of Assent Form Health Care 35 1 20/60 12
(Attach. 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 1 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 (Attach. C03) Health Care 10 1 15/60 3
Practitioner.
CIRB Customer Satisfaction Participants.... 600 1 15/60 150
Survey (Attach. C04).
Follow-up Survey Participants/ 300 1 15/60 75
(Communication Audit) Board Members.
(Attach. C05).
CIRB Board Member Annual Board Members... 60 1 15/60 15
Assessment Survey (Attach.
C07).
PIO Customer Satisfaction Health Care 60 1 5/60 5
Survey (Attach. C08). Practitioner.
Audit Scheduling Form (Attach. Group/CTMS Users 152 5 21/60 266
D01).
Preliminary Audit Findings Auditor......... 152 5 10/60 127
Form (Attach. D02).
Audit Maintenance Form Group/CTMS Users 152 5 9/60 114
(Attach. D03).
Final Audit Finding Report Group/CTMS Users 75 11 1,098/60 15,098
Form (Attach. D04).
Follow-up Form (Attach. D05).. Group/CTMS Users 75 7 27/60 236
Roster Maintenance Form CTMS Users...... 5 1 18/60 2
(Attach. D06).
[[Page 63564]]
Final Report and CAPA Request CTMS Users...... 12 9 1,800/60 3,240
Form (Attach. D07).
NCI/DCTD/CTEP FDA Form 1572 Physician....... 26,500 1 15/60 6,625
for Annual Submission
(Attach. E01).
NCI/DCTD/CTE Biosketch Physician; 48,000 1 120/60 96,000
(Attach. E02). Health Care
Practitioner.
NCI/DCTD/CTEP Financial Physician; 48,000 1 15/60 12,000
Disclosure Form (Attach. E03). Health Care
Practitioner.
NCI/DCTD/CTEP Agent Shipment Physician....... 24,000 1 10/60 4,000
Form (ASF) (Attach. E04).
---------------------------------------------------------------------------------
Totals.................... ................ 167,715 276 .............. 151,716
----------------------------------------------------------------------------------------------------------------
Dated: October 1, 2020.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer Institute, National
Institutes of Health.
[FR Doc. 2020-22265 Filed 10-7-20; 8:45 am]
BILLING CODE 4140-01-P
