published 30-day FRN

9524

Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices

Bethesda, MD 20892, (301) 402–4128,
[email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: February 9, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–03019 Filed 2–12–21; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; CTEP Branch and
Support Contracts Forms and Surveys
(National Cancer Institute)
AGENCY:

National Institutes of Health,

HHS.
ACTION:

Notice.

In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
and Budget (OMB) a request for review
and approval of the information
collection listed below.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30 days of the date of this
publication.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
SUMMARY:

Institute (NCI) Cancer Therapy
Evaluation Program (CTEP) and the
Division of Cancer Prevention (DCP)
fund an extensive national program of
cancer research, sponsoring clinical
trials in cancer prevention, symptom
management and treatment for qualified
clinical investigators. As part of this
effort, CTEP implements programs to
register clinical site investigators and
clinical site staff, and to oversee the
conduct of research at the clinical sites.
CTEP and DCP also oversee two support
programs, the NCI Central Institutional
Review Board (CIRB) and the Cancer
Trial Support Unit (CTSU). The
combined systems and processes for
initiating and managing clinical trials is
termed the Clinical Oncology Research
Enterprise (CORE) and represents an
integrated set of information systems
and processes which support
investigator registration, trial oversight,
patient enrollment, and clinical data
collection. The information collected is
required to ensure compliance with
applicable federal regulations governing
the conduct of human subjects research
(45 CFR 46 and 21 CRF 50), and when
CTEP acts as the Investigational New
Drug (IND) holder, FDA regulations
pertaining to the sponsor of clinical
trials and the selection of qualified
investigators under 21 CRF 312.53).
Survey collections assess satisfaction
and provide feedback to guide
improvements with processes and
technology.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
151,792.

notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Michael Montello, Pharm. D., Cancer
Therapy Evaluation Program (CTEP),
9609 Medical Center Drive, MSC 9742,
Rockville, MD 20850 or call non-tollfree number 240–276–6080 or Email
your request, including your address to:
[email protected].
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register on October 8, 2020, page 63565
(Vol. 85, No. 196, FR 63565) and
allowed 60 days for public comment. No
public comments were received. The
National Cancer Institute (NCI),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection Title: CTEP
Support Contract Forms and Surveys
(NCI), OMB #0925–0753 Expiration Date
07/31/2021, REVISION, National Cancer
Institute (NCI), National Institutes of
Health (NIH).
Need and Use of Information
Collection: The National Cancer

khammond on DSKJM1Z7X2PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Average
burden
per response
(in hours)

Total
annual
burden
hours

Type of
respondent

CTSU IRB/Regulatory Approval Transmittal Form
(Attachment A01).
CTSU IRB Certification Form (Attachment A02) ..
Withdrawal from Protocol Participation Form (Attachment A03).
Site Addition Form (Attachment A04) ...................
CTSU Request for Clinical Brochure (Attachment
A06).
CTSU Supply Request Form (Attachment A07) ..
RTOG 0834 CTSU Data Transmittal Form (Attachment A10).
CTSU Patient Enrollment Transmittal Form (Attachment A15).
CTSU Transfer Form (Attachment A16) ...............
CTSU System Access Request Form (Attachment A17).
CTSU OPEN Rave Request Form (Attachment
A18).

Health Care Practitioner

2,444

12

2/60

978

Health Care Practitioner
Health Care Practitioner

2,444
279

12
1

10/60
10/60

4,888
47

Health Care Practitioner
Health Care Practitioner

80
360

12
1

10/60
10/60

160
60

Health Care Practitioner
Health Care Practitioner

90
12

12
76

10/60
10/60

180
152

Health Care Practitioner

12

12

10/60

24

Health Care Practitioner
Health Care Practitioner

360
180

2
1

10/60
10/60

120
30

Health Care Practitioner

30

21

10/60

105

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Number of
respondents

Number of
responses per
respondent

Form name

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9525

Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices

khammond on DSKJM1Z7X2PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent

Total
annual
burden
hours

Type of
respondent

CTSU LPO Form Creation (Attachment A19) ......
CTSU Site Form Creation (Attachment A20) .......
CTSU Electronic Signature Form (Attachment
A21).
NCI CIRB AA & DOR between the NCI CIRB
and Signatory Institution (Attachment B01).
NCI CIRB Signatory Enrollment Form (Attachment B02).
CIRB Board Member Application (Attachment
B03).
CIRB Member COI Screening Worksheet (Attachment B08).
CIRB COI Screening for CIRB meetings (Attachment B09).
CIRB IR Application (Attachment B10) ................
CIRB IR Application for Exempt Studies (Attachment B11).
CIRB Amendment Review Application (Attachment B12).
CIRB Ancillary Studies Application (Attachment
B13).
CIRB Continuing Review Application (Attachment
B14).
Adult IR of Cooperative Group Protocol (Attachment B15).
Pediatric IR of Cooperative Group Protocol (Attachment B16).
Adult Continuing Review of Cooperative Group
Protocol (Attachment B17).
Adult Amendment of Cooperative Group Protocol
(Attachment B19).
Pediatric Amendment of Cooperative Group Protocol (Attachment B20).
Pharmacist’s Review of a Cooperative Group
Study (Attachment B21).
Adult Expedited Amendment Review (Attachment
B23).
Pediatric Expedited Amendment Review (Attachment B24).
Adult Expedited Continuing Review (Attachment
B25).
Pediatric Expedited Continuing Review (Attachment B26).
Adult Cooperative Group Response to CIRB Review (Attachment B27).
Pediatric Cooperative Group Response to CIRB
Review (Attachment B28).
Adult Expedited Study Chair Response to Required Modifications (Attachment B29).
Reviewer Worksheet—Determination of UP or
SCN (Attachment B31).
Reviewer Worksheet—CIRB Statistical Reviewer
Form (Attachment B32).
CIRB Application for Translated Documents (Attachment B33).
Reviewer Worksheet of Translated Documents
(Attachment B34).
Reviewer Worksheet of Recruitment Material (Attachment B35).
Reviewer Worksheet Expedited Study Closure
Review (Attachment B36).
Reviewer Worksheet of Expedited IR (Attachment B38).
Annual Signatory Institution Worksheet About
Local Context (Attachment B40).
Annual Principal Investigator Worksheet About
Local Context (Attachment B41).
Study-Specific Worksheet About Local Context
(Attachment B42).

Health Care Practitioner
Health Care Practitioner
Health Care Practitioner

5
400
400

2
10
10

120/60
30/60
10/60

20
2,000
667

Participants ...................

50

1

15/60

13

Participants ...................

50

1

15/60

13

Board Member ..............

100

1

30/60

50

Board Members ............

100

1

15/60

25

Board Members ............

72

1

15/60

18

Health Care Practitioner
Health Care Practitioner

80
4

1
1

60/60
30/60

80
2

Health Care Practitioner

400

1

15/60

100

Health Care Practitioner

1

1

60/60

1

Health Care Practitioner

400

1

15/60

100

Board Members ............

65

1

180/60

195

Board Members ............

15

1

180/60

45

Board Members ............

275

1

60/60

275

Board Members ............

40

1

120/60

80

Board Members ............

25

1

120/60

50

Board Members ............

50

1

120/60

100

Board Members ............

348

1

30/60

174

Board Members ............

140

1

30/60

70

Board Members ............

140

1

30/60

70

Board Members ............

36

1

30/60

18

Health Care Practitioner

30

1

60/60

30

Health Care Practitioner

5

1

60/60

5

Board Members ............

40

1

30/60

20

Board Members ............

400

1

10/60

67

Board Members ............

100

1

15/60

25

Health Care Practitioner

100

1

30/60

50

Board Members ............

100

1

15/60

25

Board Members ............

20

1

15/60

5

Board Members ............

20

1

15/60

5

Board Members ............

5

1

30/60

3

Health Care Practitioner

400

1

40/60

267

Health Care Practitioner

1,800

1

20/60

600

Health Care Practitioner

4,800

1

15/60

1,200

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Average
burden
per response
(in hours)

Form name

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9526

Federal Register / Vol. 86, No. 29 / Tuesday, February 16, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Total
annual
burden
hours

Study Closure or Transfer of Study Review Responsibility (Attachment B43).
Unanticipated Problem or Serious or Continuing
Noncompliance Reporting Form (Attachment
B44).
Change of Signatory Institution PI Form (Attachment B45).
Request Waiver of Assent Form (Attachment
B46).
CIRB Waiver of Consent Request Supplemental
Form (Attachment B47).
Review Worksheet CIRB Review for Inclusion of
Incarcerated Participants (Attachment B48).
Notification of Incarcerated Participant Form
(B49).
CTSU OPEN Survey (Attachment C03) ...............
CIRB Customer Satisfaction Survey (Attachment
C04).
Follow-up Survey (Communication Audit) (Attachment C05).
CIRB Board Member Annual Assessment Survey
(Attachment C07).
PIO Customer Satisfaction Survey (Attachment
C08).
Audit Scheduling Form (Attachment D01) ............
Preliminary Audit Finding Form (Attachment D02)
Audit Maintenance Form (Attachment D03) .........
Final Audit finding Report Form (Attachment
D04).
Follow-up Form (Attachment D05) .......................
Roster Maintenance Form (Attachment D06) ......
Final Report and CAPA Request Form (Attachment D07).
NCI/DCTD/CTEP FDA Form 1572 for Annual
Submission (Attachment E01).
NCI/DCTD/CTE Biosketch (Attachment E02) ......

Health Care Practitioner

1,680

1

15/60

420

Health Care Practitioner

360

1

20/60

120

Health Care Practitioner

120

1

20/60

40

Health Care Practitioner

35

1

20/60

12

Health Care Practitioner

20

1

15/60

5

Board Members ............

20

1

60/60

20

Health Care Practitioner

20

1

20/60

7

Health Care Practitioner
Participants ...................

10
600

1
1

15/60
15/60

3
150

Participants/Board
Members.
Board Members ............

300

1

15/60

75

60

1

15/60

15

Health Care Practitioner

60

1

5/60

5

Practitioner
Practitioner
Practitioner
Practitioner

152
152
152
75

5
5
5
11

21/60
10/60
9/60
1,098/60

266
127
114
15,098

Health Care Practitioner
Health Care Practitioner
Health Care Practitioner

75
5
12

7
1
9

27/60
18/60
1,800/60

236
2
3,240

Physician ......................

26,500

1

15/60

6,625

Physician; Health Care
Practitioner.
Physician; Health Care
Practitioner.
Physician ......................

48,000

1

120/60

96,000

48,000

1

15/60

12,000

24,000

1

10/60

4,000

.......................................

167,715

235,670

........................

151,792

NCI/DCTD/CTEP Financial Disclosure Form (Attachment E03).
NCI/DCTD/CTEP Agent Shipment Form (ASF)
(Attachment E04).
Totals .............................................................

Dated: February 1, 2021.
Diane Kreinbrink,
Project Clearance Liaison, National Cancer
Institute, National Institutes of Health.
[FR Doc. 2021–03046 Filed 2–12–21; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
khammond on DSKJM1Z7X2PROD with NOTICES

Average
burden
per response
(in hours)

Type of
respondent

Notice of Meeting
Pursuant to Public Law 92–463,
notice is hereby given that the
Substance Abuse and Mental Health
Services Administration’s (SAMHSA)
Center for Substance Abuse Prevention’s
(CSAP) Drug Testing Advisory Board

VerDate Sep<11>2014

17:04 Feb 12, 2021

Jkt 253001

Health
Health
Health
Health

Care
Care
Care
Care

Number of
respondents

Number of
responses per
respondent

Form name

(DTAB) will convene via web
conference on March 2nd, 2021, from
10:00 a.m. EST to 4:30 p.m. EST, and
March 3rd, 2021, from 10:00 a.m. EST
to 4:30 p.m. EST.
The board will meet in open-session
March 2nd, 2021, from 10:00 a.m. EST
to 2:00 p.m. EST to discuss the
Mandatory Guidelines for Federal
Workplace Drug Testing Programs with
updates from the Department of
Transportation, the Nuclear Regulatory
Commission, and the Department of
Defense. Other discussion topics
include an update on marijuana studies
and efforts as well as the Employee
Assistance Program (EAP) Toolkit. The
board will meet in closed-session on
March 2nd, 2021, from 2:15 p.m. EST to
4:30 p.m. EST, and March 3rd, 2021,
from 10:00 a.m. EST to 4:30 p.m. EST,

PO 00000

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Fmt 4703

Sfmt 4703

to discuss confidential issues
surrounding the proposed Mandatory
Guidelines for Federal Workplace Drug
Testing Programs (hair), the Federal
Drug-Free Workplace Programs and
emerging issues, updates on the
revisions of the Urine and Oral Fluid
Mandatory Guidelines and the
Biomarker Table, preliminary and
unpublished studies from the Johns
Hopkins University Behavioral
Pharmacology Research Unit (BPRU),
and cannabidiol (CBD) information from
FDA. Therefore, the March 2nd, 2021,
from 2:15 p.m. EST to 4:30 p.m. EST,
and the March 3rd, 2021, from 10:00
a.m. EST to 4:30 p.m. EST, meetings are
closed to the public, as determined by
the Assistant Secretary for Mental
Health and Substance Use, SAMHSA, in
accordance with 5 U.S.C. 552b(c)(4) and

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