pub 30-day FrN

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 ..

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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

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Care
Care
Care
Care
Care

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Practitioner
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Practitioner
Practitioner
Practitioner

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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:

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responses per
respondent

Form name

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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

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