30 day FRN

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:

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(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:

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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.

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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

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

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Health
Health
Health

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Care
Care
Care

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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

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Number of
respondents

Type of respondent

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

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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,

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