60 Day FR Notice

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Federal Register / Vol. 89, No. 113 / Tuesday, June 11, 2024 / Notices

nine participants whose submissions
meet the eligibility and selection criteria
in a 12-month period for the initial
phase of the EDSTM.
FDA has a longstanding commitment
to ensure medicines marketed in the
United States are safe through
continued surveillance and research
following approval. In the postmarket
setting, regulated industry is obligated
to review all adverse drug experience
information received or otherwise
obtained and submit timely reports to
FDA. Both industry and regulatory
authorities face challenges with timely
and efficient collection, processing, and
evaluation of single and aggregate
patient safety data compounded by everincreasing case volumes. Advances in
emerging technology have the potential
to address some of these challenges by
creating more efficiencies within a PV
system. For example, early adopters of
AI are leveraging these emerging
technologies to automate fundamental
tasks (e.g., adverse event intake, data
entry, and processing) with the
intention to drive down associated
administrative burden and costs. These
technologies can also make safety
surveillance more efficient and effective
by capturing, aggregating, and analyzing
larger and more diverse data sets.
FDA recognizes industry’s interest in
dialogue around AI capabilities that
advance PV. Knowledge and awareness
of emerging technology tools, such as
AI, and how they are used to advance
PV will help inform CDER’s regulatory
approaches and policies. FDA expects
that increased communication with
industry and/or other relevant parties
during EDSTMs will accelerate FDA’s
understanding of how AI enabled tools
are being used for PV, their associated
risks and benefits, and barriers to
implementation.
FDA has established an EDSTP
website that includes EDSTM eligibility
and selection criteria, instructions for
submission of a meeting request,
meeting request and package content
descriptions, and submission timelines.
The program’s website address is
https://www.fda.gov/drugs/science-andresearch-drugs/cder-emerging-drugsafety-technology-program-edstp.

II. Paperwork Reduction Act of 1995
Collections of information from fewer
than 10 respondents within any 12month period are not subject to the
Paperwork Reduction Act of 1995 (PRA)
(5 CFR 1320.3(c)(4)). For the initial
phase of this program, FDA will request
information from no more than nine
sponsors. Initial requests from sponsors
interested in participation in the
program are not ‘‘information’’ in
accordance with 5 CFR 1320.3(h)(1).
Therefore, clearance by the Office of
Management and Budget under the PRA
is not required.
Dated: June 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–12770 Filed 6–10–24; 8:45 am]
BILLING CODE 4164–01–P

Application Packets for Real Property
for Public Health Purposes

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: 0937–0191–60D]

Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

and project title for reference, to
Sherrette A. Funn, email:
[email protected], PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.

In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment. The ICR
is for extending the use of the approved
information collection assigned OMB
control number 0937–0191, which
expires on June 30, 2024. Prior to
submitting the ICR to OMB, OS seeks
comments from the public regarding the
burden estimate, below, or any other
aspect of the ICR.
DATES: Comments on the ICR must be
received on or before August 12, 2024.
ADDRESSES: Submit your comments to
[email protected] or by calling
(202) 264–0041 and [email protected].
FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 0937–0191–60D
SUMMARY:

Type of Collection: Reinstatement,
with no change.
OMB No.: 0937–0191.
Abstract: The Office of Assistant
Secretary for Administration, Program
Support Center, Federal Real Property
Assistance Program is requesting OMB
approval on a previously approved
information collection, 0937–0191. 40
U.S.C. 550 (the ‘‘Act’’), as amended,
provides authority to the Secretary of
Health and Human Services to convey
or lease surplus real property to States
and their political subdivisions and
instrumentalities, to tax-supported
institutions, and to nonprofit
institutions which (except for
institutions which lease property to
assist the homeless) have been held
exempt from taxation under section
501(c)(3) of the 1954 Internal Revenue
Code, and 501(c)(19) for veterans
organizations, for public health and
homeless assistance purposes. Transfers
are made to transferees at little or no
cost.
Type of respondent: Responses are
dependent on when Federal surplus real
property is made available and is
desired by a respondent/applicant for
acquisition. Likely respondents include
State, local, or Tribal units of
government or instrumentalities thereof,
and not-for-profit organizations.

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ANNUALIZED BURDEN HOUR TABLE
Average
burden per
response

Respondents
(if necessary)

Applications for surplus Federal real property .................

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

10

1

200

2,000

Total ..........................................................................

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

10

1

200

2,000

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Number of
respondents

Number of
responses per
respondents

Forms
(if necessary)

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Total burden
hours

Federal Register / Vol. 89, No. 113 / Tuesday, June 11, 2024 / Notices

[FR Doc. 2024–12683 Filed 6–10–24; 8:45 am]

Dated: June 6, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.

BILLING CODE 4150–04–P

[FR Doc. 2024–12736 Filed 6–10–24; 8:45 am]

Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.

BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

National Institutes of Health
National Cancer Institute; Notice of
Meeting

khammond on DSKJM1Z7X2PROD with NOTICES

Pursuant to section 1009 of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Cancer Institute
Council of Research Advocates.
The meeting will be held as a virtual
meeting and will be open to the public
as indicated below. Individuals who
plan to view the virtual meeting and
need special assistance or other
reasonable accommodations to view the
meeting, should notify the Contact
Person listed below in advance of the
meeting. The meeting can be accessed
from the NIH Videocast at the following
link: https://videocast.nih.gov/.
Name of Committee: National Cancer
Institute Council of Research Advocates
(NCRA).
Date: June 26, 2024.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: Welcome and Chairwoman’s
Remarks, NCI Director’s Update, NCI
Updates, and Legislative Update.
Place: National Institutes of Health,
Building 31, 9000 Rockville Pike, Bethesda,
MD 20892 (Virtual Meeting).
Contact Person: Amy Williams, Director,
NCI Office of Advocacy Relations, National
Cancer Institute, NIH, 31 Center Drive,
Building 31, Room 10A28, Bethesda, MD
20892, (301) 496–9723, williaam@
mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
deainfo.nci.nih.gov/advisory/ncra/ncra.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)

17:09 Jun 10, 2024

Jkt 262001

93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: June 6, 2024.
David W. Freeman,
Supervisory Program Analyst, Office of
Federal Advisory Committee Policy.
[FR Doc. 2024–12734 Filed 6–10–24; 8:45 am]

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

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49181

BILLING CODE 4140–01–P

National Institutes of Health

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Center for Scientific Review; Notice of
Closed Meetings

National Institutes of Health

Pursuant to section 1009 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.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Understanding Neurobiology of Aging and
Neurodegeneration.
Date: July 9, 2024.
Time: 9:30 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: 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, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
conflict: Topics on Biobehavioral Processes.
Date: July 9–10, 2024.
Time: 10:00 a.m. to 8:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892.
Meeting Format: Virtual Meeting.
Contact Person: Aruna K Behera, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4211,
MSC 7814, Bethesda, MD 20892, (301) 435–
6809, [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,

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National Institute on Alcohol Abuse
and Alcoholism; Notice of Closed
Meetings
Pursuant to section 1009 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.
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; NIAAA Special Emphasis
Panel for Member Conflict Applications.
Date: July 1, 2024.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Luis Espinoza, Ph.D.,
Scientific Review Officer, Extramural Project
Review Branch, Office of Extramural
Activities, National Institute on Alcohol
Abuse and Alcoholism, National Institutes of
Health, 6700B Rockledge Drive, Room 2109,
Bethesda, MD 20892, (301) 443–8599,
[email protected].
Name of Committee: National Institute on
Alcohol Abuse and Alcoholism Special
Emphasis Panel; NIAAA Fellowship Review
Panel.
Date: July 9, 2024.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
National Institute on Alcohol Abuse and
Alcoholism, 6700B Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Luis Espinoza, Ph.D.,
Scientific Review Officer, Extramural Project
Review Branch, Office of Extramural
Activities, National Institute on Alcohol

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