Statement of Organization, Functions, and Delegations of Authority, 71913-71914 [2024-19809]
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Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
glucosidases. Both in vitro and in vivo
testing in animal models (see
publications below) of different
infections and inflammation confirmed
radioactivity accumulation only in live
pathogenic fungi. Imaging with [18F]FCB in mice infected with Aspergillus,
for example, showed that the imaging
agent can detect whether there has been
a response to antifungal therapy. One
major advantage is that synthesis of
[18F]-FCB is simple and efficient using
readily commercially available reagents.
The radiolabeled agent can then be
administered intravenously, and
imaging performed 90–120 minutes after
injection. A radiosynthesis kit has also
been developed and can be used at
ambient temperature to produce [18F]FCB from a commercially acquired kit
in less than two hours without the need
for a cyclotron.
[18F]Fluorocellobiose Using Trasis
AllInOne Module. Journal of labelled
compounds & radiopharmaceuticals,
67(9), 308–313. https://doi.org/10.1002/
jlcr.4116.
Potential Commercial Applications
• Imaging of live infections.
Dated: August 28, 2024.
Michael A. Shmilovich,
Senior Licensing and Patenting Manager,
National Heart, Lung, and Blood Institute,
Office of Technology Transfer and
Development.
Development Stage
• In vitro data
• Preclinical in vivo data (mouse
models)
Intellectual Property
• NIH Reference No. E–163–2019;
U.S. Provisional Patent Application 62/
882,023 filed August 2, 2019;
International Patent Application PCT/
US2020/044446 filed July 31, 2020
(published as WIPO publication WO
2021/025984); and national stage patent
applications filed in Europe
(20757180.3) and the United States (17/
631,600).
• NIH Reference No. E–080–2023;
U.S. Provisional Patent Application 63/
492,302 filed March 27, 2023, and
International Patent Application PCT/
US2024/021440 filed March 26, 2024.
[FR Doc. 2024–19719 Filed 9–3–24; 8:45 am]
BILLING CODE 4140–01–P
ddrumheller on DSK120RN23PROD with NOTICES1
Related Publications
• Zhang X, Basuli F, Shi Z–D, Shah
S, Shi J, Mitchell A, Lai J, Wang Z,
Hammoud DA, Swenson RE. Synthesis
and Evaluation of Fluorine-18-Labeled
L-Rhamnose Derivatives. Molecules.
2023; 28(9):3773. https://doi.org/
10.3390/molecules28093773.
• Shah, S., Lai, J., Basuli, F.,
Martinez-Orengo, N., Patel, R., Turner,
M.L., Wang, B., Shi, Z.D., Sourabh, S.,
Peiravi, M., Lyndaker, A., Liu, S.,
Seyedmousavi, S., Williamson, P.R.,
Swenson, R.E., & Hammoud, D.A.
(2024). Development and preclinical
validation of 2-deoxy 2[18F]fluorocellobiose as an Aspergillusspecific PET tracer. Science
translational medicine, 16(760),
eadl5934. https://doi.org/10.1126/
scitranslmed.adl5934.
• Basuli, F., Shi, J., Shah, S., Lai, J.,
Hammoud, D.A., & Swenson, R.E.
(2024). Fully Automated Cassette-Based
Synthesis of 2-Deoxy-2-
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Strategic
Preparedness and Response
Statement of Organization, Functions,
and Delegations of Authority
Administration for Strategic
Preparedness and Response, HHS.
ACTION: Notice.
AGENCY:
This notice announces
revisions to the organizations within the
Administration for Strategic
Preparedness and Response (ASPR).
DATES: These revisions were approved
by the Administrator and Assistant
Secretary of ASPR on July 2, 2024, and
became effective on July 2, 2024.
SUPPLEMENTARY INFORMATION: Part A,
Office of the Secretary, Statement of
Organization, Functions, and
SUMMARY:
71913
Delegations of Authority of the U.S.
Department of Health and Human
Services (HHS) is being amended at
Chapter AN, Office of the Assistant
Secretary for Preparedness and
Response (ASPR), as last amended at 88
FR 10125 (Feb. 16, 2023), 85 FR 8302
(Feb. 13, 2020), 83 FR 33941 (July 18,
2018), 79 FR 70.535 (Nov. 26, 2014), 78
FR 25277 (April 30, 2013), 78 FR 7784
(Feb. 4, 2013), 75 FR 35.035 (June 21,
2010) to refine the functions within
ASPR to more closely align with ASPR’s
Operating Division status and expansion
of mission which includes preparing for
and responding to ever-increasing manmade and naturally occurring threats
which have the potential to degrade
public health, access to healthcare,
access to emergency medical services,
and national security.
In 2023, ASPR underwent a major
reorganization that was designed to
recognize the Agency’s expanded scope
of work as a new Operating Division,
simplify the organizational structure,
provide greater role clarity, and increase
collaboration across teams. These
changes were targeted in nature and
focused on areas where the mission had
recently expanded. Since the
implementation of ASPR’s 2023
reorganization, the Agency has
undergone additional, modest
adjustments to its organizational
structure to better clarify missions,
roles, and responsibilities at the Deputy
Assistant Secretary (DAS)-level, Officelevel, and Division level. Substantive
changes to ASPR organizations are
noted below. The changes are as
follows:
Global Change: Naming Conventions for
ASPR Components
To more closely align with the
maturation of ASPR’s Operating
Division status and mission of the
organization, the titles for the ASPR
component overseen by an ASPR
Deputy Assistant Secretary (DAS) are
now called ‘‘Centers’’ instead of
‘‘Offices.’’ The chart below provides the
previous title and the new title.
Previous title
New title
Immediate Office of the ASPR .................................................................
Office of Administration ............................................................................
Office of Preparedness .............................................................................
Office of Response ...................................................................................
Office of Biomedical Advanced Research Development Authority ..........
Office of HHS Coordination, Operations, and Response Element ..........
Office of Industrial Base Management and Supply Chain .......................
Office of the Strategic National Stockpile ................................................
Immediate Office of the ASPR (no change).
Center for Administration.
Center for Preparedness.
Center for Response.
Center for the Biomedical Advanced Research Development Authority.
Center for the HHS Coordination Operations and Response Element.
Center for Industrial Base Management and Supply Chain.
Center for the Strategic National Stockpile.
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71914
Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
The following organizational updates
by Center are modifications from the
Agency’s 2023 reorganization. All other
organizational structure remains as
previously noticed in the 2023 Federal
Register Notice.
Center for Administration
• New Office: Office of Facilities
Management
• Office Name Change: Update Office of
Human Capital to Office of Human
Resources
Center for Preparedness
• Office Name Change: Update Office of
Security and Intelligence to Office of
Security, Vetting, and Protection
• Office Name Change: Update the
Office of Information Management,
Data, and Analytics to Office of Data,
Analytics, and Information Advantage
Center for Industrial Base Management
and Supply Chain
• Office Name Change: Update Office of
Personal Protective Equipment and
Durable Medical Equipment to Office
of Critical Medical Equipment
• Office Name Change: Update Office of
Advanced Manufacturing
Technologies to the Office of Enabling
Innovations and Technologies
ddrumheller on DSK120RN23PROD with NOTICES1
Center for the HHS Coordination
Operations and Response Element
In 2022, the Secretary of HHS
transitioned the DOD–HHS partnership
that was formerly called Operation
Warp Speed into ASPR as the HHS
Coordination and Operations Response
Element or H–CORE. Moving H–CORE
fully into ASPR provided ASPR with
sole responsibility for the development,
manufacture, and distribution of the
nation’s COVID–19 vaccines and
therapeutics.
H–CORE reports to the Administrator
and Assistant Secretary for
Preparedness and Response (the ASPR)
and works in partnership with other
entities across ASPR, such as the Center
for the Biomedical Advanced Research
and Development Authority (BARDA),
the Center for the Strategic National
Stockpile (SNS), and the Center for
Industrial Base Management and Supply
Chain (IBMSC), to deploy vaccines,
therapeutics, and other medical
countermeasures products and supplies
to the American public during
infectious disease outbreaks and other
public health emergencies. H–CORE
coordinates and accelerates the logistics
readiness and operations in response to
infectious diseases, public health
emergencies, and disasters in support of
the ASPR.
VerDate Sep<11>2014
21:26 Sep 03, 2024
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H–CORE is headed by a Deputy
Assistant Secretary and includes the
following components:
• Office Name Change: Update from
Office of Analytics to Office of
Analytics, Data, and IT
• Office Name Change: Update from
Office of Plans to Office of Planning
and Operational Coordination
• Office of Supply, Production, and
Distribution
• New Office: Office of Infectious
Disease Response
• Delete Office: Office of Security and
Assurance
• Delete Office: Office of Vaccine
Development Coordination
• Delete Office: Office of Therapeutics
Development Coordination
I. Delegations of Authority: All
delegations and redelegations of
authority made to officials and
employees of affected organizational
components will endure pending
further redelegation, provided they are
consistent with this reorganization.
All updates herein supersede any
prior directives pertaining to the
establishment of Agency components,
including but not limited to directives
pertaining to the establishment of H–
CORE.
The Administrator and Assistant
Secretary for Preparedness and
Response of ASPR, Dawn O’Connell,
having reviewed and approved this
document, authorizes Adam DeVore,
who is the Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Adam DeVore,
Federal Register Liaison, Administration for
Strategic Preparedness and Response.
[FR Doc. 2024–19809 Filed 9–3–24; 8:45 am]
BILLING CODE 4150–37–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2024–0739]
Information Collection Request to
Office of Management and Budget;
OMB Control Number: 1625–0113
Coast Guard, DHS.
Sixty-day notice requesting
comments.
AGENCY:
ACTION:
In compliance with the
Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an
Information Collection Request (ICR) to
the Office of Management and Budget
(OMB), Office of Information and
SUMMARY:
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Regulatory Affairs (OIRA), requesting an
extension of its approval for the
following collection of information:
1625–0113, Crewmember Identification
Documents; without change. Our ICR
describes the information we seek to
collect from the public. Before
submitting this ICR to OIRA, the Coast
Guard is inviting comments as
described below.
DATES: Comments must reach the Coast
Guard on or before November 4, 2024.
ADDRESSES: You may submit comments
identified by Coast Guard docket
number [USCG–2024–0739] to the Coast
Guard using the Federal eRulemaking
Portal at https://www.regulations.gov.
See the ‘‘Public participation and
request for comments’’ portion of the
SUPPLEMENTARY INFORMATION section for
further instructions on submitting
comments.
A copy of the ICR is available through
the docket on the internet at https://
www.regulations.gov. Additionally,
copies are available from: Commandant
(CG–6P), Attn: Paperwork Reduction
Act Manager, U.S. Coast Guard, 2703
Martin Luther King Jr. Ave. SE, Stop
7710, Washington, DC 20593–7710.
FOR FURTHER INFORMATION CONTACT: A.L.
Craig, Office of Privacy Management,
telephone 202–475–3528, fax 202–372–
8405, or email hqs-dg-m-cg-61-pii@
uscg.mil for questions on these
documents.
SUPPLEMENTARY INFORMATION:
Public Participation and Request for
Comments
This notice relies on the authority of
the Paperwork Reduction Act of 1995;
44 U.S.C. 3501 et seq., chapter 35, as
amended. An ICR is an application to
OIRA seeking the approval, extension,
or renewal of a Coast Guard collection
of information (Collection). The ICR
contains information describing the
Collection’s purpose, the Collection’s
likely burden on the affected public, an
explanation of the necessity of the
Collection, and other important
information describing the Collection.
There is one ICR for each Collection.
The Coast Guard invites comments on
whether this ICR should be granted
based on the Collection being necessary
for the proper performance of
Departmental functions. In particular,
the Coast Guard would appreciate
comments addressing: (1) the practical
utility of the Collection; (2) the accuracy
of the estimated burden of the
Collection; (3) ways to enhance the
quality, utility, and clarity of
information subject to the Collection;
and (4) ways to minimize the burden of
the Collection on respondents,
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]]>Agencies
- DEPARTMENT OF HEALTH AND HUMAN SERVICES
- Administration for Strategic Preparedness and Response
[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Pages 71913-71914]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19809]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Strategic Preparedness and Response
Statement of Organization, Functions, and Delegations of
Authority
AGENCY: Administration for Strategic Preparedness and Response, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces revisions to the organizations within
the Administration for Strategic Preparedness and Response (ASPR).
DATES: These revisions were approved by the Administrator and Assistant
Secretary of ASPR on July 2, 2024, and became effective on July 2,
2024.
SUPPLEMENTARY INFORMATION: Part A, Office of the Secretary, Statement
of Organization, Functions, and Delegations of Authority of the U.S.
Department of Health and Human Services (HHS) is being amended at
Chapter AN, Office of the Assistant Secretary for Preparedness and
Response (ASPR), as last amended at 88 FR 10125 (Feb. 16, 2023), 85 FR
8302 (Feb. 13, 2020), 83 FR 33941 (July 18, 2018), 79 FR 70.535 (Nov.
26, 2014), 78 FR 25277 (April 30, 2013), 78 FR 7784 (Feb. 4, 2013), 75
FR 35.035 (June 21, 2010) to refine the functions within ASPR to more
closely align with ASPR's Operating Division status and expansion of
mission which includes preparing for and responding to ever-increasing
man-made and naturally occurring threats which have the potential to
degrade public health, access to healthcare, access to emergency
medical services, and national security.
In 2023, ASPR underwent a major reorganization that was designed to
recognize the Agency's expanded scope of work as a new Operating
Division, simplify the organizational structure, provide greater role
clarity, and increase collaboration across teams. These changes were
targeted in nature and focused on areas where the mission had recently
expanded. Since the implementation of ASPR's 2023 reorganization, the
Agency has undergone additional, modest adjustments to its
organizational structure to better clarify missions, roles, and
responsibilities at the Deputy Assistant Secretary (DAS)-level, Office-
level, and Division level. Substantive changes to ASPR organizations
are noted below. The changes are as follows:
Global Change: Naming Conventions for ASPR Components
To more closely align with the maturation of ASPR's Operating
Division status and mission of the organization, the titles for the
ASPR component overseen by an ASPR Deputy Assistant Secretary (DAS) are
now called ``Centers'' instead of ``Offices.'' The chart below provides
the previous title and the new title.
------------------------------------------------------------------------
Previous title New title
------------------------------------------------------------------------
Immediate Office of the ASPR........... Immediate Office of the ASPR
(no change).
Office of Administration............... Center for Administration.
Office of Preparedness................. Center for Preparedness.
Office of Response..................... Center for Response.
Office of Biomedical Advanced Research Center for the Biomedical
Development Authority. Advanced Research Development
Authority.
Office of HHS Coordination, Operations, Center for the HHS Coordination
and Response Element. Operations and Response
Element.
Office of Industrial Base Management Center for Industrial Base
and Supply Chain. Management and Supply Chain.
Office of the Strategic National Center for the Strategic
Stockpile. National Stockpile.
------------------------------------------------------------------------
[[Page 71914]]
The following organizational updates by Center are modifications
from the Agency's 2023 reorganization. All other organizational
structure remains as previously noticed in the 2023 Federal Register
Notice.
Center for Administration
New Office: Office of Facilities Management
Office Name Change: Update Office of Human Capital to Office
of Human Resources
Center for Preparedness
Office Name Change: Update Office of Security and Intelligence
to Office of Security, Vetting, and Protection
Office Name Change: Update the Office of Information
Management, Data, and Analytics to Office of Data, Analytics, and
Information Advantage
Center for Industrial Base Management and Supply Chain
Office Name Change: Update Office of Personal Protective
Equipment and Durable Medical Equipment to Office of Critical Medical
Equipment
Office Name Change: Update Office of Advanced Manufacturing
Technologies to the Office of Enabling Innovations and Technologies
Center for the HHS Coordination Operations and Response Element
In 2022, the Secretary of HHS transitioned the DOD-HHS partnership
that was formerly called Operation Warp Speed into ASPR as the HHS
Coordination and Operations Response Element or H-CORE. Moving H-CORE
fully into ASPR provided ASPR with sole responsibility for the
development, manufacture, and distribution of the nation's COVID-19
vaccines and therapeutics.
H-CORE reports to the Administrator and Assistant Secretary for
Preparedness and Response (the ASPR) and works in partnership with
other entities across ASPR, such as the Center for the Biomedical
Advanced Research and Development Authority (BARDA), the Center for the
Strategic National Stockpile (SNS), and the Center for Industrial Base
Management and Supply Chain (IBMSC), to deploy vaccines, therapeutics,
and other medical countermeasures products and supplies to the American
public during infectious disease outbreaks and other public health
emergencies. H-CORE coordinates and accelerates the logistics readiness
and operations in response to infectious diseases, public health
emergencies, and disasters in support of the ASPR.
H-CORE is headed by a Deputy Assistant Secretary and includes the
following components:
Office Name Change: Update from Office of Analytics to Office
of Analytics, Data, and IT
Office Name Change: Update from Office of Plans to Office of
Planning and Operational Coordination
Office of Supply, Production, and Distribution
New Office: Office of Infectious Disease Response
Delete Office: Office of Security and Assurance
Delete Office: Office of Vaccine Development Coordination
Delete Office: Office of Therapeutics Development Coordination
I. Delegations of Authority: All delegations and redelegations of
authority made to officials and employees of affected organizational
components will endure pending further redelegation, provided they are
consistent with this reorganization.
All updates herein supersede any prior directives pertaining to the
establishment of Agency components, including but not limited to
directives pertaining to the establishment of H-CORE.
The Administrator and Assistant Secretary for Preparedness and
Response of ASPR, Dawn O'Connell, having reviewed and approved this
document, authorizes Adam DeVore, who is the Federal Register Liaison,
to electronically sign this document for purposes of publication in the
Federal Register.
Adam DeVore,
Federal Register Liaison, Administration for Strategic Preparedness and
Response.
[FR Doc. 2024-19809 Filed 9-3-24; 8:45 am]
BILLING CODE 4150-37-P
