[Federal Register Volume 88, Number 32 (Thursday, February 16, 2023)]
[Notices]
[Pages 10125-10127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03277]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Statement of Organization, Functions and Delegations of Authority
AGENCY: Administration for Strategic Preparedness and Response, HHS.
ACTION: Notice.
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SUMMARY: This notice announces the establishment of the Administration
for Strategic Preparedness and Response.
DATES: This reorganization was approved by the Secretary of Health and
Human Services on January 27, 2023, and became effective on February
11, 2023.
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 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 realign the functions of ASPR to reflect the changes
mandated by the 21st Century Cures Act and the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act to address ever-increasing
manmade and naturally occurring threats which degrade public health,
access to healthcare, access to emergency medical services and national
security. The changes are as follows.
I. Under AN.10 Organization, delete all the components and replace
with the following:
A. Immediate Office of the Administration for Strategic Preparedness
and Response (SN)
B. Office of the Principal Deputy Assistant Secretary for Strategic
Preparedness and Response (SN)
C. Office of Administration (SNA)
D. Office of Biomedical Advanced Research and Development Authority
(SNB)
E. Office of HHS Coordination Operations and Response Element (H-CORE)
(SNH)
F. Office of Industrial Base Management and Supply Chain (SNI)
G. Office of Preparedness (SNP)
H. Office of Response (SNR)
I. Office of Strategic National Stockpile (SNS)
II. Delete AN.20 Functions, in its entirety and replace with the
following:
Section AR.20 Functions
A. Immediate Office of the Administration for Strategic Preparedness
and Response
The Immediate Office of the Administration for Strategic
Preparedness and Response (IO/ASPR) is headed by the Assistant
Secretary, who provides leadership and executive and strategic
direction for the ASPR organization. The Assistant Secretary is the
principal advisor to the Secretary on all matters related to Federal
public health and medical preparedness and response for public health
emergencies. The Assistant Secretary is responsible for carrying out
ASPR's mission and implementing the functions of ASPR. The IO/ASPR (1)
ensures development and maintenance of liaison relationships with HHS
operating and staff divisions and represents HHS at interagency
meetings, as required; (2) oversees advanced research, development and
procurement of qualified countermeasures, security countermeasures and
qualified pandemic or epidemic products; (3) coordinates with relevant
federal officials to ensure integration of public health policy and
federal preparedness and response activities for public health
emergencies; (4) coordinates the strategic and operational activities
for public health preparedness response and recovery; and (5)
establishes and maintains effective communications and outreach
guidance and support for all external communications, including
legislative and executive branch questions and inquiries, and serves as
the principal advisor to the ASPR on all legislative strategies to
fulfill the Office of the ASPR and the HHS mission under section 2811
and other relevant sections of the Public Health Service Act, as
amended.
The Immediate Office of the Administration for Strategic
Preparedness and Response is headed by the Assistant Secretary (SN),
and includes the following components:
Office of External Affairs (SN1)
Office of Legislative Affairs (SN2)
Office of Public Affairs (SN3)
B. Office of the Deputy Assistant Secretary for Strategic Preparedness
and Response (SN)
The Office of the Principal Deputy Assistant Secretary (OPDAS) is
responsible for providing a well-integrated infrastructure that
supports the Department's capabilities to prevent, prepare for, respond
to, and recover from public health and medical threats and emergencies.
The PDAS also serves as the Chief Operating Officer for ASPR.
[[Page 10126]]
The PDAS provides guidance and support to all elements within the ASPR
on behalf of the Assistant Secretary. The PDAS is responsible for the
execution of business management operations, including the management
of correspondence control for the Assistant Secretary. The PDAS also
manages coordination among HHS entities and external federal agencies
in support of ASPR missions.
The Office of the Principal Deputy Assistant Secretary is headed by
the Principal Deputy Assistant Secretary (SN), and includes the
following components:
Office of Strategy, Policy, and Requirements (SN4)
Executive Secretariat (SN5)
C. Office of Administration (SNA)
The Office of Administration provides the administrative support
services necessary to maintain day-to-day operations of ASPR, including
functions of human resources, United States Public Health Service
(USPHS) liaison, acquisitions management to include policy and
operational contracting, grants management, information technology,
facilities and all financial planning and analysis. The Office of
Administration is headed by a Deputy Assistant Secretary and includes
the following components:
Office of Head of Contracting Activity (HCA) (SNA1)
Office of Finance (SNA2)
Office of Human Capital (SNA3)
Office of Information Technology (SNA4)
D. Office of Biomedical Advanced Research and Development Authority
(SNB)
The Office of Biomedical Advanced Research and Development
Authority (BARDA), established in April 2007 in response to the
Pandemic and All-Hazards Preparedness Act of 2006, serves preparedness
and response roles to provide medical countermeasures (MCM) in order to
mitigate the medical consequences of chemical, biological,
radiological, and nuclear (CBRN) threats and agents and emerging
infectious diseases, including pandemic influenza. BARDA executes this
mission by facilitating research, development, innovation, and
acquisition of MCM and expanding domestic manufacturing infrastructure
and surge capacity of these MCM. BARDA is headed by a Director, who is
also referred to as a Deputy Assistant Secretary, and includes the
following components:
Office of Medical Countermeasures Program Support Services
(SNB2)
Office of Medical Countermeasures Program (SNB3)
E. Office of HHS Coordination, Operations and Response Element (SNH)
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 gives ASPR sole responsibility for the development,
manufacture, and distribution of the nation's COVID-19 vaccines and
therapeutics.
H-CORE works in partnership with other entities across ASPR, such
as, the Biomedical Advanced Research and Development Authority (BARDA),
the Strategic National Stockpile (SNS) and other HHS and Interagency
partners, to deliver COVID-19 countermeasures to the American public
while solidifying enhanced capability to respond to future public-
health threats.
The Office of HHS Coordination, Operations and Response Element is
headed by a Deputy Assistant Secretary and includes the following
components:
Office of Plans (SNH1)
Office of Analytics (SNH2)
Office of Security and Assurance (SNH3)
Office of Supply, Production, and Distribution (SNH4)
Office of Vaccine Development Coordination (SNH5)
Office of Therapeutics Development Coordination (SNH6)
F. Office of Industrial Base Management and Supply Chain (SNI)
The Office of Industrial Base Management and Supply Chain seeks to
build permanent Industrial Base Expansion (IBx) capabilities, inclusive
of global supply chain situational awareness, market capabilities, and
rapid acquisition execution, to reinforce ASPR as the authority to
coordinate the activities related to medical industrial base expansion
and sustainment through the use of Defense Production Act and Emergency
Support Function (ESF) 8 authorities. Efforts under Presidential
Executive Orders have already galvanized a large part of the
interagency to fully implement HHS and national strategies. HHS is
expanding the Public Health Industrial Base and developing innovative
solutions to address critical deficiencies in the public health supply
chain by working across the U.S. Government and with academia and the
private sector.
The Office of Industrial Base Management and Supply Chain is headed
by a Deputy Assistant Secretary and includes the following components:
Office of Personal Protective Equipment and Durable Medical
Equipment (SNI1)
Office Testing and Diagnostics (SNI2)
Office of Advanced Manufacturing Technologies (SNI3)
Office of Supply Chain Optimization (SNI4)
Office of Defense Production Act and Emergency Response
Authorities (SNI5)
G. Office of Preparedness (SNP)
The Office of Preparedness is responsible for policy development,
planning, analysis, requirements, and strategic planning. This Office
also manages and operates the HHS Secretary's Operation Center (SOC),
intelligence, security, information management and analysis, and is
also responsible for the HHS Continuity of Operations (COOP) and the
development of the ASPR COOP Plan.
The Office of Preparedness is headed by a Deputy Assistant
Secretary and includes the following components:
Office of Security and Intelligence (SNP1)
Office of Information Management Data and Analytics (SNP2)
Office of Critical Infrastructure Protection (SNP3)
Office of Health Care Readiness (SNP4)
Office of Medical Reserve Corps (SNP5)
Office of Planning and Exercises (SNP6)
Office of Continuity (SNP7)
Office of Secretary's Operations Center (SNP8)
H. Office of Response (SNR)
The Office of Response oversees activities required to coordinate
public health and healthcare response systems and activities with
relevant federal, state, tribal, territorial, local, and international
communities under the National Response Framework and Emergency Support
Annexes #8, #6 and #14. This Office also provides oversight and
guidance to the National Disaster Medical System and provides an
important liaison function to other agencies engaged in federal
response activities.
The Office of Response is headed by a Deputy Assistant Secretary
and includes the following components:
Office of Regional Response (SNR1)
Office of Response Logistics (SNR2)
Office of National Disaster Medical System (SNR3)
Office of Community Mitigation and Recovery (SNR4)
[[Page 10127]]
I. Office of the Strategic National Stockpile (SNS)
The Strategic National Stockpile (SNS) is part of the federal
medical response infrastructure and can supplement medical
countermeasures needed by states, tribal nations, territories, and the
largest metropolitan areas during public health emergencies. The
supplies, medicines, and devices for lifesaving care contained in the
stockpile can be used as a short-term, stopgap buffer when the
immediate supply of these materials may not be available or sufficient.
The SNS team works every day to prepare and respond to emergencies,
support state and local preparedness activities, and ensure
availability of critical medical assets to protect the health of
Americans.
The Office of the Strategic National Stockpile is headed by a
Deputy Assistant Secretary and includes the following components:
Office of Management and Business Operations (SNS1)
Office of Logistics (SNS2)
Office of State Tribal Local and Territories Preparedness
(SNS3)
Office of National Readiness and Response (SNS4)
Office of Supply Chain Alliance and Development (SNS5)
Office of Science (SNS6)
III. Delegations of Authority: All delegations and redelegations of
authority made to officials and employees of affected organizational
components will continue in them or their successors pending further
redelegation, provided they are consistent with this reorganization.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2023-03277 Filed 2-15-23; 8:45 am]
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