[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]
BILLING CODE 4150-37-P