[Federal Register Volume 85, Number 30 (Thursday, February 13, 2020)]
[Notices]
[Pages 8302-8304]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02839]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Office of the Assistant Secretary for Preparedness and Response; 
Statement of Organization, Functions and Delegations of Authority

    Part A, Office of the Secretary, Statement of Organization, 
Functions, and Delegations of Authority of the 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 83 FR 33941 (July 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 add the Strategic National Stockpile (SNS). This notice 
transfers the Office of the Director, Strategic National Stockpile, to 
the Office of the Principal Deputy Assistant Secretary (ANC), Division 
of Resource Management (ANC3) pursuant to 5 U.S.C. Appendix (the 
Reorganization Plan No. 1 of 1953 and the Reorganization Plan No. 3 of 
1966) and 31 U.S.C. 1531, and effective October 1, 2018 the functions, 
personnel, assets, and liabilities of the SNS to the Office of the 
Secretary, Office of the Assistant Secretary for Preparedness and 
Response (ASPR).
    The changes are as follows.
    I. Delete AR.20 Functions in its entirety and replace with the 
following:
    Section AN.20 Functions.
    A. Immediate Office of the Assistant Secretary for Preparedness and 
Response: The Immediate Office of the Assistant Secretary for 
Preparedness and Response (IO/ASPR) is headed by

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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) 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; (3) oversees advanced research, 
development and procurement of qualified countermeasures, security 
countermeasures and qualified pandemic or epidemic products; (4) 
coordinates with relevant federal officials to ensure integration of 
federal preparedness and response activities for public health 
emergencies; (5) manages correspondence control for the Assistant 
Secretary; and (6) coordinates the strategic and operational activities 
for public health preparedness response and recovery.
    B. Office of Biomedical Advance Research and Development Authority 
(ANB). 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 Deputy Assistant Secretary, and includes the 
following components:
     Office of Medical Countermeasures Program Support Services 
(ANB1)
     Division of Regulatory Science and Quality Affairs (ANB12)
     Division of Clinical Development (ANB13)
     Division of Non-Clinical Development (ANB14)
     Office of Medical Countermeasures Program (ANB2)
     Division of Chemical, Biological, Radiological and Nuclear 
Program (ANB21)
     Division of Influenza, Emerging & Infectious Diseases 
(ANB22)
     Division of Detection, Diagnostics, Device Infrastructure 
(ANB23)
     Division of Pharmaceutical Countermeasure Infrastructure 
(ANB24)
     Division of Research, Innovation and Ventures (ANB25)
     Division of Contracting Management & Acquisitions (ANBA1)
    C. Office of the Principal Deputy Assistant Secretary (ANC). 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 natural public health and medical threats and 
emergencies. OPDAS leads the preparedness and response 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. OPDAS is 
responsible for the execution of business management operations and 
managing coordination. OPDAS provides for the facility, logistics, 
information technology and infrastructure support services necessary to 
maintain day-to-day operations of ASPR, including functions of Human 
Resources, Organization and Employee Development, Ethics, United States 
Public Health Service (USPHS) liaison, acquisitions management, 
contracts, grants, and all financial planning and analysis.
    The Office of the Principal Deputy Assistant Secretary is headed by 
the Principal Deputy Assistant Secretary, and includes the following 
components:
     Office of Management Finance and Human Capital (ANC1)
     Office of Emergency Management and Medical Operations 
(ANC2)
     Office of Resource Management (ANC3)
    Division of the Strategic National Stockpile (ANC34). The Office of 
the Director, Division of the Strategic National Stockpile, (1) Leads 
executive planning and management of the Division of Strategic National 
Stockpile (DSNS); (2) protects U.S. health security by collaborating 
with, and recruiting for, partners to enhance international medical 
supply chain planning, coordination, and management in coordination 
with operating components of HHS; and (3) supports the U.S. 
government's Global Health Security Agenda to improve the capabilities 
of emerging nations' medical countermeasure (MCM) supply chain to 
combat communicable diseases and other health threats in coordination 
with operating components of HHS.
    Information and Planning Branch. (ANC341) The Information and 
Planning Branch (1) Coordinates and integrates information and 
preparedness activities for DSNS and partners to build, sustain, and 
improve alternative emergency supply chain capabilities and readiness 
during a response; (2) captures, develops, and shares information and 
knowledge to facilitate preparedness; (3) designs and delivers learning 
activities to DSNS staff and partners to enhance knowledge base for 
alternative emergency medical supply chain capabilities; (4) supports 
partner exercises and plans, coordinates, and conducts DSNS exercises 
to enhance and validate alternative emergency medical supply chain 
preparedness; (5) maintains day-to-day situational awareness, 
connectivity, and readiness to ensure rapid transition to SNS response 
operations; (6) supervises the preparation and readiness of all SNS on-
site and off-site response coordination facilities to maintain each in 
a ready state; (7) manages the development, coordination, and 
maintenance of DSNS response plans; (8) manages the staffing, 
preparation, and readiness of DSNS staff to respond to emergencies as 
part of the DSNS incident management structure and on DSNS deployable 
teams; (9) coordinates staffing for the DSNS incident management 
structure during exercises or upon a federal deployment of the 
strategic national stockpile (SNS) to accompany SNS medical 
countermeasures and provide technical assistance; (10) manages the DSNS 
Corrective Action Program for exercises and responses to actual 
emergencies; and (11) manages DSNS personal and program response 
communications devices and systems.
    Operational Logistics Branch. (ANC342) The Operational Logistics 
Branch (1) Develops logistical requirements for DSNS formulary MCMs 
established by HHS and the Public Health Emergency Medical 
Countermeasure Enterprise (PHEMCE); (2) maintains inventory 
accountability for all DSNS MCMs utilizing an inventory management 
system; (3) manages the procurement of medical materiel to meet 
formulary

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requirements; (4) manages and tracks expenditure of DSNS funds for the 
procurement, storage, and transport of medical materiel; (5) manages 
the development and oversight of contracts for Stockpile Managed 
Inventory (SMI) and Vendor Managed Inventory (VMI); (6) establishes and 
manages third party logistics contracts for the storage and maintenance 
of DSNS MCMs; (7) manages the rotation and programmed replacement of 
DSNS MCMs; (8) coordinates safety of DSNS MCMs; (9) provides logistics 
staff for deployable teams that accompany SNS MCMs deployed in response 
to a public health emergency or full scale exercise; (10) provides 
emergency operations support to the DSNS Emergency Operations Center 
(EOC); (11) coordinates transportation contracts needed to deploy DSNS 
MCMs; (12) manages cold chain storage and deployment capabilities; (13) 
manages the forward deployment and sustainment of CHEMPACK chemical 
countermeasures in project areas; (14) manages and maintains 
calibration and maintenance of DSNS equipment; (15) manages the Shelf 
Life Extension Program in coordination with the Food and Drug 
Administration and the Department of Defense (DoD); (16) serves as a 
storage and distribution partner to the DoD for biologic products; (17) 
coordinates quality assurance and quality control; (18) in coordination 
with Centers for Disease Control and Prevention (CDC) will provide 
support for small scale releases; and (19) conducts physical 
inventories for stored DSNS materiel.
    Management and Business Operations Branch. (ANC343) The Management 
and Business Operations Branch (1) Provides leadership of all 
management and operations aspects for the division; (2) manages the 
development of program policies and procedures; (3) procures, 
maintains, and supports division information technology systems; (4) 
monitors and manages reporting of DSNS performance measures; (5) 
provides leadership in issue and risk management, business 
transformation, and change management; (6) maintains contract 
management responsibility within DSNS; (7) provides guidance and other 
support for all division acquisitions; (8) plans, manages, and 
coordinates all aspects of program business services and resource 
management operations; (9) provides editing and writing services and 
coordinates and clears internal and external communications; (10) acts 
as the Division's liaison for internal/external audits and reviews; 
(11) directs and monitors a comprehensive strategy for managing and 
executing the critical systems in operating a successful commercial 
good manufacturing practice compliance program; (12) develops and 
leverages systems to manage, track and report the disposition of 
deployed SNS MCMs; (13) in coordination with CDC, manages and 
coordinates SNS tasks from Congress, Office of Management and Budget, 
and other federal agencies; (14) manages the development and oversight 
of DSNS-wide annual budget and spend plans and handles all aspects of 
DSNS budget execution; (15) executes the opening and closing of 
Stockpile Resource Planning (SRP) accounting periods, oversees SRP 
financial reconciliation (e.g., inventory procurement and finance 
modules), and coordinates SRP accounting and reporting; and (16) 
manages budget formulation and produces 7-year budget requirement 
projections to support procurement planning and strategic decision 
making.
    Science Branch. (ANC344) The Science Branch (1) In collaboration 
with CDC, guides scientific and medical integration for MCM planning 
and response with Federal, state, local, and non-government partners; 
(2) in collaboration with CDC and PHEMCE partners, steers SNS medical 
countermeasure acquisition, sustainment, and deployment; (3) manages 
administrative, medical, pharmaceutical, and scientific oversight of 
the SNS formulary; (4) ASPR and CDC will work together to engage 
federal officials and subject matter experts in reviewing and 
disseminating the best available guidance for use of stockpiled MCMs; 
(5) engages public and private sector partners to develop and deliver 
information and training on SNS assets to specialized healthcare 
delivery audiences to increase nationwide knowledge base and 
preparedness for MCM response; (6) ASPR and CDC will coordinate medical 
surveillance program for all SNS deployable teams; (7) responds to 
inquiries regarding the SNS formulary and program from local, state, 
and federal agencies; and (8) collaborates with academic institutions, 
governmental and nongovernmental agencies on research, regulatory, 
licensing and compliance issues surrounding stockpiling of MCMs.
    Strategic Logistics Branch (ANC45). The Strategic Logistics Branch 
(1) In collaboration with CDC, provides technical assistance to State, 
Local, Tribal, and Territorial (SLTT) partners to improve their medical 
countermeasure response capabilities; (2) performs analysis and 
assessment of public health supply chain functions to enhance 
operational efficiencies; (3) educates partners on Strategic National 
Stockpile activities and capabilities; (4) evaluates, analyzes, and 
develops supply chain processes or procedures and recommends 
enhancements or new procedures, as necessary; (5) plans, manages, 
coordinates, and evaluates DSNS functions associated with commercial 
supply chain collaboration and distribution; (6) analyzes manufacturer 
and commercial supply chain data to identify trends and obstacles to 
achieve MCM goals and operational requirements; (7) in collaboration 
with CDC and non-government experts, conducts analysis to evaluate 
medical countermeasure supply chain characteristics to determine supply 
chain capacity and probable areas of vulnerability; and (8) develops 
partnerships with associations, for-profit business, professional 
organizations and private groups to improve public access to medical 
countermeasures during a public health emergency.
    D. Deputy Assistant Secretary Incident Command and Control (ANG): 
The Deputy Assistant Secretary (DAS/ICC) is responsible for the policy 
development, planning analysis, requirements and strategic planning. 
DAS/ICC manages and operates the HHS Secretary's Operation Center 
(SOC), intelligence, security, information management and is also 
responsible for the HHS Continuity of Operations (COOP) and the 
development of the ASPR COOP Plan. The Office of the Assistant 
Secretary Incident Command and Control (DAS/ICC) is headed by the 
Deputy Assistant Secretary Incident Command and Control, and includes 
the following components:
     Office of Security Intelligence and Information Management
     Office of Strategy, Policy, Planning and Requirements
    III. Delegations of Authority. Delegations of authority made to 
officials and employees of affected organizational components will be 
established in them or their successors to be consistent with this 
reorganization.

    Dated: February 7, 2020.
Alex M. Azar II,
Secretary.
[FR Doc. 2020-02839 Filed 2-12-20; 8:45 am]
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