[Federal Register Volume 75, Number 118 (Monday, June 21, 2010)]
[Notices]
[Pages 35035-35038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-14997]


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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 Public 
Health Emergency Preparedness (OPHEP), as last amended at 71 FR 38403-
05 dated July 6, 2006. This organizational change is to retitle the 
OPHEP as the Office of the Assistant Secretary for Preparedness and 
Response (ASPR), and to realign the functions of ASPR to reflect the 
changes mandated by the Pandemic and All-Hazards Preparedness Act (Pub. 
L. 109-417) (PAHPA). The changes are as follows.
    I. Under Part A, Chapter AN, ``Office of Public Health Emergency 
Preparedness (AN),'' delete in its entirety and replace with the 
following:

CHAPTER AN: Office of the Assistant Secretary for Preparedness and 
Response

AN.00 Mission
AN.10 Organization
AN.20 Functions

[[Page 35036]]

Section AN.00 Mission

    On behalf of the Secretary of HHS, the Assistant Secretary for 
Preparedness and Response (ASPR) serves as the principal advisor on all 
matters related to Federal public health and medical preparedness and 
response for public health emergencies. The ASPR serves as the primary 
advisor to the Secretary of HHS for national public health and medical 
preparedness, including Emergency Support Function 8 (ESF 8). 
Furthermore, the ASPR exercises the responsibilities of the Secretary 
with respect to direction of ESF 8 activities, and coordination of HHS 
assets in accord with the PAHPA, including the Strategic National 
Stockpile (SNS) and the Cities Readiness Initiative (CRI).
    ASPR leads the Federal public health and medical response to acts 
of terrorism, nature, and other public health and medical emergencies; 
coordinates the development and implementation of national policies and 
plans related to public health and medical preparedness and response; 
oversees the advanced research, development, and procurement of 
qualified countermeasures and qualified pandemic or epidemic products; 
coordinates services for at-risk individuals, preparedness planning, 
and response efforts; and provides guidance in international programs, 
initiatives, and policies that deal with public health and medical 
emergency preparedness and response. ASPR is responsible for ensuring a 
consolidated approach to developing public health and medical 
preparedness and response capabilities and leading and coordinating the 
relevant activities of the HHS Operating Divisions (OPDIVs) and Staff 
Divisions (STAFFDIVs).
    The Office of the ASPR is charged with strategic and operational 
responsibilities for medical and public health preparedness and 
response. The Immediate Office of the ASPR provides staff guidance to 
maximize operational effectiveness and is responsible for reviewing 
staff recommendations of policies developed to further the ASPR and HHS 
mission.
    Strategic responsibilities include policy development and 
implementation, oversight of the National Health Security Strategy, and 
coordination across HHS, with other Federal agencies, and state, local 
and private sector entities. The ASPR is the primary HHS liaison to and 
leads coordination of Homeland and National Security Councils' policy 
initiatives and is responsible for the integration of national public 
health and medical preparedness and response efforts into the Federal 
interagency planning and policy processes.
    Operational responsibilities include (but are not limited to) the 
following:
     Serves as the Incident Manager for ESF 8 during 
activations;
     Directs and coordinates the development of ESF 8 
Playbooks, Concepts of Operations (CONOPS), Operating Plans (OPLANS), 
and other planning or procedural documents that set forth how HHS 
response assets are to be employed in various emergency contexts;
     Coordinates preparedness and response planning with state, 
local, and private sector entities in furtherance of the National ESF 8 
mission;
     Assures that planning and procedural documents make 
explicit the respective roles of ASPR Headquarters staff, ASPR Regional 
Emergency Coordinators, the ASPR field incident management teams, HHS 
Secretary's Operations Center (SOC), Centers for Disease Control and 
Prevention (CDC) Headquarters staff, the Director's Emergency 
Operations Center, Federal Emergency Management Agency (FEMA) 
Operations Center, Department of Homeland Security (DHS) National SOC, 
CDC field staff such as SNS consultants, and other HHS division 
response assets;
     Assures clarity in state ESF 8 planning by convening state 
ESF 8 planning meetings with the Department of State, ASPR, CDC, and 
other organizations as necessary to ensure medical, public health, and 
human service functions are integrated;
     Manages the Hospital Preparedness Program (HPP) 
Cooperative Agreement, which provides financial and technical support 
for medical preparedness to health care facilities throughout the 
country;
     Facilitates HHS participation in development of 
International Health Regulations (IHR);
     Manages the National Disaster Medical System (NDMS);
     Manages the Biomedical Advanced Research and Development 
Authority (BARDA); and
     Manages and operates the HHS SOC.

Section AN.10 Organization

    The Office of the Assistant Secretary for Preparedness and Response 
is headed by the Assistant Secretary for Preparedness and Response 
(ASPR), who reports directly to the Secretary, and includes the 
following components:
     Immediate Office/Chief Operating Officer (ANA)
     Office of Biomedical Advanced Research and Development 
Authority (ANB)
     Office of Preparedness and Emergency Operations (ANC)
     Office of Acquisitions Management, Contracts, and Grants 
(AND)
     Office of Policy and Planning (ANE)
     Office of Financial Planning and Analysis (ANF)

Section AN.20 Functions

    A. Immediate Office/Chief Operating Officer (ANA). The Immediate 
Office (IO) develops and maintains liaison relationships with HHS 
operating and staff divisions and represents HHS at interagency 
meetings, as required. The IO provides information to those individuals 
and organizations that inquire about or express interest in ASPR. The 
IO establishes and maintains effective communications to advise mid- 
and long-range plans to emphasize recent or forthcoming changes in 
plans and regulations, to receive effective feedback; and explore ways 
to implement suggestions for improved business operations and 
performance. The IO is responsible for the direction of executive level 
business management operations and managing division staff 
coordination. The IO is responsible for the timely and quality 
execution of all management related matters under the ASPR mission. The 
IO provides staff guidance to maximize operational effectiveness. The 
IO is responsible for reviewing staff recommendations of policies 
developed to further the ASPR and HHS mission. The IO staff considers 
the potential impact of political, social, economic, technical, and 
administrative factors on the recommended policies and formally 
recommends actions on approving/disapproving policies to the ASPR.
    The Immediate Office/Chief Operating Officer (ANA) includes the 
following components:
     Division of Administrative Management (ANA1)
     Division of Communications (ANA2)
     Division of Legislative Coordination (ANA3)
     Division of Workforce Development (ANA4)
     Division of Executive Secretariat (ANA5)
    The Immediate Office/Chief Operating Officer provides for the 
facility, logistics, and infrastructure support services necessary to 
maintain day-to-day operations of ASPR; the office provides 
communication and outreach guidance and support for all external 
communications, including legislative and executive branch questions 
and

[[Page 35037]]

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 the PAHPA. Furthermore, the Office covers the functions 
of Human Resources, Organization and Employee Development, Ethics, and 
United States Public Health Service (USPHS) Liaison, and develops and 
maintains liaison relationships with HHS OPDIVs and STAFFDIVs. The 
Chief Operating Officer manages correspondence control for the 
Assistant Secretary. In addition, the office provides oversight in the 
development and operation of tracking systems, which are designed to 
identify and resolve early warnings and bottleneck problems with 
executive correspondence.
    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 medical countermeasures and expanding domestic 
manufacturing infrastructure and surge capacity of these medical 
countermeasures.
    BARDA is headed by a Deputy Assistant Secretary, and includes the 
following components:
     Division of Influenza (ANB1)
     Division of Emerging Infectious Diseases (ANB2)
     Division of Chemical, Biological, Radiological and Nuclear 
Threats (ANB3)
     Division of Strategic Science and Technology (ANB4)
     Division of Regulatory and Quality Affairs (ANB5)
    C. Office of Preparedness and Emergency Operations (ANC). The 
Office of Preparedness and Emergency Operations (OPEO) 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. 
OPEO leads the preparedness and response activities required to 
coordinate public health and medical response systems and activities 
with relevant Federal, state, Tribal, Territorial, local, and 
international communities under ESF 8, ESF 6 and ESF 14 of the NRF. 
OPEO is also responsible for the HHS Continuity of Operations (COOP) 
and the development of the ASPR COOP Plan.
    The Office of Preparedness and Emergency Operations (OPEO) is 
headed by a Deputy Assistant Secretary, and includes the following 
components:
     Division of Mass Care (ANC1)
     Division of Operations (ANC2)
     Division of Planning (ANC3)
     Division of Infrastructure Coordination (ANC4)
     Division of Emergency Care Coordination Center (ECCC) 
(ANC5)
     Division of National Disaster Medical System (NDMS) (ANC6)
    D. Office of Acquisitions Management, Contracts and Grants (AND). 
The Office of Acquisitions Management, Contracts and Grants (AMCG) 
provides ASPR with acquisition support to prepare and respond to the 
adverse health emergencies and disasters and provides contractual 
support to the Immediate Office of the ASPR, BARDA, Office of Policy 
and Planning (OPP), and Office of Financial Planning and Analysis 
(FPA). The office focuses on providing acquisition and contractual 
support to BARDA in two specific program divisions: Chemical, 
Biological, Radiological, and Nuclear Threats (CBRNT) and Influenza 
(Flu). The Division of Acquisition Programs Support (APS) provides a 
wide range of program management support to the ASPR as well as direct 
program support to the following BARDA divisions--CBRN, Influenza, 
Emerging Infectious Diseases, and Strategic Science and Technology. 
Functional support activities of the Office include requirements 
analysis for statement of work/statement of operations development, 
acquisition strategy development and tracking assistance to include 
contractual milestone development with measurable success criteria. The 
office also serves as ASPR's focal point for management, leadership and 
administration of discretionary and mandatory grants and cooperative 
agreements.
    The Office of Acquisitions Management, Contracts and Grants (AMCG) 
is headed by a Director, and includes the following components:
     Division of ASPR Support (AND1)
     Division of BARDA Support (AND2)
     Division of Acquisition Programs Support (AND3)
     Division of Grants Management (AND4)
     Division of Acquisition Policy (AND5)
    E. Office of Policy and Planning (ANE). The Office of Policy and 
Planning (OPP) is responsible for policy development, analysis and 
coordination, research and evaluation, and strategic planning. The OPP: 
(1) Analyzes proposed policies, Presidential Directives, and 
regulations, and develops short- and long-term policy objectives for 
ASPR; (2) leads the development and implementation of an integrated 
ASPR approach to policy; (3) serves as the focal point for the Homeland 
Security Council (HSC) and the National Security Council (NSC) policy 
coordination activities on behalf of ASPR and represents the ASPR, as 
appropriate, in interagency policy coordination meetings and 
activities; (4) undertakes studies of preparedness and response issues, 
identifying gaps in policy, and initiating policy planning and 
formulation to fill these gaps; (5) leads in the implementation of the 
PAHPA and is responsible for developing the quadrennial National Health 
Security Strategy and implementation plan for public health emergency 
preparedness and response; (6) develops strategic partnerships with 
stakeholders and leads in the development of ASPR strategies for 
knowledge and information management; (7) manages the development of 
the ASPR strategic plan, annual plan, and balanced scorecard, and 
compiles the ASPR Organizational Assessment by tracking Key Performance 
Indicators as part of the ASPR strategic management system; (8) 
develops and maintains liaison relationships with strategic planning 
personnel of HHS and ESF 8 partner organizations; and (9) manages 
strategic planning program objectives to ensure programs are consistent 
with ASPR goals and monitors program development to make sure that 
timelines are met accordingly.
    OPP is headed by a Deputy Assistant Secretary and includes the 
following components:
     Division of Policy and Strategic Planning (ANE1)
     Division of Medical Countermeasures Policy and Planning 
(ANE2)
     Division of Health Systems Policy (ANE3)
     Division of International Health (ANE4)
     Division of Biosecurity/Biosafety/Countering Biologic 
Threats (ANE5)
    F. Office of Financial Planning and Analysis (ANF). The Office of 
Financial Planning and Analysis (OFPA) ensures that ASPR's financial 
resources are aligned to its strategic priorities. OFPA carries out its 
responsibilities by

[[Page 35038]]

formulating, monitoring, and evaluating ASPR budgets and financial 
plans that support program activities and ensures the effective and 
efficient execution of ASPR financial resources. OFPA has 
administrative oversight of the Administration & Finance section of the 
emergency management group that is activated under ESF 8 of the NRF 
during a public health emergency. On behalf of the ASPR, OFPA serves as 
the primary point of contact with the Office of the Assistant Secretary 
for Financial Resources, the Office of Management and Budget (OMB) and 
Congressional Appropriation Committees. In compliance with OMB Circular 
A-123, FPA ensures accountability and effectiveness of ASPR's financial 
programs and operations by establishing, assessing, correcting, and 
reporting on internal controls.
    The Office of Financial Planning and Analysis is headed by a 
Director and includes the following components:
     Division of Budget Formulation and Execution (ANF1)
     Division of Requisition Services (ANF2)
     Division of Management Assurance (ANF3)
     Division of Administration and Finance (ANF4)
    II. 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.

    Dated: June 14, 2010.
E.J. Holland, Jr.,
Assistant Secretary for Administration.
[FR Doc. 2010-14997 Filed 6-18-10; 8:45 am]
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