2010-14997. 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

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 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 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.