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, as last amended at 70 FR 5183-5184, dated February 1, 2005. This organizational change is primarily to realign the functions of OPHEP to more clearly delineate responsibilities for the various activities associated with advanced research and development and acquisition of medical countermeasures and emergency preparedness and response. 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:
Section AN.00 Mission: On behalf of the Secretary, the Office of Public Health Emergency Preparedness (OPHEP) leads the Federal public health and medical response to acts of terrorism or nature, and other public health and medical emergencies. OPHEP is a component of the Public Health Service (PHS) and is responsible for ensuring a One-Deparmtent approach to developing public health and medical preparedness and response capabilities and leading and coordinating the relevant activities of the HHS Operating Division (OPDIV). The principal areas of program emphasis are (1) enhancement of State and local public health and medical preparedness—primarily health departments and hospitals; (2) development and use of National and Departmental policies and plans relating to the response to public health and medical threats and emergencies (e.g., Emergency Support Function (ESF) 8 of the National Response Plan (NRP), Homeland Security Presidential Directives (HSPD) 5 and 10, HHS's Concept of Operations Plans (CONOPS) for Public Health and Medical Emergencies and for the Incident Response Coordination Team (IRCT)); (3) coordination with relevant entities inside and outside HHS such as State, local and Tribal public health and medical officials, the private sector, the Departments of Homeland Security (DHS), Defense (DOD), Veterans Affairs (VA), Justice (DOJ), the Homeland Security Council (HSC) and National Security Council (NSC), other ESF 8 partner organizations and others within the National security community; (4) rapid public health and medical support to Federal, State, local and Tribal governments who may be responding to incidents of national significance or public health and medical emergencies; (5) coordination, support of, and participation in research, development and procurement activities related to public health emergency medical countermeasures destined for the Strategic National Stockpile, including under Project BioShield; (6) leadership in international programs, initiatives, and policies that deal with public health and medical emergency preparedness and response related to naturally occurring threats such as infectious deceases and deliberate threats from biologic, chemical, nuclear and radiation sources and (7) leadership and oversight on medical, science, and public health policies, issues, and programs.
Section 10.AN Organization: OPHEP is headed by the Assistant Secretary for Public Health Emergency Preparedness (ASPHEP), who reports directly to the Secretary, and includes the following components:
1. Immediate Office of the ASPHEP (ANA)
2. Office of the Public Health Emergency Medical Countermeasures (ANB)
3. Office of Preparedness and Emergency Operations (ANC)
4. Office of Medicine, Science and Public Health (ANF)
5. Office of Policy and Strategic Planning (ANE)
Section 20.AN Functions:
1. Immediate Office of the ASPHEP (ANA). The Immediate Office of the ASPHEP (IO/ASPHEP) provides executive and administrative direction to all OHEP components. The ASPHEP is the principal advisor to the Secretary on matters relating to public health and medical emergencies, whether resulting from acts of nature, accidents, or terrorism. The ASPHEP coordinates interagency interfaces between HHS, the Homeland Security Council, the National Security Council, other Federal Departments and Agencies, State, local and Tribal public health and medical Start Printed Page 38404entities and the private sector. The ASPHEP directs and coordinates the Department's activities relating to protecting the U.S. population from acts of terrorism and other public health and medical threats and emergencies. The ASPHEP provides leadership in the coordination of activities for public health and medical emergency preparedness and represents the Department in working closely with DHS, DOD, VA, and other Federal Departments and Agencies.
2. Office of Public Health Emergency Medical Countermeasures (ANB). The Office of Public Health Emergency Medical Countermeasures (OPHEMC) is headed by a Director and is responsible for coordination of the Public Health Medical Countermeasures Enterprise (PHMCE). The PHMCE is a coordinated interagency effort to: (1) Define and prioritize requirements for public health medical emergency countermeasures, (2) coordinate research, early and late stage product development and procurement activities addressing the requirements and (3) set deployment and use strategies for medical countermeasures held in the Strategic National Stockpile.
OPHEMC undertakes public health modeling of population exposures to assist in determining requirements and assessing deployment and utilization strategies, supports late-stage medical countermeasure research and development to address prioritized requirements for addressing the health effects of naturally-occurring infectious diseases and deliberately released biologic, and chemical and radiation threats that could cause a public health emergency, facilitates collaboration among the Department of Health and Human Services agencies, relevant industries, academia, and others with respect to advanced product research and development, facilitates contacts between interested persons and companies interested in requirements set by the Food and Drug Administration regarding such products, and procures targeted medical countermeasures destined for the Strategic National Stockpile, including vaccines, antivirals, and diagnostics for pandemic preparedness authorized under the Project BioShield Act of 2004 (Pub. L. 108-276). OPHEMC is responsible for coordinating, supporting, and providing leadership and expert advice with respect to a public health medical countermeasure late stage advanced development and procurement. OPHEMC supports the ASPHEP by working with all scientific agencies of the Department, including the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), as well as other Governmental, private ,and nonprofit scientific entities.
3. Office of Preparedness and Emergency Operations (ANC). The Office of Preparedness and Emergency Operations (OPEO) is headed by a Director and is responsible for developing operational plans, analytical products, and developing and participating in training and exercises to ensure the preparedness of the Office, the Department, the Government and the public to respond to domestic and international public health and medical threats and emergencies. OPEO is also responsible for ensuring that OPHEP has the systems, logistical support and procedures necessary to coordinate the Department's operational response to acts of terrorism and other public health and medical threats and emergencies. OPEO leads the HHS and interagency planning and response activities required to fulfill HHS responsibilities under ESF #8 of the NRP and HSPD #10. OPEO manages the Secretary's Operations Center (SOC); trains and manages the Incident Response Coordination Team (IRCT); plans, implements, and evaluates Departmental and interagency response exercises and the HHS Continuity of Operations (COOP) and Continuity of Government (COG) programs. OPEO maintains a regional planning and response coordination capability. OPEO has operational responsibility for HHS functions related to the National Disaster Medical Systems (NDMS) and is also the primary operational liaison to emergency response entities within HHS (e.g., FDA, HRSA, SAMHSA, CDC), within the interagency community (e.g., HDS, VA, DoD), and the public. OPEO manages the continued planning for capabilities to meet public health and medical response missions, including development of Federal Medical Stations (FMS) and other mobile medical units. OPEO works to integrate mass casualty preparedness activities, through its surge capacity efforts, across local, State and Federal levels consistent with the National Incident Management System (NIMS) and the National Response Plan Catastrophic Incident Annex. In collaboration with DHS, OPEO coordinates preparedness grant activities across the Department in compliance with HSPD 8 and the National Preparedness Goal. OPEO is the primary OPHEP liaison with the Health Resources and Services Administration (HRSA) regarding its programs for hospital bioterrorism preparedness, volunteer health professionals and terrorism-related preparedness and response education and training for health care professionals. OPEO coordinates with CDC on public health preparedness issues and consults with the HHS scientific community on the inclusion of newly acquired countermeasures into response plans.
4. Office of Medicine, Science and Public Health (ANF). The Office of Medicine, Science and Public Health (OMSPH) is headed by a Director and is responsible for providing expert medical, scientific, and public health advice on domestic and international medical preparedness policies, programs, initiatives, and activities of OPHEP. OMSPH serves as the OPHEP liaison to health and science professional organizations for domestic and international issues. OMSPH carries out special scientific and public health related projects directly and works with others to establish activities, programs, policies, and standards to protect the public from acts of terrorism, naturally occurring infectious disease threats, and other natural or man-made public health threats. OMSPH coordinates OPHEP's overall influenza pandemic effort and works closely with HHS components (e.g., National Vaccine Program Office, Office of Global Health Affairs, CDC, NIH, and FDA), and other agencies and offices such as the Department of State, the U.S. Department of Agriculture (USDA) and the World Health Organization (WHO) to ensure that programs and plans for dealing with avian influenza and pandemic influenza are as effective as possible. OMSPH oversees the development of medical policies related to providing access to medical products, including those needed on an emergency basis as medical countermeasures to counteract terrorism or naturally occurring biological, chemical or radiological/nuclear threats. These policies and their implementation include use of investigational and emergency use authorities. OMSPH serves as the focal point in HHS for biosafety, biosecurity and dual use technology issues and is the liaison to the National Science Advisory Board on Biosecurity and to the State Department on the Biological and Chemical Weapons Convention. In addition to domestic issues and programs, OMSPH is the OPHEP focal point for all international activities related to public heath emergency preparedness. OMSPH supports the Early Warning Infectious Disease Surveillance (EWIDS) program at the national borders with Mexico and Start Printed Page 38405Canada and works with other nations and multilateral organizations (e.g., WHO) in combating public health threats, emergencies, and bioterrorism by establishing bilateral and multilateral international arrangements to develop early warning surveillance and response capability for infectious disease outbreaks, including those involving potential bioterrorism agents. OMSPH provides leadership in the activities of the regional and multilateral groups including the Global Health Security Action Group (GHSAG) and the Security and Prosperity Partnership (SPP) and the implementation of the WHO International Health Regulations (IHR), in coordination with the Office of Global Health Affairs.
5. Office of Policy and Strategic Planning (ANE). The Office of Policy and Strategic Planning (OPSP) is headed by a Director and is responsible for policy formulation, analysis, coordination, and evaluation for preparedness, response, and strategic planning. In coordination with other OPHEP and Departmental offices, OPSP analyzes proposed policies, Presidential directives and regulations. OPSP also develops short and long-term policy and strategic objectives for OPHEP, and leads in the development and implementation of an integrated OPHEP approach to policy, strategy, and long-term, planning processes. On behalf of the ASPHEP, OPSP serves as the focal point for HSC/NSC policy coordination activities and represent the ASPHEP, as appropriate, in interagency meetings. The office undertakes studies of preparedness and response issues, identifying gaps in policy, and initiating policy planning and formulation to fill these gaps. OPSP takers the lead on special projects, initiatives, and policy analysis and evaluation as tasked by the ASPHEP.
II. Continuation of Policy: Except as inconsistent with this reorganization, all statements of policy and interpretations with respect to the Office of Public Health Emergency Preparedness heretofore issued and in effect prior to the date of this reorganization are continued in full force and effect.
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.
IV. Funds, Personnel and Equipment: Transfer of organizations and functions affected by this reorganization shall be accompanied in each instance by direct and support funds, positions, personnel, records, equipment and other resources.Start Signature
Dated: June 27, 2006.
Assistant Secretary for Administration and Management.
[FR Doc. 06-6004 Filed 7-5-06; 8:45 am]
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