[Federal Register Volume 71, Number 129 (Thursday, July 6, 2006)]
[Notices]
[Pages 38403-38405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-6004]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary


Office of Public Health Emergency Preparedness; 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, 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

[[Page 38404]]

entities 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

[[Page 38405]]

Canada 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.

    Dated: June 27, 2006.
Joe Ellis,
Assistant Secretary for Administration and Management.
[FR Doc. 06-6004 Filed 7-5-06; 8:45 am]
BILLING CODE 4150-37-M