[Federal Register Volume 70, Number 20 (Tuesday, February 1, 2005)]
[Notices]
[Pages 5183-5184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-1813]


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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 69 FR 51679-51680, 
dated August 20, 2004. This organizational change is primarily to 
realign the functions of OPHEP to more clearly delineate 
responsibilities for the various activities associated with emergency 
preparedness and response. This includes the designation by the 
President that HHS is the principal Federal agency for planning and 
coordinating response to mass casualty incidents. Also, on behalf of 
HHS, OPHEP will develop and implement policies and procedures with 
respect to physical and information security. 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) directs and coordinates 
HHS-wide efforts with respect to preparedness for and response to 
bioterrorism and other public health and medical emergencies. OPHEP is 
an office of the Public Health Service (PHS) and is responsible for 
ensuring a ``One-Department'' approach to developing such preparedness 
and response capabilities and directing and coordinating the relevant 
activities of the HHS Operation Divisions (OPDIV). The principal areas 
of program emphasis are (1) enhancement of State and local 
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 Plan for 
Public Health and Medical Emergencies (CONOPS) and the Secretary's 
Emergency Response Team (SERT) System Description); (3) coordination 
with relevant entities inside and outside HHS such as State, local and 
Tribal public health and medical officials, the Departments of Homeland 
Security (DHS), Defense (DOD), Veterans Affairs (VA), Justice (DOJ), 
the Homeland Security Council (HSC), other ESF 8 partner 
organizations and others within the National security community; and 
(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 emergencies.
    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:
     Immediate Office of the ASPHEP (ANA).
     Office of Research and Development Coordination (ANB).
     Office of Mass Casualty Planning (ANC).
     Office of Emergency Operations and Security Programs 
(ANE).
     Office of Medicine, Science and Public Health (ANF).
    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 OPHEP components; coordinates and assists in the development of 
training programs and standards to prepare Federal agencies to deal 
with the public health and medical response to emergencies; and 
represents the ASPHEP at interagency and HSC policy coordination 
meetings. The ASPHEP is the principal advisor to the Secretary on 
matters relating to bioterrorism and other public health and medical 
emergencies. The ASPHEP coordinates interagency interfaces between HHS 
and other Federal Departments and Agencies, State, local and Tribal 
public health and medical entities. The ASPHEP directs the Department's 
activities relating to protecting the U.S. population from acts of 
bioterrorism 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 matters 
internal to the Office of the Secretary and represents the Department 
in working closely with DHS and other Federal Departments and Agencies.
    2. Office of Research and Development Coordination (ANB). The 
Office of Research and Development Coordination (ORDC) is headed by a 
Director and is responsible for

[[Page 5184]]

coordinating research and development toward new vaccines, diagnostics, 
and drug related to the pathogenic organisms most likely to be used in 
a terrorist attack on the U.S. homeland. A key function of ORDC is to 
direct and coordinate Project BioShield activities related to the 
advanced development and acquisition of vaccines and other 
pharmaceuticals to be included in the Strategic National Stockpile 
(SNS). ORDC supports the ASPHEP by working with all scientific agencies 
of the Department, including the National Institutes of Health (NIH), 
the Center for Disease Control and Prevention (CDC), the Food and Drug 
Administration (FDA), as well as other Government, private, and non-
profit scientific entities.
    3. Office of Mass Casualty Planning (ANC). The Office of Mass 
Casualty Planning (OMCP) is headed by a Director and is responsible for 
developing policies, plans, and analytical products that ensure the 
readiness of the office, the Department and the Government to respond 
to public health and medical threats and emergencies. OMCP leads the 
planning activities required to fulfill HHS responsibilities under ESF 
8 of the NRP and HSPD 10. OMCP manages the continuing 
development of Public Health Service Catastrophe Contingency Care 
(PHSC3) mobile medical units. OMCP also acquires physical response 
assets (e.g., medical equipment and supplies) for Federal Government 
public health and medical preparedness and response activities relevant 
to catastrophic public health and medical emergency preparedness. OMCP 
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). OMCP 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 
education and training for health care professionals.
    4. Office of Emergency Operations and Security Programs (ANE). The 
Office of Emergency and Security Programs. (OEOSP) is headed by a 
Director and is responsible for ensuring that OPHEP has the systems and 
processes necessary to coordinate the Department's response to 
bioterrorism and other public health and medical threats and 
emergencies. OEOSP leads the response activities required to fulfill 
HHS responsibilities under ESF 8 of the NRP. OEOSP develops 
and directs the Secretary's Operations Center (SOC); trains and manages 
the Secretary's Emergency Response Team (SERT); coordinates and 
executes the HHS Continuity of Operations (COOP) and Continuity of 
Government (COG) programs; plans, implements and evaluates Departmental 
and interagency response exercises; and develops security related 
policies establishing procedures to manage the Department's risks, 
threats and vulnerabilities. OEOSP also is the primary operational 
liaison to emergency response entities within HHS (e.g., the Substance 
Abuse and Mental Health Services Administration (SAMHSA) CDC, FDA, and 
HRSA) and within the interagency community (e.g., DHS, DOD, VA).
    5. 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 leadership and direction with respect 
to the analysis, review and advice on medical preparedness programs, 
policies, initiatives, and activities of OPHEP. OMSPH serves as the 
OPHEP focal point for all international activities related to public 
health emergency preparedness. OMSPH coordinates OPHEP's overall 
influenza pandemic effort and works closely with HHS components (e.g., 
CDC, NIH, FDA), the Department of State, the U.S. Department of 
Agriculture (USDA) and the World Health Organization (WHO) to ensure 
that programs for dealing with avian influenza and plans for dealing 
with pandemic influenza are as effective as possible. OMSPH oversees 
the development of medical policies related to providing access to 
medical products that have not been approved for marketing in the U.S. 
but must be made available 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 using procedures associated with the 
investigational new drug (IND) and Emergency Use Authorization 
authorities. OMSPH also carries out special scientific and public 
health oriented projects directly and works with others to establish 
activities, programs, and standards to protect the public from 
bioterrorism and naturally occurring infectious disease threats. OMSPH 
works with other nations and multilateral organizations in combating 
public health threats, emergencies, and bioterrorism by establishing 
bilateral and multi-national international partnerships to develop 
early warning surveillance capability for infectious disease outbreaks, 
including those involving potential bioterrorism agents. OMSPH also 
provides HHS leadership in the activities of the Biological Weapon 
Convention and the Global Health Security Action Group. In coordination 
with the Office of Global Health Affairs (OGHA), OMSPH provides 
leadership in coordinating U.S. government activities related to the 
WHO International Health Regulations (IHR).
    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: January 25, 2005.
Ed Sontag,
Assistant Secretary for Administration.
[FR Doc. 05-1813 Filed 1-31-05; 8:45 am]
BILLING CODE 4150-03-M