Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Office of the Secretary

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                           ( print 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