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Statement of Organization, Functions, and Delegations of Authority

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Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772-76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 70 FR 34772-34774, dated June 15, 2005) is amended to reflect the establishment of the Coordinating Officer for Terrorism Preparedness and Emergency Response.

After the mission statement for the Centers for Disease Control and Prevention (C), insert the following:

Coordinating Office for Terrorism Preparedness and Emergency Response (CG), The mission of the Coordinating Office for Terrorism and Preparedness and Emergency Response (COTPER) is to protect health and enhance the potential for full, satisfying and productive living across the lifespan of all people in all communities related to community preparedness and response. To carry out its mission COTPER (1) fosters collaborations, partnerships, integration, and resource leveraging to increase the Centers for Disease Control and Prevention's (CDC) health impact and achieve population health goals; (2) provides strategic direction to support CDC's terrorism preparedness and emergency response efforts; (3) manage CDC-wide preparedness and emergency response programs; (4) maintains concerted emergency response operations—including the Strategic National Stockpile and the Director's Emergency Operations Center; (5) communicates terrorism preparedness and emergency response activities to internal and external stakeholders.

Office of the Director (CGA). (1) Manages, directs, and coordinates the activities of the office; (2) coordinates CDC legislative agenda and activities related to public health preparedness and emergency response; (3) provides leadership in policy formation, program operations, strategic direction, and fiscal Start Printed Page 46528oversight; (4) identifies needs and resources for new initiatives and assigns responsibilities for their development; (5) serves as the principal CDC liaison to the Department of Health and Human Services as well as other federal agencies, international organizations, foreign governments and other organization concerned with terrorism preparedness and response; (6) directs and coordinates CDC and national activities to better prepare the public health workforce through training and education; (7) serves as the liaison from the Office of the Director, CDC, to the emergency operations of CDC; (8) coordinates CDC emergency operations; (9) serves as spokesperson for CDC policies and strategies regarding terrorism; (10) develops and maintains the CDC-wide Terrorism Preparedness and Response Strategic Plan; (11) coordinates CDC-wide terrorism budget formulation with the Financial Management Office, coordinating centers and coordinating offices, centers and staff offices; (12) develops and analyzes legislation and potential legislation for their impact on CDC and the nation's safety; (13) coordinates and provides on training and education programs, international activities, partnership and special projects related to terrorism.

Division of Business Services (CGB). The Division of Business Services (DBS) provides the coordinating office with a centralized business hub where customer service and business administration is the focal point of all business support functions. To carry out its mission, the division: (1) Develops and implements supplemental and/or unique to COPTER administrative policies and procedures that govern business administration, procurement practices, facilities management, time and attendance reporting, travel, records management, personnel and a wide scope of other business services; (2) plans, coordinates, tracks, and provides management advice and direction of fiscal management for the organization's annual budgets and spend plans; (3) provides consultation on human capital needs and facilitates hiring and training practices as described in the Office of Personnel Management and agency guidelines; (4) coordinates and manages all business services related to management, administration, and training for COPTER; (5) coordinates all issues related to physical security, telecommunications, office space and design, procurement of equipment, furniture, IT services, and facilities management; (6) provides assistance in formulating, developing, negotiating, managing, and administering various COPTER contracts; (7) coordinates and manages all controlled correspondence and Freedom of Information Act requests; (8) maintains liaison with the other offices within COPTER and other business services divisions within CDC and the Agency for Toxic Substances and Disease Registry.

Division of State and Local Readiness (CGC). The Division of State and Local Readiness provides support, technical guidance and fiscal oversight to State, local, and territorial public health department grantees for the development and enhancement of public health plans, infrastructure and systems to prepare for and respond to terrorism, outbreaks of disease, and other public health emergencies.

Office of the Director (CGC1). (1) Plans, directs, and evaluates the activities of the division; (2) develops goals and objectives and provides national leadership and guidance in public health preparedness policy formulation and program planning and development; (3) ensures multidisciplinary collaboration in State and local public health preparedness activities; (4) provides leadership and guidance in the development of training and educational programs; (5) coordinates the development of guidelines and standards to ensure ongoing, effective public health preparedness programs and their evaluations; (6) oversees the creation of programmatic materials, and ensures appropriate clearance of these materials; (7) assists in the preparation of speeches and Congressional testimony on State and local cooperative agreements and State and local preparedness for the division director, the center director, and other public health officials; (8) monitors divisional resource allocation and utilization in relation to State and local preparedness projects; (9) provides technical consultation and assistance to State and local health departments, community planning groups, and non-governmental and other prevention partners in operational aspects of public health preparedness.

Program Services Branch (CGCB). (1) Provides technical consultation and assistance to State and local health departments in operational aspects of public health preparedness, through coordination with multiple agency components; (2) facilitates linkages with public health preparedness programs at Federal, State, and local levels to ensure their readiness to respond to a terrorist event or other public health threats or emergencies; (3) monitors activities of cooperative agreement projects to assure program objectives and key performance indicators are achieved; (4) identifies and resolves problems in project areas through on-site program reviews; (5) identifies and promotes CDC recommendations, promising practices, and lessons learned; (6) conducts and coordinates technical reviews and provides funding recommendations related to cooperative agreement activities; (7) provides supervision for State and local public health preparedness field staff; (8) facilitates coordination within State/local project areas regarding preparedness activities with other program partners.

Outcome Monitoring and Evaluation Branch (CGCC). (1) Collaborates and consults with CDC staff, other Public Health Service agencies, State and local health departments, and other groups and organizations involved in preparedness activities to develop performance goals and indicators for readiness; (2) summarizes and synthesizes the preparedness research literature to derive research priorities and specify the characteristics of effective preparedness interventions; (3) conducts evaluation research activities to evaluate the effectiveness and impact of preparedness strategies and programs and development of both process and outcome measures that preparedness programs can use to assess their ongoing performance; (4) collects, analyzes, interprets and applies information to identify gaps in State and local public health preparedness; (5) disseminates guidance and recommendations in coordination with other OTPER/CDC coordinating centers and coordinating offices, centers and staff offices, partners and stakeholders to improve State and local preparedness; (6) monitors State and local achievement of public health preparedness performance measures; (7) develops and maintains a real-time management information system to monitor projects funded by the State and Local Preparedness Cooperative Agreement requirements.

Division of Strategic National Stockpile (CGE). The Division of Strategic National Stockpile (DSNS) delivers critical medical assets to the site of a national emergency. The Strategic National Stockpile (SNS) is a national repository of antibiotics, chemical antidotes, vaccines, antitoxins, life-support medications, intravenous administration and airway maintenance supplies, and medical/surgical items. It is designed to re-supply State and local public health agencies in the event of a biological and/or chemical terrorism incident anywhere, at anytime within the U.S. The DSNS ensures the availability and rapid deployment of the SNS and supports, guides, and advises Start Printed Page 46529on efforts by State and local governments to effectively manage and use SNS assets that may be deployed. The DSNS stands ready for immediate deployment to any U.S. location in the event of a terrorist attack using a biological or chemical agent, or in response to any natural or technological disaster as National Command Authority may direct.

Office of the Director (CGEI). (1) Conducts the executive planning and management of the division; (2) plans strategies and methods for educating the public health and emergency response communities about the SNS and its effective use; (3) represents the SNS in State, local, and federally sponsored exercises to test community response to chemical/nerve agent or bioterrorism event; (4) provides technical assistance to leaders in State and local governments in their planning and preparations to effectively manage and use SNS assets; (5) directs and monitors a comprehensive strategy for managing and executing the critical systems in operating a successful commercial good manufacturing practice compliance program; (6) supports and maintains an intragovernmental committee to advise CDC Director on SNS formulary; (7) provides medical, pharmaceutical, and scientific oversight of the SNS formulary.

Logistics Branch (CGEB). (1) Operationally defines requirements once they are established by the Office of the Director and the intra-governmental committee on the SNS formulary and ratified by CDC; (2) manages the procurement of medical materiel to meet requirements through the CDC Federal procurement partner for the DSNS; (3) manages and tracks the expenditure of DSNS funds for the procurement, storage, and transport of medical materiel assets; (4) supervises the storage of the SNS 12-hour Push Packages; (5) manages the development and oversight of contracts for Stockpile Managed Inventory (SMI) and Vendor Managed Inventory (VMI) with commercial manufacturers and distributors of medical materiel; (6) manages the rotation of freshness-dated products in the 12-hour Push Packages, in SMI, and in VMI; (7) coordinates the physical security and safety of SNS assets with all storage sites; (8) provides logistics expertise for the Technical Advisory Response Unit (TARU), in full exercises or upon a Federal deployment of the SNS that will accompany the SNS to the scene of the chemical/nerve agent or bioterrorism event as well as for the team staffing the DSNS Operations Center; (9) coordinates the recovery of unused SNS assets deployed in an actual chemical/nerve agent or bioterrorism event, including the recovery of SNS air cargo containers; (10) maintains the capacity to transport any and all SNS assets by overseeing contractual arrangements with commercial cargo carrier partners; (11) stores and maintains vaccines, therapeutic blood products, and antitoxins in selected repositories designated for managing and shipping these and other special medical countermeasures.

Program Preparedness Branch (CGEC). (1) Supervises the development, refinement, and dissemination of guidance for CDC project areas to plan for the management and use of deployed SNS assets and for building necessary infrastructure; (1) analyzes overall development needs of personnel in State/local SNS Preparedness Programs and creates, implements, directs, reviews, and manages training and other developmental activities designed to meet those needs; (3) manages coordination with project area officials on the planning and execution of both tabletop and full exercises to test the function teams and the entire contingent organization created for SNS preparedness; (4) collaborates with the Division of State and Local Readiness in COTPER by providing support for their responsibilities as project officers relative to the SNS Preparedness component of the CDC Bioterrorism Preparedness cooperative agreement; (5) evaluates readiness of each of the 62 CDC Bioterrorism Preparedness project areas to effectively manage and use deployed SNS assets; (6) plans, designs and prepares SNS-related communications and educational materials in support of State/local SNS Preparedness Programs; (7) provides health communication products before, during, and after an event to assist State/local SNS Preparedness Program personnel and other public health officials deal with the public; (8) serves as the DSNS point of contact for collaboration with various Federal agencies and nongovernmental organizations (e.g., Association of State and Territorial Health Organizations, National Association of City and County Health Officials) on programmatic initiatives and issues affecting State/local SNS preparedness; (9) reviews and comments on SNS-specific components of applications submitted for CDC Bioterrorism Preparedness cooperative agreements; (10) collaborates with the DSNS Response Branch on the CHEMPACK project, and other special projects, to ensure smooth implementation and successful ongoing performance; (11) develops, in collaboration with various contractors, the Department of Defense, and universities, models for use by Project Areas in implementing elements of the SNS Program.

Program Coordination Branch (CGED). (1) Interfaces with external agencies and organizations with interest and involvement in SNS activities and information; (2) manages the development of program policies and procedures and performance of periodic analysis of existing policies to assess compliance and requirements; (3) supervises the SNS Training Steering Committee that identifies, prioritizes, coordinates, and recommends internal and external training needs and events; (4) supervises the Stockpile Configuration Management Board that reviews, reconciles, and adjusts SNS package and kit design and contents to maintain consistency with medical, scientific, resource, and end user requirements; (5) manages day-to-day execution of a commercial good manufacturing practice compliance program in support of the Director; (6) supervises all aspects of asset (material and personnel) safeguarding and protection; (7) manages development, testing, implementation, training, and operation of the DSNS unique information management systems and technology; (8) manages the DSNS internal review program; (9) provides project management for new missions and initiatives within the DSNS.

Response Branch (CGEE). (1) Plans and manages response operations during both day-to-day operations and activation in response to emergencies; (2) manages continuity of operations of operations centers to ensure effective response operations should any adversity affect the capability of the DSNS primary operations center; (3) supervises the development, coordination, maintenance, and exercise of DSNS response and deployment plans; (4) manages the planning, coordination, and conduct of the SNS Technical Advisory Response Unit (TARU) Academy to train staff for duties on this immediate response team that deploys with SNS assets; (5) manages the planning, coordination, and conduct of the SNS Mobile Training Teams to train State and local SNS Preparedness Program personnel, in collaboration with other DSNS branches and teams; (6) manages the coordination, planning, and conduct of DSNS participation and support for Federal, State, and local exercises; (7) supervises the preparation and readiness of the Technical Advisory Response Unit (TARU) to respond to emergencies; (8) provides operations Start Printed Page 46530and communications expertise for the TARU, in full exercises or upon a Federal deployment of the SNS, that accompanies the SNS to the scene of the chemical/nerve agent or bioterrorism events.

Division of Select Agents and Toxins (CGF). The Division of Select Agents and Toxins ensures the safe and secure possession, use, transfer, and storage of select agents and toxins in the United States of America. This mission is achieved by establishing, monitoring and enforcing regulations, and by collaborating with partners from other agencies and professional associations. To carry out its mission, the division: (1) Registers all laboratories, institutes and other facilities that possess select agents or toxins; (2) establish and maintains a national database of all entities that possess select agents; (3) receives and review entity applications; (4) inspects laboratory facilities (entities) to ensure that required bio-safety and bio-security requirements are met; (5) approves all select agents or toxin transfers; (6) receives and monitorings all reports on theft, loss, or release of a select agent or toxin; (7) partners with other government agencies, public health organizations, and registered entities to ensure compliance with the Select Agent Regulations; (8) develops and implements appropriate policies or regulations to ensure the safety and security of select agents and toxins; (9) issues permits for the importation of etiologic agents and hosts of vectors of human diseases.

Division of Emergency Operations (OGG). The Division of Emergency Operations (DEO) provides operational, administrative and logistical support to all coordinating centers and coordination offices, centers and staff officers in respondent to public health events and is CDC's focal point for the consideration of plans, training (emergency response) and exercises that are conducted at the national, Federal and collective CDC level. To carry out it mission, the division: (1) Oversees the operational, administrative and communications functions of a state of the art emergency operations center on a 24 hours, 7 days a week basis; (2) collaborates with lead coordinating centers and coordination offices, centers and staff offices to deploy personnel, gathers and prepared situations reports, analyses, and disseminates information; (3) coordinates the use of resources from the coordination centers and coordinating offices, centers and staff offices to oversee the delivery of initial and prolonged emergency management consultative services to States and localities experiencing public health emergencies or other Federal and international agencies supporting them; (4) establishes and monitoring external coordination and communications with other CDC organization components, including the Department of Health and Human Services Secretary's Operations Center, and other Federal agencies operations centers including the Homeland Security Operations Center of the Department of Homeland Security, and other Federal agencies; as appropriate; (5) coordinates the training of deploying CDC staff and tracks their locations and mission activities during a deployment; (6) procures and maintains supplies, services and equipment in response to emergency deployment operations and coordinates equipment and personnel movement; (7) coordinates and tracks specimen and other hazardous cargo shipments including all CDC medical evacuation mission involving the movement of suspected infectious and contagious patients; (8) provides deployment support of 24 hours a days, 7 ways a week (travel orders, equipment, etc.) and tracks the expenditure of funds for CDC personnel responding to emergency deployments; (9) manages the operations and use of the CDC aircraft; (10) provides a public health logistics capability to respond to natural and man-made disasters in foreign countries/U.S. territories.

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Dated: July 28, 2005.

William H. Gimson,

Chief Operating Officer, Centers for Disease Control and Prevention (CDC).

End Signature End Preamble

[FR Doc. 05-15798 Filed 8-9-05; 8:45 am]