2010-6372. Statement of Organization, Functions, and Delegations of Authority

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 75 FR 10296, dated March 5, 2010) is amended to reflect the reorganization of the Office of Public Health Preparedness and Response, Office of the Director, Centers for Disease Control and Prevention.

Section C-B, Organization and Functions, is hereby amended as follows: Delete in its entirety the title and functional statements for the Office of Public Health Preparedness and Response (CG) and insert the following:

Office of Public Health Preparedness and Response (CG). The mission of the Office of Public Health Preparedness and Response (OPHPR) is to safeguard health and save lives by providing a platform for public health preparedness and emergency response. To carry out its mission, OPHPR: (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 public health preparedness and response efforts; (3) manages CDC-wide preparedness and emergency response programs; (4) maintains CDC's platforms for emergency response operations—including the Emergency Operations Center (EOC), the Strategic National Stockpile (SNS), the Public Health Emergency Preparedness Cooperative Agreement Program and the Select Agent and Toxins regulatory program; (5) communicates the mission, functions and activities of public health preparedness and emergency response to internal and external stakeholders; (6) delivers critical medical assets to the site of a national emergency; (7) provides program support, technical assistance, guidance and fiscal oversight to State, local, Tribal and territorial public health department grantees; (8) provides CDC's core incident management structure to coordinate and execute preparedness and response activities; (9) regulates the possession, use and transfer of select agents and toxins and the importation of etiological agents, hosts, and vectors of human disease to protect public health in the United States; and (10) provides the centralized management and coordination of national scenario capabilities planning and exercising of these plans for CDC.

Office of the Director (CGA). (1) Manages, directs, and coordinates the activities of the office; (2) coordinates the development and implementation of OPHPR strategy in support of CDC's preparedness and response goals and priorities; (3) develops CDC policy and legislative strategy, as related to public health preparedness and emergency response; (4) serves as spokesperson for CDC policies and strategies regarding public health preparedness and response; (5) establishes, implements and communicates a comprehensive and integrated framework of preparedness and response performance goals and associated outcome, output, and process measures; (6) identifies needs and resources for new initiatives and assigns responsibilities for their development; (7) assures CDC preparedness and response plans align with National and Federal preparedness and response policy, doctrine, and plans; (8) develops performance profiles to monitor, report, and improve public health preparedness and response; (9) coordinates and implements CDC's preparedness and response learning strategy in support of OPHPR goals and priorities; (10) develops, implements, and evaluates workforce development programs for internal CDC responders and external audiences with public health preparedness and response responsibilities; (11) establishes and implements a communications strategy in support of OPHPR overarching goals and priorities; (12) develops budget formulation documents for OPHPR to support CDC's Public Health Preparedness and Response (PHPR) budget; (13) evaluates programmatic performance of all funded PHPR activities; (14) provides the OPHPR OD and Divisions with centralized business and program services; (15) plans, coordinates, and manages all aspects of program business services including human and fiscal resources, procurement, cooperative agreements, space and all administrative services; (16) devises information technology practices and procedures, and provides direction, planning and evaluation for information technology systems and services, information security, and information resources for OPHPR; (17) provides scientific oversight, advice, guidance and leadership for the development of OPHPR science and public health; (18) coordinates the development of a research agenda for emergency preparedness and response priorities; (19) coordinates and manages the activities of the Board of Scientific Counselors for OPHPR; (20) provides consultation, support and service to OPHPR divisions for planning, evaluation, policy, education and training, business and fiscal management, information resource, and workforce planning services; and (21) oversees quality assurance and quality control of stockpile assets.

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

Office of the Director (CGC1). (1) Provides national leadership and guidance that supports and advances the work of State, local, Tribal and territorial public health emergency preparedness programs; (2) coordinates the development of scientific guidelines and standards for programmatic materials within the division to provide technical assistance and program planning at the State, local, Tribal, and territorial level; (3) represents the interests and needs of the State, local, Tribal, and territorial interests on State and local preparedness; (4) develops and ensures effective partnerships with national stakeholders and preparedness partners; and (5) provides oversight and management of division contracts, technical assistance plan development, training needs, response activities, grantee awards and fiscal accountability, and research agenda development and compliance.

Program Services Branch (CGCB). (1) Provides consultation to State, territorial, Tribal and local health departments in the management and operation of activities to support public health preparedness, response and recovery; (2) facilitates partnerships between public health preparedness programs at Federal, State, and local levels to ensure their consistency, sharing promising practices, and integration; (3) engages and supports other National Centers across CDC to ensure high quality technical assistance is available to the grantees on preparedness capabilities; (4) supervises Federal field staff providing technical assistance to State and local public health preparedness programs; (5) provides oversight to partnership organization cooperative agreements; and (6) monitors activities of cooperative agreements and grants of partners and State, local, Tribal and territorial organizations to assure program objectives and key performance indicators are achieved.

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 measures; (2) summarizes and synthesizes the preparedness research literature; identifies promising program practices and translates findings into public health preparedness program guidance, technical assistance, and evaluation practices to be shared and implemented at the State and local level; (3) conducts evaluation research activities to evaluate the effectiveness and impact of preparedness programs; (4) provides guidance, training and technical assistance to grantees on the collection and use of program evaluation data; (5) serves as a resource for building evaluation capability with CDC staff, partners and stakeholders; (6) collects, analyzes, interprets and applies information to identify gaps in State and local public health preparedness; (7) monitors State and local achievement of public health preparedness performance measures; and (8) 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 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 catastrophic health event anywhere, at anytime within the U.S. The DSNS ensures the availability and rapid deployment of the SNS and supports, guides, and advises on 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 catastrophic health event.

Office of the Director (CGE1). (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 a catastrophic health event; (4) directs and monitors a comprehensive strategy for managing and executing the critical systems in operating a successful commercial good manufacturing practice compliance program; (5) provides medical, pharmaceutical, and scientific oversight of the SNS formulary; (6) partners with other governmental agencies, public health organizations, and commercial entities with interest and involvement in SNS activities and information; and (7) coordinates the Stockpile Configuration Management Board that is responsible for reviewing, reconciling, and adjusting SNS package and kit design and contents to maintain consistency with medical, scientific, resource, and end user requirements.

Logistics Branch (CGEB). (1) Defines operational requirements once the SNS formulary is established by the Office of the Director and HHS Public Health Emergency Countermeasures Enterprise (PHEMCE); (2) manages the procurement of medical materiel to meet those requirements through the CDC Federal procurement system; (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) acquires facilities and provides the infrastructure for storage of SNS assets; (7) manages the rotation of dated products in the 12-hour Push Packages, in SMI, and in VMI; (8) coordinates the physical security and safety of SNS assets with all storage sites through the Office of Security and Emergency Preparedness; (9) in full exercises or upon a Federal deployment of the SNS, provides logistics expertise for the Technical Advisory Response Unit (TARU) or other deployable/deployed teams that will accompany the SNS to the scene of the chemical/nerve agent or bio-terrorism event as well as for the team staffing the DSNS Team Room in the CDC Emergency Operations Center; (10) coordinates the recovery of unused SNS assets that will be returned to the SNS inventory which were deployed in an actual chemical/nerve agent or bio-terrorism event, including the recovery of SNS air cargo containers; (11) maintains the capacity to transport any and all SNS assets by overseeing contractual arrangements with commercial cargo carrier partners; (12) stores and maintains vaccines, therapeutic blood products, and antitoxins in selected repositories designated for managing and shipping these and other special medical countermeasures; (13) manages the forward deployment and sustainment of CHEMPACK chemical countermeasures in State-determined locations throughout the U.S. in conjunction with the other functional areas of DSNS; (14) manages the routine maintenance of SNS equipment; (15) manages the Shelf Life Extension Program in coordination with the Food and Drug Administration and the Department of Defense; (16) serves as a storage and distribution source to the Department of Defense for biologic products; (17) provides continuing development of the Federal Medical Stations (FMS) program to deploy a surge capability throughout the Nation; and (18) coordinates quality assurance and quality control visits of stockpile assets.

Program Preparedness Branch (CGEC). (1) Coordinates the development, refinement, and dissemination of guidance for CDC-funded public health project areas to plan for and build the infrastructure and systems necessary to manage and use deployed SNS assets; (2) analyzes the overall developmental needs of personnel in State/local Public Health Preparedness Programs and creates, implements, and manages technical assistance and other developmental activities designed to meet those needs; (3) coordinates DSNS supported exercises with the Response Branch and project area Preparedness Plans; (4) collaborates with the Division of State and Local Readiness (DSLR) by providing support for their responsibilities as project officers relative to the SNS components of the CDC Public Health and Emergency Preparedness cooperative agreement and supplemental awards; (5) reviews response plans of each of the CDC funded project areas and all Cities Readiness Initiative (CRI) participants to effectively manage and use deployed SNS assets; (6) functions as the primary agent for the CR1, providing assistance to State and local governments and public health agencies in engaging communities of major metropolitan areas to prepare for effective responses to large scale bioterrorist events by dispensing antibiotics and other medical supplies to their entire populations, if necessary, within 48 hours of the decision to do so; (7) plans, designs and prepares SNS related communications and select educational materials support of State/local SNS Preparedness Programs; (8) provides health communications guidance and products before, during, and after an event to assist State/local SNS Preparedness Program personnel and other public health officials in dealing with the public; (9) serves as the DSNS point of contact for collaboration with various Federal agencies and nongovernmental organizations (e.g., ASTHO, NACCHO) on programmatic initiatives and issues affecting State/local SNS preparedness; (10) collaborates with the DSNS Response and Logistics Branches on special projects to ensure smooth implementation and successful ongoing performance; and (11) during exercises or upon a Federal deployment of the SNS assets, provides Project Area liaison expertise for the TARU and for the DSNS Team Room of the CDC EOC.

Planning and Analysis Branch (CGED). (1) Supervises the design, implementation, and day-to-day execution of processes and systems to improve cost analysis, cost evaluation, planning and financial management for DSNS; (2) manages the development of program policies and procedures as well as performing periodic analysis of existing policies to assess compliance and requirements; (3) coordinates in collaboration with the other branches the development, testing, implementation, training, and selected operations of DSNS's unique information management systems and technology; (4) monitors and manages reporting of DSNS performance measures; (5) provides project management for new missions and initiatives within the division; (6) provides leadership in issue and risk management, business transformation, and change management; (7) provides support to the Veterans Administration (VA) contracting office by acting as a primary liaison between DSNS and the VA National Acquisition Center; (8) maintains contract management responsibility within DSNS; and (9) develops, in collaboration with various contractors and universities, models for use by Project Areas in implementing SNS elements of their Public Health Preparedness Programs.

Response Branch (CGEE). (1) Plans and manages response operations of the DSNS during day-to-day operations and activation in response to emergencies and exercises; (2) supervises the preparation and readiness of all on site and off site response coordination facilities to maintain each in a ready state, including oversight of all related equipment, plans, and procedures; (3) manages the development, coordination, and maintenance of DSNS response and deployment plans; (4) supervises the staffing, preparation, and readiness of TARU and Team Room staff to respond to emergencies (5) manages the planning, coordination, and conduct of internal and partner training; (6) manages the planning, coordination, and conduct of internal DSNS exercises and participation in Federal, State, and local exercises; (7) manages the DSNS Corrective Action Program for exercises and responses to actual emergencies; (8) manages personnel transport capability through overseeing and exercising contractual arrangements with the contract air service partner; (9) manages DSNS personal and program response communications devices and systems; (10) in full exercises or upon a Federal deployment of the SNS, provides staff for the SNS Team Room in the CDC EOC as well as for the TARU that will accompany the SNS assets; (11) participates in periodic Quality Assurance/Quality Control visits to SNS storage sites coordinated by the Logistics Branch; and (12) oversees the day-to-day operation and administration of DSNS' Stockpile Resource Planning (SRP) solution to ensure real time access to mission critical data and provide 24/7/365 redundant network infrastructure in coordination with ITSO.

Division of Select Agents and Toxins (CGF). The Division of Select Agents and Toxins (DSAT): (1) Conducts registration of entities with the United States (academic, military, commercial, private, Federal and non-Federal government) that use, possess and transfer select agents and toxins; (2) establishes and maintains a national database of all entities that possess select agents; (3) inspects entities to ensure that bio-safety and biosecurity regulations and national standards are met; (4) approves all select agent or toxin transfers; (5) receives and investigates reports of theft, loss, or release of a select agent or toxin; (6) partners with other government agencies, public health organizations, and registered entities to ensure compliance with the Select Agent Regulations; (7) issues permits for the importation of etiologic agents and hosts or vectors of human disease; and (8) provides guidelines and training to regulated community on requirements.

Office of the Director (CGF1). (1) Manages operations; (2) provides scientific leadership and consultation; (3) coordinates and supports the CDC Intra-governmental Select Agent and Toxin Technical Advisory Committee and the development and implementation of training programs for select agent inspectors; (4) provides oversight over the execution of regulatory rulemaking activities associated with the DSAT Select Agent and Import Permit Programs; (5) provides leadership and guidance in the area of biosafety; (6) manages and responds to reports of potential theft, loss, or release of select agents; (7) coordinates special inspections and other oversight or incidence response activities involving highly complex entities, including facilities that house BSL-4 laboratories; and (8) provides input to divisional training programs and outreach activities for the regulated community.

Operations Branch (CGFB). (1) Conducts on-site inspections of entities that use, possess and transfer select agents and toxins; (2) schedules and coordinates on-site inspections; (3) reviews entity applications, amendments and other entity documentation; (4) prepares reports of on-site inspections and conducts follow-up on noted deficiencies; (5) maintains entity files to ensure that the Program has the most current and accurate information; (6) communicates with entities Responsible Officials on any issues related to applications, amendments, inspections, and other entity documentation; (7) coordinates all activities related to operations with the records management group; and (8) serves as a liaison for the USDA, APHIS Select Agent Program.

Program Management and Operations Branch (CGFC). (1) Provides oversight and leadership over all business activities for the Division; (2) manages all space and facilities issues for DSAT; (3) develops DSAT budget planning and formulation; (4) provides leadership for DSAT management team and oversight on budget execution activities; (5) coordinates strategic planning/operations; (6) provides oversight on all contract and grant formulation, award, and administration; (7) manages division IT development, operations, and compliance; (8) manages all negotiation and/or oversight of Inter- and Intra-Agency Agreements, Memorandums of Agreements, and Service Level Agreement between the division and various entities/organizations; (9) provides property management oversight, assignment, administration, and accountability; and (10) interacts with the appropriate CDC and OPHPR business and operations offices.

Program Services Branch (CGFD). (1) Processes requests for transfer of select agents and toxins; (2) processes permit applications to import etiological agents, hosts, and vectors of human disease (not limited to select agents) into the United States; (3) evaluates entities' security plans and practices and submits reports to entities' file managers; (4) manages the security risk assessment (SRA) process to ensure that no restricted persons have access to select agents and toxins; (5) provides consultation on DSAT security policies and practices; (6) processes reports of select agents or toxins identified through diagnosis, verification, or proficiency testing; (7) reviews non-compliance issues, assists with evidence gathering, makes recommendations concerning non-compliance issues, drafts compliance letters and tracks non-compliance issues; (8) assists in the writing and tracking of Federal Register notices and other legal documents for the Division; (9) serves as liaison for DSAT for the HHS Office of Inspector General and Federal Bureau of Investigation (FBI); (10) processes requests for exemptions for investigational products that are, bear, or contain select agents or toxins, or to provide a response to a public health emergency; (11) works with the FBI and the DSAT ADB on criminal investigations of the theft or loss of select agents or toxins; (12) coordinates all emergency notification functions; and (13) manages the Program's sharing of select agent information with the States.

Division of Emergency Operations (CGG). The Division of Emergency Operations (DEO) utilizing the Incident Command System (ICS) structure: (1) Staffs and utilizes the EOC to assist Centers and Offices to manage the utilization of resources to support public health routine and emergency situations, domestically and internationally; (2) serves as the primary point of contact under the Homeland Security Presidential Directive (HSPD-5) Emergency Support Function #8 (Public Health and Medical Services); (3) maintains and operates the CDC National-level EOC which serves as the focal point for collaboration and information sharing throughout CDC, 24/7/365; (4) coordinates with all CDC's Centers/Institute/Offices with planning, training, exercising, reporting and coordinating logistical support during pre-response activities and during responses; and (5) apprises CDC leadership and outside agencies of CDC response activities and subject-matter expert situational reports.

Office of the Director (CGG1). (1) Manages the day-to-day operations of the division and provides leadership, resource prioritization, and guidance during public health responses; (2) coordinates the daily management of resources for the division including budget, personnel, and acquisitions in coordination with OPHPR Office of Management Services; (3) coordinates technology improvements and information support requirements for the division and EOC; (4) provides strategic planning to develop performance management goals, objectives, and measurements for the division; (5) manages DEO's scientific activities within the division and across CDC; (6) improves the timeliness and accuracy of public health information gathering, analysis, and sharing through knowledge management and situational awareness in an effort to maximize the speed and accuracy of decision making; and (7) provides a 24/7/365 situational awareness capability to maximize accurate information flow.

Emergency and Risk Communications Branch (CGGB). (1) Identifies and implements strategies for translation and delivery of CDC's emergency risk communication messages and information to key targeted audiences for maximum health impact; (2) coordinates and integrates cross-agency communication activities to fulfill emergency risk communication strategies to respond to public health emergencies; (3) provides leadership and core staffing for the Joint Information Center in CDC's EOC during public health emergencies; (4) serves as CDC's primary communication liaison during public health emergencies to other responding agencies to ensure communication coordination with local, State, Federal, and international partners; (5) monitors, evaluates, and refines risk and emergency communication messages and channels messages based on feedback, communication research, and best practices; (6) evaluates the reach and effectiveness of CDC's risk and emergency communication messages and products; (7) ensures that the content of CDC's emergency risk communication messages are accessible (available, understandable, actionable) and disseminated to the public and target audiences; (8) develops and manages selected channels to deliver national emergency and terrorism-related messages; (9) coordinates the distribution of emergency risk communication messages and information through additional non-CDC channels and engagement mechanisms including news media, social media networks, and partner outreach; (10) provides an integrated marketing perspective to risk emergency communication; (11) employs a systematic process for assessing public awareness, knowledge, attitudes, reactions, and behaviors related to urgent health threats, CDC's emergency risk communication messages, and CDC programs; (12) uses the results of assessment process as input into agency decision making and communication planning; (13) provides technical assistance in emergency risk communication and operations to internal and external partners and supports emergency risk communication capacity building; and (14) sponsors/initiates original research related to emergency risk communication messages on customer, stakeholder, and partner needs, interests, and reactions.

Logistics Support Branch (CGGC). (1) Ensures policies, plans and procedures are in place to provide logistical, administrative, and crisis movement support to CDC deployed personnel and response assets, including communications; (2) provides deployment support for CDC personnel to provide on-site logistical and administrative support to CDC response assets, including communications; (3) coordinates with external logistical and transportation offices during emergencies; (4) advises the DEO Director regarding logistics and transportation activities and provides logistics and transportation planning support for operations plan development and during emergency responses; (5) manages property accountability; procures, maintains, manages, tracks, and coordinates movement of supplies, services, and equipment for CDC including specimens and hazardous cargo shipments in response to emergency deployment operations; (6) coordinates with the CDC Office of Health and Safety (OHS) and other CDC entities for all CDC medical evacuation missions involving the movement of suspected infectious and contagious patients; (7) coordinates off-site communications and reach-back capabilities, to include real time exchange of information for deployed personnel and teams; and (8) manages the operation and employment of the CDC aircraft.

Operations Branch (CGGD). (1) Maintains a 24/7/365 capability to respond to emergencies and coordinate emergency management processes and protocols across CDC; (2) monitors national and international public health emergencies and maintains a common operating picture for CDC leadership and HHS/ASPR; (3) serves as the central point of contact between CDC and public health agencies nationally and internationally for emergency management and response; (4) supports the myriad of sophisticated audiovisual, administrative, and communication functions, including equipment, necessary to maintain a state-of-the-art national emergency operations center; (5) identifies the requirements to fully staff all of the functional roles of the IMS to meet a 24/7/365, all hazard, public health emergency, including identifying personnel across CDC to staff operations functional roles; (6) conducts coordination, planning, and training necessary to implement Continuity of Operations (COOP); (7) coordinates movement/deployment of resourced requirements with logistics; (8) ensures the agency deployment coordination plan represents a comprehensive strategy to identify, recruit, prepare, and maintain a workforce capable of responding rapidly and efficiently to all events requiring CDC public health response leadership, guidance, or support; (9) maintains and coordinates deployment activities supporting deployer health and safety requirements; and (10) monitors, tracks, and assists HHS/Office of Force Readiness and Deployment (OFRD) deployments which utilize Commissioned Corps officers stationed at CDC.

Plans, Training, Exercise and Evaluation Branch (CGGE). (1) Develops CDC emergency operations plans, event-specific incident annexes, and national special security event plans, and collaborates across CDC to facilitate development of internal standard operating procedures to support these plans; (2) acts as planning liaison to other organizations and reviews, analyzes and provides comments on Federal and national plans or inquires; (3) provides policy oversight and coordinates the incorporation of national policy into CDC operations plans; (4) represents the agency regarding operational planning and facilitates or participates in planning-focused work groups; (5) manages the CDC exercise and incident response evaluation program; (6) coordinates training and exercise programs and provides feedback and recommendations for After Action Reports for activities conducted at the CDC level; (7) collaborates with SMEs across CDC and external partners to facilitate evaluation of training, planning, and exercises to improve public health preparedness; (8) develops and coordinates Corrective Action Plans and tracks Improvement Plans; (9) coordinates Improvement Plans with CDC SMEs; (10) designs and delivers up-to-date CDC and preparation for exercises in emergency response training to prepare staff for emergency situations; (11) tracks CDC responder and staff certifications; (12) ensures that Division training programs support Agency goals; (13) manages exercises to test the readiness of the CDC IMS and ensures it supports the National Planning Scenarios; (14) coordinates and manages CDC's participation in pertinent external all-hazards exercises; (15) serves as the Chairperson of the CDCs Exercise Steering Committee and manages the CDC's internal exercise program in collaboration with subject matter experts across CDC; and (16) facilitates the involvement of States and other response partners in CDC exercises.

Dated: March 11, 2010.

William P. Nichols,

Chief Operating Officer, Centers for Disease Control and Prevention.