Statement of Organization, Functions, and Delegations of Authority, 14449-14454 [2010-6372]

Download as PDF Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices keeping informed and working together; (7) FDA conduct of clinical investigator inspections; (8) meetings with FDA: why, when, and how; (9) investigator initiated research; (10) medical device aspects of clinical research; (11) working with FDA’s Center for Biologics Evaluation and Research; and (12) The inspection is over—what happens next? What are the possible FDA compliance actions? FDA has made education of the drug and device manufacturing community a high priority to help ensure the quality of FDA-regulated drugs and devices. The public workshop helps to achieve objectives set forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C. 393) which includes working closely with stakeholders and maximizing the availability and clarity of information to stakeholders and the public. The workshop also is consistent with the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104–121) as an outreach activity by Government agencies to small businesses. Dated: March 19, 2010. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010–6579 Filed 3–24–10; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention mstockstill on DSKH9S0YB1PROD with NOTICES 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 establishment of the Office of the Associate Director for Policy. Section C–B, Organization and Functions, is hereby amended as follows: Delete in their entirety the title and functional statements for the CDC Washington Office (CAQ) and insert the following: Office of the Associate Director for Policy (CAQ). The mission of CDCs Office of the Associate Director for Policy (OADP) is to bring about policies that result in demonstrable improvements in public health-globally and at the federal, state, and local levels. VerDate Nov<24>2008 16:42 Mar 24, 2010 Jkt 220001 In carrying out its mission, OADP: (1) Provides advice to CDC leadership in developing agency policy and legislative strategies; (2) creates and maintains partnerships to implement policy and legislative strategies; (3) implements key policies to improve public health; (4) ensures the agency’s scientific credibility, reputation, and needs are respected and supported by policy makers and stakeholders. Office of the Director (CAQ1). (1) Provides strategic advice to CDC leadership on overall agency direction and priorities, and drives CDC towards actions to reduce leading preventable causes of morbidity and mortality; (2) ensures organizational effectiveness in policy or strategy across the agency; (3) ensures capacity throughout CDC for policy and strategy; (4) leads the development and management of policy agendas with federal agencies and other organizations; (5) establishes strategy and maintains relations with key organizations and individuals working on public health policies or legislation. Office of Prevention through Healthcare (CAQ 12). (1) Uses policy tools to gain the maximum preventive benefit from the clinical system and to integrate clinical care with community health interventions; (2) draws upon expertise and functional roles resident in other units of the Office of the Associate Director for Policy as well as from across CDC to apply that expertise and functionality to advancing prevention through healthcare; (3) crafts a coordinated agency response to implementing provisions of health reform legislation once it is enacted. Policy Research, Analysis, and Development Office (CAQB). (1) Identifies and assists CDC leadership in establishing policy at multiple levels (federal, state, local, global and in the private sector); (2) conducts policy analysis (including regulatory, legal, economic); (3) develops and implements strategies (including regulatory, legal, economic) to deliver on policy priorities; (4) coordinates agency work with the healthcare system and other health-related organizations to advance CDCs policy agenda within the healthcare sector; (5) develops expertise in programs, regulations, and initiatives of other agencies that may provide opportunity for health impact; (6) builds relations with government agencies and other organizations to advance policy agendas, with a special emphasis on state and local agencies; (7) monitors and evaluates impact of policy implementation priorities; (8) identifies and assesses policy best practices and helps diffuse and replicate those practices; (9) leads the strengthening PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 14449 and development of policy capacity and talent within CDC, as well as within the larger public health community; (10) leads the development and implementation of CDCs health policy research agenda; (11) ensures CDC operates in an integrated, consistent manner in policy-related activities; (12) leverages relationships with think tanks, policy consultancies, and academic institutions; (13) manages selected partner cooperative agreements and contracts that focus on policy; and (14) develops an agency-wide strategy related to advancing policy for partner relations that are managed elsewhere in CDC. CDC Washington Office (CAQC). (1) Directs and manages CDC interactions with Congress; (2) leads the development and oversees the execution of appropriations strategies; (3) develops and executes legislative strategies; (4) builds Congressional relations; (5) tracks and analyzes legislation; (6) develops strategy and leads response efforts for Congressional oversight; (7) builds relations with government agencies and other organizations to advance policy agendas, with an emphasis on federal agencies; (8) protects and advances the agency’s reputation, scientific credibility, and interests; (9) informs CDC leadership of current developments and provides insight into the Washington policy environment; (10) coordinates District of Columbia-area assignees and helps maximize their impact in supporting the agency’s strategies and priorities. Dated: March 11, 2010. William P. Nichols, Acting Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2010–6375 Filed 3–24–10; 8:45 am] BILLING CODE 4160–18–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention 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, E:\FR\FM\25MRN1.SGM 25MRN1 mstockstill on DSKH9S0YB1PROD with NOTICES 14450 Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices 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 VerDate Nov<24>2008 16:42 Mar 24, 2010 Jkt 220001 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 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 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 E:\FR\FM\25MRN1.SGM 25MRN1 mstockstill on DSKH9S0YB1PROD with NOTICES Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices 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) VerDate Nov<24>2008 16:42 Mar 24, 2010 Jkt 220001 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 bioterrorism 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 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 14451 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 CDCfunded 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) E:\FR\FM\25MRN1.SGM 25MRN1 mstockstill on DSKH9S0YB1PROD with NOTICES 14452 Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices 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 VerDate Nov<24>2008 16:42 Mar 24, 2010 Jkt 220001 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 PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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 followup 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 Interand 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 noncompliance issues, assists with evidence gathering, makes recommendations E:\FR\FM\25MRN1.SGM 25MRN1 mstockstill on DSKH9S0YB1PROD with NOTICES Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices 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 VerDate Nov<24>2008 16:42 Mar 24, 2010 Jkt 220001 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 terrorismrelated messages; (9) coordinates the distribution of emergency risk communication messages and information through additional nonCDC 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 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 14453 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 offsite 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 E:\FR\FM\25MRN1.SGM 25MRN1 mstockstill on DSKH9S0YB1PROD with NOTICES 14454 Federal Register / Vol. 75, No. 57 / Thursday, March 25, 2010 / Notices 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, eventspecific 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 planningfocused 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) VerDate Nov<24>2008 16:42 Mar 24, 2010 Jkt 220001 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. [FR Doc. 2010–6372 Filed 3–24–10; 8:45 am] BILLING CODE 4160–18–M DEPARTMENT OF HOMELAND SECURITY [Docket No. DHS–2010–0025] National Protection and Programs Directorate; National Infrastructure Advisory Council National Protection and Programs Directorate, DHS. ACTION: Committee Management; Notice of Federal Advisory Council Meeting. AGENCY: SUMMARY: The National Infrastructure Advisory Council (NIAC) will meet on Tuesday, April 13, 2010, at the National Press Club’s Ballroom, 529 14th Street, NW., Washington, DC 20045. DATES: The National Infrastructure Advisory Council will meet Tuesday, April 13, 2010 from 1:30 p.m. to 4:30 p.m. The meeting may close early if the committee has completed its business. For additional information, please consult the NIAC Web site, https:// www.dhs.gov/niac, or contact the NIAC Secretariat by phone at 703–235–2888 or by e-mail at NIAC@dhs.gov. ADDRESSES: The meeting will be held at the National Press Club’s Ballroom, 529 14th Street, NW., Washington, DC 20045. While we will be unable to accommodate oral comments from the public, written comments may be sent to Nancy J. Wong, Department of Homeland Security, National Protection and Programs Directorate, 245 Murray Lane, SW., Mail Stop 0607, Arlington, VA 20598–0607. Written comments should reach the contact person listed no later than March 30, 2010. Comments must be identified by DHS–2010–0025 and may be submitted by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • E-mail: NIAC@dhs.gov. Include the docket number in the subject line of the message. • Fax: 703–603–5098. • Mail: Nancy J. Wong, Department of Homeland Security, National Protection and Programs Directorate, 245 Murray Lane, SW., Mail Stop 0607, Arlington, VA 20598–0607. PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Instructions: All submissions received must include the words ‘‘Department of Homeland Security’’ and the docket number for this action. Comments received will be posted without alteration at https://www.regulations.gov, including any personal information provided. Docket: For access to the docket to read background documents or comments received by the NIAC, go to https://www.regulations.gov. FOR FURTHER INFORMATION CONTACT: Nancy J. Wong, National Protection and Programs Directorate, 245 Murray Lane, SW., Mail Stop 0607, Arlington, VA, 20598–0607; telephone 703–235–2888. Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92–463). The NIAC shall provide the President through the Secretary of Homeland Security with advice on the security of the critical infrastructure sectors and their information systems. The NIAC will meet to address issues relevant to the protection of critical infrastructure as directed by the President. The April 13, 2010, meeting will receive updates on the progress of two National Infrastructure Advisory Council working groups. The Meeting Agenda is as Follows: SUPPLEMENTARY INFORMATION: I. Opening of Meeting II. Roll Call of Members III. Opening Remarks and Introductions IV. Approval of January 2010 Minutes V. Working Group Status: A Framework for Establishing Critical Infrastructure Resilience Goals VI. Working Group Status: Optimization of Resources for Mitigating Infrastructure Disruptions VII. New Business VIII. Closing Remarks IX. Adjournment Procedural While this meeting is open to the public, participation in the National Infrastructure Advisory Council deliberations is limited to committee members, Department of Homeland Security officials, and persons invited to attend the meeting for special presentations. Information on Services for Individuals With Disabilities For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the NIAC Secretariat at 703–235–2888 as soon as possible. E:\FR\FM\25MRN1.SGM 25MRN1

Agencies

[Federal Register Volume 75, Number 57 (Thursday, March 25, 2010)]
[Notices]
[Pages 14449-14454]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-6372]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


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,

[[Page 14450]]

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

[[Page 14451]]

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)

[[Page 14452]]

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

[[Page 14453]]

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

[[Page 14454]]

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.
[FR Doc. 2010-6372 Filed 3-24-10; 8:45 am]
BILLING CODE 4160-18-M
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