2023-02930. Establishment of the Coronavirus and Other Respiratory Viruses Division

AGENCY:

Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS).

ACTION:

Notice.

SUMMARY:

CDC has modified its structure. This notice announces the establishment of the Coronavirus and other Respiratory Viruses Division and other organizational components within the National Center for Immunization and Respiratory Diseases (NCIRD), Deputy Director for Infectious Diseases (DDID), CDC.

DATES:

This reorganization was approved by the Secretary of HHS on January 24, 2023, and became effective February 8, 2023.

SUPPLEMENTARY INFORMATION:

Part C CDC 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 87 FR 51670-51675, dated August 23, 2022) is amended to reflect the reorganization of NCIRD, DDID, CDC. Specifically, the changes are as follows:

Under Part C, Section C-B, Organization and Functions, delete and/or update functional statements for NCIRD in their entirety and replace with the following:

NCIRD (CVG)

NCIRD prevents disease, disability, and death through immunization and by control of respiratory and related diseases. In carrying out its mission, NCIRD: (1) Provides leadership, expertise, and service in laboratory and epidemiological sciences, and in immunization program delivery; (2) conducts applied research on disease prevention and control; (3) translates research findings into public health policies and practices; (4) provides diagnostic and reference laboratory services to relevant partners; (5) conducts surveillance and research to determine disease distribution, determinants, and burden nationally and internationally; (6) responds to disease outbreaks domestically and abroad; (7) ensures that public health decisions are made objectively and based upon the highest quality of scientific data; (8) provides technical expertise, education, and training to domestic and international partners; (9) provides leadership to internal and external partners for establishing and maintaining immunization, and other prevention and control programs; (10) develops, implements, and evaluates domestic and international public health policies; (11) communicates information to increase awareness, knowledge, and understanding of public health issues domestically and internationally, and to promote effective immunization programs; (12) aligns NCIRD's focus with the overall strategic goals of CDC; (13) synchronizes all aspects of CDC's pandemic preparedness and response from strategy through implementation and evaluation; and (14) implements, coordinates, and evaluates programs across NCIRD, DDID, and CDC to optimize public health impact.

Office of the Director (OD) (CVG1)

(1) Provides leadership, expertise, and service in laboratory and epidemiological sciences for respiratory and vaccine preventable diseases and in immunization program delivery; (2) provides diagnostic and reference laboratory services to relevant partnerships; (3) works with DDID to ensure spending plans, budget planning, and budget execution are in line with the overall infectious disease strategies and priorities; (4) ensures that NCIRD's strategy is executed by the divisions and aligned with overall CDC goals; (5) co-develops execution strategies for NCIRD with the division directors; (6) provides program and science quality oversight; (7) builds leadership at the division and branch levels; (8) evaluates the strategies, focus, and prioritization of the division research, program, and budget activities; (9) identifies and coordinates synergies between NCIRD and relevant partners; (10) ensures that policy development is consistent and appropriate; (11) facilitates research and program activities by providing leadership support; (12) proposes resource priorities throughout the budget cycle; (13) ensures scientific quality, ethics, and regulatory compliance; (14) fosters an integrated approach to research, program, and policy activities; (15) liaises with HHS and other domestic and international immunization and respiratory disease partners as well as with NCIRD divisions; (16) coordinates center's emergency response activities related to immunization issues and complex acute respiratory infectious disease emergencies; (17) applies communication science, media principles, and web design to support NCIRD and CDC's efforts to reduce morbidity and mortality caused by vaccine-preventable and respiratory diseases; ensuring that communication distributed by the center is timely, accurate, clear and relevant to intended audiences; (18) provides guidance for key scientific and laboratory services in the functional areas of extramural research (research and non-research), human studies oversight and review, regulatory affairs; activities in the area of space planning, advising, coordination and evaluation, safety management and coordination, and shared services in controlled correspondence, and programmatic services in the area of workforce and career development; (19) provides and coordinates center-wide administrative, management, and support services in the areas of fiscal management, personnel, travel, procurement, facility management, and other administrative services; and (20) manages the coordination of workforce development and succession planning activities, and provides human capital management, planning, and training consultation services.

Office of Informatics (CVG12)

(1) Manages all IT project costs, schedules, performances, and risks; (2) provides expertise in leading application development techniques in information science and technology to affect the best use of resources; (3) performs technical evaluation and/or integrated baseline reviews of all information systems' products and services prior to procurement to ensure software purchases align with DDID strategy; (4) provides access to quality data in support of programmatic data analysis; (5) coordinates all enterprise-wide IT security policies and procedures with the Office of the Chief Information Officer and relevant enterprise governance bodies, such as the IT and Data Governance; (6) ensures operations are in accordance with CDC Capital Planning and Investment Control guidelines; (7) ensures adherence to CDC enterprise architecture guidelines and standards; (8) consults with users to determine IT needs and to develop strategic and action plans; (9) participates in the evolution, identification, development, or adoption of appropriate informatics standards in conjunction with the DDID; and (10) provides leadership in initiatives focused on data and IT modernization that aligns with CDC agency goals for public health data modernization.

Office of Policy (CVG13)

(1) Serves as liaison with CDC/OD and other Centers, Institute, Offices (CIO) policy offices, HHS and other government agencies, and external partners on policy, program, legislative, and budgetary issues related to NCIRD; (2) leads annual NCIRD budget formulation and development of appropriations materials; (3) provides expertise and guidance for strategic planning and performance measurement; (4) oversees and coordinates NCIRD accountability activities, including Government Accountability Office and Inspector General studies, audits and reviews, as well as center responses to Freedom of Information Act requests, and correspondence from partners, Congress, and the public; (5) creates and provides briefing documents and materials for executive leadership within NCIRD, DDID, and CDC on NCIRD's policy and programmatic issues; (6) conducts legislative monitoring and analysis; (7) provides NCIRD with leadership and advice in the management of congressional and governmental relations; (8) works with NCIRD divisions to coordinate policy requests across the center; (9) manages cross-cutting policy issues within NCIRD and, as appropriate, with other CIO and OD offices within CDC; and (10) collaborates across NCIRD and CDC to build and maintain partnerships that support NCIRD's domestic and global goals and initiatives, including promoting vaccination across the lifespan; prevention, detection and control of respiratory diseases; and preparedness for pandemics and other respiratory disease outbreaks.

Office of Health Communications Science (CVG15)

(1) Supports NCIRD's mission through the planning, development, implementation, and evaluation of science-based health communication activities and programs; (2) applies communication science, media principles, and web design to support NCIRD and CDC's efforts to reduce morbidity and mortality caused by vaccine-preventable and respiratory diseases; (3) conducts projects that translate scientific and medical information into messages for a variety of audiences using an array of media/formats; (4) improves understanding of vaccine benefits and risks among partners, healthcare providers and public audiences; (5) improves understanding among specialized audiences such as policy-makers and public health officials nationally and internally of NCIRD's work; (6) supports public health partners via technical assistance and other methods; (7) demonstrates best practices in writing using plain language and health literacy principles, creating culturally appropriate materials; (8) coordinates CDC's pandemic influenza communication preparedness activities; (9) leads the development and implementation and evaluation of major cross cutting communication campaigns for vaccines preventable diseases; and (10) conducts behavioral and communication research to ensure that messages and strategies are clear, relevant, and potentially impactful to intended audiences.

Office of Management & Operations (CVG16)

(1) Plans, coordinates, directs and provides advice and guidance on management and administrative operations of NCIRD in the areas of fiscal management, personnel, human capital, workforce training and development, travel, records management, facility management, and other administrative related services; (2) prepares and distributes annual budget plans and provides overall direction for planning and management oversight of allocated resources; (3) provides guidance on NCIRD requirements related to intramural and extramural activities, purchases, and agreements; (4) reviews the effectiveness and efficiency of the operation and administration of all NCIRD programs; (5) develops and implements administrative policies and procedures; (6) prepares special reports and studies in the administrative management areas; and (7) coordinates workforce development and succession planning activities for and with the center, providing human capital management, planning, and training consultation services to manage evolving workforce needs and skillset requirements.

Office of Science (CVG17)

(1) Links strategies and priorities of the primarily programmatic-focused NCIRD divisions with those of primarily disease-based divisions; (2) facilitates development and ongoing implementation of integrated infectious respiratory disease (including influenza) surveillance, research and prevention, and control activities across the divisions, both domestically and globally, including supporting implementation of NCIRD's respiratory diseases strategic prevention priorities; (3) meets with other CDC CIOs working in the area of respiratory diseases; (4) coordinates and facilitates NCIRD's overall respiratory and vaccine preventable disease scientific/research agenda; (5) assumes responsibility for the protection of human research subjects, scientific review, clearance of manuscripts and other written materials; (6) provides planning and coordination of overall surveillance strategies, preparedness, response, and prevention effectiveness related to a center-wide public health scientific agenda and quantifies how programs and activities promote cost-effective and high impact prevention strategies with respect to immunization and other vaccine-preventable disease programs; (7) provides leadership (agency and center-wide) for vaccine-preventable and respiratory disease surveillance to include guidance and coordination of NCIRD surveillance activities and systems, leadership on issues related to internal and external integration of CDC surveillance activities, and alignment with enterprise-wide data and IT governance and modernization strategy; (8) coordinates, facilitates, and integrates domestic and international respiratory and vaccine-preventable disease surveillance activities through existing methods while developing new approaches, tools, and analyses for these activities; (9) fosters a multidisciplinary approach to epidemiology, statistics, informatics, laboratory methods, and evaluation; (10) provides leadership, expertise, and service in laboratory science; (11) represents NCIRD's interests in cross-cutting laboratory services in DDID which include, but are not limited to, laboratory information systems, quality management systems, and bioinformatics; (12) ensures a safe working environment in NCIRD laboratories; (13) collaborates effectively with other centers and offices in carrying out its functions; (14) manages CDC's intellectual property ( e.g., patents, trademarks, copyrights) and promotes the transfer of new technology from CDC research to the private sector to facilitate and enhance the development of diagnostic products, vaccines, and products to improve occupational safety; (15) provides oversight, guidance and coordination relating to the application of social and behavioral sciences to support impactful research and programs to achieve healthy behavior change; (16) coordinates and tracks health equity science and program activities within NCIRD and with partners; and (17) supports research, surveillance, education, training, and program development to achieve healthy equity and reduce health disparities.

Office of Global Health, Preparedness, and Response (CVG18)

(1) Advises NCIRD and CDC leadership on global health and pandemic preparedness related to current and known threats such as coronavirus disease 2019 (COVID-19) and influenza, and to emerging pandemic threats; (2) provides strategic leadership for CDC in the areas of pandemic preparedness and response and global health related to respiratory and vaccine preventable diseases including establishing NCIRD priorities, promoting science, policies, and new programs; (3) coordinates NCIRD efforts related to funding and budgets for global health security and pandemic preparedness and response; (4) supports NCIRD's work across CDC and the federal government on global health security, respiratory diseases, and pandemic preparedness and response; and (5) coordinates across NCIRD, CDC, and with partners to plan for and exercise responses to pandemic and other threats.

Immunization Services Division (ISD) (CVGB)

ISD protects individuals and communities from vaccine-preventable diseases across the lifespan through: provision of federal funds and contracts to purchase and distribute vaccines; provision of technical and financial support for immunization programs, partners, and for efforts to increase equity in immunization; provision of provider, patient, and public immunization education and communication; surveillance of vaccination coverage and vaccine attitudes; and evaluation and research to identify root causes of under vaccination and vaccine inequity.

ISD Office of the Director (CVGB1)

(1) Supports ISD's mission through leadership across the branches related to domestic vaccination efforts and vaccine-preventable disease preparedness and response elements and links strategies and priorities with other NCIRD divisions; (2) facilitates development and ongoing implementation of vaccination coverage surveillance, health services and economic research, and program evaluation across ISD branches; (3) provides direct management, oversight, and execution of national vaccine supply contracts; (4) provides direct management and execution of procurement requisitions, contracts, and cooperative agreements, and performs administrative tasks related to initiating, processing, and maintaining interagency agreements; (5) provides direct management and execution of human resources, administrative functions, and workplace climate and facility management across ISD; (6) provides guidance related to and protection of human research subjects, Office of Management and Budget and Paperwork Reduction Act compliance, and scientific initiatives across ISD branches; (7) furthers data strategy, IT governance, and data-related policy across the division, through coordinated work across ISD; (8) provides leadership for activities in ISD related to health equity, including improving equity in access to vaccination opportunities and vaccination coverage rates across different populations; (9) coordinates programs and activities to help achieve and sustain increased vaccination coverage among uninsured and underinsured adults; (10) coordinates and supports activities across the division related to cross-cutting topics, such as emergency preparedness, clinical expertise, jurisdictional coordination, and vaccine confidence and demand; (11) provides direct management and oversight for division-wide communications and policy, including liaisons to the branches; (12) serves as liaison to other policy offices, other government agencies, and external partners on policy, program, legislative, and budgetary issues related to ISD; (13) manages and executes cross-cutting communications to support ISD's mission to protect individuals and communities from vaccine-preventable diseases; (14) promotes internal awareness of division initiatives and guidance through timely, accurate, clear, and relevant communications; (15) provides technical assistance to ISD branches in the development and revision of operational manuals, job aids, and web pages; (16) manages the all-jurisdiction email account by maintaining distribution lists (in collaboration with ISD branches) and disseminating messaging to jurisdictions and partners on behalf of ISD and its branches and programs.

Immunization Operations and Services Branch (CVGBB)

(1) Serves as CDC's primary interface with the state, local, and territorial health department immunization programs funded by cooperative agreements related to Vaccines for Children (VFC), Section 317, and other programs that support immunization across the lifespan, supporting them with development, implementation, assessment, and promotion of vaccination-related activities with the goal of achieving and sustaining high and equitable vaccination coverage levels across the lifespan; (2) serves as ISD's lead in the management, processing, and monitoring of the funding provided through the cooperative agreements related to VFC, Section 317, and other programs supporting immunization across the lifespan; (3) administers the operations of the VFC, Section 317, and other appropriate programs for eligible jurisdictions; (4) provides technical assistance to jurisdictions on program implementation for child, adolescent, and adult activities, including implementation of all components of the cooperative agreements; (5) provides subject-matter expertise on adult immunization program implementation and guidance; (6) monitors performance of recipients of the cooperative agreements related to VFC, Section 317, and other programs supporting immunization across the lifespan; (7) oversees management and operations of jurisdiction-vaccination provider engagement programs and efforts ( i.e., VFC and Section 317 quality assurance, quality improvement [in cooperation with the Applied Research, Implementation Science, and Evaluation Branch] perinatal hepatitis B prevention, and vaccine accountability [in cooperation with the Vaccine Supply and Assurance Branch]).

Vaccine Supply and Assurance Branch (CVGBC)

(1) Manages logistics for the public sector vaccine supply chain; (2) supports supply chain immunization activities carried out by state, local, and territorial health department immunization programs and their enrolled providers, funded by cooperative agreements related to VFC, Section 317, or other programs that support immunization across the lifespan; (3) provides planning, purchasing, ordering, distribution, and management of vaccine supply shortages and constraints; (4) establishes and manages contracts for the purchase of vaccines across the lifespan; (5) creates and maintains pediatric vaccine stockpiles for the VFC program; (6) tracks and monitors seasonal influenza vaccine distribution; (7) maintains subject matter expertise and provides technical assistance related to jurisdiction vaccine planning activities and vaccine storage and handling; (8) serves as the business owner for CDC's vaccine order management system (VTrckS); engage in strategic planning for the modernization and defect/enhancement testing for VTrckS [in collaboration with the Informatics and Data Analytics Branch]; provides support and training for jurisdiction users of VTrckS; (9) manages contracts that provide technical, operational, and user support for VTrckS; (10) uses vaccine purchase and order data to support activities within the branch, respond to internal and external data calls, provide jurisdiction feedback, and collaborate on CDC-sponsored evaluation activities.

Informatics and Data Analytics Branch (CVGBE)

(1) Provides leadership, technical assistance, technology tools, data quality assurance, and resource support to develop capacity for a nationwide network of fully operational and integrated immunization information systems (IISs); (2) increases the quality of IIS data across the lifespan and system functionality and security by identifying, developing, implementing, promoting, and evaluating standards and best practices in collaboration with other federal agencies and partners; (3) supports exchange of high-quality IIS data between jurisdictions' clinical, administrative, public health immunization stakeholders, and federal partners; (4) promotes the effective use of IIS data and systems to support vaccination providers, public health programs, and other immunization stakeholders; (5) monitors, evaluates, and reports on IIS data to improve operations and immunization program outcomes; (6) maintains informatics capability and information technology tools to support immunization programs at the provider, jurisdiction, and federal level; and (7) influences health information technology policies and standards to improve the quality of immunization data submitted by healthcare systems.

Surveillance and Epidemiology Branch (CVGBG)

(1) Leads domestic vaccination coverage and vaccine confidence and demand assessment across the lifespan; (2) collects, analyzes, and disseminates accurate and timely data for action—including data related to vaccination coverage, utilization data, and related information from available data sources (including but not limited to data from national surveys, health systems, and medical claims) in conjunction with subject matter experts in other ISD branches as appropriate; (3) assesses equity in vaccination coverage and vaccine confidence and demand among racial/ethnic minorities and other populations disproportionately affected by health inequities; (4) in conjunction with other ISD branches, assists national, state, and local immunization programs in collection, analysis, interpretation, and use of vaccination coverage and vaccine confidence and demand assessment to guide policy and program activities; (5) conduct and manage the family of surveys under the National Immunization Survey contract to assess vaccination coverage and behavioral and social drivers of vaccination; and (6) evaluate and find methods to improve the usefulness of existing and potential new data sources for assessment of vaccination coverage and behavioral and social drivers of vaccination.

Health Education and Communication Branch (CVGBH)

(1) Provides education and communication materials and resources to improve knowledge and acceptance of vaccines among healthcare providers and the public to increase vaccine uptake across the lifespan, thus reducing vaccine-preventable diseases; (2) provides education and communication materials and resources to improve clinical knowledge among healthcare providers and other healthcare personnel about the proper storage, handling, preparation, and administration of vaccines to help ensure vaccine safety; (3) collaborates across NCIRD to develop communication strategies to increase vaccinations across the lifespan; (4) develops and disseminates, by a variety of mechanisms, domestic immunization messages, materials, educational resources, and training for healthcare providers and patients related to ISD's scientific, clinical, and programmatic work; (5) provides technical assistance for healthcare providers, state and local health departments, and other groups on communication science and implementation, scalable programmatic action, and evaluation of education and communication strategies to improve vaccine confidence and vaccination coverage rates; (6) provides continuing education credits for immunization-related education and training products; (7) leads the Advisory Committee on Immunization Practices (ACIP) Child and Adolescent and Adult Immunization Schedules Work Group and General Best Practices Work Group, participates in other ACIP work groups, and develops and promotes resources related to ACIP schedules and recommendations; (8) develops and promotes social media and other initiatives to combat immunization misinformation and/or disinformation and promote vaccine confidence and equity; (9) collaborates with ISD policy, communication, and implementation science functions to address communication science needs; (10) responds to clinically or programmatically relevant immunization inquiries via NIP-INFO, an email inquiry service for health departments and healthcare providers; and (11) develops vaccine information statements as required by law.

Applied Research, Implementation Science, and Evaluation Branch (CVGBJ)

(1) Synthesizes literature/data and conducts health services and economic research to understand reasons for under-vaccination and vaccine inequities across the lifespan; (2) designs strategies to increase vaccination coverage, equity, and confidence, and assess strategy effectiveness; (3) translates and adapts evidence-based strategies for scalable programmatic action; (4) designs ISD's quality improvement activities; define their standards and requirements for implementation and for data collection, reporting, and sharing; (5) provides technical assistance and facilitate research and evaluation capacity building among CDC-funded immunization programs; (6) supports program effectiveness activities conducted by CDC-funded immunization programs; (7) monitors trends in access to vaccines, vaccine knowledge, attitudes, and perceptions, including vaccine confidence; (8) provides division-wide subject matter expertise on evaluation; and (9) conducts over-arching evaluation of the national immunization program to inform program improvement.

Field Services Branch (CVGBK)

(1) Provides support to the state, local, and territorial health department immunization programs funded by cooperative agreements related to VFC, Section 317, and other programs supporting immunization across the lifespan for immunization program implementation through the assignment of CDC staff as requested by jurisdictions to address gaps in capacity; (2) based on the agreements with each jurisdiction, provides official supervision and high-level training of staff assigned to health departments to assist with jurisdiction immunization program operations; and (3) supports the needs and provides tools for staff embedded in jurisdictions and local health departments.

Partnership and Health Equity Branch (CVGBL)

(1) Collaborates with public health partner groups to achieve national immunization program goals and scalable programmatic action; (2) partners with national, state, local, and community-based organizations to achieve greater equity in access to and demand for administration of vaccines across the lifespan; (3) partners with non-governmental professional organizations to support immunization recommendations, and education, communication, training, and quality improvement strategies; (4) partners with other federal agencies to ensure coordination of efforts related to equity and vaccination; (5) provides technical assistance and capacity-building support to funded and unfunded partners to achieve immunization and equity goals; (6) facilitates a shared learning forum and learning opportunities for partners to provide strategies and resources on promoting vaccine equity; (7) monitors opportunities for future partnerships, especially those that serve adult, underrepresented, and disproportionately affected populations; (8) evaluates funded partnerships to ensure that projects are meeting workplan objectives and other requirements; and (9) monitors and supports needs of immunization partners external to ISD.

Influenza Division (ID) (CVGD)

ID improves global control and prevention of seasonal and novel influenza and improves influenza pandemic preparedness and response. In collaboration with domestic and global partners, ID: (1) Builds surveillance and response capacity; (2) monitors and assesses influenza viruses and illness; (3) improves vaccines and other interventions; and (4) applies research to provide science-based enhancement of prevention and control policies and programs.

ID Office of the Director (CVGD1)

(1) Provides vision, leadership, and direction for the division; (2) fosters external partnerships and cross-cutting activities that support quality science and strong global partnerships; (3) provides leadership and guidance in policy formulation; (4) provides technical expertise and leadership for national and international pandemic preparedness activities; and (5) provides technical expertise for communications, public health guidance, informatics, epidemiologic, and laboratory science, and reagent resources.

Virology, Surveillance, and Diagnosis Branch (CVGDB)

(1) Conducts comprehensive antigenic, phenotypic, genotypic, structural, and evolutionary characterization of human and animal influenza viruses; (2) performs genetic and antigenic pandemic risk assessment of novel influenza viruses; (3) develops and evaluates novel and seasonal candidate vaccine viruses; (4) provides expert guidance on influenza vaccine virus selection; (5) develops methods to detect and characterize influenza viruses; and (6) trains and supports laboratories that perform influenza testing.

Epidemiology and Prevention Branch (CVGDC)

(1) Conducts surveillance, research, modeling, and forecasting activities to better understand and monitor the epidemiology of influenza viruses and disease; (2) improves understanding of the effectiveness of influenza antiviral drugs, vaccines, and non-pharmaceutical interventions; (3) assists state and local health departments to conduct surveillance and optimize activities related to the detection and response to emerging and novel influenza viruses; (4) supports influenza vaccine policy; and (5) supports influenza pandemic preparedness activities.

Immunology and Pathogenesis Branch (CVGDE)

(1) Increases knowledge and improves understanding of immunity and immune correlates of protection; (2) develops and improves vaccines; (3) determines virus and host factors that impact virulence and transmission of influenza viruses; (4) conducts immunologic and virologic pandemic risk assessment of novel influenza viruses; and (5) trains and supports laboratories that perform immunologic testing.

Global Influenza Branch (CVGDG)

(1) Supports capacity building to improve global surveillance for influenza viruses and disease; (2) conducts surveillance, program evaluations, research, and modeling activities to improve our understanding of global influenza; (3) assists with detection and response to emerging and novel influenza viruses outside the United States; (4) promotes prevention and control activities including the expanded use of influenza vaccines globally; and (5) supports global pandemic preparedness activities.

Division of Viral Diseases (DVD)(CVGE)

DVD prevents disease, disability, and death through immunization and control of enteric, and related viral diseases. In carrying out this mission, DVD: (1) Conducts surveillance and related activities to determine patterns of infection and disease and impact of prevention programs; supports and provides technical assistance to state and local health departments to conduct surveillance and related activities; (2) conducts epidemiologic and laboratory studies to define patterns of, and risk factors for, infection, disease, and disease burden; estimates vaccine effectiveness, determines cost effectiveness of vaccines, and evaluates other aspects of immunization programs; identifies and evaluates non-vaccine prevention strategies; and provides epidemiologic and laboratory expertise to other Nation Centers (NCs), collaborators, and partners on vaccination and other prevention strategies; (3) provides consultation on viral vaccine preventable, and enteric diseases, and the use of vaccines and other measures to prevent infections; (4) provides consultation and support and/or participates in investigations of viral vaccine preventable and enteric viral diseases domestically and internationally, and recommends appropriate control measures; (5) provides scientific leadership and advice, analyzes and synthesizes available data, and develops science-based statements for use of viral vaccines to ACIP and other groups to support the development and evaluation of immunization practices and policies domestically and internationally; (6) provides laboratory support for surveillance and epidemiologic studies and maintains reference/diagnostic services and expertise; (7) conducts studies of immunology and pathogenesis of disease and the biologic, biochemical, genetic and antigenic characteristics of the agents; (8) develops, evaluates, and improves diagnostic methods and reagents, and transfers assays and techniques to other public health laboratories; (9) facilitates and participates in the development and evaluation of antiviral compounds, vaccines, and vaccination programs; (10) provides and supports public health training; (11) responds to and assists internal and external partners on other public health problems of national and international significance, as needed; (12) provides technical support to state immunization programs for all aspects of vaccine-preventable diseases and their vaccines; (13) provides leadership in vaccine science; and (14) supports CDC's Immunization Safety Office (ISO) in vaccine safety risk assessment and leadership in vaccine safety risk management.

DVD Office of the Director (CVGE1)

(1) Manages, directs, coordinates and monitors the activities of the division; (2) provides overall guidance and direction for the division's epidemiologic, surveillance, research, laboratory, outbreak response, and other scientific and immunization-related activities; (3) sets short- and long-term programmatic goals and outlines strategic achievements in alignment with NCIRD priorities; (4) monitors and evaluates progress of division- and branch-led programs, promotes program improvements, and facilitates strategic decision-making; (5) provides analysis and facilitates strategic use of public health policies and operational procedures for continuous risk management and operational efficiencies; (6) identifies needs and allocates resources for ongoing and new initiatives and assigns responsibilities for their development; (7) communicates division public health messages to internal and external audiences via conventional media, web, social media, professional organizations, and other venues, to maximize impact of division programs; (8) provides leadership and guidance in policy formulation, partnerships, program planning and development, program management, and operations of the division; (9) provides division leadership, expertise, and technical collaboration for the application of statistics, economics, operations research, geospatial analysis, other quantitative sciences, informatics, and data management to prevent disease, disability and death through immunization and control of enteric, and other viral diseases; (10) provides next-generation sequencing laboratory support for method development and bioinformatics infrastructure across division and with external partners; (11) provides leadership for division informatics, data, and surveillance modernization initiatives; (12) prepares, reviews, and coordinates informational, scientific, and programmatic documents; (13) assures the overall quality of the science conducted by the division and provides guidance and new initiatives to support the enhancement of laboratory quality and bio-safety; (14) oversees and facilitates the division's scientific support to other groups within CDC and national and international public health and healthcare partners; (15) guides and facilitates efficient coordination and cooperation for administrative, programmatic, and scientific activities within the division and with other groups inside and outside of CDC; and (16) supports the division related to Management & Operations functions such as budget, program resource management, extramural administration, and human resource management.

Polio and Picornavirus Branch (CVGEC)

(1) Provides laboratory assistance, technical expertise and support for surveillance and related activities to monitor impact of vaccination and other prevention programs, and determine patterns of infection and disease due to poliovirus and other human picornaviruses; (2) provides laboratory support and technical expertise for epidemiologic and laboratory studies to define patterns and risk factors for infection, disease, and disease burden; (3) studies vaccine-related issues; (4) identifies and evaluates non-vaccine prevention strategies; (5) provides laboratory consultation and technical expertise regarding use of vaccines and other measures to prevent infections to other NCs, collaborators, and partners; (6) provides laboratory and epidemiologic consultation and support and/or participates in investigations of national and international outbreaks of viral vaccine-preventable and enteric viral diseases; (7) provides laboratory leadership and technical expertise to develop science-based statements to Global Polio Eradication Initiative, ACIP, and other groups to support the development and evaluation of immunization practices and policies in the United States and internationally; (8) provides epidemiology and laboratory consultation and support and/or participates in investigations of national and international outbreaks of viral diseases, and recommends appropriate control measures; (9) provides scientific leadership and advice, in both epidemiologic and laboratory areas; (10) provides support for surveillance and epidemiologic studies and maintains reference/diagnostic services and expertise; (11) conducts studies of immunology and pathogenesis of disease and the biology, biochemical, genetic, and antigenic characteristics of the agents; (12) develops, evaluates, and improves diagnostic methods and reagents, transfers assays and techniques to national and international public health laboratories, and provides and supports training for laboratorians; (13) facilitates and participates in the development and evaluation of antiviral compounds, vaccines, and vaccination programs; (14) responds to and assists internal and external partners on other public health problems of national and international significance as needed; and (15) serves as the National Reference Laboratory (poliovirus and enteroviruses) and World Health Organization (WHO) Global Polio Specialized Reference Laboratory.

Viral Vaccine-Preventable Diseases Branch (CVGED)

(1) Conducts surveillance to determine patterns of infection and disease, provides laboratory assistance, technical expertise, and support for surveillance and related activities to monitor the impact of vaccination on the prevention of viral disease; (2) conducts epidemiologic and laboratory studies to define patterns of and risk factors for infection, disease, and disease burden; (3) estimates vaccine effectiveness, evaluates other aspects of immunization practices; (4) identifies and evaluates non-vaccine prevention strategies; (5) provides epidemiological and laboratory expertise and technical support to other NCs, collaborators, and partners across center working groups on vaccines and other prevention strategies; (6) supports the development of vaccine practices and policies by providing consultation and epidemiologic and laboratory expertise to other federal agencies, state health departments, ministries of health, WHO, Pan American Health Organization (PAHO), private industry, academia, and other governmental organizations on viral vaccine-preventable diseases, and on the use of vaccines and other measures to prevent infections; (7) provides epidemiologic and laboratory consultation and support and/or participates in investigations of national and international outbreaks of viral vaccine-preventable diseases and recommends appropriate control measures; (8) assists internal and external partners on other public health problems of national and international significance; (9) provides scientific leadership and advice, analyzes available data, and develops science-based statements for viral vaccines to the ACIP and other groups to support the development and evaluation of immunization practices and policies in the United States and internationally; (10) responsible for human papilloma virus (HPV), measles, mumps, rubella (MMR), zoster, and varicella vaccine policy in the United States by working with ACIP; (11) provides and supports public health training; (12) responds to public inquires and prepares communication materials; (13) works with health economists to determine cost effectiveness of vaccination strategies; (14) provides laboratory support for surveillance and epidemiologic studies and maintains reference and diagnostic services and expertise; (15) assists in investigation of adverse events following vaccination; (16) conducts studies of immunology and pathogenesis of disease and the biological, biochemical, genetic, and antigenic characteristics of viral agents; (17) develops, evaluates, and improves diagnostic methods and reagents; (18) transfers assays and techniques to other public health laboratories; (19) provides and supports laboratory training; (20) serves as the National Reference Laboratory for MMR, and varicella zoster virus and the PAHO Regional and WHO Global Specialized Laboratory for measles and rubella; (21) collaborates with CDC's HPV laboratory in conducting epidemiologic investigations; (22) facilitates and participates in the development and evaluation of vaccines, and vaccination programs; and (23) conducts studies to measure the immune response to viral vaccines and population immunity.

Viral Gastroenteritis Branch (CVGEE)

(1) Provides epidemiologic and laboratory assistance to studies and related activities to better understand the evolution, (molecular) epidemiology and immunity of rotavirus, norovirus, and other gastroenteritis viruses; (2) provides consultation on the safety and impact of rotavirus vaccination and other prevention programs (rotavirus, norovirus); (3) provides consultation and technical assistance to state and local health departments to monitor the burden of disease and epidemiology of gastroenteritis virus infections; (4) provides consultation and support on the research and development of new rotavirus vaccines and other prevention technologies; (5) provides consultation, support and/or participates in investigations of national and international outbreaks of viral vaccine-preventable and other enteric viral diseases, and recommends appropriate control measures; (6) provides scientific leadership and advice, analyzes available data, and develops science-based statements for rotavirus vaccines to ACIP and other groups to support the development and evaluation of immunization practices and policies in the United States and internationally; (7) provides and supports public health training; (8) responds to and assists internal and external partners on other public health problems of national and international significance, as needed; (9) serves as the National Reference Laboratory for rotavirus, norovirus and other agents of viral gastroenteritis; and (10) serves as the WHO Global Reference Center for Rotavirus and other agents of viral gastroenteritis.

Division of Bacterial Diseases (DBD) (CVGG)

DBD prevents and controls illness and death from vaccine-preventable and other respiratory bacterial diseases, in the United States and worldwide, through leadership in epidemiologic and laboratory science and vaccine policy. DBD plays a critical role in outbreak response, surveillance and epidemiologic research, laboratory diagnosis and pathogen characterization, and vaccine development, and provides scientific support for development of vaccine policy and public health guidance to control vaccine-preventable and other respiratory bacterial diseases. In carrying out its mission, DBD: (1) Conducts and assists state and local health departments to conduct surveillance, including surveillance for antimicrobial resistance in the bacteria under the division's purview, and prepares and distributes surveillance information; (2) conducts epidemiologic and laboratory studies to define etiology, patterns of disease, disease burden, and risk factors; determines safety, effectiveness, and cost effectiveness of vaccines, updates immunization policy, and evaluates other aspects of immunization practices; and identifies and evaluates other (non-vaccine) prevention strategies; (3) provides consultation on the use of bacterial vaccines and other measures to prevent infections; (4) participates, provides consultation, and supports investigations of outbreaks, epidemics, and other public health problems in the United States and internationally, and recommends and evaluates appropriate control measures; (5) provides scientific leadership for development and evaluation of immunization policy related to vaccines in the United States by compiling and analyzing information on vaccine-preventable diseases and helping prepare statements on bacterial vaccines for the ACIP and other groups to support the development and evaluation of immunization policy; in international settings, provides guidance and technical expertise on vaccine-preventable disease policy development; (6) provides laboratory support for surveillance and epidemiologic studies and reference diagnostic services, to state and local health departments, other federal agencies, and national and international health organizations; (7) conducts studies of the biology, biochemical, genetic, and antigenic characteristics, immunology, and pathogenesis of disease; (8) develops, analyzes, and improves diagnostic methods and reagents; (9) facilitates development and evaluation of immunologic compounds, vaccines, and vaccination programs; (10) provides intramural and extramural assistance with professional training; (11) assists internal and external partners with other public health problems of national and international significance when needed; (12) provides technical support to state immunization programs for all aspects of vaccine-preventable diseases and their vaccines; (13) provides leadership in vaccine science; and (14) supports CDC's ISO in vaccine safety risk assessment and leadership in vaccine safety risk management.

DBD Office of the Director (CVGG1)

(1) Directs, coordinates, and manages the programs and activities of the division; (2) provides leadership and guidance on policy, program planning and development, program management, and operations; (3) coordinates or assures coordination with the appropriate CDC, DDID, and NCIRD offices on administrative and program matters; (4) reviews, prepares, and coordinates congressional testimony and briefing documents related to bacterial respiratory and vaccine-preventable diseases, and analyzes programmatic and policy implications of legislative proposals; (5) serves as CDC, DDID, and NCIRD's primary internal and external communications contact regarding bacterial respiratory and vaccine-preventable disease issues; (6) advises CDC, DDID, and NCIRD on policy and communications matters concerning the division's programs and activities; (7) assures the overall quality of the science conducted by the division; (8) coordinates division activities on cross-cutting agency initiatives; (9) guides and coordinates division laboratories to implement quality management systems and maintain safety; (10) guides and facilitates efficient coordination and cooperation for administrative, programmatic, and scientific activities within the division, and with other groups in and outside of CDC; (11) provides statistical consultation for epidemiologic and laboratory research studies conducted by the division, including developing new methods for statistical applications; and (12) provides a center of excellence for the study of immunologic response to infection, vaccination, and therapeutic interventions against bacterial diseases.

Respiratory Diseases Branch (CVGGB)

(1) Provides assistance in control of epidemics and works to improve control and prevention of respiratory and other syndromes caused by Streptococcus pneumoniae, group A and group B streptococci, and atypical respiratory bacteria (Legionella, Mycoplasma, and Chlamydia species), as well as community-acquired drug resistant bacterial infections, community-acquired pneumonia, otitis media, and neonatal sepsis; (2) develops, implements, and evaluates prevention methods for these diseases, including vaccines and non-vaccine strategies; (3) provides consultation and support to domestic and international partners on use of vaccines and other prevention measures to reduce bacterial respiratory diseases; (4) coordinates activities within and outside the division related to Active Bacterial Core surveillance with the Emerging Infections Program states, and assists with coordination of other surveillance platforms that include bacterial respiratory diseases; (5) provides reference and diagnostic activities for respiratory bacterial diseases and for the identification of unknown gram positive cocci; (6) develops and evaluates new diagnostic methods for bacterial respiratory pathogens; (7) develops, maintains, and implements genetic analyses of bacteria to enhance surveillance programs, outbreak investigations, and public health research; and (8) collaborates with other CDC groups, state and federal agencies, ministries of health, WHO, PAHO, private industry, academia, and other governmental organizations involved in public health.

Meningitis and Vaccine Preventable Diseases Branch (CVGGC)

(1) Provides assistance in control of endemic and epidemic disease and exploits opportunities to improve control and prevention of bacterial illness including: meningococcal disease, Haemophilus influenzae infections, diphtheria, pertussis, tetanus, and bacterial meningitis syndrome; (2) provides reference and diagnostic activities for agents causing these diseases; (3) provides cross-cutting vaccine responsibilities for DBD and develops, implements, and evaluates prevention strategies for these bacterial diseases; (4) develops, implements, and evaluates vaccines and vaccine candidates for these bacterial diseases; (5) conducts surveillance and epidemiological research for meningococcal disease, H. influenzae infections, diphtheria, pertussis, tetanus, and bacterial meningitis syndrome; (6) maintains WHO Collaborating Center for Control and Prevention of Epidemic Meningitis; and (7) collaborates with other CDC groups, state and federal agencies, ministries of health, WHO, PAHO, private industry, and other governmental organizations involved in public health.

Coronavirus and Other Respiratory Viruses Division (CRVD) (CVGH)

CRVD prevents disease, disability, and death through immunization and control of coronaviruses, respiratory, and other related viral diseases. In carrying out this mission, CRVD: (1) Conducts surveillance and related activities to determine patterns of infection and disease and impact of prevention programs; (2) supports and provides technical assistance to state and local health departments to conduct surveillance and related activities; (3) conducts epidemiologic and laboratory studies to define patterns of, and risk factors for, infection, disease, and disease burden; (4) estimates vaccine effectiveness, determines cost effectiveness of vaccines, and evaluates other aspects of immunization programs; (5) identifies and evaluates non-vaccine prevention strategies and provides epidemiologic and laboratory expertise to other NCs, collaborators, and partners on vaccination and other prevention strategies; (6) provides consultation on viral vaccine preventable, and enteric diseases, and the use of vaccines and other measures to prevent infections; (7) provides consultation and support and/or participates in investigations of respiratory viral diseases domestically and internationally, and recommends appropriate control measures; (8) analyzes and synthesizes available data to support the development and evaluation of immunization practices and policies domestically and internationally; (9) provides laboratory support for surveillance and epidemiologic studies and maintains reference/diagnostic services and expertise; (10) conducts studies of immunology and pathogenesis of disease and the biologic, biochemical, genetic and antigenic characteristics of the agents; (11) develops, evaluates, and improves diagnostic methods and reagents; (12) transfers assays and techniques to other public health laboratories; (13) facilitates and participates in the development and evaluation of antiviral compounds, vaccines, and vaccination programs; (14) provides and supports public health training; (15) responds to and assists internal and external partners on other public health problems of national and international significance, as needed; (16) provides technical support to state immunization programs for all aspects of vaccine-preventable diseases and their vaccines; (17) provides leadership in vaccine science; and (18) supports CDC's ISO in vaccine safety risk assessment and leadership in vaccine safety risk management.

CRVD Office of the Director (CVGH1)

(1) Manages, directs, coordinates and monitors the activities of the division; (2) provides overall guidance and direction for the division's epidemiologic, surveillance, research, laboratory, outbreak response, and other scientific and immunization-related activities; (3) sets short- and long-term programmatic goals and outlines strategic achievements in alignment with NCIRD priorities; (4) monitors and evaluates progress of division- and branch-led programs, promotes program improvements, and facilitates strategic decision-making; (5) provides analysis and facilitates strategic use of public health policies and operational procedures for continuous risk management and operational efficiencies; (6) identifies needs and allocates resources for ongoing and new initiatives and assigns responsibilities for their development; (7) communicates division public health messages to internal and external audiences via conventional media, web, social media, professional organizations, and other venues, to maximize impact of division programs; (8) provides leadership and guidance in policy formulation, partnerships, program planning and development, program management, and operations of the division; (9) provides division leadership, expertise, and technical collaboration for the application of statistics, economics, operations research, geospatial analysis, other quantitative sciences, informatics, and data management to prevent disease, disability and death through immunization and control of enteric, and other viral diseases; (10) provides next-generation sequencing laboratory support for method development and bioinformatics infrastructure across division and with external partners; (11) provides leadership for division informatics, data, and surveillance modernization initiatives; (12) prepares, reviews, and coordinates informational, scientific, and programmatic documents; (13) assures the overall quality of the science conducted by the division and provides guidance and new initiatives to support the enhancement of laboratory quality and bio-safety; (14) oversees and facilitates the division's scientific support to other groups within CDC and national and international public health and healthcare partners; (15) guides and facilitates efficient coordination and cooperation for administrative, programmatic, and scientific activities within the division and with other groups inside and outside of CDC; (16) coordinates program and Division-level pandemic preparedness activities related to current and known threats such as COVID-19 and preparedness for future or emerging threats; (17) advises NCIRD and CDC leadership in the areas of pandemic preparedness and response and global health related to respiratory and vaccine preventable diseases including establishing CRVD priorities, promoting science, policies, and new programs; (18) coordinates across NCIRD, CDC, and with partners to plan for and exercise responses to pandemic and other threats; and (19) supports the division and all branches through a management and operations hub, providing functional support such as budget, program resource management, extramural administration, and human resource management.

Coronavirus and Other Respiratory Viruses Laboratory Branch (CVGHB)

(1) Designs and conducts studies of the biological, genetic, and antigenic characteristics of non-influenza respiratory viruses including SARS-CoV-2, the virus the causes COVID-19, and the immunology and pathogenesis of associated diseases; (2) designs and conducts laboratory-related activities to support surveillance and epidemiologic studies, and to monitor impact of vaccination and other respiratory virus prevention measures; (3) provides laboratory support and technical expertise for studies to define patterns and risk factors for respiratory virus infections, diseases, and disease burden; (4) develops, evaluates, and improves diagnostic methods and reagents, conducts strain characterization for molecular epidemiology, and provides technology transfer support to public health laboratories for known and unknown viral etiologic agents for respiratory diseases of human and animal origin; (5) characterizes immune correlates of protection to advise partners on vaccine program policies; (6) determines virus and host factors that impact virulence and transmission of SARS-CoV-2 and other respiratory viruses; (7) facilitates and participates in the evaluation of respiratory virus countermeasures including prophylactics, therapeutics, and vaccines; (8) provides laboratory consultation and support for investigation of domestic and international respiratory viral disease outbreaks; (9) serves as CDC technical lead for providing guidance to WHO and key partners on classification of viral variants, performing variant risk assessments to inform COVID-19 vaccination policies, as well as in supporting platforms for genomic monitoring of coronaviruses and other respiratory viruses; (10) provides laboratory leadership and technical expertise to develop science-based statements to ACIP and other domestic and international collaborators to support the development and evaluation of practices, policies, and vaccine considerations for SARS-CoV-2 and other respiratory viruses; and (11) provides technical assistance to international partners to conduct comprehensive antigenic, phenotypic, genotypic, structural, and evolutionary characterization of SARS-CoV2 and other respiratory viruses.

Coronavirus and Other Respiratory Viruses Surveillance and Prevention Branch (CVGHC)

(1) Conducts surveillance and related activities to monitor patterns of respiratory virus infection and disease incidence and assess impact of interventions; (2) provides technical expertise and support to state and local health departments for surveillance and related activities; (3) provides expertise and support on data analysis and visualization of respiratory virus surveillance data for internal and external use; (4) performs applied modeling analyses to characterize disease burden and impact of interventions; (5) conducts vaccine effectiveness evaluations for coronaviruses and other respiratory viruses to support the development and evaluation of immunization practices and policies; (6) analyzes and synthesizes available data and develops science-based statements for potential respiratory viral vaccines to support the development and evaluation of immunization practices and policies related to coronaviruses and other respiratory virus vaccines by ACIP and other groups; (7) Coordinates quantitative science and data management planning, policy development, and project monitoring and evaluation; (8) designs, develops and conducts statistical, economic, cost, resource allocation, geospatial and other analyses and models; (9) develops data management methodologies and strategies for division activities and programs; and (10) collaborates with scientists, program experts, and senior public health officials throughout the division to implement strategies, models, and methodologies in support of enteric, and related viral disease research, surveillance, and prevention programs.

Coronavirus and Other Respiratory Viruses Epidemiology Branch (CVGHD)

(1) Characterizes the spectrum of disease and sequelae from respiratory virus infections, including, but not limited to multisystem inflammatory syndrome and post-COVID conditions, the burden and incidence of sequelae, and risk factors for sequelae; (2) characterizes transmission dynamics and risk factors for coronavirus and other respiratory virus infections; (3) characterizes acute and long-term immunity to understand correlates of protection; (4) conducts and supports field epidemiologic studies to characterize unusual disease clusters and unexpected disease manifestations or trends of viral respiratory diseases; (5) provides consultation and technical assistance to state and local health departments and others in the investigation, management, mitigation and control of viral respiratory disease clusters and outbreaks; (6) evaluates the implementation, effectiveness and impact of community-level mitigation measures; (7) develops and updates public health guidance on community-based non-pharmaceutical interventions for the prevention and control of respiratory viruses, such as masking, screening, quarantine, and isolation; and (8) provides consultation and technical support on clinical management and secondary prevention for respiratory viral diseases.

Global Coronavirus and Other Respiratory Viruses Branch (CVGHE)

(1) Implements global respiratory virus surveillance including supporting enhanced epidemiologic and laboratory capacity and data analyses to improve understanding of the epidemiological characteristics, trends, and emergence of respiratory pathogens; (2) builds capacity for global surveillance and epidemic intelligence to detect and respond to respiratory events including those of pandemic potential; (3) assists global partners in pandemic preparedness activities; (4) provides support and/or participates in investigations of international respiratory outbreaks including implementing appropriate control measures; (5) conducts research studies with global partners, division, and agency stakeholders to better understand burden of disease, impact of prevention programs, and molecular epidemiology of respiratory viruses; (6) provides technical assistance to global partners to conduct or support comprehensive antigenic, phenotypic, genotypic, structural, and evolutionary characterization of SARS-CoV-2 and respiratory viruses; and (7) provides expertise to global partners in the development of evidence-based surveillance standards and methods.

Delegations of Authority

All delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegation, provided they are consistent with this reorganization.

(Authority: 44 U.S.C. 3101)

Xavier Becerra,

Secretary, Department of Health and Human Services.