2020-10598. 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 85 FR 21008, dated April 15, 2020) is amended to reorganize the National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention.

Section C-B, Organization and Functions, is hereby amended as follows:

Delete mission statements for the National Center for Immunization and Respiratory Diseases (CVG) insert the following:

National Center for Immunization and Respiratory Diseases (CVG). The National Center for Immunization and Respiratory Diseases (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 the national center focus with the overall strategic goals of CDC; (13) synchronizes all aspects of CDC's pandemic influenza preparedness and response from strategy through implementation and evaluation; and (14) implements, coordinates, and evaluates programs across NCIRD, Deputy Director for Infectious Diseases(DDID), and CDC to optimize public health impact.

Delete the functional statements for the Office of the Director (CVG1) and insert the following:

Office of the Director (CVG1). (1) Provides leadership, expertise, and service in laboratory and epidemiological sciences 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 the NCIRD strategy is executed by the divisions and aligned with overall CDC goals; (5) co-develops execution strategies for the center 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 center 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, the Vaccine Management Improvement Project and other administrative services; and (20) manages the coordination of workforce development and succession planning activities and provide human capital management, planning and training consultation services.

Delete the functional statements for the Office of Informatics (CVG12) and insert the following:

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; (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; and (9) participates in the evolution, identification, development, or adoption of appropriate informatics standards in conjunction with the DDID.

Delete in its entirety the title and functional statement for the Office of Administrative Services (CVG16) and insert the following:

Office of Management and 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 programmatic direction for planning and management oversight of allocated resources; (3) provides guidance on NCIRD requirements related to contracts, grants, cooperative agreements, reimbursable agreements, interagency agreements, memorandums of agreement/understanding, and intergovernmental personnel act agreements; (4) reviews the effectiveness and efficiency of the operation and administration of all NCIRD programs; (5) develops and implements administrative policies and procedures; and (6) prepares special reports and studies in the administrative management areas.

Delete in its entirety the title and functional statement for the Office of Science and Integrated Programs (CVG17) and insert the following:

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) interfaces with other CDC CIOs working in the area of respiratory diseases; (4) coordinates and facilitates the center'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 in quantifying 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, as well as leadership on issues related to internal and external integration of CDC surveillance activities; (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; and (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.

After the functional statement for the Influenza Coordination Unit (CVG18), insert the following:

VTrckS Management Office (CVG19). Responsible for providing day-to-day management and support for VTrckS/NABIP internal and external customers including: (1) Co-chair and support of VTrckS PMO; (2) testing and troubleshooting of all VTrckS and NABIP functionality and break fixes; (3) OCM and communications for internal and external VTrckS and NABIP customers; (4) web-based and in person training for internal and external VTrckS and NABIP customers; (5) conducting annual VTrckS User Satisfaction survey; (6) Level 1 and Level 2 support for VTrckS and NABIP; and (7) managing contracts for Business Analysts, VTrckS operations and maintenance technical support, training and program support, and VTrckS contact center operations.

Delete in its entirety the title and functional statement for the Division of Bacterial Diseases (CVGG) and insert the following:

Division of Bacterial Diseases (CVGG). The Division of Bacterial Diseases (DBD) prevents respiratory and vaccine-preventable diseases caused by bacteria through strategic planning, coordination, scientific investigation, and leadership. 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 U.S. 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 U.S. 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 VPD 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 Immunization Safety Office in vaccine safety risk assessment and leadership in vaccine safety risk management.

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, CCID, 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, CCID, and NCIRD's primary internal and external communications contact regarding bacterial respiratory and vaccine-preventable disease issues; (6) advises CDC, CCID, and NCIRD on policy matters concerning the division's programs and activities; (7) assures the overall quality of the science conducted by the division; (8) 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; (9) provides statistical methodology and participates in the division's outbreak investigations and disease reporting systems for ongoing surveillance; (10) develops new methods or adapts existing methods for statistical applications in epidemiologic or laboratory research studies for the division; (11) provides statistical consultation for epidemiologic and laboratory research studies conducted by the division; (12) assists researchers with statistical aspects of report writing and prepares statistical portions of papers, protocols, and reports written by staff of the division; (13) trains professional staff of the division in statistical methods; and (14) provides a center of excellence for the study of immunologic response to infection, vaccination, and therapeutic interventions against bacterial diseases, including Bacillus anthracis.

Respiratory Diseases Branch (CVGGB). (1) Provides assistance and 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 Disease Branch (CVGGC). (1) Provides assistance in control of endemic and epidemic disease and exploits opportunities to improve control and prevention of bacterial illness including: disease due to Neisseria meningitidis, 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 the division of bacterial diseases; 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

Sherri A. Berger,

Chief Operating Officer, Centers for Disease Control and Prevention.