82 FR 57455 - Statement of Organization, Functions, and Delegations of Authority
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 232 (December 5, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 232 (December 5, 2017)
| Page Range | 57455-57457 | |
| FR Document | 2017-26150 |
[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)] [Notices] [Pages 57455-57457] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26150] [[Page 57455]] ----------------------------------------------------------------------- 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 81 FR 84583-84591, dated November 23, 2016) is amended to reflect the reorganization of the Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Office of Infectious Disease, Centers for Disease Control and Prevention. Section C-B, Organization and Functions, is hereby amended as follows: Delete and replace the title and the mission and function statements for the Division of Viral Disease (CVGE) and insert the following: Division of Viral Disease (CVGE). The Division of Viral Diseases (DVD) prevents disease, disability, and death through immunization and by control of respiratory, enteric, and related viral diseases. In carrying out this mission, the DVD: (1) Conducts surveillance and related activities; supports and provides technical assistance to state and local health departments to conduct surveillance and related activities to monitor the impact of vaccination and other prevention programs; and determine patterns of infection and disease; (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 practices; identifies and evaluates non- vaccine prevention strategies; and provides epidemiological and laboratory expertise to other Nation Centers (NCs), collaborators, and partners on vaccine and other prevention strategies; (3) provides consultation on viral vaccine preventable, respiratory, 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 national and international outbreaks of viral vaccine preventable and other respiratory and enteric viral diseases, and recommends appropriate control measures; (5) provides scientific leadership and advice, analyzes available data, and develops science- based statements for viral vaccines to the Advisory Committee on Immunization Practices (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 biology, 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 in vaccine safety risk assessment and leadership in vaccine safety risk management. Office of the Director (CVGE1). (1) Manages, directs, and coordinates the activities of the division; (2) provides leadership and guidance in policy formulation, program planning and development, program management, and operations of the division; (3) identifies needs and resources for ongoing and new initiatives and assigns responsibilities for their development; (4) prepares, reviews, and coordinates informational, scientific, and programmatic documents; (5) oversees the division's activities and expenditures; (6) assures the overall quality of the science conducted by the division; (7) provides overall guidance and direction for the division's surveillance, research, and other scientific and immunization activities; (8) provides overall guidance and direction for division's epidemiologic, laboratory, and outbreak response capacity and activities; (9) oversees and facilitates the division's scientific support to other groups within CDC, the national and international healthcare, and public health communities regarding viral respiratory and enteric diseases and viral immunization programs; (10) 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 (11) provides division leadership, expertise, and technical collaboration for the application of statistics, economics, operations research, geography, other quantitative sciences, and data management to prevent disease, disability and death through immunization and control of respiratory, enteric, and related viral diseases. Analysis and Data Management Activity (CVGE12). (1) Coordinates quantitative science and data management planning, policy development, and project monitoring and evaluation; (2) designs and develops statistical, economic, cost, resource allocation, geospatial and data management strategies, models, and methodologies in the public health arena; and (3) collaborates with scientists, program experts, and senior public health officials throughout the division to implement these strategies, models, and methodologies in support of respiratory, enteric and related viral diseases surveillance and prevention studies, prevention resource allocation issues, and prevention program activities. Respiratory Viruses Branch (CVGEB). (1) Conducts surveillance, laboratory assistance, and related activities, and supports and provides technical assistance to state and local health departments to conduct surveillance and related activities to monitor the impact of prevention programs, and determine patterns of infection and disease; (2) conducts and provides laboratory support and expertise for epidemiologic and laboratory studies to define patterns of and risk factors for infection, disease, and disease burden; (3) provides epidemiology and laboratory consultation and support and/or participates in investigations of national and international outbreaks of viral respiratory diseases, and recommends appropriate control measures; (4) provides scientific, both epidemiologic and laboratory, leadership and advice; (5) analyzes available data, and develops science-based statements for potential respiratory viral vaccines to the ACIP and other groups to support the development and evaluation of immunization practices and policies in the U.S and internationally; (6) provides and supports public health training; (7) responds to and assists internal and [[Page 57456]] external partners on other public health problems of national and international significance, as needed; (8) provides laboratory support for surveillance and epidemiologic studies and maintains reference/ diagnostic services and expertise; (9) conducts studies of immunology and pathogenesis of disease and the biology, biochemical, genetic, and antigenic characteristics of the agents; (10) develops, evaluates, and improves diagnostic methods and reagents, and transfers assays and techniques to other public health laboratories and provides and supports laboratory training; (11) facilitates and participates in the development and evaluation of antiviral compounds, vaccines, and vaccination programs; and (12) responds to and assists internal and external partners on other public health problems of national and international significance as needed. Polio and Picornavirus Laboratory 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; (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 evaluate 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 consultation and support and/or participates in investigations of national and international outbreaks of viral vaccine preventable and other respiratory and enteric viral diseases; (7) provides laboratory leadership and technical expertise to develop science-based statements to Global Polio Eradication Initiative, the ACIP, and other groups to support the development and evaluation of immunization practices and policies in the U.S and internationally; (8) provides epidemiology and laboratory consultation and support and/or participates in investigations of national and international outbreaks of viral respiratory diseases, and recommends appropriate control measures; (9) provides scientific, both epidemiologic and laboratory, leadership and advice; (10) provides laboratory 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), World Health Organization (WHO) Collaborating Center for Poliovirus and Enteroviruses Virus Reference and Research, and WHO Global Specialized Polio Reference Laboratory. Viral Vaccine Preventable Diseases Branch (CVGED). (1) Conducts surveillance, provides laboratory assistance, technical expertise, and support for surveillance and related activities to monitor the impact of vaccination on the prevention of viral disease and to determine patterns of infection and 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, 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 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 U.S and internationally; (10) responsible for human papilloma virus (HPV), measles, mumps, rubella (MMR), domestic polio, 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; (17) transfers assays and techniques to other public health laboratories; (18) provides and supports laboratory training; (19) 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; and (20) works closely with the laboratory that handles HPV to define and conduct epidemiologic investigations. Viral Gastroenteritis Branch (CVGEE) (1) Provides epidemiologic and laboratory assistance 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 (rotavirus, norovirus); (4) provides consultation and support on the research and development of new rotavirus vaccines and other prevention technologies; (5) provides consultation and 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 the ACIP and other groups to support the development and evaluation of [[Page 57457]] immunization practices and policies in the U.S 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 (rotavirus and norovirus) and other agents of viral gastroenteritis; and (10) serves as the WHO Global Reference Center for Rotavirus and other agents of viral gastroenteritis. Sherri Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2017-26150 Filed 12-4-17; 8:45 am] BILLING CODE 4160-18-P
![Federal Register / Vol. 82, No. 232 / Tuesday, December 5, 2017 / Notices 57457
immunization practices and policies in development of strategic goals, based laboratory training, fellowships,
the U.S and internationally; (7) provides objectives, and milestones to advance and education; (4) engages agency and
and supports public health training; (8) the vision and mission of the Division laboratory community experts to
responds to and assists internal and of Laboratory Systems (DLS), the Center collaboratively assess and develop
external partners on other public health for Surveillance Epidemiology and effective training products to maintain a
problems of national and international Laboratory Services (CSELS), and CDC; competent, prepared, and sustainable
significance, as needed; (9) serves as the (2) ensures optimal planning and national and global laboratory
National Reference Laboratory (rotavirus allocation of resources to achieve workforce; (5) designs and implements
and norovirus) and other agents of viral program objectives, conducts training pertaining to clinical and
gastroenteritis; and (10) serves as the management and operations analyses, public health laboratory methodology,
WHO Global Reference Center for and oversees required reporting; (3) technology, quality and safety and
Rotavirus and other agents of viral provides administrative management practice for public health, clinical, CDC,
gastroenteritis. support, advice, and guidance to DLS and other federal agency laboratory
regarding administrative policies, fiscal professionals; and (6) evaluates the
Sherri Berger,
management, property management, efficiency and effectiveness of public
Chief Operating Officer, Centers for Disease
human resources, and travel; (4) leads health laboratory education and
Control and Prevention.
coordination and stewardship of DLS training, including measuring the
[FR Doc. 2017–26150 Filed 12–4–17; 8:45 am]
procurement, grants, cooperative outcomes of all training to ensure the
BILLING CODE 4160–18–P
agreements, materials management, effective transfer of knowledge and
interagency agreements, and extramural skills to improved laboratory practice.
resources; (5) fosters collaborations and Quality and Safety Systems Branch
DEPARTMENT OF HEALTH AND
cross-cutting activities with other CDC (CPNBD). (1) Develops, promotes,
HUMAN SERVICES
components and external organizations implements, and evaluates intervention
Centers for Disease Control and to support the mission, activities, and strategies to improve quality and safety
Prevention operations of DLS; (6) enhances internal in clinical and public health laboratory
and external partnerships and partner/ systems; (2) provides scientific and
Statement of Organization, Functions, stakeholder communication; (7) technical support for the Clinical
and Delegations of Authority provides leadership in evaluating and Laboratory Improvement Amendments
improving program performance, (CLIA) program to assure the quality,
Part C (Centers for Disease Control monitoring progress and
and Prevention) of the Statement of including safety, of clinical and public
accomplishments to ensure that health laboratory testing nationwide; (3)
Organization, Functions, and programmatic goals are achieved with
Delegations of Authority of the facilitates and conducts studies to
measurable impact; (8) manages issues, provide scientific evidence and assess
Department of Health and Human policy development, and tracks
Services (45 FR 67772–76, dated the impact of CLIA regulations and
regulatory and legislative activities; (9) voluntary guidelines for laboratory
October 14, 1980, and corrected at 45 FR manages CDC Specimen Policy Board
69296, October 20, 1980, as amended quality and safety; (4) provides expertise
and the CDC/ATSDR Specimen and guidance in the development or
most recently at 81 FR 84583–84591, Packaging, Inventory, and Repository
dated November 23, 2016) is amended revision of CLIA technical standards
(CASPIR) Advisory Committee; (10) and voluntary guidelines for laboratory
to reflect the reorganization of the collaborates with leadership of the
Center for Surveillance, Epidemiology quality and safety, especially in light of
Centers for Medicare & Medicaid new and evolving laboratory technology
and Laboratory Services, Office of Services (CMS) and the Food and Drug
Public Health Preparedness and and practices; (5) develops,
Administration (FDA) in advancement disseminates, promotes, and evaluates
Response, Centers for Disease Control of the Clinical Laboratory Improvement
and Prevention. the impact of educational materials to
Amendments (CLIA) program and support the understanding of and
Section C–B, Organization and
oversees CDC responsibilities therein; compliance with CLIA regulations and
Functions, is hereby amended as
(11) provides scientific oversight for voluntary quality and safety guidelines;
follows:
Delete in its entirety the title for the DLS, performing scientific review and (6) hosts and manages the Clinical
Center for Surveillance, Epidemiology clearance for DLS publications, Laboratory Improvement Advisory
and Laboratory Service (CPN) and insert presentations, and reports; (12) provides Committee (CLIAC) and its workgroups
the following title which includes the DLS communications, Web support, on behalf of a tri-agency partnership
Oxford comma: Center for Surveillance, responses to media requests, and among CDC, CMS, and FDA; (7)
Epidemiology, and Laboratory Service communication outreach efforts; and provides information to the laboratory
(CPN). (13) coordinates requests from other medicine and public health
Delete in its entirety the title and the CDC programs for international communities, as well as policy makers,
mission and function statements for the technical assistance among DLS regarding the interpretation and
Division of Laboratory Systems (CPNB) capabilities. application of the CLIA technical
and insert the following: Training and Workforce Development standards and other issues of laboratory
Division of Laboratory Systems Branch (CPNBC). (1) Provides quality and safety; (8) provides
(CPNB). The mission of the Division of leadership and support of laboratory technical assistance in the review of
workforce through initiatives that laboratory accreditation and state
sradovich on DSK3GMQ082PROD with NOTICES
Laboratory Systems (DLS) is to
strengthen the nation’s clinical and strengthen recruitment, retention, licensure programs, and CLIA-approved
public health laboratory system by management, and training; (2) supports proficiency testing programs; (9)
continually improving quality and the development, promotion, adoption, facilitates and supports collaborations
safety, informatics and data science, and and implementation of competencies with federal partners and other
workforce competency. relevant to the laboratory workforce; (3) stakeholders (including other CDC
Office of the Director (CPNB1). (1) develops frameworks, models, and programs upon request) for the
Provides leadership and guidance on resources that support competency- exchange of information about
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Document Created: 2017-12-04 23:44:49
Document Modified: 2017-12-04 23:44:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 82 FR 57455 |
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