[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Notices]
[Pages 54091-54094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19302]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Statement of Organization, Functions, and Delegations of 
Authority

    Part C (Centers for Disease Control and Prevention) of the 
Statement of Organization, Functions, and Delegations of Authority of 
the Department of Health and Human Services (45 FR 67772-76, dated 
October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as 
amended most recently at 81 FR 46677, dated July

[[Page 54092]]

18, 2016) is amended to reflect the reorganization of the Division of 
Tuberculosis Elimination, National Center for HIV/AIDS, Viral 
Hepatitis, STD, and TB Prevention, Office of Infectious Diseases, 
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 Tuberculosis Elimination (CVJE) and 
insert the following:
    Division of Tuberculosis Elimination (CVJE). The Division of 
Tuberculosis Elimination (DTBE) promotes health and quality of life by 
preventing, controlling, and eventually eliminating tuberculosis (TB) 
from the United States (U.S.), and collaborates with international 
partners by representing the U.S. national TB program. In carrying out 
its mission, the Division conducts the following activities under each 
focus area: (1) Administers and promotes a national program for the 
prevention, control, and elimination of TB; (2) supports a nationwide 
framework for surveillance of TB and evaluation of national TB 
prevention and control performance; (3) provides programmatic 
consultation, technical assistance, and outbreak response assistance to 
state and local TB programs; (4) co-chairs and coordinates 
administrative support for the Federal TB Task Force, and supports and 
collaborates with the National Tuberculosis Controllers Association 
(NTCA) and the Tuberculosis Education and Training Network to promote 
effective national communications and coordinated feedback on urgent 
policy and program performance issues; (5) supports development of TB 
patient education materials and interventions, capacity development, 
and access to medical consultation; (6) provides national and 
supranational reference laboratory function for identification and drug 
susceptibility testing of Mycobacterium tuberculosis; (7) fosters 
patient-centered messages, including those regarding directly-observed 
therapy, to promote adherence with long-term treatment for improvements 
in well-being and interruption in community transmission of M. 
tuberculosis; (8) promotes targeted testing of epidemiologically-
defined at-risk populations and treatment of persons with latent TB; 
(9) conducts epidemiologic, laboratory, behavioral, health systems, and 
clinical research; (10) supports patient and provider research to 
identify barriers and facilitators to TB services; (11) supports 
multicenter consortia for epidemiologic, laboratory, diagnostics, 
clinical, and vaccine development research; (12) develops and applies 
mathematical TB transmission models to forecast future incidence and 
prevalence trends; (13) provides leadership and formulates policies and 
guidelines; (14) provides technical supervision and training to federal 
assignees working in state, and local TB control programs; (15) 
develops training and educational materials, and provides technical 
assistance on communications and training needs; (16) participates in 
the development of policies and guidelines for TB prevention and 
control within populations at high risk, such as persons infected with 
HIV or racial and ethnic minorities; (17) supports technical activities 
and operational research to reduce TB in foreign-born populations; (18) 
Represents the U.S. national TB program with regard to the global 
health initiatives for the prevention and control of TB and drug-
resistant TB; (19) Represents the U.S. national TB control program with 
regard to the World Health Organization (WHO)-hosted Stop TB 
Partnership for implementation of the Global Plan to Stop TB and 
Millennium Development Goals; (20) monitors progress and trends towards 
TB elimination, including progress towards CDC's Healthy People 2020; 
(21) provides progress reports to, and solicits advice from, the 
Advisory Council for the Elimination of Tuberculosis (ACET); and (22) 
facilitates partnerships with affected communities, nongovernmental, 
professional, and global organizations.
    Office of the Director (CVJE1). (1) Provides leadership and 
guidance in program planning and management, policy formulation, and 
development of training, surveillance, and research programs in TB; (2) 
directs and evaluates the operations of the Division; (3) establishes 
contact with, and promotes TB activities of, other organizations that 
have an important role to play in achieving TB elimination; (4) 
coordinates administrative and logistical support services for the 
Division; (5) provides consultation and assistance in writing reports 
for presentation at local, regional, national, and international 
scientific meetings and for publication in scientific journals; (6) 
coordinates and tracks materials for purposes of clearance and approval 
for publications and presentations; (7) presents findings at national 
and international scientific meetings; (8) presents Division overview 
at the ACET meetings; (9) collaborates and coordinates Division 
activities with other components of NCHHSTP and CDC; (10) provides 
technical support to ACET; (11) provides administrative and technical 
support for STOP TB USA (previously the National Coalition for the 
Elimination of Tuberculosis) and the Federal TB Task Force; and (12) 
provides representation of the U.S. national TB program to WHO and 
other international entities.
    Communications, Education, and Behavioral Studies Branch (CVJEB). 
(1) Provides technical assistance to health departments and other 
health care providers in assessing and meeting their TB training, 
education, and communication needs; (2) provides technical expertise to 
assess the impact of training and education activities by health 
departments; (3) provides technical assistance to health departments 
and other TB health care providers regarding behavioral studies 
research and intervention development; (4) provides consultation and 
assistance in coordinating TB training, education, behavioral studies 
and interventions, and communication activities carried out by other 
CDC programs, Regional Training and Medical Consultation Centers, and 
Stop TB USA members, and develops, markets, and maintains electronic 
mailing lists for persons with TB-related education, training, and 
communication responsibilities; (5) provides DTBE coordination and 
oversight and technical information for CDC INFO; (6) organizes and 
maintains scientific and non-scientific information resources related 
to TB; (7) conducts formative research and evaluation on approaches to 
patient, provider, and public education, and conducts research on 
individual and social factors affecting health-care seeking behavior 
and treatment outcomes related to TB; (8) based on research findings, 
develops behavioral interventions targeted to health care providers, 
persons with or at risk for TB, and other high-risk populations; (9) 
provides consultation to national organizations on behavioral research 
needs and study designs; on the technical transfer of behavioral 
research findings into TB program practice and TB training and 
educational strategies; and provides consultation, technical assistance 
and coordination to other branches within the Division regarding 
development and implementation of behavioral interventions and training 
for branch specific activities such as Report of Verified Case of 
Tuberculosis, Aggregate Reports for Program Evaluation, and 
surveillance activities; (10) presents findings at national and 
international scientific meetings and develops, disseminates and 
evaluates training and

[[Page 54093]]

educational materials and courses providing TB information to the 
scientific and public health communities, as well as the general 
population; (11) conducts training and education needs assessments; 
identifies resources available for health department TB control 
officers and senior managers, TB nurse consultants, TB training and 
education directors and for senior staff carrying out TB activities in 
other programs or facilities serving persons at high risk for TB; and 
develops, conducts, and coordinates training courses on TB for state 
and big city TB program managers and nurse consultants; (12) based on 
needs assessments, develops and conducts or coordinates training 
courses and materials for staff who train and/or supervise front-line 
TB program staff; (13) provides oversight in the planning, 
coordination, and maintenance of the Division's Internet and Intranet 
Web sites; (14) conducts and/or coordinates communications programs 
designed to build public support and sustain public interest and 
commitment to the elimination of TB; (15) conducts communications 
research and identifies communications resources available for health 
department TB control officers and senior managers, TB nurse 
consultants, and for senior staff carrying out activities in other 
programs or facilities serving persons at high risk for TB; (16) 
provides coordination and oversight for Division responses and 
relations with the media and public and serves as point of contact for 
telephonic, written, and electronic (email) requests for information 
from the media and public; (17) develops, coordinates, and staffs the 
Division's exhibit booth at conferences/meetings; (18) provides 
oversight and coordination for TB-related voice and web-based TB 
information, training, and education resources; and (19) presents 
communications issues to ACET and at national and international 
scientific meetings.
    Data Management, Statistics, and Evaluation Branch (CVJEC). (1) 
Provides Division-wide leadership in and coordination of data 
management, statistics, program evaluation, and economic planning, 
policy development, and monitoring within an integrated systems 
framework, playing a central role in the education of all DTBE staff on 
the science and methods of data management, statistics, program 
evaluation, and health economics; (2) consults and assists in 
appropriate data collection, management, analysis, and reporting for 
scientific studies conducted Division-wide; (3) collaborates in the 
statistical analysis of data and in the preparation of materials for 
publication; (4) coordinates and oversees data management and 
statistical design, implementation and analysis support, and 
consultation for the TB Clinical Trials and the TB Epidemiologic 
Studies Consortia; (5) conducts statistical research and methods 
development, including mathematical models of TB transmission and 
diagnostic test performance to improve the effectiveness of prevention 
and control activities; (6) coordinates data management, statistics, 
and evaluation services provided under contractual services; (7) 
collaborates with other components of the Division to develop and 
implement strategies and activities to meet goals for Division 
priorities; (8) translates overall NCHHSTP and DTBE strategies into 
branch-specific implementation plans for research and programs; and (9) 
participates in the development of comprehensive evaluation methods for 
TB prevention and control programs; (10) consults on the implementation 
of key provisions of program evaluation contained in cooperative 
agreements between CDC and external state and local TB programs; (11) 
provides transparent and easily understood program evaluation and 
health economic data to TB control programs that serve them in meeting 
TB national goals and objectives; (12) galvanizes external TB control 
programs to implement and use National TB Indicators Project data to 
prioritize program areas for improvement; (13) provides major 
authoritative technical advice on economics and be an authority on all 
matters related to the analysis and collection of economic data 
relevant to Division goals, and (14) presents data management, 
statistical, and economic considerations, and reporting issues to ACET 
and other national and international scientific meetings.
    Field Services Branch (CVJED). (1) Provides medical and 
programmatic consultation to assist state and local health departments 
in developing, implementing and evaluating their activities toward 
achieving tuberculosis prevention, control, and elimination; (2) 
promotes adoption of CDC tuberculosis-related policies by national 
organizations, health departments, and health care providers; (3) 
provides consultation and assists state and local health departments in 
the methodology and application of tuberculosis control techniques 
recommended by CDC; (4) provides technical assistance to states and 
localities for improving program operations; (5) encourages and 
facilitates the transfer of new technology and guidelines into clinical 
and public health practice; (6) serves as a liaison or focal point to 
assist TB programs in state and local health departments in linking 
with proper resource persons and obtaining technical assistance, both 
within and outside the Division; (7) participates in development of 
national policies and guidelines for tuberculosis elimination; (8) 
identifies and facilitates sharing of best practices to ensure that 
good program methodology in one program is known and made available to 
other state and local programs; (9) serves as the lead branch for 
administration and management of cooperative agreement programs with 
state and local health department tuberculosis programs and others who 
support state and local health department tuberculosis programs; (10) 
develops funding opportunities based on Division strategic priorities; 
(11) coordinates technical reviews of cooperative agreement 
applications and makes appropriate funding recommendations; (12) 
monitors grantee performance on activities specified in the cooperative 
agreement; (13) identifies specific management, operational, and staff 
performance problems associated with not achieving TB control 
objectives or with not implementing essential TB components, and 
recommends solutions; (14) participates in the development of 
comprehensive evaluation methods for TB prevention and control 
programs; (15) collaborates with other DTBE branches in the evaluation 
of tuberculosis programs and development of program management and 
evaluation reports for publication; (16) provides supervision and 
support for the CDC field staff; (17) conducts a continuing analysis of 
the effectiveness of field personnel and utilization of other resources 
in relation to the tuberculosis problems; (18) provides input in to the 
development of Division policy, priorities and operational procedures; 
(19) provides programmatic oversight, technical assistance, and medical 
consultation to the Regional Training and Medical Consultation Centers; 
and (20) presents programmatic activities to ACET and at national and 
international scientific meetings.
    Clinical Research Branch (CVJEE). (1) Assesses the need for and 
conducts studies of new or existing drugs and regimens used in the 
prevention and treatment of TB, including dosage, duration, 
pharmacokinetics and toxicity; (2) supports the TB Trials Consortium in 
the conduct of studies of

[[Page 54094]]

new treatments for active TB and latent TB infection; (3) supports 
coordinated and standardized data management for branch research, and 
serves as the Data and Coordinating Center for the TB Trials 
Consortium, collaborating as needed with both internal and external 
partners; (4) provides clinical support and oversight for the 
distribution of investigational drugs for the treatment and prevention 
of TB by CIOs/Scientific Resources/Drug Service; (5) assesses the need 
for and conducts clinical and field trials of more specific and rapid 
tests to diagnose active TB and latent TB infection and to identify 
drug-resistant TB in collaboration with the Laboratory Branch; (6) 
collaborates with and provides consultation and technical assistance to 
national and international organizations on the design and conduct of 
clinical trials and research needs; (7) conducts, participates in, and 
collaborates with other DTBE units in research on clinical, 
epidemiologic, immunologic and genetic aspects of TB prevention and 
control; (8) collaborates with external partners in implementation of 
research; (9) maintains expertise and addresses special research needs 
relevant to drug pharmacokinetics, microbiology, drug resistant TB & 
special populations, including children and persons living with HIV; 
(10) provides consultation and training to local, state, national and 
international organizations and to TB program field staff, on design 
and conducts of clinical trials, TB therapeutics and diagnostics, 
health care systems research needs, decision and economic analyses, 
evaluation techniques, qualitative research methods, and research on TB 
transmission; (11) has responsibility for Divisional engagement in 
preparing for and participating in trials of new TB vaccines and when 
appropriate, collaborates with private and public institutions in the 
area of vaccine development; (12) reports study results to public 
health practitioners through direct communication, articles in 
scientific journals and CDC publications, and oral and poster 
presentations at national and international scientific and program 
meetings; (13) provides input into statements and guidelines issued by 
the CDC, the ACET, and professional organizations; and (14) presents 
research issues and findings to ACET and at national and international 
scientific meetings.
    Surveillance, Epidemiology, and Outbreak Investigations Branch 
(CVJEG). (1) Directs national surveillance of tuberculosis to provide 
accurate and timely national data and to monitor progress toward the 
elimination of tuberculosis in the U.S.; (2) conducts analyses of 
national TB surveillance data to monitor national trends in TB in order 
to assist n program planning, evaluation, and policy development and to 
identify areas for further study to guide elimination efforts; (3) 
conducts surveillance-related studies that evaluate current TB 
surveillance systems and develops new surveillance methods and systems 
in order to better monitor and accelerate TB elimination efforts; (4) 
provides technical surveillance expertise to state and local TB control 
programs, other federal agencies, and other organizations involved in 
TB prevention and control; (5) conducts epidemiologic research to 
assess the characteristics of persons with M. tuberculosis disease and 
infection in the U.S.; (6) analyzes research findings to develop 
improved interventions for eliminating tuberculosis and better analytic 
tools for future studies; (7) provides technical epidemiologic 
expertise to state and local tuberculosis control programs; (8) 
supports the TB Epidemiologic Studies Consortium in the conduct of 
studies of programmatically relevant epidemiologic, behavioral, 
economic, laboratory, and operational research concerning the 
identification, diagnosis, prevention and control of TB disease and 
latent infection; (9) conducts molecular epidemiologic analyses of TB 
cases to identify, track, and guide interventions to stop TB outbreaks; 
(10) investigates outbreaks of tuberculosis; (11) provides consultation 
and technical expertise on TB surveillance, epidemiology and outbreaks 
to state and local tuberculosis control programs; (12) analyzes TB 
outbreak investigation findings in order to improve the ability of 
tuberculosis control programs to detect future outbreaks and respond to 
them promptly and appropriately to limit transmission; (13) supervises 
EIS officers in the conduct of their two-year assignments; (14) 
prepares manuscripts for publication in scientific journals; (15) 
presents findings at national and international scientific meetings; 
and (16) presents surveillance, epidemiology, and outbreak findings to 
ACET and at national and international scientific meetings
    Laboratory Branch (CVJEJ). (1) Serves as the national reference 
laboratory in support of the mission of DTBE, fulfilling public health 
function in leadership, clinical and consultative service, and 
research; (2) provides laboratory support for epidemiological 
investigations, surveillance activities, and special studies of 
Mycobacterium tuberculosis, in collaboration with other branches; (3) 
administers contracts to provide M. tuberculosis genotyping, maintains 
a national database of genotypes, and conducts operational research to 
evaluate genotyping and optimize use of state-of-the-art methods; (4) 
serves as primary CDC source for reference laboratory services for M. 
tuberculosis; (5) administers grants and cooperative agreements to 
strengthen laboratory activities and advance testing services; (6) 
provides consultation, technical assistance, and training to state and 
municipal public health laboratories; (7) develops, evaluates, or 
improves conventional and molecular methods for the detection, 
characterization, and susceptibility testing of M. tuberculosis; (8) 
conducts studies to define the role of bacterial virulence factors and 
host factors in disease processes and protection, and develops, 
evaluates, and improves methods for the diagnosis and prevention of TB; 
(9) develops experimental models of TB and conducts studies on therapy, 
pathogenesis, and prevention for TB; (10) prepares manuscripts for 
publication in scientific journals; (11) presents findings at national 
and international scientific meetings; (12) supervises and trains 
fellows in temporary or multi-year educationally-based programs in 
areas related to the mission of the branch; and (13) elevates awareness 
of laboratory issues to ACET and other stakeholders.

Sherri Berger,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2016-19302 Filed 8-12-16; 8:45 am]
 BILLING CODE 4160-18-P