81_FR_54248 81 FR 54091 - Statement of Organization, Functions, and Delegations of Authority

81 FR 54091 - Statement of Organization, Functions, and Delegations of Authority

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 157 (August 15, 2016)

Page Range54091-54094
FR Document2016-19302

Federal Register, Volume 81 Issue 157 (Monday, August 15, 2016)
[Federal Register Volume 81, Number 157 (Monday, August 15, 2016)]
[Notices]
[Pages 54091-54094]
From the Federal Register Online  [www.thefederalregister.org]
[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



                                                                             Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices                                                   54091

                                                10% are non-GLBA entities (6,275), and                  burden hours for the FTC, staff added                     Postal mail addressed to the
                                                90% are GLBA entities (56,475).                         the costs associated with motor vehicle                Commission is subject to delay due to
                                                Applying an assumed rate of affiliation                 dealers ($501,032), resulting in a total               heightened security screening. As a
                                                of 16.75%, staff estimates that there are               cost burden for the FTC of $18,472,938.                result, we encourage you to submit your
                                                1,051 non-GLBA and 9,460 GLBA motor                                                                            comments online. To make sure that the
                                                                                                        Request for Comment
                                                vehicle dealerships in affiliated                                                                              Commission considers your online
                                                families. Staff further assumes there are                  You can file a comment online or on                 comment, you must file it at https://
                                                an average of 5 businesses per family or                paper. For the Commission to consider                  public.commentworks.com/ftc/
                                                affiliated relationship, leaving                        your comment, we must receive it on or                 affiliatemarketingpra by following the
                                                approximately 210 non-GLBA and 1,892                    before October 14, 2016. Write ‘‘Affiliate             instructions on the web-based form. If
                                                GLBA motor vehicle dealership                           Marketing Disclosure Rule, PRA                         this Notice appears at http://
                                                families, respectively.                                 Comment: FTC File No. P0105411’’ on                    www.regulations.gov/#!home, you also
                                                   Staff further estimates that non-GLBA                your comment. Your comment,                            may file a comment through that Web
                                                business families will spend 14 hours in                including your name and your state—                    site.
                                                the first year and 0 hours thereafter to                will be placed on the public record of                    If you file your comment on paper,
                                                comply with the Rule, while GLBA                        this proceeding, including, to the extent              write ‘‘Affiliate Marketing Disclosure
                                                business families will spend 6 hours in                 practicable, on the public Commission                  Rule, PRA Comment: FTC File No.
                                                the first year, and 4 hours in each of the              Web site, at http://www.ftc.gov/os/                    P0105411’’ on your comment, and on
                                                following two years. The cumulative                     publiccomments.shtm. As a matter of                    the envelope, and mail or deliver it to
                                                average annual burden for the non-                      discretion, the Commission tries to                    the following address: Federal Trade
                                                GLBA and GLBA motor vehicle                             remove individuals’ home contact                       Commission, Office of the Secretary,
                                                dealership families is 9,809 hours.20                   information from comments before                       600 Pennsylvania Avenue NW., Suite
                                                   To calculate the FTC’s total shared                  placing them on the Commission Web                     CC–5610 (Annex J), Washington, DC
                                                burden hours, staff deducted from                       site.                                                  20580, or deliver your comment to the
                                                overall estimated burden hours (910,602                    Because your comment will be made                   following address: Federal Trade
                                                hours) the hours attributed to motor                    public, you are solely responsible for                 Commission, Office of the Secretary,
                                                vehicle dealerships (9,809 hours),                      making sure that your comment doesn’t                  Constitution Center, 400 7th Street SW.,
                                                leaving a total of 900,793 hours to split               include any sensitive personal                         5th Floor, Suite 5610 (Annex J),
                                                between the CFPB and the FTC. The                       information, like anyone’s Social                      Washington, DC 20024. If possible,
                                                resulting shared burden for the CFPB is                 Security number, date of birth, driver’s               submit your paper comment to the
                                                half that amount, or 450,396 hours. To                  license number or other state                          Commission by courier or overnight
                                                calculate the total burden hours                        identification number or foreign country               service.
                                                apportioned to the FTC, staff added to                  equivalent, passport number, financial                    The FTC Act and other laws that the
                                                the shared sub-total (450,396 hours) the                account number, or credit or debit card                Commission administers permit the
                                                hours separately attributed to motor                    number. You are also solely responsible                collection of public comments to
                                                vehicle dealers (9,809 hours), which                    for making sure that your comment                      consider and use in this proceeding as
                                                yields for the FTC an apportioned                       doesn’t include any sensitive health                   appropriate. The Commission will
                                                burden estimate of 460,205 hours.                       information, like medical records or                   consider all timely and responsive
                                                   Staff used the same approach to                      other individually identifiable health                 public comments that it receives on or
                                                estimate the shared costs for the FTC.                  information. In addition, don’t include                before October 14, 2016. For
                                                Staff estimated the costs attributed to                 any ‘‘[t]rade secret or any commercial or              information on the Commission’s
                                                motor vehicle dealers as follows: Non-                  financial information which is . . .                   privacy policy, including routine uses
                                                GLBA business families have                             privileged or confidential,’’ as provided              permitted by the Privacy Act, see http://
                                                $35,626,785 in annualized labor costs,21                in Section 6(f) of the FTC Act, 15 U.S.C.              www.ftc.gov/ftc/privacy.htm.
                                                and GLBA business families have                         46(f), and FTC Rule 4.10(a)(2), 16 CFR
                                                                                                                                                               David C. Shonka,
                                                $818,059 in annualized labor costs,22 for               4.10(a)(2). In particular, don’t include
                                                cumulative annualized costs of                                                                                 Acting General Counsel.
                                                                                                        competitively sensitive information
                                                $36,444,844.                                            such as costs, sales statistics,                       [FR Doc. 2016–19226 Filed 8–12–16; 8:45 am]
                                                   To calculate, on an annualized basis,                inventories, formulas, patterns, devices,              BILLING CODE 6750–01–P
                                                the FTC’s cumulative share of labor cost                manufacturing processes, or customer
                                                burden, staff deducted from overall total               names.
                                                labor costs ($36,444,844) the labor costs                  If you want the Commission to give                  DEPARTMENT OF HEALTH AND
                                                attributed to motor vehicle dealerships                 your comment confidential treatment,                   HUMAN SERVICES
                                                ($501,032), leaving a net amount of                     you must file it in paper form, with a
                                                $35,943,812 to split between the CFPB                   request for confidential treatment, and                Centers for Disease Control and
                                                and the FTC. The resulting shared                       you have to follow the procedure                       Prevention
                                                burden for the CFPB is half that amount,                explained in FTC Rule 4.9(c), 16 CFR
                                                or $17,971,906. To calculate the total                                                                         Statement of Organization, Functions,
                                                                                                        4.9(c).23 Your comment will be kept
                                                                                                                                                               and Delegations of Authority
                                                                                                        confidential only if the FTC General
                                                dealers) (81 FR 33,255 at 33,257 n9 (May 25, 2016)      Counsel grants your request in                           Part C (Centers for Disease Control
                                                (FTC Prescreen Opt-Out Rule PRA analysis).
                                                                                                        accordance with the law and the public                 and Prevention) of the Statement of
sradovich on DSK3GMQ082PROD with NOTICES




                                                  20 (210 non-GLBA business families × 4.666667

                                                average hours = 980 hours, annualized) + (1,892         interest.                                              Organization, Functions, and
                                                GLBA business families × 4.666667 average hours                                                                Delegations of Authority of the
                                                per family = 8,829 hours, annualized) = 9,809             23 In particular, the written request for            Department of Health and Human
                                                hours, annualized.                                      confidential treatment that accompanies the
                                                  21 191,779 non-GLBA business families ×
                                                                                                                                                               Services (45 FR 67772–76, dated
                                                                                                        comment must include the actual and legal basis for
                                                combined rate of $557.31 (see supra note 13) ÷ 3        the request, and must identify the specific portions
                                                                                                                                                               October 14, 1980, and corrected at 45 FR
                                                = $35,626,785.                                          of the comment to be withheld from the public          69296, October 20, 1980, as amended
                                                  22 See supra note 18.                                 record. See FTC Rule 4.9(c), 16 CFR 4.9(c).            most recently at 81 FR 46677, dated July


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                                                54092                        Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices

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


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                                                                             Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices                                             54093

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


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                                                54094                        Federal Register / Vol. 81, No. 157 / Monday, August 15, 2016 / Notices

                                                new treatments for active TB and latent                 accurate and timely national data and to              and special studies of Mycobacterium
                                                TB infection; (3) supports coordinated                  monitor progress toward the elimination               tuberculosis, in collaboration with other
                                                and standardized data management for                    of tuberculosis in the U.S.; (2) conducts             branches; (3) administers contracts to
                                                branch research, and serves as the Data                 analyses of national TB surveillance                  provide M. tuberculosis genotyping,
                                                and Coordinating Center for the TB                      data to monitor national trends in TB in              maintains a national database of
                                                Trials Consortium, collaborating as                     order to assist n program planning,                   genotypes, and conducts operational
                                                needed with both internal and external                  evaluation, and policy development and                research to evaluate genotyping and
                                                partners; (4) provides clinical support                 to identify areas for further study to                optimize use of state-of-the-art methods;
                                                and oversight for the distribution of                   guide elimination efforts; (3) conducts               (4) serves as primary CDC source for
                                                investigational drugs for the treatment                 surveillance-related studies that                     reference laboratory services for M.
                                                and prevention of TB by CIOs/Scientific                 evaluate current TB surveillance                      tuberculosis; (5) administers grants and
                                                Resources/Drug Service; (5) assesses the                systems and develops new surveillance                 cooperative agreements to strengthen
                                                need for and conducts clinical and field                methods and systems in order to better                laboratory activities and advance testing
                                                trials of more specific and rapid tests to              monitor and accelerate TB elimination                 services; (6) provides consultation,
                                                diagnose active TB and latent TB                        efforts; (4) provides technical                       technical assistance, and training to
                                                infection and to identify drug-resistant                surveillance expertise to state and local             state and municipal public health
                                                TB in collaboration with the Laboratory                 TB control programs, other federal                    laboratories; (7) develops, evaluates, or
                                                Branch; (6) collaborates with and                       agencies, and other organizations                     improves conventional and molecular
                                                provides consultation and technical                     involved in TB prevention and control;                methods for the detection,
                                                assistance to national and international                (5) conducts epidemiologic research to                characterization, and susceptibility
                                                organizations on the design and conduct                 assess the characteristics of persons                 testing of M. tuberculosis; (8) conducts
                                                of clinical trials and research needs; (7)              with M. tuberculosis disease and                      studies to define the role of bacterial
                                                conducts, participates in, and                          infection in the U.S.; (6) analyzes                   virulence factors and host factors in
                                                collaborates with other DTBE units in                   research findings to develop improved                 disease processes and protection, and
                                                research on clinical, epidemiologic,                    interventions for eliminating                         develops, evaluates, and improves
                                                immunologic and genetic aspects of TB                   tuberculosis and better analytic tools for            methods for the diagnosis and
                                                prevention and control; (8) collaborates                future studies; (7) provides technical                prevention of TB; (9) develops
                                                with external partners in                               epidemiologic expertise to state and                  experimental models of TB and
                                                implementation of research; (9)                         local tuberculosis control programs; (8)              conducts studies on therapy,
                                                maintains expertise and addresses                       supports the TB Epidemiologic Studies                 pathogenesis, and prevention for TB;
                                                special research needs relevant to drug                 Consortium in the conduct of studies of               (10) prepares manuscripts for
                                                pharmacokinetics, microbiology, drug                    programmatically relevant                             publication in scientific journals; (11)
                                                resistant TB & special populations,                     epidemiologic, behavioral, economic,                  presents findings at national and
                                                including children and persons living                   laboratory, and operational research                  international scientific meetings; (12)
                                                with HIV; (10) provides consultation                    concerning the identification, diagnosis,             supervises and trains fellows in
                                                and training to local, state, national and              prevention and control of TB disease                  temporary or multi-year educationally-
                                                international organizations and to TB                   and latent infection; (9) conducts                    based programs in areas related to the
                                                program field staff, on design and                      molecular epidemiologic analyses of TB                mission of the branch; and (13) elevates
                                                conducts of clinical trials, TB                         cases to identify, track, and guide                   awareness of laboratory issues to ACET
                                                therapeutics and diagnostics, health                    interventions to stop TB outbreaks; (10)              and other stakeholders.
                                                care systems research needs, decision                   investigates outbreaks of tuberculosis;               Sherri Berger,
                                                and economic analyses, evaluation                       (11) provides consultation and technical              Chief Operating Officer, Centers for Disease
                                                techniques, qualitative research                        expertise on TB surveillance,                         Control and Prevention.
                                                methods, and research on TB                             epidemiology and outbreaks to state and               [FR Doc. 2016–19302 Filed 8–12–16; 8:45 am]
                                                transmission; (11) has responsibility for               local tuberculosis control programs; (12)             BILLING CODE 4160–18–P
                                                Divisional engagement in preparing for                  analyzes TB outbreak investigation
                                                and participating in trials of new TB                   findings in order to improve the ability
                                                vaccines and when appropriate,                          of tuberculosis control programs to                   DEPARTMENT OF HEALTH AND
                                                collaborates with private and public                    detect future outbreaks and respond to                HUMAN SERVICES
                                                institutions in the area of vaccine                     them promptly and appropriately to
                                                development; (12) reports study results                 limit transmission; (13) supervises EIS               Centers for Disease Control and
                                                to public health practitioners through                  officers in the conduct of their two-year             Prevention
                                                direct communication, articles in                       assignments; (14) prepares manuscripts                [CDC–2016–0067, Docket Number NIOSH
                                                scientific journals and CDC                             for publication in scientific journals;               270–A]
                                                publications, and oral and poster                       (15) presents findings at national and
                                                presentations at national and                           international scientific meetings; and                NIOSH Center for Motor Vehicle Safety:
                                                international scientific and program                    (16) presents surveillance,                           Midcourse Review of Strategic Plan
                                                meetings; (13) provides input into                      epidemiology, and outbreak findings to
                                                                                                                                                              AGENCY:  National Institute for
                                                statements and guidelines issued by the                 ACET and at national and international
                                                                                                                                                              Occupational Safety and Health
                                                CDC, the ACET, and professional                         scientific meetings
                                                                                                                                                              (NIOSH) of the Centers for Disease
                                                organizations; and (14) presents                           Laboratory Branch (CVJEJ). (1) Serves
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                                                                                                                                                              Control and Prevention (CDC),
                                                research issues and findings to ACET                    as the national reference laboratory in               Department of Health and Human
                                                and at national and international                       support of the mission of DTBE,                       Services (HHS).
                                                scientific meetings.                                    fulfilling public health function in                  ACTION: Notice of public web meeting
                                                   Surveillance, Epidemiology, and                      leadership, clinical and consultative                 and request for comment.
                                                Outbreak Investigations Branch                          service, and research; (2) provides
                                                (CVJEG). (1) Directs national                           laboratory support for epidemiological                SUMMARY: The National Institute for
                                                surveillance of tuberculosis to provide                 investigations, surveillance activities,              Occupational Safety and Health of the


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Document Created: 2016-08-13 02:22:44
Document Modified: 2016-08-13 02:22:44
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 54091 

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