Statement of Organization, Functions, and Delegations of Authority, 54091-54094 [2016-19302]
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10% are non-GLBA entities (6,275), and
90% are GLBA entities (56,475).
Applying an assumed rate of affiliation
of 16.75%, staff estimates that there are
1,051 non-GLBA and 9,460 GLBA motor
vehicle dealerships in affiliated
families. Staff further assumes there are
an average of 5 businesses per family or
affiliated relationship, leaving
approximately 210 non-GLBA and 1,892
GLBA motor vehicle dealership
families, respectively.
Staff further estimates that non-GLBA
business families will spend 14 hours in
the first year and 0 hours thereafter to
comply with the Rule, while GLBA
business families will spend 6 hours in
the first year, and 4 hours in each of the
following two years. The cumulative
average annual burden for the nonGLBA and GLBA motor vehicle
dealership families is 9,809 hours.20
To calculate the FTC’s total shared
burden hours, staff deducted from
overall estimated burden hours (910,602
hours) the hours attributed to motor
vehicle dealerships (9,809 hours),
leaving a total of 900,793 hours to split
between the CFPB and the FTC. The
resulting shared burden for the CFPB is
half that amount, or 450,396 hours. To
calculate the total burden hours
apportioned to the FTC, staff added to
the shared sub-total (450,396 hours) the
hours separately attributed to motor
vehicle dealers (9,809 hours), which
yields for the FTC an apportioned
burden estimate of 460,205 hours.
Staff used the same approach to
estimate the shared costs for the FTC.
Staff estimated the costs attributed to
motor vehicle dealers as follows: NonGLBA business families have
$35,626,785 in annualized labor costs,21
and GLBA business families have
$818,059 in annualized labor costs,22 for
cumulative annualized costs of
$36,444,844.
To calculate, on an annualized basis,
the FTC’s cumulative share of labor cost
burden, staff deducted from overall total
labor costs ($36,444,844) the labor costs
attributed to motor vehicle dealerships
($501,032), leaving a net amount of
$35,943,812 to split between the CFPB
and the FTC. The resulting shared
burden for the CFPB is half that amount,
or $17,971,906. To calculate the total
dealers) (81 FR 33,255 at 33,257 n9 (May 25, 2016)
(FTC Prescreen Opt-Out Rule PRA analysis).
20 (210 non-GLBA business families × 4.666667
average hours = 980 hours, annualized) + (1,892
GLBA business families × 4.666667 average hours
per family = 8,829 hours, annualized) = 9,809
hours, annualized.
21 191,779 non-GLBA business families ×
combined rate of $557.31 (see supra note 13) ÷ 3
= $35,626,785.
22 See supra note 18.
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burden hours for the FTC, staff added
the costs associated with motor vehicle
dealers ($501,032), resulting in a total
cost burden for the FTC of $18,472,938.
Request for Comment
You can file a comment online or on
paper. For the Commission to consider
your comment, we must receive it on or
before October 14, 2016. Write ‘‘Affiliate
Marketing Disclosure Rule, PRA
Comment: FTC File No. P0105411’’ on
your comment. Your comment,
including your name and your state—
will be placed on the public record of
this proceeding, including, to the extent
practicable, on the public Commission
Web site, at https://www.ftc.gov/os/
publiccomments.shtm. As a matter of
discretion, the Commission tries to
remove individuals’ home contact
information from comments before
placing them on the Commission Web
site.
Because your comment will be made
public, you are solely responsible for
making sure that your comment doesn’t
include any sensitive personal
information, like anyone’s Social
Security number, date of birth, driver’s
license number or other state
identification number or foreign country
equivalent, passport number, financial
account number, or credit or debit card
number. You are also solely responsible
for making sure that your comment
doesn’t include any sensitive health
information, like medical records or
other individually identifiable health
information. In addition, don’t include
any ‘‘[t]rade secret or any commercial or
financial information which is . . .
privileged or confidential,’’ as provided
in Section 6(f) of the FTC Act, 15 U.S.C.
46(f), and FTC Rule 4.10(a)(2), 16 CFR
4.10(a)(2). In particular, don’t include
competitively sensitive information
such as costs, sales statistics,
inventories, formulas, patterns, devices,
manufacturing processes, or customer
names.
If you want the Commission to give
your comment confidential treatment,
you must file it in paper form, with a
request for confidential treatment, and
you have to follow the procedure
explained in FTC Rule 4.9(c), 16 CFR
4.9(c).23 Your comment will be kept
confidential only if the FTC General
Counsel grants your request in
accordance with the law and the public
interest.
23 In particular, the written request for
confidential treatment that accompanies the
comment must include the actual and legal basis for
the request, and must identify the specific portions
of the comment to be withheld from the public
record. See FTC Rule 4.9(c), 16 CFR 4.9(c).
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Postal mail addressed to the
Commission is subject to delay due to
heightened security screening. As a
result, we encourage you to submit your
comments online. To make sure that the
Commission considers your online
comment, you must file it at https://
public.commentworks.com/ftc/
affiliatemarketingpra by following the
instructions on the web-based form. If
this Notice appears at https://
www.regulations.gov/#!home, you also
may file a comment through that Web
site.
If you file your comment on paper,
write ‘‘Affiliate Marketing Disclosure
Rule, PRA Comment: FTC File No.
P0105411’’ on your comment, and on
the envelope, and mail or deliver it to
the following address: Federal Trade
Commission, Office of the Secretary,
600 Pennsylvania Avenue NW., Suite
CC–5610 (Annex J), Washington, DC
20580, or deliver your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW.,
5th Floor, Suite 5610 (Annex J),
Washington, DC 20024. If possible,
submit your paper comment to the
Commission by courier or overnight
service.
The FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before October 14, 2016. For
information on the Commission’s
privacy policy, including routine uses
permitted by the Privacy Act, see https://
www.ftc.gov/ftc/privacy.htm.
David C. Shonka,
Acting General Counsel.
[FR Doc. 2016–19226 Filed 8–12–16; 8:45 am]
BILLING CODE 6750–01–P
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
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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 atrisk 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,
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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 drugresistant 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
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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
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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 TBrelated 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)
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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 tuberculosisrelated 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
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54093
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
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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
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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,
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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 educationallybased 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[CDC–2016–0067, Docket Number NIOSH
270–A]
NIOSH Center for Motor Vehicle Safety:
Midcourse Review of Strategic Plan
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of public web meeting
and request for comment.
AGENCY:
The National Institute for
Occupational Safety and Health of the
SUMMARY:
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Agencies
[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
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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
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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
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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