Statement of Organization, Functions, and Delegations of Authority, 22821-22829 [2010-9910]
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organizations with common interests to
consolidate or coordinate their
presentations to allow adequate time for
each request for presentation. Persons
registered to make an oral presentation
should check in before the hearing.
Participants should submit a copy of
each presentation to Paras M. Patel. We
will file the hearing schedule, indicating
the order of presentation and the time
allotted to each person, with the
Division of Dockets Management (see
ADDRESSES). We will mail, e-mail, or fax
the schedule to each participant before
the hearing. Participants are encouraged
to arrive early to ensure the designated
order of presentation.
If you need special accommodations
due to a disability, please contact Paras
M. Patel at least 14 days in advance.
IV. Notice of Hearing Under 21 CFR
Part 15
The Commissioner of Food and Drugs
is announcing that the public hearing
will be held in accordance with part 15
(21 CFR part 15). The hearing will be
conducted by a presiding officer,
accompanied by FDA senior
management from the Office of the
Commissioner, the Office of Orphan
Products Development, as well as
representatives from the committee
established by section 740 of the
Agriculture, Rural Development, Food
and Drug Administration, and Related
Agencies Appropriations Act, 2010.
Under paragraph § 15.30(f), the
hearing is informal, and the rules of
evidence do not apply. No participant
may interrupt the presentation of
another participant. Only the presiding
officer and panel members may question
any person during or at the conclusion
of each presentation (§ 15.30(e)).
Public hearings under part 15 are
subject to FDA’s policy and procedures
for electronic media coverage of FDA’s
public administrative proceedings (21
CFR 10.203(a)). Under 21 CFR 10.205,
representatives of the electronic media
may be permitted, subject to certain
limitations, to videotape, film, or
otherwise record FDA’s public
administrative proceedings, including
presentations by participants.
The hearing will be transcribed as
stipulated in paragraph § 15.30(b).
Transcripts of the hearing will be
available for review at the Division of
Dockets Management and on the
Internet at https://www.regulations.gov
approximately 45 days after the hearing.
A transcript will also be available in
either hardcopy or on a CD–ROM after
submission of a Freedom of Information
request. Submit written requests to the
Division of Freedom of Information
(HFI–35), Office of Management
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Programs, Food and Drug
Administration, 5600 Fishers Lane, rm.
6–30, Rockville, MD 20857.
To the extent that the conditions for
the hearing, as described in this
document, conflict with any provisions
set out in part 15, this notice acts as a
waiver of those provisions as specified
in § 15.30(h).
V. Request for Comments
Interested persons may submit written
or electronic comments for
consideration to the Division of Dockets
Management (see ADDRESSES). Persons
who wish to provide additional
materials for consideration should file
these materials with the Division of
Dockets Management. You should
annotate and organize your comments to
identify the specific questions identified
by topic to which they refer. Submit a
single copy of electronic comments or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments
should be identified with the docket
number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m. Monday through Friday.
Dated: April 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–10079 Filed 4–29–10; 8:45 am]
BILLING CODE 4160–01–S
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 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 75
FR 14608, dated March 26, 2010) is
amended to reflect the reorganization of
the Center for Global Health, Centers for
Disease Control and Prevention.
Section C–B, Organization and
Functions, is hereby amended as
follows: Delete in their entirety the titles
and functional statements for the Center
for Global Health (CW), and insert the
following:
Center for Global Health (CW). The
Center for Global Health (CGH): (1)
Leads the execution of the Center for
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Disease Control and Prevention’s (CDC)
global health strategy; (2) works in
partnership to assist Ministries of
Health to plan, manage effectively, and
evaluate health programs; (3) achieves
U.S. Government program and
international organization goals to
improve health, including disease
eradication and elimination targets; (4)
expands CDC’s global health programs
that focus on the leading causes of
mortality, morbidity and disability,
especially chronic disease and injuries;
(5) generates and applies new
knowledge to achieve health goals; and
(6) strengthens health systems and their
impact.
Office of the Director (CWA). (1)
Provides strategic direction and
guidance on the execution of CDC’s
global health strategy including
decision-making, policy development
and program planning and evaluation;
(2) ensures the impact and effectiveness
of Congressionally-mandated programs;
(3) improves implementation and
coordination of CDC global programs;
(4) harmonizes CDC global health
priorities with host country priorities to
improve essential public health
functions and maximize positive health
outcomes, country ownership and
sustainability; (5) supervises all CDC
country directors and provides
leadership in the selection of additional
countries to expand or establish
collaboration; (6) measures the
performance of CDC’s global health
programs in terms of public health
impact and fiscal accountability; (7)
facilitates the conduct and maintenance
of ethical and high quality, evidencebased scientific investigations by
implementing regulatory requirements,
monitoring human subjects compliance,
and clearing scientific products; (8)
promotes cross-cutting agendas and
harmonizes CDC’s global laboratory
science activities to improve diagnostic
methodologies and respond to threats of
emerging pathogens; (9) provides
leadership to promote growth of CDC
global health programs; (10) analyzes,
measures, and evaluates the global
burden and distribution of disease; (11)
promotes scientific innovation and best
technical practices in global health
surveillance, epidemiology, outbreak
investigation, monitoring and
evaluation, and informatics; (12)
provides leadership on issues
management, budget formulation and
performance integration, and countryspecific issues through triaging to
programs; (13) participates in defining,
developing, shaping and implementing
U.S. global health policy and actions;
(14) manages inter-governmental and
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external affairs and cultivates strategic
partnerships; (15) plans and executes
CDC’s global health communications
strategy and public affairs media
response/outreach; (16) provides
oversight, guidance, and accountability
for all operations functions, human
resources, workforce management,
budget formulation and distribution,
extramural reviews and processing,
internal and domestic travel, and
property management responsibilities of
CGH; and (17) develops standardized
management processes and solutions for
CDC country offices.
Division of Public Health Systems and
Workforce Development (CWF). The
Division of Public Health Systems and
Workforce Development (DPHSWD)
contributes to improving the health of
the people of the U.S. and other nations
by partnering with relevant foreign
government ministries, educational
institutions, Federal agencies, and
international organizations to strengthen
capacity of countries around the world
to improve public health. To carry out
its mission, the division performs the
following functions: (1) Works with
partners to build strong, transparent,
and sustained public health systems
through training, consultation, capacity
building, and technical assistance in
applied epidemiology, public health
surveillance, evaluation, operational
and implementation research, and
laboratory systems; and promotes
organizational excellence in public
health through strengthening leadership
and management capacity; (2) assists in
developing and implementing CGH
policy on public health system
strengthening and sustainability; (3)
collaborates with other CDC
organizations, Federal agencies,
international agencies, partner
countries, and non-governmental
organizations assisting ministries of
health to build public health capacity in
other areas of public health; and (4)
supports and performs primary research
on health systems and health systems
performance that are relevant to the
improvement of the division’s own
programs as well as the programs with
which it collaborates.
Office of the Director (CWF1). (1)
Provides leadership, overall direction,
and evaluation for the division; (2)
formulates and coordinates execution of
CDC’s strategy for developing global
public health capacity in applied
epidemiology, public health systems
management and leadership; (3)
provides leadership and guidance on
policy, program planning, program
management, and operations; (4) plans,
allocates, and monitors resources; (5)
formulates, executes, and monitors
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CORE budgets; (6) monitors and assists
in the formulation and execution of
branch and county project’s budgets; (7)
provides support and assistance to the
branches in management,
administrative, and personnel services;
(8) develops and manages cooperative
agreements, grants and contracts; (9)
develops and disseminates
communication material; (10) provides
leadership in assisting national
ministries of health, international
agencies, and nongovernmental
organizations in the delivery of
epidemiologic services and the
development of international
epidemiologic networks; (11) liaises
with other CDC organizations, other
Federal agencies, ministries of health,
and international organizations; (12)
provides consultations with partners
and stakeholders including
nongovernmental organizations and the
private sector on program development
and overall public health systems and
sub-systems; (13) develops and
produces communication materials
documenting the division’s public
health programs, accomplishments, and
impact (e.g., annual reports, newsletters,
Web sites, training materials); (14)
develops and maintains intranet and
internet Web sites for the division and
its programs; (15) provides consultation
and technical assistance to programs
and partners in scientific
communication, health communication,
and public health marketing programs;
and (16) assesses scientific
communication needs for partners, and
develops and delivers public health
materials and information, and training
tailored to the specific needs of the
partners.
Sustainable Management
Development Program (CWF12). (1)
Partners with ministries of health,
educational institutions, and
nongovernmental organizations to
promote organizational excellence in
public health through strengthening
leadership and management capacity;
(2) works with partners to build
capacity for public health leadership
and management development through
a multi-phased approach including
situational analysis, capacity
development, technical assistance, and
sustainability; (3) develops strategic
institutional partnerships for public
health leadership and management
capacity-building efforts; (4) develops
faculty to enhance in-country leadership
and management training capacity
through the Management for
International Public Health course and
in-country training-of-trainers; (5)
provides support to training faculty in
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partner institutions to conduct
performance needs assessments;
develops locally appropriate curricula;
and designs in-country leadership and
management workshops that provide
participants with practical skills needed
to manage public health teams,
programs, and organizations; (6) works
with partner institutions to ensure the
long-term sustainability of global public
health leadership and management
development programs; and (7) supports
and performs primary operational and
implementation research in support of
continuous improvement of its own and
partners’ leadership and management
programs.
FELTP and Systems Development
Branch (Africa) (CWFB). (1) With
partners, designs and conducts
evidence-based instruction in public
health disciplines needed to strengthen
their public health systems, including
instructional design, epidemiology,
surveillance, laboratory operations and
management, communications, and
economic evaluation; (2) assists
ministries of health in the African
region and elsewhere to develop
sustainable field epidemiology and
laboratory training programs for public
health systems strengthening; (3)
develops models for continuous
tracking and improvement of critical
outputs and outcomes from field
epidemiology and laboratory training
programs around the world; (4) working
with DPHSWD technical program
components, provides consultation to
ministries of health in development of
surveillance systems (e.g.,
communicable and non communicable
disease surveillance, injury, chronic
diseases, etc.); (5) coordinates CDC’s
support the World Health
Organization’s (WHO) Integrated
Disease Surveillance and Response
strategy; (6) creates and maintains
division wide computer-based and
distance-based learning methods, and
develops the capacity of partners to
create, evaluate, and share their own; (7)
develops and evaluates competency
based training materials for the FETP
and similar program for use of the
division and its partners; (8) maintains
a divisional training material library and
website; and (9) collaborates within
CDC and with national or international
organizations in development of
competency-based training materials,
evaluation of training, and design of
surveillance systems needed to
accomplish the mission.
FELTP and Systems Development
Branch (Asia and the Americas)
(CWFC). (1) Assists partners in assessing
their needs for health systems
strengthening; (2) plans, directs,
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supports, implements, and coordinates
field epidemiology and laboratory
training programs, Data for Decision
Making Projects, operational and
implementation research projects, and
other partnerships with ministries of
health; (3) provides leadership and
management oversight in assisting
ministries of health in capacity building
by training epidemiologists and other
health professionals through the
development of competency based,
residency-style, applied training
programs; (4) provides leadership and
expertise in assisting national ministries
of health to utilize trained public health
workers for developing health policy,
and implementing and evaluating health
programs; (5) assigns and manages
expert consultants as long-term, incountry advisors to ministry of health
programs; (6) collaborates within CDC,
with other Federal agencies, and with
national and international organizations
in support of partner programs; (7)
provides consultation to ministries of
health in development of surveillance
systems (e.g., communicable and noncommunicable disease surveillance,
injury, chronic diseases, etc.); (8)
develops and evaluates competencybased training materials for the FETP
and similar programs for use of the
division and its partners; and (9)
collaborates within CDC and with
national or international organizations
in development of competency-based
training materials, evaluation of
training, and design of surveillance
systems needed to accomplish mission.
Division of Global HIV/AIDS (CWG)
The Division of Global HIV/AIDS
(DGHA) provides technical assistance to
host governments, working through its
strong partnerships with Ministries of
Health and local and international
partners to implement integrated HIV/
AIDS clinical and preventive services
and systems; develop and strengthen
laboratory services; and provide
epidemiologic science, informatics, and
research support to develop sustainable
public health systems in resourceconstrained countries. DGHA: (1)
Provides leadership, management, and
services to DGHA country offices; (2)
implements integrated evidence-based
prevention, care, and treatment
programs and services; (3) evaluates
program cost effectiveness and impact
to assist with prioritization, inform
program planning, and determine
appropriate rates of program expansion,
and supports transition of responsibility
for implementation of HIV programs to
indigenous partners and Ministries of
Health; (4) builds sustainable public
health capacity in laboratory services
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and systems; (5) ensures epidemiologic
and scientific excellence in HIV/AIDS
programs; (6) contributes to the broader
scientific body of knowledge in global
public health by systematically
evaluating the scope and quality of
global HIV/AIDS programs; (7)
implements operations and
effectiveness research to inform the
design of current and future programs as
well as optimize allocation of human
and financial resources; (8) strengthens
in-country capacity to design and
implement HIV/AIDS surveillance
systems and surveys; (9) builds host
government public health management
capacity and trains in-country public
heath workforce with the goal of long
term program sustainability; (10)
supports host government capacity to
monitor and evaluate the process,
outcome, and impact of HIV prevention,
care, and treatment programs, and (11)
helps countries respond to public health
emergencies, assisting in response
planning and implementation with
Ministries of Health and other
international partners.
Office of the Director (CWG1). (1)
Provides strategic leadership, guidance,
management and oversight to all DGHA
programs and ensures coordination and
communication across its branches and
with other CDC programs including
CDC/Washington; U.S. Government
(USG) agencies, including the
Department of Health and Human
Services (HHS), the United States
Agency for International Development
(USAID), and Department of State (DoS);
and other international organizations;
(2) plans, implements, and oversees all
field programs along with other USG
agencies; (3) manages all DGHA country
directors and provides leadership and
guidance to country offices in all
matters of daily operation, including
management of global workforce staff;
(4) provides leadership and guidance on
policy development and interpretation,
budget formulation, program planning,
issues management, management and
operations, and evaluation; (5) helps to
build capacity and strengthen the public
health response by sharing best
practices through communication
materials and coordinating
dissemination of resources to the media,
partners, and other audiences; (6)
identifies opportunities for leveraging
and enhancing partnerships for public
health protection and synergies with
other Agency programs and partners; (7)
provides DGHA management and
operations services in coordination with
appropriate CDC staff offices, including
processing travel and assisting with
accountability and management of HHS/
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CDC property, facilities, and equipment;
(8) ensures timely and sufficient DGHA
domestic staff placement through
recruitment, hiring, and orienting of
qualified staff; (9) ensures retention of
qualified staff by providing workforce
management and career development
services for DGHA domestic staff; (10)
ensures scientific excellence for all
DGHA scientific, programmatic, and
informational documents/materials
which includes providing scientific
review and clearance of manuscripts for
publication, abstracts for presentation,
and protocols for institutional review
boards and human subjects review; (11)
provides coordination and support for,
as well as contributes to, global public
health evaluation and operational
research to maximize the effectiveness
and quality of global HIV/AIDS
interventions to guide DGHA programs
and policies; (12) establishes and
implements standards for organizational
excellence; (13) provides direct
technical assistance and maintains
relationships with host country partners
and responds to other health needs as
required; (14) assures accountability of
program funds and reports on progress;
and (15) collaborates with other CDC
and HHS programs and offices; other
USG agencies; and other national and
international organizations.
International Laboratory Branch
(CWGB). (1) Serves as a reference
laboratory that provides guidance on
quality assurance and certification for
international sites; (2) provides
technical assistance to country programs
in the areas of laboratory information
systems and laboratory systems; (3)
provides training packages, training,
guidance, and support to host nations,
other USG agencies and international
and national partners on HIV, Sexually
Transmitted Infection (STI), and
opportunistic infection (OI) diagnostics
and monitoring techniques; HIV
incidence testing; hematology;
chemistry; CD4; TB/OI testing;
antiretroviral treatment (ART) resistance
testing; dried blood spot polymerase
chain reaction for early infant diagnosis;
viral load monitoring; and ensuring the
quality of laboratories and testing
activities; (4) serves as a training center
of excellence for HIV/STI/OI diagnostics
for international sites; (5) provides
laboratory assistance to international
surveillance activities to monitor trends
of HIV prevalence and incidence; (6)
assists in the surveillance of HIV
subtypes in the overall context of
supporting sero-surveillance programs;
(7) assists in the surveillance and
evaluation of HIV drug resistance as part
of antiretroviral care and treatment
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programs and serves as a reference
laboratory for the World Health
Organization (WHO)–CDC HIV drug
resistance network; (8) develops
strategies and methodologies to meet the
clinical and diagnostic needs of HIV/
AIDS programs; (9) assists in the
evaluation and validation of serologic
and nucleic acid assays for
measurement of HIV incidence to enable
evaluation of effectiveness of prevention
programs; (10) develops comprehensive
testing algorithms for HIV diagnosis;
(11) contributes to operational research
to maximize the effectiveness and
quality of global HIV/AIDS
interventions to guide DGHA programs
and policies; (12) conducts laboratory
capacity assessments and assists in
development of infrastructure for
effective implementation of programs in
countries where DGHA operates; (13)
provides laboratory guidance and
support on national strategic planning
and quality management of tiered
laboratory systems in host nations and
consults on all technical aspects of
laboratory procurement,
standardization, quality control and
quality assurance; (14) works with
international accrediting organizations
to establish guidance, training, and tools
for accreditation of laboratory systems
in resource-poor settings; (15) supports
ongoing collaboration with international
laboratory experts and national and
regional laboratory personnel to resolve
technical issues and develops
international tools, guidelines,
curriculum and other resources to
improve laboratory capacity in host
nations; (16) develops and implements
strategies to expand the laboratory
health workforce and increase human
capacity of host government public
health programs to strengthen and
ensure a sustainable public health
response to HIV/AIDS; (17) promotes a
transition toward greater sustainability
of laboratory systems through the
support of country-driven efforts; (18)
establishes strategic Public Private
Partnerships for strengthening
laboratory systems, training,
development of referral systems for
transporting samples, and quality
management schemes; (19) ensures
scientific excellence for all branch
manuscripts, protocols, and programs in
collaboration with the DGHA Office of
the Director (OD) Science Office; (20)
contributes to the greater body of
scientific knowledge through the
presentation of laboratory operational
research findings at conferences and
through publications in peer reviewed
journals; and (21) collaborates with
other DGHA branches; other CDC and
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HHS programs and offices; other USG
agencies; and other national and
international organizations.
HIV Prevention Branch (CWGC). (1)
Provides technical assistance and builds
capacity to implement, improve,
expand, sustain, and maximize
effectiveness of HIV prevention
programs; (2) provides technical
assistance for scale-up of prevention
and biomedical interventions and
linkage with other HIV clinical services;
(3) assists DGHA country programs in
the recruitment of safe blood (products)
donors, quality testing, blood bank
management, appropriate use of blood
and blood products, and prevention of
severe anemia; (4) fosters the
improvement of HIV prevention and
counseling services through blood
donor education, mobilization, and
retention of safe blood donors; (5)
supports development of safe injection
practices, improved sharps waste
management, safer blood transfusions,
and avoidance of unnecessary medical
injections; (6) assists in the
development, implementation, and
evaluation of model behavior change
interventions and programs to reduce
risk-behaviors and enhance healthseeking behaviors; (7) helps strengthen,
expand, and make accessible programs
to prevent, diagnose, and treat STIs in
high risk populations and to prevent
HIV infection among persons seeking
treatment for STIs; (8) assists in tailoring
HIV prevention programs to meet the
special needs of youth and drug-using
populations; (9) helps to develop,
expand, and evaluate voluntary HIV
counseling and testing programs in both
clinical and community settings; (10)
assists in the provision of technical
support to DGHA programs in
developing laboratory, clinical, and
administrative capacities to prevent
HIV/AIDS; (11) assists in implementing,
and monitoring the quality and impact
of, prevention programs for persons
living with HIV/AIDS and their families
and integrating HIV prevention
programs within health services for HIV
care and treatment; (12) assists in safe
and effective implementation of
biomedical interventions, including the
scale-up of male circumcision; (13)
assists in monitoring the training of
health care workers to prevent HIV; (14)
contributes to operational research to
maximize the effectiveness and quality
of global HIV/AIDS interventions to
guide DGHA programs and policies; (15)
establishes strategic Public Private
Partnerships to build capacity for and
maximize effectiveness of HIV
prevention programs in host countries;
(16) ensures scientific excellence for all
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branch manuscripts, protocols, and
programs in collaboration with the
DGHA OD Science Office; and (17)
collaborates with other DGHA branches;
other CDC and HHS programs and
offices; other USG agencies; and other
national and international
organizations.
HIV Care and Treatment Branch
(CWGD). (1) Provides technical
assistance and builds capacity in
developing and implementing
sustainable comprehensive care and
treatment programs for persons with
HIV/AIDS. This includes prevention,
diagnosis, and treatment services for
HIV/AIDS, tuberculosis, other
opportunistic infections, and
opportunistic cancers; (2) provides
technical expertise and support to
country programs, partners, and
Ministries of Health in planning,
implementing, and evaluating effective
strategies for care and treatment of
persons with HIV; (3) provides HIV care
and treatment expertise to country
programs, partners, and Ministries of
Health on management, standard
operating procedures, human resources,
physical infrastructure, training, drug
and health commodities management,
laboratory services, monitoring and
evaluation, community services, linkage
between HIV and other programs,
promotion of prevention, and
sustainability; (4) provides support for
continuous quality improvement of HIV
care and treatment programs; (5)
promotes appropriate integration of
services, including HIV prevention
interventions into clinical care and
treatment settings and HIV services into
general medical services; (6) conducts
operational research in collaboration
with country programs to identify best
practices, address barriers, and respond
to emerging scientific issues related to
HIV care and treatment service delivery;
(7) collaborates with international
partners to synthesize the scientific
body of knowledge on HIV care and
treatment, including TB/HIV coinfection; (8) collaborates with
international partners to develop and
disseminate tools (e.g., protocols and
training curricula), guidelines and
policies; (9) supports analysis of
program costs and cost effectiveness to
assist with prioritization, inform
program planning, and determine
appropriate rates of program expansion;
(10) supports capacity building of host
countries to transition responsibility for
implementation of HIV care and
treatment services to indigenous
partners and Ministries of Health, with
result of increasing ownership,
sustainability and service delivery cost
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efficiencies; (11) establishes strategic
Public Private Partnerships aimed at
augmenting capacity for developing and
implementing sustainable
comprehensive care and treatment
programs, including prevention,
diagnosis, and treatment services for
HIV/AIDS, tuberculosis, other
opportunistic infections, and
opportunistic cancers; (12) ensures
scientific excellence for all branch
manuscripts, protocols, and programs in
collaboration with the DGHA OD
Science Office; (13) collaborates with
other DGHA branches; other CDC and
HHS programs and offices; other USG
agencies; and other national and
international organizations.
Maternal and Child Health Branch
(CWGE). (1) Supports the international
scale up of comprehensive, quality
prevention of mother-to-child HIV
transmission (PMTCT) and pediatric
(Peds) programs by developing
adaptable training tools, utilizing
operational research to identify and
implement models of service delivery
adapted to district, regional, subnational and national contexts; (2)
provides technical expertise and
support to countries in planning,
implementing, and evaluating effective
strategies for scaling up of sustainable
programs for the prevention, diagnosis,
and treatment of HIV/AIDS,
tuberculosis, and other opportunistic
infections in women, infants, and
children, including linking PMTCT/
Peds HIV programs with HIV clinical
and preventive services and other
maternal and child health settings/
contexts; (3) builds national capacity for
and provides guidance on development
of policy for formulations for and access
to appropriate long-term combination
ART for HIV-infected children; (4)
conducts operational research in
collaboration with country programs to
promote best practices, address barriers,
and respond to emerging scientific
issues for PMTCT/Peds HIV service
delivery; (5) collaborates with
international partners to contribute to
the scientific body of knowledge on
global PMTCT/Peds and broader
maternal arid child health issues and to
develop and disseminate tools,
guidelines, and policies to translate
research for improved program
implementation in resource-constrained
countries; (6) provides support for
continuous quality improvement of
PMTCT and Peds HIV care and
treatment programs, including those
within broader maternal and child
health programs; (7) supports analysis of
program costs and cost-effectiveness to
assist with prioritization, inform
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program planning, and determine
appropriate rates of program expansion;
(8) acts as a key part of a broader CDC
strategic response to address health
needs and gender-related issues of
maternal and child health worldwide,
supporting a comprehensive,
multidisciplinary approach to building
maternal and child health services and
systems capacity in host countries; (9)
establishes strategic Public Private
Partnerships for HIV maternal and child
health services and systems capacity in
host countries; (10) ensures scientific
excellence for all branch manuscripts,
protocols, and programs in collaboration
with the DGHA OD Science Office; and
(11) collaborates with other DGHA
branches; other CDC and HHS programs
and offices; other USG agencies; and
other national and international
organizations.
Epidemiology and Strategic
Information Branch (CWGG). (1) Assists
countries in developing and/or
enhancing HIV-related surveillance
systems and in using the results of
surveillance surveys for impact
monitoring, program planning, and HIV/
AIDS policy making; (2) assists and
provides training on analyzing,
disseminating, and using HIV/AIDS
data; (3) assists and provides training to
CDC programs and host country
governments to assess and ensure the
quality of the data collected in HIVrelated surveillance systems and HIV/
AIDS program monitoring systems; (4)
strengthens host government capacity to
monitor and evaluate the process,
outcome, and impact of HIV/AIDS
prevention, care, and treatment
programs, other related global health
programs, and health systems through
the development of guidelines,
curricula, and other tools; (5)
implements and evaluates novel
approaches for conducting surveillance
and surveys, and conducting program
monitoring and evaluation; (6) performs
epidemiologic investigations of HIV/
AIDS as well as provides statistical and
epidemiologic technical assistance for
in-country investigations; (7) supports
surveys and monitoring and evaluation
systems that measure HIV prevalence,
changes in HIV-related behavior, and
health status among individuals and at
the population level; (8) strengthens
country monitoring systems that track
program service delivery and ensure
effective, evidence based programming;
(9) provides support to the DoS Office
of the US Global AIDS Coordinator
(OGAC) and to interagency USG incountry teams to monitor and evaluate
the outputs, outcomes, and impact of
global HIV/AIDS activities and advises
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interagency in-country teams on
planning of strategic information
activities; (10) improves the collection
and analysis of data through
development of guidelines on HIV
surveillance and assists countries to
develop procedures to standardize HIV
surveillance systems, write protocols for
HIV surveillance, train for data
collection, and assist with data cleaning
and data analysis; (11) provides a wide
range of statistical and epidemiologic
support and technical expertise to
agencies and staff engaged in global
HIV/AIDS activities, including
consultation and direct assistance at all
stages of a public health study;
specifically, development of study
design, sample size and power
estimation, questionnaire design, data
monitoring, statistical analysis and
report writing; (12) provides
comprehensive data management
support to staff and countries engaged
in global HIV/AIDS activities, including
development of data organization plan
and standards for coding of data
elements, quality assurance,
maintenance of databases, report
generation, and implementation of
policies on electronic record retention
and data security; (13) coordinates,
oversees, or assists in the formulation of
epidemiology and strategic information
funding/budgets and in the execution of
a variety of acquisition and assistance
awards; (14) ensures scientific
excellence for all branch manuscripts,
protocols, and programs in collaboration
with the DGHA OD Science Office; and
(15) collaborates with other DGHA
branches; other CDC and HHS programs
and offices; other USG agencies; and
other national and international
organizations.
Health Economics, Systems, and
Integration Branch (CWGH). (1)
Identifies priority information needs for
program planning, resource allocation,
efficiency and program integration, and
develops economic analysis and
operational research activities; (2)
implements economic studies,
including costing and cost-effectiveness
studies, and applies advanced modeling
techniques to inform and optimize
global health planning, policy and
programs, and provide a broader
understanding of the effects of health
programs on improving economic and
other non-health outcomes; (3) supports
USG efforts in projecting financing
needs to efficiently meet program targets
in areas of prevention, care and
treatment, and human resources for
health (HRH); (4) guides development
and implementation of monitoring
systems to routinely capture program
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expenditure data to support planning,
accountability and efficient
programming; (5) trains and mentors
partner country personnel in the
methods and application of economic
analysis of global health programs and
policy; (6) provides technical input,
guidance, review and implementation
support to operational research on and
evaluation of global HIV/AIDS
activities; (7) supports the development
of partner country health finance
systems and capacity to develop
sustainable and accountable programs,
and assists in the implementation of
national AIDS spending assessment
activities; (8) assists countries in the
collection, transmission, classification,
storage, and analysis of strategic
information, and helps countries to
design, implement, maintain, and
evaluate a wide range of information
systems to both support implementation
of global HIV/AIDS services, and to
monitor and evaluate the results to
inform policy and program decisions;
(9) supports the integration of HIV data
into broader, more comprehensive
health information systems, supports
development of comprehensive health
information systems, and works to
ensure that systems are not duplicative;
(10) works with in-country counterparts
to provide technical assistance on
strengthening health information
systems in-country, including systems
needs assessments, identifying and
resolving DGHAs, describing data
exchanges needed across these systems,
and developing standards for data and
for system interoperability; (11) in
conjunction with WHO/Joint United
Nations Program on HIV/AIDS
develops: standardized definitions for
data that support ART, HIV/TB,
maternal child health, PMTCT, and
other clinical care; open source tools for
the implementation of electronic patient
record and other systems; security and
confidentiality guidance for HIV/AIDS
data; guidance on unique identification
and matching of patient records across
disparate information systems; (12)
participates in USG interagency
technical working groups and provides
technical leadership to address global
health information systems, Health
Systems Strengthening (HSS), and HRH
issues and initiatives; (13) provides
technical support for the routine
monitoring of health related governance
including financial accountability,
programmatic transparency, policy
development and enforcement, and
engagement and regulation of the
private health sector, including the
Global Fund to Fight AIDS,
Tuberculosis, and Malaria; (14)
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develops the HSS operational research
agenda for DGHA and implements
public health evaluations related to
health systems; (15) provides broad HSS
technical assistance and support to USG
in-country teams and host countries to
improve the delivery of HIV and other
health services and work toward
transition to country ownership of
program; (16) supports branches in
strengthening health systems,
developing metrics to assess DGHA’s
contribution to HSS and implementing
monitoring systems to routinely collect
DGHA’s health system impact,
especially in the areas of laboratory
systems, maternal child health services,
HIV care and treatment service delivery,
blood safety programs, and prevention
services; (17) helps define CDC’s role
and identify priority needs for
strengthening HRH to support
sustainability of HIV programs; (18)
provides HRH technical assistance and
other support to meet priority HRH
needs, including pre-service and inservice training, task-shifting, capacitybuilding of accreditation and
credentialing bodies, HRH planning and
management, workplace performance
and safety, and the development of
human resource information systems
and their use in health decision-making;
(19) conducts monitoring and
evaluation of US-supported HRH
activities, to help inform U.S. resource
and program decision-making; (20)
ensures that public health
epidemiologists, laboratorians, and
administrators are represented in the
goal of training and retaining 140,000
new health professionals; (21) supports
operational research activities and
public health evaluations that address
current HRH questions and monitoring
needs; (22) ensures scientific excellence
for all branch manuscripts, protocols,
and programs in collaboration with the
DGHA OD Science Office; and (23)
collaborates with other DGHA branches;
other CDC and HHS programs and
offices; other USG agencies; and other
national and international
organizations.
Country Operations Branch (CWGJ).
(1) Provides operations support to
facilitate effective delivery of global
HIV/AIDS activities in DGHA country
programs in the areas of fiscal
management, procurement, personnel,
extramural (grants, cooperative
agreements and contracts) programs,
and other administrative services; (2)
serves as the key linkage between DGHA
headquarters and DGHA country offices
coordinating calls and liaising with the
CDC Financial Management Office
(FMO) and Procurement and Grants
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Office (PGO), Atlanta Human Resources
Center, and OGAC; (3) serves as the CDC
representative on the OGAC core team/
country support team; (4) develops
strategies to improve the technical skills
and problem-solving abilities of country
program managers and locally employed
staff who work in the administrative,
management and operational area; (5)
provides short- and long-term
consultation, technical assistance, and
backstopping for management and
operations issues and staff to DGHA
country offices; (6) provides long-term
management and operations support for
smaller countries; (7) ensures timely
and sufficient CDC international staff
placement through recruitment, hiring,
orienting, deploying, and assisting with
relocation of qualified staff; (8) ensures
retention of qualified staff by providing
workforce management and career
development services for CDC
international staff; and (9) collaborates
with other DGHA branches; other CDC
and HHS programs and offices; other
USG agencies; and other national and
international organizations.
Program Budget and Extramural
Management Branch (CWGK). (1)
Coordinates all DGHA procurement and
extramural activities in creating spend
plans in compliance with federal
appropriations law, congressional
intent, and global HIV/AIDS policies; (2)
facilitates and manages the
development, clearance, and award of
all new and ongoing DGHA
headquarters and field grants,
cooperative agreements, and contracts;
(3) provides technical assistance and
guidance to the countries and branches
on budget and extramural issues
including assisting programs in
determining the appropriate funding
mechanism to support global HIV/AIDS
activities; (4) provides training and tools
to DGHA country programs to improve
budget and cooperative agreement
management; (5) manages DGHA
headquarters budget and tracks overall
DGHA budget, which includes
conducting budget planning exercises
and managing the annual close-out
process; (6) provides funding and
budgetary data for regular reports
including the Headquarters Operational
Plan, GAO and IG audits, country
Annual Program Results to OGAC, and
other requests for data; (8) reviews and
provides input on budgetary and
procurement policy-related documents;
(9) liaises and collaborates, as
appropriate, with the DGHA Associate
Director for Science, other financial and
procurement-related units and offices
including FMO and PGO, as well as
other CDC and HHS offices, OGAC, and
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other USG agencies; (10) collaborates
with other DGHA branches; other CDC
and HHS programs and offices; other
USG agencies; and other national and
international organizations. Division of
Parasitic Diseases and Malaria (CWH).
The Division of Parasitic Diseases and
Malaria (DPDM) prevents and controls
parasitic diseases in the U.S. and
throughout the world by providing
diagnostic, consultative, epidemiologic
services, and training. In carrying out its
mission, DPDM: (1) Conducts
surveillance, investigations, and studies
of parasitic diseases to define disease
etiology, mode of transmission, and
populations at risk, and to develop
effective methods for diagnosis,
prevention, control, and elimination; (2)
conducts or participates in clinical,
field, and laboratory research to
develop, evaluate, and improve
laboratory methodologies, materials and
therapeutic practices used for rapid and
accurate diagnosis and treatment of
parasitic diseases; (3) provides epidemic
aid, epidemiologic consultation, and
reference diagnostic services to state
and local health departments, other
federal agencies, and national and
international health organizations; (4)
conducts a program of laboratory and
field research in the biology, ecology,
and host-parasitic relationships to
develop better methods for diagnosis,
prevention, and control of parasitic
diseases; (5) provides scientific and
technical assistance to other
components within CDC when the work
requires unique expertise or specialized
equipment not available in other CDC
components; (6) serves as WHO
Collaborating Centers for Cysticercosis,
Research Training and Eradication of
Dracunculiasis, Control and Elimination
of Lymphatic Filariasis, Evaluating and
Testing New Insecticides, Insecticide
Resistance, Insect Vectors; Malaria
Control in Africa, Human African
Trypanosomiasis, Production and
Distribution of Malaria Sporozoite
ELISAs; (7) maintains field-based
research and program activities in
numerous developing countries; and (8)
provides marketing communications
support for responsive, evidence-based
information targeted to the public, local
and state health officials, international
partners, and private organizations to
inform health decisions, to prevent, and
control parasitic diseases in the U.S.
and abroad. Office of the Director
(CWH1). (1) Works with CGH OD to
ensure spending plans and budget are in
line with the overall infectious disease
strategies and priorities; (2) ensures that
the CGH strategy is executed by the
divisions and aligned with overall CDC
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goals; (3) co-develops execution
strategies for the division with the
branch chiefs; (4) provides program and
science quality oversight; (5) builds
leadership at the division and branch
levels; (6) evaluates the strategies, focus,
and prioritization of the division
research, program, and budget activities;
(7) identifies and coordinates synergies
between the division and relevant
partners; (8) ensures that policy
development is consistent and
appropriate; (9) facilitates research and
program activities by providing
leadership support; (10) proposes
resource priorities throughout the
budget cycle; (11) ensures scientific
quality, ethics, and regulatory
compliance; (12) fosters an integrated
approach to research, program, and
policy activities; and (13) liaises with
HHS and partners as defined in the
partnership management plan.
Malaria Branch (CWHB). (1) Conducts
malaria surveillance, prevention, and
control in U.S. residents and visitors by
monitoring the frequency and
distribution of malaria cases that occur
in U.S. residents and visitors and the
efficacy and safety of antimalarial drugs
for chemoprophylaxis and
chemotherapy; (2) provides clinical
advice and epidemiologic assistance on
the treatment, control, and prevention of
malaria in the U.S. and in malaria
endemic countries; (3) provides
information to the U.S. public and to
appropriate agencies and groups on
appropriate measures to prevent and
control malaria; (4) provides
consultation, technical assistance, and
training to malaria-endemic countries
and to international and U.S. agencies
and organizations on issues of malaria
prevention and control; (5) conducts
epidemiologic, laboratory, and fieldbased research projects, including
laboratory and field studies on parasitic
diseases to define biology, ecology,
transmission dynamics, parasite species
differences, host-parasite relationships,
diagnostics, host immune responses,
populations at risk, and determinants of
morbidity and mortality; (6) conducts
laboratory studies of malaria parasites
utilizing animal models and in vitro
systems for parasitic relationships,
chemotherapy, and vaccine evaluation
studies; (7) conducts field studies of
malaria prevention and control tools
and strategies; and (8) conducts
assessments of malaria monitoring and
evaluation methods and program use of
these methods.
Parasitic Diseases Branch (CWHC). (1)
Investigates outbreaks and unusual
occurrences of parasitic diseases in
concert with states, ministries of health,
WHO, and other agencies and
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22827
organizations; (2) conducts surveillance
of foodborne disease outbreaks and
other parasitic diseases in the U.S.; (3)
provides reference and laboratory
diagnostic services to physicians and
laboratories; (4) transfers technologies
and expertise in laboratory diagnosis of
parasitic infections to public health
laboratories; (5) provides consultation
on the prevention, treatment, and
management of parasitic diseases to
clinicians, laboratorians, departments of
health, and other agencies; and provides
otherwise unavailable anti-parasitic
drugs to healthcare providers and
ensures compliance with FDA’s
regulations; (6) supports the agency’s
overall emergency response mandate;
(7) conducts field and laboratory
investigations and research on the
etiology, biology, epidemiology,
ecology, pathogenesis, immunology,
genetics, host-parasite relationships,
chemotherapy and other aspects of
parasitic diseases to develop new tools
for identifying and controlling parasitic
diseases; (8) develops and tests new
laboratory methods and tools for
improved diagnosis, control, and
prevention of parasitic diseases, and
conducts laboratory training courses for
public health laboratories; (9) carries out
and evaluates operational research to
evaluate current strategies and develops
new strategies to support programmatic
activities for the control and elimination
of parasitic diseases, and provides
technical assistance to ministries of
health, WHO, and other agencies and
organizations for these programs; (10)
provides training to Epidemic
Intelligence Service officers, Emerging
Infectious Disease fellows, American
Society of Microbiology/Postdoctoral
Fellows, Preventive Medicine Residents,
public health prevention specialists,
and other fellows and students; and (11)
prepares and disseminates health
communication materials on the
prevention and treatment of parasitic
diseases.
Entomology Branch (CWHD). (1)
Conducts surveillance, field
investigations, and laboratory studies on
the vectors of parasitic diseases of
humans, with a focus on malaria,
Chagas’ disease, lymphatic filariasis,
onchocerciasis, and leishmaniasis, with
a particular emphasis on the anopheline
vectors of malaria; (2) serves as WHO
Collaborating Centers for pesticides
resistance, anopheline vector
identification, antimalarial drug
evaluation, and vector control; (3)
develops methods supporting the use of
pesticides for control of vector-borne
diseases, the management of insecticide
resistance, and the monitoring of anti-
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parasitic drugs; (4) serves as an
international reference reagent and
anopheline vector repository, providing
materials, training, and information
related to malaria vectors; and (5)
provides entomological consultation,
epidemic aid, and training to local,
state, federal and foreign agencies and
international health organizations on
surveillance and control of vectors and
vector-borne diseases.
Division of Global Disease Detection
and Emergency Response (CWJ). The
Division of Disease Detection and
Emergency Response (DGDDBER)
supports CDC global efforts to
strengthen public health systems abroad
and build essential infrastructure in
host countries. By providing leadership
and coordinating with global partners,
the Division increases preparedness and
response to prevent and control
naturally occurring and man-made
threats to health. To carry out its
mission, the Division performs the
following functions: (1) Supports the
requirements of the revised
International Health Regulations by
fostering collaborations, partnerships,
integration, and resource leveraging to
increase CDCs impact and achieve
public health goals; (2) works with
partners to build strong, transparent,
and sustained global public health
systems through training, consultation,
capacity building, and technical
assistance in applied epidemiology,
public health surveillance, evaluation,
and laboratory systems; (3) coordinates
management and oversight of critical
global health preparedness and
emergency response activities across
CDC, including situational awareness
and partnership management at the
global and regional level; (4) coordinates
with and responds to requests from a
wide array of internal CDC and external
partners and stakeholders; and (5)
provides stewardship and leadership
support to global health preparedness
programs housed in the Division.
Office of the Director (CWJ1). (1)
Provides leadership, oversight,
evaluation and overall direction and
management for the activities of the
Division; (2) develops Division overall
strategy, policies on planning,
evaluation, management, and
operations; (3) plans, allocates, and
monitors resources; (4) provides liaison
with other CDC organizations, other
Federal agencies, national ministries of
health, international organizations, non
governmental organizations, private
sector, and others that CDC cooperates
with in global health programs and
activities; and (5) promotes high
standards in science and ethics among
CDC’s international activities.
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Global Disease Detection Branch
(CWJB). The Global Disease Detection
(GDDB) Branch: (1) Provides leadership
and works with partners around the
globe to increase preparedness for and
mitigate the consequences of a
catastrophic public-health event,
whether by an intentional act of
terrorism, or the natural emergence of a
deadly infectious disease; (2) provides
program support, resources and
technical assistance to the seven Global
Disease Detection (GDD) Centers around
the world; (3) supports emerging
infectious disease detection and
response, pandemic influenza
preparedness, health communications,
zoonotic disease investigation,
laboratory systems and biosafety, and
training in field epidemiology and
laboratory methods through the GDD
Centers and other CDC field locations;
(4) provides epidemic intelligence and
response capacity to provide an early
warning about international disease
threats, and coordinates with partners
throughout the U.S. government to
provide rapid response; (5) leads and
administers CDCs GDD program through
coordination with relevant
implementing programs across the
Agency; (6) provides leadership,
guidance, technical assistance support
and resources for global infectious
disease surveillance, applied
epidemiologic and laboratory research,
and response to emerging infectious
disease threats; (7) provides resources
and assists in developing country-level
epidemiologic, laboratory, and other
capacity to ensure country emergency
preparedness and response to outbreaks
and incidents of local importance and of
international interests; and (8)
maintains staff in the CDC Emergency
Operations Center to manage, direct,
coordinate and evaluate biosurveillance
data from domestic and international
networks and serve as a central focus for
global outbreak and incident response
activities.
Global Health Security Branch
(CWJC). The Global Health Security
Branch (GHSB): (1) Serves as the
principal point of coordination at CDC
for global health security activities at
HHS/OS, the DoS, the Department of
Defense (DoD), USAID, USDA, other
U.S. government agencies, and
international and multilateral
organizations; (2) aligns the activities
formerly conducted by CDC units
supporting the Biosecurity Engagement
Program (BEP), the Defense Threat
Reduction Agency Program and the
International Influenza Unit (IIU); (3)
provides support and coordination
regarding the development of policies
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and priorities on international
influenza; (4) serves as liaison with HHS
and technical agency (CDC, NIH, FDA)
representative for international
pandemic preparedness related to
budget formulation, program
development, strategic planning, and
global health policy development; (5)
provides leadership, coordination,
management and oversight of technical
agency reports, briefing documents, and
talking points for the HHS Secretary and
staff related to global health policy; (6)
provides technical assistance through
training, and capacity building in
supporting efforts to reduce the threat
from chemical, biological, and nuclear
disasters that are either natural or manmade; (7) provides liaison with the DoS
Biosecurity Engagement Program and
DoD Defense Threat Reduction Agency
to coordinate on global biological
threats; and (8) coordinates
international aspects of CDC’s terrorism
preparedness and emergency response
activities in collaboration with OPHPR.
International Emergency and Refugee
Health Branch (CWJD). The
International Emergency and Refugee
Health Branch (IERHB) applies public
health and epidemiologic principles to
improve the health of refugees,
internally displaced persons (IDPs) and
populations affected by complex
humanitarian and other international
emergencies. Specifically, it: (1)
Coordinates, supervises, and monitors,
CDC’s work in international emergency
settings and in refugee or displaced
populations in collaboration with other
U.S. government agencies, United
Nations agencies, and non-governmental
organizations; (2) provides direct
technical assistance to refugees/IDPs
and emergency affected populations in
the field, focusing on rapid health and
nutrition assessments, public health
surveillance, epidemic investigations,
communicable disease prevention and
control and program evaluation; (3)
develops and implements operational
research aimed at developing more
effective public health and nutrition
interventions in emergency-affected
populations; (4) plans, implements, and
evaluates training courses and
workshops to help strengthen CDC
technical capacity in emergency public
health of CDC, as well as that of other
U.S. government agencies, international
and private voluntary organizations, and
schools of public health; (5) develops
technical guidelines on public health
issues associated with international
complex humanitarian emergencies; (6)
serves as the CDC liaison with other
international, bilateral, and nongovernmental relief organizations
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involved with humanitarian
emergencies; and (7) helps prepare CDC
country offices, host countries, and local
partners to respond to the full range of
public health emergencies.
Delete in its entirety the title and
functional statements for the Division of
Global AIDS (CVJG) within the National
Center for HIV/AIDS, Viral Hepatitis,
STD and TB Prevention.
Delete in its entirety the title and
functional statement for the
International Emergency and Refugee
Health Branch (CTBBD) within the
Division of Emergency and
Environmental Health Services of the
National Center for Environmental
Health.
Dated: April 19, 2010.
William P. Nichols,
Chief Operating Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–9910 Filed 4–29–10; 8:45 am]
BILLING CODE 4163–18–M
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2006–24163]
National Environmental Policy Act;
Final Environmental Impact Statement
on U.S. Coast Guard Pacific Area
Operations: Districts 11 and 13
You may submit comments
identified by docket number USCG–
2006–24163 using any of the following
methods:
(1) Federal eRulemaking Portal:
https://www.regulations.gov.
(2) Fax: 202–493–2251.
(3) Mail: Docket Management Facility
(M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue SE., Washington, DC 20590–
0001.
(4) Hand delivery: Same as mail
address above, between 9 a.m. and 5
p.m., Monday through Friday, except
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To avoid duplication, please use only
one of these four methods. See the
‘‘Public Participation and Request for
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SUPPLEMENTARY INFORMATION section
below for instructions on submitting
comments.
ADDRESSES:
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you have questions on this notice, call
or e-mail LCDR Jeff Bray, Office of
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e-mail JEFF.R.BRAY@USCG.MIL. If you
have questions on viewing or submitting
material to the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–366–9826.
SUPPLEMENTARY INFORMATION:
AGENCY:
Public Participation and Request for
Comments
SUMMARY: The U.S. Coast Guard
announces the availability of the Final
Environmental Impact Statement (FEIS)
to implement enhanced environmental
protection measures, as necessary, for
marine protected species (MPS) and
marine protected areas (MPAs) that
occur in the Coast Guard’s District 11
(California) and 13 (Oregon and
Washington) areas of responsibility
(AORs). The FEIS analyzes the potential
environmental impacts of specific Coast
Guard vessel and aircraft operations on
MPS and MPAs when engaged in the
following missions and activities: law
enforcement, national security, search
and rescue (SAR), aids to navigation
(ATON), and oil pollution and vessel
grounding response. We request your
comments on the FEIS.
DATES: Comments and related material
must either be submitted to our online
docket via https://www.regulations.gov
on or before June 1, 2010 or reach the
Docket Management Facility by that
date.
We encourage you to submit
comments and related material on the
FEIS. All comments received will be
posted, without change, to https://
www.regulations.gov and will include
any personal information you have
provided.
Submitting comments: If you submit a
comment, please include the docket
number for this notice (USCG–2006–
24163) and provide a reason for each
suggestion or recommendation. You
may submit your comments and
material online, or by fax, mail or hand
delivery, but please use only one of
these means. We recommend that you
include your name and a mailing
address, an e-mail address, or a
telephone number in the body of your
document so that we can contact you if
we have questions regarding your
submission.
To submit your comment online, go to
https://www.regulations.gov, click on the
‘‘submit a comment’’ box, which will
then become highlighted in blue. In the
‘‘Document Type’’ drop down menu
select ‘‘Notices’’ and insert ‘‘USCG–
2006–24163’’ in the ‘‘Keyword’’ box.
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Coast Guard, DHS.
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request for comments.
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Click ‘‘Search’’ then click on the balloon
shape in the ‘‘Actions’’ column. If you
submit your comments by mail or hand
delivery, submit them in an unbound
format, no larger than 81⁄2 by 11 inches,
suitable for copying and electronic
filing. If you submit them by mail and
would like to know that they reached
the Facility, please enclose a stamped,
self-addressed postcard or envelope. We
will consider all comments and material
received during the comment period.
Viewing the comments, Draft
Environmental Impact Statement
(DEIS), FEIS, and associated documents:
To view the comments, FEIS, DEIS, and
other documents, go to https://
www.regulations.gov, click on the ‘‘read
comments’’ box, which will then
become highlighted in blue. In the
‘‘Keyword’’ box, insert ‘‘USCG–2006–
24163’’ and click ‘‘Search.’’ Click the
‘‘Open Docket Folder’’ in the ‘‘Actions’’
column. If you do not have access to the
Internet, you may view the docket
online by visiting the Docket
Management Facility in Room W12–140
on the ground floor of the Department
of Transportation West Building, 1200
New Jersey Avenue SE., Washington,
DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal
holidays. We have an agreement with
the Department of Transportation to use
the Docket Management Facility. In
addition, the Coast Guard has posted the
FEIS at the following Web site: https://
pacareaeis.uscg.e2m-inc.com.
Privacy Act: Anyone can search the
electronic form of comments received
into any of our dockets by the name of
the individual submitting the comment
(or signing the comment, if submitted
on behalf of an association, business,
labor union, etc.). You may review a
Privacy Act, system of records notice
regarding our public dockets in the
January 17, 2008, issue of the Federal
Register (73 FR 3316).
Background and Purpose
Final Environmental Impact Statement
We have prepared an FEIS to
implement enhanced protective
measures, as necessary, for MPS and
MPAs that occur in the Eleventh Coast
Guard District (California) (D11) and
Thirteenth Coast Guard District
(Washington and Oregon) (D13) AORs.
The FEIS analyzes the potential
environmental impacts of specific Coast
Guard vessel and aircraft operations on
MPS and MPAs when engaged in law
enforcement, national security, SAR,
ATON, and oil pollution and vessel
grounding response.
The Coast Guard published a notice of
intent to prepare an EIS in the Federal
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Agencies
[Federal Register Volume 75, Number 83 (Friday, April 30, 2010)]
[Notices]
[Pages 22821-22829]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-9910]
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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 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 75 FR 14608, dated March 26, 2010) is amended to
reflect the reorganization of the Center for Global Health, Centers for
Disease Control and Prevention.
Section C-B, Organization and Functions, is hereby amended as
follows: Delete in their entirety the titles and functional statements
for the Center for Global Health (CW), and insert the following:
Center for Global Health (CW). The Center for Global Health (CGH):
(1) Leads the execution of the Center for Disease Control and
Prevention's (CDC) global health strategy; (2) works in partnership to
assist Ministries of Health to plan, manage effectively, and evaluate
health programs; (3) achieves U.S. Government program and international
organization goals to improve health, including disease eradication and
elimination targets; (4) expands CDC's global health programs that
focus on the leading causes of mortality, morbidity and disability,
especially chronic disease and injuries; (5) generates and applies new
knowledge to achieve health goals; and (6) strengthens health systems
and their impact.
Office of the Director (CWA). (1) Provides strategic direction and
guidance on the execution of CDC's global health strategy including
decision-making, policy development and program planning and
evaluation; (2) ensures the impact and effectiveness of
Congressionally-mandated programs; (3) improves implementation and
coordination of CDC global programs; (4) harmonizes CDC global health
priorities with host country priorities to improve essential public
health functions and maximize positive health outcomes, country
ownership and sustainability; (5) supervises all CDC country directors
and provides leadership in the selection of additional countries to
expand or establish collaboration; (6) measures the performance of
CDC's global health programs in terms of public health impact and
fiscal accountability; (7) facilitates the conduct and maintenance of
ethical and high quality, evidence-based scientific investigations by
implementing regulatory requirements, monitoring human subjects
compliance, and clearing scientific products; (8) promotes cross-
cutting agendas and harmonizes CDC's global laboratory science
activities to improve diagnostic methodologies and respond to threats
of emerging pathogens; (9) provides leadership to promote growth of CDC
global health programs; (10) analyzes, measures, and evaluates the
global burden and distribution of disease; (11) promotes scientific
innovation and best technical practices in global health surveillance,
epidemiology, outbreak investigation, monitoring and evaluation, and
informatics; (12) provides leadership on issues management, budget
formulation and performance integration, and country-specific issues
through triaging to programs; (13) participates in defining,
developing, shaping and implementing U.S. global health policy and
actions; (14) manages inter-governmental and
[[Page 22822]]
external affairs and cultivates strategic partnerships; (15) plans and
executes CDC's global health communications strategy and public affairs
media response/outreach; (16) provides oversight, guidance, and
accountability for all operations functions, human resources, workforce
management, budget formulation and distribution, extramural reviews and
processing, internal and domestic travel, and property management
responsibilities of CGH; and (17) develops standardized management
processes and solutions for CDC country offices.
Division of Public Health Systems and Workforce Development (CWF).
The Division of Public Health Systems and Workforce Development
(DPHSWD) contributes to improving the health of the people of the U.S.
and other nations by partnering with relevant foreign government
ministries, educational institutions, Federal agencies, and
international organizations to strengthen capacity of countries around
the world to improve public health. To carry out its mission, the
division performs the following functions: (1) Works with partners to
build strong, transparent, and sustained public health systems through
training, consultation, capacity building, and technical assistance in
applied epidemiology, public health surveillance, evaluation,
operational and implementation research, and laboratory systems; and
promotes organizational excellence in public health through
strengthening leadership and management capacity; (2) assists in
developing and implementing CGH policy on public health system
strengthening and sustainability; (3) collaborates with other CDC
organizations, Federal agencies, international agencies, partner
countries, and non-governmental organizations assisting ministries of
health to build public health capacity in other areas of public health;
and (4) supports and performs primary research on health systems and
health systems performance that are relevant to the improvement of the
division's own programs as well as the programs with which it
collaborates.
Office of the Director (CWF1). (1) Provides leadership, overall
direction, and evaluation for the division; (2) formulates and
coordinates execution of CDC's strategy for developing global public
health capacity in applied epidemiology, public health systems
management and leadership; (3) provides leadership and guidance on
policy, program planning, program management, and operations; (4)
plans, allocates, and monitors resources; (5) formulates, executes, and
monitors CORE budgets; (6) monitors and assists in the formulation and
execution of branch and county project's budgets; (7) provides support
and assistance to the branches in management, administrative, and
personnel services; (8) develops and manages cooperative agreements,
grants and contracts; (9) develops and disseminates communication
material; (10) provides leadership in assisting national ministries of
health, international agencies, and nongovernmental organizations in
the delivery of epidemiologic services and the development of
international epidemiologic networks; (11) liaises with other CDC
organizations, other Federal agencies, ministries of health, and
international organizations; (12) provides consultations with partners
and stakeholders including nongovernmental organizations and the
private sector on program development and overall public health systems
and sub-systems; (13) develops and produces communication materials
documenting the division's public health programs, accomplishments, and
impact (e.g., annual reports, newsletters, Web sites, training
materials); (14) develops and maintains intranet and internet Web sites
for the division and its programs; (15) provides consultation and
technical assistance to programs and partners in scientific
communication, health communication, and public health marketing
programs; and (16) assesses scientific communication needs for
partners, and develops and delivers public health materials and
information, and training tailored to the specific needs of the
partners.
Sustainable Management Development Program (CWF12). (1) Partners
with ministries of health, educational institutions, and
nongovernmental organizations to promote organizational excellence in
public health through strengthening leadership and management capacity;
(2) works with partners to build capacity for public health leadership
and management development through a multi-phased approach including
situational analysis, capacity development, technical assistance, and
sustainability; (3) develops strategic institutional partnerships for
public health leadership and management capacity-building efforts; (4)
develops faculty to enhance in-country leadership and management
training capacity through the Management for International Public
Health course and in-country training-of-trainers; (5) provides support
to training faculty in partner institutions to conduct performance
needs assessments; develops locally appropriate curricula; and designs
in-country leadership and management workshops that provide
participants with practical skills needed to manage public health
teams, programs, and organizations; (6) works with partner institutions
to ensure the long-term sustainability of global public health
leadership and management development programs; and (7) supports and
performs primary operational and implementation research in support of
continuous improvement of its own and partners' leadership and
management programs.
FELTP and Systems Development Branch (Africa) (CWFB). (1) With
partners, designs and conducts evidence-based instruction in public
health disciplines needed to strengthen their public health systems,
including instructional design, epidemiology, surveillance, laboratory
operations and management, communications, and economic evaluation; (2)
assists ministries of health in the African region and elsewhere to
develop sustainable field epidemiology and laboratory training programs
for public health systems strengthening; (3) develops models for
continuous tracking and improvement of critical outputs and outcomes
from field epidemiology and laboratory training programs around the
world; (4) working with DPHSWD technical program components, provides
consultation to ministries of health in development of surveillance
systems (e.g., communicable and non communicable disease surveillance,
injury, chronic diseases, etc.); (5) coordinates CDC's support the
World Health Organization's (WHO) Integrated Disease Surveillance and
Response strategy; (6) creates and maintains division wide computer-
based and distance-based learning methods, and develops the capacity of
partners to create, evaluate, and share their own; (7) develops and
evaluates competency based training materials for the FETP and similar
program for use of the division and its partners; (8) maintains a
divisional training material library and website; and (9) collaborates
within CDC and with national or international organizations in
development of competency-based training materials, evaluation of
training, and design of surveillance systems needed to accomplish the
mission.
FELTP and Systems Development Branch (Asia and the Americas)
(CWFC). (1) Assists partners in assessing their needs for health
systems strengthening; (2) plans, directs,
[[Page 22823]]
supports, implements, and coordinates field epidemiology and laboratory
training programs, Data for Decision Making Projects, operational and
implementation research projects, and other partnerships with
ministries of health; (3) provides leadership and management oversight
in assisting ministries of health in capacity building by training
epidemiologists and other health professionals through the development
of competency based, residency-style, applied training programs; (4)
provides leadership and expertise in assisting national ministries of
health to utilize trained public health workers for developing health
policy, and implementing and evaluating health programs; (5) assigns
and manages expert consultants as long-term, in-country advisors to
ministry of health programs; (6) collaborates within CDC, with other
Federal agencies, and with national and international organizations in
support of partner programs; (7) provides consultation to ministries of
health in development of surveillance systems (e.g., communicable and
non-communicable disease surveillance, injury, chronic diseases, etc.);
(8) develops and evaluates competency-based training materials for the
FETP and similar programs for use of the division and its partners; and
(9) collaborates within CDC and with national or international
organizations in development of competency-based training materials,
evaluation of training, and design of surveillance systems needed to
accomplish mission.
Division of Global HIV/AIDS (CWG) The Division of Global HIV/AIDS
(DGHA) provides technical assistance to host governments, working
through its strong partnerships with Ministries of Health and local and
international partners to implement integrated HIV/AIDS clinical and
preventive services and systems; develop and strengthen laboratory
services; and provide epidemiologic science, informatics, and research
support to develop sustainable public health systems in resource-
constrained countries. DGHA: (1) Provides leadership, management, and
services to DGHA country offices; (2) implements integrated evidence-
based prevention, care, and treatment programs and services; (3)
evaluates program cost effectiveness and impact to assist with
prioritization, inform program planning, and determine appropriate
rates of program expansion, and supports transition of responsibility
for implementation of HIV programs to indigenous partners and
Ministries of Health; (4) builds sustainable public health capacity in
laboratory services and systems; (5) ensures epidemiologic and
scientific excellence in HIV/AIDS programs; (6) contributes to the
broader scientific body of knowledge in global public health by
systematically evaluating the scope and quality of global HIV/AIDS
programs; (7) implements operations and effectiveness research to
inform the design of current and future programs as well as optimize
allocation of human and financial resources; (8) strengthens in-country
capacity to design and implement HIV/AIDS surveillance systems and
surveys; (9) builds host government public health management capacity
and trains in-country public heath workforce with the goal of long term
program sustainability; (10) supports host government capacity to
monitor and evaluate the process, outcome, and impact of HIV
prevention, care, and treatment programs, and (11) helps countries
respond to public health emergencies, assisting in response planning
and implementation with Ministries of Health and other international
partners.
Office of the Director (CWG1). (1) Provides strategic leadership,
guidance, management and oversight to all DGHA programs and ensures
coordination and communication across its branches and with other CDC
programs including CDC/Washington; U.S. Government (USG) agencies,
including the Department of Health and Human Services (HHS), the United
States Agency for International Development (USAID), and Department of
State (DoS); and other international organizations; (2) plans,
implements, and oversees all field programs along with other USG
agencies; (3) manages all DGHA country directors and provides
leadership and guidance to country offices in all matters of daily
operation, including management of global workforce staff; (4) provides
leadership and guidance on policy development and interpretation,
budget formulation, program planning, issues management, management and
operations, and evaluation; (5) helps to build capacity and strengthen
the public health response by sharing best practices through
communication materials and coordinating dissemination of resources to
the media, partners, and other audiences; (6) identifies opportunities
for leveraging and enhancing partnerships for public health protection
and synergies with other Agency programs and partners; (7) provides
DGHA management and operations services in coordination with
appropriate CDC staff offices, including processing travel and
assisting with accountability and management of HHS/CDC property,
facilities, and equipment; (8) ensures timely and sufficient DGHA
domestic staff placement through recruitment, hiring, and orienting of
qualified staff; (9) ensures retention of qualified staff by providing
workforce management and career development services for DGHA domestic
staff; (10) ensures scientific excellence for all DGHA scientific,
programmatic, and informational documents/materials which includes
providing scientific review and clearance of manuscripts for
publication, abstracts for presentation, and protocols for
institutional review boards and human subjects review; (11) provides
coordination and support for, as well as contributes to, global public
health evaluation and operational research to maximize the
effectiveness and quality of global HIV/AIDS interventions to guide
DGHA programs and policies; (12) establishes and implements standards
for organizational excellence; (13) provides direct technical
assistance and maintains relationships with host country partners and
responds to other health needs as required; (14) assures accountability
of program funds and reports on progress; and (15) collaborates with
other CDC and HHS programs and offices; other USG agencies; and other
national and international organizations.
International Laboratory Branch (CWGB). (1) Serves as a reference
laboratory that provides guidance on quality assurance and
certification for international sites; (2) provides technical
assistance to country programs in the areas of laboratory information
systems and laboratory systems; (3) provides training packages,
training, guidance, and support to host nations, other USG agencies and
international and national partners on HIV, Sexually Transmitted
Infection (STI), and opportunistic infection (OI) diagnostics and
monitoring techniques; HIV incidence testing; hematology; chemistry;
CD4; TB/OI testing; antiretroviral treatment (ART) resistance testing;
dried blood spot polymerase chain reaction for early infant diagnosis;
viral load monitoring; and ensuring the quality of laboratories and
testing activities; (4) serves as a training center of excellence for
HIV/STI/OI diagnostics for international sites; (5) provides laboratory
assistance to international surveillance activities to monitor trends
of HIV prevalence and incidence; (6) assists in the surveillance of HIV
subtypes in the overall context of supporting sero-surveillance
programs; (7) assists in the surveillance and evaluation of HIV drug
resistance as part of antiretroviral care and treatment
[[Page 22824]]
programs and serves as a reference laboratory for the World Health
Organization (WHO)-CDC HIV drug resistance network; (8) develops
strategies and methodologies to meet the clinical and diagnostic needs
of HIV/AIDS programs; (9) assists in the evaluation and validation of
serologic and nucleic acid assays for measurement of HIV incidence to
enable evaluation of effectiveness of prevention programs; (10)
develops comprehensive testing algorithms for HIV diagnosis; (11)
contributes to operational research to maximize the effectiveness and
quality of global HIV/AIDS interventions to guide DGHA programs and
policies; (12) conducts laboratory capacity assessments and assists in
development of infrastructure for effective implementation of programs
in countries where DGHA operates; (13) provides laboratory guidance and
support on national strategic planning and quality management of tiered
laboratory systems in host nations and consults on all technical
aspects of laboratory procurement, standardization, quality control and
quality assurance; (14) works with international accrediting
organizations to establish guidance, training, and tools for
accreditation of laboratory systems in resource-poor settings; (15)
supports ongoing collaboration with international laboratory experts
and national and regional laboratory personnel to resolve technical
issues and develops international tools, guidelines, curriculum and
other resources to improve laboratory capacity in host nations; (16)
develops and implements strategies to expand the laboratory health
workforce and increase human capacity of host government public health
programs to strengthen and ensure a sustainable public health response
to HIV/AIDS; (17) promotes a transition toward greater sustainability
of laboratory systems through the support of country-driven efforts;
(18) establishes strategic Public Private Partnerships for
strengthening laboratory systems, training, development of referral
systems for transporting samples, and quality management schemes; (19)
ensures scientific excellence for all branch manuscripts, protocols,
and programs in collaboration with the DGHA Office of the Director (OD)
Science Office; (20) contributes to the greater body of scientific
knowledge through the presentation of laboratory operational research
findings at conferences and through publications in peer reviewed
journals; and (21) collaborates with other DGHA branches; other CDC and
HHS programs and offices; other USG agencies; and other national and
international organizations.
HIV Prevention Branch (CWGC). (1) Provides technical assistance and
builds capacity to implement, improve, expand, sustain, and maximize
effectiveness of HIV prevention programs; (2) provides technical
assistance for scale-up of prevention and biomedical interventions and
linkage with other HIV clinical services; (3) assists DGHA country
programs in the recruitment of safe blood (products) donors, quality
testing, blood bank management, appropriate use of blood and blood
products, and prevention of severe anemia; (4) fosters the improvement
of HIV prevention and counseling services through blood donor
education, mobilization, and retention of safe blood donors; (5)
supports development of safe injection practices, improved sharps waste
management, safer blood transfusions, and avoidance of unnecessary
medical injections; (6) assists in the development, implementation, and
evaluation of model behavior change interventions and programs to
reduce risk-behaviors and enhance health-seeking behaviors; (7) helps
strengthen, expand, and make accessible programs to prevent, diagnose,
and treat STIs in high risk populations and to prevent HIV infection
among persons seeking treatment for STIs; (8) assists in tailoring HIV
prevention programs to meet the special needs of youth and drug-using
populations; (9) helps to develop, expand, and evaluate voluntary HIV
counseling and testing programs in both clinical and community
settings; (10) assists in the provision of technical support to DGHA
programs in developing laboratory, clinical, and administrative
capacities to prevent HIV/AIDS; (11) assists in implementing, and
monitoring the quality and impact of, prevention programs for persons
living with HIV/AIDS and their families and integrating HIV prevention
programs within health services for HIV care and treatment; (12)
assists in safe and effective implementation of biomedical
interventions, including the scale-up of male circumcision; (13)
assists in monitoring the training of health care workers to prevent
HIV; (14) contributes to operational research to maximize the
effectiveness and quality of global HIV/AIDS interventions to guide
DGHA programs and policies; (15) establishes strategic Public Private
Partnerships to build capacity for and maximize effectiveness of HIV
prevention programs in host countries; (16) ensures scientific
excellence for all branch manuscripts, protocols, and programs in
collaboration with the DGHA OD Science Office; and (17) collaborates
with other DGHA branches; other CDC and HHS programs and offices; other
USG agencies; and other national and international organizations.
HIV Care and Treatment Branch (CWGD). (1) Provides technical
assistance and builds capacity in developing and implementing
sustainable comprehensive care and treatment programs for persons with
HIV/AIDS. This includes prevention, diagnosis, and treatment services
for HIV/AIDS, tuberculosis, other opportunistic infections, and
opportunistic cancers; (2) provides technical expertise and support to
country programs, partners, and Ministries of Health in planning,
implementing, and evaluating effective strategies for care and
treatment of persons with HIV; (3) provides HIV care and treatment
expertise to country programs, partners, and Ministries of Health on
management, standard operating procedures, human resources, physical
infrastructure, training, drug and health commodities management,
laboratory services, monitoring and evaluation, community services,
linkage between HIV and other programs, promotion of prevention, and
sustainability; (4) provides support for continuous quality improvement
of HIV care and treatment programs; (5) promotes appropriate
integration of services, including HIV prevention interventions into
clinical care and treatment settings and HIV services into general
medical services; (6) conducts operational research in collaboration
with country programs to identify best practices, address barriers, and
respond to emerging scientific issues related to HIV care and treatment
service delivery; (7) collaborates with international partners to
synthesize the scientific body of knowledge on HIV care and treatment,
including TB/HIV co-infection; (8) collaborates with international
partners to develop and disseminate tools (e.g., protocols and training
curricula), guidelines and policies; (9) supports analysis of program
costs and cost effectiveness to assist with prioritization, inform
program planning, and determine appropriate rates of program expansion;
(10) supports capacity building of host countries to transition
responsibility for implementation of HIV care and treatment services to
indigenous partners and Ministries of Health, with result of increasing
ownership, sustainability and service delivery cost
[[Page 22825]]
efficiencies; (11) establishes strategic Public Private Partnerships
aimed at augmenting capacity for developing and implementing
sustainable comprehensive care and treatment programs, including
prevention, diagnosis, and treatment services for HIV/AIDS,
tuberculosis, other opportunistic infections, and opportunistic
cancers; (12) ensures scientific excellence for all branch manuscripts,
protocols, and programs in collaboration with the DGHA OD Science
Office; (13) collaborates with other DGHA branches; other CDC and HHS
programs and offices; other USG agencies; and other national and
international organizations.
Maternal and Child Health Branch (CWGE). (1) Supports the
international scale up of comprehensive, quality prevention of mother-
to-child HIV transmission (PMTCT) and pediatric (Peds) programs by
developing adaptable training tools, utilizing operational research to
identify and implement models of service delivery adapted to district,
regional, sub-national and national contexts; (2) provides technical
expertise and support to countries in planning, implementing, and
evaluating effective strategies for scaling up of sustainable programs
for the prevention, diagnosis, and treatment of HIV/AIDS, tuberculosis,
and other opportunistic infections in women, infants, and children,
including linking PMTCT/Peds HIV programs with HIV clinical and
preventive services and other maternal and child health settings/
contexts; (3) builds national capacity for and provides guidance on
development of policy for formulations for and access to appropriate
long-term combination ART for HIV-infected children; (4) conducts
operational research in collaboration with country programs to promote
best practices, address barriers, and respond to emerging scientific
issues for PMTCT/Peds HIV service delivery; (5) collaborates with
international partners to contribute to the scientific body of
knowledge on global PMTCT/Peds and broader maternal arid child health
issues and to develop and disseminate tools, guidelines, and policies
to translate research for improved program implementation in resource-
constrained countries; (6) provides support for continuous quality
improvement of PMTCT and Peds HIV care and treatment programs,
including those within broader maternal and child health programs; (7)
supports analysis of program costs and cost-effectiveness to assist
with prioritization, inform program planning, and determine appropriate
rates of program expansion; (8) acts as a key part of a broader CDC
strategic response to address health needs and gender-related issues of
maternal and child health worldwide, supporting a comprehensive,
multidisciplinary approach to building maternal and child health
services and systems capacity in host countries; (9) establishes
strategic Public Private Partnerships for HIV maternal and child health
services and systems capacity in host countries; (10) ensures
scientific excellence for all branch manuscripts, protocols, and
programs in collaboration with the DGHA OD Science Office; and (11)
collaborates with other DGHA branches; other CDC and HHS programs and
offices; other USG agencies; and other national and international
organizations.
Epidemiology and Strategic Information Branch (CWGG). (1) Assists
countries in developing and/or enhancing HIV-related surveillance
systems and in using the results of surveillance surveys for impact
monitoring, program planning, and HIV/AIDS policy making; (2) assists
and provides training on analyzing, disseminating, and using HIV/AIDS
data; (3) assists and provides training to CDC programs and host
country governments to assess and ensure the quality of the data
collected in HIV-related surveillance systems and HIV/AIDS program
monitoring systems; (4) strengthens host government capacity to monitor
and evaluate the process, outcome, and impact of HIV/AIDS prevention,
care, and treatment programs, other related global health programs, and
health systems through the development of guidelines, curricula, and
other tools; (5) implements and evaluates novel approaches for
conducting surveillance and surveys, and conducting program monitoring
and evaluation; (6) performs epidemiologic investigations of HIV/AIDS
as well as provides statistical and epidemiologic technical assistance
for in-country investigations; (7) supports surveys and monitoring and
evaluation systems that measure HIV prevalence, changes in HIV-related
behavior, and health status among individuals and at the population
level; (8) strengthens country monitoring systems that track program
service delivery and ensure effective, evidence based programming; (9)
provides support to the DoS Office of the US Global AIDS Coordinator
(OGAC) and to interagency USG in-country teams to monitor and evaluate
the outputs, outcomes, and impact of global HIV/AIDS activities and
advises interagency in-country teams on planning of strategic
information activities; (10) improves the collection and analysis of
data through development of guidelines on HIV surveillance and assists
countries to develop procedures to standardize HIV surveillance
systems, write protocols for HIV surveillance, train for data
collection, and assist with data cleaning and data analysis; (11)
provides a wide range of statistical and epidemiologic support and
technical expertise to agencies and staff engaged in global HIV/AIDS
activities, including consultation and direct assistance at all stages
of a public health study; specifically, development of study design,
sample size and power estimation, questionnaire design, data
monitoring, statistical analysis and report writing; (12) provides
comprehensive data management support to staff and countries engaged in
global HIV/AIDS activities, including development of data organization
plan and standards for coding of data elements, quality assurance,
maintenance of databases, report generation, and implementation of
policies on electronic record retention and data security; (13)
coordinates, oversees, or assists in the formulation of epidemiology
and strategic information funding/budgets and in the execution of a
variety of acquisition and assistance awards; (14) ensures scientific
excellence for all branch manuscripts, protocols, and programs in
collaboration with the DGHA OD Science Office; and (15) collaborates
with other DGHA branches; other CDC and HHS programs and offices; other
USG agencies; and other national and international organizations.
Health Economics, Systems, and Integration Branch (CWGH). (1)
Identifies priority information needs for program planning, resource
allocation, efficiency and program integration, and develops economic
analysis and operational research activities; (2) implements economic
studies, including costing and cost-effectiveness studies, and applies
advanced modeling techniques to inform and optimize global health
planning, policy and programs, and provide a broader understanding of
the effects of health programs on improving economic and other non-
health outcomes; (3) supports USG efforts in projecting financing needs
to efficiently meet program targets in areas of prevention, care and
treatment, and human resources for health (HRH); (4) guides development
and implementation of monitoring systems to routinely capture program
[[Page 22826]]
expenditure data to support planning, accountability and efficient
programming; (5) trains and mentors partner country personnel in the
methods and application of economic analysis of global health programs
and policy; (6) provides technical input, guidance, review and
implementation support to operational research on and evaluation of
global HIV/AIDS activities; (7) supports the development of partner
country health finance systems and capacity to develop sustainable and
accountable programs, and assists in the implementation of national
AIDS spending assessment activities; (8) assists countries in the
collection, transmission, classification, storage, and analysis of
strategic information, and helps countries to design, implement,
maintain, and evaluate a wide range of information systems to both
support implementation of global HIV/AIDS services, and to monitor and
evaluate the results to inform policy and program decisions; (9)
supports the integration of HIV data into broader, more comprehensive
health information systems, supports development of comprehensive
health information systems, and works to ensure that systems are not
duplicative; (10) works with in-country counterparts to provide
technical assistance on strengthening health information systems in-
country, including systems needs assessments, identifying and resolving
DGHAs, describing data exchanges needed across these systems, and
developing standards for data and for system interoperability; (11) in
conjunction with WHO/Joint United Nations Program on HIV/AIDS develops:
standardized definitions for data that support ART, HIV/TB, maternal
child health, PMTCT, and other clinical care; open source tools for the
implementation of electronic patient record and other systems; security
and confidentiality guidance for HIV/AIDS data; guidance on unique
identification and matching of patient records across disparate
information systems; (12) participates in USG interagency technical
working groups and provides technical leadership to address global
health information systems, Health Systems Strengthening (HSS), and HRH
issues and initiatives; (13) provides technical support for the routine
monitoring of health related governance including financial
accountability, programmatic transparency, policy development and
enforcement, and engagement and regulation of the private health
sector, including the Global Fund to Fight AIDS, Tuberculosis, and
Malaria; (14) develops the HSS operational research agenda for DGHA and
implements public health evaluations related to health systems; (15)
provides broad HSS technical assistance and support to USG in-country
teams and host countries to improve the delivery of HIV and other
health services and work toward transition to country ownership of
program; (16) supports branches in strengthening health systems,
developing metrics to assess DGHA's contribution to HSS and
implementing monitoring systems to routinely collect DGHA's health
system impact, especially in the areas of laboratory systems, maternal
child health services, HIV care and treatment service delivery, blood
safety programs, and prevention services; (17) helps define CDC's role
and identify priority needs for strengthening HRH to support
sustainability of HIV programs; (18) provides HRH technical assistance
and other support to meet priority HRH needs, including pre-service and
in-service training, task-shifting, capacity-building of accreditation
and credentialing bodies, HRH planning and management, workplace
performance and safety, and the development of human resource
information systems and their use in health decision-making; (19)
conducts monitoring and evaluation of US-supported HRH activities, to
help inform U.S. resource and program decision-making; (20) ensures
that public health epidemiologists, laboratorians, and administrators
are represented in the goal of training and retaining 140,000 new
health professionals; (21) supports operational research activities and
public health evaluations that address current HRH questions and
monitoring needs; (22) ensures scientific excellence for all branch
manuscripts, protocols, and programs in collaboration with the DGHA OD
Science Office; and (23) collaborates with other DGHA branches; other
CDC and HHS programs and offices; other USG agencies; and other
national and international organizations.
Country Operations Branch (CWGJ). (1) Provides operations support
to facilitate effective delivery of global HIV/AIDS activities in DGHA
country programs in the areas of fiscal management, procurement,
personnel, extramural (grants, cooperative agreements and contracts)
programs, and other administrative services; (2) serves as the key
linkage between DGHA headquarters and DGHA country offices coordinating
calls and liaising with the CDC Financial Management Office (FMO) and
Procurement and Grants Office (PGO), Atlanta Human Resources Center,
and OGAC; (3) serves as the CDC representative on the OGAC core team/
country support team; (4) develops strategies to improve the technical
skills and problem-solving abilities of country program managers and
locally employed staff who work in the administrative, management and
operational area; (5) provides short- and long-term consultation,
technical assistance, and backstopping for management and operations
issues and staff to DGHA country offices; (6) provides long-term
management and operations support for smaller countries; (7) ensures
timely and sufficient CDC international staff placement through
recruitment, hiring, orienting, deploying, and assisting with
relocation of qualified staff; (8) ensures retention of qualified staff
by providing workforce management and career development services for
CDC international staff; and (9) collaborates with other DGHA branches;
other CDC and HHS programs and offices; other USG agencies; and other
national and international organizations.
Program Budget and Extramural Management Branch (CWGK). (1)
Coordinates all DGHA procurement and extramural activities in creating
spend plans in compliance with federal appropriations law,
congressional intent, and global HIV/AIDS policies; (2) facilitates and
manages the development, clearance, and award of all new and ongoing
DGHA headquarters and field grants, cooperative agreements, and
contracts; (3) provides technical assistance and guidance to the
countries and branches on budget and extramural issues including
assisting programs in determining the appropriate funding mechanism to
support global HIV/AIDS activities; (4) provides training and tools to
DGHA country programs to improve budget and cooperative agreement
management; (5) manages DGHA headquarters budget and tracks overall
DGHA budget, which includes conducting budget planning exercises and
managing the annual close-out process; (6) provides funding and
budgetary data for regular reports including the Headquarters
Operational Plan, GAO and IG audits, country Annual Program Results to
OGAC, and other requests for data; (8) reviews and provides input on
budgetary and procurement policy-related documents; (9) liaises and
collaborates, as appropriate, with the DGHA Associate Director for
Science, other financial and procurement-related units and offices
including FMO and PGO, as well as other CDC and HHS offices, OGAC, and
[[Page 22827]]
other USG agencies; (10) collaborates with other DGHA branches; other
CDC and HHS programs and offices; other USG agencies; and other
national and international organizations. Division of Parasitic
Diseases and Malaria (CWH). The Division of Parasitic Diseases and
Malaria (DPDM) prevents and controls parasitic diseases in the U.S. and
throughout the world by providing diagnostic, consultative,
epidemiologic services, and training. In carrying out its mission,
DPDM: (1) Conducts surveillance, investigations, and studies of
parasitic diseases to define disease etiology, mode of transmission,
and populations at risk, and to develop effective methods for
diagnosis, prevention, control, and elimination; (2) conducts or
participates in clinical, field, and laboratory research to develop,
evaluate, and improve laboratory methodologies, materials and
therapeutic practices used for rapid and accurate diagnosis and
treatment of parasitic diseases; (3) provides epidemic aid,
epidemiologic consultation, and reference diagnostic services to state
and local health departments, other federal agencies, and national and
international health organizations; (4) conducts a program of
laboratory and field research in the biology, ecology, and host-
parasitic relationships to develop better methods for diagnosis,
prevention, and control of parasitic diseases; (5) provides scientific
and technical assistance to other components within CDC when the work
requires unique expertise or specialized equipment not available in
other CDC components; (6) serves as WHO Collaborating Centers for
Cysticercosis, Research Training and Eradication of Dracunculiasis,
Control and Elimination of Lymphatic Filariasis, Evaluating and Testing
New Insecticides, Insecticide Resistance, Insect Vectors; Malaria
Control in Africa, Human African Trypanosomiasis, Production and
Distribution of Malaria Sporozoite ELISAs; (7) maintains field-based
research and program activities in numerous developing countries; and
(8) provides marketing communications support for responsive, evidence-
based information targeted to the public, local and state health
officials, international partners, and private organizations to inform
health decisions, to prevent, and control parasitic diseases in the
U.S. and abroad. Office of the Director (CWH1). (1) Works with CGH OD
to ensure spending plans and budget are in line with the overall
infectious disease strategies and priorities; (2) ensures that the CGH
strategy is executed by the divisions and aligned with overall CDC
goals; (3) co-develops execution strategies for the division with the
branch chiefs; (4) provides program and science quality oversight; (5)
builds leadership at the division and branch levels; (6) evaluates the
strategies, focus, and prioritization of the division research,
program, and budget activities; (7) identifies and coordinates
synergies between the division and relevant partners; (8) ensures that
policy development is consistent and appropriate; (9) facilitates
research and program activities by providing leadership support; (10)
proposes resource priorities throughout the budget cycle; (11) ensures
scientific quality, ethics, and regulatory compliance; (12) fosters an
integrated approach to research, program, and policy activities; and
(13) liaises with HHS and partners as defined in the partnership
management plan.
Malaria Branch (CWHB). (1) Conducts malaria surveillance,
prevention, and control in U.S. residents and visitors by monitoring
the frequency and distribution of malaria cases that occur in U.S.
residents and visitors and the efficacy and safety of antimalarial
drugs for chemoprophylaxis and chemotherapy; (2) provides clinical
advice and epidemiologic assistance on the treatment, control, and
prevention of malaria in the U.S. and in malaria endemic countries; (3)
provides information to the U.S. public and to appropriate agencies and
groups on appropriate measures to prevent and control malaria; (4)
provides consultation, technical assistance, and training to malaria-
endemic countries and to international and U.S. agencies and
organizations on issues of malaria prevention and control; (5) conducts
epidemiologic, laboratory, and field-based research projects, including
laboratory and field studies on parasitic diseases to define biology,
ecology, transmission dynamics, parasite species differences, host-
parasite relationships, diagnostics, host immune responses, populations
at risk, and determinants of morbidity and mortality; (6) conducts
laboratory studies of malaria parasites utilizing animal models and in
vitro systems for parasitic relationships, chemotherapy, and vaccine
evaluation studies; (7) conducts field studies of malaria prevention
and control tools and strategies; and (8) conducts assessments of
malaria monitoring and evaluation methods and program use of these
methods.
Parasitic Diseases Branch (CWHC). (1) Investigates outbreaks and
unusual occurrences of parasitic diseases in concert with states,
ministries of health, WHO, and other agencies and organizations; (2)
conducts surveillance of foodborne disease outbreaks and other
parasitic diseases in the U.S.; (3) provides reference and laboratory
diagnostic services to physicians and laboratories; (4) transfers
technologies and expertise in laboratory diagnosis of parasitic
infections to public health laboratories; (5) provides consultation on
the prevention, treatment, and management of parasitic diseases to
clinicians, laboratorians, departments of health, and other agencies;
and provides otherwise unavailable anti-parasitic drugs to healthcare
providers and ensures compliance with FDA's regulations; (6) supports
the agency's overall emergency response mandate; (7) conducts field and
laboratory investigations and research on the etiology, biology,
epidemiology, ecology, pathogenesis, immunology, genetics, host-
parasite relationships, chemotherapy and other aspects of parasitic
diseases to develop new tools for identifying and controlling parasitic
diseases; (8) develops and tests new laboratory methods and tools for
improved diagnosis, control, and prevention of parasitic diseases, and
conducts laboratory training courses for public health laboratories;
(9) carries out and evaluates operational research to evaluate current
strategies and develops new strategies to support programmatic
activities for the control and elimination of parasitic diseases, and
provides technical assistance to ministries of health, WHO, and other
agencies and organizations for these programs; (10) provides training
to Epidemic Intelligence Service officers, Emerging Infectious Disease
fellows, American Society of Microbiology/Postdoctoral Fellows,
Preventive Medicine Residents, public health prevention specialists,
and other fellows and students; and (11) prepares and disseminates
health communication materials on the prevention and treatment of
parasitic diseases.
Entomology Branch (CWHD). (1) Conducts surveillance, field
investigations, and laboratory studies on the vectors of parasitic
diseases of humans, with a focus on malaria, Chagas' disease, lymphatic
filariasis, onchocerciasis, and leishmaniasis, with a particular
emphasis on the anopheline vectors of malaria; (2) serves as WHO
Collaborating Centers for pesticides resistance, anopheline vector
identification, antimalarial drug evaluation, and vector control; (3)
develops methods supporting the use of pesticides for control of
vector-borne diseases, the management of insecticide resistance, and
the monitoring of anti-
[[Page 22828]]
parasitic drugs; (4) serves as an international reference reagent and
anopheline vector repository, providing materials, training, and
information related to malaria vectors; and (5) provides entomological
consultation, epidemic aid, and training to local, state, federal and
foreign agencies and international health organizations on surveillance
and control of vectors and vector-borne diseases.
Division of Global Disease Detection and Emergency Response (CWJ).
The Division of Disease Detection and Emergency Response (DGDDBER)
supports CDC global efforts to strengthen public health systems abroad
and build essential infrastructure in host countries. By providing
leadership and coordinating with global partners, the Division
increases preparedness and response to prevent and control naturally
occurring and man-made threats to health. To carry out its mission, the
Division performs the following functions: (1) Supports the
requirements of the revised International Health Regulations by
fostering collaborations, partnerships, integration, and resource
leveraging to increase CDCs impact and achieve public health goals; (2)
works with partners to build strong, transparent, and sustained global
public health systems through training, consultation, capacity
building, and technical assistance in applied epidemiology, public
health surveillance, evaluation, and laboratory systems; (3)
coordinates management and oversight of critical global health
preparedness and emergency response activities across CDC, including
situational awareness and partnership management at the global and
regional level; (4) coordinates with and responds to requests from a
wide array of internal CDC and external partners and stakeholders; and
(5) provides stewardship and leadership support to global health
preparedness programs housed in the Division.
Office of the Director (CWJ1). (1) Provides leadership, oversight,
evaluation and overall direction and management for the activities of
the Division; (2) develops Division overall strategy, policies on
planning, evaluation, management, and operations; (3) plans, allocates,
and monitors resources; (4) provides liaison with other CDC
organizations, other Federal agencies, national ministries of health,
international organizations, non governmental organizations, private
sector, and others that CDC cooperates with in global health programs
and activities; and (5) promotes high standards in science and ethics
among CDC's international activities.
Global Disease Detection Branch (CWJB). The Global Disease
Detection (GDDB) Branch: (1) Provides leadership and works with
partners around the globe to increase preparedness for and mitigate the
consequences of a catastrophic public-health event, whether by an
intentional act of terrorism, or the natural emergence of a deadly
infectious disease; (2) provides program support, resources and
technical assistance to the seven Global Disease Detection (GDD)
Centers around the world; (3) supports emerging infectious disease
detection and response, pandemic influenza preparedness, health
communications, zoonotic disease investigation, laboratory systems and
biosafety, and training in field epidemiology and laboratory methods
through the GDD Centers and other CDC field locations; (4) provides
epidemic intelligence and response capacity to provide an early warning
about international disease threats, and coordinates with partners
throughout the U.S. government to provide rapid response; (5) leads and
administers CDCs GDD program through coordination with relevant
implementing programs across the Agency; (6) provides leadership,
guidance, technical assistance support and resources for global
infectious disease surveillance, applied epidemiologic and laboratory
research, and response to emerging infectious disease threats; (7)
provides resources and assists in developing country-level
epidemiologic, laboratory, and other capacity to ensure country
emergency preparedness and response to outbreaks and incidents of local
importance and of international interests; and (8) maintains staff in
the CDC Emergency Operations Center to manage, direct, coordinate and
evaluate biosurveillance data from domestic and international networks
and serve as a central focus for global outbreak and incident response
activities.
Global Health Security Branch (CWJC). The Global Health Security
Branch (GHSB): (1) Serves as the principal point of coordination at CDC
for global health security activities at HHS/OS, the DoS, the
Department of Defense (DoD), USAID, USDA, other U.S. government
agencies, and international and multilateral organizations; (2) aligns
the activities formerly conducted by CDC units supporting the
Biosecurity Engagement Program (BEP), the Defense Threat Reduction
Agency Program and the International Influenza Unit (IIU); (3) provides
support and coordination regarding the development of policies and
priorities on international influenza; (4) serves as liaison with HHS
and technical agency (CDC, NIH, FDA) representative for international
pandemic preparedness related to budget formulation, program
development, strategic planning, and global health policy development;
(5) provides leadership, coordination, management and oversight of
technical agency reports, briefing documents, and talking points for
the HHS Secretary and staff related to global health policy; (6)
provides technical assistance through training, and capacity building
in supporting efforts to reduce the threat from chemical, biological,
and nuclear disasters that are either natural or man-made; (7) provides
liaison with the DoS Biosecurity Engagement Program and DoD Defense
Threat Reduction Agency to coordinate on global biological threats; and
(8) coordinates international aspects of CDC's terrorism preparedness
and emergency response activities in collaboration with OPHPR.
International Emergency and Refugee Health Branch (CWJD). The
International Emergency and Refugee Health Branch (IERHB) applies
public health and epidemiologic principles to improve the health of
refugees, internally displaced persons (IDPs) and populations affected
by complex humanitarian and other international emergencies.
Specifically, it: (1) Coordinates, supervises, and monitors, CDC's work
in international emergency settings and in refugee or displaced
populations in collaboration with other U.S. government agencies,
United Nations agencies, and non-governmental organizations; (2)
provides direct technical assistance to refugees/IDPs and emergency
affected populations in the field, focusing on rapid health and
nutrition assessments, public health surveillance, epidemic
investigations, communicable disease prevention and control and program
evaluation; (3) develops and implements operational research aimed at
developing more effective public health and nutrition interventions in
emergency-affected populations; (4) plans, implements, and evaluates
training courses and workshops to help strengthen CDC technical
capacity in emergency public health of CDC, as well as that of other
U.S. government agencies, international and private voluntary
organizations, and schools of public health; (5) develops technical
guidelines on public health issues associated with international
complex humanitarian emergencies; (6) serves as the CDC liaison with
other international, bilateral, and non-governmental relief
organizations
[[Page 22829]]
involved with humanitarian emergencies; and (7) helps prepare CDC
country offices, host countries, and local partners to respond to the
full range of public health emergencies.
Delete in its entirety the title and functional statements for the
Division of Global AIDS (CVJG) within the National Center for HIV/AIDS,
Viral Hepatitis, STD and TB Prevention.
Delete in its entirety the title and functional statement for the
International Emergency and Refugee Health Branch (CTBBD) within the
Division of Emergency and Environmental Health Services of the National
Center for Environmental Health.
Dated: April 19, 2010.
William P. Nichols,
Chief Operating Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-9910 Filed 4-29-10; 8:45 am]
BILLING CODE 4163-18-M