Statement of Organization, Functions, and Delegations of Authority, 1157-1160 [2020-00181]
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Federal Register / Vol. 85, No. 6 / Thursday, January 9, 2020 / Notices
Terminations of Agreements: .25–.5
hours.
Filing of Agreement meeting minutes:
2–5 hours.
Filing of Monitoring Reports:
VOCC Rate Discussion Agreements:
71–120 hours.
Alliance Agreements: 60–155 hours.
Other reporting agreements: 5–75
hours.
Total Annual Burden: The
Commission estimates the total annual
burden at 15,655 hours.
Rachel Dickon,
Secretary.
BILLING CODE 6731–AA–P
FEDERAL RESERVE SYSTEM
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Formations of, Acquisitions by, and
Mergers of Bank Holding Companies
The companies listed in this notice
have applied to the Board for approval,
pursuant to the Bank Holding Company
Act of 1956 (12 U.S.C. 1841 et seq.)
(BHC Act), Regulation Y (12 CFR part
225), and all other applicable statutes
and regulations to become a bank
holding company and/or to acquire the
assets or the ownership of, control of, or
the power to vote shares of a bank or
bank holding company and all of the
banks and nonbanking companies
owned by the bank holding company,
including the companies listed below.
The applications listed below, as well
as other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
Reserve Bank indicated. The
applications will also be available for
inspection at the offices of the Board of
Governors. Interested persons may
express their views in writing on the
standards enumerated in the BHC Act
(12 U.S.C. 1842(c)).
Comments regarding each of these
applications must be received at the
Reserve Bank indicated or the offices of
the Board of Governors, Ann E.
Misback, Secretary of the Board, 20th
Street and Constitution Avenue NW,
Washington, DC 20551–0001, not later
than February 10, 2020.
A. Federal Reserve Bank of Atlanta
(Kathryn Haney, Assistant Vice
President) 1000 Peachtree Street NE,
Atlanta, Georgia 30309. Comments can
also be sent electronically to
Applications.Comments@atl.frb.org:
1. Pinnacle Financial Corporation,
Elberton, Georgia; to acquire SBT
Bancorp, Inc., and thereby indirectly
acquire Southern Bank & Trust, both of
Clarkesville, Georgia.
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[FR Doc. 2020–00185 Filed 1–8–20; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Statement of Organization, Functions,
and Delegations of Authority
[FR Doc. 2020–00116 Filed 1–8–20; 8:45 am]
VerDate Sep<11>2014
Board of Governors of the Federal Reserve
System, January 6, 2020.
Margaret M. Shanks,
Deputy Secretary of the Board.
Part J (Agency for Toxic Substances
and Disease Registry) of the Statement
of Organization, Functions, and
Delegations of Authority of the
Department of Health and Human
Services (50 FR 25129–25130, dated
June 17, 1985, as amended most
recently at 82 FR 42555, dated
September 8, 2017) is amended to
reflect the reorganization of the Agency
for Toxic Substances and Disease
Registry. This reorganization will
combine the programmatic, technical
expertise and resources of two divisions
into one.
I. Under Part C, Section C–B,
Organization and Functions, the
following organizational unit is deleted
in its entirety:
• Division of Community Health
Investigations (JAAM)
• Eastern Branch (JAAMB)
• Central Branch (JAAMC)
• Western Branch (JAAMD)
• Science Support Branch (JAAME)
• Division of Toxicology and Human
Health Science (JAAN)
• Geospatial Research, Analysis and
Services Program (JAAN12)
• Emergency Response Program
(JAAN13)
• Environmental Epidemiology Branch
(JAANB)
• Environmental Health Surveillance
Branch (JAANC)
• Environmental Medicine Branch
(JAAND)
• Environmental Toxicology Branch
(JAANE)
II. Under Part C, Section C–B,
Organization and Functions, make the
following change:
• Update the functional statement for
the Agency for Toxic Substances and
Disease Registry (J)
• Update the functional statement for
the Office of the Administrator (JA)
• Update the functional statement for
the Office of the Director (JAA)
• Retitle the Office of Financial,
Administrative, and Information
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Services to the Office of the Office of
Management and Analytics (JAA2)
• Retitle the Office of Policy, Planning
and Evaluation to the Office of Policy,
Partnerships, and Planning (JAA3)
• Update the functional statements for
the Office of Communication (JAA7)
• Establish the Office of Science (JAA9)
• Establish the Office of the Associate
Director (JAAQ)
• Establish the Office of Innovation and
Analytics (JAAQB)
• Establish the Office of Community
Health Hazard Assessment (JAAQC)
• Establish the Office of Capacity
Development and Applied Prevention
Science (JAAQD)
III. Under Part C, Section C–B,
Organization and Functions, insert the
following:
• Agency for Toxic Substance and
Disease Registry (J). The mission of the
Agency for Toxic Substances and
Disease Registry (ATSDR) is to protect
communities from harmful health
effects of hazardous waste sites and
hazardous material spills. The ATSDR
responsibilities are specified in the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA) as amended in
the Superfund Amendments and
Reauthorization Act of 1986 and in
amendments (Hazardous and Solid
Waste Amendments of 1984) to the
Resource Conservation and Recovery
Act (RCRA). ATSDR works closely with
state, tribal, territory, local, other federal
agencies, and other organizations to
reduce or eliminate illness, disability,
and death that result from exposure of
the public to toxic substances at spill
and waste disposal sites. Through
additional laws, ATSDR provides
environmental support to other national
efforts, such as the disposal of medical
wastes. To carry out its CERCLA
mission, ATSDR:
(1) Evaluates data and information on
the release of hazardous substances into
the environment to assess any current or
future impact on public health,
develops health advisories or other
health recommendations, and identifies
studies or actions needed to evaluate
and mitigate or prevent adverse human
health effects; (2) summarizes and
interprets available data on the health
effects of hazardous substances in
consultation with the Environmental
Protection Agency (EPA) and other
programs and Public Health Service
(PHS) agencies, and in cooperation with
the National Toxicology Program,
initiates toxicologic research to
determine the health effects of
designated hazardous substances, where
needed; (3) provides health-related
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support in public health emergencies,
including public health advisories
involving exposure to hazardous
substances; (4) establishes and
maintains a registry of persons exposed
to chemical or disease specific
hazardous substances and a registry of
serious diseases and illnesses in persons
exposed to specific toxic substances as
a result of environmental exposure; (5)
expands knowledge of the relationship
between exposure to hazardous
substances and adverse human health
effects, through epidemiologic,
toxicologic, laboratory, and human,
animal, and other scientific studies on
hazardous substances; (6) develops and
disseminates to physicians and other
health care providers informational
materials on the health effects of toxic
substances. To carry out its RCRA
mission, ATSDR (1) provides immediate
or short-term assistance to EPA regional
and headquarters staff to provide health
advice and health effect information
about releases of hazardous substances
at landfills and surface impoundments;
and (2) conducts health assessments
when environmental contamination has
been found to pose a substantial
potential risk to human health.
• Office of the Administrator (JA). (1)
Directs and evaluates the programs and
activities of the Agency; (2) provides
leadership for implementing statutory
responsibilities; (3) approves the
Agency’s goals and objectives; (4)
provides overall policy direction to the
scientific/medical program; (5) plans,
promotes, and coordinates an ongoing
program to assure equal employment
opportunities; (6) provides leadership
for and assessment of administrative
management activities; (7) assures
coordination with appropriate PHS staff
offices and other relevant agencies for
administrative and program matters,
such as coordinating emergency
response activities that involve action at
the PHS level.
• Office of the Director (JAA). (1)
Manages, directs, coordinates, and
evaluates all health-related programs of
the National Center for Environmental
Health (NCEH) and ATSDR; (2) provides
overall leadership in health-related
activities for hazardous substances,
hazardous waste sites and chemical
releases; (3) provides overall
coordination for the research programs
and science policies of the agencies; (4)
develops goals and objectives and
provides leadership, policy formulation,
scientific oversight, and guidance in
program planning and development; (5)
provides overall programmatic direction
for planning and management oversight
of allocated resources, human resource
management and administrative
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support; (6) provides information,
publication and distribution services to
NCEH/ATSDR; (7) maintains liaison
with other federal, state, and local
agencies, institutions, and
organizations; (8) coordinates NCEH/
ATSDR program activities with other
Centers for Disease Control and
Prevention (CDC) components, other
federal, state and local government
agencies, the private sector, and other
nations; and (9) directs and coordinates
activities in support of the Department’s
Equal Employment Opportunity
program and employee development.
• Office of Management and
Analytics (JAA2). (1) Plans, manages,
directs, and conducts the administrative
and financial management operations of
NCEH/ATSDR; (2) reviews the
effectiveness and efficiency of
administration and operation of all
NCEH/ATSDR programs; (3) develops
and directs systems for human resource
management, financial services,
procurement requisitioning, and travel
authorization; (4) provides and
coordinates services for the extramural
award activities of NCEH/ATSDR; (5)
formulates and provides overall
programmatic direction for planning
and management oversight of allocated
resources, human resource management
and administrative support; (6) develops
and directs a system for cost recovery;
and (7) enables and supports NCEH/
ATSDR data management, systems
development, and information security
needs; (8) develops and directs
employee engagement programs; and (9)
analyzes NCEH/ATSDR workforce,
systems, and resources.
• Office of Policy, Partnerships and
Planning (JAA3). (1) Coordinates,
develops, recommends and implements
strategic planning and tracking for
NCEH/ATSDR; (2) develops and
coordinates performance management to
ensure achievement of goals in NCEH/
ATSDR programs; (3) participates in
reviewing, coordinating, and preparing
legislation, briefing documents,
Congressional testimony, and other
legislative matters; (4) maintains liaison
and coordinates with other federal
agencies for program planning and
performance; (5) assists in the
development of NCEH/ATSDR budget
and program initiatives; (6) provides
liaison with staff offices and other
officials of CDC; (7) monitors and
prepares reports on health-related
activities to comply with provisions of
relevant legislation; (8) coordinates the
development, review, and approval of
Federal regulations, Federal Register
announcements, Freedom of
Information Act requests, Government
Accountability Office and Department
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of Health and Human Services (HHS)
Inspector General reports, and related
activities; (9) develops and strengthens
strategic partnerships with key
constituent groups; and (10) facilitates
communication between NCEH/ATSDR
and its partners.
• Office of Communication (JAA7).
(1) Serves as the principal advisor to the
Assistant Administrator, director and
divisions on communication and
marketing science, research, practice,
and public affairs; (2) leads agency
strategic planning for communication
and marketing science and public affairs
programs and projects; (3) analyzes
context, situation, and environment to
inform agency-wide communication and
marketing programs and projects; (4)
ensures use of scientifically sound
research for marketing and
communication programs and projects;
(5) ensures accurate, accessible, timely,
and effective translation of science for
use by multiple audiences; (6) leads
identification and implementation of
information dissemination channels; (7)
provides communication and marketing
project management expertise; (8)
collaborates with external organizations
and the news, public service, and
entertainment and other media to
ensure that scientific findings and their
implications for public health reach the
intended audiences; (9) collaborates
closely with divisions to produce
materials tailored to meet the
requirements of news and other media
channels, including press releases,
letters to the editor, public service
announcements, television
programming, video news releases, and
other electronic and printed materials;
(10) coordinates the development and
maintenance of accessible public
information through the internet, social
media and other applicable channels;
(11) provides training and technical
assistance in the areas of health
communication, risk communication,
social marketing, and public affairs; (12)
manages or coordinates communication
services such as internet/intranet,
application development, social media,
video production, graphics,
photography, CDC name/logo use and
other brand management; (13) provides
editorial services, including writing,
editing, and technical editing; (14)
facilitates internal communication to
agency staff and allied audiences; (15)
supervises and manages Office of
Communication activities, programs,
and staff; (16) serves as liaison to
internal and external groups to advance
the agency’s mission; (17) collaborates
with the CDC Office of the Associate
Director for Communication on media
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relations, electronic communication,
health media production, and brand
management activities; (18) collaborates
with the Center for Preparedness and
Response and other NCEH/ATSDR
entities to fulfill communication
responsibilities in emergency response
situations; (19) collaborates with other
CDC Centers/Institute/Offices in the
development of marketing
communications targeted to populations
that would benefit from a crossfunctional approach; (20) ensures
NCEH/ATSDR materials meet CDC and
HHS standards.
• Office of Science (JAA9). (1)
Ensures NCEH/ATSDR compliance with
the various statutes, regulations, and
policies governing the conduct of
science by the federal government,
including: Human subjects research
determinations, the protection of human
research subjects and the use of
Institutional Review Boards (IRBs), the
OMB Paperwork Reduction Act (relating
to the collection of information from ten
or more people in a 12-month period),
the OMB Information Quality Bulletin,
Confidentiality Protection, and the
Health Insurance Portability and
Accountability Act of 1996 (HIPAA, and
its ‘‘Privacy Rule’’); and others; (2)
develops and maintains the NCEH/
ATSDR Clearance Policy and managing
and conducting clearance for NCEH/
ATSDR documents; (3) coordinates and
manages document cross-clearance
between NCEH/ATSDR and other parts
of CDC; facilitating agency reviews of
external documents, coordinating and
managing information quality requests
concerning NCEH/ATSDR documents;
(4) coordinates and manages external
peer review for NCEH/ATSDR
documents and intramural programs; (5)
coordinates and manages the activities
of the NCEH/ATSDR Board of Scientific
Counselors (a federal advisory
committee and its subcommittees and
workgroups; (6) coordinates interagency
workgroups/committees such as the
President’s Task Force on
Environmental Health Risks and Safety
Risks to Children, and the National
Toxicology Program Executive
Committee; (7) coordinates and manages
NCEH/ATSDR involvement in the
Epidemic Intelligence Service (EIS)
Program; (8) coordinates NCEH/ATSDR
involvement in CDC public health
ethics activities; (9) coordinates NCEH/
ATSDR involvement in CDC science
awards activities (e.g., the Shepard
Award, and CDC/ATSDR Honor
Awards); (10) organizes and sponsors
select training opportunities (e.g.,
human subjects/IRB, OMB/PRA, and
eClearance Training for Authors and
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Reviewers); (11) represents NCEH/
ATSDR on various CDC/ATSDR
committees, work groups, and task
forces, such as the CDC/ATSDR Office
of the Chief Science Officer’s Excellence
in Science Committee, and the CDC
Surveillance Science Advisory Group;
(12) coordinates NCEH/ATSDR global
health activities; (13) coordinates and
manages the NCEH/ATSDR Healthy
People 2020; (14) prepares an annual
inventory of NCEH/ATSDR
publications; and (15) pursuant to the
National Environmental Policy Act,
reviews draft Environmental Impact
Statements on behalf of HHS where the
proposed federal actions impact human
health.
• Office of the Associate Director
(JAAQ). (1) Provides leadership in
directing, coordinating, evaluating, and
managing all programmatic and
administrative operations of ATSDR; (2)
develops programmatic goals and
objectives and provides leadership,
policy formation, and guidance in
program planning, development, and
evaluation; (3) coordinates activities
with other components of ATSDR and
other federal, tribal, state, and local
agencies; (4) works with the
Washington, DC regional office to
ensure coordination with EPA at the
national level; (5) ensures the quality
and consistency in the science and
format used in the development of
products and materials; (6) develops
outreach messages following the
procedures and policies of the Agency’s
Office of Communications; (7) provides
timely responses to policy activities
(i.e., FOIA, congressional inquiries,
budget formulation, and briefings); (8)
develops measures of divisional
productivity and reports to the Agency
and CDC director; (9) coordinates NCEH
and ATSDR emergency management
resources to support efforts to protect
the public’s health from environmental
threats; (10) provides incident
management and coordination for
complex emergency management
including the development, approval,
and updating of standardized processes
to enable appropriate and adequate
management of resources; (11) develops,
implements, and manages programs to
enhance the emergency response
readiness of CDC and other national,
regional, state, local, and international
public health programs; and (12)
develops capacity within the states to
integrate new and existing
epidemiological and scientific
principles into operational and
programmatic expertise in emergency
preparedness, response, and recovery
and; (13) manages and conducts a
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1159
records management program, including
the National Archives and Records
Administration standards, for ATSDR in
accordance with Congressional
mandate.
• Office of Innovation and Analytics
(JAAQB). (1) Uses best practices to
collect, analyze, and interpret data and
disseminate scientific information to
enable internal and external partners to
make actionable decisions regarding
exposure to hazardous substances; (2)
provides analytical and modeling
expertise, develops new analytical tools,
and integrates the use of geospatial
science in public health activities; (3)
conducts environmental and biological
computer simulation and other
statistical modeling expertise to support
internal and external stakeholders; (4)
integrates geospatial science, data
analytics and visualization, and
manages processes, and analyzes data;
(5) supports the CDC Emergency
Operations Center as requested; (6)
identifies, develops, and promotes new
tools through authoring manuscripts,
reports, and community-facing products
as well as through leveraging new
technologies in order to maintain and
improve ATSDR’s state of the art
science practice; (7) develops
toxicological profiles and repositories of
data, conducts synthesis of research,
evaluates methodological and
programmatic best practices internal
and externally, and conducts
surveillance and registry programs; (8)
coordinates the development of
contaminant-specific information, and
provides chemical-specific toxicologic
consultations; (9) determines health
guidelines which estimates the highest
level of exposure to a toxic substance
that is thought to not have adverse
health effects, and exposure-dose
reconstruction; (10) creates and
maintains surveillance systems and
registries to understand the relationship
between toxic exposure and health; and
(11) develops repository of
programmatic methodological best
practices through meta-analyses of
ATSDR documents, databases, and
analyses.
• Office of Community Health Hazard
Assessment (JAAQC). (1) Conducts
public health assessments, health
consultations, and other related public
health activities to determine the health
implications of releases or threatened
releases of toxic substances into the
environment; in particular, such
activities are conducted for Superfund
and RCRA sites, petition requests, and
other sites or instances where
communities have been or may have
been exposed to toxic substances in the
environment; (2) plans, manages,
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directs, and conducts the regional
operations of the agency; (3) provides
liaison, technical advice, and
consultation to the EPA, other federal,
tribal, state, and local agencies, private
organizations, community groups, and
individuals on eliminating or mitigating
public health problems resulting from
the release of hazardous substances into
the environment; (4) conducts and
evaluates exposure pathways analyses
and other exposure screening analyses
to identify impacted communities, to
include exposure investigations
(biologic sampling, personal monitoring,
etc.), and related environmental
assessments, as appropriate; (5) issues
public health advisories when a release
or threatened release of a toxic
substance poses an imminent health
hazard; (6) provides technical support
and field presence for routine
emergency and disaster response as
appropriate; (7) engages with regional
partners to accomplish special programs
that promote environmental health; (8)
provides scientific expertise in
environmental epidemiology; (9)
designs and conducts human health,
including epidemiologic, studies to
evaluate the association between
exposure to hazardous substances and
adverse health effects; (10) provides
expert medical and environmental
epidemiologic consultation; and (11)
implements extramural research
programs that involve human health
investigations.
• Office of Capacity Development and
Applied Prevention Science (JAAQD).
(1) Builds capabilities by translating
science into tools and actions that
individuals, communities, and
organizations apply to identify, reduce,
or prevent health effects from exposures
to hazardous substances; (2) coordinates
and conducts training, community
engagement, and system development
that addresses internal and external
needs as well as builds capacity of endusers; (3) develops best practices, tools,
and strategies for engaging with
communities, and providing community
engagement consultation to internal
ATSDR partners (e.g., health educators);
(4) conducts grant management, project
officers’ activities, and builds capacity
development through strategy
development, monitoring, and training;
(5) serves as an incubator for new
preventions, interventions, and
implementation science; supports
testing, development, and material
design for community and health
professional audiences; (6) designs and
standardizes intervention initiatives for
community audiences, evaluating
intervention design methods, and
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designing education campaigns; (7)
designs and standardize intervention
initiatives for health professionals,
evaluating intervention design methods,
and promoting environmental health
content within clinical education
programs; (8) designs, reviews and
evaluates the scientific accuracy and
clarity of health education materials; (9)
informs and promotes integration of
environmental health content within
clinical education programs (e.g.,
coursework, clinical rotations, and
primary care residency programs) and
environmental medicine practice; (10)
identifies and cultivates partnerships
with academic and professional
organizations to encourage uptake of
environmental public health awareness
curricula and career tracks; (11)
develops community/population and
clinical intervention initiatives to
reduce risk factors associated with
environmental exposures; (12) develops
integrated clinical support guidance for
patient care; (13) provides, promotes,
and/or implements ATSDR-approved
tools and training to partners (both
internal [e.g., health educators] and
external [e.g., state partners]) so that
they can effectively engage communities
using a standardized approach; (14)
provides evaluation guidance and
facilitates evaluation feedback loops
related to ATSDR intervention
initiatives, guidance materials, and
support tools for continuous quality
improvement and effectiveness of grantsupported work; (15) implements
ATSDR’s Site-Specific Cooperative
Agreement Program; (16) plans,
prepares, and executes appropriate
community involvement and health
educational strategies/activities/
programs for communities affected or
potentially affected by toxic substances
released into the environment; (17)
develops and tests metrics that could be
used for public health surveillance or
evaluation of intervention effectiveness;
and (18) partners with relevant internal
and external stakeholders to incorporate
prevention strategies into existing
programs, policies, and practices.
IV. Delegations of Authority: All
delegations and redelegations of
authority made to officials and
employees of affected organizational
components will continue in them or
their successors pending further
redelegation, provided they are
consistent with this reorganization.
(Authority: 44 U.S.C. 3101)
Alex M. Azar II,
Secretary.
[FR Doc. 2020–00181 Filed 1–8–20; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5254]
Fresenius USA, Inc., et al.; Proposal To
Withdraw Approval of 249 Abbreviated
New Drug Applications; Opportunity
for a Hearing
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA or Agency)
Center for Drug Evaluation and Research
(CDER) is proposing to withdraw
approval of 249 abbreviated new drug
applications (ANDAs) from multiple
holders of those ANDAs and is
announcing an opportunity for the
ANDA holders to request a hearing on
this proposal. The basis for the proposal
is that these ANDA holders have
repeatedly failed to file required annual
reports for those ANDAs.
DATES: The ANDA holders may submit
a request for a hearing by February 10,
2020. Submit all data, information, and
analyses upon which the request for a
hearing relies by March 9, 2020. Submit
electronic or written comments by
March 9, 2020.
ADDRESSES: The request for a hearing
may be submitted by the ANDA holders
by either of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments to
submit your request for a hearing.
Comments submitted electronically to
https://www.regulations.gov, including
any attachments to the request for a
hearing, will be posted to the docket
unchanged.
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• Because your request for a hearing
will be made public, you are solely
responsible for ensuring that your
request does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
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Agencies
[Federal Register Volume 85, Number 6 (Thursday, January 9, 2020)]
[Notices]
[Pages 1157-1160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00181]
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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 J (Agency for Toxic Substances and Disease Registry) of the
Statement of Organization, Functions, and Delegations of Authority of
the Department of Health and Human Services (50 FR 25129-25130, dated
June 17, 1985, as amended most recently at 82 FR 42555, dated September
8, 2017) is amended to reflect the reorganization of the Agency for
Toxic Substances and Disease Registry. This reorganization will combine
the programmatic, technical expertise and resources of two divisions
into one.
I. Under Part C, Section C-B, Organization and Functions, the
following organizational unit is deleted in its entirety:
Division of Community Health Investigations (JAAM)
Eastern Branch (JAAMB)
Central Branch (JAAMC)
Western Branch (JAAMD)
Science Support Branch (JAAME)
Division of Toxicology and Human Health Science (JAAN)
Geospatial Research, Analysis and Services Program (JAAN12)
Emergency Response Program (JAAN13)
Environmental Epidemiology Branch (JAANB)
Environmental Health Surveillance Branch (JAANC)
Environmental Medicine Branch (JAAND)
Environmental Toxicology Branch (JAANE)
II. Under Part C, Section C-B, Organization and Functions, make the
following change:
Update the functional statement for the Agency for Toxic
Substances and Disease Registry (J)
Update the functional statement for the Office of the
Administrator (JA)
Update the functional statement for the Office of the Director
(JAA)
Retitle the Office of Financial, Administrative, and
Information Services to the Office of the Office of Management and
Analytics (JAA2)
Retitle the Office of Policy, Planning and Evaluation to the
Office of Policy, Partnerships, and Planning (JAA3)
Update the functional statements for the Office of
Communication (JAA7)
Establish the Office of Science (JAA9)
Establish the Office of the Associate Director (JAAQ)
Establish the Office of Innovation and Analytics (JAAQB)
Establish the Office of Community Health Hazard Assessment
(JAAQC)
Establish the Office of Capacity Development and Applied
Prevention Science (JAAQD)
III. Under Part C, Section C-B, Organization and Functions, insert
the following:
Agency for Toxic Substance and Disease Registry (J). The
mission of the Agency for Toxic Substances and Disease Registry (ATSDR)
is to protect communities from harmful health effects of hazardous
waste sites and hazardous material spills. The ATSDR responsibilities
are specified in the Comprehensive Environmental Response,
Compensation, and Liability Act of 1980 (CERCLA) as amended in the
Superfund Amendments and Reauthorization Act of 1986 and in amendments
(Hazardous and Solid Waste Amendments of 1984) to the Resource
Conservation and Recovery Act (RCRA). ATSDR works closely with state,
tribal, territory, local, other federal agencies, and other
organizations to reduce or eliminate illness, disability, and death
that result from exposure of the public to toxic substances at spill
and waste disposal sites. Through additional laws, ATSDR provides
environmental support to other national efforts, such as the disposal
of medical wastes. To carry out its CERCLA mission, ATSDR:
(1) Evaluates data and information on the release of hazardous
substances into the environment to assess any current or future impact
on public health, develops health advisories or other health
recommendations, and identifies studies or actions needed to evaluate
and mitigate or prevent adverse human health effects; (2) summarizes
and interprets available data on the health effects of hazardous
substances in consultation with the Environmental Protection Agency
(EPA) and other programs and Public Health Service (PHS) agencies, and
in cooperation with the National Toxicology Program, initiates
toxicologic research to determine the health effects of designated
hazardous substances, where needed; (3) provides health-related
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support in public health emergencies, including public health
advisories involving exposure to hazardous substances; (4) establishes
and maintains a registry of persons exposed to chemical or disease
specific hazardous substances and a registry of serious diseases and
illnesses in persons exposed to specific toxic substances as a result
of environmental exposure; (5) expands knowledge of the relationship
between exposure to hazardous substances and adverse human health
effects, through epidemiologic, toxicologic, laboratory, and human,
animal, and other scientific studies on hazardous substances; (6)
develops and disseminates to physicians and other health care providers
informational materials on the health effects of toxic substances. To
carry out its RCRA mission, ATSDR (1) provides immediate or short-term
assistance to EPA regional and headquarters staff to provide health
advice and health effect information about releases of hazardous
substances at landfills and surface impoundments; and (2) conducts
health assessments when environmental contamination has been found to
pose a substantial potential risk to human health.
Office of the Administrator (JA). (1) Directs and
evaluates the programs and activities of the Agency; (2) provides
leadership for implementing statutory responsibilities; (3) approves
the Agency's goals and objectives; (4) provides overall policy
direction to the scientific/medical program; (5) plans, promotes, and
coordinates an ongoing program to assure equal employment
opportunities; (6) provides leadership for and assessment of
administrative management activities; (7) assures coordination with
appropriate PHS staff offices and other relevant agencies for
administrative and program matters, such as coordinating emergency
response activities that involve action at the PHS level.
Office of the Director (JAA). (1) Manages, directs,
coordinates, and evaluates all health-related programs of the National
Center for Environmental Health (NCEH) and ATSDR; (2) provides overall
leadership in health-related activities for hazardous substances,
hazardous waste sites and chemical releases; (3) provides overall
coordination for the research programs and science policies of the
agencies; (4) develops goals and objectives and provides leadership,
policy formulation, scientific oversight, and guidance in program
planning and development; (5) provides overall programmatic direction
for planning and management oversight of allocated resources, human
resource management and administrative support; (6) provides
information, publication and distribution services to NCEH/ATSDR; (7)
maintains liaison with other federal, state, and local agencies,
institutions, and organizations; (8) coordinates NCEH/ATSDR program
activities with other Centers for Disease Control and Prevention (CDC)
components, other federal, state and local government agencies, the
private sector, and other nations; and (9) directs and coordinates
activities in support of the Department's Equal Employment Opportunity
program and employee development.
Office of Management and Analytics (JAA2). (1) Plans,
manages, directs, and conducts the administrative and financial
management operations of NCEH/ATSDR; (2) reviews the effectiveness and
efficiency of administration and operation of all NCEH/ATSDR programs;
(3) develops and directs systems for human resource management,
financial services, procurement requisitioning, and travel
authorization; (4) provides and coordinates services for the extramural
award activities of NCEH/ATSDR; (5) formulates and provides overall
programmatic direction for planning and management oversight of
allocated resources, human resource management and administrative
support; (6) develops and directs a system for cost recovery; and (7)
enables and supports NCEH/ATSDR data management, systems development,
and information security needs; (8) develops and directs employee
engagement programs; and (9) analyzes NCEH/ATSDR workforce, systems,
and resources.
Office of Policy, Partnerships and Planning (JAA3). (1)
Coordinates, develops, recommends and implements strategic planning and
tracking for NCEH/ATSDR; (2) develops and coordinates performance
management to ensure achievement of goals in NCEH/ATSDR programs; (3)
participates in reviewing, coordinating, and preparing legislation,
briefing documents, Congressional testimony, and other legislative
matters; (4) maintains liaison and coordinates with other federal
agencies for program planning and performance; (5) assists in the
development of NCEH/ATSDR budget and program initiatives; (6) provides
liaison with staff offices and other officials of CDC; (7) monitors and
prepares reports on health-related activities to comply with provisions
of relevant legislation; (8) coordinates the development, review, and
approval of Federal regulations, Federal Register announcements,
Freedom of Information Act requests, Government Accountability Office
and Department of Health and Human Services (HHS) Inspector General
reports, and related activities; (9) develops and strengthens strategic
partnerships with key constituent groups; and (10) facilitates
communication between NCEH/ATSDR and its partners.
Office of Communication (JAA7). (1) Serves as the
principal advisor to the Assistant Administrator, director and
divisions on communication and marketing science, research, practice,
and public affairs; (2) leads agency strategic planning for
communication and marketing science and public affairs programs and
projects; (3) analyzes context, situation, and environment to inform
agency-wide communication and marketing programs and projects; (4)
ensures use of scientifically sound research for marketing and
communication programs and projects; (5) ensures accurate, accessible,
timely, and effective translation of science for use by multiple
audiences; (6) leads identification and implementation of information
dissemination channels; (7) provides communication and marketing
project management expertise; (8) collaborates with external
organizations and the news, public service, and entertainment and other
media to ensure that scientific findings and their implications for
public health reach the intended audiences; (9) collaborates closely
with divisions to produce materials tailored to meet the requirements
of news and other media channels, including press releases, letters to
the editor, public service announcements, television programming, video
news releases, and other electronic and printed materials; (10)
coordinates the development and maintenance of accessible public
information through the internet, social media and other applicable
channels; (11) provides training and technical assistance in the areas
of health communication, risk communication, social marketing, and
public affairs; (12) manages or coordinates communication services such
as internet/intranet, application development, social media, video
production, graphics, photography, CDC name/logo use and other brand
management; (13) provides editorial services, including writing,
editing, and technical editing; (14) facilitates internal communication
to agency staff and allied audiences; (15) supervises and manages
Office of Communication activities, programs, and staff; (16) serves as
liaison to internal and external groups to advance the agency's
mission; (17) collaborates with the CDC Office of the Associate
Director for Communication on media
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relations, electronic communication, health media production, and brand
management activities; (18) collaborates with the Center for
Preparedness and Response and other NCEH/ATSDR entities to fulfill
communication responsibilities in emergency response situations; (19)
collaborates with other CDC Centers/Institute/Offices in the
development of marketing communications targeted to populations that
would benefit from a cross-functional approach; (20) ensures NCEH/ATSDR
materials meet CDC and HHS standards.
Office of Science (JAA9). (1) Ensures NCEH/ATSDR
compliance with the various statutes, regulations, and policies
governing the conduct of science by the federal government, including:
Human subjects research determinations, the protection of human
research subjects and the use of Institutional Review Boards (IRBs),
the OMB Paperwork Reduction Act (relating to the collection of
information from ten or more people in a 12-month period), the OMB
Information Quality Bulletin, Confidentiality Protection, and the
Health Insurance Portability and Accountability Act of 1996 (HIPAA, and
its ``Privacy Rule''); and others; (2) develops and maintains the NCEH/
ATSDR Clearance Policy and managing and conducting clearance for NCEH/
ATSDR documents; (3) coordinates and manages document cross-clearance
between NCEH/ATSDR and other parts of CDC; facilitating agency reviews
of external documents, coordinating and managing information quality
requests concerning NCEH/ATSDR documents; (4) coordinates and manages
external peer review for NCEH/ATSDR documents and intramural programs;
(5) coordinates and manages the activities of the NCEH/ATSDR Board of
Scientific Counselors (a federal advisory committee and its
subcommittees and workgroups; (6) coordinates interagency workgroups/
committees such as the President's Task Force on Environmental Health
Risks and Safety Risks to Children, and the National Toxicology Program
Executive Committee; (7) coordinates and manages NCEH/ATSDR involvement
in the Epidemic Intelligence Service (EIS) Program; (8) coordinates
NCEH/ATSDR involvement in CDC public health ethics activities; (9)
coordinates NCEH/ATSDR involvement in CDC science awards activities
(e.g., the Shepard Award, and CDC/ATSDR Honor Awards); (10) organizes
and sponsors select training opportunities (e.g., human subjects/IRB,
OMB/PRA, and eClearance Training for Authors and Reviewers); (11)
represents NCEH/ATSDR on various CDC/ATSDR committees, work groups, and
task forces, such as the CDC/ATSDR Office of the Chief Science
Officer's Excellence in Science Committee, and the CDC Surveillance
Science Advisory Group; (12) coordinates NCEH/ATSDR global health
activities; (13) coordinates and manages the NCEH/ATSDR Healthy People
2020; (14) prepares an annual inventory of NCEH/ATSDR publications; and
(15) pursuant to the National Environmental Policy Act, reviews draft
Environmental Impact Statements on behalf of HHS where the proposed
federal actions impact human health.
Office of the Associate Director (JAAQ). (1) Provides
leadership in directing, coordinating, evaluating, and managing all
programmatic and administrative operations of ATSDR; (2) develops
programmatic goals and objectives and provides leadership, policy
formation, and guidance in program planning, development, and
evaluation; (3) coordinates activities with other components of ATSDR
and other federal, tribal, state, and local agencies; (4) works with
the Washington, DC regional office to ensure coordination with EPA at
the national level; (5) ensures the quality and consistency in the
science and format used in the development of products and materials;
(6) develops outreach messages following the procedures and policies of
the Agency's Office of Communications; (7) provides timely responses to
policy activities (i.e., FOIA, congressional inquiries, budget
formulation, and briefings); (8) develops measures of divisional
productivity and reports to the Agency and CDC director; (9)
coordinates NCEH and ATSDR emergency management resources to support
efforts to protect the public's health from environmental threats; (10)
provides incident management and coordination for complex emergency
management including the development, approval, and updating of
standardized processes to enable appropriate and adequate management of
resources; (11) develops, implements, and manages programs to enhance
the emergency response readiness of CDC and other national, regional,
state, local, and international public health programs; and (12)
develops capacity within the states to integrate new and existing
epidemiological and scientific principles into operational and
programmatic expertise in emergency preparedness, response, and
recovery and; (13) manages and conducts a records management program,
including the National Archives and Records Administration standards,
for ATSDR in accordance with Congressional mandate.
Office of Innovation and Analytics (JAAQB). (1) Uses best
practices to collect, analyze, and interpret data and disseminate
scientific information to enable internal and external partners to make
actionable decisions regarding exposure to hazardous substances; (2)
provides analytical and modeling expertise, develops new analytical
tools, and integrates the use of geospatial science in public health
activities; (3) conducts environmental and biological computer
simulation and other statistical modeling expertise to support internal
and external stakeholders; (4) integrates geospatial science, data
analytics and visualization, and manages processes, and analyzes data;
(5) supports the CDC Emergency Operations Center as requested; (6)
identifies, develops, and promotes new tools through authoring
manuscripts, reports, and community-facing products as well as through
leveraging new technologies in order to maintain and improve ATSDR's
state of the art science practice; (7) develops toxicological profiles
and repositories of data, conducts synthesis of research, evaluates
methodological and programmatic best practices internal and externally,
and conducts surveillance and registry programs; (8) coordinates the
development of contaminant-specific information, and provides chemical-
specific toxicologic consultations; (9) determines health guidelines
which estimates the highest level of exposure to a toxic substance that
is thought to not have adverse health effects, and exposure-dose
reconstruction; (10) creates and maintains surveillance systems and
registries to understand the relationship between toxic exposure and
health; and (11) develops repository of programmatic methodological
best practices through meta-analyses of ATSDR documents, databases, and
analyses.
Office of Community Health Hazard Assessment (JAAQC). (1)
Conducts public health assessments, health consultations, and other
related public health activities to determine the health implications
of releases or threatened releases of toxic substances into the
environment; in particular, such activities are conducted for Superfund
and RCRA sites, petition requests, and other sites or instances where
communities have been or may have been exposed to toxic substances in
the environment; (2) plans, manages,
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directs, and conducts the regional operations of the agency; (3)
provides liaison, technical advice, and consultation to the EPA, other
federal, tribal, state, and local agencies, private organizations,
community groups, and individuals on eliminating or mitigating public
health problems resulting from the release of hazardous substances into
the environment; (4) conducts and evaluates exposure pathways analyses
and other exposure screening analyses to identify impacted communities,
to include exposure investigations (biologic sampling, personal
monitoring, etc.), and related environmental assessments, as
appropriate; (5) issues public health advisories when a release or
threatened release of a toxic substance poses an imminent health
hazard; (6) provides technical support and field presence for routine
emergency and disaster response as appropriate; (7) engages with
regional partners to accomplish special programs that promote
environmental health; (8) provides scientific expertise in
environmental epidemiology; (9) designs and conducts human health,
including epidemiologic, studies to evaluate the association between
exposure to hazardous substances and adverse health effects; (10)
provides expert medical and environmental epidemiologic consultation;
and (11) implements extramural research programs that involve human
health investigations.
Office of Capacity Development and Applied Prevention
Science (JAAQD). (1) Builds capabilities by translating science into
tools and actions that individuals, communities, and organizations
apply to identify, reduce, or prevent health effects from exposures to
hazardous substances; (2) coordinates and conducts training, community
engagement, and system development that addresses internal and external
needs as well as builds capacity of end-users; (3) develops best
practices, tools, and strategies for engaging with communities, and
providing community engagement consultation to internal ATSDR partners
(e.g., health educators); (4) conducts grant management, project
officers' activities, and builds capacity development through strategy
development, monitoring, and training; (5) serves as an incubator for
new preventions, interventions, and implementation science; supports
testing, development, and material design for community and health
professional audiences; (6) designs and standardizes intervention
initiatives for community audiences, evaluating intervention design
methods, and designing education campaigns; (7) designs and standardize
intervention initiatives for health professionals, evaluating
intervention design methods, and promoting environmental health content
within clinical education programs; (8) designs, reviews and evaluates
the scientific accuracy and clarity of health education materials; (9)
informs and promotes integration of environmental health content within
clinical education programs (e.g., coursework, clinical rotations, and
primary care residency programs) and environmental medicine practice;
(10) identifies and cultivates partnerships with academic and
professional organizations to encourage uptake of environmental public
health awareness curricula and career tracks; (11) develops community/
population and clinical intervention initiatives to reduce risk factors
associated with environmental exposures; (12) develops integrated
clinical support guidance for patient care; (13) provides, promotes,
and/or implements ATSDR-approved tools and training to partners (both
internal [e.g., health educators] and external [e.g., state partners])
so that they can effectively engage communities using a standardized
approach; (14) provides evaluation guidance and facilitates evaluation
feedback loops related to ATSDR intervention initiatives, guidance
materials, and support tools for continuous quality improvement and
effectiveness of grant-supported work; (15) implements ATSDR's Site-
Specific Cooperative Agreement Program; (16) plans, prepares, and
executes appropriate community involvement and health educational
strategies/activities/programs for communities affected or potentially
affected by toxic substances released into the environment; (17)
develops and tests metrics that could be used for public health
surveillance or evaluation of intervention effectiveness; and (18)
partners with relevant internal and external stakeholders to
incorporate prevention strategies into existing programs, policies, and
practices.
IV. Delegations of Authority: All delegations and redelegations of
authority made to officials and employees of affected organizational
components will continue in them or their successors pending further
redelegation, provided they are consistent with this reorganization.
(Authority: 44 U.S.C. 3101)
Alex M. Azar II,
Secretary.
[FR Doc. 2020-00181 Filed 1-8-20; 8:45 am]
BILLING CODE 4163-70-P