Notice2022-25241
Input on the National Public Health Strategy for the Prevention and Control of Vector-Borne Diseases in Humans: Request for Information
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Published
November 21, 2022
Issuing agencies
Health and Human Services Department
Abstract
This Request for information (RFI) invites comments and suggestions on the National Strategy for the Prevention and Control of Vector-Borne Diseases. The Strategy represents the Federal Government's priorities for addressing vector-borne disease (VBD) threats.
Full Text
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<title>Federal Register, Volume 87 Issue 223 (Monday, November 21, 2022)</title>
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[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70836-70848]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-25241]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Input on the National Public Health Strategy for the Prevention
and Control of Vector-Borne Diseases in Humans: Request for Information
AGENCY: Office of the Assistant Secretary for Health (OASH), Office of
the Secretary, Department of Health and Human Services.
ACTION: Request for information.
-----------------------------------------------------------------------
SUMMARY: This Request for information (RFI) invites comments and
suggestions on the National Strategy for the Prevention and Control of
Vector-Borne Diseases. The Strategy represents the Federal Government's
priorities for addressing vector-borne disease (VBD) threats.
DATES: To be assured consideration, comments must be received via the
method provided below, no later than midnight Eastern Time (ET) on
December 21, 2022. Submissions received after the deadline will not be
reviewed.
ADDRESSES: Comments, including mass comment submissions, must be
submitted electronically at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Search for this
RFI by typing a keyword in the search field on the homepage. Click on
the ``Comment Now'' button on RFI and you can submit your comments
including attachments in a window titled, ``Your Information.'' For
help finding this RFI and/or submitting comments, please visit <a href="https://www.regulations.gov/help">https://www.regulations.gov/help</a>.
FOR FURTHER INFORMATION CONTACT: Dr. Kristen Honey, Chief Data
Scientist and Executive Director of InnovationX, Office of the
Assistant Secretary for Health, Department of Health and Human
Services, 200 Independence Avenue SW, Washington, DC 20201,
<a href="/cdn-cgi/l/email-protection#691f0c0a1d061b0b061b070c0d001a0c081a0c2901011a470e061f"><span class="__cf_email__" data-cfemail="790f1c1a0d160b1b160b171c1d100a1c180a1c3911110a571e160f">[email protected]</span></a>, (202) 853-7680.
SUPPLEMENTARY INFORMATION: It is important to read this entire RFI
notice to ensure an adequate response is prepared and to have a full
understanding of how your response will be acknowledged and used.
Inspection of Public Comments: All comments received before the close
of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following
website as soon as possible after they have been received: <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Follow the search instructions on that website to
view public comments.
I. Background
The Federal Government is developing a national strategy for the
prevention and control of vector-borne diseases (VBD) in humans.
The Federal Government has identified 5 goals and 19 strategic
priorities which were developed using the framework of the previously
released National Public Health Framework for the Prevention and
Control of Vector-Borne Diseases in Humans:
<bullet> Goal 1: Better understand when, where, and how people are
exposed to and become sick or die from vector-borne diseases (VBDs).
[cir] Strategic Priority 1: Better understand vectors, the
pathogens they transmit, and the potential effects of a changing
climate.
[cir] Strategic Priority 2: Modernize and maintain surveillance
systems for vectors, reservoirs, and VBDs.
[cir] Strategic Priority 3: Better understand the risk factors for
and effects of VBDs on humans.
<bullet> Goal 2: Develop, evaluate, and improve tools and guidance
for the diagnosis and detection of vector-borne diseases.
[cir] Strategic Priority 1: Identify and characterize novel VBD
pathogens and their clinical manifestations.
[cir] Strategic Priority 2: Develop, evaluate, and improve
diagnostic tests for VBDs.
[cir] Strategic Priority 3: Develop and evaluate evidence-based
recommendations and guidelines on VBD diagnosis in humans.
[cir] Strategic Priority 4: Develop, maintain, and distribute non-
commercial diagnostic resources to facilitate VBD testing.
<bullet> Goal 3: Develop, evaluate, and improve tools and guidance
for the prevention and control of vector-borne diseases.
[cir] Strategic Priority 1: Develop, evaluate, and improve safe and
effective VBD prevention tools such as vaccines, vector control
strategies, and health communication tools and products that are
tailored for communities that are disproportionately affected.
[cir] Strategic Priority 2: Develop and evaluate data-driven and
adaptive predictive models and decision support tools for VBDs.
[cir] Strategic Priority 3: Develop and evaluate evidence-based
recommendations and guidelines on VBD prevention.
[cir] Strategic Priority 4: Develop and evaluate tools and
processes for responding to public health emergencies.
<bullet> Goal 4: Develop and assess drugs and treatment strategies
for VBDs.
[cir] Strategic Priority 1: Identify, develop, and evaluate safe
and effective drugs and treatment strategies (regimens) for VBDs.
[cir] Strategic Priority 2: Develop evidence-based recommendations
and guidelines on the treatment and management of VBDs.
[cir] Strategic Priority 3: Evaluate drug and treatment use
patterns.
<bullet> Goal 5: Disseminate and support the implementation of
effective public health products, tools, programs, collaborations, and
innovations to prevent, detect, diagnose, and respond to VBD threats.
[cir] Strategic Priority 1: Disseminate evidence-based information
about VBD prevention and control, guidelines, and recommendations to
partners and the public.
[cir] Strategic Priority 2: Ensure current and future capacity to
implement and adequately and equitably scale safe, effective, and
publicly accepted VBD prevention and control programs.
[cir] Strategic Priority 3: Monitor and evaluate evidence-based
public health programs and tools.
[cir] Strategic Priority 4: Respond to public health emergencies
resulting from VBD threats.
[cir] Strategic Priority 5: Clarify, facilitate, and improve
processes to bring regulated diagnostic tests, treatment strategies,
vaccines, and vector control products to market.
[[Page 70837]]
A detailed copy of the goals and strategic priorities of this
strategy can be found in the next section of this RFI.
The focus areas listed above are not exhaustive but represent the
Federal Government's priorities for preventing and controlling VBDs.
Although critical to public health and wellness, healthcare
utilization, access to care, and reimbursement or payment for clinical
services are outside the scope of this prevention and control strategy.
HHS/OASH recognizes the extensive work of the Tick-Borne Disease
Working Group, including the two (2) reports delivered to Congress as
of the release of this Request for Information. These reports included
55 recommendations, which have been cross-walked against the Goals and
Strategies of the National Strategy for the Prevention and Control of
Vector-Borne Diseases. This crosswalk reflects the alignment between
the TBDWG recommendations and the Strategy. A copy of this crosswalk
can be found in the last section of this RFI.
II. Information Requested/Questions
HHS/OASH invites input from stakeholders throughout the scientific
research, advocacy, and clinical practice communities, as well as the
general public, on the proposed national strategy. This input is a
valuable component in finalizing the strategy, and the community's time
and consideration are appreciated.
HHS/OASH also invites thoughts on preferred strategies for partner
engagement as the strategy is further developed and modified over time
(e.g., webinars, listening sessions, additional RFIs, etc.).
HHS/OASH encourages organizations (e.g., patient advocacy groups,
professional organizations) to submit a single response reflective of
the views of the organization/membership as a whole when possible.
III. How To Submit Your Response
Please respond concisely, in plain language, and in narrative
format. You may respond to some or all of the topic areas covered in
the RFI, and you can suggest other factors or relevant questions. You
may also include links to online material or interactive presentations.
Clearly mark any proprietary information and place it in its own
section or file.
Please note that this is a request for information (RFI) only. In
accordance with the implementing regulations of the Paperwork Reduction
Act of 1995 (PRA), specifically 5 CFR 1320.3(h) (4), this general
solicitation is exempt from the PRA. Facts or opinions submitted in
response to general solicitations of comments from the public,
published in the Federal Register or other publications, regardless of
the form or format thereof, provided that no person is required to
supply specific information pertaining to the commenter, other than
that necessary for self-identification, as a condition of the agency's
full consideration, are not generally considered information
collections and therefore not subject to the PRA.
This RFI is issued solely for information and planning purposes; it
does not constitute a Request for Proposal (RFP), applications,
proposal abstracts, or quotations. This RFI does not commit the U.S.
Government to contract for any supplies or services or make a grant
award. Further, we are not seeking proposals through this RFI and will
not accept unsolicited proposals. We note that not responding to this
RFI does not preclude participation in any future procurement, if
conducted. It is the responsibility of the potential responders to
monitor this RFI announcement for additional information pertaining to
this request.
HHS may or may not choose to contact individual responders. Such
communications would be for the sole purpose of clarifying statements
in written responses. Contractor support personnel may be used to
review responses to this RFI. Responses to this notice are not offers
and cannot be accepted by the Government to form a binding contract or
issue a grant. Information obtained as a result of this RFI may be used
by the Government for program planning on a non-attribution basis. This
RFI should not be construed as a commitment or authorization to incur
cost for which reimbursement would be required or sought. All
submissions become U.S. Government property; they will not be returned,
and we may publish some of their non-proprietary content.
Dated: November 15, 2022.
Kristen Honey,
Chief Data Scientist and Executive Director of InnovationX, Office of
the Assistant Secretary for Health, Department of Health and Human
Services.
National Public Health Strategy for the Prevention and Control of
Vector-Borne Diseases in Humans
Vision
A nation where vector-borne diseases no longer threaten human
health and well-being.
Mission
Protect people from illness, suffering, and death due to vector-
borne diseases.
Goal 1: Better understand when, where, and how people are exposed to
and become sick or die from vector-borne diseases (VBDs)
Strategic Priority 1--Better Understand Vectors, the Pathogens They
Transmit, and the Potential Effects of a Changing Climate
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Determine how vector-borne DHHS (CDC, NIH).
pathogens are transmitted to humans: USDA.
<bullet> Sub-objective 1: Develop animal DOI.
and vector models for VBD research. DOD.
<bullet> Sub-objective 2: Identify key
animal reservoirs for vector-borne
pathogens.
<bullet> Sub-objective 3: Identify the
factors associated with the ability of
vectors to effectively transmit pathogens
to humans.
<bullet> Sub-objective 4: Determine if
co-infections within vectors and
animal reservoirs impact transmission
to humans.
Objective 2: Identify the environmental DHHS (CDC, NIH).
factors associated with vector and animal DOD.
reservoir populations: DOI.
<bullet> Sub-objective 1: Identify key NOAA.
factors, such as climate and ecological NASA.
factors, associated with the distribution USDA (APHIS).
and abundance of vectors and animal
reservoirs.
<bullet> Sub-objective 2: Identify key
factors, such as climate and ecological
factors, associated with the seasonality
of vectors and animal reservoirs.
[[Page 70838]]
Objective 3: Determine which vectors found DHHS (CDC, NIH).
outside the United States and its DOD.
territories pose the greatest near-term DOI (USGS, NISC, NPS).
risk of becoming established in the United NOAA.
States and its territories: USDA (APHIS).
<bullet> Sub-objective 1: Conduct
assessments and develop a list of vectors
that pose the highest risk for
establishment in the United States and its
territories.
<bullet> Sub-objective 2: Develop habitat
suitability models for the potential
distribution of vectors based on their
distribution outside the United States and
its territories.
------------------------------------------------------------------------
Goal 1: Better understand when, where, and how people are exposed to
and get sick or die from vector-borne diseases
---------------------------------------------------------------------------
\1\ Data modernization is the result of the nation strengthening
data reporting, management, and analytics across public health;
conducting proper surveillance; supporting staff in pursuing
innovation and building state-of-the-art data science skills; and
delivering guidance the public can trust. <a href="https://www.cdc.gov/surveillance/projects/dmi-initiative/">https://www.cdc.gov/surveillance/projects/dmi-initiative/</a>.
Strategic Priority 2--Modernize \1\ and Maintain Surveillance Systems
for Vectors, Reservoirs, and VBDs
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Evaluate, improve, and DHHS (CDC, NIH).
maintain surveillance systems for vectors, USDA.
reservoirs, pathogens, and VBDs in humans DOI (USGS, NPS).
and animals:
<bullet> Sub-objective 1: Identify existing
complementary public and private
surveillance systems.
<bullet> Sub-objective 2: Evaluate existing
surveillance systems to identify gaps both
within and across systems.
<bullet> Sub-objective 3: Address
surveillance gaps within and across
existing surveillance systems.
<bullet> Sub-objective 4: Increase
usability of surveillance data by
expanding data access and timeliness
and enhancing data visualizations of
data from VBD systems.
<bullet> Sub-objective 5: Evaluate the
utility of alternative data sources
and tools (e.g., artificial
intelligence, citizen science,
crowdsourcing, patient registries) and
use these evaluations to leverage
relevant systems to further inform
surveillance.
Objective 2: Increase data integration of DHHS (CDC, NIH).
and data sharing across surveillance DOD.
systems: USDA.
<bullet> Sub-objective 1: Identify USGS.
opportunities for and challenges to
increase the integration of and data
sharing across surveillance systems.
<bullet> Sub-objective 2: Implement steps
to increase data integration and
interoperability of surveillance systems.
------------------------------------------------------------------------
Goal 1: Better understand when, where, and how people are exposed to
and get sick or die from vector-borne diseases
---------------------------------------------------------------------------
\2\ Social determinants of health are conditions in the places
where people live, learn, work, and play that affect a wide range of
health and quality-of life-risks and outcomes. <a href="https://www.cdc.gov/socialdeterminants/about.html">https://www.cdc.gov/socialdeterminants/about.html</a>.
\3\ The built environment includes the physical makeup of where
we live, learn, work, and play--our homes, schools, businesses,
streets and sidewalks, open spaces, and transportation. <a href="https://www.cdc.gov/nccdphp/dnpao/state-local-programs/built-environment-assessment/index.htm">https://www.cdc.gov/nccdphp/dnpao/state-local-programs/built-environment-assessment/index.htm</a>.
Strategic Priority 3--Better Understand the Risk Factors for and Effects
of VBDs on Humans
------------------------------------------------------------------------
Federal entities with
Objectives and sub objectives accountability
------------------------------------------------------------------------
Objective 1: Determine the social, DHHS (CDC, NIH).
behavioral, and environmental factors for NOAA.
human exposure to VBD pathogens: NASA.
<bullet> Sub-objective 1: Determine the
social determinants of health \2\ and
associated with human exposure to VBD
pathogens.
<bullet> Sub-objective 2: Determine the
environmental factors, including the built
environment,\3\ associated with human
exposure to VBD pathogens.
<bullet> Sub-objective 3: Determine the
knowledge, attitudes, and behaviors
influencing and impacting human
exposure to VBD pathogens, including
differences among population groups.
<bullet> Sub-objective 4: Identify,
monitor, and evaluate policies and
laws that help to reduce risk of human
exposure to VBD pathogens.
Objective 2: Determine the disease DHHS (CDC, NIH).
processes, progression, and clinical USDA.
outcomes of VBDs:
<bullet> Sub-objective 1: Describe the
disease processes, progression, and
clinical outcomes associated with priority
VBDs, including symptom persistence.
<bullet> Sub-objective 2: Describe the
frequency and effect of VBD co-
infections on diagnosis, treatment,
and clinical outcomes.
<bullet> Sub-objective 3: Identify
differences in the clinical
presentation, disease processes,
progression, and clinical outcomes of
VBDs associated with specific
demographic factors, co-morbidities,
and social determinants of health,
particularly as they relate to
differences across population groups.
Objective 3: Determine the disease burden DHHS (CDC).
of VBDs in the United States, including USDA (APHIS).
identifying differences in disease burden
across population groups:
[[Page 70839]]
<bullet> Sub-objective 1: Describe the
epidemiology of VBDs, including social
determinants of health.\2\
<bullet> Sub-objective 2: Describe the
burden of VBDs, including costs to
society and health-related quality of
life.
------------------------------------------------------------------------
Goal 2: Develop, evaluate, and improve tools and guidance for the
diagnosis and detection of vector-borne diseases
Strategic Priority 1--Identify and Characterize Novel VBD Pathogens and
Their Clinical Manifestations
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Determine a strategy for DHHS (CDC, NIH).
detecting novel pathogens and variants: USDA.
<bullet> Sub-objective 1: Develop and DOD.
disseminate strategies and algorithms that
seek to detect novel VBD pathogens,
including the use of new technologies
(e.g., machine learning, genomics,
emerging tech).
<bullet> Sub-objective 2: Apply the
algorithms and strategies to detect novel
pathogens; publish a list of novel
pathogens that pose a potential risk to
human health.
<bullet> Sub-objective 3: Describe the
knowledge gaps related to newly
identified pathogens that pose a risk
to human health.
<bullet> Sub-objective 4: Collaborate
with agricultural and other non-health
partners to detect novel VBD pathogens
in vectors and animals that may pose
risk to human health.
Objective 2: Conduct studies and DHHS (CDC, NIH, FDA,
investigations to address knowledge gaps BARDA).
related to novel pathogens that are DOD.
potentially vector-transmitted: USDA.
<bullet> Sub-objective 1: Investigate
potential VBD transmission in people and
animals with illness of unknown origin
that may be attributed to an emerging
vector-borne pathogen.
<bullet> Sub-objective 2: Fill critical
knowledge gaps to be prepared for and
able to respond to novel VBD emergence
events.
------------------------------------------------------------------------
Goal 2: Develop, evaluate, and improve tools and guidance for the
diagnosis and detection of vector-borne diseases
Strategic Priority 2--Develop, Evaluate, and Improve Diagnostic Tests
for VBDs
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Develop diagnostic tests for DHHS (CDC, NIH, FDA,
novel pathogens: BARDA).
<bullet> Sub-objective 1: Determine the DOD.
specimen types that provide optimal USDA.
diagnostic performance.
<bullet> Sub-objective 2: Develop pathogen-
detection tests, including more rapid
tests, within 1 year of identifying a
novel pathogen.
<bullet> Sub-objective 3: Develop
serologic tests and, when applicable,
biomarker tests within 1 year of
identifying a novel pathogen.
<bullet> Sub-objective 4: Investigate
new methods for pathogen detection as
new technologies advance.
<bullet> Sub-objective 5: Make new
diagnostic tests available for
expanded use and commercialization as
public health needs arise.
Objective 2: Develop and make improved DHHS (CDC, NIH, FDA,
diagnostic tests available for known BARDA).
pathogens: DOD.
<bullet> Sub-objective 1: Develop pathogen-
detection tests that significantly improve
test accuracy, precision, efficiency,
performance, and/or speed.
<bullet> Sub-objective 2: Develop
serologic tests that significantly
improve test accuracy, precision,
efficiency, performance, and/or speed.
<bullet> Sub-objective 3: Investigate
new methods (e.g., for detecting
biomarkers) for detecting existing
vector-borne pathogens as new
technologies advance.
<bullet> Sub-objective 4: Make new
diagnostic tests available for
expanded use and commercialization as
public health needs arise.
Objective 3: Compare the performance of new DHHS (CDC, BARDA, FDA).
and existing diagnostic tests for people, USDA.
vectors, animals, and animal reservoirs:
<bullet> Sub-objective 1: Develop,
maintain, and disseminate panels for
use in evaluations of diagnostic
tests.
<bullet> Sub-objective 2: Compare the
characteristics and performance of
diagnostic tests.
------------------------------------------------------------------------
Goal 2: Develop, evaluate, and improve tools and guidance for the
diagnosis and detection of vector-borne diseases
[[Page 70840]]
Strategic Priority 3--Develop and Evaluate Evidence-Based
Recommendations and Guidelines on VBD Diagnosis in Humans
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: For novel pathogens, DHHS (CDC, NIH).
collaborate with external partners to DOD.
develop guidance, recommendations, or USDA.
guidelines on clinical and laboratory
diagnosis:
<bullet> Sub-objective 1: Establish a
surveillance case definition for each VBD
caused by a novel pathogen within 1 year
of its identification.
<bullet> Sub-objective 2: Develop and
disseminate guidance, recommendations, or
guidelines on appropriate test methods/
procedures, to include interpretation of
test results (including lab and clinical
parameters).
Objective 2: Review and revise existing DHHS (CDC).
diagnostic guidance, recommendations, or DOD.
guidelines to incorporate new knowledge: USDA.
<bullet> Sub-objective 1: Continuously
monitor emerging science that informs the
diagnosis of VBDs.
<bullet> Sub-objective 2: Revise and
disseminate existing guidance,
recommendations, and guidelines for vector-
borne diagnosis with new knowledge.
------------------------------------------------------------------------
Goal 2: Develop, evaluate, and improve tools and guidance for the
diagnosis and detection of vector-borne diseases
Strategic Priority 4--Develop, Maintain, and Distribute Non-Commercial
Diagnostic Resources To Facilitate VBD Testing
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Ensure sufficient supplies of DHHS (CDC, NIH).
diagnostic resources for VBD pathogens to USDA.
facilitate research, development, and
surveillance:
<bullet> Sub-objective 1: Identify
reagents that need to be developed.
<bullet> Sub-objective 2: Identify
reagents that require production to
complement commercial resources.
<bullet> Sub-objective 3: Inventory
supplies of diagnostic resources
(e.g., reagents, standards, and
biospecimens) available for VBD
pathogens of concern.
<bullet> Sub-objective 4: Generate and
disseminate sufficient diagnostic
resources needed to facilitate
research, development, and
surveillance and diagnostic testing
capacity for priority VBD pathogens.
------------------------------------------------------------------------
Goal 3: Develop, evaluate, and improve tools and guidance for the
prevention and control of vector-borne diseases
Strategic Priority 1--Develop, Evaluate, and Improve Safe and Effective
VBD Prevention Tools Such as Vaccines, Vector Control Strategies, and
Health Communication Tools and Products That Are Tailored for
Communities That Are Disproportionately Affected
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Prioritize, develop, and DHHS (CDC, NIH, FDA).
evaluate vaccines against priority VBD USDA.
pathogens:
<bullet> Sub-objective 1: Design and
implement a decision process to
prioritize VBDs for vaccine
development.
<bullet> Sub-objective 2: Identify key
potential challenges to and
opportunities for successful
development of vaccines.
<bullet> Sub-objective 3: Facilitate
partnerships across sectors, including
with communities who are
disproportionately affected, for
vaccine development.
<bullet> Sub-objective 4: Develop,
evaluate, and refine vaccines.
Objective 2: Identify, develop, prioritize, DHHS (CDC, NIH).
and evaluate vector control tools and DOD.
approaches, including engagement with USDA.
communities who are disproportionately
affected as appropriate:
<bullet> Sub-objective 1: Evaluate the
factors that make vectors more or less
susceptible to vector control tools.
<bullet> Sub-objective 2: Design and
implement a decision process to
prioritize vector control tools for
development.
<bullet> Sub-objective 3: Identify key
potential challenges to and
opportunities for successful
development of novel vector control
tools.
<bullet> Sub-objective 4: Facilitate
partnerships across sectors for vector
control tool development.
<bullet> Sub-objective 5: Identify,
develop, evaluate, and refine new and
existing vector control tools and
approaches.
Objective 3: Develop and evaluate public DHHS (CDC).
health communication tools and products to USDA.
encourage public acceptance and adoption
of prevention and control guidance:
<bullet> Sub-objective 1: Conduct
formative research to inform the
development of public health
communication tools and products.
<bullet> Sub-objective 2: Develop
appropriate outreach strategies as
informed by formative research.
[[Page 70841]]
<bullet> Sub-objective 3: Evaluate
public health communication tools and
products to ensure fit within intended
communities.
------------------------------------------------------------------------
Goal 3: Develop, evaluate, and improve tools and guidance for the
prevention and control of vector-borne diseases
Strategic Priority 2--Develop and Evaluate Data-Driven and Adaptive
Predictive Models and Decision Support Tools for VBDs
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Develop predictive models and DHHS (CDC, NIH).
decision support tools to guide prevention USDA.
and control activities:. NOAA (NCAR).
<bullet> Sub-objective 1: Elicit and
prioritize decision-maker needs and
requirements for decision-support
tools.
<bullet> Sub-objective 2: Prioritize
VBDs for the development of predictive
models and decision support tools.
<bullet> Sub-objective 3: Develop
predictive VBD transmission models and
other nowcasting and forecasting
tools.
Objective 2: Evaluate and refine predictive DHHS (CDC, NIH).
models and decision support tools. NOAA (NCAR).
<bullet> Sub-objective 1: Evaluate the
accuracy and utility of predictive
models and decision support tools.
<bullet> Sub-objective 2: Refine
predictive models and decision support
tools based on evaluation outcomes.
------------------------------------------------------------------------
Goal 3: Develop, evaluate, and improve tools and guidance for the
prevention and control of vector-borne diseases
Strategic Priority 3--Develop and Evaluate Evidence-Based
Recommendations and Guidelines on VBD Prevention \4\
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Develop and update evidence- DHHS (CDC, NIH).
based recommendations and guidelines: USDA.
<bullet> Sub-objective 1: Regularly
update recommendations and guidelines
based on the state of the science.
<bullet> Sub-objective 2: Identify and
prioritize VBDs for which new
recommendations and guidelines are
needed.
<bullet> Sub-objective 3: Collaborate
with internal and external partners to
develop new recommendations and
guidelines for priority VBDs, ensuring
specific population needs are
considered and addressed.
<bullet> Sub-objective 4: Monitor and
evaluate the implementation of
recommendations and guidelines
------------------------------------------------------------------------
Goal 3: Develop, evaluate, and improve tools and guidance for the
prevention and control of vector-borne diseases
---------------------------------------------------------------------------
\4\ To include vector control and prophylaxis.
\5\ To include relevant partners across animal and public
health.
Strategic Priority 4--Develop and evaluate tools and processes for
responding to public health emergencies
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Ensure national preparedness DHHS (CDC, NIH).
through the development of national, USDA.
tribal, state, and territorial FEMA.
preparedness and emergency response plans
for vector-borne disease outbreaks:
<bullet> Sub-objective 1: Develop,
maintain, and exercise preparedness
and emergency response plans,
including partner engagement
strategies.
<bullet> Sub-objective 2: Ensure
equitable availability of medical
countermeasures and vector-borne
disease prevention and control tools,
consistent with preparedness and
emergency response plans.
[[Page 70842]]
Objective 2: Develop inclusive \5\ public DHHS (CDC).
health communication plans, products, and FEMA.
tools for responding to vector-borne USDA.
disease outbreaks that are consistent with
and integrated into preparedness and
emergency response plans:
<bullet> Sub-objective 1: Develop key
messages and tools to effectively
communicate health information in a
way that is inclusive of all
communities.
<bullet> Sub-objective 2: Identify and
address challenges to implementation
of response communication plans,
ensuring equitable accessibility of
information.
Objective 3: Evaluate tools and processes DHHS (CDC).
for responding to vector-borne disease FEMA.
emergencies, including reducing associated
health inequities:
<bullet> Sub-objective 1: Conduct and
support tabletop exercises integrating
multiple sectors and community
partners as appropriate.
<bullet> Sub-objective 2: Conduct and
support after action reviews and
develop reports.
<bullet> Sub-objective 3: Evaluate and
improve effectiveness of public health
communication products and tools.
------------------------------------------------------------------------
Goal 4: Develop and assess drugs and treatment strategies for VBDs
Strategic Priority 1--Identify, Develop, and Evaluate Safe and Effective
Drugs and Treatment Strategies (Regimens) for VBDs
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Develop new safe and effective DHHS (NIH, FDA).
drugs, including immunotherapies:
<bullet> Sub-objective 1: Identify and DOD.
characterize new molecular targets for
therapeutics for priority VBDs.
<bullet> Sub-objective 2: Develop USDA.
effective drugs from newly identified
molecular targets including evaluating/
comparing clinical efficacy.
Objective 2: Evaluate or repurpose existing DHHS (NIH, FDA).
therapeutic strategies for use in the
treatment and management of VBDs:
<bullet> Sub-objective 1: Optimize
existing therapeutic strategies for
VBDs.
<bullet> Sub-objective 2: Optimize
therapeutic strategies repurposed for
VBDs..
<bullet> Sub-objective 3: Evaluate
complementary and integrative health
therapies for safety and efficacy..
<bullet> Sub-objective 4: Conduct and
disseminate comparative effectiveness
studies of existing VBD treatments..
Objective 3: Advance research on treatment DHHS (NIH).
for persistent symptoms associated with
VBDs:
<bullet> Sub-objective 1: Assess
treatment strategies for extended or
long-term symptoms associated with
VBDs.
<bullet> Sub-objective 2: Collaborate
across fields of medicine to learn
about promising therapeutic strategies
for persistent symptoms following VBD
infections..
------------------------------------------------------------------------
Goal 4: Develop and assess drugs and treatment strategies for VBDs.
Strategic Priority 2--Develop Evidence-Based Recommendations and
Guidelines on the Treatment and Management of VBDs
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Periodically review the DHHS (CDC, NIH).
evidence and update existing federally USDA.
developed recommendations and guidelines
to treat and manage VBDs:
<bullet> Sub-objective 1: Coordinate
expert review of the evidence to
inform revisions of federally
developed recommendations and
guidelines.
<bullet> Sub-objective 2: Update and
disseminate existing federally
developed recommendations or
guidelines on VBD treatment and
management..
Objective 2: Develop new guidance for the DHHS (CDC, NIH).
treatment and management of VBDs when peer- USDA.
reviewed recommendations or guidelines do
not exist:
<bullet> Sub-objective 1: Coordinate
expert review of the evidence to
inform the development of new
federally developed recommendations
and guidelines.
<bullet> Sub-objective 2: Disseminate
new federally developed
recommendations or guidelines on VBD
treatment and management..
------------------------------------------------------------------------
Goal 4: Develop and assess drugs and treatment strategies for VBDs.
[[Page 70843]]
Strategic Priority 3: Evaluate Treatment and Management Use Patterns
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Describe patterns of treatment DHHS (CDC, FDA).
and management:
<bullet> Sub-objective 1: Conduct and
disseminate studies of drug and
treatment use patterns as well as
management of VBDs, including
conducting surveys and analyzing
administrative claims data for
surveillance purposes.
Objective 2: Develop clinician and public DHHS (CDC, FDA).
advisories pertaining to the treatment and
management of VBDs:
<bullet> Sub-objective 1: Disseminate
clinician and public advisories
pertaining to the treatment and
management of VBDs.
------------------------------------------------------------------------
Goal 5: Disseminate and support the implementation of effective public
health products, tools, programs, collaborations, and innovations to
prevent, detect, diagnose, and respond to VBD threats
---------------------------------------------------------------------------
\6\ To be developed in G3, SP1, O3.
Strategic Priority 1--Disseminate Evidence-Based Information About VBD
Prevention and Control, Guidelines, and Recommendations to Partners and
the Public
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Disseminate evidence-based DHHS (CDC, FDA).
recommendations and guidelines to key USDA.
professional audiences (for example,
healthcare providers, health departments,
veterinarians, and professional
societies):
<bullet> Sub-objective 1: Tailor
dissemination of products and tools
based on audience needs.
<bullet> Sub-objective 2: Develop and
implement a dissemination plan to
distribute evidence-based
recommendations and guidelines..
Objective 2: Disseminate health DHHS (CDC).
communication products and tools \6\ that
are tailored for communities and partners:
<bullet> Sub-objective 1: Collaborate USDA.
with a diverse set of impacted
populations, multi-sectoral partners,
and community members to co-create
dissemination plans to reach
communities of focus using traditional
and innovative strategies.
<bullet> Sub-objective 2: Implement the
dissemination plan to distribute VBD
prevention and control information and
guidance using appropriate channels,
methods, and messages.
------------------------------------------------------------------------
Goal 5: Disseminate and support the implementation of effective public
health products, tools, programs, collaborations, and innovations to
prevent, detect, diagnose, and respond to VBD threats
Strategic Priority 2--Ensure Current and Future Capacity to Implement
and Adequately and Equitably Scale Safe, Effective, and Publicly
Accepted VBD Prevention and Control Programs
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Equitably support state, DHHS (CDC).
tribal, territories and collaborating USDA.
partners in their efforts to implement VBD
programs, to include surveillance,
diagnosis and detection, prevention, and
control:
<bullet> Sub-objective 1: Provide
support to jurisdictions, Tribes, and
partners to implement effective VBD
programs, including providing staffing
support.
<bullet> Sub-objective 2: Provide
technical assistance to implementing
jurisdictions, Tribes, and partners in
their selection, planning, and
implementation of programs, tools,
collaborations, and innovations..
Objective 2: Collaborate with partners DHHS (CDC).
across levels, sectors, and disciplines to
build and sustain implementation capacity:
<bullet> Sub-objective 1: Assess and USDA.
monitor training needs on evidence-
based information, guidelines, and
recommendations.
<bullet> Sub-objective 2: Provide
trainings on evidence-based
information, guidelines, and
recommendations.
<bullet> Sub-objective 3: Provide
funding and technical assistance to
partners to build, expand, and
diversify the Public Health workforce.
------------------------------------------------------------------------
Goal 5: Disseminate and support the implementation of effective public
health products, tools, programs, collaborations, and innovations to
prevent, detect, diagnose, and respond to VBD threats
Strategic Priority 3--Monitor and Evaluate Evidence-Based Public Health
Programs and Tools
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Monitor and evaluate Public DHHS (CDC).
Health implementation efforts in
communities:
<bullet> Sub-objective 1: Monitor the
implementation of programs and tools
over time and across communities.
<bullet> Sub-objective 2: Collaborate
with implementers to evaluate
acceptability, suitability,
effectiveness, and sustainability of
Public Health programs and tools..
<bullet> Sub-objective 3: Broadly
disseminate evaluation findings to
implementers, the scientific field,
and the public..
Objective 2: Adapt and optimize Public DHHS (CDC).
Health efforts:
[[Page 70844]]
<bullet> Sub-objective 1: Regularly
review and update Public Health
products, tools, and guidance based on
findings from program evaluations.
<bullet> Sub-objective 2: Disseminate
updated Public Health products, tools,
and guidance as warranted..
<bullet> Sub-objective 3: Synthesize
the state of the field and share
lessons learned, promising and best
practices, technologies, and
opportunities for continuous
improvement..
------------------------------------------------------------------------
Goal 5: Disseminate and support the implementation of effective public
health products, tools, programs, collaborations, and innovations to
prevent, detect, diagnose, and respond to VBD threats
Strategic Priority 4--Respond to Public Health Emergencies Resulting
From VBD Threats
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Provide direct response to DHHS (CDC, NIH).
public health emergencies:
<bullet> Sub-objective 1: Provide USDA.
laboratory testing for state, tribal,
local, and territorial jurisdictions.
<bullet> Sub-objective 2: Deploy staff FEMA.
to support local response efforts (for
example, vector surveillance and
vector control) when requested by
jurisdictions and Tribes.
<bullet> Sub-objective 3: Disseminate
Public Health messaging to support
local response efforts.
<bullet> Sub-objective 4: Disseminate
data that identifies
disproportionately affected
populations.
<bullet> Sub-objective 5: Facilitate
the process for emergency use of VBD
tools during public health
emergencies.
Objective 2: Support jurisdictions in their DHHS (CDC, NIH).
response to public health emergencies,
including addressing the needs of
disproportionately affected populations:
<bullet> Sub-objective 1: Support
implementation of local preparedness
and emergency response plans.
<bullet> Sub-objective 2: Provide
direct technical assistance to
jurisdictions in the implementation of
their emergency response plans..
<bullet> Sub-objective 3: Make medical
countermeasures and VBD prevention and
control tools available and ensure
equitable access and distribution..
<bullet> Sub-objective 4: Ensure the
collection and public access of
quality data to inform public health
actions..
------------------------------------------------------------------------
Goal 5: Disseminate and support the implementation of effective public
health products, tools, programs, collaborations, and innovations to
prevent, detect, diagnose, and respond to VBD threats
Strategic Priority 5--Clarify, Facilitate, and Improve Processes To
Bring Regulated Diagnostic Tests, Treatment Strategies, Vaccines, and
Vector Control Products to Market
------------------------------------------------------------------------
Federal entities with
Objectives and sub-objectives accountability
------------------------------------------------------------------------
Objective 1: Clarify and facilitate the DHHS (FDA).
regulatory process for vector control and
VBD products, tools, and guidelines:
<bullet> Sub-objective 1: Develop EPA.
communication strategies that clearly
articulate the regulatory process.
<bullet> Sub-objective 2: Provide USDA.
direction to applicants in their
submission and response to regulatory
process requirements.
<bullet> Sub-objective 3: Clarify
jurisdiction of federal agencies in
their regulatory responsibilities for
new and innovative products.
Objective 2: Develop innovative strategies DHHS (FDA).
to identify and address challenges in EPA.
bringing vector control and VBD products
and tools to market:
<bullet> Sub-objective 1: Conduct
regulatory science to ensure that
regulatory knowledge gaps are
identified for new and emerging
technologies.
<bullet> Sub-objective 2: Address the
scientific knowledge gaps identified
through regulatory science as
appropriate..
------------------------------------------------------------------------
HHS Tick-Borne Disease Working Group Cross Walk
The purpose of this document is to crosswalk the HHS Tick-borne
Diseases Working Group 2018 and 2020 congressional report
recommendations with the goals and strategic priorities of the draft
National Public Health Strategy for the Prevention and Control of
Vector-Borne Diseases in Humans.
Goal 1: Better understand when, where, and how people are exposed
to and become sick or die from vector-borne diseases (VBDs).
<bullet> TBDWG 2018 7.2 Allocate increased funding for tick-borne
disease in the areas of research, treatment, and prevention
proportional to the burden of illness and need.
Strategic Priority 1: Better understand vectors, the pathogens they
transmit, and the potential effects of a changing climate.
<bullet> TBDWG 2018 3.1 Fund studies and activities on tick biology
and tick-borne disease ecology, including systematic tick surveillance
efforts particularly in regions beyond the Northeast and Upper Midwest.
<bullet> TBDWG 2018 6.3 Improve the education and research on
transmission (including transmission via the blood supply and
pregnancy) and treatment of other tick-borne diseases and coinfections.
<bullet> TBDWG 2020 9.2 DoD: Recommend that the DoD enhance inter-
agency communication and collaboration to
[[Page 70845]]
study Lyme disease and other tick-borne diseases.
Strategic Priority 2: Modernize and maintain surveillance systems
for vectors, reservoirs, and VBDs.
<bullet> TBDWG 2018 3.1 Fund studies and activities on tick biology
and tick-borne disease ecology, including systematic tick surveillance
efforts particularly in regions beyond the Northeast and Upper Midwest.
<bullet> TBDWG 2018 3.4 Have public health authorities formally
recognize complementary, validated systematic approaches to tick-borne
disease surveillance for humans, such as systematic sampling of tick-
borne disease reports for investigation that reduce the burden on tick-
borne disease reporting but allow for comparability of surveillance
findings across states and over time.
<bullet> TBDWG 2018 7.7a Testing and Diagnostic Bands: How They Are
Used Today and What That Is Doing to Patients: Empower Patients with
Data
<bullet> TBDWG 2018 8.2 CDC: Dedicate funding within CDC to study--
with performance indicators--babesiosis incidence, prevalence,
treatment resistance, and prevention, including maternal-fetal and
transplantation/transfusion transmission risk. Consider using advanced
data tools, such as patient registries, to study the potential role of
Babesia in tick-borne disease patients with continuing manifestations
of disease after initial treatment.
<bullet> TBDWG 2018 8.3 DoD: Commence study of tick-borne disease
incidence and prevalence of active duty Servicemembers and their
dependents. Compile data on the impact of tick-borne diseases on
military readiness. Create education and preparedness programs that
specifically address the unique risks faced by Servicemembers in
training and on deployment and by their families.
<bullet> TBDWG 2018 8.4 VA: Commence study of tick-borne disease
incidence and prevalence of Veterans and eligible family members.
<bullet> TBDWG 2020 3.1 Implement multi-agency, ecologically-based
One Health efforts on tick-borne diseases promoting research and
enhanced vector surveillance to identify and validate integrated tick
management in keystone wildlife hosts, particularly white-tailed deer,
and the sustainable management of their populations.
<bullet> TBDWG 2020 3.3 Provide funding to support CDC-directed
expanded tick surveillance and promoting the development and
implementation of best practices for integrated tick management
capturing human tick bite events, and streamlining education, training,
and coordination amongst relevant Federal, state, and local agencies.
<bullet> TBDWG 2020 4.4 Provide HHS with resources to partner with
national Integrated Delivery Networks (IDNs) (for example, Geisinger,
Kaiser, etc.) to conduct a pilot feasibility study to leverage
Electronic Medical Records (EMRs) using Best Practice Alerts at the
patient point-of-care for Alpha-gal Syndrome in endemic areas
(upholding patient confidentiality).
<bullet> TBDWG 2020 4.5 Provide HHS with resources to partner with
national Integrated Delivery Networks (IDNs) (for example, Geisinger,
Kaiser, etc.) to conduct a pilot feasibility study to leverage
Electronic Medical Records (EMRs) using Best Practice Alerts at the
patient point-of-care for rickettsial diseases, ehrlichiosis, and
anaplasmosis in endemic areas (upholding patient confidentiality).
<bullet> TBDWG 2020 8.2 Recommend that CDC work with Council of
State and Territorial Epidemiologists (CSTE) to streamline the
surveillance process and to reduce the burden on both clinicians and
public health departments by permitting direct laboratory reporting of
positive cases.
<bullet> TBDWG 2020 9.1 VA: Recommend that the VA continue with
Recommendation 8.4 from 2018 Working Group report, ``Commence study of
tick-borne disease incidence and prevalence of Veterans and eligible
family members'' and additionally
[cir] Establish and update efforts on tracking and investigating
the prevalence of Lyme and other tick-borne diseases;
<bullet> TBDWG 2020 9.2 DoD: Recommend that the DoD enhance inter-
agency communication and collaboration to study Lyme disease and other
tick-borne diseases.
Strategic Priority 3: Better understand the risk factors for and
effects of VBDs on humans.
<bullet> TBDWG 2018 6.1 Prioritize research into the potential
pathogenic mechanisms (such as immune response, cross-reactivity,
autoimmunity, bacterial persistence, coinfections, and other
mechanisms) of persistent symptoms in patients who have received
standard treatment regimens for tick-borne diseases, including Lyme
disease.
<bullet> TBDWG 2018 6.2 Promote research on animal models of
Borrelia burgdorferi infection (that is, Lyme disease) and the
mechanisms of disease processes in humans with an emphasis on
pathologies that are currently lacking, for example, neuroborreliosis.
<bullet> TBDWG 2018 6.5 Improve the education and research on the
pathogenesis of alpha-gal allergy, also known as the tick-caused ``meat
allergy.''
<bullet> TBDWG 2018 8.2 CDC: Dedicate funding within CDC to study--
with performance indicators--babesiosis incidence, prevalence,
treatment resistance, and prevention, including maternal-fetal and
transplantation/transfusion transmission risk. Consider using advanced
data tools, such as patient registries, to study the potential role of
Babesia in tick-borne disease patients with continuing manifestations
of disease after initial treatment.
<bullet> TBDWG 2020 4.1 Fund research aimed at characterizing the
full clinical spectrum, clinical manifestations, and potential
complications of human monocytic ehrlichiosis (HME) and human
granulocytic anaplasmosis (HGA), including identification of risk
factors for severe illness and the importance of specific
comorbidities, patient characteristics (age, gender, and race), immune
impairment, and genetic host factors.
<bullet> TBDWG 2020 5.1 Provide HHS with resources necessary to
fund basic science research and clinical research to investigate the
pathology of the human immune response following tick bites (e.g.,
Alpha-gal Syndrome [AGS]).
<bullet> TBDWG 2020 5.2 Support the targeted funding of research to
understand the role of persistence of bacteria and bacterial products
in the pathogenesis and management of Lyme disease (e.g., antibiotic
regimens and other therapeutics).
<bullet> TBDWG 2020 5.3 Support targeted funding opportunities for
research to better inform the diagnosis, pathogenesis, and management
of Lyme carditis.
<bullet> TBDWG 2020 8.1 Fund prospective studies of acute febrile
illnesses to assess the burden of tick-borne diseases, including
rickettsial, ehrlichial, and anaplasmal pathogens.
<bullet> TBDWG 2020 8.3 Further evaluation of non-tick bite
transmission of Lyme disease, for example maternal-fetal transmission.
<bullet> TBDWG 2020 9.2 DoD: Recommend that the DoD enhance inter-
agency communication and collaboration to study Lyme disease and other
tick-borne diseases.
<bullet> TBDWG 2020 9.4 NIH: Recommend that the NIH create one or
more study sections composed of members whose expertise is human
clinical diseases and their pathogenesis and immunity not just basic
science to evaluate applications focused on practical impact on human
health related to tick-borne diseases.
[[Page 70846]]
<bullet> TBDWG 2020 9.5 NIH: Recommend that NIH receive additional
funding which must be dedicated to study Lyme disease including
persistent Lyme disease and other tick-borne diseases and conditions;
and they encourage researchers to apply for these studies.
Goal 2: Develop, evaluate, and improve tools and guidance for the
diagnosis and detection of vector-borne diseases.
Strategic Priority 1: Identify and characterize novel VBD pathogens
and their clinical manifestations.
<bullet> TBDWG 2018 3.2 Fund systematic studies and activities to
identify and characterize novel tick-borne disease agents in the United
States.
<bullet> TBDWG 2020 4.3 Establish and fund research for sensitive
and specific diagnostic tests for the broader range of tick-borne
diseases, including tick-borne relapsing fever, Powassan virus, and
other emerging tick-borne pathogens. Encourage development of these
tests as in vitro diagnostics approved by FDA.
Strategic Priority 2: Develop, evaluate, and improve diagnostic
tests for VBDs.
<bullet> TBDWG 2018 5.1 Evaluate new technology or approaches for
the diagnosis of Lyme disease and other tick-borne diseases.
<bullet> TBDWG 2018 5.2 Include special populations, especially
children, in Lyme disease and other tick-borne diseases diagnostic
studies.
<bullet> TBDWG 2020 4.2 Establish and fund research for sensitive
and specific diagnostic tests for acute rickettsial, ehrlichial, and
anaplasmal diseases. Encourage development of these tests as in vitro
diagnostics approved by FDA.
<bullet> TBDWG 2020 4.3 Establish and fund research for sensitive
and specific diagnostic tests for the broader range of tick-borne
diseases, including tick-borne relapsing fever, Powassan virus, and
other emerging tick-borne pathogens. Encourage development of these
tests as in vitro diagnostics approved by FDA.
<bullet> TBDWG 2020 5.3 Support targeted funding opportunities for
research to better inform the diagnosis, pathogenesis, and management
of Lyme carditis.
Strategic Priority 3: Develop and evaluate evidence-based
recommendations and guidelines on VBD diagnosis in humans.
Strategic Priority 4: Develop, maintain, and distribute non-
commercial diagnostic resources to facilitate VBD testing.
Goal 3: Develop, evaluate, and improve tools and guidance for the
prevention and control of vector-borne diseases.
<bullet> TBDWG 2018 7.2 Allocate increased funding for tick-borne
disease in the areas of research, treatment, and prevention
proportional to the burden of illness and need.
Strategic Priority 1: Develop, evaluate, and improve safe and
effective VBD prevention tools such as vaccines, vector control
strategies, and health communication tools and products that are
tailored for communities that are disproportionately affected.
<bullet> TBDWG 2018 4.1 Fund additional studies and activities on
the development and evaluation of novel and traditional tick-control
methods that have shown promise in other areas of public health
entomology.
<bullet> TBDWG 2018 4.2 Build trust via a transparent mechanism by
which all stakeholders examine and discuss past vaccine activities and
potential adverse events to inform future vaccine development in Lyme
disease.
<bullet> TBDWG 2018 4.3 Support the development of safe and
effective human vaccines to prevent Lyme disease with transparent
mechanisms by which all stakeholders examine and discuss past vaccine
activities and potential adverse events to inform future vaccine
development.
<bullet> TBDWG 2018 8.3 DoD: Commence study of tick-borne disease
incidence and prevalence of active duty Servicemembers and their
dependents. Compile data on the impact of tick-borne diseases on
military readiness. Create education and preparedness programs that
specifically address the unique risks faced by Servicemembers in
training and on deployment and by their families
<bullet> TBDWG 2018 8.5 Develop and disseminate more comprehensive
clinician education that highlights diverse symptomology, expanding
geography of infecting ticks, and limitations of current testing
procedure. In developing the curriculum, include diverse stakeholder
groups, including clinicians, research scientists, and patients who
represent the spectrum of scientific and medical expertise and
perspectives on tick-borne disease.
<bullet> TBDWG 2020 6.2 Conduct laboratory, clinical, and field
research to address gaps in our capacity to treat and prevent the
broader range of tick-borne diseases, including particularly
babesiosis, tick-borne relapsing fever, Powassan virus infection, and
other low-incidence tick-borne diseases.
<bullet> TBDWG 2020 7.5 Generate broad awareness of Alpha-gal
Syndrome through the following two mechanisms:
[cir] Label foods/beverages, medications and medical products,
cosmetics, etc. containing mammalian-derived components for the safety
of consumers with Alpha-gal Syndrome.
Strategic Priority 2: Develop and evaluate data-driven and adaptive
predictive models and decision support tools for VBDs.
Strategic Priority 3: Develop and evaluate evidence-based
recommendations and guidelines on VBD prevention.
<bullet> TBDWG 2020 6.2 Conduct laboratory, clinical, and field
research to address gaps in our capacity to treat and prevent the
broader range of tick-borne diseases, including particularly
babesiosis, tick-borne relapsing fever, Powassan virus infection, and
other low-incidence tick-borne diseases.
Strategic Priority 4: Develop and evaluate tools and processes for
responding to public health emergencies.
<bullet> TBDWG 2018 8.1 NIH: Create an NIH tick-borne disease
strategic plan, with public input during creation and implementation,
to address tick-borne diseases, including all stages of Lyme disease.
Include in the strategic plan the coordination of research funding
across NIAID, NINDS, NIAMS, and NIMH to increase knowledge of
pathogenesis, improve diagnosis, and develop and test new therapeutics
for tick-borne diseases. Update every five years.
Goal 4: Develop and assess drugs and treatment strategies for VBDs.
<bullet> TBDWG 2018 7.2 Allocate increased funding for tick-borne
disease in the areas of research, treatment, and prevention
proportional to the burden of illness and need.
Strategic Priority 1: Identify, develop, and evaluate safe and
effective drugs and treatment strategies (regimens) for VBDs.
<bullet> TBDWG 2018 6.3 Improve the education and research on
transmission (including transmission via the blood supply and
pregnancy) and treatment of other tick-borne diseases and coinfections.
<bullet> TBDWG 2018 6.4 Conduct additional clinical trials
appropriate to the target populations where gaps may exist.
<bullet> TBDWG 2020 5.2 Support the targeted funding of research to
understand the role of persistence of bacteria and bacterial products
in the pathogenesis and management of Lyme disease (e.g., antibiotic
regimens and other therapeutics).
<bullet> TBDWG 2020 5.3 Support targeted funding opportunities for
research to better inform the diagnosis, pathogenesis, and management
of Lyme carditis.
<bullet> TBDWG 2020 6.1 Encourage clinical trials on early and
persistent Lyme disease.
[[Page 70847]]
<bullet> TBDWG 2020 6.2 Conduct laboratory, clinical, and field
research to address gaps in our capacity to treat and prevent the
broader range of tick-borne diseases, including particularly
babesiosis, tick-borne relapsing fever, Powassan virus infection, and
other low-incidence tick-borne diseases.
Strategic Priority 2: Develop evidence-based recommendations and
guidelines on the treatment and management of VBDs.
<bullet> TBDWG 2020 6.2 Conduct laboratory, clinical, and field
research to address gaps in our capacity to treat and prevent the
broader range of tick-borne diseases, including particularly
babesiosis, tick-borne relapsing fever, Powassan virus infection, and
other low-incidence tick-borne diseases.
Strategic Priority 3: Evaluate drug and treatment use patterns.
Goal 5: Disseminate and support the implementation of effective
public health products, tools, programs, collaborations, and
innovations to prevent, detect, diagnose, and respond to VBD threats.
<bullet> TBDWG 2018 7.2 Allocate increased funding for tick-borne
disease in the areas of research, treatment, and prevention
proportional to the burden of illness and need.
Strategic Priority 1: Disseminate evidence-based information about
VBD prevention and control, guidelines, and recommendations to partners
and the public.
<bullet> TBDWG 2018 3.5 The Lyme disease surveillance criteria are
not to be used alone for diagnostic purposes; public health authorities
shall annually and when opportune (such as during Tick-Borne Disease
Awareness Month) communicate this and inform doctors, insurers, state
and local health departments, the press, and the public through
official communication channels, including the CDC's Morbidity and
Mortality Weekly Report (MMWR).
<bullet> TBDWG 2018 4.4 Prioritize education by informing
clinicians and the general public about the regional and specific risks
related to tick-borne diseases.
<bullet> TBDWG 2018 6.3 Improve the education and research on
transmission (including transmission via the blood supply and
pregnancy) and treatment of other tick-borne diseases and coinfections.
<bullet> TBDWG 2018 6.5 Improve the education and research on the
pathogenesis of alpha-gal allergy, also known as the tick-caused ``meat
allergy.''
<bullet> TBDWG 2018 7.1 Create a Federal repository for information
on Lyme disease and other tick-borne diseases.
<bullet> TBDWG 2018 7.7c Testing and Diagnostic Bands: How They Are
Used Today and What That Is Doing to Patients: Relay Information as a
Neutral Knowledge Broker
<bullet> TBDWG 2018 8.5 Develop and disseminate more comprehensive
clinician education that highlights diverse symptomology, expanding
geography of infecting ticks, and limitations of current testing
procedure. In developing the curriculum, include diverse stakeholder
groups, including clinicians, research scientists, and patients who
represent the spectrum of scientific and medical expertise and
perspectives on tick-borne disease.
<bullet> TBDWG 2020 3.3 Provide funding to support CDC-directed
expanded tick surveillance and promoting the development and
implementation of best practices for integrated tick management
capturing human tick bite events, and streamlining education, training,
and coordination amongst relevant Federal, state, and local agencies.
<bullet> TBDWG 2020 7.1 Recommend Federal government websites and
educational materials and seminars for clinicians, the public, and
public health departments, which discuss Lyme disease, provide
information that the state of the science relating to persistent
symptoms associated with Lyme disease, is limited, emerging, and
unsettled; and increase public awareness that there are divergent views
on diagnosis and treatment. Consider that shared medical decision-
making may be appropriate in some circumstances.
<bullet> TBDWG 2020 7.2 Fund and support a directive for CDC (or
other appropriate HHS OPDIV or agency) to develop (either directly or
through an approved federal contract) a multi-leveled and nationwide
curriculum on Lyme disease for clinicians-in-training as well as
continuing medical education modules to increase the pool of qualified
and practicing clinicians. Provide funding for the U.S. military to
participate in this nationwide training and education on Lyme disease
and other tick-borne diseases and conditions. This curriculum should be
introduced and encouraged at the State level. The final curriculum
shall incorporate feedback from patients, clinicians, and research
scientists with expertise/experience that represents diverse scientific
and clinical experiences on the full spectrum of Lyme disease and other
tick-borne diseases/conditions.
<bullet> TBDWG 2020 7.3 Fund efforts across the U.S. to expand/
require medical education to inform emergency, primary care, and other
healthcare providers and to raise clinician and public awareness of
rickettsial (including Rocky Mountain spotted fever), ehrlichial, and
anaplasmal diseases.
<bullet> TBDWG 2020 7.4 Fund efforts across the U.S. to expand/
require medical education to inform emergency, primary care, and other
healthcare providers and to raise clinician and public awareness of
babesiosis, tick-borne relapsing fever, emerging tick-borne viral
infections, and other low-incidence tick-borne diseases.
<bullet> TBDWG 2020 7.5 Generate broad awareness of Alpha-gal
Syndrome through the following two mechanisms:
[cir] Provide funding/support/resources necessary to create a
National Tick-Borne Alpha-gal Syndrome Alert that is focused on
awareness, prevention, and education regarding tick associated Alpha-
gal Syndrome and that targets key stakeholder groups.
<bullet> TBDWG 2020 9.1 VA: Recommend that the VA continue with
Recommendation 8.4 from 2018 Working Group report, ``Commence study of
tick-borne disease incidence and prevalence of Veterans and eligible
family members'' and additionally
[cir] Make educational modules available to practitioners.
<bullet> TBDWG 2020 9.3 CDC: Recommend that if the CDC posts any
Lyme treatment guidelines, that they include guidelines on persistent
Lyme Disease.
Strategic Priority 2: Ensure current and future capacity to
implement and adequately and equitably scale safe, effective, and
publicly accepted VBD prevention and control programs.
<bullet> TBDWG 2020 3.2 Minimize the public health threat of Lyme
disease and other tickborne diseases through special funding for
integrated tick management, disruption of tick biological processes
contributing to pathogen transmission, and the support of public/
private partnerships to develop and promote area-wide tick control
strategies.
<bullet> TBDWG 2020 3.3 Provide funding to support CDC-directed
expanded tick surveillance and promoting the development and
implementation of best practices for integrated tick management
capturing human tick bite events, and streamlining education, training,
and coordination amongst relevant Federal, state, and local agencies.
Strategic Priority 3: Monitor and evaluate evidence-based public
health programs and tools.
[[Page 70848]]
<bullet> TBDWG 2018 7.7b Testing and Diagnostic Bands: How They Are
Used Today and What That Is Doing to Patients: Engage Diverse
Stakeholders--Update the CSTE Surveillance Case Definition with 21st-
Century Evidence
<bullet> TBDWG 2020 3.1 Implement multi-agency, ecologically-based
One Health efforts on tick-borne diseases promoting research and
enhanced vector surveillance to identify and validate integrated tick
management in keystone wildlife hosts, particularly white-tailed deer,
and the sustainable management of their populations.
<bullet> TBDWG 2020 8.2 Recommend that CDC work with Council of
State and Territorial Epidemiologists (CSTE) to streamline the
surveillance process and to reduce the burden on both clinicians and
public health departments by permitting direct laboratory reporting of
positive cases.
Strategic Priority 4: Respond to Public Health emergencies
resulting from VBD threats.
Strategic Priority 5: Clarify, facilitate, and improve processes to
bring regulated diagnostic tests, treatment strategies, vaccines, and
vector control products to market.
Although critical to public health and wellness, the following
recommendations related to healthcare utilization, access to care,
reimbursement or payment for clinical services, and legal protections
are outside the scope of this prevention and control strategy:
<bullet> TBDWG 2018 3.3 Support economic studies and activities to
estimate the total cost of illness associated with tick-borne diseases
in the United States, beginning first with Lyme disease and including
both financial and societal impacts.
<bullet> TBDWG 2018 7.3 Ensure the rights of those dealing with
Lyme disease and tick-borne diseases and conditions by reducing the
burden of the processes under which patients are currently diagnosed
and treated and by which they access care. Basic protections must
include, but not necessarily be limited to, those that protect patients
from employment discrimination.
<bullet> TBDWG 2018 7.4 Ensure the rights of those dealing with
Lyme disease and tick-borne diseases and conditions by reducing the
burden of the processes under which patients are currently diagnosed
and treated and by which they access care. Basic protections must
include, but not necessarily be limited to, those that protect students
of all ages from discrimination.
<bullet> TBDWG 2018 7.5 Ensure the rights of those dealing with
Lyme disease and tick-borne diseases and conditions by reducing the
burden of the processes under which patients are currently diagnosed
and treated and by which they access care. Basic protections must
include, but not necessarily be limited to, those that protect patients
from health care and disability insurance coverage and reimbursement
policies that are unduly burdensome.
<bullet> TBDWG 2018 7.6 Ensure the rights of those dealing with
Lyme disease and tick-borne diseases and conditions by reducing the
burden of the processes under which patients are currently diagnosed
and treated and by which they access care. Basic protections must
include, but not necessarily be limited to, those that protect the
rights of licensed and qualified clinicians to use individual clinical
judgment, as well as recognized guidelines, to diagnose and treat
patients in accordance with the needs and goals of each individual
patient.
<bullet> TBDWG 2020 9.6 CMS: Recommend that CMS provides all
information and data on Lyme disease and other tick-borne diseases and
all applicable agency activities pertaining to these conditions which
may include but should not be limited to:
[cir] Reimbursement costs for the diagnosis and treatment of
beneficiaries with Lyme disease and other tick-borne diseases;
[cir] Demonstration and pilot projects with Lyme disease and other
tick-borne diseases as their focus; and
[cir] Quality measure development and implementation related to
Lyme disease and other tick-borne diseases.
[FR Doc. 2022-25241 Filed 11-18-22; 8:45 am]
BILLING CODE 4150-28-P
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</html>Indexed from Federal Register on November 21, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.