[Federal Register Volume 87, Number 223 (Monday, November 21, 2022)]
[Notices]
[Pages 70836-70848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 http://www.regulations.gov. 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 https://www.regulations.gov/help.

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, 
[email protected], (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: http://www.regulations.gov. 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:
     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.
     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.
     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.
     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.
     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.
 Sub-objective 1: Develop animal     DOI.
 and vector models for VBD research.         DOD.
 Sub-objective 2: Identify key
 animal reservoirs for vector-borne
 pathogens.
 Sub-objective 3: Identify the
 factors associated with the ability of
 vectors to effectively transmit pathogens
 to humans.
     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.
 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.
 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).
 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.
 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. https://www.cdc.gov/surveillance/projects/dmi-initiative/.

  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:
 Sub-objective 1: Identify existing
 complementary public and private
 surveillance systems.
 Sub-objective 2: Evaluate existing
 surveillance systems to identify gaps both
 within and across systems.
 Sub-objective 3: Address
 surveillance gaps within and across
 existing surveillance systems.
     Sub-objective 4: Increase
     usability of surveillance data by
     expanding data access and timeliness
     and enhancing data visualizations of
     data from VBD systems.
     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.
 Sub-objective 1: Identify           USGS.
 opportunities for and challenges to
 increase the integration of and data
 sharing across surveillance systems.
 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. https://www.cdc.gov/socialdeterminants/about.html.
    \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. https://www.cdc.gov/nccdphp/dnpao/state-local-programs/built-environment-assessment/index.htm.

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.
 Sub-objective 1: Determine the
 social determinants of health \2\ and
 associated with human exposure to VBD
 pathogens.
 Sub-objective 2: Determine the
 environmental factors, including the built
 environment,\3\ associated with human
 exposure to VBD pathogens.
     Sub-objective 3: Determine the
     knowledge, attitudes, and behaviors
     influencing and impacting human
     exposure to VBD pathogens, including
     differences among population groups.
     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:
 Sub-objective 1: Describe the
 disease processes, progression, and
 clinical outcomes associated with priority
 VBDs, including symptom persistence.
     Sub-objective 2: Describe the
     frequency and effect of VBD co-
     infections on diagnosis, treatment,
     and clinical outcomes.
     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]]

 
     Sub-objective 1: Describe the
     epidemiology of VBDs, including social
     determinants of health.\2\
     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.
 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).
 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.
     Sub-objective 3: Describe the
     knowledge gaps related to newly
     identified pathogens that pose a risk
     to human health.
     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.
 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.
     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).
 Sub-objective 1: Determine the      DOD.
 specimen types that provide optimal         USDA.
 diagnostic performance.
 Sub-objective 2: Develop pathogen-
 detection tests, including more rapid
 tests, within 1 year of identifying a
 novel pathogen.
     Sub-objective 3: Develop
     serologic tests and, when applicable,
     biomarker tests within 1 year of
     identifying a novel pathogen.
     Sub-objective 4: Investigate
     new methods for pathogen detection as
     new technologies advance.
     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.
 Sub-objective 1: Develop pathogen-
 detection tests that significantly improve
 test accuracy, precision, efficiency,
 performance, and/or speed.
     Sub-objective 2: Develop
     serologic tests that significantly
     improve test accuracy, precision,
     efficiency, performance, and/or speed.
     Sub-objective 3: Investigate
     new methods (e.g., for detecting
     biomarkers) for detecting existing
     vector-borne pathogens as new
     technologies advance.
     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:
     Sub-objective 1: Develop,
     maintain, and disseminate panels for
     use in evaluations of diagnostic
     tests.
     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:
 Sub-objective 1: Establish a
 surveillance case definition for each VBD
 caused by a novel pathogen within 1 year
 of its identification.
 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.
 Sub-objective 1: Continuously
 monitor emerging science that informs the
 diagnosis of VBDs.
 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:
     Sub-objective 1: Identify
     reagents that need to be developed.
     Sub-objective 2: Identify
     reagents that require production to
     complement commercial resources.
     Sub-objective 3: Inventory
     supplies of diagnostic resources
     (e.g., reagents, standards, and
     biospecimens) available for VBD
     pathogens of concern.
     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:
     Sub-objective 1: Design and
     implement a decision process to
     prioritize VBDs for vaccine
     development.
     Sub-objective 2: Identify key
     potential challenges to and
     opportunities for successful
     development of vaccines.
     Sub-objective 3: Facilitate
     partnerships across sectors, including
     with communities who are
     disproportionately affected, for
     vaccine development.
     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:
     Sub-objective 1: Evaluate the
     factors that make vectors more or less
     susceptible to vector control tools.
     Sub-objective 2: Design and
     implement a decision process to
     prioritize vector control tools for
     development.
     Sub-objective 3: Identify key
     potential challenges to and
     opportunities for successful
     development of novel vector control
     tools.
     Sub-objective 4: Facilitate
     partnerships across sectors for vector
     control tool development.
     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:
     Sub-objective 1: Conduct
     formative research to inform the
     development of public health
     communication tools and products.
     Sub-objective 2: Develop
     appropriate outreach strategies as
     informed by formative research.

[[Page 70841]]

 
     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).
     Sub-objective 1: Elicit and
     prioritize decision-maker needs and
     requirements for decision-support
     tools.
     Sub-objective 2: Prioritize
     VBDs for the development of predictive
     models and decision support tools.
     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).
     Sub-objective 1: Evaluate the
     accuracy and utility of predictive
     models and decision support tools.
     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.
     Sub-objective 1: Regularly
     update recommendations and guidelines
     based on the state of the science.
     Sub-objective 2: Identify and
     prioritize VBDs for which new
     recommendations and guidelines are
     needed.
     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.
     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:
     Sub-objective 1: Develop,
     maintain, and exercise preparedness
     and emergency response plans,
     including partner engagement
     strategies.
     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:
     Sub-objective 1: Develop key
     messages and tools to effectively
     communicate health information in a
     way that is inclusive of all
     communities.
     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:
     Sub-objective 1: Conduct and
     support tabletop exercises integrating
     multiple sectors and community
     partners as appropriate.
     Sub-objective 2: Conduct and
     support after action reviews and
     develop reports.
     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:
     Sub-objective 1: Identify and   DOD.
     characterize new molecular targets for
     therapeutics for priority VBDs.
     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:
     Sub-objective 1: Optimize
     existing therapeutic strategies for
     VBDs.
     Sub-objective 2: Optimize
     therapeutic strategies repurposed for
     VBDs..
     Sub-objective 3: Evaluate
     complementary and integrative health
     therapies for safety and efficacy..
     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:
     Sub-objective 1: Assess
     treatment strategies for extended or
     long-term symptoms associated with
     VBDs.
     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:
     Sub-objective 1: Coordinate
     expert review of the evidence to
     inform revisions of federally
     developed recommendations and
     guidelines.
     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:
     Sub-objective 1: Coordinate
     expert review of the evidence to
     inform the development of new
     federally developed recommendations
     and guidelines.
     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:
     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:
     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):
     Sub-objective 1: Tailor
     dissemination of products and tools
     based on audience needs.
     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:
     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.
     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:
     Sub-objective 1: Provide
     support to jurisdictions, Tribes, and
     partners to implement effective VBD
     programs, including providing staffing
     support.
     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:
     Sub-objective 1: Assess and     USDA.
     monitor training needs on evidence-
     based information, guidelines, and
     recommendations.
     Sub-objective 2: Provide
     trainings on evidence-based
     information, guidelines, and
     recommendations.
     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:
     Sub-objective 1: Monitor the
     implementation of programs and tools
     over time and across communities.
     Sub-objective 2: Collaborate
     with implementers to evaluate
     acceptability, suitability,
     effectiveness, and sustainability of
     Public Health programs and tools..
     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]]

 
     Sub-objective 1: Regularly
     review and update Public Health
     products, tools, and guidance based on
     findings from program evaluations.
     Sub-objective 2: Disseminate
     updated Public Health products, tools,
     and guidance as warranted..
     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:
     Sub-objective 1: Provide        USDA.
     laboratory testing for state, tribal,
     local, and territorial jurisdictions.
     Sub-objective 2: Deploy staff   FEMA.
     to support local response efforts (for
     example, vector surveillance and
     vector control) when requested by
     jurisdictions and Tribes.
     Sub-objective 3: Disseminate
     Public Health messaging to support
     local response efforts.
     Sub-objective 4: Disseminate
     data that identifies
     disproportionately affected
     populations.
     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:
     Sub-objective 1: Support
     implementation of local preparedness
     and emergency response plans.
     Sub-objective 2: Provide
     direct technical assistance to
     jurisdictions in the implementation of
     their emergency response plans..
     Sub-objective 3: Make medical
     countermeasures and VBD prevention and
     control tools available and ensure
     equitable access and distribution..
     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:
     Sub-objective 1: Develop        EPA.
     communication strategies that clearly
     articulate the regulatory process.
     Sub-objective 2: Provide        USDA.
     direction to applicants in their
     submission and response to regulatory
     process requirements.
     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:
     Sub-objective 1: Conduct
     regulatory science to ensure that
     regulatory knowledge gaps are
     identified for new and emerging
     technologies.
     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).
     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.
     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.
     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.
     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.
     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.
     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.
     TBDWG 2018 7.7a Testing and Diagnostic Bands: How They Are 
Used Today and What That Is Doing to Patients: Empower Patients with 
Data
     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.
     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.
     TBDWG 2018 8.4 VA: Commence study of tick-borne disease 
incidence and prevalence of Veterans and eligible family members.
     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.
     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.
     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).
     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).
     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.
     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;
     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.
     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.
     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.
     TBDWG 2018 6.5 Improve the education and research on the 
pathogenesis of alpha-gal allergy, also known as the tick-caused ``meat 
allergy.''
     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.
     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.
     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]).
     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).
     TBDWG 2020 5.3 Support targeted funding opportunities for 
research to better inform the diagnosis, pathogenesis, and management 
of Lyme carditis.
     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.
     TBDWG 2020 8.3 Further evaluation of non-tick bite 
transmission of Lyme disease, for example maternal-fetal transmission.
     TBDWG 2020 9.2 DoD: Recommend that the DoD enhance inter-
agency communication and collaboration to study Lyme disease and other 
tick-borne diseases.
     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]]

     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.
     TBDWG 2018 3.2 Fund systematic studies and activities to 
identify and characterize novel tick-borne disease agents in the United 
States.
     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.
     TBDWG 2018 5.1 Evaluate new technology or approaches for 
the diagnosis of Lyme disease and other tick-borne diseases.
     TBDWG 2018 5.2 Include special populations, especially 
children, in Lyme disease and other tick-borne diseases diagnostic 
studies.
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     TBDWG 2018 6.4 Conduct additional clinical trials 
appropriate to the target populations where gaps may exist.
     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).
     TBDWG 2020 5.3 Support targeted funding opportunities for 
research to better inform the diagnosis, pathogenesis, and management 
of Lyme carditis.
     TBDWG 2020 6.1 Encourage clinical trials on early and 
persistent Lyme disease.

[[Page 70847]]

     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.
     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.
     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.
     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).
     TBDWG 2018 4.4 Prioritize education by informing 
clinicians and the general public about the regional and specific risks 
related to tick-borne diseases.
     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.
     TBDWG 2018 6.5 Improve the education and research on the 
pathogenesis of alpha-gal allergy, also known as the tick-caused ``meat 
allergy.''
     TBDWG 2018 7.1 Create a Federal repository for information 
on Lyme disease and other tick-borne diseases.
     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
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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.
     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]]

     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
     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.
     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:
     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.
     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.
     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.
     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.
     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.
     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