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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 220 Introduced in House (IH)]

<DOC>

116th CONGRESS
  1st Session
                                H. R. 220

To provide for a national strategy to address and overcome Lyme disease 
         and other tick-borne diseases, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            January 3, 2019

  Mr. Smith of New Jersey (for himself, Mr. Peterson, Mr. Posey, Ms. 
 Stefanik, Mr. Fitzpatrick, Mr. Sires, Ms. Pingree, and Mrs. Hartzler) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
To provide for a national strategy to address and overcome Lyme disease 
         and other tick-borne diseases, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``National Lyme and Tick-Borne 
Diseases Control and Accountability Act of 2019''.

SEC. 2. OFFICE OF OVERSIGHT AND COORDINATION FOR TICK-BORNE DISEASES.

    (a) Establishment.--The Secretary of Health and Human Services 
shall establish in the Office of the Secretary the Office of Oversight 
and Coordination for Tick-Borne Diseases, to be headed by a director 
appointed by the Secretary--
            (1) to oversee the creation and updating of an integrated 
        national strategy to overcome Lyme disease and other tick-borne 
        diseases; and
            (2) to oversee and coordinate Lyme disease and other tick-
        borne disease programs and activities across the agencies and 
        offices of the Department of Health and Human Services.
    (b) Objective of Office.--In carrying out subsection (a), the 
Director of the Office shall facilitate and work to ensure 
accomplishment of the following activities:
            (1) Expansion and enhancement of epidemiological research 
        and basic, translational, and clinical biological and 
        biomedical research.
            (2) Expansion and improvement of the surveillance and 
        reporting of Lyme disease and other tick-borne disease, 
        including coinfections with agents of more than one tick-borne 
        disease.
            (3) Development of effective diagnostic tests to accurately 
        and timely diagnose Lyme disease and other tick-borne disease, 
        including direct detention tests.
            (4) Development of treatments to cure or improve the lives 
        of those who are infected with Lyme disease or other tick-borne 
        disease or who suffer from a tick-induced disorder.
            (5) Design and conduct of clinical trials of sufficient 
        size and duration to support clinical recommendations.
            (6) Development and maintenance of one or more registries 
        of patients and their experiences relating to exposure to, 
        diagnosis for, and treatment of tick-borne disease, including 
        outcomes, which registries shall protect the confidentiality 
        and safety of patient data.
            (7) Systematic documentation of the experiences of health 
        care professionals in diagnosing and treating tick-borne 
        disease, including diagnostic and treatment outcomes.
            (8) Inclusion of individuals with chronic Lyme disease in 
        clinical, research, and service efforts.
            (9) Coordination with international bodies to integrate and 
        inform the fight against Lyme disease and tick-borne disease 
        globally.
    (c) Integration of Tick-Borne Disease Working Group Findings and 
Recommendations.--In carrying out this section, the Director of the 
Office shall, as directed by the Secretary, with any modifications made 
by and as otherwise determined appropriate by the Secretary, oversee 
and coordinate integration and implementation, into the activities of 
the Office and the activities and programs of the agencies and offices 
of the Department of Health and Human Services, of the recommendations 
to the Secretary and the findings and conclusions in the latest report 
of the Tick-Borne Disease Working Group submitted to the Secretary and 
congressional committees.
    (d) Priority Based on Disease Burden.--In carrying out this 
section, the Director of the Office shall give priority to Lyme disease 
and other tick-borne disease based on assessments of disease burden in 
the United States.

SEC. 3. NATIONAL STRATEGY.

    (a) In General.--The Secretary, in coordination with the Director 
of the Office, and in consultation with the Tick-Borne Disease Working 
Group, the agencies and offices of the Department of Health and Human 
Services, and other Federal agencies outside of the Department of 
Health and Human Services as appropriate, shall--
            (1) not later than 2 years after the date of enactment of 
        this Act, develop and submit to the Congress a national 
        strategy for the conduct and support of Lyme disease and other 
        tick-borne disease or disorder programs and activities; and
            (2) not less than every 2 years thereafter, update such 
        strategy.
    (b) Contents.--The strategy under subsection (a) shall include--
            (1) proposed budgetary requirements;
            (2) an assessment of all federally funded programs and 
        activities related to surveillance, diagnosis, treatment, 
        education, or prevention with respect to Lyme disease or other 
        tick-borne disease, an evaluation of progress and performance 
        based on mission and purpose, and a description of significant 
        challenges or barriers to performance, including an assessment 
        of Federal grants awarded;
            (3) a strategy for improving diagnosis, treatment, and 
        prevention, including increasing the impact of grants awarded 
        by the National Institutes of Health, the Centers for Disease 
        Control and Prevention, and other agencies and offices of the 
        Department of Health and Human Services;
            (4) a strategy for improving outcomes of individuals with 
        Lyme disease or another tick-borne disease or disorder, 
        including progress related to chronic or persistent symptoms 
        and chronic or persistent infection and coinfections, including 
        plans for evaluating the potential value of and supporting the 
        conduct of observational studies, comparative effectiveness 
        research, patient-centered outcomes research, or other real 
        world evidence;
            (5) the appropriate benchmarks to measure progress in 
        achieving the improvements described in paragraphs (3) and (4);
            (6) a strategy for improving interactions, coordination, 
        and partnerships with other Federal agencies, State and local 
        governments, and global entities; and
            (7) the latest recommendations of the Tick-Borne Disease 
        Working Group and the steps taken by the agencies and offices 
        of the Department of Health and Human Services to implement 
        those recommendations.

SEC. 4. FEDERAL ACTIVITIES RELATED TO THE DIAGNOSIS, SURVEILLANCE, AND 
              PREVENTION OF, AND RESEARCH ON, LYME DISEASE AND OTHER 
              TICK-BORNE DISEASES AND DISORDERS.

    (a) In General.--The Secretary, in coordination with the Director 
of the Office, acting as the Secretary determines appropriate through 
the Director of the Centers for Disease Control and Prevention, the 
Director of the National Institutes of Health, the Commissioner of Food 
and Drugs, the Director of the Agency for Healthcare Research and 
Quality, the Administrator of the Health Resources and Services 
Administration, the Director of the Indian Health Service, and the 
heads of other Federal agencies, and in consultation with the Tick-
Borne Disease Working Group, shall provide for--
            (1) the conduct or support of the activities described in 
        paragraphs (1) through (8) of subsection (b); and
            (2) the coordination of all programs and activities of the 
        Department of Health and Human Services related to Lyme disease 
        and other tick-borne diseases and disorders and Bartonella.
    (b) Activities.--The activities to be conducted or supported under 
subsection (a)(1) consist of the following:
            (1) Expansion and enhancement of research.--
                    (A) In general.--The Secretary shall expand and 
                intensify epidemiological, basic, translational, and 
                clinical research regarding Lyme disease and other 
                tick-borne disease and disorders and bartonellosis to 
                better understand--
                            (i) the pathophysiology of Borrelia 
                        burgdorferi and other tick-borne microorganisms 
                        that are human pathogens and of Bartonella;
                            (ii) pathophysiological changes over time, 
                        including pathogen persistence profiles for 
                        patients with differing treatment histories;
                            (iii) activation and deactivation of immune 
                        system processes; and
                            (iv) whether, and what species of, 
                        Bartonella are transmitted by ticks.
                    (B) Clinical outcomes research.--The Secretary 
                shall conduct or support clinical outcomes research 
                to--
                            (i) establish epidemiological research 
                        objectives to determine the long-term course of 
                        illness for Lyme disease and other tick-borne 
                        diseases and disorders;
                            (ii) establish patient-centered treatment 
                        outcome objectives to allow for the comparative 
                        effectiveness of different treatment 
                        modalities; and
                            (iii) establish patient-centered research 
                        objectives to help elucidate promising 
                        treatment protocols for individuals suspected 
                        of harboring coinfections with more than one 
                        tick-transmitted pathogen.
                    (C) Collaborative, multidisciplinary research.--The 
                Secretary shall encourage the solicitation of proposals 
                for collaborative, multidisciplinary research that 
                would--
                            (i) result in innovative approaches to 
                        study emerging scientific opportunities or 
                        eliminate gaps in research to improve the 
                        research portfolio, including application of 
                        successful and promising advances in the study 
                        of other types of diseases, such as 
                        upregulating or downregulating immune system 
                        cells or processes;
                            (ii) outline key research questions, 
                        methodologies, and knowledge gaps;
                            (iii) expand the number of research 
                        proposals that involve collaboration between 2 
                        or more national research institutes or 
                        national centers of the National Institutes of 
                        Health, including proposals for research 
                        through the Common Fund pursuant to section 
                        402(b)(7) of the Public Health Service Act (42 
                        U.S.C. 282(b)(7)) to improve the research 
                        portfolio;
                            (iv) expand the number of collaborative 
                        multi-institutional research grants related to 
                        tick-borne disease; and
                            (v) involve additional national research 
                        institutes and national centers of the National 
                        Institutes of Health in intramural and 
                        extramural research on tick-borne disease, such 
                        as the National Institute of Neurological 
                        Disorders and Stroke conducting or sponsoring 
                        research on neurologic Lyme disease.
                    (D) Evaluation.--Not later than 2 years after the 
                date of enactment of this Act, the Secretary shall 
                evaluate and make findings on--
                            (i) the feasibility and potential value to 
                        the research community of establishing a 
                        deidentified human subjects database for Lyme 
                        disease and other tick-borne diseases and 
                        disorders;
                            (ii) existing government or private 
                        biorepositories for Lyme disease and other 
                        tick-borne diseases and disorders and whether--
                                    (I) specimens and samples are 
                                adequate and available to meet 
                                researcher needs; or
                                    (II) there are problems or 
                                challenges for researcher acquisition 
                                of samples and specimens; and
                            (iii) the scope and use of specimens and 
                        samples from cadavers, the questions and 
                        answers such research may provide, and the need 
                        for additional support of researchers using 
                        cadaver specimens.
                    (E) Priority.--In carrying out this paragraph, the 
                Secretary shall make it a priority to determine the 
                extent of posttreatment persistence of Borrelia 
                burgdorferi and the clinical significance of such 
                persistence.
            (2) Development of new and improved diagnostic tests.--
                    (A) In general.--The Secretary, in cooperation with 
                the Director of the Office, and acting through the 
                Directors of the Centers for Disease Control and 
                Prevention and the Director of the National Institutes 
                of Health, shall conduct and support research to--
                            (i) provide for the timely evaluation of 
                        promising new and improved diagnostic methods, 
                        including direct-detection tests, antibody-
                        based tests, and tests based on biosignature 
                        and biomarker profiles to make a specific 
                        diagnosis or aid in differential diagnoses;
                            (ii) improve the sensitivity of Lyme 
                        disease tests at all stages of disease 
                        progression;
                            (iii) develop a Lyme disease test capable 
                        of distinguishing between past and active 
                        infections;
                            (iv) improve timely, sensitive, and 
                        specific diagnostic tools and tests for Rocky 
                        Mountain spotted fever; and
                            (v) improve the performance (timeliness and 
                        accuracy) of tools and tests for other tick-
                        borne diseases found in the United States.
                    (B) Strategies for expediting clearance.--The 
                Secretary shall direct the Commissioner of Food and 
                Drugs to design and propose or implement, as 
                appropriate within the authorities and public health 
                priorities vested in the Secretary by other provisions 
                of law, strategies for facilitating and expediting the 
                clearance or approval of improved diagnostic tests for 
                Lyme disease and other tick-borne disease, particularly 
                where--
                            (i) there are no cleared diagnostic tests; 
                        or
                            (ii) cleared diagnostic tests lack a high 
                        level of specificity or sensitivity or are 
                        unable to confirm the presence or absence of 
                        active infection.
            (3) Ensuring safety and efficacy of vaccines.--The 
        Secretary shall--
                    (A) ensure the safety and efficacy of any new, 
                renewed, or modified human vaccine for Lyme disease, 
                other tick-borne disease, or a combination of such 
                diseases; and
                    (B) require the Commissioner of Food and Drugs to 
                submit to the Secretary prior to final approval of the 
                vaccine being reviewed, a report, with appropriate 
                provisions for commercial confidentiality, detailing 
                the safety of the vaccine and contrasting its safety 
                profile based on its mechanisms of action to safety 
                concerns expressed to the Food and Drug Administration 
                regarding the human vaccine withdrawn from the market 
                in 2002 and how those concerns with the withdrawn 
                vaccine have been addressed or why they are not 
                relevant.
            (4) Monitoring and understanding human cases of lyme 
        disease and other tick-borne diseases.--
                    (A) In general.--The Secretary shall--
                            (i) establish and maintain a statistically 
                        sound, scientifically credible surveillance 
                        system to be known as the National Tick-Borne 
                        Disease Surveillance System;
                            (ii) enhance and expand infrastructure and 
                        activities to track the epidemiology of Lyme 
                        disease and other tick-borne diseases and 
                        disorders; and
                            (iii) incorporate information obtained 
                        through such activities into the National Tick-
                        Borne Disease Surveillance System.
                    (B) Research.--The Secretary shall ensure that the 
                National Tick-Borne Disease Surveillance System is 
                designed in a manner that facilitates further research 
                on Lyme disease and other tick-borne diseases and 
                disorders.
                    (C) Content.--In carrying out subparagraph (A), the 
                Secretary--
                            (i) shall provide for the collection and 
                        storage of information on the incidence and 
                        prevalence of tick-borne disease in the United 
                        States--
                                    (I) while continuing to support 
                                activities in the 14 States with the 
                                highest number of reported cases of 
                                Lyme disease, and intensifying efforts 
                                in other States where Lyme disease has 
                                been reported and where all reported 
                                cases cannot be affirmatively 
                                associated with out-of-State travel in 
                                order to better determine where the 
                                disease is emerging;
                                    (II) working with the States and 
                                treating physicians, in consultation 
                                with the Council of State and 
                                Territorial Epidemiologists (in this 
                                clause referred to as the ``CSTE''), to 
                                improve evaluation of the feasibility 
                                of capturing data on cases that do not 
                                meet surveillance criteria of the CSTE 
                                and the Centers for Disease Control and 
                                Prevention;
                                    (III) in consultation with the 
                                CSTE, working with States that are 
                                using averaging or similar techniques 
                                to estimate case reports to ensure that 
                                data produced by that process are able 
                                to be reported out by the Centers for 
                                Disease Control and Prevention;
                                    (IV) in consultation with the CSTE, 
                                working with the States to encourage 
                                and improve laboratory reporting of 
                                Lyme disease and other tick-borne 
                                diseases, and evaluate the feasibility 
                                of creating a national uniform 
                                reporting system including mandatory 
                                reporting by States and physicians and 
                                laboratories in each State;
                                    (V) including in the surveillance 
                                system bartonellosis transmitted by any 
                                vector and, if it is known, by the 
                                vector of transmission; and
                                    (VI) tracking incidence and 
                                prevalence data for tick-borne 
                                disorders; and
                            (ii) to the extent practicable, shall 
                        provide for the collection and storage of other 
                        available information on Lyme disease and other 
                        tick-borne diseases and disorders, including 
                        information related to persons who have been 
                        diagnosed with and treated for tick-borne 
                        disease who choose to participate, such as--
                                    (I) demographics, such as age, 
                                race, sex, geographic location, and 
                                other information, as appropriate;
                                    (II) family history and experience 
                                with tick-borne disease or tick induced 
                                disorder;
                                    (III) history of exposure and known 
                                tick bites;
                                    (IV) progression of signs and 
                                symptoms;
                                    (V) diagnostic and treatment 
                                history and outcomes; and
                                    (VI) additional screening conducted 
                                and related data, such as biological 
                                markers.
                    (D) Consultation.--In carrying out this paragraph, 
                the Secretary shall consult with individuals with 
                appropriate expertise, which may include--
                            (i) epidemiologists with experience in 
                        disease surveillance or registries;
                            (ii) representatives of national patient 
                        advocacy and research organizations that focus 
                        on tick-borne disease and have demonstrated 
                        experience in research, data collection, or 
                        patient access to care;
                            (iii) health information technology experts 
                        or other information management specialists;
                            (iv) clinicians with expertise in Lyme 
                        disease or other tick-borne diseases or 
                        disorders; and
                            (v) research scientists with experience 
                        conducting translational research or utilizing 
                        surveillance systems for scientific research 
                        purposes.
                    (E) Grants.--The Secretary may award grants to, or 
                enter into contracts or cooperative agreements with, 
                public or private nonprofit entities to carry out 
                activities under this paragraph.
                    (F) Coordination with federal, state, and local 
                agencies.--Subject to subparagraph (H), the Secretary 
                shall--
                            (i) establish agreements and mechanisms, as 
                        appropriate, for improved collecting and 
                        reporting of tick-borne disease surveillance 
                        data under subparagraphs (A), (B), and clause 
                        (i) of subparagraph (C) and other available 
                        information under clause (ii) of subparagraph 
                        (C) from community health centers funded by the 
                        Health Resources and Services Administration 
                        and medical facilities of the Indian Health 
                        Service;
                            (ii) establish formal agreements, as 
                        appropriate and may be worked out, to provide 
                        for improved collection and reporting of 
                        surveillance data under subparagraphs (A), (B) 
                        or clause (i) of subparagraph (C) and other 
                        available information under clause (ii) of 
                        subparagraph (C), obtained from hospitals and 
                        medical clinics run by other Federal 
                        departments and agencies;
                            (iii) make information and analysis in the 
                        National Tick-Borne Disease Surveillance System 
                        available, as appropriate, to all components of 
                        the Department of Health and Human Services, to 
                        other Federal agencies, and to State and local 
                        agencies; and
                            (iv) identify, build upon, leverage, and 
                        coordinate among existing data and surveillance 
                        systems, surveys, registries, and other Federal 
                        public health infrastructure, wherever 
                        practicable.
                    (G) Public access.--Subject to subparagraph (H), 
                the Secretary shall ensure that information and 
                analysis in the National Tick-Borne Disease 
                Surveillance System are available, as appropriate, to 
                the public and other interested parties on the website 
                of the Department of Health and Human Services.
                    (H) Privacy.--The Secretary shall ensure that 
                information and analysis in the National Tick-Borne 
                Disease Surveillance System are made available only to 
                the extent permitted by applicable Federal and State 
                law, and in a manner that protects personal privacy, to 
                the extent required by applicable Federal and State 
                privacy law, at a minimum.
            (5) Education and prevention.--
                    (A) Consumer and community education.--The 
                Secretary shall increase public education related to 
                Lyme disease and other tick-borne diseases and 
                disorders through the expansion of the community-based 
                education programs of the Centers for Disease Control 
                and Prevention to include development and publication 
                of a consumer tick disease pamphlet, available online 
                and by hard copy, addressing--
                            (i) ticks and tick-borne diseases common to 
                        the geographic area, tick-borne disease that 
                        could be acquired while on domestic or 
                        international travel, and ticks that, while not 
                        common to the geographic area, could migrate to 
                        the area;
                            (ii) signs and symptoms of such tick-borne 
                        disease;
                            (iii) tick removal instructions;
                            (iv) the most effective actions individuals 
                        can take to reduce risk of exposure to ticks 
                        and risk of disease transmission; and
                            (v) additional community-based actions to 
                        reduce risk of exposure to ticks.
                    (B) Coordination.--In carrying out subparagraph 
                (A), the Secretary, acting through the Director of the 
                Centers for Disease Control and Prevention, shall 
                coordinate with legally incorporated Lyme disease or 
                other tick-borne disease organizations.
                    (C) Dissemination.--The Administrator of the Health 
                Resources and Services Administration and the Director 
                of the Indian Health Service shall make available in 
                rural health centers and clinics which they operate or 
                fund--
                            (i) the consumer tick disease pamphlets 
                        developed under subparagraph (A); or
                            (ii) such other appropriate consumer tick 
                        disease pamphlets as the Administration or 
                        Service may develop or acquire.
                    (D) Physician education.--The Secretary shall carry 
                out a physician education program that addresses the 
                full spectrum of scientific research related to Lyme 
                disease and other tick-borne diseases and disorders, 
                including--
                            (i) the role of clinical diagnosis;
                            (ii) the limitations of serological 
                        diagnostic tests;
                            (iii) enhanced, validated diagnostics 
                        available from laboratories certified under 
                        section 353 of the Public Health Service Act 
                        (42 U.S.C. 263a) that may aid the physician;
                            (iv) guidelines available on the National 
                        Guideline Clearinghouse;
                            (v) the voluntary nature of clinical 
                        practice guidelines;
                            (vi) the complexities presented by 
                        coinfections relating to symptomology, 
                        diagnosis, and treatment, including prudently 
                        acting in the patient's interest in non- or 
                        low-incidence States; and
                            (vii) the identification of significant 
                        research gaps most impacting diagnosis and 
                        treatment, and significant research being 
                        conducted to address those gaps.
                    (E) Process for developing physician education 
                program.--The Secretary of Health and Human Services 
                shall--
                            (i) conduct a public meeting to solicit 
                        input for the design of the physician education 
                        program under subparagraph (D);
                            (ii) give the public notice of such meeting 
                        at least 45 days in advance;
                            (iii) also solicit input on the design of 
                        the physician education program from the Tick-
                        Borne Disease Working Group;
                            (iv) publish a proposed syllabus for the 
                        physician education program not more than 120 
                        days after the public meeting;
                            (v) allow for a 60-day public comment 
                        period before publishing such syllabus in final 
                        form; and
                            (vi) publish on the public website of the 
                        Department of Health and Human Services a 
                        summary of the comments received from the 
                        public under this subparagraph before 
                        conducting the first training program under 
                        subparagraph (D).
            (6) Monitoring, understanding, and controlling vectors and 
        animal reservoirs of lyme disease and other tick-borne 
        disease.--
                    (A) Tick surveillance and testing.--The Secretary, 
                in coordination with the Director of the Office, acting 
                through the Director of the Centers for Disease Control 
                and Prevention and other agencies and offices of the 
                Department of Health and Human Services as appropriate, 
                shall--
                            (i) not later than 180 days after the date 
                        of enactment of this Act, provide a report to 
                        the Congress describing the tick surveillance 
                        and pathogen testing activities of the 
                        Department and entities funded by the 
                        Department, including--
                                    (I) a detailed description of the 
                                tick surveillance and tick pathogen 
                                testing activities and planned 
                                activities of the Vector-Borne Disease 
                                Regional Centers of Excellence as 
                                established under Funding Opportunity 
                                Announcement RFA-CK-17-005, Catalog of 
                                Federal Domestic Assistance Number 
                                93.084; and
                                    (II) within such description, the 
                                roles of participating academic, 
                                governmental, and private institutions;
                            (ii) not later than 2 years after the date 
                        of enactment of this Act, in consultation and 
                        coordination with other Federal agencies and 
                        State and local government agencies, as 
                        appropriate, and established academic or 
                        nonprofit tick-testing centers, develop a 
                        framework and an implementation plan for a 
                        comprehensive nationwide strategy for the 
                        surveillance and testing of ticks for human 
                        pathogens and microorganisms with unknown 
                        pathogenicity, including a plan for a network 
                        of tick identification and testing 
                        laboratories;
                            (iii) not later than 2 years after the date 
                        of enactment of this Act, establish agreements 
                        and procedures for sharing data on surveillance 
                        and testing of ticks with other Federal 
                        departments and agencies engaged in such 
                        activities; and
                            (iv) consult and coordinate with the 
                        American Veterinary Medical Association and the 
                        Companion Animal Parasite Council on obtaining 
                        and sharing data on the surveillance and 
                        testing of ticks and tick-borne pathogens, 
                        including geographic information from 
                        veterinary encounters.
                    (B) Investigation.--In carrying out subparagraph 
                (A), the Secretary, in coordination with the Director 
                of the Office, acting through the Director of the 
                Centers for Disease Control and Prevention, in 
                consultation and coordination with other Federal 
                agencies that conduct or support tick surveillance or 
                testing activities, as appropriate, and public and 
                private laboratories, shall--
                            (i) investigate and, where appropriate, 
                        promote the use of advanced new technologies, 
                        such as tools to discover all known and all 
                        previously unidentified microorganisms in a 
                        vector; and
                            (ii) while being informed by previous 
                        surveillance studies, allow for the possibility 
                        of rapid geographic migration of tick vectors 
                        and pathogens and unexpected findings.
                    (C) Tick control and prevention.--The Secretary, in 
                coordination with the Director of the Office, acting 
                through the Director of the Centers for Disease Control 
                and Prevention and the Director of the National 
                Institutes of Health, shall, as appropriate and 
                pursuant to authorities vested in the Secretary by 
                other provisions of law, support activities of and 
                coordinate and share, information with other Federal, 
                State, and local government agencies, involved or 
                interested in tick prevention and control activities 
                on--
                            (i) the development of safer and more 
                        effective tick repellents, both natural and 
                        chemical;
                            (ii) the use of acaricides or other 
                        chemical interventions;
                            (iii) nonchemical environmental measures to 
                        lessen human exposure to ticks;
                            (iv) genetic therapies for vectors or 
                        animal hosts to interfere with the life cycle 
                        of pathogens; and
                            (v) the development of vector or reservoir 
                        host vaccines.
                    (D) Leveraging existing tick management 
                resources.--In carrying out this paragraph, the 
                Secretary, in coordination with the Director of the 
                Office, acting through the Director of the Centers for 
                Disease Control and Prevention, shall identify, build 
                upon, leverage, and coordinate among existing tick 
                surveillance, testing, and management resources and 
                infrastructure wherever practicable.
                    (E) Public access to data.--In carrying out this 
                paragraph, the Secretary, in coordination with the 
                Director of the Office, acting through the Director of 
                the Centers for Disease Control and Prevention, in 
                coordination and consultation with other Federal 
                agencies and State and local agencies as appropriate, 
                make data on tick surveillance, testing, control and 
                prevention available to the public on the website of 
                the Department of Health and Human Services.
            (7) Conferences, symposia, seminars, and other public 
        meetings.--
                    (A) Sense of congress.--It is the sense of the 
                Congress that public meetings, conferences, symposia, 
                and seminars (including webinars) sponsored by the 
                Federal Government are a valuable input to strategic 
                and operational programmatic planning within Federal 
                agencies and to the work of the Tick-Borne Disease 
                Working Group.
                    (B) Requirements.--The Secretary and the Director 
                of the Office, in cooperation with the Director of the 
                Centers for Disease Control and Prevention, the 
                Director of the National Institutes of Health, and the 
                Tick-Borne Disease Working Group, shall--
                            (i) no later than 24 months after the date 
                        of enactment of this Act, sponsor a state-of-
                        the-science conference on Lyme disease and 
                        other tick-borne disease including 
                        identification of research gaps and top 
                        research priorities;
                            (ii) for any scientific or medical 
                        conference on Lyme disease or other tick-borne 
                        disease that is organized, sponsored, or paid 
                        for by the Department of Health and Human 
                        Services, ensure that a controlling statement 
                        of work and significant modifications thereto, 
                        whether in the contract or as a separate 
                        document, issued to the vendor organizing or 
                        conducting the conference are in writing and 
                        made available to the public prior to the 
                        conference;
                            (iii) not later than 120 days after the 
                        conclusion of the conference under clause (i), 
                        make available a final report on the conference 
                        to the Tick-Borne Disease Working Group and to 
                        the public;
                            (iv) not later than 18 months after the 
                        date of enactment of this Act, working through 
                        the Director of the Agency for Healthcare 
                        Research and Quality, sponsor a symposium on 
                        the use of real-world evidence (meaning data 
                        from sources other than randomized clinical 
                        trials, such as observational studies, 
                        comparative effectiveness and patient-centered 
                        outcomes research, and patient clinical data or 
                        human subject data), including the standards 
                        and methodologies for collection and analysis 
                        of real-world evidence in managing Lyme disease 
                        and other tick-borne disease;
                            (v) include in such symposium 
                        identification and analysis of existing data 
                        sources, such as patient registries and human 
                        subjects' databases;
                            (vi) sponsor a researcher workshop on 
                        challenges and solutions for clinical trial 
                        design and implementation for Lyme disease to 
                        be held no later than 24 months after the date 
                        of enactment of this Act, which workshop may 
                        consider other tick-borne disease or 
                        coinfections with more than one tick-borne 
                        pathogen as may be feasible and practicable;
                            (vii) not later than 9 months after the 
                        date of enactment of this Act, in consultation 
                        with the Tick-Borne Disease Working Group, 
                        design a survey instrument or instruments 
                        targeted to patients and patient advocates, 
                        physicians and health care providers, and 
                        researchers regarding recommended subjects and 
                        agendas for federally sponsored meetings, 
                        conferences, and seminars, including webinars, 
                        on Lyme disease and other tick-borne disease;
                            (viii) not later than 6 months after the 
                        conduct of the survey, provide an analysis of 
                        the results of the survey to the Tick-Borne 
                        Disease Working Group and publish such results 
                        in the Federal Register for a 60-day public 
                        comment period; and
                            (ix) provide a final analysis and a 
                        proposed schedule and agenda for public 
                        meetings, conferences, and seminars, including 
                        webinars, for incorporation into the national 
                        strategy under section 3 as appropriate and to 
                        the Tick-Borne Disease Working Group.
            (8) Common research bibliography.--The Secretary, in 
        coordination with the Director of the Office, shall direct the 
        Director of the Agency for Healthcare Research and Quality to 
        assemble a bibliography of peer-reviewed literature of tick-
        borne diseases and disorders in the United States, as well as 
        for bartonellosis from whatever cause, appropriately organized 
        for use by the scientific community, treating physicians, and 
        the public. The bibliography should include literature relating 
        to possible mechanisms of persistent infection with Borrelia 
        burgdorferi or other types of Borrelia.
    (c) Priority Based on Disease Burden.--In conducting and supporting 
activities under this section, the Secretary shall give priority to 
Lyme disease and other tick-borne diseases based on assessments of 
disease burden in the United States.

SEC. 5. BIENNIAL REPORTS.

    (a) In General.--Not later than 24 months after the date of the 
enactment of this Act, and biennially thereafter, the Secretary shall 
submit to the Congress a report on the activities carried out under 
this Act and the activities of the Tick-Borne Disease Working Group.
    (b) Content.--Reports under subsection (a) shall contain--
            (1) a scientifically qualified assessment of Lyme disease 
        and other tick-borne disease, including a summary of 
        prevalence, geography, important exposure characteristics, 
        disease stages and manifestations or symptoms of those stages, 
        based on a synthesis of the broad spectrum of empirical 
        evidence of treating physicians, as well as published peer-
        reviewed data, to include for each tick-borne disease a state-
        of-the-science diagnosis and treatment;
            (2) a description of all programs and activities funded by 
        the Department of Health and Human Services that are related to 
        the surveillance, diagnosis, treatment, education, or 
        prevention of Lyme disease or other tick-borne disease, and an 
        evaluation of progress and performance based on mission and 
        purpose, and discussion of significant challenges or barriers 
        to performance, to include--
                    (A) for the initial report under this section, a 
                description of the intramural and extramural research 
                portfolios of the Centers for Disease Control and 
                Prevention, the National Institutes of Health, and 
                other agencies and offices of the Department of Health 
                and Human Services which conducted or contracted for 
                research projects related to Lyme disease or on other 
                tick-borne disease or disorder, including information 
                on--
                            (i) the award amount, institution, primary 
                        investigator, principal investigative question 
                        or questions, and significant conclusions; and
                            (ii) studies that received Federal funds 
                        and were terminated, in progress, or initiated 
                        in the fiscal year including the date of 
                        enactment of this Act and the 5 prior fiscal 
                        years;
                    (B) for reports in subsequent years, all of the 
                information described in subparagraph (A), except the 
                reference in subparagraph (A)(ii) to Federal funds 
                terminated, in progress, or awarded in the 6 prior 
                fiscal years shall be treated as reference to such 
                funds in the 2 prior fiscal years;
                    (C) a status and summary report on the National 
                Tick-Borne Disease Surveillance System, including--
                            (i) the type of information collected and 
                        stored in the System;
                            (ii) the use, distribution, and 
                        availability of such information, including 
                        guidelines for such use; and
                            (iii) the use and coordination of 
                        surveillance and patient information databases; 
                        and
                    (D) information on agreements, partnerships, 
                cooperation, coordination, and data sharing with 
                external entities, such as State and local governments, 
                other Federal agencies, working groups, and global 
                entities;
            (3) a description of major externally funded research, 
        surveillance, education, or other programs and initiatives 
        impacting the management or science of tick-borne disease;
            (4) recommendations for addressing research gaps in 
        scientific understanding of Lyme disease and other tick-borne 
        diseases and disorders and relevant to development of effective 
        diagnostic tools and treatment protocols for Lyme disease and 
        other tick-borne diseases and disorders;
            (5) a description of clinical practice guidelines for any 
        tick-borne disease published on the National Guideline 
        Clearinghouse;
            (6) recommendations for addressing research gaps in tick 
        biology and tick management;
            (7) a description of activities for the promotion of public 
        awareness and physician education initiatives to improve the 
        knowledge of health care providers and the public in support of 
        clinical and behavioral decision making in relationship to Lyme 
        disease and other tick-borne disease; and
            (8) a copy of the most recent annual report issued by the 
        Tick-Borne Disease Working Group and an assessment of progress 
        in achieving recommendations of that Working Group.
    (c) Biennial Reports of NIH.--The Secretary shall ensure that each 
biennial report under title III of the Public Health Service Act (42 
U.S.C. 241 et seq.) or each triennial report under section 403 of such 
Act (42 U.S.C. 283) includes information on actions undertaken by the 
National Institutes of Health to carry out research with respect to 
Lyme disease and other tick-borne disease.

SEC. 6. DEFINITIONS.

    In this Act:
            (1) Bartonellosis.--The term ``bartonellosis'' means 
        disease caused by Bartonella infection from any vector or 
        source, unless otherwise specified.
            (2) Disorder.--The term ``disorder'' means a disorder 
        caused by ticks, but not inducing human infection, such as tick 
        paralysis and Alpha-Gal meat allergy.
            (3) Office.--The term ``Office'' means the Office of 
        Oversight and Coordination for Tick-Borne Diseases established 
        under section 2.
            (4) Other federal agency.--Other Federal agency means a 
        Federal Department, agency or office outside of the U.S. 
        Department of Health and Human Services.
            (5) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
            (6) Tick-borne disease.--The term ``tick-borne disease'' 
        means a disease that is known to be transmitted by ticks in the 
        United States, unless otherwise specified, or that may be 
        discovered to be transmitted by ticks in the United States.
            (7) Tick-borne disease working group.--The term ``Tick-
        Borne Disease Working Group'' means the Tick-Borne Disease 
        Working Group established under section 2062 of the 21st 
        Century Cures Act (42 U.S.C. 284s).
                                 <all>
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