I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘National Lyme and 

5 Tick-Borne Diseases Control and Accountability Act of 

6 2019’’. 


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1 SEC. 2. OFFICE OF OVERSIGHT AND COORDINATION FOR 

2 TICK-BORNE DISEASES. 

3 (a) ESTABLISHMENT.—The Secretary of Health and 

4 Human Services shall establish in the Office of the Sec5 retary the Office of Oversight and Coordination for Tick6 Borne Diseases, to be headed by a director appointed by 

7 the Secretary— 

8 (1) to oversee the creation and updating of an 

9 integrated national strategy to overcome Lyme dis10 ease and other tick-borne diseases; and 

11 (2) to oversee and coordinate Lyme disease and 

12 other tick-borne disease programs and activities 

13 across the agencies and offices of the Department of 

14 Health and Human Services. 

15 (b) OBJECTIVE OF OFFICE.—In carrying out sub16 section (a), the Director of the Office shall facilitate and 

17 work to ensure accomplishment of the following activities: 

18 (1) Expansion and enhancement of epidemiolog19 ical research and basic, translational, and clinical bi20 ological and biomedical research. 

21 (2) Expansion and improvement of the surveil22 lance and reporting of Lyme disease and other tick23 borne disease, including coinfections with agents of 

24 more than one tick-borne disease. 

25 (3) Development of effective diagnostic tests to 

26 accurately and timely diagnose Lyme disease and 


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1 other tick-borne disease, including direct detention 

2 tests. 

3 (4) Development of treatments to cure or im4 prove the lives of those who are infected with Lyme 

5 disease or other tick-borne disease or who suffer 

6 from a tick-induced disorder. 

7 (5) Design and conduct of clinical trials of suf8 ficient size and duration to support clinical rec9 ommendations. 

10 (6) Development and maintenance of one or 

11 more registries of patients and their experiences re12 lating to exposure to, diagnosis for, and treatment 

13 of tick-borne disease, including outcomes, which reg14 istries shall protect the confidentiality and safety of 

15 patient data. 

16 (7) Systematic documentation of the experi17 ences of health care professionals in diagnosing and 

18 treating tick-borne disease, including diagnostic and 

19 treatment outcomes. 

20 (8) Inclusion of individuals with chronic Lyme 

21 disease in clinical, research, and service efforts. 

22 (9) Coordination with international bodies to in23 tegrate and inform the fight against Lyme disease 

24 and tick-borne disease globally. 


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1 (c) INTEGRATION OF TICK-BORNE DISEASE WORK2 ING GROUP FINDINGS AND RECOMMENDATIONS.—In car3 rying out this section, the Director of the Office shall, as 

4 directed by the Secretary, with any modifications made by 

5 and as otherwise determined appropriate by the Secretary, 

6 oversee and coordinate integration and implementation, 

7 into the activities of the Office and the activities and pro8 grams of the agencies and offices of the Department of 

9 Health and Human Services, of the recommendations to 

10 the Secretary and the findings and conclusions in the lat11 est report of the Tick-Borne Disease Working Group sub12 mitted to the Secretary and congressional committees. 

13 (d) PRIORITY BASED ON DISEASE BURDEN.—In car14 rying out this section, the Director of the Office shall give 

15 priority to Lyme disease and other tick-borne disease 

16 based on assessments of disease burden in the United 

17 States. 

18 SEC. 3. NATIONAL STRATEGY. 

19 (a) IN GENERAL.—The Secretary, in coordination 

20 with the Director of the Office, and in consultation with 

21 the Tick-Borne Disease Working Group, the agencies and 

22 offices of the Department of Health and Human Services, 

23 and other Federal agencies outside of the Department of 

24 Health and Human Services as appropriate, shall— 


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1 (1) not later than 2 years after the date of en2 actment of this Act, develop and submit to the Con3 gress a national strategy for the conduct and sup4 port of Lyme disease and other tick-borne disease or 

5 disorder programs and activities; and 

6 (2) not less than every 2 years thereafter, up7 date such strategy. 

8 (b) CONTENTS.—The strategy under subsection (a) 

9 shall include— 

10 (1) proposed budgetary requirements; 

11 (2) an assessment of all federally funded pro12 grams and activities related to surveillance, diag13 nosis, treatment, education, or prevention with re14 spect to Lyme disease or other tick-borne disease, an 

15 evaluation of progress and performance based on 

16 mission and purpose, and a description of significant 

17 challenges or barriers to performance, including an 

18 assessment of Federal grants awarded; 

19 (3) a strategy for improving diagnosis, treat20 ment, and prevention, including increasing the im21 pact of grants awarded by the National Institutes of 

22 Health, the Centers for Disease Control and Preven23 tion, and other agencies and offices of the Depart24 ment of Health and Human Services; 


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1 (4) a strategy for improving outcomes of indi2 viduals with Lyme disease or another tick-borne dis3 ease or disorder, including progress related to chron4 ic or persistent symptoms and chronic or persistent 

5 infection and coinfections, including plans for evalu6 ating the potential value of and supporting the con7 duct of observational studies, comparative effective8 ness research, patient-centered outcomes research, 

9 or other real world evidence; 

10 (5) the appropriate benchmarks to measure 

11 progress in achieving the improvements described in 

12 paragraphs (3) and (4); 

13 (6) a strategy for improving interactions, co14 ordination, and partnerships with other Federal 

15 agencies, State and local governments, and global 

16 entities; and 

17 (7) the latest recommendations of the Tick18 Borne Disease Working Group and the steps taken 

19 by the agencies and offices of the Department of 

20 Health and Human Services to implement those rec21 ommendations. 


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1 SEC. 4. FEDERAL ACTIVITIES RELATED TO THE DIAGNOSIS, 

2 SURVEILLANCE, AND PREVENTION OF, AND 

3 RESEARCH ON, LYME DISEASE AND OTHER 

4 TICK-BORNE DISEASES AND DISORDERS. 

5 (a) IN GENERAL.—The Secretary, in coordination 

6 with the Director of the Office, acting as the Secretary 

7 determines appropriate through the Director of the Cen8 ters for Disease Control and Prevention, the Director of 

9 the National Institutes of Health, the Commissioner of 

10 Food and Drugs, the Director of the Agency for 

11 Healthcare Research and Quality, the Administrator of 

12 the Health Resources and Services Administration, the Di13 rector of the Indian Health Service, and the heads of other 

14 Federal agencies, and in consultation with the Tick-Borne 

15 Disease Working Group, shall provide for— 

16 (1) the conduct or support of the activities de17 scribed in paragraphs (1) through (8) of subsection 

18 (b); and 

19 (2) the coordination of all programs and activi20 ties of the Department of Health and Human Serv21 ices related to Lyme disease and other tick-borne 

22 diseases and disorders and Bartonella. 

23 (b) ACTIVITIES.—The activities to be conducted or 

24 supported under subsection (a)(1) consist of the following: 

25 (1) EXPANSION AND ENHANCEMENT OF RE26 SEARCH.— 


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1 (A) IN GENERAL.—The Secretary shall ex2 pand and intensify epidemiological, basic, 

3 translational, and clinical research regarding 

4 Lyme disease and other tick-borne disease and 

5 disorders and bartonellosis to better under6 stand— 

7 (i) the pathophysiology of Borrelia 

8 burgdorferi and other tick-borne micro9 organisms that are human pathogens and 

10 of Bartonella; 

11 (ii) pathophysiological changes over 

12 time, including pathogen persistence pro13 files for patients with differing treatment 

14 histories; 

15 (iii) activation and deactivation of im16 mune system processes; and 

17 (iv) whether, and what species of, 

18 Bartonella are transmitted by ticks. 

19 (B) CLINICAL OUTCOMES RESEARCH.—The 

20 Secretary shall conduct or support clinical out21 comes research to— 

22 (i) establish epidemiological research 

23 objectives to determine the long-term 

24 course of illness for Lyme disease and 

25 other tick-borne diseases and disorders; 


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1 (ii) establish patient-centered treat2 ment outcome objectives to allow for the 

3 comparative effectiveness of different treat4 ment modalities; and 

5 (iii) establish patient-centered re6 search objectives to help elucidate prom7 ising treatment protocols for individuals 

8 suspected of harboring coinfections with 

9 more than one tick-transmitted pathogen. 

10 (C) COLLABORATIVE, MULTIDISCIPLINARY

11 RESEARCH.—The Secretary shall encourage the 

12 solicitation of proposals for collaborative, multi13 disciplinary research that would— 

14 (i) result in innovative approaches to 

15 study emerging scientific opportunities or 

16 eliminate gaps in research to improve the 

17 research portfolio, including application of 

18 successful and promising advances in the 

19 study of other types of diseases, such as 

20 upregulating or downregulating immune 

21 system cells or processes; 

22 (ii) outline key research questions, 

23 methodologies, and knowledge gaps; 

24 (iii) expand the number of research 

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1 tween 2 or more national research insti2 tutes or national centers of the National 

3 Institutes of Health, including proposals 

4 for research through the Common Fund 

5 pursuant to section 402(b)(7) of the Public 

6 Health Service Act (42 U.S.C. 282(b)(7)) 

7 to improve the research portfolio; 

8 (iv) expand the number of collabo9 rative multi-institutional research grants 

10 related to tick-borne disease; and 

11 (v) involve additional national re12 search institutes and national centers of 

13 the National Institutes of Health in intra14 mural and extramural research on tick15 borne disease, such as the National Insti16 tute of Neurological Disorders and Stroke 

17 conducting or sponsoring research on 

18 neurologic Lyme disease. 

19 (D) EVALUATION.—Not later than 2 years 

20 after the date of enactment of this Act, the Sec21 retary shall evaluate and make findings on— 

22 (i) the feasibility and potential value 

23 to the research community of establishing 

24 a deidentified human subjects database for 


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1 Lyme disease and other tick-borne diseases 

2 and disorders; 

3 (ii) existing government or private 

4 biorepositories for Lyme disease and other 

5 tick-borne diseases and disorders and 

6 whether— 

7 (I) specimens and samples are 

8 adequate and available to meet re9 searcher needs; or 

10 (II) there are problems or chal11 lenges for researcher acquisition of 

12 samples and specimens; and 

13 (iii) the scope and use of specimens 

14 and samples from cadavers, the questions 

15 and answers such research may provide, 

16 and the need for additional support of re17 searchers using cadaver specimens. 

18 (E) PRIORITY.—In carrying out this para19 graph, the Secretary shall make it a priority to 

20 determine the extent of posttreatment persist21 ence of Borrelia burgdorferi and the clinical sig22 nificance of such persistence. 

23 (2) DEVELOPMENT OF NEW AND IMPROVED DI24 AGNOSTIC TESTS.— 


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1 (A) IN GENERAL.—The Secretary, in co2 operation with the Director of the Office, and 

3 acting through the Directors of the Centers for 

4 Disease Control and Prevention and the Direc5 tor of the National Institutes of Health, shall 

6 conduct and support research to— 

7 (i) provide for the timely evaluation of 

8 promising new and improved diagnostic 

9 methods, including direct-detection tests, 

10 antibody-based tests, and tests based on 

11 biosignature and biomarker profiles to 

12 make a specific diagnosis or aid in dif13 ferential diagnoses; 

14 (ii) improve the sensitivity of Lyme 

15 disease tests at all stages of disease pro16 gression; 

17 (iii) develop a Lyme disease test capa18 ble of distinguishing between past and ac19 tive infections; 

20 (iv) improve timely, sensitive, and spe21 cific diagnostic tools and tests for Rocky 

22 Mountain spotted fever; and 

23 (v) improve the performance (timeli24 ness and accuracy) of tools and tests for 


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1 other tick-borne diseases found in the 

2 United States. 

3 (B) STRATEGIES FOR EXPEDITING CLEAR4 ANCE.—The Secretary shall direct the Commis5 sioner of Food and Drugs to design and pro6 pose or implement, as appropriate within the 

7 authorities and public health priorities vested in 

8 the Secretary by other provisions of law, strate9 gies for facilitating and expediting the clearance 

10 or approval of improved diagnostic tests for 

11 Lyme disease and other tick-borne disease, par12 ticularly where— 

13 (i) there are no cleared diagnostic 

14 tests; or 

15 (ii) cleared diagnostic tests lack a 

16 high level of specificity or sensitivity or are 

17 unable to confirm the presence or absence 

18 of active infection. 

19 (3) ENSURING SAFETY AND EFFICACY OF VAC20 CINES.—The Secretary shall— 

21 (A) ensure the safety and efficacy of any 

22 new, renewed, or modified human vaccine for 

23 Lyme disease, other tick-borne disease, or a 

24 combination of such diseases; and 


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1 (B) require the Commissioner of Food and 

2 Drugs to submit to the Secretary prior to final 

3 approval of the vaccine being reviewed, a report, 

4 with appropriate provisions for commercial con5 fidentiality, detailing the safety of the vaccine 

6 and contrasting its safety profile based on its 

7 mechanisms of action to safety concerns ex8 pressed to the Food and Drug Administration 

9 regarding the human vaccine withdrawn from 

10 the market in 2002 and how those concerns 

11 with the withdrawn vaccine have been addressed 

12 or why they are not relevant. 

13 (4) MONITORING AND UNDERSTANDING HUMAN

14 CASES OF LYME DISEASE AND OTHER TICK-BORNE

15 DISEASES.— 

16 (A) IN GENERAL.—The Secretary shall— 

17 (i) establish and maintain a statis18 tically sound, scientifically credible surveil19 lance system to be known as the National 

20 Tick-Borne Disease Surveillance System; 

21 (ii) enhance and expand infrastructure 

22 and activities to track the epidemiology of 

23 Lyme disease and other tick-borne diseases 

24 and disorders; and 


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1 (iii) incorporate information obtained 

2 through such activities into the National 

3 Tick-Borne Disease Surveillance System. 

4 (B) RESEARCH.—The Secretary shall en5 sure that the National Tick-Borne Disease Sur6 veillance System is designed in a manner that 

7 facilitates further research on Lyme disease and 

8 other tick-borne diseases and disorders. 

9 (C) CONTENT.—In carrying out subpara10 graph (A), the Secretary— 

11 (i) shall provide for the collection and 

12 storage of information on the incidence 

13 and prevalence of tick-borne disease in the 

14 United States— 

15 (I) while continuing to support 

16 activities in the 14 States with the 

17 highest number of reported cases of 

18 Lyme disease, and intensifying efforts 

19 in other States where Lyme disease 

20 has been reported and where all re21 ported cases cannot be affirmatively 

22 associated with out-of-State travel in 

23 order to better determine where the 

24 disease is emerging; 


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1 (II) working with the States and 

2 treating physicians, in consultation 

3 with the Council of State and Terri4 torial Epidemiologists (in this clause 

5 referred to as the ‘‘CSTE’’), to im6 prove evaluation of the feasibility of 

7 capturing data on cases that do not 

8 meet surveillance criteria of the CSTE 

9 and the Centers for Disease Control 

10 and Prevention; 

11 (III) in consultation with the 

12 CSTE, working with States that are 

13 using averaging or similar techniques 

14 to estimate case reports to ensure that 

15 data produced by that process are 

16 able to be reported out by the Centers 

17 for Disease Control and Prevention; 

18 (IV) in consultation with the 

19 CSTE, working with the States to en20 courage and improve laboratory re21 porting of Lyme disease and other 

22 tick-borne diseases, and evaluate the 

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1 datory reporting by States and physi2 cians and laboratories in each State; 

3 (V) including in the surveillance 

4 system bartonellosis transmitted by 

5 any vector and, if it is known, by the 

6 vector of transmission; and 

7 (VI) tracking incidence and prev8 alence data for tick-borne disorders; 

9 and 

10 (ii) to the extent practicable, shall 

11 provide for the collection and storage of 

12 other available information on Lyme dis13 ease and other tick-borne diseases and dis14 orders, including information related to 

15 persons who have been diagnosed with and 

16 treated for tick-borne disease who choose 

17 to participate, such as— 

18 (I) demographics, such as age, 

19 race, sex, geographic location, and 

20 other information, as appropriate; 

21 (II) family history and experience 

22 with tick-borne disease or tick induced 

23 disorder; 

24 (III) history of exposure and 

25 known tick bites; 


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1 (IV) progression of signs and 

2 symptoms; 

3 (V) diagnostic and treatment his4 tory and outcomes; and 

5 (VI) additional screening con6 ducted and related data, such as bio7 logical markers. 

8 (D) CONSULTATION.—In carrying out this 

9 paragraph, the Secretary shall consult with in10 dividuals with appropriate expertise, which may 

11 include— 

12 (i) epidemiologists with experience in 

13 disease surveillance or registries; 

14 (ii) representatives of national patient 

15 advocacy and research organizations that 

16 focus on tick-borne disease and have dem17 onstrated experience in research, data col18 lection, or patient access to care; 

19 (iii) health information technology ex20 perts or other information management 

21 specialists; 

22 (iv) clinicians with expertise in Lyme 

23 disease or other tick-borne diseases or dis24 orders; and 


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1 (v) research scientists with experience 

2 conducting translational research or uti3 lizing surveillance systems for scientific re4 search purposes. 

5 (E) GRANTS.—The Secretary may award 

6 grants to, or enter into contracts or cooperative 

7 agreements with, public or private nonprofit en8 tities to carry out activities under this para9 graph. 

10 (F) COORDINATION WITH FEDERAL, 

11 STATE, AND LOCAL AGENCIES.—Subject to sub12 paragraph (H), the Secretary shall— 

13 (i) establish agreements and mecha14 nisms, as appropriate, for improved col15 lecting and reporting of tick-borne disease 

16 surveillance data under subparagraphs (A), 

17 (B), and clause (i) of subparagraph (C) 

18 and other available information under 

19 clause (ii) of subparagraph (C) from com20 munity health centers funded by the 

21 Health Resources and Services Administra22 tion and medical facilities of the Indian 

23 Health Service; 

24 (ii) establish formal agreements, as 

25 appropriate and may be worked out, to 


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1 provide for improved collection and report2 ing of surveillance data under subpara3 graphs (A), (B) or clause (i) of subpara4 graph (C) and other available information 

5 under clause (ii) of subparagraph (C), ob6 tained from hospitals and medical clinics 

7 run by other Federal departments and 

8 agencies; 

9 (iii) make information and analysis in 

10 the National Tick-Borne Disease Surveil11 lance System available, as appropriate, to 

12 all components of the Department of 

13 Health and Human Services, to other Fed14 eral agencies, and to State and local agen15 cies; and 

16 (iv) identify, build upon, leverage, and 

17 coordinate among existing data and sur18 veillance systems, surveys, registries, and 

19 other Federal public health infrastructure, 

20 wherever practicable. 

21 (G) PUBLIC ACCESS.—Subject to subpara22 graph (H), the Secretary shall ensure that in23 formation and analysis in the National Tick24 Borne Disease Surveillance System are avail25 able, as appropriate, to the public and other inVerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220

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1 terested parties on the website of the Depart2 ment of Health and Human Services. 

3 (H) PRIVACY.—The Secretary shall ensure 

4 that information and analysis in the National 

5 Tick-Borne Disease Surveillance System are 

6 made available only to the extent permitted by 

7 applicable Federal and State law, and in a 

8 manner that protects personal privacy, to the 

9 extent required by applicable Federal and State 

10 privacy law, at a minimum. 

11 (5) EDUCATION AND PREVENTION.— 

12 (A) CONSUMER AND COMMUNITY EDU13 CATION.—The Secretary shall increase public 

14 education related to Lyme disease and other 

15 tick-borne diseases and disorders through the 

16 expansion of the community-based education 

17 programs of the Centers for Disease Control 

18 and Prevention to include development and 

19 publication of a consumer tick disease pam20 phlet, available online and by hard copy, ad21 dressing— 

22 (i) ticks and tick-borne diseases com23 mon to the geographic area, tick-borne dis24 ease that could be acquired while on do25 mestic or international travel, and ticks 


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1 that, while not common to the geographic 

2 area, could migrate to the area; 

3 (ii) signs and symptoms of such tick4 borne disease; 

5 (iii) tick removal instructions; 

6 (iv) the most effective actions individ7 uals can take to reduce risk of exposure to 

8 ticks and risk of disease transmission; and 

9 (v) additional community-based ac10 tions to reduce risk of exposure to ticks. 

11 (B) COORDINATION.—In carrying out sub12 paragraph (A), the Secretary, acting through 

13 the Director of the Centers for Disease Control 

14 and Prevention, shall coordinate with legally in15 corporated Lyme disease or other tick-borne 

16 disease organizations. 

17 (C) DISSEMINATION.—The Administrator 

18 of the Health Resources and Services Adminis19 tration and the Director of the Indian Health 

20 Service shall make available in rural health cen21 ters and clinics which they operate or fund— 

22 (i) the consumer tick disease pam23 phlets developed under subparagraph (A); 

24 or 


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1 (ii) such other appropriate consumer 

2 tick disease pamphlets as the Administra3 tion or Service may develop or acquire. 

4 (D) PHYSICIAN EDUCATION.—The Sec5 retary shall carry out a physician education 

6 program that addresses the full spectrum of sci7 entific research related to Lyme disease and 

8 other tick-borne diseases and disorders, includ9 ing— 

10 (i) the role of clinical diagnosis; 

11 (ii) the limitations of serological diag12 nostic tests; 

13 (iii) enhanced, validated diagnostics 

14 available from laboratories certified under 

15 section 353 of the Public Health Service 

16 Act (42 U.S.C. 263a) that may aid the 

17 physician; 

18 (iv) guidelines available on the Na19 tional Guideline Clearinghouse; 

20 (v) the voluntary nature of clinical 

21 practice guidelines; 

22 (vi) the complexities presented by co23 infections relating to symptomology, diag24 nosis, and treatment, including prudently 


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1 acting in the patient’s interest in non- or 

2 low-incidence States; and 

3 (vii) the identification of significant 

4 research gaps most impacting diagnosis 

5 and treatment, and significant research 

6 being conducted to address those gaps. 

7 (E) PROCESS FOR DEVELOPING PHYSICIAN

8 EDUCATION PROGRAM.—The Secretary of 

9 Health and Human Services shall— 

10 (i) conduct a public meeting to solicit 

11 input for the design of the physician edu12 cation program under subparagraph (D); 

13 (ii) give the public notice of such 

14 meeting at least 45 days in advance; 

15 (iii) also solicit input on the design of 

16 the physician education program from the 

17 Tick-Borne Disease Working Group; 

18 (iv) publish a proposed syllabus for 

19 the physician education program not more 

20 than 120 days after the public meeting; 

21 (v) allow for a 60-day public comment 

22 period before publishing such syllabus in 

23 final form; and 

24 (vi) publish on the public website of 

25 the Department of Health and Human 


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1 Services a summary of the comments re2 ceived from the public under this subpara3 graph before conducting the first training 

4 program under subparagraph (D). 

5 (6) MONITORING, UNDERSTANDING, AND CON6 TROLLING VECTORS AND ANIMAL RESERVOIRS OF

7 LYME DISEASE AND OTHER TICK-BORNE DISEASE.— 

8 (A) TICK SURVEILLANCE AND TESTING.— 

9 The Secretary, in coordination with the Direc10 tor of the Office, acting through the Director of 

11 the Centers for Disease Control and Prevention 

12 and other agencies and offices of the Depart13 ment of Health and Human Services as appro14 priate, shall— 

15 (i) not later than 180 days after the 

16 date of enactment of this Act, provide a re17 port to the Congress describing the tick 

18 surveillance and pathogen testing activities 

19 of the Department and entities funded by 

20 the Department, including— 

21 (I) a detailed description of the 

22 tick surveillance and tick pathogen 

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1 lished under Funding Opportunity 

2 Announcement RFA–CK–17–005, 

3 Catalog of Federal Domestic Assist4 ance Number 93.084; and 

5 (II) within such description, the 

6 roles of participating academic, gov7 ernmental, and private institutions; 

8 (ii) not later than 2 years after the 

9 date of enactment of this Act, in consulta10 tion and coordination with other Federal 

11 agencies and State and local government 

12 agencies, as appropriate, and established 

13 academic or nonprofit tick-testing centers, 

14 develop a framework and an implementa15 tion plan for a comprehensive nationwide 

16 strategy for the surveillance and testing of 

17 ticks for human pathogens and microorga18 nisms with unknown pathogenicity, includ19 ing a plan for a network of tick identifica20 tion and testing laboratories; 

21 (iii) not later than 2 years after the 

22 date of enactment of this Act, establish 

23 agreements and procedures for sharing 

24 data on surveillance and testing of ticks 


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1 with other Federal departments and agen2 cies engaged in such activities; and 

3 (iv) consult and coordinate with the 

4 American Veterinary Medical Association 

5 and the Companion Animal Parasite Coun6 cil on obtaining and sharing data on the 

7 surveillance and testing of ticks and tick8 borne pathogens, including geographic in9 formation from veterinary encounters. 

10 (B) INVESTIGATION.—In carrying out sub11 paragraph (A), the Secretary, in coordination 

12 with the Director of the Office, acting through 

13 the Director of the Centers for Disease Control 

14 and Prevention, in consultation and coordina15 tion with other Federal agencies that conduct 

16 or support tick surveillance or testing activities, 

17 as appropriate, and public and private labora18 tories, shall— 

19 (i) investigate and, where appropriate, 

20 promote the use of advanced new tech21 nologies, such as tools to discover all 

22 known and all previously unidentified 

23 microorganisms in a vector; and 

24 (ii) while being informed by previous 

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1 bility of rapid geographic migration of tick 

2 vectors and pathogens and unexpected 

3 findings. 

4 (C) TICK CONTROL AND PREVENTION.— 

5 The Secretary, in coordination with the Direc6 tor of the Office, acting through the Director of 

7 the Centers for Disease Control and Prevention 

8 and the Director of the National Institutes of 

9 Health, shall, as appropriate and pursuant to 

10 authorities vested in the Secretary by other pro11 visions of law, support activities of and coordi12 nate and share, information with other Federal, 

13 State, and local government agencies, involved 

14 or interested in tick prevention and control ac15 tivities on— 

16 (i) the development of safer and more 

17 effective tick repellents, both natural and 

18 chemical; 

19 (ii) the use of acaricides or other 

20 chemical interventions; 

21 (iii) nonchemical environmental meas22 ures to lessen human exposure to ticks; 

23 (iv) genetic therapies for vectors or 

24 animal hosts to interfere with the life cycle 

25 of pathogens; and 


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1 (v) the development of vector or res2 ervoir host vaccines. 

3 (D) LEVERAGING EXISTING TICK MANAGE4 MENT RESOURCES.—In carrying out this para5 graph, the Secretary, in coordination with the 

6 Director of the Office, acting through the Di7 rector of the Centers for Disease Control and 

8 Prevention, shall identify, build upon, leverage, 

9 and coordinate among existing tick surveillance, 

10 testing, and management resources and infra11 structure wherever practicable. 

12 (E) PUBLIC ACCESS TO DATA.—In car13 rying out this paragraph, the Secretary, in co14 ordination with the Director of the Office, act15 ing through the Director of the Centers for Dis16 ease Control and Prevention, in coordination 

17 and consultation with other Federal agencies 

18 and State and local agencies as appropriate, 

19 make data on tick surveillance, testing, control 

20 and prevention available to the public on the 

21 website of the Department of Health and 

22 Human Services. 

23 (7) CONFERENCES, SYMPOSIA, SEMINARS, AND

24 OTHER PUBLIC MEETINGS.— 


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1 (A) SENSE OF CONGRESS.—It is the sense 

2 of the Congress that public meetings, con3 ferences, symposia, and seminars (including 

4 webinars) sponsored by the Federal Govern5 ment are a valuable input to strategic and oper6 ational programmatic planning within Federal 

7 agencies and to the work of the Tick-Borne 

8 Disease Working Group. 

9 (B) REQUIREMENTS.—The Secretary and 

10 the Director of the Office, in cooperation with 

11 the Director of the Centers for Disease Control 

12 and Prevention, the Director of the National 

13 Institutes of Health, and the Tick-Borne Dis14 ease Working Group, shall— 

15 (i) no later than 24 months after the 

16 date of enactment of this Act, sponsor a 

17 state-of-the-science conference on Lyme 

18 disease and other tick-borne disease includ19 ing identification of research gaps and top 

20 research priorities; 

21 (ii) for any scientific or medical con22 ference on Lyme disease or other tick23 borne disease that is organized, sponsored, 

24 or paid for by the Department of Health 

25 and Human Services, ensure that a conVerDate Sep 11 2014 23:10 Jan 16, 2019 Jkt 089200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6201 E:\BILLS\H220.IH H220

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1 trolling statement of work and significant 

2 modifications thereto, whether in the con3 tract or as a separate document, issued to 

4 the vendor organizing or conducting the 

5 conference are in writing and made avail6 able to the public prior to the conference; 

7 (iii) not later than 120 days after the 

8 conclusion of the conference under clause 

9 (i), make available a final report on the 

10 conference to the Tick-Borne Disease 

11 Working Group and to the public; 

12 (iv) not later than 18 months after 

13 the date of enactment of this Act, working 

14 through the Director of the Agency for 

15 Healthcare Research and Quality, sponsor 

16 a symposium on the use of real-world evi17 dence (meaning data from sources other 

18 than randomized clinical trials, such as ob19 servational studies, comparative effective20 ness and patient-centered outcomes re21 search, and patient clinical data or human 

22 subject data), including the standards and 

23 methodologies for collection and analysis of 

24 real-world evidence in managing Lyme dis25 ease and other tick-borne disease; 


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1 (v) include in such symposium identi2 fication and analysis of existing data 

3 sources, such as patient registries and 

4 human subjects’ databases; 

5 (vi) sponsor a researcher workshop on 

6 challenges and solutions for clinical trial 

7 design and implementation for Lyme dis8 ease to be held no later than 24 months 

9 after the date of enactment of this Act, 

10 which workshop may consider other tick11 borne disease or coinfections with more 

12 than one tick-borne pathogen as may be 

13 feasible and practicable; 

14 (vii) not later than 9 months after the 

15 date of enactment of this Act, in consulta16 tion with the Tick-Borne Disease Working 

17 Group, design a survey instrument or in18 struments targeted to patients and patient 

19 advocates, physicians and health care pro20 viders, and researchers regarding rec21 ommended subjects and agendas for feder22 ally sponsored meetings, conferences, and 

23 seminars, including webinars, on Lyme dis24 ease and other tick-borne disease; 


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1 (viii) not later than 6 months after 

2 the conduct of the survey, provide an anal3 ysis of the results of the survey to the 

4 Tick-Borne Disease Working Group and 

5 publish such results in the Federal Reg6 ister for a 60-day public comment period; 

7 and 

8 (ix) provide a final analysis and a pro9 posed schedule and agenda for public 

10 meetings, conferences, and seminars, in11 cluding webinars, for incorporation into the 

12 national strategy under section 3 as appro13 priate and to the Tick-Borne Disease 

14 Working Group. 

15 (8) COMMON RESEARCH BIBLIOGRAPHY.—The 

16 Secretary, in coordination with the Director of the 

17 Office, shall direct the Director of the Agency for 

18 Healthcare Research and Quality to assemble a bib19 liography of peer-reviewed literature of tick-borne 

20 diseases and disorders in the United States, as well 

21 as for bartonellosis from whatever cause, appro22 priately organized for use by the scientific commu23 nity, treating physicians, and the public. The bibliog24 raphy should include literature relating to possible 


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1 mechanisms of persistent infection with Borrelia 

2 burgdorferi or other types of Borrelia. 

3 (c) PRIORITY BASED ON DISEASE BURDEN.—In con4 ducting and supporting activities under this section, the 

5 Secretary shall give priority to Lyme disease and other 

6 tick-borne diseases based on assessments of disease bur7 den in the United States. 

8 SEC. 5. BIENNIAL REPORTS. 

9 (a) IN GENERAL.—Not later than 24 months after 

10 the date of the enactment of this Act, and biennially there11 after, the Secretary shall submit to the Congress a report 

12 on the activities carried out under this Act and the activi13 ties of the Tick-Borne Disease Working Group. 

14 (b) CONTENT.—Reports under subsection (a) shall 

15 contain— 

16 (1) a scientifically qualified assessment of Lyme 

17 disease and other tick-borne disease, including a 

18 summary of prevalence, geography, important expo19 sure characteristics, disease stages and manifesta20 tions or symptoms of those stages, based on a syn21 thesis of the broad spectrum of empirical evidence of 

22 treating physicians, as well as published peer-re23 viewed data, to include for each tick-borne disease a 

24 state-of-the-science diagnosis and treatment; 


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1 (2) a description of all programs and activities 

2 funded by the Department of Health and Human 

3 Services that are related to the surveillance, diag4 nosis, treatment, education, or prevention of Lyme 

5 disease or other tick-borne disease, and an evalua6 tion of progress and performance based on mission 

7 and purpose, and discussion of significant challenges 

8 or barriers to performance, to include— 

9 (A) for the initial report under this section, 

10 a description of the intramural and extramural 

11 research portfolios of the Centers for Disease 

12 Control and Prevention, the National Institutes 

13 of Health, and other agencies and offices of the 

14 Department of Health and Human Services 

15 which conducted or contracted for research 

16 projects related to Lyme disease or on other 

17 tick-borne disease or disorder, including infor18 mation on— 

19 (i) the award amount, institution, pri20 mary investigator, principal investigative 

21 question or questions, and significant con22 clusions; and 

23 (ii) studies that received Federal 

24 funds and were terminated, in progress, or 

25 initiated in the fiscal year including the 


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1 date of enactment of this Act and the 5 

2 prior fiscal years; 

3 (B) for reports in subsequent years, all of 

4 the information described in subparagraph (A), 

5 except the reference in subparagraph (A)(ii) to 

6 Federal funds terminated, in progress, or 

7 awarded in the 6 prior fiscal years shall be 

8 treated as reference to such funds in the 2 prior 

9 fiscal years; 

10 (C) a status and summary report on the 

11 National Tick-Borne Disease Surveillance Sys12 tem, including— 

13 (i) the type of information collected 

14 and stored in the System; 

15 (ii) the use, distribution, and avail16 ability of such information, including 

17 guidelines for such use; and 

18 (iii) the use and coordination of sur19 veillance and patient information data20 bases; and 

21 (D) information on agreements, partner22 ships, cooperation, coordination, and data shar23 ing with external entities, such as State and 

24 local governments, other Federal agencies, 

25 working groups, and global entities; 


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1 (3) a description of major externally funded re2 search, surveillance, education, or other programs 

3 and initiatives impacting the management or science 

4 of tick-borne disease; 

5 (4) recommendations for addressing research 

6 gaps in scientific understanding of Lyme disease and 

7 other tick-borne diseases and disorders and relevant 

8 to development of effective diagnostic tools and 

9 treatment protocols for Lyme disease and other tick10 borne diseases and disorders; 

11 (5) a description of clinical practice guidelines 

12 for any tick-borne disease published on the National 

13 Guideline Clearinghouse; 

14 (6) recommendations for addressing research 

15 gaps in tick biology and tick management; 

16 (7) a description of activities for the promotion 

17 of public awareness and physician education initia18 tives to improve the knowledge of health care pro19 viders and the public in support of clinical and be20 havioral decision making in relationship to Lyme 

21 disease and other tick-borne disease; and 

22 (8) a copy of the most recent annual report 

23 issued by the Tick-Borne Disease Working Group 

24 and an assessment of progress in achieving rec25 ommendations of that Working Group. 


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1 (c) BIENNIAL REPORTS OF NIH.—The Secretary 

2 shall ensure that each biennial report under title III of 

3 the Public Health Service Act (42 U.S.C. 241 et seq.) or 

4 each triennial report under section 403 of such Act (42 

5 U.S.C. 283) includes information on actions undertaken 

6 by the National Institutes of Health to carry out research 

7 with respect to Lyme disease and other tick-borne disease. 

8 SEC. 6. DEFINITIONS. 

9 In this Act: 

10 (1) BARTONELLOSIS.—The term ‘‘bartonello11 sis’’ means disease caused by Bartonella infection 

12 from any vector or source, unless otherwise speci13 fied. 

14 (2) DISORDER.—The term ‘‘disorder’’ means a 

15 disorder caused by ticks, but not inducing human in16 fection, such as tick paralysis and Alpha-Gal meat 

17 allergy. 

18 (3) OFFICE.—The term ‘‘Office’’ means the Of19 fice of Oversight and Coordination for Tick-Borne 

20 Diseases established under section 2. 

21 (4) OTHER FEDERAL AGENCY.—Other Federal 

22 agency means a Federal Department, agency or of23 fice outside of the U.S. Department of Health and 

24 Human Services. 


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1 (5) SECRETARY.—The term ‘‘Secretary’’ means 

2 the Secretary of Health and Human Services. 

3 (6) TICK-BORNE DISEASE.—The term ‘‘tick4 borne disease’’ means a disease that is known to be 

5 transmitted by ticks in the United States, unless 

6 otherwise specified, or that may be discovered to be 

7 transmitted by ticks in the United States. 

8 (7) TICK-BORNE DISEASE WORKING GROUP.— 

9 The term ‘‘Tick-Borne Disease Working Group’’ 

10 means the Tick-Borne Disease Working Group es11 tablished under section 2062 of the 21st Century 

12 Cures Act (42 U.S.C. 284s). 

Æ 


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