I 

115TH CONGRESS 

2D SESSION H. R. 5878 

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 

MAY 18, 2018 

Mr. SMITH of New Jersey 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 2018’’. 

7 SEC. 2. OFFICE OF OVERSIGHT AND COORDINATION FOR 

8 TICK-BORNE DISEASES. 

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

10 Human Services shall establish in the Office of the SecVerDate Sep 11 2014 23:04 May 31, 2018 Jkt 079200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5878.IH H5878

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1 retary the Office of Oversight and Coordination for Tick2 Borne Diseases, to be headed by a director appointed by 

3 the Secretary— 

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

5 integrated national strategy to overcome Lyme dis6 ease and other tick-borne diseases; and 

7 (2) to oversee and coordinate Lyme disease and 

8 other tick-borne disease programs and activities 

9 across the agencies and offices of the Department of 

10 Health and Human Services. 

11 (b) OBJECTIVE OF OFFICE.—In carrying out sub12 section (a), the Director of the Office shall facilitate and 

13 work to ensure accomplishment of the following activities: 

14 (1) Expansion and enhancement of epidemiolog15 ical research and basic, translational, and clinical bi16 ological and biomedical research. 

17 (2) Expansion and improvement of the surveil18 lance and reporting of Lyme disease and other tick19 borne disease, including coinfections with agents of 

20 more than one tick-borne disease. 

21 (3) Development of effective diagnostic tests to 

22 accurately and timely diagnose Lyme disease and 

23 other tick-borne disease, including direct detention 

24 tests. 


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1 (4) Development of treatments to cure or im2 prove the lives of those who are infected with Lyme 

3 disease or other tick-borne disease or who suffer 

4 from a tick-induced disorder. 

5 (5) Design and conduct of clinical trials of suf6 ficient size and duration to support clinical rec7 ommendations. 

8 (6) Development and maintenance of one or 

9 more registries of patients and their experiences re10 lating to exposure to, diagnosis for, and treatment 

11 of tick-borne disease, including outcomes, which reg12 istries shall protect the confidentiality and safety of 

13 patient data. 

14 (7) Systematic documentation of the experi15 ences of health care professionals in diagnosing and 

16 treating tick-borne disease, including diagnostic and 

17 treatment outcomes. 

18 (8) Inclusion of individuals with chronic Lyme 

19 disease in clinical, research, and service efforts. 

20 (9) Coordination with international bodies to in21 tegrate and inform the fight against Lyme disease 

22 and tick-borne disease globally. 

23 (c) INTEGRATION OF TICK-BORNE DISEASE WORK24 ING GROUP FINDINGS AND RECOMMENDATIONS.—In car25 rying out this section, the Director of the Office shall, as 


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1 directed by the Secretary, with any modifications made by 

2 and as otherwise determined appropriate by the Secretary, 

3 oversee and coordinate integration and implementation, 

4 into the activities of the Office and the activities and pro5 grams of the agencies and offices of the Department of 

6 Health and Human Services, of the recommendations to 

7 the Secretary and the findings and conclusions in the lat8 est report of the Tick-Borne Disease Working Group sub9 mitted to the Secretary and congressional committees. 

10 (d) PRIORITY BASED ON DISEASE BURDEN.—In car11 rying out this section, the Director of the Office shall give 

12 priority to Lyme disease and other tick-borne disease 

13 based on assessments of disease burden in the United 

14 States. 

15 SEC. 3. NATIONAL STRATEGY. 

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

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

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

19 offices of the Department of Health and Human Services, 

20 and other Federal agencies outside of the Department of 

21 Health and Human Services as appropriate, shall— 

22 (1) not later than 2 years after the date of en23 actment of this Act, develop and submit to the Con24 gress a national strategy for the conduct and supVerDate Sep 11 2014 23:04 May 31, 2018 Jkt 079200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5878.IH H5878

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1 port of Lyme disease and other tick-borne disease or 

2 disorder programs and activities; and 

3 (2) not less than every 2 years thereafter, up4 date such strategy. 

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

6 shall include— 

7 (1) proposed budgetary requirements; 

8 (2) an assessment of all federally funded pro9 grams and activities related to surveillance, diag10 nosis, treatment, education, or prevention with re11 spect to Lyme disease or other tick-borne disease, an 

12 evaluation of progress and performance based on 

13 mission and purpose, and a description of significant 

14 challenges or barriers to performance, including an 

15 assessment of Federal grants awarded; 

16 (3) a strategy for improving diagnosis, treat17 ment, and prevention, including increasing the im18 pact of grants awarded by the National Institutes of 

19 Health, the Centers for Disease Control and Preven20 tion, and other agencies and offices of the Depart21 ment of Health and Human Services; 

22 (4) a strategy for improving outcomes of indi23 viduals with Lyme disease and other tick-borne dis24 eases and disorders, including progress related to 

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1 sistent infection and coinfections, including plans for 

2 evaluating the potential value of and supporting the 

3 conduct of observational studies, comparative effec4 tiveness research, patient-centered outcomes re5 search, or other real world evidence; 

6 (5) the appropriate benchmarks to measure 

7 progress in achieving the improvements described in 

8 paragraphs (3) and (4); 

9 (6) a strategy for improving interactions, co10 ordination, and partnerships with other Federal 

11 agencies, State and local governments, and global 

12 entities; and 

13 (7) the latest recommendations of the Tick14 Borne Disease Working Group and the steps taken 

15 by the agencies and offices of the Department of 

16 Health and Human Services to implement those rec17 ommendations. 

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

19 SURVEILLANCE, AND PREVENTION OF, AND 

20 RESEARCH ON, LYME DISEASE AND OTHER 

21 TICK-BORNE DISEASES AND DISORDERS. 

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

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

24 determines appropriate through the Director of the Cen25 ters for Disease Control and Prevention, the Director of 


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1 the National Institutes of Health, the Commissioner of 

2 Food and Drugs, the Director of the Agency for 

3 Healthcare Research and Quality, the Administrator of 

4 the Health Resources and Services Administration, the Di5 rector of the Indian Health Service, and the heads of other 

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

7 Disease Working Group, shall provide for— 

8 (1) the conduct or support of the activities de9 scribed in paragraphs (1) through (8) of subsection 

10 (b); and 

11 (2) the coordination of all programs and activi12 ties of the Department of Health and Human Serv13 ices related to Lyme disease and other tick-borne 

14 diseases and disorders and Bartonella. 

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

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

17 (1) EXPANSION AND ENHANCEMENT OF RE18 SEARCH.— 

19 (A) IN GENERAL.—The Secretary shall ex20 pand and intensify epidemiological, basic, 

21 translational, and clinical research regarding 

22 Lyme disease and other tick-borne disease and 

23 disorders and bartonellosis to better under24 stand— 


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1 (i) the pathophysiology of Borrelia 

2 burgdorferi and other tick-borne micro3 organisms that are human pathogens and 

4 of Bartonella; 

5 (ii) pathophysiological changes over 

6 time, including pathogen persistence pro7 files for patients with differing treatment 

8 histories; 

9 (iii) activation and deactivation of im10 mune system processes; and 

11 (iv) whether, and what species of, 

12 Bartonella are transmitted by ticks. 

13 (B) CLINICAL OUTCOMES RESEARCH.—The 

14 Secretary shall conduct or support clinical out15 comes research to— 

16 (i) establish epidemiological research 

17 objectives to determine the long-term 

18 course of illness for Lyme disease and 

19 other tick-borne diseases and disorders; 

20 (ii) establish patient-centered treat21 ment outcome objectives to allow for the 

22 comparative effectiveness of different treat23 ment modalities; and 

24 (iii) establish patient-centered re25 search objectives to help elucidate promVerDate Sep 11 2014 23:04 May 31, 2018 Jkt 079200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H5878.IH H5878

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1 ising treatment protocols for individuals 

2 suspected of harboring coinfections with 

3 more than one tick-transmitted pathogen. 

4 (C) COLLABORATIVE, MULTIDISCIPLINARY

5 RESEARCH.—The Secretary shall encourage the 

6 solicitation of proposals for collaborative, multi7 disciplinary research that would— 

8 (i) result in innovative approaches to 

9 study emerging scientific opportunities or 

10 eliminate gaps in research to improve the 

11 research portfolio, including application of 

12 successful and promising advances in the 

13 study of other types of diseases, such as 

14 upregulating or downregulating immune 

15 system cells or processes; 

16 (ii) outline key research questions, 

17 methodologies, and knowledge gaps; 

18 (iii) expand the number of research 

19 proposals that involve collaboration be20 tween 2 or more national research insti21 tutes or national centers of the National 

22 Institutes of Health, including proposals 

23 for research through the Common Fund 

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


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

2 to improve the research portfolio; 

3 (iv) expand the number of collabo4 rative multi-institutional research grants 

5 related to tick-borne disease; and 

6 (v) involve additional national re7 search institutes and national centers of 

8 the National Institutes of Health in intra9 mural and extramural research on tick10 borne disease, such as the National Insti11 tute of Neurological Disorders and Stroke 

12 conducting or sponsoring research on 

13 neurologic Lyme disease. 

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

15 after the date of enactment of this Act, the Sec16 retary shall evaluate and make findings on— 

17 (i) the feasibility and potential value 

18 to the research community of establishing 

19 a deidentified human subjects database for 

20 Lyme disease and other tick-borne diseases 

21 and disorders; 

22 (ii) existing government or private 

23 biorepositories for Lyme disease and other 

24 tick-borne diseases and disorders and 

25 whether— 


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1 (I) specimens and samples are 

2 adequate and available to meet re3 searcher needs; or 

4 (II) there are problems or chal5 lenges for researcher acquisition of 

6 samples and specimens; and 

7 (iii) the scope and use of specimens 

8 and samples from cadavers, the questions 

9 and answers such research may provide, 

10 and the need for additional support of re11 searchers using cadaver specimens. 

12 (E) PRIORITY.—In carrying out this para13 graph, the Secretary shall make it a priority to 

14 determine the extent of posttreatment persist15 ence of Borrelia burgdorferi and the clinical sig16 nificance of such persistence. 

17 (2) DEVELOPMENT OF NEW AND IMPROVED DI18 AGNOSTIC TESTS.— 

19 (A) IN GENERAL.—The Secretary, in co20 operation with the Director of the Office, and 

21 acting through the Directors of the Centers for 

22 Disease Control and Prevention and the Direc23 tor of the National Institutes of Health, shall 

24 conduct and support research to— 


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1 (i) provide for the timely evaluation of 

2 promising new and improved diagnostic 

3 methods, including direct-detection tests, 

4 antibody-based tests, and tests based on 

5 biosignature and biomarker profiles to 

6 make a specific diagnosis or aid in dif7 ferential diagnoses; 

8 (ii) improve the sensitivity of Lyme 

9 disease tests at all stages of disease pro10 gression; 

11 (iii) develop a Lyme disease test capa12 ble of distinguishing between past and ac13 tive infections; 

14 (iv) improve timely, sensitive, and spe15 cific diagnostic tools and tests for Rocky 

16 Mountain spotted fever; and 

17 (v) improve the performance (timeli18 ness and accuracy) of tools and tests for 

19 other tick-borne diseases found in the 

20 United States. 

21 (B) STRATEGIES FOR EXPEDITING CLEAR22 ANCE.—The Secretary shall direct the Commis23 sioner of Food and Drugs to design and pro24 pose or implement, as appropriate within the 

25 authorities and public health priorities vested in 


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1 the Secretary by other provisions of law, strate2 gies for facilitating and expediting the clearance 

3 or approval of improved diagnostic tests for 

4 Lyme disease and other tick-borne disease, par5 ticularly where— 

6 (i) there are no cleared diagnostic 

7 tests; or 

8 (ii) cleared diagnostic tests lack a 

9 high level of specificity or sensitivity or are 

10 unable to confirm the presence or absence 

11 of active infection. 

12 (3) ENSURING SAFETY AND EFFICACY OF VAC13 CINES.—The Secretary shall— 

14 (A) ensure the safety and efficacy of any 

15 new, renewed, or modified human vaccine for 

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

17 combination of such diseases; and 

18 (B) require the Commissioner of Food and 

19 Drugs to submit to the Secretary prior to final 

20 approval of the vaccine being reviewed, a report, 

21 with appropriate provisions for commercial con22 fidentiality, detailing the safety of the vaccine 

23 and contrasting its safety profile based on its 

24 mechanisms of action to safety concerns ex25 pressed to the Food and Drug Administration 


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1 regarding the human vaccine withdrawn from 

2 the market in 2002 and how those concerns 

3 with the withdrawn vaccine have been addressed 

4 or why they are not relevant. 

5 (4) MONITORING AND UNDERSTANDING HUMAN

6 CASES OF LYME DISEASE AND OTHER TICK-BORNE

7 DISEASES.— 

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

9 (i) establish and maintain a statis10 tically sound, scientifically credible surveil11 lance system to be known as the National 

12 Tick-Borne Disease Surveillance System; 

13 (ii) enhance and expand infrastructure 

14 and activities to track the epidemiology of 

15 Lyme disease and other tick-borne diseases 

16 and disorders; and 

17 (iii) incorporate information obtained 

18 through such activities into the National 

19 Tick-Borne Disease Surveillance System. 

20 (B) RESEARCH.—The Secretary shall en21 sure that the National Tick-Borne Disease Sur22 veillance System is designed in a manner that 

23 facilitates further research on Lyme disease and 

24 other tick-borne diseases and disorders. 


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1 (C) CONTENT.—In carrying out subpara2 graph (A), the Secretary— 

3 (i) shall provide for the collection and 

4 storage of information on the incidence 

5 and prevalence of tick-borne disease in the 

6 United States— 

7 (I) while continuing to support 

8 activities in the 14 States with the 

9 highest number of reported cases of 

10 Lyme disease, and intensifying efforts 

11 in other States where Lyme disease 

12 has been reported and where all re13 ported cases cannot be affirmatively 

14 associated with out-of-State travel in 

15 order to better determine where the 

16 disease is emerging; 

17 (II) working with the States and 

18 treating physicians, in consultation 

19 with the Council of State and Terri20 torial Epidemiologists (in this clause 

21 referred to as the ‘‘CSTE’’), to im22 prove evaluation of the feasibility of 

23 capturing data on cases that do not 

24 meet surveillance criteria of the CSTE 


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1 and the Centers for Disease Control 

2 and Prevention; 

3 (III) in consultation with the 

4 CSTE, working with States that are 

5 using averaging or similar techniques 

6 to estimate case reports to ensure that 

7 data produced by that process are 

8 able to be reported out by the Centers 

9 for Disease Control and Prevention; 

10 (IV) in consultation with the 

11 CSTE, working with the States to en12 courage and improve laboratory re13 porting of Lyme disease and other 

14 tick-borne diseases, and evaluate the 

15 feasibility of creating a national uni16 form reporting system including man17 datory reporting by States and physi18 cians and laboratories in each State; 

19 (V) including in the surveillance 

20 system bartonellosis transmitted by 

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

22 vector of transmission; and 

23 (VI) tracking incidence and prev24 alence data for tick-borne disorders; 

25 and 


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1 (ii) to the extent practicable, shall 

2 provide for the collection and storage of 

3 other available information on Lyme dis4 ease and other tick-borne diseases and dis5 orders, including information related to 

6 persons who have been diagnosed with and 

7 treated for tick-borne disease who choose 

8 to participate, such as— 

9 (I) demographics, such as age, 

10 race, sex, geographic location, and 

11 other information, as appropriate; 

12 (II) family history and experience 

13 with tick-borne disease or tick induced 

14 disorder; 

15 (III) history of exposure and 

16 known tick bites; 

17 (IV) progression of signs and 

18 symptoms; 

19 (V) diagnostic and treatment his20 tory and outcomes; and 

21 (VI) additional screening con22 ducted and related data, such as bio23 logical markers. 

24 (D) CONSULTATION.—In carrying out this 

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1 dividuals with appropriate expertise, which may 

2 include— 

3 (i) epidemiologists with experience in 

4 disease surveillance or registries; 

5 (ii) representatives of national patient 

6 advocacy and research organizations that 

7 focus on tick-borne disease and have dem8 onstrated experience in research, data col9 lection, or patient access to care; 

10 (iii) health information technology ex11 perts or other information management 

12 specialists; 

13 (iv) clinicians with expertise in Lyme 

14 disease or other tick-borne diseases or dis15 orders; and 

16 (v) research scientists with experience 

17 conducting translational research or uti18 lizing surveillance systems for scientific re19 search purposes. 

20 (E) GRANTS.—The Secretary may award 

21 grants to, or enter into contracts or cooperative 

22 agreements with, public or private nonprofit en23 tities to carry out activities under this para24 graph. 


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1 (F) COORDINATION WITH FEDERAL, 

2 STATE, AND LOCAL AGENCIES.—Subject to sub3 paragraph (H), the Secretary shall— 

4 (i) establish agreements and mecha5 nisms, as appropriate, for improved col6 lecting and reporting of tick-borne disease 

7 surveillance data under subparagraphs (A), 

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

9 and other available information under 

10 clause (ii) of subparagraph (C) from com11 munity health centers funded by the 

12 Health Resources and Services Administra13 tion and medical facilities of the Indian 

14 Health Service; 

15 (ii) establish formal agreements, as 

16 appropriate and may be worked out, to 

17 provide for improved collection and report18 ing of surveillance data under subpara19 graphs (A), (B) or clause (i) of subpara20 graph (C) and other available information 

21 under clause (ii) of subparagraph (C), ob22 tained from hospitals and medical clinics 

23 run by other Federal departments and 

24 agencies; 


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1 (iii) make information and analysis in 

2 the National Tick-Borne Disease Surveil3 lance System available, as appropriate, to 

4 all components of the Department of 

5 Health and Human Services, to other Fed6 eral agencies, and to State and local agen7 cies; and 

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

9 coordinate among existing data and sur10 veillance systems, surveys, registries, and 

11 other Federal public health infrastructure, 

12 wherever practicable. 

13 (G) PUBLIC ACCESS.—Subject to subpara14 graph (H), the Secretary shall ensure that in15 formation and analysis in the National Tick16 Borne Disease Surveillance System are avail17 able, as appropriate, to the public and other in18 terested parties on the website of the Depart19 ment of Health and Human Services. 

20 (H) PRIVACY.—The Secretary shall ensure 

21 that information and analysis in the National 

22 Tick-Borne Disease Surveillance System are 

23 made available only to the extent permitted by 

24 applicable Federal and State law, and in a 

25 manner that protects personal privacy, to the 


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1 extent required by applicable Federal and State 

2 privacy law, at a minimum. 

3 (5) EDUCATION AND PREVENTION.— 

4 (A) CONSUMER AND COMMUNITY EDU5 CATION.—The Secretary shall increase public 

6 education related to Lyme disease and other 

7 tick-borne diseases and disorders through the 

8 expansion of the community-based education 

9 programs of the Centers for Disease Control 

10 and Prevention to include development and 

11 publication of a consumer tick disease pam12 phlet, available online and by hard copy, ad13 dressing— 

14 (i) ticks and tick-borne diseases com15 mon to the geographic area, tick-borne dis16 ease that could be acquired while on do17 mestic or international travel, and ticks 

18 that, while not common to the geographic 

19 area, could migrate to the area; 

20 (ii) signs and symptoms of such tick21 borne disease; 

22 (iii) tick removal instructions; 

23 (iv) the most effective actions individ24 uals can take to reduce risk of exposure to 

25 ticks and risk of disease transmission; and 


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1 (v) additional community-based ac2 tions to reduce risk of exposure to ticks. 

3 (B) COORDINATION.—In carrying out sub4 paragraph (A), the Secretary, acting through 

5 the Director of the Centers for Disease Control 

6 and Prevention, shall coordinate with legally in7 corporated Lyme disease or other tick-borne 

8 disease organizations. 

9 (C) DISSEMINATION.—The Administrator 

10 of the Health Resources and Services Adminis11 tration and the Director of the Indian Health 

12 Service shall make available in rural health cen13 ters and clinics which they operate or fund— 

14 (i) the consumer tick disease pam15 phlets developed under subparagraph (A); 

16 or 

17 (ii) such other appropriate consumer 

18 tick disease pamphlets as the Administra19 tion or Service may develop or acquire. 

20 (D) PHYSICIAN EDUCATION.—The Sec21 retary shall carry out a physician education 

22 program that addresses the full spectrum of sci23 entific research related to Lyme disease and 

24 other tick-borne diseases and disorders, includ25 ing— 


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1 (i) the role of clinical diagnosis; 

2 (ii) the limitations of serological diag3 nostic tests; 

4 (iii) enhanced, validated diagnostics 

5 available from laboratories certified under 

6 section 353 of the Public Health Service 

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

8 physician; 

9 (iv) guidelines available on the Na10 tional Guideline Clearinghouse; 

11 (v) the voluntary nature of clinical 

12 practice guidelines; 

13 (vi) the complexities presented by co14 infections relating to symptomology, diag15 nosis, and treatment, including prudently 

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

17 low-incidence States; and 

18 (vii) the identification of significant 

19 research gaps most impacting diagnosis 

20 and treatment, and significant research 

21 being conducted to address those gaps. 

22 (E) PROCESS FOR DEVELOPING PHYSICIAN

23 EDUCATION PROGRAM.—The Secretary of 

24 Health and Human Services shall— 


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1 (i) conduct a public meeting to solicit 

2 input for the design of the physician edu3 cation program under subparagraph (D); 

4 (ii) give the public notice of such 

5 meeting at least 45 days in advance; 

6 (iii) also solicit input on the design of 

7 the physician education program from the 

8 Tick-Borne Disease Working Group; 

9 (iv) publish a proposed syllabus for 

10 the physician education program not more 

11 than 120 days after the public meeting; 

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

13 period before publishing such syllabus in 

14 final form; and 

15 (vi) publish on the public website of 

16 the Department of Health and Human 

17 Services a summary of the comments re18 ceived from the public under this subpara19 graph before conducting the first training 

20 program under subparagraph (D). 

21 (6) MONITORING, UNDERSTANDING, AND CON22 TROLLING VECTORS AND ANIMAL RESERVOIRS OF

23 LYME DISEASE AND OTHER TICK-BORNE DISEASE.— 

24 (A) TICK SURVEILLANCE AND TESTING.— 

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1 tor of the Office, acting through the Director of 

2 the Centers for Disease Control and Prevention 

3 and other agencies and offices of the Depart4 ment of Health and Human Services as appro5 priate, shall— 

6 (i) not later than 180 days after the 

7 date of enactment of this Act, provide a re8 port to the Congress describing the tick 

9 surveillance and pathogen testing activities 

10 of the Department and entities funded by 

11 the Department, including— 

12 (I) a detailed description of the 

13 tick surveillance and tick pathogen 

14 testing activities and planned activi15 ties of the Vector-Borne Disease Re16 gional Centers of Excellence as estab17 lished under Funding Opportunity 

18 Announcement RFA–CK–17–005, 

19 Catalog of Federal Domestic Assist20 ance Number 93.084; and 

21 (II) within such description, the 

22 roles of participating academic, gov23 ernmental, and private institutions; 

24 (ii) not later than 2 years after the 

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1 tion and coordination with other Federal 

2 agencies and State and local government 

3 agencies, as appropriate, and established 

4 academic or nonprofit tick-testing centers, 

5 develop a framework and an implementa6 tion plan for a comprehensive nationwide 

7 strategy for the surveillance and testing of 

8 ticks for human pathogens and microorga9 nisms with unknown pathogenicity, includ10 ing a plan for a network of tick identifica11 tion and testing laboratories; 

12 (iii) not later than 2 years after the 

13 date of enactment of this Act, establish 

14 agreements and procedures for sharing 

15 data on surveillance and testing of ticks 

16 with other Federal departments and agen17 cies engaged in such activities; and 

18 (iv) consult and coordinate with the 

19 American Veterinary Medical Association 

20 and the Companion Animal Parasite Coun21 cil on obtaining and sharing data on the 

22 surveillance and testing of ticks and tick23 borne pathogens, including geographic in24 formation from veterinary encounters. 


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1 (B) INVESTIGATION.—In carrying out sub2 paragraph (A), the Secretary, in coordination 

3 with the Director of the Office, acting through 

4 the Director of the Centers for Disease Control 

5 and Prevention, in consultation and coordina6 tion with other Federal agencies that conduct 

7 or support tick surveillance or testing activities, 

8 as appropriate, and public and private labora9 tories, shall— 

10 (i) investigate and, where appropriate, 

11 promote the use of advanced new tech12 nologies, such as tools to discover all 

13 known and all previously unidentified 

14 microorganisms in a vector; and 

15 (ii) while being informed by previous 

16 surveillance studies, allow for the possi17 bility of rapid geographic migration of tick 

18 vectors and pathogens and unexpected 

19 findings. 

20 (C) TICK CONTROL AND PREVENTION.— 

21 The Secretary, in coordination with the Direc22 tor of the Office, acting through the Director of 

23 the Centers for Disease Control and Prevention 

24 and the Director of the National Institutes of 

25 Health, shall, as appropriate and pursuant to 


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1 authorities vested in the Secretary by other pro2 visions of law, support activities of and coordi3 nate and share, information with other Federal, 

4 State, and local government agencies, involved 

5 or interested in tick prevention and control ac6 tivities on— 

7 (i) the development of safer and more 

8 effective tick repellents, both natural and 

9 chemical; 

10 (ii) the use of acaricides or other 

11 chemical interventions; 

12 (iii) nonchemical environmental meas13 ures to lessen human exposure to ticks; 

14 (iv) genetic therapies for vectors or 

15 animal hosts to interfere with the life cycle 

16 of pathogens; and 

17 (v) the development of vector or res18 ervoir host vaccines. 

19 (D) Leveraging existing tick management 

20 resources.—In carrying out this paragraph, the 

21 Secretary, in coordination with the Director of 

22 the Office, acting through the Director of the 

23 Centers for Disease Control and Prevention, 

24 shall identify, build upon, leverage, and coordi25 nate among existing tick surveillance, testing, 


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1 and management resources and infrastructure 

2 wherever practicable. 

3 (E) Public access to data.—In carrying out 

4 this paragraph, the Secretary, in coordination 

5 with the Director of the Office, acting through 

6 the Director of the Centers for Disease Control 

7 and Prevention, in coordination and consulta8 tion with other Federal agencies and State and 

9 local agencies as appropriate, make data on tick 

10 surveillance, testing, control and prevention 

11 available to the public on the website of the De12 partment of Health and Human Services. 

13 (7) CONFERENCES, SYMPOSIA, SEMINARS, AND

14 OTHER PUBLIC MEETINGS.— 

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

16 of the Congress that public meetings, con17 ferences, symposia, and seminars (including 

18 webinars) sponsored by the Federal Govern19 ment are a valuable input to strategic and oper20 ational programmatic planning within Federal 

21 agencies and to the work of the Tick-Borne 

22 Disease Working Group. 

23 (B) REQUIREMENTS.—The Secretary and 

24 the Director of the Office, in cooperation with 

25 the Director of the Centers for Disease Control 


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1 and Prevention, the Director of the National 

2 Institutes of Health, and the Tick-Borne Dis3 ease Working Group, shall— 

4 (i) no later than 24 months after the 

5 date of enactment of this Act, sponsor a 

6 state-of-the-science conference on Lyme 

7 disease and other tick-borne disease includ8 ing identification of research gaps and top 

9 research priorities; 

10 (ii) for any scientific or medical con11 ference on Lyme disease or other tick12 borne disease that is organized, sponsored, 

13 or paid for by the Department of Health 

14 and Human Services, ensure that a con15 trolling statement of work and significant 

16 modifications thereto, whether in the con17 tract or as a separate document, issued to 

18 the vendor organizing or conducting the 

19 conference are in writing and made avail20 able to the public prior to the conference; 

21 (iii) not later than 120 days after the 

22 conclusion of the conference under clause 

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

24 conference to the Tick-Borne Disease 

25 Working Group and to the public; 


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1 (iv) not later than 18 months after 

2 the date of enactment of this Act, working 

3 through the Director of the Agency for 

4 Healthcare Research and Quality, sponsor 

5 a symposium on the use of real-world evi6 dence (meaning data from sources other 

7 than randomized clinical trials, such as ob8 servational studies, comparative effective9 ness and patient-centered outcomes re10 search, and patient clinical data or human 

11 subject data), including the standards and 

12 methodologies for collection and analysis of 

13 real-world evidence in managing Lyme dis14 ease and other tick-borne disease; 

15 (v) include in such symposium identi16 fication and analysis of existing data 

17 sources, such as patient registries and 

18 human subjects’ databases; 

19 (vi) sponsor a researcher workshop on 

20 challenges and solutions for clinical trial 

21 design and implementation for Lyme dis22 ease to be held no later than 24 months 

23 after the date of enactment of this Act, 

24 which workshop may consider other tick25 borne disease or coinfections with more 


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1 than one tick-borne pathogen as may be 

2 feasible and practicable; 

3 (vii) not later than 9 months after the 

4 date of enactment of this Act, in consulta5 tion with the Tick-Borne Disease Working 

6 Group, design a survey instrument or in7 struments targeted to patients and patient 

8 advocates, physicians and health care pro9 viders, and researchers regarding rec10 ommended subjects and agendas for feder11 ally sponsored meetings, conferences, and 

12 seminars, including webinars, on Lyme dis13 ease and other tick-borne disease; 

14 (viii) not later than 6 months after 

15 the conduct of the survey, provide an anal16 ysis of the results of the survey to the 

17 Tick-Borne Disease Working Group and 

18 publish such results in the Federal Reg19 ister for a 60-day public comment period; 

20 and 

21 (ix) provide a final analysis and a pro22 posed schedule and agenda for public 

23 meetings, conferences, and seminars, in24 cluding webinars, for incorporation into the 

25 national strategy under section 3 as approVerDate Sep 11 2014 23:04 May 31, 2018 Jkt 079200 PO 00000 Frm 00032 Fmt 6652 Sfmt 6201 E:\BILLS\H5878.IH H5878

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1 priate and to the Tick-Borne Disease 

2 Working Group. 

3 (8) COMMON RESEARCH BIBLIOGRAPHY.—The 

4 Secretary, in coordination with the Director of the 

5 Office, shall direct the Director of the Agency for 

6 Healthcare Research and Quality to assemble a bib7 liography of peer-reviewed literature of tick-borne 

8 diseases and disorders in the United States, as well 

9 as for bartonellosis from whatever cause, appro10 priately organized for use by the scientific commu11 nity, treating physicians, and the public. The bibliog12 raphy should include literature relating to possible 

13 mechanisms of persistent infection with Borrelia 

14 burgdorferi or other types of Borrelia. 

15 (c) PRIORITY BASED ON DISEASE BURDEN.—In con16 ducting and supporting activities under this section, the 

17 Secretary shall give priority to Lyme disease and other 

18 tick-borne diseases based on assessments of disease bur19 den in the United States. 

20 SEC. 5. BIENNIAL REPORTS. 

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

22 the date of the enactment of this Act, and biennially there23 after, the Secretary shall submit to the Congress a report 

24 on the activities carried out under this Act and the activi25 ties of the Tick-Borne Disease Working Group. 


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

2 contain— 

3 (1) a scientifically qualified assessment of Lyme 

4 disease and other tick-borne disease, including a 

5 summary of prevalence, geography, important expo6 sure characteristics, disease stages and manifesta7 tions or symptoms of those stages, based on a syn8 thesis of the broad spectrum of empirical evidence of 

9 treating physicians, as well as published peer-re10 viewed data, to include for each tick-borne disease a 

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

12 (2) a description of all programs and activities 

13 funded by the Department of Health and Human 

14 Services that are related to the surveillance, diag15 nosis, treatment, education, or prevention of Lyme 

16 disease or other tick-borne disease, and an evalua17 tion of progress and performance based on mission 

18 and purpose, and discussion of significant challenges 

19 or barriers to performance, to include— 

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

21 a description of the intramural and extramural 

22 research portfolios of the Centers for Disease 

23 Control and Prevention, the National Institutes 

24 of Health, and other agencies and offices of the 

25 Department of Health and Human Services 


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1 which conducted or contracted for research 

2 projects related to Lyme disease or on other 

3 tick-borne disease or disorder, including infor4 mation on— 

5 (i) the award amount, institution, pri6 mary investigator, principal investigative 

7 question or questions, and significant con8 clusions; and 

9 (ii) studies that received Federal 

10 funds and were terminated, in progress, or 

11 initiated in the fiscal year including the 

12 date of enactment of this Act and the 5 

13 prior fiscal years; 

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

15 the information described in subparagraph (A), 

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

17 Federal funds terminated, in progress, or 

18 awarded in the 6 prior fiscal years shall be 

19 treated as reference to such funds in the 2 prior 

20 fiscal years; 

21 (C) a status and summary report on the 

22 National Tick-Borne Disease Surveillance Sys23 tem, including— 

24 (i) the type of information collected 

25 and stored in the System; 


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1 (ii) the use, distribution, and avail2 ability of such information, including 

3 guidelines for such use; and 

4 (iii) the use and coordination of sur5 veillance and patient information data6 bases; and 

7 (D) information on agreements, partner8 ships, cooperation, coordination, and data shar9 ing with external entities, such as State and 

10 local governments, other Federal agencies, 

11 working groups, and global entities; 

12 (3) a description of major externally funded re13 search, surveillance, education, or other programs 

14 and initiatives impacting the management or science 

15 of tick-borne disease; 

16 (4) recommendations for addressing research 

17 gaps in scientific understanding of Lyme disease and 

18 other tick-borne diseases and disorders and relevant 

19 to development of effective diagnostic tools and 

20 treatment protocols for Lyme disease and other tick21 borne diseases and disorders; 

22 (5) a description of clinical practice guidelines 

23 for any tick-borne disease published on the National 

24 Guideline Clearinghouse; 


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1 (6) recommendations for addressing research 

2 gaps in tick biology and tick management; 

3 (7) a description of activities for the promotion 

4 of public awareness and physician education initia5 tives to improve the knowledge of health care pro6 viders and the public in support of clinical and be7 havioral decision making in relationship to Lyme 

8 disease and other tick-borne disease; and 

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

10 issued by the Tick-Borne Disease Working Group 

11 and an assessment of progress in achieving rec12 ommendations of that Working Group. 

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

14 shall ensure that each biennial report under title III of 

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

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

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

18 by the National Institutes of Health to carry out research 

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

20 SEC. 6. DEFINITIONS. 

21 In this Act: 

22 (1) BARTONELLOSIS.—The term ‘‘bartonello23 sis’’ means disease caused by Bartonella infection 

24 from any vector or source, unless otherwise speci25 fied. 


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

2 disorder caused by ticks, but not inducing human in3 fection, such as tick paralysis and Alpha-Gal meat 

4 allergy. 

5 (3) OFFICE.—The term ‘‘Office’’ means the Of6 fice of Oversight and Coordination for Tick-Borne 

7 Diseases established under section 2. 

8 (4) OTHER FEDERAL AGENCY.—Other Federal 

9 agency means a Federal Department, agency or of10 fice outside of the U.S. Department of Health and 

11 Human Services. 

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

13 the Secretary of Health and Human Services. 

14 (6) TICK-BORNE DISEASE.—The term ‘‘tick15 borne disease’’ means a disease that is known to be 

16 transmitted by ticks in the United States, unless 

17 otherwise specified, or that may be discovered to be 

18 transmitted by ticks in the United States. 

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

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

21 means the Tick-Borne Disease Working Group es22 tablished under section 2062 of the 21st Century 

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

Æ 


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