II 

114TH CONGRESS 

1ST SESSION S. 1503 

To provide for enhanced Federal efforts concerning the prevention, education, 

treatment, and research activities related to Lyme disease and other 

tick-borne diseases, including the establishment of a Tick-Borne Diseases 

Advisory Committee. 

IN THE SENATE OF THE UNITED STATES 

JUNE 4, 2015 

Mr. BLUMENTHAL (for himself, Ms. AYOTTE, Mrs. GILLIBRAND, Mr. REED, 

Ms. KLOBUCHAR, Mr. COONS, Mr. WHITEHOUSE, Mr. CASEY, and Mr. 

SCHUMER) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide for enhanced Federal efforts concerning the prevention, education, treatment, and research activities related to Lyme disease and other tick-borne diseases, including the establishment of a Tick-Borne Diseases Advisory Committee. 

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 ‘‘Lyme and Tick-Borne 

5 Disease Prevention, Education, and Research Act of 

6 2015’’. 


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1 SEC. 2. FINDINGS. 

2 Congress makes the following findings: 

3 (1) Lyme disease is a common but frequently 

4 misunderstood illness that, if not caught early and 

5 treated properly, can cause serious health problems. 

6 (2) Lyme disease is caused by the bacterium 

7 Borrelia burgdorferi, which belongs to the class of 

8 spirochaetes, and is transmitted to humans by the 

9 bite of infected ticks. Early signs of infection may 

10 include a rash and flu-like symptoms, such as fever, 

11 muscle aches, headaches, and fatigue. 

12 (3) Although Lyme disease can be treated with 

13 antibiotics if caught early, the disease often goes un14 detected because it mimics other illnesses or may be 

15 misdiagnosed. Untreated, Lyme disease can lead to 

16 severe heart, neurological, and joint problems be17 cause the bacteria can affect many different organs 

18 and organ systems. 

19 (4) If an individual with Lyme disease does not 

20 receive treatment, such individual can develop severe 

21 heart, neurological, and joint problems. 

22 (5) Although Lyme disease accounts for 90 per23 cent of all vector-borne disease in the United States, 

24 the ticks that spread Lyme disease also spread other 

25 diseases, such as anaplasmosis and babesiosis, and 

26 carry other strains of Borrelia burgdorferi. Other 


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1 tick species, such as the aggressive lone star tick, 

2 spread ehrlichiosis, Rocky Mountain spotted fever, 

3 and southern tick-associated rash illness (STARI). 

4 Multiple diseases in 1 patient make diagnosis and 

5 treatment more difficult. 

6 (6) The Centers for Disease Control and Pre7 vention reported over 36,000 confirmed or probable 

8 Lyme disease cases in 2013 and has estimated that 

9 the total number of people diagnosed with Lyme dis10 ease annually is roughly 10 times higher than the 

11 number of cases reported. 

12 (7) According to the Centers for Disease Con13 trol and Prevention, from 1992 to 2006, the inci14 dence of Lyme disease was highest among children 

15 5 to 14 years of age. 

16 (8) Persistence of symptomatology in many pa17 tients without reliable testing makes diagnosis and 

18 treatment of patients more difficult. 

19 (9) In the absence of a safe and effective 

20 human vaccine, reducing exposure to ticks is the 

21 best defense against Lyme disease, Rocky Mountain 

22 spotted fever, and other tick-borne diseases. Ento23 mology-based approaches to prevent tick-borne dis24 eases include the use and development of insect reVerDate Sep 11 2014 21:53 Jun 08, 2015 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1503.IS S1503

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1 pellent, prompt tick removal, application of pes2 ticides, and reduction of tick habitat. 

3 SEC. 3. ESTABLISHMENT OF A TICK-BORNE DISEASES ADVI4 SORY COMMITTEE. 

5 (a) ESTABLISHMENT.—Not later than 180 days after 

6 the date of the enactment of this Act, the Secretary of 

7 Health and Human Services (referred to in this Act as 

8 the ‘‘Secretary’’) shall establish within the Office of the 

9 Secretary an advisory committee to be known as the Tick10 Borne Diseases Advisory Committee (referred to in this 

11 section as the ‘‘Committee’’). 

12 (b) DUTIES.—The Committee shall— 

13 (1) advise the Secretary and the Assistant Sec14 retary for Health regarding the manner in which 

15 such officials can— 

16 (A) ensure interagency coordination and 

17 communication and minimize overlap regarding 

18 efforts to address tick-borne diseases; 

19 (B) identify opportunities to coordinate ef20 forts with other Federal agencies and private 

21 organizations addressing such diseases; 

22 (C) ensure interagency coordination and 

23 communication with constituency groups; 

24 (D) ensure that a broad spectrum of sci25 entific viewpoints are considered in public 


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1 health policy decisions and that information dis2 seminated to the public and physicians is based 

3 on the best available science and is appro4 priately balanced; and 

5 (E) advise relevant Federal agencies on 

6 priorities related to Lyme disease and other 

7 tick-borne diseases; and 

8 (2) in coordination with relevant agencies with9 in the Department of Health and Human Services, 

10 regularly review published public and private treat11 ment guidelines and evaluate such guidelines for ef12 fective representation of a wide diversity of views. 

13 (c) MEMBERSHIP.— 

14 (1) APPOINTED MEMBERS.— 

15 (A) IN GENERAL.—From among individ16 uals who are not officers or employees of the 

17 Federal Government, the Secretary shall ap18 point to the Committee, as voting members, the 

19 following: 

20 (i) Not fewer than 4 members from 

21 the scientific community representing the 

22 broad spectrum of viewpoints held within 

23 the scientific community related to Lyme 

24 disease and other tick-borne diseases, in25 cluding experts in the areas of— 


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1 (I) medicine, epidemiology, and 

2 public health; 

3 (II) veterinary medicine and ani4 mal health; 

5 (III) entomology and pest man6 agement; and 

7 (IV) microbiology. 

8 (ii) Not fewer than 2 representatives 

9 of tick-borne disease voluntary advocacy 

10 organizations, which may include 1 rep11 resentative of a patient-supported tick12 borne disease advocacy organization. 

13 (iii) Not fewer than 2 health care pro14 viders, including not fewer than 1 physi15 cian involved in direct patient care, with 

16 relevant experience providing care for indi17 viduals with a broad range of acute and 

18 chronic Lyme disease and other tick-borne 

19 diseases. 

20 (iv) Not fewer than 2 patient rep21 resentatives who are individuals who have 

22 been diagnosed with Lyme disease or an23 other tick-borne disease or who have had 

24 an immediate family member diagnosed 

25 with such a disease. 


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1 (v) Not fewer than 2 representatives 

2 of State and local health departments and 

3 national organizations that represent State 

4 and local health professionals who inves5 tigate or treat patients with Lyme disease 

6 or other tick-borne diseases. 

7 (B) DIVERSITY.—In appointing members 

8 under this paragraph, the Secretary shall en9 sure that such members, as a group, represent 

10 a diversity of scientific perspectives relevant to 

11 the duties of the Committee. 

12 (2) EX OFFICIO MEMBERS.—The Secretary 

13 shall designate, as nonvoting, ex officio members of 

14 the Committee, representatives overseeing tick-borne 

15 disease activities from each of the following Federal 

16 agencies: 

17 (A) The Centers for Disease Control and 

18 Prevention. 

19 (B) The National Institutes of Health. 

20 (C) The Agency for Healthcare Research 

21 and Quality. 

22 (D) The Food and Drug Administration. 

23 (E) The Office of the Assistant Secretary 

24 for Health. 

25 (F) The Department of Agriculture. 


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1 (G) Such additional Federal departments 

2 and agencies as the Secretary determines ap3 propriate. 

4 (3) CO-CHAIRPERSONS.—The Committee shall 

5 be headed by the following co-chairpersons: 

6 (A) The Assistant Secretary of Health. 

7 (B) A public chairperson appointed by the 

8 members of the Committee, who shall serve a 2- 

9 year term. 

10 (4) TERM OF APPOINTMENT.—The term of 

11 service for each member of the Committee appointed 

12 under paragraph (1) shall be 4 years. 

13 (5) VACANCY.—A vacancy in the membership of 

14 the Committee shall be filled in the same manner as 

15 the original appointment. Any member appointed to 

16 fill a vacancy for an unexpired term shall be ap17 pointed for the remainder of that term. Members 

18 may serve after the expiration of their terms until 

19 their successors have taken office. 

20 (d) MEETINGS.—The Committee shall hold public 

21 meetings after providing notice to the public of such meet22 ings, and shall meet at least twice a year with additional 

23 meetings subject to the call of the co-chairpersons. Agenda 

24 items with respect to such meetings may be added at the 

25 request of the members of the Committee, including the 


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1 co-chairpersons. Meetings shall be conducted, and records 

2 of the proceedings shall be maintained, as required by ap3 plicable law and by regulations of the Secretary. 

4 (e) REPORT.—Not later than 1 year after the date 

5 of enactment of this Act and annually thereafter, the Com6 mittee, acting through the members representing the Cen7 ters for Disease Control and Prevention and the National 

8 Institutes of Health, shall submit a report to the Sec9 retary. Each such report shall contain, at a minimum— 

10 (1) a description of the Committee’s functions; 

11 (2) a list of the Committee’s members and their 

12 affiliations; and 

13 (3) a summary of the Committee’s activities 

14 and recommendations during the previous year, in15 cluding any significant issues regarding the func16 tioning of the Committee. 

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

18 SURVEILLANCE, PREVENTION, AND RE19 SEARCH OF LYME DISEASE AND OTHER TICK20 BORNE DISEASES. 

21 (a) IN GENERAL.—The Secretary, acting, as appro22 priate, through the Director of the Centers for Disease 

23 Control and Prevention, the Director of the National Insti24 tutes of Health, the Commissioner of Food and Drugs, 

25 the Director of the Agency for Healthcare Research and 


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1 Quality, the Chief of the Forest Service, or other Federal 

2 agencies as the Secretary determines appropriate, and in 

3 consultation with the Tick-Borne Diseases Advisory Com4 mittee, shall— 

5 (1) conduct or support the activities described 

6 in subsection (b); and 

7 (2) coordinate all Federal programs and activi8 ties related to Lyme disease and other tick-borne 

9 diseases. 

10 (b) ACTIVITIES.—The activities described in this sub11 section are the following: 

12 (1) The development of diagnostic tests, includ13 ing— 

14 (A) the development of sensitive and more 

15 accurate diagnostic tools and tests, including a 

16 direct detection test for Lyme disease capable 

17 of distinguishing active infection from past in18 fection; 

19 (B) improving the efficient utilization of 

20 diagnostic tests that have been adequately vali21 dated clinically available to account for the mul22 tiple clinical manifestations of both acute and 

23 chronic Lyme disease; 

24 (C) providing for the timely evaluation of 

25 promising emerging diagnostic methods; and 


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1 (D) the development of quantitative assays 

2 for the detection of tick-borne pathogens in 

3 ticks. 

4 (2) Surveillance and reporting of Lyme disease 

5 and other tick-borne diseases— 

6 (A) to accurately determine the incidence 

7 of Lyme disease and other tick-borne diseases; 

8 (B) to evaluate the feasibility of developing 

9 a reporting system for the collection of data on 

10 cases of Lyme disease that do not meet the sur11 veillance criteria of the Centers for Disease 

12 Control and Prevention in order to more accu13 rately gauge disease incidence; 

14 (C) to evaluate the feasibility of creating a 

15 national uniform reporting system including re16 quired reporting by laboratories in each State; 

17 and 

18 (D) to evaluate the feasibility of creating a 

19 national monitoring system for tick populations. 

20 (3) Prevention activities, including— 

21 (A) the provision and promotion of access 

22 to a comprehensive, up-to-date clearinghouse of 

23 peer-reviewed information on Lyme disease and 

24 other tick-borne diseases; 


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1 (B) increased public education related to 

2 Lyme disease and other tick-borne diseases 

3 through the expansion of the Community Based 

4 Education Programs of the Centers for Disease 

5 Control and Prevention to include expansion of 

6 information access points to the public; 

7 (C) the creation of a physician education 

8 program that includes the full spectrum of sci9 entific research related to the identification of 

10 symptoms associated with, and the diagnosis of, 

11 Lyme disease and other tick-borne diseases, 

12 and, in coordination with the Tick-Borne Dis13 eases Advisory Committee established under 

14 section 3, the publication of an annual report 

15 that evaluates published guidelines and current 

16 research available on Lyme disease, in order to 

17 best educate health professionals on the latest 

18 research and diversity of treatment options for 

19 Lyme disease; 

20 (D) research to understand mechanisms of 

21 tick repellents and to develop new chemical and 

22 non-chemical strategies for the control of ticks; 

23 and 

24 (E) exploring the utility and potential for 

25 the development of a safe and effective vaccine 


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1 against Lyme disease and other tick-borne dis2 eases. 

3 (4) Sponsoring scientific conferences on Lyme 

4 disease and other tick-borne diseases, including re5 porting in accordance with subsection (c) and con6 sideration of the full spectrum of clinically based 

7 knowledge, with the first of such conferences to be 

8 held not later than 2 years after the date of enact9 ment of this Act. 

10 (5) Clinical outcomes research, including— 

11 (A) the establishment of epidemiological 

12 research objectives to determine the long-term 

13 course of illness for Lyme disease; and 

14 (B) determination of the effectiveness of 

15 different treatment modalities by establishing 

16 treatment outcome objectives. 

17 (c) SCIENTIFIC CONFERENCES.— 

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

19 Congress that participation in or sponsorship of sci20 entific conferences and meetings is essential to the 

21 mission of the Department of Health and Human 

22 Services in addressing Lyme disease and other tick23 borne diseases. 

24 (2) CONFERENCE REPORTING.— 


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1 (A) IN GENERAL.—The Secretary shall 

2 submit to Congress an annual report regarding 

3 the costs and contracting procedures related to 

4 conferences with respect to addressing Lyme 

5 disease and other tick-borne diseases that are 

6 organized by the Federal Government or at7 tended by representatives of the Federal Gov8 ernment, for which the cost to the Federal Gov9 ernment was more than $100,000. 

10 (B) CONTENTS.—Each report submitted 

11 under subparagraph (A) shall include, with re12 spect to each such conference held during the 

13 applicable period— 

14 (i) a description of the purpose of the 

15 conference; 

16 (ii) the number of participants attend17 ing; 

18 (iii) a detailed statement of the costs 

19 to the Federal Government, including— 

20 (I) the cost of any food or bev21 erages; 

22 (II) the cost of any audio-visual 

23 services; 


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1 (III) the cost of employee or con2 tractor travel to and from the con3 ference; and 

4 (IV) a discussion of the method5 ology used to determine which costs 

6 relate to the conference; and 

7 (iv) a description of the contracting 

8 procedures used in coordinating the con9 ference, including— 

10 (I) whether contracts were 

11 awarded on a competitive basis; and 

12 (II) a discussion of any cost com13 parison conducted by the depart14 mental component or office in evalu15 ating potential contractors for the 

16 conference. 

17 SEC. 5. REPORTS ON LYME DISEASE AND OTHER TICK18 BORNE DISEASES. 

19 (a) IN GENERAL.—Not later than 18 months after 

20 the date of enactment of this Act and annually thereafter, 

21 the Secretary shall submit to Congress a report on the 

22 activities carried out under this Act. 

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

24 include— 


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1 (1) information relating to significant activities 

2 or developments related to the surveillance, diag3 nosis, treatment, education, or prevention of Lyme 

4 disease or other tick-borne diseases, including sug5 gestions for further research and education; 

6 (2) a scientifically qualified assessment of Lyme 

7 disease and other tick-borne diseases, including both 

8 acute and chronic instances, related to the broad 

9 spectrum of clinical evidence of treating physicians 

10 involved in direct patient care, as well as published 

11 peer reviewed data, that shall include recommenda12 tions for addressing interagency research gaps in 

13 tick biology and tick management, and the diag14 nosis, transmission, and treatment of Lyme disease 

15 and other tick-borne diseases, and an evaluation of 

16 treatment guidelines and the utilization of such 

17 guidelines; 

18 (3) details regarding progress in the develop19 ment of accurate diagnostic tools that are more use20 ful in the clinical setting for both acute and chronic 

21 disease; 

22 (4) information relating to the promotion of 

23 public awareness and physician education initiatives 

24 to improve the knowledge of health care providers 

25 and the public regarding clinical and surveillance 


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1 practices for Lyme disease and other tick-borne dis2 eases; and 

3 (5) a copy of the most recent annual report of 

4 the Tick-Borne Diseases Advisory Committee issued 

5 under section 3(e), and an assessment of progress in 

6 achieving the recommendations included in such re7 port. 

8 SEC. 6. APPROPRIATIONS. 

9 Funds for the purpose of carrying out this Act may 

10 be derived from amounts appropriated to the Department 

11 of Health and Human Services and otherwise available for 

12 obligation and expenditure for each of the fiscal years 

13 2016 through 2020. Amounts appropriated under the pre14 ceding sentence shall be used for the expenses and per 

15 diem costs incurred by the Tick-Borne Diseases Advisory 

16 Committee established under section 3 in accordance with 

17 the Federal Advisory Committee Act (5 U.S.C. App.), ex18 cept that no voting member of the Tick-Borne Diseases 

19 Advisory Committee shall be a permanent salaried em20 ployee. 

Æ 


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