II 

112TH CONGRESS 

1ST SESSION S. 1381 

To provide for the expansion of Federal efforts concerning the prevention, 

education, treatment, and research activities related to Lyme and other 

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

Advisory Committee. 

IN THE SENATE OF THE UNITED STATES 

JULY 18, 2011 

Mr. BLUMENTHAL (for himself, Mr. REED, Mrs. GILLIBRAND, Mr. WHITEHOUSE, Mr. LIEBERMAN, and Mr. FRANKEN) introduced the following 

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

A BILL 

To provide for the expansion of Federal efforts concerning 

the prevention, education, treatment, and research activities related to Lyme 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 2011’’. 


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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 spirochetes, and is transmitted to humans by the 

9 bite of infected black-legged ticks. Early signs of in10 fection may include a rash and flu-like symptoms 

11 such as fever, 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. 

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

17 receive treatment, such individual can develop severe 

18 heart, neurological, eye, and joint problems. 

19 (5) Although Lyme disease accounts for 90 per20 cent of all vector-borne infections in the United 

21 States, the ticks that spread Lyme disease also 

22 spread other diseases, such as anaplasmosis, 

23 babesiosis, and tularemia, and carry Bartonella and 

24 other strains of Borrelia. Other tick species, such as 

25 the aggressive lone star, spread ehrlichiosis, Rocky 

26 Mountain spotted fever, and southern tick-associated 


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1 rash illness (STARI). Multiple diseases in 1 patient 

2 make diagnosis and treatment more difficult. 

3 (6) The Centers for Disease Control and Pre4 vention reported more than 38,000 confirmed and 

5 probable Lyme disease cases in 2009. Over the past 

6 decade, the incidence of Lyme disease has increased 

7 by 84 percent. 

8 (7) According to the Centers for Disease Con9 trol and Prevention, from 1992 to 2006, the inci10 dence of Lyme disease was highest among children 

11 aged 5 to 14 years of age. 

12 (8) Persistence of symptomatology in many pa13 tients without reliable testing makes diagnosis and 

14 treatment of patients more difficult. 

15 SEC. 3. ESTABLISHMENT OF A TICK-BORNE DISEASES ADVI16 SORY COMMITTEE. 

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

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

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

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

21 Secretary an advisory committee to be known as the Tick22 Borne Diseases Advisory Committee (referred to in this 

23 section as the ‘‘Committee’’). 

24 (b) DUTIES.—The Committee shall— 


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1 (1) advise the Secretary and the Assistant Sec2 retary for Health regarding the manner in which 

3 such officials can— 

4 (A) ensure interagency coordination and 

5 communication and minimize overlap regarding 

6 efforts to address tick-borne diseases; 

7 (B) identify opportunities to coordinate ef8 forts with other Federal agencies and private 

9 organizations addressing such diseases; 

10 (C) ensure interagency coordination and 

11 communication with constituency groups; 

12 (D) ensure that a broad spectrum of sci13 entific viewpoints are represented in public 

14 health policy decisions and that information dis15 seminated to the public and physicians is bal16 anced; and 

17 (E) advise relevant Federal agencies on 

18 priorities related to Lyme and other tick-borne 

19 diseases; and 

20 (2) in coordination with relevant agencies with21 in the Department of Health and Human Services, 

22 regularly review published public and private treat23 ment guidelines and evaluate such guidelines for ef24 fective representation of a wide diversity of views. 

25 (c) MEMBERSHIP.— 


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1 (1) APPOINTED MEMBERS.— 

2 (A) IN GENERAL.—From among individ3 uals who are not officers or employees of the 

4 Federal Government, the Secretary shall ap5 point to the Committee, as voting members, the 

6 following: 

7 (i) Not less than 4 members from the 

8 scientific community representing the 

9 broad spectrum of viewpoints held within 

10 the scientific community related to Lyme 

11 and other tick-borne diseases. 

12 (ii) Not less than 2 representatives of 

13 tick-borne disease voluntary organizations. 

14 (iii) Not less than 2 health care pro15 viders, including not less than 1 full-time 

16 practicing physician, with relevant experi17 ence providing care for individuals with a 

18 broad range of acute and chronic tick19 borne diseases. 

20 (iv) Not less than 2 patient represent21 atives who are individuals who have been 

22 diagnosed with a tick-borne disease or who 

23 have had an immediate family member di24 agnosed with such a disease. 


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1 (v) At least 2 representatives of State 

2 and local health departments and national 

3 organizations that represent State and 

4 local health professionals. 

5 (B) DIVERSITY.—In appointing members 

6 under this paragraph, the Secretary shall en7 sure that such members, as a group, represent 

8 a diversity of scientific perspectives relevant to 

9 the duties of the Committee. 

10 (2) EX OFFICIO MEMBERS.—The Secretary 

11 shall designate, as nonvoting, ex officio members of 

12 the Committee, representatives overseeing tick-borne 

13 disease activities from each of the following Federal 

14 agencies: 

15 (A) The Centers for Disease Control and 

16 Prevention. 

17 (B) The National Institutes of Health. 

18 (C) The Agency for Healthcare Research 

19 and Quality. 

20 (D) The Food and Drug Administration. 

21 (E) The Office of the Assistant Secretary 

22 for Health. 

23 (F) Such additional Federal agencies as 

24 the Secretary determines to be appropriate. 


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1 (3) CO-CHAIRPERSONS.—The Secretary shall 

2 designate the Assistant Secretary of Health as the 

3 co-chairperson of the Committee. The appointed 

4 members of the Committee shall also elect a public 

5 co-chairperson. The public co-chairperson shall serve 

6 a 2-year term. 

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

8 service for each member of the Committee appointed 

9 under paragraph (1) shall be 4 years. 

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

11 the Committee shall be filled in the same manner as 

12 the original appointment. Any member appointed to 

13 fill a vacancy for an unexpired term shall be ap14 pointed for the remainder of that term. Members 

15 may serve after the expiration of their terms until 

16 their successors have taken office. 

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

18 meetings, except as otherwise determined by the Sec19 retary, after providing notice to the public of such meet20 ings, and shall meet at least twice a year with additional 

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

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

23 request of the members of the Committee, including the 

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


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1 of the proceedings shall be maintained, as required by ap2 plicable law and by regulations of the Secretary. 

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

4 of enactment of this Act, and annually thereafter, the 

5 Committee, acting through the members representing the 

6 Centers for Disease Control and Prevention and the Na7 tional Institutes of Health, shall submit a report to the 

8 Secretary. Each such report shall contain, at a min9 imum— 

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 (f) AUTHORIZATION OF APPROPRIATIONS.—For the 

18 purpose of carrying out this section, there is authorized 

19 to be appropriated such sums a may be necessary for each 

20 of the fiscal years 2012 through 2016. Amounts appro21 priated under the preceding sentence shall be used for the 

22 expenses and per diem costs incurred by the Committee 

23 under this section in accordance with the Federal Advisory 

24 Committee Act (5 U.S.C. App.), except that no voting 


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1 member of the Committee shall be a permanent salaried 

2 employee. 

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

4 SURVEILLANCE, PREVENTION, AND RE5 SEARCH OF LYME AND OTHER TICK-BORNE 

6 DISEASES. 

7 (a) IN GENERAL.—The Secretary, acting as appro8 priate through the Director of the Centers for Disease 

9 Control and Prevention, the Director of the National Insti10 tutes of Health, the Commissioner of Food and Drugs, 

11 and the Director of the Agency for Healthcare Research 

12 and Quality, as well as additional Federal agencies as the 

13 Secretary determines to be appropriate, and in consulta14 tion with the Tick-Borne Diseases Advisory Committee, 

15 shall provide for— 

16 (1) the conduct or support of the activities de17 scribed in subsection (b); and 

18 (2) the coordination of all Federal programs 

19 and activities related to Lyme disease and other 

20 tick-borne diseases. 

21 (b) ACTIVITIES.—The activities described in this sub22 section are the following: 

23 (1) DEVELOPMENT OF DIAGNOSTIC TESTS.— 

24 Such activities include— 


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1 (A) the development of sensitive and more 

2 accurate diagnostic tools and tests, including a 

3 direct detection test for Lyme disease capable 

4 of distinguishing active infection from past in5 fection; 

6 (B) improving the efficient utilization of 

7 diagnostic testing currently available to account 

8 for the multiple clinical manifestations of both 

9 acute and chronic Lyme disease; and 

10 (C) providing for the timely evaluation of 

11 promising emerging diagnostic methods. 

12 (2) SURVEILLANCE AND REPORTING.—Such ac13 tivities include surveillance and reporting of Lyme 

14 and other tick-borne diseases— 

15 (A) to accurately determine the prevalence 

16 of Lyme and other tick-borne diseases; 

17 (B) to evaluate the feasibility of developing 

18 a reporting system for the collection of data on 

19 physician-diagnosed cases of Lyme disease that 

20 do not meet the surveillance criteria of the Cen21 ters for Disease Control and Prevention in 

22 order to more accurately gauge disease inci23 dence; and 


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1 (C) to evaluate the feasibility of creating a 

2 national uniform reporting system including re3 quired reporting by laboratories in each State. 

4 (3) PREVENTION.—Such activities include— 

5 (A) the provision and promotion of access 

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

7 peer-reviewed information on Lyme and other 

8 tick-borne diseases; 

9 (B) increased public education related to 

10 Lyme and other tick-borne diseases through the 

11 expansion of the Community Based Education 

12 Programs of the Centers for Disease Control 

13 and Prevention to include expansion of informa14 tion access points to the public; 

15 (C) the creation of a physician education 

16 program that includes the full spectrum of sci17 entific research related to Lyme and other tick18 borne diseases, and, in coordination with the 

19 Advisory Committee established under section 

20 3, the publication of an annual report that eval21 uates published guidelines and current research 

22 available on Lyme disease, in order to best edu23 cate health professionals on the latest research 

24 and diversity of treatment options for Lyme 

25 disease; and 


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1 (D) the sponsoring of scientific conferences 

2 on Lyme and other tick-borne diseases, includ3 ing reporting and consideration of the full spec4 trum of clinically based knowledge, with the 

5 first of such conferences to be held not later 

6 than 24 months after the date of enactment of 

7 this Act. 

8 (4) CLINICAL OUTCOMES RESEARCH.—Such ac9 tivities include— 

10 (A) the establishment of epidemiological 

11 research objectives to determine the long-term 

12 course of illness for Lyme disease; and 

13 (B) determination of the effectiveness of 

14 different treatment modalities by establishing 

15 treatment outcome objectives. 

16 (c) AUTHORIZATION OF APPROPRIATIONS.— 

17 (1) IN GENERAL.—For the purposes of carrying 

18 out this section, and for the purposes of providing 

19 for additional research, prevention, and educational 

20 activities for Lyme and other tick-borne diseases, 

21 there is authorized to be appropriated such sums as 

22 may be necessary for each of the fiscal years 2012 

23 through 2016. 

24 (2) ADDITIONAL AMOUNTS.—The authorization 

25 of appropriations under this subsection is in addition 


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1 to any other authorization of appropriations avail2 able for the purposes described in paragraph (1). 

3 SEC. 5. REPORTS ON LYME AND OTHER TICK-BORNE DIS4 EASES. 

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

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

7 the Secretary shall submit to Congress a report on the 

8 activities carried out under this Act. 

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

10 contain— 

11 (1) significant activities or developments related 

12 to the surveillance, diagnosis, treatment, education, 

13 or prevention of Lyme or other tick-borne diseases, 

14 including suggestions for further research and edu15 cation; 

16 (2) a scientifically qualified assessment of Lyme 

17 and other tick-borne diseases, including both acute 

18 and chronic instances, related to the broad spectrum 

19 of empirical evidence of treating physicians, as well 

20 as published peer reviewed data, that shall include 

21 recommendations for addressing research gaps in di22 agnosis and treatment of Lyme and other tick-borne 

23 diseases and an evaluation of treatment guidelines 

24 and their utilization; 


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1 (3) progress in the development of accurate di2 agnostic tools that are more useful in the clinical 

3 setting for both acute and chronic disease; 

4 (4) the promotion of public awareness and phy5 sician education initiatives to improve the knowledge 

6 of health care providers and the public regarding 

7 clinical and surveillance practices for Lyme disease 

8 and other tick-borne diseases; and 

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

10 issued by the Tick-Borne Diseases Advisory Com11 mittee established under section 3 and an assess12 ment of progress in achieving the recommendations 

13 included in the Committee’s report. 

Æ 


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