I 

109TH CONGRESS 

1ST SESSION H. R. 3427 

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 HOUSE OF REPRESENTATIVES 

JULY 26, 2005 

Mr. SMITH of New Jersey (for himself and Mrs. KELLY) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

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 2005’’. 
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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 a bacterial infection that is 

7 transmitted by a tick bite. Early signs of infection 

8 may include a rash and flu-like symptoms such as 

9 fever, muscle aches, headaches, and fatigue. 

10 (3) Although Lyme disease can be treated with 

11 antibiotics if caught early, the disease often goes un12 detected because it mimics other illnesses or may be 

13 misdiagnosed. Untreated, Lyme disease can lead to 

14 severe heart, neurological, eye, and joint problems 

15 because the bacteria can affect many different or16 gans and organ systems. 

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

18 receive treatment, such individual can develop severe 

19 heart, neurological, eye, and joint problems. 

20 (5) Although Lyme disease accounts for 90 per21 cent of all vector-borne infections in the United 

22 States, the ticks that spread Lyme disease also 

23 spread other diseases, such as ehrlichiosis, 

24 babesiosis, and other strains of Borrelia. All of these 

25 diseases in 1 patient makes diagnosis and treatment 

26 more difficult. 
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1 (6) Studies indicate that the actual number of 

2 tick-borne disease cases are approximately 10 times 

3 the amount reported. 

4 (7) Persistence of symptomatology in many pa5 tients without reliable testing makes treatment of 

6 patients more difficult. 

7 SEC. 3. ESTABLISHMENT OF A TICK-BORNE DISEASES ADVI8 SORY COMMITTEE. 

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

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

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

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

13 Secretary an advisory committee to be known as the Tick14 Borne Diseases Advisory Committee (referred to in this 

15 section as the ‘‘Committee’’). 

16 (b) DUTIES.—The Committee shall advise the Sec17 retary and the Assistant Secretary for Health regarding 

18 the manner in which such officials can— 

19 (1) ensure interagency coordination and com20 munication and minimize overlap regarding efforts 

21 to address tick-borne diseases; 

22 (2) identify opportunities to coordinate efforts 

23 with other Federal agencies and private organiza24 tions addressing such diseases; 
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1 (3) ensure interagency coordination and com2 munication with constituency groups; 

3 (4) ensure that a broad spectrum of scientific 

4 viewpoints are represented in public health policy de5 cisions and that information disseminated to the 

6 public and physicians is balanced; and 

7 (5) advise relevant Federal agencies on prior8 ities related to the Lyme and tick-borne diseases. 

9 (c) MEMBERSHIP.— 

10 (1) APPOINTED MEMBERS.— 

11 (A) IN GENERAL.—From among individ12 uals who are not officers or employees of the 

13 Federal Government, the Secretary shall ap14 point to the Committee, as voting members, an 

15 equal number of individuals from each of the 

16 groups described in clauses (i) through (v) of 

17 subparagraph (B). 

18 (B) GROUPS.—The groups described in 

19 this subparagraph include the following: 

20 (i) Scientific community members rep21 resenting the broad spectrum of viewpoints 

22 held within the scientific community re23 lated to Lyme and other tick-borne dis24 eases. 
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1 (ii) Representatives of tick-borne dis2 ease voluntary organizations. 

3 (iii) Health care providers, including 

4 at least 1 full-time practicing physician, 

5 with relevant experience providing care for 

6 individuals with a broad range of acute 

7 and chronic tick-borne diseases. 

8 (iv) Patient representatives who are 

9 individuals who have been diagnosed with a 

10 tick-borne disease or who have had an im11 mediate family member diagnosed with 

12 such a disease. 

13 (v) Representatives of State and local 

14 health departments and national organiza15 tions that represent State and local health 

16 professionals. 

17 (C) DIVERSITY.—In appointing members 

18 under this paragraph, the Secretary shall en19 sure that such members, as a group, represent 

20 a diversity of scientific perspectives relevant to 

21 the duties of the Committee. 

22 (2) EX OFFICIO MEMBERS.—The Secretary 

23 shall designate, as nonvoting, ex officio members of 

24 the Committee, representatives overseeing tick-borne 
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1 disease activities from each of the following Federal 

2 agencies: 

3 (A) The Centers for Disease Control and 

4 Prevention. 

5 (B) The National Institutes of Health. 

6 (C) The Agency for Healthcare Research 

7 and Quality. 

8 (D) The Food and Drug Administration. 

9 (E) The Office of the Assistant Secretary 

10 for Health. 

11 (F) Such additional Federal agencies as 

12 the Secretary determines to be appropriate. 

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

14 designate the Assistant Secretary of Health as the 

15 co-chairperson of the Committee. The appointed 

16 members of the Committee shall also elect a public 

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

18 a 2-year term. 

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

20 service for each member of the Committee appointed 

21 under paragraph (1) shall be 4 years. 

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

23 the Committee shall be filled in the same manner as 

24 the original appointment. Any member appointed to 

25 fill a vacancy for an unexpired term shall be ap-
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1 pointed for the remainder of that term. Members 

2 may serve after the expiration of their terms until 

3 their successors have taken office. 

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

5 meetings, except as otherwise determined by the Sec6 retary, after providing notice to the public of such meet7 ings, and shall meet at least twice a year with additional 

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

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

10 request of the members of the Committee, including the 

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

12 of the proceedings shall be maintained, as required by ap13 plicable law and by regulations of the Secretary. 

14 (e) AUTHORIZATION OF APPROPRIATIONS.—For the 

15 purpose of carrying out this section, there is authorized 

16 to be appropriated $250,000 for each of the fiscal years 

17 2006 through 2009. Amounts appropriated under the pre18 ceding sentence shall be used for the expenses and per 

19 diem costs incurred by the Committee under this section 

20 in accordance with the Federal Advisory Committee Act, 

21 except that no voting member of the Committee shall be 

22 a permanent salaried employee. 
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1 SEC. 4. FEDERAL ACTIVITIES RELATED TO THE DIAGNOSIS, 

2 SURVEILLANCE, PREVENTION, AND RE3 SEARCH OF LYME AND OTHER TICK-BORNE 

4 DISEASES. 

5 (a) IN GENERAL.—The Secretary, acting as appro6 priate through the Director of the Centers for Disease 

7 Control and Prevention, the Director of the National Insti8 tutes of Health, the Commissioner of Food and Drugs, 

9 and the Director of the Agency for Healthcare Research 

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

11 Secretary determines to be appropriate, and in consulta12 tion with the Tick-Borne Diseases Advisory Committee, 

13 shall provide for the coordination of all Federal programs 

14 and activities related to Lyme and other tick-borne dis15 eases, including the activities described in paragraphs (1) 

16 through (4) of subsection (b). 

17 (b) ACTIVITIES.—The activities described in this sub18 section are the following: 

19 (1) DEVELOPMENT OF DIAGNOSTIC TESTS.— 

20 Such activities include— 

21 (A) the development of sensitive and more 

22 accurate diagnostic tools and tests, including a 

23 direct detection test for Lyme disease capable 

24 of distinguishing active infection from past in25 fection; 
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1 (B) improving the efficient utilization of 

2 diagnostic testing currently available to account 

3 for the multiple clinical manifestations of both 

4 acute and chronic Lyme disease; and 

5 (C) providing for the timely evaluation of 

6 promising emerging diagnostic methods. 

7 (2) SURVEILLANCE AND REPORTING.—Such ac8 tivities include surveillance and reporting of Lyme 

9 and other tick-borne diseases— 

10 (A) to accurately determine the prevalence 

11 of Lyme and other tick-borne disease; 

12 (B) to evaluate the feasibility of developing 

13 a reporting system for the collection of data on 

14 physician-diagnosed cases of Lyme disease that 

15 do not meet the surveillance criteria of the Cen16 ters for Disease Control and Prevention in 

17 order to more accurately gauge disease inci18 dence; and 

19 (C) to evaluate the feasibility of creating a 

20 national uniform reporting system including re21 quired reporting by laboratories in each State. 

22 (3) PREVENTION.—Such activities include— 

23 (A) the provision and promotion of access 

24 to a comprehensive, up-to-date clearinghouse of 
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1 peer-reviewed information on Lyme and other 

2 tick-borne disease; 

3 (B) increased public education related to 

4 Lyme and other tick-borne diseases through the 

5 expansion of the Community Based Education 

6 Programs of the Centers for Disease Control 

7 and Prevention to include expansion of informa8 tion access points to the public; 

9 (C) the creation of a physician education 

10 program that includes the full spectrum of sci11 entific research related to Lyme and other tick12 borne diseases; and 

13 (D) the sponsoring of scientific conferences 

14 on Lyme and other tick-borne diseases, includ15 ing reporting and consideration of the full spec16 trum of clinically-based knowledge, with the 

17 first of such conferences to be held not later 

18 than 24 months after the date of enactment of 

19 this Act. 

20 (4) CLINICAL OUTCOMES RESEARCH.—Such ac21 tivities include— 

22 (A) the establishment of epidemiological 

23 research objectives to determine the long term 

24 course of illness for Lyme disease; and 
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1 (B) determination of the effectiveness of 

2 different treatment modalities by establishing 

3 treatment outcome objectives. 

4 (c) AUTHORIZATION OF APPROPRIATIONS.—For the 

5 purposes of carrying out this section, and for the purposes 

6 of providing for additional research, prevention, and edu7 cational activities for Lyme and other tick-borne diseases, 

8 there is authorized to be appropriated $20,000,000 for 

9 each of the fiscal years 2006 through 2010. Such author10 ization is in addition to any other authorization of appro11 priations available for such purpose. 

12 SEC. 5. REPORTS ON LYME AND OTHER TICK-BORNE DIS13 EASES . 

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

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

16 the Secretary shall submit to Congress a report on the 

17 activities carried out under this Act. 

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

19 contain— 

20 (1) significant activities or developments related 

21 to the surveillance, diagnosis, treatment, education, 

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

23 including suggestions for further research and edu24 cation; 
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1 (2) a scientifically qualified assessment of Lyme 

2 and other tick-borne diseases, including both acute 

3 and chronic instances, related to the broad spectrum 

4 of empirical evidence of treating physicians, as well 

5 as published peer reviewed data, that shall include 

6 recommendations for addressing research gaps in di7 agnosis and treatment of Lyme and other tick-borne 

8 diseases and an evaluation of treatment guidelines 

9 and their utilization; 

10 (3) progress in the development of accurate di11 agnostic tools that are more useful in the clinical 

12 setting for both acute and chronic disease; and 

13 (4) the promotion of public awareness and phy14 sician education initiatives to improve the knowledge 

15 of health care providers and the public regarding 

16 clinical and surveillance practices for Lyme disease 

17 and other tick-borne diseases. 

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