I 

109TH CONGRESS 

1ST SESSION H. R. 2877

To provide for the expansion and intensification of efforts for prevention, 

education, and research activities with respect to Lyme and other tickborne diseases, including the establishment of a Tick-Borne Diseases 

Advisory Committee. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 14, 2005

Mr. SMITH of New Jersey (for himself, Mr. GILCHREST, and Mr. PLATTS) introduced the following bill; which was referred to the Committee on Energy and Commerce 

A BILL

To provide for the expansion and intensification of efforts 

for prevention, education, and research activities with 

respect 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 ‘‘Act for Lyme Edu5 cation and Research and Tick-Borne Diseases’’ or the 

6 ‘‘ALERT Act’’. 
2

•HR 2877 IH 

1 SEC. 2. FINDINGS. 

2 The Congress finds as follows: 

3 (1) The United States alone has 82 species of 

4 ticks causing at least 10 major diseases, which are 

5 Lyme disease, anaplasmosis, human monocytic 

6 ehrlichosis, babesiosis, tick paralysis, relapsing fever, 

7 tularemia, Rocky Mountain spotted fever, Colorado 

8 tick fever, and southern tick-associated rash illness 

9 (STARI) (also known as Masters’ disease). New tick 

10 species continue to be classified, and new diseases 

11 continue to emerge. 

12 (2) Lyme disease is the most prevalent vector13 borne disease in the United States today. 

14 (3) According to the Centers for Disease Con15 trol and Prevention, only 10 percent of cases that 

16 meet its surveillance criteria are reported; thus, an 

17 estimated 200,000 to 240,000 new cases occur each 

18 year. 

19 (4) Tests to detect serum antibodies for Lyme 

20 disease can yield a high number of false-positive and 

21 false-negative results. False-negative results may 

22 delay diagnosis and treatment, which may lead to 

23 chronic, more debilitating, persistent and costly dis24 ease. 

25 (5) The diagnosis and treatment picture of 

26 Lyme disease and other tick-borne diseases can be 
3

•HR 2877 IH 

1 complicated because more than one tick-borne dis2 ease can be acquired by the bite of the same tick. 

3 (6) If it is not diagnosed and treated early, 

4 Lyme disease can lead to chronic illness and can af5 fect every system in the body, including the central 

6 nervous system. Diagnosis is complicated because 

7 Lyme disease can mimic diseases such as meningitis, 

8 multiple sclerosis, brain tumor, Alzheimer’s disease, 

9 Parkinson’s disease, ALS, and psychiatric illness. 

10 (7) According to a study by the National Insti11 tutes of Health, patients with persistent Lyme dis12 ease suffer physical disability equivalent to that of 

13 congestive heart failure, severe pain equivalent to 

14 post-operative pain, and profound fatigue similar to 

15 multiple sclerosis. 

16 SEC. 3. GOALS. 

17 (a) FIVE-YEAR PLAN.—The Secretary of Health and 

18 Human Services, acting as appropriate through the Direc19 tor of the Agency for Healthcare Research and Quality, 

20 the Director of the Centers for Disease Control and Pre21 vention, and the Director of the National Institutes of 

22 Health, shall establish a plan that, for the five fiscal years 

23 following the date of the enactment of this Act, provides 

24 for activities to be carried out during such fiscal years to25 ward achieving the goals described in paragraphs (1) 
4

•HR 2877 IH 

1 through (4) of subsection (b). The plan shall, as appro2 priate to such goals, provide for the coordination of pro3 grams and activities regarding Lyme disease and other 

4 tick-borne diseases that are conducted or supported by the 

5 Federal Government. 

6 (b) GOALS.—

7 (1) FIRST GOAL: DIAGNOSTIC TEST.—The first 

8 goal under subsection (a) shall be—

9 (A) to develop a sensitive and definitive 

10 test for the diagnosis of Lyme disease capable 

11 of distinguishing active infection from past in12 fection; 

13 (B) to improve efficient utilization of diag14 nostic testing currently available to account for 

15 the multiple clinical manifestations of both 

16 acute and chronic Lyme disease; and 

17 (C) to provide for the rapid evaluation and 

18 adoption of emerging test methods. 

19 (2) SECOND GOAL: SURVEILLANCE AND RE20 PORTING OF LYME DISEASE AND OTHER TICK21 BORNE DISEASES.—The second goal under sub22 section (a) shall be—

23 (A) to accurately determine the prevalence 

24 of Lyme disease and other tick-borne diseases 

25 in the United States; 
5

•HR 2877 IH 

1 (B) to evaluate the feasibility of developing 

2 a reporting system for collecting data on physi3 cian-diagnosed cases that do not meet the sur4 veillance criteria of the Centers for Disease 

5 Control and Prevention in order to more accu6 rately gauge disease outbreaks and incidence; 

7 and 

8 (C) to evaluate the feasibility of creating a 

9 national uniform reporting system to include 

10 mandatory reporting by laboratories in each 

11 State. 

12 (3) THIRD GOAL: PREVENTION OF LYME DIS13 EASE AND OTHER TICK-BORNE DISEASES AND COM14 PLICATIONS DUE TO DELAYED DIAGNOSIS AND

15 TREATMENT.—The third goal under subsection (a) 

16 shall be—

17 (A) for the Director of the Agency for 

18 Healthcare Research and Quality, in coordina19 tion with the Director of the Centers for Dis20 ease Control and Prevention and the Director 

21 of the National Institutes of Health, to provide 

22 and promote access to a comprehensive, up-to23 date clearinghouse of peer-reviewed information 

24 on Lyme and other tick-borne diseases; 
6

•HR 2877 IH 

1 (B) to provide for public education by ex2 panding the Community Based Education Pro3 grams of the Centers for Disease Control and 

4 Prevention to include expansion of information 

5 access points available to the public; 

6 (C) to create a physician education pro7 gram that includes the full spectrum of sci8 entific research on Lyme and other tick-borne 

9 diseases; and 

10 (D) for the Secretary to sponsor scientific 

11 conferences on Lyme and other tick-borne dis12 eases, including reporting and consideration of 

13 the full spectrum of clinically-based knowledge, 

14 with the first of such conferences held within 

15 24 months after the date of the enactment of 

16 this Act and with further conferences held as 

17 determined appropriate by the Secretary. 

18 (4) FOURTH GOAL: CLINICAL OUTCOMES RE19 SEARCH.—The fourth goal under subsection (a) 

20 shall be—

21 (A) to establish epidemiological research 

22 goals to determine the long term course of ill23 ness for Lyme disease; and 
7

•HR 2877 IH 

1 (B) to establish treatment outcomes re2 search goals to determine the effectiveness of 

3 different treatment modalities. 

4 SEC. 4. STUDY BY INSTITUTE OF MEDICINE. 

5 (a) IN GENERAL.—Not later than 90 days after the 

6 date of the enactment of this Act, the Secretary shall re7 quest the Institute of Medicine, National Academies of 

8 Sciences, to enter into an agreement with the Secretary 

9 for the conduct of a study of chronic Lyme disease. Such 

10 study shall include a systematic assessment of empirical 

11 evidence of treating physicians, as well as published peer12 reviewed data, and shall include recommendations for ad13 dressing research gaps in diagnosis and treatment of 

14 chronic Lyme disease and an assessment of treatment 

15 guidelines, such as those of the Infectious Diseases Society 

16 of America and those of the International Lyme and Asso17 ciated Diseases Society, and their utilization. 

18 (b) REPORT.—The Secretary shall ensure that, not 

19 later than one year after the Secretary enters into the 

20 agreement under subsection (a), a report providing the re21 sults of the study under such subsection is submitted to 

22 the Secretary and the Tick-Borne Diseases Advisory Com23 mittee under section 6. 
8

•HR 2877 IH 

1 SEC. 5. INCREASED FUNDING FOR RESEARCH AND EDU2 CATION. 

3 (a) IN GENERAL.—For the purpose of providing for 

4 research and educational activities for Lyme and other 

5 tick-borne diseases, and for carrying out efforts to prevent 

6 Lyme and other tick-borne diseases, there is authorized 

7 to be appropriated $20,000,000 for each of the fiscal years 

8 2006 through 2010. Such authorization is in addition to 

9 other authorizations of appropriations that are available 

10 for such purpose. 

11 (b) STUDY.—Of the amounts appropriated under 

12 subsection (a), the Secretary shall reserve not more than 

13 $500,000 for conducting the study under section 4. 

14 SEC. 6. ESTABLISHMENT OF TICK-BORNE DISEASES ADVI15 SORY COMMITTEE. 

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

17 the date of the enactment of this Act, the Secretary shall 

18 establish within the Office of the Secretary an advisory 

19 committee to be known as the Tick-Borne Diseases Advi20 sory Committee (referred to in this section as the ‘‘Com21 mittee’’). 

22 (b) DUTIES.—The Committee shall advise the Sec23 retary and the Assistant Secretary for Health regarding 

24 the manner in which such officials can—
9

•HR 2877 IH 

1 (1) ensure interagency coordination and com2 munication and minimize overlap regarding efforts 

3 to address tick-borne diseases; 

4 (2) identify opportunities to coordinate efforts 

5 with other Federal agencies and private organiza6 tions addressing such diseases; 

7 (3) ensure interagency coordination and com8 munication with constituency groups; 

9 (4) ensure that a broad spectrum of scientific 

10 viewpoints are represented in public health policy de11 cisions and that information disseminated to the 

12 public and physicians is balanced; and 

13 (5) advise relevant Federal agencies on prior14 ities. 

15 (c) MEMBERSHIP.—

16 (1) APPOINTED MEMBERS.—

17 (A) IN GENERAL.—From among individ18 uals who are not officers or employees of the 

19 Federal Government, the Secretary shall ap20 point to the Committee, as voting members, an 

21 equal number of individuals from each of the 

22 groups described in clauses (i) through (v), as 

23 follows: 

24 (i) Scientific community members rep25 resenting the broad spectrum of viewpoints 
10

•HR 2877 IH 

1 held within the scientific community, such 

2 as members of the International Lyme and 

3 Associated Diseases Society. 

4 (ii) Representatives of tick-borne dis5 ease voluntary organizations. 

6 (iii) Health care providers who are 

7 full-time practicing physicians providing 

8 care for acute and chronic tick-borne dis9 eases. 

10 (iv) Patient representatives who are 

11 individuals who have been diagnosed with 

12 tick-borne diseases or who have had an im13 mediate family member diagnosed with 

14 such a disease. 

15 (v) Representatives of State and local 

16 health departments and national organiza17 tions that represent State and local health 

18 professionals. 

19 (B) CERTAIN REQUIREMENT.—In appoint20 ing members under subparagraph (A), the Sec21 retary shall ensure that such members, as a 

22 group, represent a diversity of scientific per23 spectives relevant to the duties of the Com24 mittee. 
11

•HR 2877 IH 

1 (2) EX OFFICIO MEMBERS.—The Secretary 

2 shall designate the Assistant Secretary for Health as 

3 a nonvoting, ex officio member of the Committee. In 

4 addition, the Secretary shall designate, as nonvoting 

5 members of the Committee, representatives from 

6 each of the following Federal agencies: 

7 (A) The Agency for Healthcare Research 

8 and Quality. 

9 (B) The National Institutes of Health. 

10 (C) The Centers for Disease Control and 

11 Prevention. 

12 (D) The Food and Drug Administration. 

13 (E) The Office of the Assistant Secretary 

14 for Health. 

15 (F) Such additional Federal agencies as 

16 the Secretary determines to be appropriate. 

17 (3) CHAIR.—The members of the Committee 

18 appointed under paragraph (1) shall select an indi19 vidual from among such members to serve as the 

20 chair of the Committee. The term for serving as the 

21 chair shall be two years. 

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

23 service for each member of the Committee, other 

24 than the Assistant Secretary for Health, shall be 

25 four years. 
12

•HR 2877 IH 

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

2 the Committee shall be filled in the same manner as 

3 the original appointment. Any member appointed to 

4 fill a vacancy for an unexpired term shall be ap5 pointed for the remainder of that term. Members 

6 may serve after the expiration of their terms until 

7 their successors have taken office. 

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

9 meetings, except as otherwise determined by the Sec10 retary, giving notice to the public of such, and meet at 

11 least twice a year with additional meetings subject to the 

12 call of the Chair. Agenda items may be added at the re13 quest of members of the Committee, including the Chairs. 

14 Meetings shall be conducted, and records of the pro15 ceedings shall be maintained, as required by applicable law 

16 and by regulations of the Secretary. 

17 (e) AUTHORIZATION OF APPROPRIATIONS.—For the 

18 purpose of carrying out this section, there is authorized 

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

20 2006 and 2007. Amounts appropriated under the pre21 ceding sentence shall be used for the expenses and per 

22 diem costs incurred by the Committee under this section 

23 in accordance with the Federal Advisory Committee Act, 

24 except that no voting member of the Committee shall be 

25 a permanent salaried employee. 
13

•HR 2877 IH 

1 SEC. 7. REPORTS. 

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

3 the date of the enactment of this Act, and annually there4 after, the Secretary shall submit to the Congress a report 

5 on the activities carried out under this Act. 

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

7 describe—

8 (1) progress in the development of accurate di9 agnostic tools and treatment modalities and their 

10 use in clinical settings; 

11 (2) the promotion of public awareness and phy12 sician education initiatives to improve the knowledge 

13 of health care providers and the public regarding 

14 clinical and surveillance practices for Lyme disease 

15 and other tick-borne diseases; and 

16 (3) other significant activities relating to sur17 veillance, diagnosis, treatment, or prevention of 

18 Lyme and other tick-borne diseases. 

19 SEC. 8. DEFINITION. 

20 For purposes of this Act, the ‘‘Secretary’’ means the 

21 Secretary of Health and Human Services.

Æ