I 

113TH CONGRESS 

1ST SESSION H. R. 611 

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 

FEBRUARY 12, 2013 

Mr. SMITH of New Jersey (for himself, Mr. WOLF, Mr. GIBSON, and Mr. 

PETERSON) 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 Diseases Prevention, Education, and Research Act of 

6 2013’’. 


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1 SEC. 2. ESTABLISHMENT OF A TICK-BORNE DISEASES ADVI2 SORY COMMITTEE. 

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

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

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

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

7 Secretary an advisory committee to be known as the Tick8 Borne Diseases Advisory Committee (referred to in this 

9 section as the ‘‘Committee’’). 

10 (b) DUTIES.—The Committee shall advise the Sec11 retary and the Assistant Secretary for Health regarding 

12 the manner in which such officials can— 

13 (1) ensure interagency coordination and com14 munication and minimize overlap regarding efforts 

15 to address tick-borne diseases; 

16 (2) identify opportunities to coordinate efforts 

17 with other Federal agencies and private organiza18 tions addressing such diseases; 

19 (3) ensure interagency coordination and com20 munication with constituency groups; 

21 (4) ensure that a broad spectrum of scientific 

22 viewpoints is represented in public health policy deci23 sions and that information disseminated to the pub24 lic and physicians is balanced; and 

25 (5) advise relevant Federal agencies on prior26 ities related to the Lyme and tick-borne diseases. 


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1 (c) MEMBERSHIP.— 

2 (1) APPOINTED MEMBERS.— 

3 (A) IN GENERAL.—The Secretary shall ap4 point the voting members of the Committee 

5 from among individuals who are not officers or 

6 employees of the Federal Government. 

7 (B) GROUPS.—The voting members of the 

8 Committee shall include the following: 

9 (i) At least 4 members from the sci10 entific community representing the broad 

11 spectrum of viewpoints held within the sci12 entific community related to Lyme and 

13 other tick-borne diseases. 

14 (ii) At least 2 representatives of tick15 borne disease voluntary organizations. 

16 (iii) At least 2 health care providers, 

17 including at least 1 full-time practicing 

18 physician, with relevant experience pro19 viding care for individuals with a broad 

20 range of acute and chronic tick-borne dis21 eases. 

22 (iv) At least 2 patient representatives 

23 who are individuals who have been diag24 nosed with a tick-borne disease or who 


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1 have had an immediate family member di2 agnosed with such a disease. 

3 (v) At least 2 representatives of State 

4 and local health departments and national 

5 organizations that represent State and 

6 local health professionals. 

7 (C) 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. 


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1 (F) Such additional Federal agencies as 

2 the Secretary determines to be appropriate. 

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

4 designate the Assistant Secretary of Health as the 

5 co-chairperson of the Committee. The appointed 

6 members of the Committee shall also elect a public 

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

8 a 2-year term. 

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

10 service for each member of the Committee appointed 

11 under paragraph (1) shall be 4 years. 

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

13 the Committee shall be filled in the same manner as 

14 the original appointment. Any member appointed to 

15 fill a vacancy for an unexpired term shall be ap16 pointed for the remainder of that term. Members 

17 may serve after the expiration of their terms until 

18 their successors have taken office. 

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

20 meetings, except as otherwise determined by the Sec21 retary, 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 the enactment of this Act, and annually thereafter, the 

6 Committee, through the Director of the Centers for Dis7 ease Control and Prevention and the Director of the Na8 tional Institutes of Health, shall submit a report to the 

9 Secretary. Each such report shall contain, at a min10 imum— 

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

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

13 affiliations; and 

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

15 and recommendations during the previous year, in16 cluding any significant issues regarding the func17 tioning of the Committee. 

18 (f) AUTHORIZATION OF APPROPRIATIONS.—For the 

19 purpose of carrying out this section, there is authorized 

20 to be appropriated $250,000 for each of fiscal years 2014 

21 through 2018. Amounts appropriated under the preceding 

22 sentence shall be used for the expenses and per diem costs 

23 incurred by the Committee under this section in accord24 ance with the Federal Advisory Committee Act, except 


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1 that no voting member of the Committee shall be a perma2 nent salaried employee. 

3 SEC. 3. 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 activities de17 scribed in paragraphs (1) through (4) of subsection 

18 (b); and 

19 (2) the coordination of all Federal programs 

20 and activities related to Lyme disease and other 

21 tick-borne diseases. 

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

23 supported under subsection (a) include the following: 

24 (1) DEVELOPMENT OF DIAGNOSTIC TESTS.— 


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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. 

10 (C) Providing for the timely evaluation of 

11 promising emerging diagnostic methods. 

12 (2) SURVEILLANCE AND REPORTING.— 

13 (A) Accurately determining the prevalence 

14 of Lyme and other tick-borne disease. 

15 (B) Evaluating the feasibility of developing 

16 a reporting system for the collection of data on 

17 physician-diagnosed cases of Lyme disease that 

18 do not meet the surveillance criteria of the Cen19 ters for Disease Control and Prevention in 

20 order to more accurately gauge disease inci21 dence. 

22 (C) Evaluating the feasibility of creating a 

23 national uniform reporting system including re24 quired reporting by laboratories in each State. 

25 (3) PREVENTION.— 


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1 (A) The provision and promotion of access 

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

3 peer-reviewed information on Lyme and other 

4 tick-borne disease. 

5 (B) Increased public education related to 

6 Lyme and other tick-borne diseases through the 

7 expansion of the community-based education 

8 programs of the Centers for Disease Control 

9 and Prevention to include expansion of informa10 tion access points to the public. 

11 (C) The creation of a physician education 

12 program that includes the full spectrum of sci13 entific research related to Lyme and other tick14 borne diseases. 

15 (D) The sponsoring of scientific con16 ferences on Lyme and other tick-borne diseases, 

17 including reporting and consideration of the full 

18 spectrum of clinically based knowledge, with the 

19 first of such conferences to be held not later 

20 than 24 months after the date of the enactment 

21 of this Act. 

22 (4) CLINICAL OUTCOMES RESEARCH.— 

23 (A) The establishment of epidemiological 

24 research objectives to determine the long-term 

25 course of illness for Lyme disease. 


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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 providing for ad6 ditional research, prevention, and educational activities for 

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

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

9 2014 through 2018. Such authorization of appropriations 

10 is in addition to any other authorization of appropriations 

11 available for such purpose. Of the amounts authorized to 

12 be appropriated under this subsection— 

13 (1) for fiscal year 2014, at least $7,500,000 

14 shall be for activities of the Centers for Disease Con15 trol and Prevention; and 

16 (2) for each of fiscal years 2015 through 2018, 

17 at least $5,000,000 shall be for activities of the Cen18 ters for Disease Control and Prevention. 

19 SEC. 4. REPORTS ON LYME AND OTHER TICK-BORNE DIS20 EASES. 

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

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

24 on the activities carried out under this Act. 


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

2 contain— 

3 (1) a description of significant activities or de4 velopments related to the surveillance, diagnosis, 

5 treatment, education, or prevention of Lyme or other 

6 tick-borne diseases, including suggestions for further 

7 research and education; 

8 (2) a scientifically qualified assessment of Lyme 

9 and other tick-borne diseases, including both acute 

10 and chronic instances, related to the broad spectrum 

11 of empirical evidence of treating physicians, as well 

12 as published peer-reviewed data, that shall include 

13 recommendations for addressing research gaps in di14 agnosis and treatment of Lyme and other tick-borne 

15 diseases and an evaluation of treatment guidelines 

16 and their utilization; 

17 (3) a description of progress in the development 

18 of accurate diagnostic tools that are more useful in 

19 the clinical setting for both acute and chronic dis20 ease; 

21 (4) a description of activities for the promotion 

22 of public awareness and physician education initia23 tives to improve the knowledge of health care pro24 viders and the public regarding clinical and surveilVerDate Mar 15 2010 00:46 Feb 20, 2013 Jkt 029200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H611.IH H611

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1 lance practices for Lyme disease and other tick2 borne diseases; and 

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

4 issued by the Tick-Borne Diseases Advisory Com5 mittee established in section 2 and an assessment of 

6 progress in achieving recommendations of that Com7 mittee. 

Æ 


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