II

105TH CONGRESS

2D SESSION S. 2034

To establish a program to provide for a reduction in the incidence and

prevalence of Lyme disease.

IN THE SENATE OF THE UNITED STATES

MAY 5, 1998

Mr. DODD introduced the following bill; which was read twice and referred to

the Committee on Labor and Human Resources

A BILL

To establish a program to provide for a reduction in the

incidence and prevalence of Lyme disease.

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 Disease Initia5 tive Act of 1998’’.

6 SEC. 2. FINDINGS.

7 The Congress finds as follows:

8 (1) The incidence of Lyme disease in the

9 United States is increasing more rapidly than most

10 other diseases. The Centers for Disease Control and
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1 Prevention has determined that, since 1982, there

2 has been a 32-fold increase in reported cases.

3 (2) For 1996, such Centers determined that

4 16,455 cases of the disease were reported.

5 (3) There is no reliable standardized diagnostic

6 test for Lyme disease, and it is therefore likely that

7 the disease is severely underreported. The disease is

8 often misdiagnosed because the symptoms of the dis9 ease mimic other health conditions.

10 (4) Lyme disease costs our Nation at least

11 $60,000,000 a year in direct medical costs for early,

12 acute cases. The costs of chronic cases of the dis13 ease, as well as the costs of lost wages and produc14 tivity, are many times higher.

15 (5) Many health care providers lack the nec16 essary knowledge and expertise—particularly in non17 endemic areas—to accurately diagnose Lyme dis18 ease. As a result, patients often visit multiple doc19 tors before obtaining a diagnosis of the disease, re20 sulting in prolonged pain and suffering, unnecessary

21 tests, and costly and futile treatments.

22 SEC. 3. PUBLIC HEALTH GOALS; FIVE-YEAR PLAN.

23 (a) IN GENERAL.—The Secretary of Health and

24 Human Services (acting as appropriate through the Direc25 tor of the Centers for Disease Control and Prevention and
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1 the Director of the National Institutes of Health) and the

2 Secretary of Defense shall collaborate to carry out the fol3 lowing:

4 (1) The Secretaries shall establish the goals de5 scribed in subsections (c) through (f) (relating to ac6 tivities to provide for a reduction in the incidence

7 and prevalence of Lyme disease).

8 (2) The Secretaries shall carry out activities to9 ward achieving the goals, which may include activi10 ties carried out directly by the Secretaries and ac11 tivities carried out through awards of grants or con12 tracts to public or nonprofit private entities.

13 (3) In carrying out paragraph (2), the Secretar14 ies shall give priority—

15 (A) first, to achieving the goal under sub16 section (c);

17 (B) second, to achieving the goal under

18 subsection (d);

19 (C) third, to achieving the goal under sub20 section (e); and

21 (D) fourth, to achieving the goal under

22 subsection (f).

23 (b) FIVE-YEAR PLAN.—In carrying out subsection

24 (a), the Secretaries shall establish a plan that, for the 5

25 fiscal years following the date of the enactment of this
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1 Act, provides for the activities to be carried out during

2 such fiscal years toward achieving the goals under sub3 sections (c) through section (f). The plan shall, as appro4 priate to such goals, provide for the coordination of pro5 grams and activities regarding Lyme disease that are con6 ducted or supported by the Federal Government.

7 (c) FIRST GOAL: DETECTION TEST.—

8 (1) IN GENERAL.—For purposes of subsection

9 (a), the goal described in this subsection is the de10 velopment, by the expiration of the 18-year period

11 beginning on the date of the enactment of this Act,

12 of—

13 (A) a test for accurately determining

14 whether an individual who has been bitten by a

15 tick has Lyme disease; and

16 (B) a test for accurately determining

17 whether a patient with such disease has been

18 cured of the disease.

19 (d) SECOND GOAL: IMPROVED SURVEILLANCE AND

20 REPORTING SYSTEM.—For purposes of subsection (a), the

21 goal described in this subsection is to review the system

22 in the United States for surveillance and reporting with

23 respect to Lyme disease and to determine whether and in

24 what manner the system can be improved (relative to the
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1 date of the enactment of this Act). In carrying out activi2 ties toward such goal, the Secretaries shall—

3 (1) consult with the States, units of local gov4 ernment, physicians, patients with Lyme disease,

5 and organizations representing such patients;

6 (2) consider whether uniform formats should be

7 developed for the reporting by physicians of cases of

8 Lyme disease to public health officials; and

9 (3) with respect to health conditions that are

10 reported by physicians as cases of Lyme disease but

11 do not meet the criteria established by the Director

12 of the Centers for Disease Control and Prevention to

13 be counted as such cases, consider whether data on

14 such health conditions should be maintained and

15 analyzed to assist in understanding the cir16 cumstances in which Lyme disease is being diag17 nosed and the manner in which it is being treated.

18 (e) THIRD GOAL: INDICATOR REGARDING ACCURATE

19 DIAGNOSIS.—For purposes of subsection (a), the goal de20 scribed in this subsection is to determine the average num21 ber of visits to physicians that are made by patients with

22 Lyme disease before a diagnosis of such disease is made.

23 In carrying out activities toward such goal, the Secretaries

24 shall conduct a study of patients and physicians in 2 or
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1 more geographic areas in which there is a significant inci2 dence or prevalence of cases of Lyme disease.

3 (f) FOURTH GOAL: PHYSICIAN KNOWLEDGE.—For

4 purposes of subsection (a), the goals described in this sub5 section are to make a significant increase in the number

6 of physicians who have an appropriate level of knowledge

7 regarding Lyme disease, and to develop and apply an ob8 jective method of determining the number of physicians

9 who have such knowledge.

10 SEC. 4. LYME DISEASE TASK FORCE.

11 (a) IN GENERAL.—Not later than 120 days after the

12 date of enactment of this Act, there shall be established

13 in accordance with this section an advisory committee to

14 be known as the Lyme Disease Task Force (in this section

15 referred to as the Task Force).

16 (b) DUTIES.—The Task Force shall provide advice

17 to the Secretaries with respect to achieving the goals

18 under section 3, including advice on the plan under sub19 section (b) of such section.

20 (c) COMPOSITION.—The Task Force shall be com21 posed of 9 members with appropriate knowledge or experi22 ence regarding Lyme disease. Of such members—

23 (1) 2 shall be appointed by the Secretary of

24 Health and Human Services, after consultation with
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1 the Director of the Centers for Disease Control and

2 Prevention;

3 (2) 2 shall be appointed by the Secretary of

4 Health and Human Services, after consultation with

5 the Director of the National Institutes of Health;

6 (3) 1 shall be appointed by the Secretary of De7 fense;

8 (4) 2 shall be appointed by the Speaker of the

9 House of Representatives, after consultation with

10 the Minority Leader of the House; and

11 (5) 2 shall be appointed by the President Pro

12 Tempore of the Senate, after consultation with the

13 Minority Leader of the Senate.

14 (d) CHAIR.—The Task Force shall, from among the

15 members of the Task Force, designate an individual to

16 serve as the chair of the Task Force.

17 (e) MEETINGS.—The Task Force shall meet at the

18 call of the Chair or a majority of the members.

19 (f) TERM OF SERVICE.—The term of service of a

20 member of the Task Force is the duration of the Task

21 Force.

22 (g) VACANCIES.—Any vacancy in the membership of

23 the Task Force shall be filled in the manner in which the

24 original appointment was made and shall not affect the
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1 power of the remaining members to carry out the duties

2 of the Task Force.

3 (h) COMPENSATION; REIMBURSEMENT OF EX4 PENSES.—Members of the Task Force may not receive

5 compensation for service on the Task Force. Such mem6 bers may, in accordance with chapter 57 of title 5, United

7 States Code, be reimbursed for travel, subsistence, and

8 other necessary expenses incurred in carrying out the du9 ties of the Task Force.

10 (i) STAFF; ADMINISTRATIVE SUPPORT.—The Sec11 retary of Health and Human Services shall, on a reim12 bursable basis, provide to the Task Force such staff, ad13 ministrative support, and other assistance as may be nec14 essary for the Task Force to effectively carry out the du15 ties under subsection (b).

16 (j) TERMINATION.—The Task Force shall terminate

17 on the date that is 90 days after the end of the fifth fiscal

18 year that begins after the date of the enactment of this

19 Act.

20 SEC. 5. ANNUAL REPORTS.

21 The Secretaries shall submit to the Congress periodic

22 reports on the activities carried out under this Act and

23 the extent of progress being made toward the goals estab24 lished under section 3. The first such report shall be sub25 mitted not later than 18 months after the date of the en-
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1 actment of this Act, and subsequent reports shall be sub2 mitted annually thereafter until the goals are met.

3 SEC. 6. DEFINITION.

4 For purposes of this Act, the term ‘‘Secretaries’’

5 means—

6 (1) the Secretary of Health and Human Serv7 ices, acting as appropriate through the Director of

8 the Centers for Disease Control and Prevention and

9 the Director of the National Institutes of Health;

10 and

11 (2) the Secretary of Defense.

12 SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

13 (a) NATIONAL INSTITUTES OF HEALTH.—In addi14 tion to other authorizations of appropriations that are

15 available for carrying out the purposes described in this

16 Act and that are established for the National Institutes

17 of Health, there are authorized to be appropriated to the

18 Director of such Institutes for such purposes $9,000,000

19 for each of the fiscal years 1999 through 2003.

20 (b) CENTERS FOR DISEASE CONTROL AND PREVEN21 TION.—In addition to other authorizations of appropria22 tions that are available for carrying out the purposes de23 scribed in this Act and that are established for the Centers

24 for Disease Control and Prevention, there are authorized

25 to be appropriated to the Director of such Centers for such
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1 purposes $8,000,000 for each of the fiscal years 1999

2 through 2003.

3 (c) DEPARTMENT OF DEFENSE.—In addition to

4 other authorizations of appropriations that are available

5 for carrying out the purposes described in this Act and

6 that are established for the Department of Defense, there

7 are authorized to be appropriated to the Secretary of De8 fense for such purposes $3,000,000 for each of the fiscal

9 years 1999 through 2003.

10 SEC. 8. SENSE OF THE CONGRESS.

11 It is the sense of the Congress that the Food and

12 Drug Administration should—

13 (1) conduct a rapid and thorough review of new

14 drug applications for drugs to immunize individuals

15 against Lyme disease; and

16 (2) ensure that the labeling approved for such

17 drugs specifically indicate the particular strains of

18 Lyme disease for which the drugs provide immuniza19 tion, the duration of the period of immunization,

20 and the reliability rate of the drugs.

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