Lyme Disease Initiative Act of 1998

Summary: Lyme Disease Initiative Act of 1998 - Directs the Secretary of Health and Human Services (acting through the Director of the Centers for Disease Control and Prevention and the Director of the National Institute of Health and the Secretary of Defense to collaborate in: (1) establishing specified public health goals relating to activities providing for a reduction in the incidence and prevalence of Lyme disease; and (2) carrying out activities toward achieving the goals directly or through grant awards or contracts to public or nonprofit private entities.  Requires the Secretaries to establish a five-year plan for carrying out such activities and coordinating the programs and activities conducted or supported by the Government. 
Lists as goals, in priority order:  (1) developing a test to determine whether an individual has been bitten by a tick that has Lyme disease and a test for determining whether a patient has been cured; (2) reviewing the U.S. system for Lyme disease surveillance and reporting; (3) determining the average number of doctor visits before the disease is diagnosed; and (4) significantly increasing the number of physicians who have appropriate knowledge regarding the disease. 
(Sec. 4) Establishes the Lyme Disease Task Force to provide advice to the Secretaries on achieving the goals. 
(Sec. 5) Requires the submission of annual reports by the Secretaries to the Congress until the goals are met. 
(Sec. 7) Authorizes appropriations. 
(Sec. 8) Expresses the sense of the Congress that the Food and Drug Administration should:  (1) conduct a rapid and thorough review of new drug applications for drugs to immunize individuals against Lyme disease; and (2) ensure that the labeling approved for such drugs specifically indicates the particular strains of Lyme disease for which the drugs provide immunization, the duration of the period of immunization, and the drugs' reliability rate.

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Lyme Disease Initiative Act of 
1998''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) The incidence of Lyme disease in the United States is 
        increasing more rapidly than most other diseases. The Centers 
        for Disease Control and Prevention has determined that, since 
        1982, there has been a 32-fold increase in reported cases.
            (2) For 1996, such Centers determined that 16,455 cases of 
        the disease were reported.
            (3) There is no reliable standardized diagnostic test for 
        Lyme disease, and it is therefore likely that the disease is 
        severely underreported. The disease is often misdiagnosed 
        because the symptoms of the disease mimic other health 
        conditions.
            (4) Lyme disease costs our Nation at least $60,000,000 a 
        year in direct medical costs for early, acute cases. The costs 
        of chronic cases of the disease, as well as the costs of lost 
        wages and productivity, are many times higher.
            (5) Many health care providers lack the necessary knowledge 
        and expertise--particularly in non-endemic areas--to accurately 
        diagnose Lyme disease. As a result, patients often visit 
        multiple doctors before obtaining a diagnosis of the disease, 
        resulting in prolonged pain and suffering, unnecessary tests, 
        and costly and futile treatments.

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

    (a) In General.--The Secretary of Health and Human Services (acting 
as appropriate through the Director of the Centers for Disease Control 
and Prevention and the Director of the National Institutes of Health) 
and the Secretary of Defense shall collaborate to carry out the 
following:
            (1) The Secretaries shall establish the goals described in 
        subsections (c) through (f) (relating to activities to provide 
        for a reduction in the incidence and prevalence of Lyme 
        disease).
            (2) The Secretaries shall carry out activities toward 
        achieving the goals, which may include activities carried out 
        directly by the Secretaries and activities carried out through 
        awards of grants or contracts to public or nonprofit private 
        entities.
            (3) In carrying out paragraph (2), the Secretaries shall 
        give priority--
                    (A) first, to achieving the goal under subsection 
                (c);
                    (B) second, to achieving the goal under subsection 
                (d);
                    (C) third, to achieving the goal under subsection 
                (e); and
                    (D) fourth, to achieving the goal under subsection 
                (f).
    (b) Five-Year Plan.--In carrying out subsection (a), the 
Secretaries shall establish a plan that, for the 5 fiscal years 
following the date of the enactment of this Act, provides for the 
activities to be carried out during such fiscal years toward achieving 
the goals under subsections (c) through section (f). The plan shall, as 
appropriate to such goals, provide for the coordination of programs and 
activities regarding Lyme disease that are conducted or supported by 
the Federal Government.
    (c) First Goal: Detection Test.--
            (1) In general.--For purposes of subsection (a), the goal 
        described in this subsection is the development, by the 
        expiration of the 18-year period beginning on the date of the 
        enactment of this Act, of--
                    (A) a test for accurately determining whether an 
                individual who has been bitten by a tick has Lyme 
                disease; and
                    (B) a test for accurately determining whether a 
                patient with such disease has been cured of the 
                disease.
    (d) Second Goal: Improved Surveillance and Reporting System.--For 
purposes of subsection (a), the goal described in this subsection is to 
review the system in the United States for surveillance and reporting 
with respect to Lyme disease and to determine whether and in what 
manner the system can be improved (relative to the date of the 
enactment of this Act). In carrying out activities toward such goal, 
the Secretaries shall--
            (1) consult with the States, units of local government, 
        physicians, patients with Lyme disease, and organizations 
        representing such patients;
            (2) consider whether uniform formats should be developed 
        for the reporting by physicians of cases of Lyme disease to 
        public health officials; and
            (3) with respect to health conditions that are reported by 
        physicians as cases of Lyme disease but do not meet the 
        criteria established by the Director of the Centers for Disease 
        Control and Prevention to be counted as such cases, consider 
        whether data on such health conditions should be maintained and 
        analyzed to assist in understanding the circumstances in which 
        Lyme disease is being diagnosed and the manner in which it is 
        being treated.
    (e) Third Goal: Indicator Regarding Accurate Diagnosis.--For 
purposes of subsection (a), the goal described in this subsection is to 
determine the average number of visits to physicians that are made by 
patients with Lyme disease before a diagnosis of such disease is made. 
In carrying out activities toward such goal, the Secretaries shall 
conduct a study of patients and physicians in 2 or more geographic 
areas in which there is a significant incidence or prevalence of cases 
of Lyme disease.
    (f) Fourth Goal: Physician Knowledge.--For purposes of subsection 
(a), the goals described in this subsection are to make a significant 
increase in the number of physicians who have an appropriate level of 
knowledge regarding Lyme disease, and to develop and apply an objective 
method of determining the number of physicians who have such knowledge.

SEC. 4. LYME DISEASE TASK FORCE.

    (a) In General.--Not later than 120 days after the date of 
enactment of this Act, there shall be established in accordance with 
this section an advisory committee to be known as the Lyme Disease Task 
Force (in this section referred to as the Task Force).
    (b) Duties.--The Task Force shall provide advice to the Secretaries 
with respect to achieving the goals under section 3, including advice 
on the plan under subsection (b) of such section.
    (c) Composition.--The Task Force shall be composed of 9 members 
with appropriate knowledge or experience regarding Lyme disease. Of 
such members--
            (1) 2 shall be appointed by the Secretary of Health and 
        Human Services, after consultation with the Director of the 
Centers for Disease Control and Prevention;
            (2) 2 shall be appointed by the Secretary of Health and 
        Human Services, after consultation with the Director of the 
        National Institutes of Health;
            (3) 1 shall be appointed by the Secretary of Defense;
            (4) 2 shall be appointed by the Speaker of the House of 
        Representatives, after consultation with the Minority Leader of 
        the House; and
            (5) 2 shall be appointed by the President Pro Tempore of 
        the Senate, after consultation with the Minority Leader of the 
        Senate.
    (d) Chair.--The Task Force shall, from among the members of the 
Task Force, designate an individual to serve as the chair of the Task 
Force.
    (e) Meetings.--The Task Force shall meet at the call of the Chair 
or a majority of the members.
    (f) Term of Service.--The term of service of a member of the Task 
Force is the duration of the Task Force.
    (g) Vacancies.--Any vacancy in the membership of the Task Force 
shall be filled in the manner in which the original appointment was 
made and shall not affect the power of the remaining members to carry 
out the duties of the Task Force.
    (h) Compensation; Reimbursement of Expenses.--Members of the Task 
Force may not receive compensation for service on the Task Force. Such 
members may, in accordance with chapter 57 of title 5, United States 
Code, be reimbursed for travel, subsistence, and other necessary 
expenses incurred in carrying out the duties of the Task Force.
    (i) Staff; Administrative Support.--The Secretary of Health and 
Human Services shall, on a reimbursable basis, provide to the Task 
Force such staff, administrative support, and other assistance as may 
be necessary for the Task Force to effectively carry out the duties 
under subsection (b).
    (j) Termination.--The Task Force shall terminate on the date that 
is 90 days after the end of the fifth fiscal year that begins after the 
date of the enactment of this Act.

SEC. 5. ANNUAL REPORTS.

    The Secretaries shall submit to the Congress periodic reports on 
the activities carried out under this Act and the extent of progress 
being made toward the goals established under section 3. The first such 
report shall be submitted not later than 18 months after the date of 
the enactment of this Act, and subsequent reports shall be submitted 
annually thereafter until the goals are met.

SEC. 6. DEFINITION.

    For purposes of this Act, the term ``Secretaries'' means--
            (1) the Secretary of Health and Human Services, acting as 
        appropriate through the Director of the Centers for Disease 
        Control and Prevention and the Director of the National 
        Institutes of Health; and
            (2) the Secretary of Defense.

SEC. 7. AUTHORIZATION OF APPROPRIATIONS.

    (a) National Institutes of Health.--In addition to other 
authorizations of appropriations that are available for carrying out 
the purposes described in this Act and that are established for the 
National Institutes of Health, there are authorized to be appropriated 
to the Director of such Institutes for such purposes $9,000,000 for 
each of the fiscal years 1999 through 2003.
    (b) Centers for Disease Control and Prevention.--In addition to 
other authorizations of appropriations that are available for carrying 
out the purposes described in this Act and that are established for the 
Centers for Disease Control and Prevention, there are authorized to be 
appropriated to the Director of such Centers for such purposes 
$8,000,000 for each of the fiscal years 1999 through 2003.
    (c) Department of Defense.--In addition to other authorizations of 
appropriations that are available for carrying out the purposes 
described in this Act and that are established for the Department of 
Defense, there are authorized to be appropriated to the Secretary of 
Defense for such purposes $3,000,000 for each of the fiscal years 1999 
through 2003.

SEC. 8. SENSE OF THE CONGRESS.

    It is the sense of the Congress that the Food and Drug 
Administration should--
            (1) conduct a rapid and thorough review of new drug 
        applications for drugs to immunize individuals against Lyme 
        disease; and
            (2) ensure that the labeling approved for such drugs 
        specifically indicate the particular strains of Lyme disease 
        for which the drugs provide immunization, the duration of the 
        period of immunization, and the reliability rate of the drugs.