[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2877 Introduced in House (IH)]






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 tick-borne 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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Act for Lyme Education and Research 
and Tick-Borne Diseases'' or the ``ALERT Act''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (1) The United States alone has 82 species of ticks causing 
        at least 10 major diseases, which are Lyme disease, 
        anaplasmosis, human monocytic ehrlichosis, babesiosis, tick 
        paralysis, relapsing fever, tularemia, Rocky Mountain spotted 
        fever, Colorado tick fever, and southern tick-associated rash 
        illness (STARI) (also known as Masters' disease). New tick 
        species continue to be classified, and new diseases continue to 
        emerge.
            (2) Lyme disease is the most prevalent vector-borne disease 
        in the United States today.
            (3) According to the Centers for Disease Control and 
        Prevention, only 10 percent of cases that meet its surveillance 
        criteria are reported; thus, an estimated 200,000 to 240,000 
        new cases occur each year.
            (4) Tests to detect serum antibodies for Lyme disease can 
        yield a high number of false-positive and false-negative 
        results. False-negative results may delay diagnosis and 
        treatment, which may lead to chronic, more debilitating, 
        persistent and costly disease.
            (5) The diagnosis and treatment picture of Lyme disease and 
        other tick-borne diseases can be complicated because more than 
        one tick-borne disease can be acquired by the bite of the same 
        tick.
            (6) If it is not diagnosed and treated early, Lyme disease 
        can lead to chronic illness and can affect every system in the 
        body, including the central nervous system. Diagnosis is 
        complicated because Lyme disease can mimic diseases such as 
        meningitis, multiple sclerosis, brain tumor, Alzheimer's 
        disease, Parkinson's disease, ALS, and psychiatric illness.
            (7) According to a study by the National Institutes of 
        Health, patients with persistent Lyme disease suffer physical 
        disability equivalent to that of congestive heart failure, 
        severe pain equivalent to post-operative pain, and profound 
        fatigue similar to multiple sclerosis.

SEC. 3. GOALS.

    (a) Five-Year Plan.--The Secretary of Health and Human Services, 
acting as appropriate through the Director of the Agency for Healthcare 
Research and Quality, the Director of the Centers for Disease Control 
and Prevention, and the Director of the National Institutes of Health, 
shall establish a plan that, for the five fiscal years following the 
date of the enactment of this Act, provides for activities to be 
carried out during such fiscal years toward achieving the goals 
described in paragraphs (1) through (4) of subsection (b). The plan 
shall, as appropriate to such goals, provide for the coordination of 
programs and activities regarding Lyme disease and other tick-borne 
diseases that are conducted or supported by the Federal Government.
    (b) Goals.--
            (1) First goal: diagnostic test.--The first goal under 
        subsection (a) shall be--
                    (A) to develop a sensitive and definitive test for 
                the diagnosis of Lyme disease capable of distinguishing 
                active infection from past infection;
                    (B) to improve efficient utilization of diagnostic 
                testing currently available to account for the multiple 
                clinical manifestations of both acute and chronic Lyme 
                disease; and
                    (C) to provide for the rapid evaluation and 
                adoption of emerging test methods.
            (2) Second goal: surveillance and reporting of lyme disease 
        and other tick-borne diseases.--The second goal under 
        subsection (a) shall be--
                    (A) to accurately determine the prevalence of Lyme 
                disease and other tick-borne diseases in the United 
                States;
                    (B) to evaluate the feasibility of developing a 
                reporting system for collecting data on physician-
                diagnosed cases that do not meet the surveillance 
                criteria of the Centers for Disease Control and 
                Prevention in order to more accurately gauge disease 
                outbreaks and incidence; and
                    (C) to evaluate the feasibility of creating a 
                national uniform reporting system to include mandatory 
                reporting by laboratories in each State.
            (3) Third goal: prevention of lyme disease and other tick-
        borne diseases and complications due to delayed diagnosis and 
        treatment.--The third goal under subsection (a) shall be--
                    (A) for the Director of the Agency for Healthcare 
                Research and Quality, in coordination with the Director 
                of the Centers for Disease Control and Prevention and 
                the Director of the National Institutes of Health, to 
                provide and promote access to a comprehensive, up-to-
                date clearinghouse of peer-reviewed information on Lyme 
                and other tick-borne diseases;
                    (B) to provide for public education by expanding 
                the Community Based Education Programs of the Centers 
                for Disease Control and Prevention to include expansion 
                of information access points available to the public;
                    (C) to create a physician education program that 
                includes the full spectrum of scientific research on 
                Lyme and other tick-borne diseases; and
                    (D) for the Secretary to sponsor scientific 
                conferences on Lyme and other tick-borne diseases, 
                including reporting and consideration of the full 
                spectrum of clinically-based knowledge, with the first 
                of such conferences held within 24 months after the 
                date of the enactment of this Act and with further 
                conferences held as determined appropriate by the 
                Secretary.
            (4) Fourth goal: clinical outcomes research.--The fourth 
        goal under subsection (a) shall be--
                    (A) to establish epidemiological research goals to 
                determine the long term course of illness for Lyme 
                disease; and
                    (B) to establish treatment outcomes research goals 
                to determine the effectiveness of different treatment 
                modalities.

SEC. 4. STUDY BY INSTITUTE OF MEDICINE.

    (a) In General.--Not later than 90 days after the date of the 
enactment of this Act, the Secretary shall request the Institute of 
Medicine, National Academies of Sciences, to enter into an agreement 
with the Secretary for the conduct of a study of chronic Lyme disease. 
Such study shall include a systematic assessment of empirical evidence 
of treating physicians, as well as published peer-reviewed data, and 
shall include recommendations for addressing research gaps in diagnosis 
and treatment of chronic Lyme disease and an assessment of treatment 
guidelines, such as those of the Infectious Diseases Society of America 
and those of the International Lyme and Associated Diseases Society, 
and their utilization.
    (b) Report.--The Secretary shall ensure that, not later than one 
year after the Secretary enters into the agreement under subsection 
(a), a report providing the results of the study under such subsection 
is submitted to the Secretary and the Tick-Borne Diseases Advisory 
Committee under section 6.

SEC. 5. INCREASED FUNDING FOR RESEARCH AND EDUCATION.

    (a) In General.--For the purpose of providing for research and 
educational activities for Lyme and other tick-borne diseases, and for 
carrying out efforts to prevent Lyme and other tick-borne diseases, 
there is authorized to be appropriated $20,000,000 for each of the 
fiscal years 2006 through 2010. Such authorization is in addition to 
other authorizations of appropriations that are available for such 
purpose.
    (b) Study.--Of the amounts appropriated under subsection (a), the 
Secretary shall reserve not more than $500,000 for conducting the study 
under section 4.

SEC. 6. ESTABLISHMENT OF TICK-BORNE DISEASES ADVISORY COMMITTEE.

    (a) Establishment.--Not later than 180 days after the date of the 
enactment of this Act, the Secretary shall establish within the Office 
of the Secretary an advisory committee to be known as the Tick-Borne 
Diseases Advisory Committee (referred to in this section as the 
``Committee'').
    (b) Duties.--The Committee shall advise the Secretary and the 
Assistant Secretary for Health regarding the manner in which such 
officials can--
            (1) ensure interagency coordination and communication and 
        minimize overlap regarding efforts to address tick-borne 
        diseases;
            (2) identify opportunities to coordinate efforts with other 
        Federal agencies and private organizations addressing such 
        diseases;
            (3) ensure interagency coordination and communication with 
        constituency groups;
            (4) ensure that a broad spectrum of scientific viewpoints 
        are represented in public health policy decisions and that 
        information disseminated to the public and physicians is 
        balanced; and
            (5) advise relevant Federal agencies on priorities.
    (c) Membership.--
            (1) Appointed members.--
                    (A) In general.--From among individuals who are not 
                officers or employees of the Federal Government, the 
                Secretary shall appoint to the Committee, as voting 
                members, an equal number of individuals from each of 
                the groups described in clauses (i) through (v), as 
                follows:
                            (i) Scientific community members 
                        representing the broad spectrum of viewpoints 
                        held within the scientific community, such as 
                        members of the International Lyme and 
                        Associated Diseases Society.
                            (ii) Representatives of tick-borne disease 
                        voluntary organizations.
                            (iii) Health care providers who are full-
                        time practicing physicians providing care for 
                        acute and chronic tick-borne diseases.
                            (iv) Patient representatives who are 
                        individuals who have been diagnosed with tick-
                        borne diseases or who have had an immediate 
                        family member diagnosed with such a disease.
                            (v) Representatives of State and local 
                        health departments and national organizations 
                        that represent State and local health 
                        professionals.
                    (B) Certain requirement.--In appointing members 
                under subparagraph (A), the Secretary shall ensure that 
                such members, as a group, represent a diversity of 
                scientific perspectives relevant to the duties of the 
                Committee.
            (2) Ex officio members.--The Secretary shall designate the 
        Assistant Secretary for Health as a nonvoting, ex officio 
        member of the Committee. In addition, the Secretary shall 
        designate, as nonvoting members of the Committee, 
        representatives from each of the following Federal agencies:
                    (A) The Agency for Healthcare Research and Quality.
                    (B) The National Institutes of Health.
                    (C) The Centers for Disease Control and Prevention.
                    (D) The Food and Drug Administration.
                    (E) The Office of the Assistant Secretary for 
                Health.
                    (F) Such additional Federal agencies as the 
                Secretary determines to be appropriate.
            (3) Chair.--The members of the Committee appointed under 
        paragraph (1) shall select an individual from among such 
        members to serve as the chair of the Committee. The term for 
        serving as the chair shall be two years.
            (4) Term of appointment.--The term of service for each 
        member of the Committee, other than the Assistant Secretary for 
        Health, shall be four years.
            (5) Vacancy.--A vacancy in the membership of the Committee 
        shall be filled in the same manner as the original appointment. 
        Any member appointed to fill a vacancy for an unexpired term 
        shall be appointed for the remainder of that term. Members may 
        serve after the expiration of their terms until their 
        successors have taken office.
    (d) Meetings.--The Committee shall hold public meetings, except as 
otherwise determined by the Secretary, giving notice to the public of 
such, and meet at least twice a year with additional meetings subject 
to the call of the Chair. Agenda items may be added at the request of 
members of the Committee, including the Chairs. Meetings shall be 
conducted, and records of the proceedings shall be maintained, as 
required by applicable law and by regulations of the Secretary.
    (e) Authorization of Appropriations.--For the purpose of carrying 
out this section, there is authorized to be appropriated $250,000 for 
each of the fiscal years 2006 and 2007. Amounts appropriated under the 
preceding sentence shall be used for the expenses and per diem costs 
incurred by the Committee under this section in accordance with the 
Federal Advisory Committee Act, except that no voting member of the 
Committee shall be a permanent salaried employee.

SEC. 7. REPORTS.

    (a) In General.--Not later than 24 months after the date of the 
enactment of this Act, and annually thereafter, the Secretary shall 
submit to the Congress a report on the activities carried out under 
this Act.
    (b) Content.--Reports under subsection (a) shall describe--
            (1) progress in the development of accurate diagnostic 
        tools and treatment modalities and their use in clinical 
        settings;
            (2) the promotion of public awareness and physician 
        education initiatives to improve the knowledge of health care 
        providers and the public regarding clinical and surveillance 
        practices for Lyme disease and other tick-borne diseases; and
            (3) other significant activities relating to surveillance, 
        diagnosis, treatment, or prevention of Lyme and other tick-
        borne diseases.

SEC. 8. DEFINITION.

    For purposes of this Act, the ``Secretary'' means the Secretary of 
Health and Human Services.
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