[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[S. 719 Introduced in Senate (IS)]

113th CONGRESS
  1st Session
                                 S. 719

    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 SENATE OF THE UNITED STATES

                             April 11, 2013

Mr. Blumenthal (for himself, Mrs. Gillibrand, Mr. Reed, Mr. Lautenberg, 
Mr. Whitehouse, Mr. Franken, Ms. Klobuchar, and Mr. Schumer) introduced 
the following bill; which was read twice and referred to the Committee 
               on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 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.

    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 ``Lyme and Tick-Borne Disease 
Prevention, Education, and Research Act of 2013''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Lyme disease is a common but frequently misunderstood 
        illness that, if not caught early and treated properly, can 
        cause serious health problems.
            (2) Lyme disease is caused by the bacterium Borrelia 
        burgdorferi, which belongs to the class of spirochetes, and is 
        transmitted to humans by the bite of infected black-legged 
        ticks. Early signs of infection may include a rash and flu-like 
        symptoms such as fever, muscle aches, headaches, and fatigue.
            (3) Although Lyme disease can be treated with antibiotics 
        if caught early, the disease often goes undetected because it 
        mimics other illnesses or may be misdiagnosed. Untreated, Lyme 
        disease can lead to severe heart, neurological, eye, and joint 
        problems because the bacteria can affect many different organs 
        and organ systems.
            (4) If an individual with Lyme disease does not receive 
        treatment, such individual can develop severe heart, 
        neurological, eye, and joint problems.
            (5) Although Lyme disease accounts for 90 percent of all 
        vector-borne infections in the United States, the ticks that 
        spread Lyme disease also spread other diseases, such as 
        anaplasmosis, babesiosis, and tularemia, and carry Bartonella 
        and other strains of Borrelia. Other tick species, such as the 
        aggressive lone star, spread ehrlichiosis, Rocky Mountain 
        spotted fever, and southern tick-associated rash illness 
        (STARI). Multiple diseases in 1 patient make diagnosis and 
        treatment more difficult.
            (6) The Centers for Disease Control and Prevention reported 
        over 33,000 confirmed or probable Lyme Disease cases in 2011.
            (7) According to the Centers for Disease Control and 
        Prevention, from 1992 to 2006, the incidence of Lyme disease 
        was highest among children aged 5 to 14 years of age.
            (8) Persistence of symptomatology in many patients without 
        reliable testing makes diagnosis and treatment of patients more 
        difficult.

SEC. 3. ESTABLISHMENT OF A TICK-BORNE DISEASES ADVISORY COMMITTEE.

    (a) Establishment.--Not later than 180 days after the date of the 
enactment of this Act, the Secretary of Health and Human Services 
(referred to in this Act as 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--
            (1) advise the Secretary and the Assistant Secretary for 
        Health regarding the manner in which such officials can--
                    (A) ensure interagency coordination and 
                communication and minimize overlap regarding efforts to 
                address tick-borne diseases;
                    (B) identify opportunities to coordinate efforts 
                with other Federal agencies and private organizations 
                addressing such diseases;
                    (C) ensure interagency coordination and 
                communication with constituency groups;
                    (D) 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
                    (E) advise relevant Federal agencies on priorities 
                related to Lyme and other tick-borne diseases; and
            (2) in coordination with relevant agencies within the 
        Department of Health and Human Services, regularly review 
        published public and private treatment guidelines and evaluate 
        such guidelines for effective representation of a wide 
        diversity of views.
    (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, the following:
                            (i) Not less than 4 members from the 
                        scientific community representing the broad 
                        spectrum of viewpoints held within the 
                        scientific community related to Lyme and other 
                        tick-borne diseases.
                            (ii) Not less than 2 representatives of 
                        tick-borne disease voluntary organizations.
                            (iii) Not less than 2 health care 
                        providers, including not less than 1 full-time 
                        practicing physician, with relevant experience 
                        providing care for individuals with a broad 
                        range of acute and chronic tick-borne diseases.
                            (iv) Not less than 2 patient 
                        representatives who are individuals who have 
                        been diagnosed with a tick-borne disease or who 
                        have had an immediate family member diagnosed 
                        with such a disease.
                            (v) At least 2 representatives of State and 
                        local health departments and national 
                        organizations that represent State and local 
                        health professionals.
                    (B) Diversity.--In appointing members under this 
                paragraph, 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, as 
        nonvoting, ex officio members of the Committee, representatives 
        overseeing tick-borne disease activities from each of the 
        following Federal agencies:
                    (A) The Centers for Disease Control and Prevention.
                    (B) The National Institutes of Health.
                    (C) The Agency for Healthcare Research and Quality.
                    (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) Co-chairpersons.--The Secretary shall designate the 
        Assistant Secretary of Health as the co-chairperson of the 
        Committee. The appointed members of the Committee shall also 
        elect a public co-chairperson. The public co-chairperson shall 
        serve a 2-year term.
            (4) Term of appointment.--The term of service for each 
        member of the Committee appointed under paragraph (1) shall be 
        4 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, after providing notice to the 
public of such meetings, and shall meet at least twice a year with 
additional meetings subject to the call of the co-chairpersons. Agenda 
items with respect to such meetings may be added at the request of the 
members of the Committee, including the co-chairpersons. Meetings shall 
be conducted, and records of the proceedings shall be maintained, as 
required by applicable law and by regulations of the Secretary.
    (e) Report.--Not later than 1 year after the date of enactment of 
this Act, and annually thereafter, the Committee, acting through the 
members representing the Centers for Disease Control and Prevention and 
the National Institutes of Health, shall submit a report to the 
Secretary. Each such report shall contain, at a minimum--
            (1) a description of the Committee's functions;
            (2) a list of the Committee's members and their 
        affiliations; and
            (3) a summary of the Committee's activities and 
        recommendations during the previous year, including any 
        significant issues regarding the functioning of the Committee.
    (f) Authorization of Appropriations.--For the purpose of carrying 
out this section, there is authorized to be appropriated such sums as 
may be necessary for each of the fiscal years 2014 through 2018. 
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 (5 U.S.C. 
App.), except that no voting member of the Committee shall be a 
permanent salaried employee.

SEC. 4. FEDERAL ACTIVITIES RELATED TO THE DIAGNOSIS, SURVEILLANCE, 
              PREVENTION, AND RESEARCH OF LYME AND OTHER TICK-BORNE 
              DISEASES.

    (a) In General.--The Secretary, acting as appropriate through the 
Director of the Centers for Disease Control and Prevention, the 
Director of the National Institutes of Health, the Commissioner of Food 
and Drugs, and the Director of the Agency for Healthcare Research and 
Quality, as well as additional Federal agencies as the Secretary 
determines to be appropriate, and in consultation with the Tick-Borne 
Diseases Advisory Committee, shall provide for--
            (1) the conduct or support of the activities described in 
        subsection (b); and
            (2) the coordination of all Federal programs and activities 
        related to Lyme disease and other tick-borne diseases.
    (b) Activities.--The activities described in this subsection are 
the following:
            (1) Development of diagnostic tests.--Such activities 
        include--
                    (A) the development of sensitive and more accurate 
                diagnostic tools and tests, including a direct 
                detection test for Lyme disease capable of 
                distinguishing active infection from past infection;
                    (B) improving the efficient utilization of 
                diagnostic testing currently available to account for 
                the multiple clinical manifestations of both acute and 
                chronic Lyme disease; and
                    (C) providing for the timely evaluation of 
                promising emerging diagnostic methods.
            (2) Surveillance and reporting.--Such activities include 
        surveillance and reporting of Lyme and other tick-borne 
        diseases--
                    (A) to accurately determine the prevalence of Lyme 
                and other tick-borne diseases;
                    (B) to evaluate the feasibility of developing a 
                reporting system for the collection of data on 
                physician-diagnosed cases of Lyme disease that do not 
                meet the surveillance criteria of the Centers for 
                Disease Control and Prevention in order to more 
                accurately gauge disease incidence; and
                    (C) to evaluate the feasibility of creating a 
                national uniform reporting system including required 
                reporting by laboratories in each State.
            (3) Prevention.--Such activities include--
                    (A) the provision and promotion of access to a 
                comprehensive, up-to-date clearinghouse of peer-
                reviewed information on Lyme and other tick-borne 
                diseases;
                    (B) increased public education related to Lyme and 
                other tick-borne diseases through the expansion of the 
                Community Based Education Programs of the Centers for 
                Disease Control and Prevention to include expansion of 
                information access points to the public;
                    (C) the creation of a physician education program 
                that includes the full spectrum of scientific research 
                related to Lyme and other tick-borne diseases, and, in 
                coordination with the Advisory Committee established 
                under section 3, the publication of an annual report 
                that evaluates published guidelines and current 
                research available on Lyme disease, in order to best 
                educate health professionals on the latest research and 
                diversity of treatment options for Lyme disease; and
                    (D) the sponsoring of 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 to 
                be held not later than 24 months after the date of 
                enactment of this Act.
            (4) Clinical outcomes research.--Such activities include--
                    (A) the establishment of epidemiological research 
                objectives to determine the long-term course of illness 
                for Lyme disease; and
                    (B) determination of the effectiveness of different 
                treatment modalities by establishing treatment outcome 
                objectives.
    (c) Authorization of Appropriations.--
            (1) In general.--For the purposes of carrying out this 
        section, and for the purposes of providing for additional 
        research, prevention, and educational activities for Lyme and 
        other tick-borne diseases, there is authorized to be 
        appropriated such sums as may be necessary for each of the 
        fiscal years 2014 through 2018.
            (2) Additional amounts.--The authorization of 
        appropriations under this subsection is in addition to any 
        other authorization of appropriations available for the 
        purposes described in paragraph (1).

SEC. 5. REPORTS ON LYME AND OTHER TICK-BORNE DISEASES.

    (a) In General.--Not later than 18 months after the date of 
enactment of this Act, and annually thereafter, the Secretary shall 
submit to Congress a report on the activities carried out under this 
Act.
    (b) Content.--Reports under subsection (a) shall contain--
            (1) significant activities or developments related to the 
        surveillance, diagnosis, treatment, education, or prevention of 
        Lyme or other tick-borne diseases, including suggestions for 
        further research and education;
            (2) a scientifically qualified assessment of Lyme and other 
        tick-borne diseases, including both acute and chronic 
        instances, related to the broad spectrum of empirical evidence 
        of treating physicians, as well as published peer reviewed 
        data, that shall include recommendations for addressing 
        research gaps in diagnosis and treatment of Lyme and other 
        tick-borne diseases and an evaluation of treatment guidelines 
        and their utilization;
            (3) progress in the development of accurate diagnostic 
        tools that are more useful in the clinical setting for both 
        acute and chronic disease;
            (4) 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
            (5) a copy of the most recent annual report issued by the 
        Tick-Borne Diseases Advisory Committee established under 
        section 3 and an assessment of progress in achieving the 
        recommendations included in the Committee's report.
                                 <all>