[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1503 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                S. 1503

  To provide for enhanced Federal efforts concerning the prevention, 
 education, treatment, and research activities related to Lyme disease 
 and other tick-borne diseases, including the establishment of a Tick-
                   Borne Diseases Advisory Committee.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              June 4, 2015

Mr. Blumenthal (for himself, Ms. Ayotte, Mrs. Gillibrand, Mr. Reed, Ms. 
   Klobuchar, Mr. Coons, Mr. Whitehouse, Mr. Casey, 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 enhanced Federal efforts concerning the prevention, 
 education, treatment, and research activities related to Lyme disease 
 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 2015''.

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 spirochaetes, and is 
        transmitted to humans by the bite of infected 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, 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, and joint problems.
            (5) Although Lyme disease accounts for 90 percent of all 
        vector-borne disease in the United States, the ticks that 
        spread Lyme disease also spread other diseases, such as 
        anaplasmosis and babesiosis, and carry other strains of 
        Borrelia burgdorferi. Other tick species, such as the 
        aggressive lone star tick, 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 36,000 confirmed or probable Lyme disease cases in 2013 
        and has estimated that the total number of people diagnosed 
        with Lyme disease annually is roughly 10 times higher than the 
        number of cases reported.
            (7) According to the Centers for Disease Control and 
        Prevention, from 1992 to 2006, the incidence of Lyme disease 
        was highest among children 5 to 14 years of age.
            (8) Persistence of symptomatology in many patients without 
        reliable testing makes diagnosis and treatment of patients more 
        difficult.
            (9) In the absence of a safe and effective human vaccine, 
        reducing exposure to ticks is the best defense against Lyme 
        disease, Rocky Mountain spotted fever, and other tick-borne 
        diseases. Entomology-based approaches to prevent tick-borne 
        diseases include the use and development of insect repellent, 
        prompt tick removal, application of pesticides, and reduction 
        of tick habitat.

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 considered in public health policy 
                decisions and that information disseminated to the 
                public and physicians is based on the best available 
                science and is appropriately balanced; and
                    (E) advise relevant Federal agencies on priorities 
                related to Lyme disease 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 fewer than 4 members from the 
                        scientific community representing the broad 
                        spectrum of viewpoints held within the 
                        scientific community related to Lyme disease 
                        and other tick-borne diseases, including 
                        experts in the areas of--
                                    (I) medicine, epidemiology, and 
                                public health;
                                    (II) veterinary medicine and animal 
                                health;
                                    (III) entomology and pest 
                                management; and
                                    (IV) microbiology.
                            (ii) Not fewer than 2 representatives of 
                        tick-borne disease voluntary advocacy 
                        organizations, which may include 1 
                        representative of a patient-supported tick-
                        borne disease advocacy organization.
                            (iii) Not fewer than 2 health care 
                        providers, including not fewer than 1 physician 
                        involved in direct patient care, with relevant 
                        experience providing care for individuals with 
                        a broad range of acute and chronic Lyme disease 
                        and other tick-borne diseases.
                            (iv) Not fewer than 2 patient 
                        representatives who are individuals who have 
                        been diagnosed with Lyme disease or another 
                        tick-borne disease or who have had an immediate 
                        family member diagnosed with such a disease.
                            (v) Not fewer than 2 representatives of 
                        State and local health departments and national 
                        organizations that represent State and local 
                        health professionals who investigate or treat 
                        patients with Lyme disease or other tick-borne 
                        diseases.
                    (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) The Department of Agriculture.
                    (G) Such additional Federal departments and 
                agencies as the Secretary determines appropriate.
            (3) Co-chairpersons.--The Committee shall be headed by the 
        following co-chairpersons:
                    (A) The Assistant Secretary of Health.
                    (B) A public chairperson appointed by the members 
                of the Committee, who 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 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.

SEC. 4. FEDERAL ACTIVITIES RELATED TO THE DIAGNOSIS, SURVEILLANCE, 
              PREVENTION, AND RESEARCH OF LYME DISEASE 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, the Director of the Agency for Healthcare Research and 
Quality, the Chief of the Forest Service, or other Federal agencies as 
the Secretary determines appropriate, and in consultation with the 
Tick-Borne Diseases Advisory Committee, shall--
            (1) conduct or support the activities described in 
        subsection (b); and
            (2) coordinate 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) The development of diagnostic tests, including--
                    (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 tests that have been adequately validated 
                clinically available to account for the multiple 
                clinical manifestations of both acute and chronic Lyme 
                disease;
                    (C) providing for the timely evaluation of 
                promising emerging diagnostic methods; and
                    (D) the development of quantitative assays for the 
                detection of tick-borne pathogens in ticks.
            (2) Surveillance and reporting of Lyme disease and other 
        tick-borne diseases--
                    (A) to accurately determine the incidence of Lyme 
                disease and other tick-borne diseases;
                    (B) to evaluate the feasibility of developing a 
                reporting system for the collection of data on 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;
                    (C) to evaluate the feasibility of creating a 
                national uniform reporting system including required 
                reporting by laboratories in each State; and
                    (D) to evaluate the feasibility of creating a 
                national monitoring system for tick populations.
            (3) Prevention activities, including--
                    (A) the provision and promotion of access to a 
                comprehensive, up-to-date clearinghouse of peer-
                reviewed information on Lyme disease and other tick-
                borne diseases;
                    (B) increased public education related to Lyme 
                disease 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 the identification of symptoms associated 
                with, and the diagnosis of, Lyme disease and other 
                tick-borne diseases, and, in coordination with the 
                Tick-Borne Diseases 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;
                    (D) research to understand mechanisms of tick 
                repellents and to develop new chemical and non-chemical 
                strategies for the control of ticks; and
                    (E) exploring the utility and potential for the 
                development of a safe and effective vaccine against 
                Lyme disease and other tick-borne diseases.
            (4) Sponsoring scientific conferences on Lyme disease and 
        other tick-borne diseases, including reporting in accordance 
        with subsection (c) and consideration of the full spectrum of 
        clinically based knowledge, with the first of such conferences 
        to be held not later than 2 years after the date of enactment 
        of this Act.
            (5) Clinical outcomes research, including--
                    (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) Scientific Conferences.--
            (1) Sense of congress.--It is the sense of Congress that 
        participation in or sponsorship of scientific conferences and 
        meetings is essential to the mission of the Department of 
        Health and Human Services in addressing Lyme disease and other 
        tick-borne diseases.
            (2) Conference reporting.--
                    (A) In general.--The Secretary shall submit to 
                Congress an annual report regarding the costs and 
                contracting procedures related to conferences with 
                respect to addressing Lyme disease and other tick-borne 
                diseases that are organized by the Federal Government 
                or attended by representatives of the Federal 
                Government, for which the cost to the Federal 
                Government was more than $100,000.
                    (B) Contents.--Each report submitted under 
                subparagraph (A) shall include, with respect to each 
                such conference held during the applicable period--
                            (i) a description of the purpose of the 
                        conference;
                            (ii) the number of participants attending;
                            (iii) a detailed statement of the costs to 
                        the Federal Government, including--
                                    (I) the cost of any food or 
                                beverages;
                                    (II) the cost of any audio-visual 
                                services;
                                    (III) the cost of employee or 
                                contractor travel to and from the 
                                conference; and
                                    (IV) a discussion of the 
                                methodology used to determine which 
                                costs relate to the conference; and
                            (iv) a description of the contracting 
                        procedures used in coordinating the conference, 
                        including--
                                    (I) whether contracts were awarded 
                                on a competitive basis; and
                                    (II) a discussion of any cost 
                                comparison conducted by the 
                                departmental component or office in 
                                evaluating potential contractors for 
                                the conference.

SEC. 5. REPORTS ON LYME DISEASE 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 include--
            (1) information relating to significant activities or 
        developments related to the surveillance, diagnosis, treatment, 
        education, or prevention of Lyme disease or other tick-borne 
        diseases, including suggestions for further research and 
        education;
            (2) a scientifically qualified assessment of Lyme disease 
        and other tick-borne diseases, including both acute and chronic 
        instances, related to the broad spectrum of clinical evidence 
        of treating physicians involved in direct patient care, as well 
        as published peer reviewed data, that shall include 
        recommendations for addressing interagency research gaps in 
        tick biology and tick management, and the diagnosis, 
        transmission, and treatment of Lyme disease and other tick-
        borne diseases, and an evaluation of treatment guidelines and 
        the utilization of such guidelines;
            (3) details regarding progress in the development of 
        accurate diagnostic tools that are more useful in the clinical 
        setting for both acute and chronic disease;
            (4) information relating to 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 of the Tick-
        Borne Diseases Advisory Committee issued under section 3(e), 
        and an assessment of progress in achieving the recommendations 
        included in such report.

SEC. 6. APPROPRIATIONS.

    Funds for the purpose of carrying out this Act may be derived from 
amounts appropriated to the Department of Health and Human Services and 
otherwise available for obligation and expenditure for each of the 
fiscal years 2016 through 2020. Amounts appropriated under the 
preceding sentence shall be used for the expenses and per diem costs 
incurred by the Tick-Borne Diseases Advisory Committee established 
under section 3 in accordance with the Federal Advisory Committee Act 
(5 U.S.C. App.), except that no voting member of the Tick-Borne 
Diseases Advisory Committee shall be a permanent salaried employee.
                                 <all>