II Calendar No. 287 116th CONGRESS 1st Session S. 1657 IN THE SENATE OF THE UNITED STATES May 23 (legislative day, May 22), 2019 Ms. Collins (for herself, Ms. Smith , Mr. King , Mrs. Capito , Mr. Blumenthal , Mrs. Hyde-Smith , Mr. Murphy , Mr. Boozman , Ms. Hassan , Mr. Braun , and Mr. Sanders ) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions November 5, 2019 Reported by Mr. Alexander , with an amendment Strike out all after the enacting clause and insert the part printed in italic A BILL To provide assistance to combat the escalating burden of Lyme disease and other tick and vector-borne diseases and disorders.

1. Short title This Act may be cited as the Ticks: Identify, Control, and Knockout Act or the TICK Act . 2. Office of Oversight and Coordination for Vector-Borne Disease (a) Establishment The Secretary of Health and Human Services (referred to in this Act as the Secretary ) shall establish in the Office of the Secretary an Office of Oversight and Coordination for Vector-Borne Diseases (referred to in this Act as the Office ), to be headed by a director to be appointed by the Secretary. (b) Duties of the Office (1) In general The Director of the Office shall— (A) oversee the creation and maintenance of a national strategy to address Lyme disease, and other tick and vector-borne diseases as provided for in paragraph (2); and (B) oversee and coordinate Lyme disease and other tick and vector-borne disease and disorder programs and activities across the agencies and offices of the Department of Health and Human Services and other Federal agencies outside of the Department of Health and Human Services, as appropriate. (2) National strategy (A) In general The Director of the Office shall provide for the conduct of an annual assessment of the progress of the United States in preparing for the escalating burden of Lyme disease and other tick and vector-borne diseases and disorders, including an assessment of all Federally funded programs and activities related to surveillance, diagnosis, treatment, education, or prevention, as well as implementation steps, and recommendations for priority actions, with appropriate benchmarks to measure progress, based on the assessment. (B) Non-federal perspectives In developing the strategy under subparagraph (A), and maintaining it, the Director shall consult with non-Federal individuals with appropriate expertise, which may include— (i) epidemiologists with experience in surveillance, treatment, education, or prevention of vector-borne diseases; (ii) representatives of national patient advocacy and research organizations that focus on vector-borne diseases, and those that focus specifically on tick-borne disease and have demonstrated experience in research, data collection, or patient access to care; (iii) health information technology experts or other information management specialists; (iv) clinicians, entomologists, vector-management professionals, integrated pest management professionals, public health professionals, and others with expertise in vector-borne disease, including Lyme disease or other tick-borne diseases or disorders; and (v) research scientists with experience conducting translational research or utilizing surveillance systems for scientific research purposes. (c) Objective of the Office In carrying out subsection (b), the Director of the Office shall facilitate and work to ensure the accomplishment of the following activities: (1) Expansion and enhancement of epidemiological research and basic, translational, and clinical biological and biomedical research. (2) Expansion and improvement of tick surveillance, linking tick surveillance to surveillance of Lyme disease, and reporting of Lyme disease and other tick- and vector-borne diseases, including coinfections with agents of more than one tick or vector-borne diseases. (3) Development of effective diagnostic tests to accurately and timely diagnose Lyme disease and other tick- and vector-borne diseases, including direct detention tests. (4) Development of treatments to cure or improve the lives of those who are infected with Lyme disease or other tick-and vector-borne diseases or who suffer from a tick-induced disorder (such as tick PIM programs). (5) Address the quality of patient care, treatment affordability, and public awareness of Lyme disease and other tick or vector-borne diseases. (6) Design and conduct clinical trials of sufficient size and duration to support clinical recommendations. (7) Systematic documentation of the experiences of health care professionals in diagnosing and treating tick- and vector-borne disease, including diagnostic and treatment outcomes. (8) Development and maintenance of one or more registries of patients and their experiences relating to exposure to, diagnosis for, and treatment of tick- and vector-borne disease, including outcomes, such that the confidentiality and safety of patient data is protected. (9) Access to data and enable emerging technologies to improve patient care, sharing data with researchers and care providers. (10) Coordination with other Federal departments to address tick- and other vector-borne diseases including the Department of Defense, the Department of Agriculture, the Environmental Protection Agency, the Department of Interior, and the Department of Homeland Security. (11) Coordination with the Tick-Borne Disease Working Group established under section 2062 of the 21st Century Cures Act ( 42 U.S.C. 284s ) to develop and implement recommendations. (12) Coordination with international bodies to integrate and inform the fight against Lyme disease, and other tick- and vector-borne diseases globally. 3. Regional Centers of Excellence in Tick and Vector-Borne Diseases (a) In general The Secretary, in coordination with the Director of the Centers for Disease Control and Prevention and the heads of other agencies as appropriate, shall award grants, contracts, or cooperative agreements to eligible entities (such as institutions of higher education, State, tribal, and local health departments, associations, or other appropriate entities) for the establishment or support of Regional Centers of Excellence in Tick and Vector-Borne Diseases. Such Regional Centers shall be designed to address Lyme disease and other tick and vector-borne diseases by— (1) building collaboration between academia and public health agencies for surveillance, prevention and response to Lyme disease and other tick and vector-borne diseases; (2) providing training for public health entomologists to deal with Lyme disease and other tick and vector-borne diseases; and (3) conducting applied research to develop and validate prevention and control tools and methods, and to anticipate and respond to outbreaks of Lyme disease and other tick and vector-borne diseases. (b) Eligibility To be eligible to receive a grant, contract, or cooperative agreement under this section, an entity shall prepare and submit to the Secretary an application at such time, in such manner, and containing such agreements and information as the Secretary may require, including a description of how the entity will— (1) coordinate, as applicable, with existing Federal, State, and tribal programs related to Lyme disease and other vector-borne diseases; (2) examine, evaluate, and promote evidence-based interventions for individuals with Lyme disease and other tick- and vector-borne diseases, including those in rural and underserved populations, and those who provide care for such individuals; and (3) prioritize activities relating to— (A) expanding efforts, as appropriate, to implement evidence-based practices to address Lyme disease and other tick- and vector-borne diseases, including through the training of State, local, and tribal public health officials and other health professionals on such practices; (B) supporting surveillance of vectors, and early detection and diagnosis of Lyme and other tick- and vector-borne diseases, including improving the quality and reliability of diagnostic tools at all stages of disease progression, and developing a Lyme disease test capable of distinguishing between past and active infections; (C) improving the safety and efficacy of any new, renewed, or modified human vaccine for Lyme disease, other tick- and vector-borne diseases, or a combination of such diseases; (D) developing a standardized screening protocol for Lyme disease and other tick- and vector-borne diseases; (E) enhancing studies and activities on tick biology, disease ecology, and surveillance, and tick management; and (F) supporting other relevant activities identified by the Secretary or the Director of the Centers for Disease Control and Prevention, as appropriate. (c) Considerations In awarding grants, contracts, and cooperative agreements under this section, the Secretary shall consider, among other factors, whether the entity— (1) provides services to rural areas or other underserved populations; (2) is able to build on an existing infrastructure of services and public health research; (3) is located in an area with a high prevalence, or in any area predicted to have a high prevalence, of Lyme disease or other tick- and vector-borne diseases; and (4) has experience with conducting research related to Lyme disease and other tick- and vector-borne diseases. (d) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $10,000,000 for each of fiscal years from 2021 through 2026. Amounts appropriated shall be allocated under this section to diseases in a manner that proportionately matches the disease burden of those diseases in the United States, which shall be reassessed and adjusted annually. 4. Cooperative agreements with the Centers for Disease Control and Prevention (a) In general The Secretary, in coordination with the Director of the Centers for Disease Control and Prevention and the heads of other agencies, as appropriate, shall enter into cooperative agreements between the Centers for Disease Control and Prevention and health departments of States, political subdivisions of States, and Indian tribes and tribal organizations, to address Lyme Disease and other tick- and vector-borne diseases, and to support the development and implementation of evidence-based research, interventions, and treatment with respect to— (1) educating and informing the public, based on evidence-based public health research and data, about Lyme Disease and other vector-borne diseases; (2) supporting early detection and diagnosis; (3) supporting prevention; (4) improving treatment; (5) supporting care planning and management for individuals with Lyme disease and other tick- and vector-borne diseases; and (6) supporting other relevant activities identified by the Secretary or the Director of the Centers for Disease Control and Prevention, as appropriate. (b) Eligibility To be eligible to enter into a cooperative agreement under this section, an entity described in subsection (a) shall prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a plan that describes— (1) how the applicant proposes to develop or expand programs to educate individuals through partnership engagement, workforce development, guidance and support for programmatic efforts, and evaluation with respect to Lyme disease and other tick- or vector-borne diseases, and how the applicant proposes to support other relevant activities identified by the Secretary or the Director of the Centers for Disease Control and Prevention, as appropriate; (2) the manner in which the applicant will coordinate with Federal, tribal, and State programs related to Lyme Disease and other vector-borne diseases, and appropriate State, tribal, and local agencies, as well as other relevant public and private organizations or agencies; and (3) the manner in which the applicant will evaluate the effectiveness of any program carried out under the cooperative agreement. (c) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $20,000,000 for each of fiscal years from (2021 through 2026). Amounts appropriated shall be allocated under this section to diseases in a manner that proportionately matches the disease burden of those diseases in the United States, which shall be reassessed and adjusted annually.

1. Short title This Act may be cited as the Kay Hagan Tick Act . 2. Combating vector-borne diseases Title III of the Public Health Service Act is amended by inserting after section 317T ( 42 U.S.C. 247b–22 ) the following: 317U. National strategy and regional centers of excellence in vector-borne diseases (a) In general The Secretary, acting through the Assistant Secretary for Health, shall— (1) ensure the development and implementation of a national strategy to address vector-borne diseases, including tick-borne diseases, consistent with subsection (b); and (2) coordinate programs and activities, including related to data collection, research, and the development of diagnostics, treatments, vaccines, and other related activities, to address vector-borne diseases, including tick-borne diseases, across the Department of Health and Human Services and with other Federal agencies or departments, as appropriate. (b) Strategy (1) In general The Secretary, in coordination with the Secretary of Defense, the Secretary of Agriculture, the Administrator of the Environmental Protection Agency, the Secretary of the Interior, the Secretary of Veterans Affairs, the Secretary of Homeland Security, and others, as appropriate, shall develop a strategy to address gaps in Federal programs, and assess the progress of the United States in, addressing vector-borne diseases, including tick-borne diseases. Such strategy shall— (A) assess gaps and unnecessary duplication in federally funded programs and activities related to surveillance, diagnosis, treatment, education, pathogenesis, or prevention of vector-borne diseases, including tick-borne diseases, which may include taking into consideration relevant strategic plans made by other agencies; (B) identify gaps and unnecessary duplication with respect to— (i) epidemiological, basic, translational, and clinical research on vector-borne diseases, including tick-borne diseases; and (ii) vector surveillance, registries, and disease monitoring, including coinfections with agents of more than one vector-borne disease; (C) identify strategic goals related to addressing vector-borne diseases, including tick-borne diseases, including goals related to the development of diagnostics, treatments, vaccines, and other related measures, as appropriate, and benchmarks to measure progress; (D) identify ways to improve the care and treatment of individuals with vector-borne diseases, including tick-borne diseases, and to improve public awareness of such diseases; and (E) update such strategy biennially. (2) Non-federal perspectives In developing and updating, as applicable, the strategy under paragraph (1), the Secretary shall— (A) coordinate with the Tick-Borne Disease Working Group established under section 2062 of the 21st Century Cures Act ( 42 U.S.C. 284s ), as appropriate; and (B) consult with non-Federal individuals with appropriate expertise, which may include— (i) epidemiologists with experience in vector-borne diseases, including tick-borne diseases; (ii) representatives of patient advocacy and research organizations that focus on vector-borne diseases, including those that focus specifically on tick-borne diseases and have demonstrated experience in related research, public health, data collection, or patient access to care; (iii) health information technology experts or other information management specialists; (iv) clinicians, entomologists, vector management professionals, public health professionals, and others with expertise in vector-borne diseases, including tick-borne diseases; and (v) researchers, including researchers with experience conducting translational research. (c) Centers of excellence The Secretary, in coordination with the Director of the Centers for Disease Control and Prevention and the heads of other agencies, as appropriate, shall award grants, contracts, or cooperative agreements to institutions of higher education for the establishment or continued support of regional centers of excellence in vector-borne diseases to address vector-borne diseases, including tick-borne diseases, by— (1) facilitating collaboration between academia and public health organizations for public health surveillance, prevention, and response activities related to vector-borne diseases, including tick-borne diseases; (2) providing training for public health entomologists and other health care professionals, as appropriate, to address vector-borne diseases, including tick-borne diseases; (3) conducting research to develop and validate prevention and control tools and methods, including evidence-based and innovative, evidence-informed tools and methods to anticipate and respond to disease outbreaks; or (4) preparing for and responding to outbreaks of vector-borne diseases, including tick-borne diseases. (d) Eligibility To be eligible to receive a grant, contract, or cooperative agreement under subsection (c), an entity shall submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a description of how the entity will conduct the activities described in such subsection. (e) Reports (1) Program summary An entity receiving an award under subsection (c) shall, not later than one year after receiving such award, and annually thereafter, submit to the Secretary a summary of programs and activities funded under the award. (2) Progress report Not later than 4 years after the date of enactment of this section, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, a report on the progress made in addressing vector-borne diseases, including tick-borne diseases, through activities carried out under this section. (f) Authorization of appropriations For the purpose of carrying out this section, there are authorized to be appropriated $10,000,000 for each of fiscal years 2021 through 2025. . 3. Enhancing capacity to address vector-borne diseases (a) Enhanced support Subtitle C of title XXVIII of the Public Health Service Act ( 42 U.S.C. 300hh-31 et seq.) is amended by adding at the end the following: 2822. Enhanced support to assist health departments in addressing vector-borne diseases (a) In general The Secretary, acting through the Director of the Centers for Disease Control and Prevention, may enter into cooperative agreements with health departments of States, political subdivisions of States, and Indian Tribes and Tribal organizations in areas at high risk of vector-borne diseases in order to increase capacity to identify, report, prevent, and respond to such diseases and related outbreaks. (b) Eligibility To be eligible to enter into a cooperative agreement under this section, an entity described in subsection (a) shall prepare and submit to the Secretary an application at such time, in such manner, and containing such information as the Secretary may require, including a plan that describes— (1) how the applicant proposes to develop or expand programs to address vector-borne diseases risks, including through— (A) related training and workforce development; (B) programmatic efforts to improve capacity to identify, report, prevent, and respond to such disease and related outbreaks; and (C) other relevant activities identified by the Director of the Centers for Disease Control and Prevention, as appropriate; (2) the manner in which the applicant will coordinate with other Federal, Tribal, and State agencies and programs, as applicable, related to vector-borne diseases, as well as other relevant public and private organizations or agencies; and (3) the manner in which the applicant will evaluate the effectiveness of any program carried out under the cooperative agreement. (c) Authorization of appropriations For the purposes of carrying out this section, there are authorized to be appropriated $20,000,000 for each of fiscal years 2021 through 2025. .

November 5, 2019 Reported with an amendment