Federal activities related to the diagnosis, surveillance, and prevention of, and research on, Lyme disease and other tick-borne diseases and disorders

(a)

In general

The Secretary, in coordination with the Director of the Office, acting as the Secretary determines 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 Administrator of the Health Resources and Services Administration, the Director of the Indian Health Service, and the heads of other Federal agencies, and in consultation with the Tick-Borne Disease Working Group, shall provide for— (1)the conduct or support of the activities described in paragraphs (1) through (8) of subsection (b); and (2)the coordination of all programs and activities of the Department of Health and Human Services related to Lyme disease and other tick-borne diseases and disorders and Bartonella. (b)

Activities

The activities to be conducted or supported under subsection (a)(1) consist of the following: (1)

Expansion and enhancement of research

(A)

In general

The Secretary shall expand and intensify epidemiological, basic, translational, and clinical research regarding Lyme disease and other tick-borne disease and disorders and bartonellosis to better understand— (i)the pathophysiology of Borrelia burgdorferi and other tick-borne microorganisms that are human pathogens and of Bartonella; (ii)pathophysiological changes over time, including pathogen persistence profiles for patients with differing treatment histories; (iii)activation and deactivation of immune system processes; and (iv)whether, and what species of, Bartonella are transmitted by ticks. (B)

Clinical outcomes research

The Secretary shall conduct or support clinical outcomes research to— (i)establish epidemiological research objectives to determine the long-term course of illness for Lyme disease and other tick-borne diseases and disorders; (ii)establish patient-centered treatment outcome objectives to allow for the comparative effectiveness of different treatment modalities; and (iii)establish patient-centered research objectives to help elucidate promising treatment protocols for individuals suspected of harboring coinfections with more than one tick-transmitted pathogen. (C)

Collaborative, multidisciplinary research

The Secretary shall encourage the solicitation of proposals for collaborative, multidisciplinary research that would— (i)result in innovative approaches to study emerging scientific opportunities or eliminate gaps in research to improve the research portfolio, including application of successful and promising advances in the study of other types of diseases, such as upregulating or downregulating immune system cells or processes; (ii)outline key research questions, methodologies, and knowledge gaps; (iii)expand the number of research proposals that involve collaboration between 2 or more national research institutes or national centers of the National Institutes of Health, including proposals for research through the Common Fund pursuant to section 402(b)(7) of the Public Health Service Act (42 U.S.C. 282(b)(7)) to improve the research portfolio; (iv)expand the number of collaborative multi-institutional research grants related to tick-borne disease; and (v)involve additional national research institutes and national centers of the National Institutes of Health in intramural and extramural research on tick-borne disease, such as the National Institute of Neurological Disorders and Stroke conducting or sponsoring research on neurologic Lyme disease. (D)

Evaluation

Not later than 2 years after the date of enactment of this Act, the Secretary shall evaluate and make findings on— (i)the feasibility and potential value to the research community of establishing a deidentified human subjects database for Lyme disease and other tick-borne diseases and disorders; (ii)existing government or private biorepositories for Lyme disease and other tick-borne diseases and disorders and whether— (I)specimens and samples are adequate and available to meet researcher needs; or (II)there are problems or challenges for researcher acquisition of samples and specimens; and (iii)the scope and use of specimens and samples from cadavers, the questions and answers such research may provide, and the need for additional support of researchers using cadaver specimens. (E)

Priority

In carrying out this paragraph, the Secretary shall make it a priority to determine the extent of posttreatment persistence of Borrelia burgdorferi and the clinical significance of such persistence. (2)

Development of new and improved diagnostic tests

(A)

In general

The Secretary, in cooperation with the Director of the Office, and acting through the Directors of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health, shall conduct and support research to— (i)provide for the timely evaluation of promising new and improved diagnostic methods, including direct-detection tests, antibody-based tests, and tests based on biosignature and biomarker profiles to make a specific diagnosis or aid in differential diagnoses; (ii)improve the sensitivity of Lyme disease tests at all stages of disease progression; (iii)develop a Lyme disease test capable of distinguishing between past and active infections; (iv)improve timely, sensitive, and specific diagnostic tools and tests for Rocky Mountain spotted fever; and (v)improve the performance (timeliness and accuracy) of tools and tests for other tick-borne diseases found in the United States. (B)

Strategies for expediting clearance

The Secretary shall direct the Commissioner of Food and Drugs to design and propose or implement, as appropriate within the authorities and public health priorities vested in the Secretary by other provisions of law, strategies for facilitating and expediting the clearance or approval of improved diagnostic tests for Lyme disease and other tick-borne disease, particularly where— (i)there are no cleared diagnostic tests; or (ii)cleared diagnostic tests lack a high level of specificity or sensitivity or are unable to confirm the presence or absence of active infection. (3)

Ensuring safety and efficacy of vaccines

The Secretary shall— (A)ensure the safety and efficacy of any new, renewed, or modified human vaccine for Lyme disease, other tick-borne disease, or a combination of such diseases; and (B)require the Commissioner of Food and Drugs to submit to the Secretary prior to final approval of the vaccine being reviewed, a report, with appropriate provisions for commercial confidentiality, detailing the safety of the vaccine and contrasting its safety profile based on its mechanisms of action to safety concerns expressed to the Food and Drug Administration regarding the human vaccine withdrawn from the market in 2002 and how those concerns with the withdrawn vaccine have been addressed or why they are not relevant. (4)

Monitoring and understanding human cases of Lyme disease and other tick-borne diseases

(A)

In general

The Secretary shall— (i)establish and maintain a statistically sound, scientifically credible surveillance system to be known as the National Tick-Borne Disease Surveillance System; (ii)enhance and expand infrastructure and activities to track the epidemiology of Lyme disease and other tick-borne diseases and disorders; and (iii)incorporate information obtained through such activities into the National Tick-Borne Disease Surveillance System. (B)

Research

The Secretary shall ensure that the National Tick-Borne Disease Surveillance System is designed in a manner that facilitates further research on Lyme disease and other tick-borne diseases and disorders. (C)

Content

In carrying out subparagraph (A), the Secretary— (i)shall provide for the collection and storage of information on the incidence and prevalence of tick-borne disease in the United States— (I)while continuing to support activities in the 14 States with the highest number of reported cases of Lyme disease, and intensifying efforts in other States where Lyme disease has been reported and where all reported cases cannot be affirmatively associated with out-of-State travel in order to better determine where the disease is emerging; (II)working with the States and treating physicians, in consultation with the Council of State and Territorial Epidemiologists (in this clause referred to as the CSTE), to improve evaluation of the feasibility of capturing data on cases that do not meet surveillance criteria of the CSTE and the Centers for Disease Control and Prevention; (III)in consultation with the CSTE, working with States that are using averaging or similar techniques to estimate case reports to ensure that data produced by that process are able to be reported out by the Centers for Disease Control and Prevention; (IV)in consultation with the CSTE, working with the States to encourage and improve laboratory reporting of Lyme disease and other tick-borne diseases, and evaluate the feasibility of creating a national uniform reporting system including mandatory reporting by States and physicians and laboratories in each State; (V)including in the surveillance system bartonellosis transmitted by any vector and, if it is known, by the vector of transmission; and (VI)tracking incidence and prevalence data for tick-borne disorders; and (ii)to the extent practicable, shall provide for the collection and storage of other available information on Lyme disease and other tick-borne diseases and disorders, including information related to persons who have been diagnosed with and treated for tick-borne disease who choose to participate, such as— (I)demographics, such as age, race, sex, geographic location, and other information, as appropriate; (II)family history and experience with tick-borne disease or tick induced disorder; (III)history of exposure and known tick bites; (IV)progression of signs and symptoms; (V)diagnostic and treatment history and outcomes; and (VI)additional screening conducted and related data, such as biological markers. (D)

Consultation

In carrying out this paragraph, the Secretary shall consult with individuals with appropriate expertise, which may include— (i)epidemiologists with experience in disease surveillance or registries; (ii)representatives of national patient advocacy and research organizations that focus 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 with expertise in 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. (E)

Grants

The Secretary may award grants to, or enter into contracts or cooperative agreements with, public or private nonprofit entities to carry out activities under this paragraph. (F)

Coordination with Federal, State, and local agencies

Subject to subparagraph (H), the Secretary shall— (i)establish agreements and mechanisms, as appropriate, for improved collecting and reporting of tick-borne disease surveillance data under subparagraphs (A), (B), and clause (i) of subparagraph (C) and other available information under clause (ii) of subparagraph (C) from community health centers funded by the Health Resources and Services Administration and medical facilities of the Indian Health Service; (ii)establish formal agreements, as appropriate and may be worked out, to provide for improved collection and reporting of surveillance data under subparagraphs (A), (B) or clause (i) of subparagraph (C) and other available information under clause (ii) of subparagraph (C), obtained from hospitals and medical clinics run by other Federal departments and agencies; (iii)make information and analysis in the National Tick-Borne Disease Surveillance System available, as appropriate, to all components of the Department of Health and Human Services, to other Federal agencies, and to State and local agencies; and (iv)identify, build upon, leverage, and coordinate among existing data and surveillance systems, surveys, registries, and other Federal public health infrastructure, wherever practicable. (G)

Public access

Subject to subparagraph (H), the Secretary shall ensure that information and analysis in the National Tick-Borne Disease Surveillance System are available, as appropriate, to the public and other interested parties on the website of the Department of Health and Human Services. (H)

Privacy

The Secretary shall ensure that information and analysis in the National Tick-Borne Disease Surveillance System are made available only to the extent permitted by applicable Federal and State law, and in a manner that protects personal privacy, to the extent required by applicable Federal and State privacy law, at a minimum. (5)

Education and prevention

(A)

Consumer and community education

The Secretary shall increase public education related to Lyme disease and other tick-borne diseases and disorders through the expansion of the community-based education programs of the Centers for Disease Control and Prevention to include development and publication of a consumer tick disease pamphlet, available online and by hard copy, addressing— (i)ticks and tick-borne diseases common to the geographic area, tick-borne disease that could be acquired while on domestic or international travel, and ticks that, while not common to the geographic area, could migrate to the area; (ii)signs and symptoms of such tick-borne disease; (iii)tick removal instructions; (iv)the most effective actions individuals can take to reduce risk of exposure to ticks and risk of disease transmission; and (v)additional community-based actions to reduce risk of exposure to ticks. (B)

Coordination

In carrying out subparagraph (A), the Secretary, acting through the Director of the Centers for Disease Control and Prevention, shall coordinate with legally incorporated Lyme disease or other tick-borne disease organizations. (C)

Dissemination

The Administrator of the Health Resources and Services Administration and the Director of the Indian Health Service shall make available in rural health centers and clinics which they operate or fund— (i)the consumer tick disease pamphlets developed under subparagraph (A); or (ii)such other appropriate consumer tick disease pamphlets as the Administration or Service may develop or acquire. (D)

Physician education

The Secretary shall carry out a physician education program that addresses the full spectrum of scientific research related to Lyme disease and other tick-borne diseases and disorders, including— (i)the role of clinical diagnosis; (ii)the limitations of serological diagnostic tests; (iii)enhanced, validated diagnostics available from laboratories certified under section 353 of the Public Health Service Act (42 U.S.C. 263a) that may aid the physician; (iv)guidelines available on the National Guideline Clearinghouse; (v)the voluntary nature of clinical practice guidelines; (vi)the complexities presented by coinfections relating to symptomology, diagnosis, and treatment, including prudently acting in the patient’s interest in non- or low-incidence States; and (vii)the identification of significant research gaps most impacting diagnosis and treatment, and significant research being conducted to address those gaps. (E)

Process for developing physician education program

The Secretary of Health and Human Services shall— (i)conduct a public meeting to solicit input for the design of the physician education program under subparagraph (D); (ii)give the public notice of such meeting at least 45 days in advance; (iii)also solicit input on the design of the physician education program from the Tick-Borne Disease Working Group; (iv)publish a proposed syllabus for the physician education program not more than 120 days after the public meeting; (v)allow for a 60-day public comment period before publishing such syllabus in final form; and (vi)publish on the public website of the Department of Health and Human Services a summary of the comments received from the public under this subparagraph before conducting the first training program under subparagraph (D). (6)

Monitoring, understanding, and controlling vectors and animal reservoirs of Lyme disease and other tick-borne disease

(A)

Tick Surveillance and Testing

The Secretary, in coordination with the Director of the Office, acting through the Director of the Centers for Disease Control and Prevention and other agencies and offices of the Department of Health and Human Services as appropriate, shall— (i)not later than 180 days after the date of enactment of this Act, provide a report to the Congress describing the tick surveillance and pathogen testing activities of the Department and entities funded by the Department, including— (I)a detailed description of the tick surveillance and tick pathogen testing activities and planned activities of the Vector-Borne Disease Regional Centers of Excellence as established under Funding Opportunity Announcement RFA–CK–17–005, Catalog of Federal Domestic Assistance Number 93.084; and (II)within such description, the roles of participating academic, governmental, and private institutions; (ii)not later than 2 years after the date of enactment of this Act, in consultation and coordination with other Federal agencies and State and local government agencies, as appropriate, and established academic or nonprofit tick-testing centers, develop a framework and an implementation plan for a comprehensive nationwide strategy for the surveillance and testing of ticks for human pathogens and microorganisms with unknown pathogenicity, including a plan for a network of tick identification and testing laboratories; (iii)not later than 2 years after the date of enactment of this Act, establish agreements and procedures for sharing data on surveillance and testing of ticks with other Federal departments and agencies engaged in such activities; and (iv)consult and coordinate with the American Veterinary Medical Association and the Companion Animal Parasite Council on obtaining and sharing data on the surveillance and testing of ticks and tick-borne pathogens, including geographic information from veterinary encounters. (B)

Investigation

In carrying out subparagraph (A), the Secretary, in coordination with the Director of the Office, acting through the Director of the Centers for Disease Control and Prevention, in consultation and coordination with other Federal agencies that conduct or support tick surveillance or testing activities, as appropriate, and public and private laboratories, shall— (i)investigate and, where appropriate, promote the use of advanced new technologies, such as tools to discover all known and all previously unidentified microorganisms in a vector; and (ii)while being informed by previous surveillance studies, allow for the possibility of rapid geographic migration of tick vectors and pathogens and unexpected findings. (C)

Tick control and prevention

The Secretary, in coordination with the Director of the Office, acting through the Director of the Centers for Disease Control and Prevention and the Director of the National Institutes of Health, shall, as appropriate and pursuant to authorities vested in the Secretary by other provisions of law, support activities of and coordinate and share, information with other Federal, State, and local government agencies, involved or interested in tick prevention and control activities on— (i)the development of safer and more effective tick repellents, both natural and chemical; (ii)the use of acaricides or other chemical interventions; (iii)nonchemical environmental measures to lessen human exposure to ticks; (iv)genetic therapies for vectors or animal hosts to interfere with the life cycle of pathogens; and (v)the development of vector or reservoir host vaccines. (D)Leveraging existing tick management resources.—In carrying out this paragraph, the Secretary, in coordination with the Director of the Office, acting through the Director of the Centers for Disease Control and Prevention, shall identify, build upon, leverage, and coordinate among existing tick surveillance, testing, and management resources and infrastructure wherever practicable. (E)Public access to data.—In carrying out this paragraph, the Secretary, in coordination with the Director of the Office, acting through the Director of the Centers for Disease Control and Prevention, in coordination and consultation with other Federal agencies and State and local agencies as appropriate, make data on tick surveillance, testing, control and prevention available to the public on the website of the Department of Health and Human Services. (7)

Conferences, symposia, seminars, and other public meetings

(A)

Sense of Congress

It is the sense of the Congress that public meetings, conferences, symposia, and seminars (including webinars) sponsored by the Federal Government are a valuable input to strategic and operational programmatic planning within Federal agencies and to the work of the Tick-Borne Disease Working Group. (B)

Requirements

The Secretary and the Director of the Office, in cooperation with the Director of the Centers for Disease Control and Prevention, the Director of the National Institutes of Health, and the Tick-Borne Disease Working Group, shall— (i)no later than 24 months after the date of enactment of this Act, sponsor a state-of-the-science conference on Lyme disease and other tick-borne disease including identification of research gaps and top research priorities; (ii)for any scientific or medical conference on Lyme disease or other tick-borne disease that is organized, sponsored, or paid for by the Department of Health and Human Services, ensure that a controlling statement of work and significant modifications thereto, whether in the contract or as a separate document, issued to the vendor organizing or conducting the conference are in writing and made available to the public prior to the conference; (iii)not later than 120 days after the conclusion of the conference under clause (i), make available a final report on the conference to the Tick-Borne Disease Working Group and to the public; (iv)not later than 18 months after the date of enactment of this Act, working through the Director of the Agency for Healthcare Research and Quality, sponsor a symposium on the use of real-world evidence (meaning data from sources other than randomized clinical trials, such as observational studies, comparative effectiveness and patient-centered outcomes research, and patient clinical data or human subject data), including the standards and methodologies for collection and analysis of real-world evidence in managing Lyme disease and other tick-borne disease; (v)include in such symposium identification and analysis of existing data sources, such as patient registries and human subjects’ databases; (vi)sponsor a researcher workshop on challenges and solutions for clinical trial design and implementation for Lyme disease to be held no later than 24 months after the date of enactment of this Act, which workshop may consider other tick-borne disease or coinfections with more than one tick-borne pathogen as may be feasible and practicable; (vii)not later than 9 months after the date of enactment of this Act, in consultation with the Tick-Borne Disease Working Group, design a survey instrument or instruments targeted to patients and patient advocates, physicians and health care providers, and researchers regarding recommended subjects and agendas for federally sponsored meetings, conferences, and seminars, including webinars, on Lyme disease and other tick-borne disease; (viii)not later than 6 months after the conduct of the survey, provide an analysis of the results of the survey to the Tick-Borne Disease Working Group and publish such results in the Federal Register for a 60-day public comment period; and (ix)provide a final analysis and a proposed schedule and agenda for public meetings, conferences, and seminars, including webinars, for incorporation into the national strategy under section 3 as appropriate and to the Tick-Borne Disease Working Group. (8)

Common research bibliography

The Secretary, in coordination with the Director of the Office, shall direct the Director of the Agency for Healthcare Research and Quality to assemble a bibliography of peer-reviewed literature of tick-borne diseases and disorders in the United States, as well as for bartonellosis from whatever cause, appropriately organized for use by the scientific community, treating physicians, and the public. The bibliography should include literature relating to possible mechanisms of persistent infection with Borrelia burgdorferi or other types of Borrelia. (c)

Priority based on disease burden

In conducting and supporting activities under this section, the Secretary shall give priority to Lyme disease and other tick-borne diseases based on assessments of disease burden in the United States.