,i #aafth ,,congress #ast ,session ,h4 ,r4 #bbj ,,in ,,the ,,house ,,of ,,representatives ,january #c1 #bjai,mr4 ,smith of ,new ,jersey 7for himself1 ,mr4 ,peterson1 ,mr4 ,posey1 ,ms4 ,stefanik1 ,mr4 ,fitzpatrick1 ,mr4 ,sires1 ,ms4 ,pingree1 and ,mrs4 ,hartzler7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,a ,,bill ,to provide for a national strategy to address and overcome ,lyme disease and other tick-borne diseases1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,national ,lyme and ,tick-,borne ,diseases ,control and ,accountability ,act of #bjai4 #b4 ,office of ,oversight and ,coordination for ,tick-,borne ,diseases 7a7 ,establishment ,the ,secretary of ,health and ,human ,services shall establish in the ,office of the ,secretary the ,office of ,oversight and ,coordination for ,tick-,borne ,diseases1 to be headed by a director appointed by the ,secretary-- 7#a7 to oversee the creation and updating of an integrated national strategy to overcome ,lyme disease and other tick-borne diseases2 and 7#b7 to oversee and coordinate ,lyme disease and other tick-borne disease programs and activities across the agencies and offices of the ,department of ,health and ,human ,services4 7b7 ,objective of office ,in carrying out subsection 7a71 the ,director of the ,office shall facilitate and work to ensure accomplishment of the following activities3 7#a7 ,expansion and enhancement of epidemiological research and basic1 translational1 and clinical biological and biomedical research4 7#b7 ,expansion and improvement of the surveillance and reporting of ,lyme disease and other tick-borne disease1 including coinfections with agents of more than one tick-borne disease4 7#c7 ,development of effective diagnostic tests to accurately and timely diagnose ,lyme disease and other tick-borne disease1 including direct detention tests4 7#d7 ,development of treatments to cure or improve the lives of those who are infected with ,lyme disease or other tick-borne disease or who suffer from a tick-induced disorder4 7#e7 ,design and conduct of clinical trials of sufficient size and duration to support clinical recommendations4 7#f7 ,development and maintenance of one or more registries of patients and their experiences relating to exposure to1 diagnosis for1 and treatment of tick-borne disease1 including outcomes1 which registries shall protect the confidentiality and safety of patient data4 7#g7 ,systematic documentation of the experiences of health care professionals in diagnosing and treating tick-borne disease1 including diagnostic and treatment outcomes4 7#h7 ,inclusion of individuals with chronic ,lyme disease in clinical1 research1 and service efforts4 7#i7 ,coordination with international bodies to integrate and inform the fight against ,lyme disease and tick-borne disease globally4 7c7 ,integration of ,tick-,borne ,disease ,working ,group findings and recommendations ,in carrying out this section1 the ,director of the ,office shall1 as directed by the ,secretary1 with any modifications made by and as otherwise determined appropriate by the ,secretary1 oversee and coordinate integration and implementation1 into the activities of the ,office and the activities and programs of the agencies and offices of the ,department of ,health and ,human ,services1 of the recommendations to the ,secretary and the findings and conclusions in the latest report of the ,tick-,borne ,disease ,working ,group submitted to the ,secretary and congressional committees4 7d7 ,priority based on disease burden ,in carrying out this section1 the ,director of the ,office shall give priority to ,lyme disease and other tick-borne disease based on assessments of disease burden in the ,united ,states4 #c4 ,national strategy 7a7 ,in general ,the ,secretary1 in coordination with the ,director of the ,office1 and in consultation with the ,tick-,borne ,disease ,working ,group1 the agencies and offices of the ,department of ,health and ,human ,services1 and other ,federal agencies outside of the ,department of ,health and ,human ,services as appropriate1 shall-- 7#a7 not later than #b years after the date of enactment of this ,act1 develop and submit to the ,congress a national strategy for the conduct and support of ,lyme disease and other tick-borne disease or disorder programs and activities2 and 7#b7 not less than every #b years thereafter1 update such strategy4 7b7 ,contents ,the strategy under subsection 7a7 shall include-- 7#a7 proposed budgetary requirements2 7#b7 an assessment of all federally funded programs and activities related to surveillance1 diagnosis1 treatment1 education1 or prevention with respect to ,lyme disease or other tick-borne disease1 an evaluation of progress and performance based on mission and purpose1 and a description of significant challenges or barriers to performance1 including an assessment of ,federal grants awarded2 7#c7 a strategy for improving diagnosis1 treatment1 and prevention1 including increasing the impact of grants awarded by the ,national ,institutes of ,health1 the ,centers for ,disease ,control and ,prevention1 and other agencies and offices of the ,department of ,health and ,human ,services2 7#d7 a strategy for improving outcomes of individuals with ,lyme disease or another tick-borne disease or disorder1 including progress related to chronic or persistent symptoms and chronic or persistent infection and coinfections1 including plans for evaluating the potential value of and supporting the conduct of observational studies1 comparative effectiveness research1 patient-centered outcomes research1 or other real world evidence2 7#e7 the appropriate benchmarks to measure progress in achieving the improvements described in paragraphs 7#c7 and 7#d72 7#f7 a strategy for improving interactions1 coordination1 and partnerships with other ,federal agencies1 ,state and local governments1 and global entities2 and 7#g7 the latest recommendations of the ,tick-,borne ,disease ,working ,group and the steps taken by the agencies and offices of the ,department of ,health and ,human ,services to implement those recommendations4 #d4 ,federal activities related to the diagnosis1 surveillance1 and prevention of1 and research on1 ,lyme disease and other tick-borne diseases and disorders 7a7 ,in general ,the ,secretary1 in coordination with the ,director of the ,office1 acting as the ,secretary determines appropriate through the ,director of the ,centers for ,disease ,control and ,prevention1 the ,director of the ,national ,institutes of ,health1 the ,commissioner of ,food and ,drugs1 the ,director of the ,agency for ,healthcare ,research and ,quality1 the ,administrator of the ,health ,resources and ,services ,administration1 the ,director of the ,indian ,health ,service1 and the heads of other ,federal agencies1 and in consultation with the ,tick-,borne ,disease ,working ,group1 shall provide for-- 7#a7 the conduct or support of the activities described in paragraphs 7#a7 through 7#h7 of subsection 7b72 and 7#b7 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 ,bartonella4 7b7 ,activities ,the activities to be conducted or supported under subsection 7a77#a7 consist of the following3 7#a7 ,expansion and enhancement of research 7,a7 ,in general ,the ,secretary shall expand and intensify epidemiological1 basic1 translational1 and clinical research regarding ,lyme disease and other tick-borne disease and disorders and bartonellosis to better understand-- 7i7 the pathophysiology of ,borrelia burgdorferi and other tick-borne microorganisms that are human pathogens and of ,bartonella2 7ii7 pathophysiological changes over time1 including pathogen persistence profiles for patients with differing treatment histories2 7iii7 activation and deactivation of immune system processes2 and 7iv7 whether1 and what species of1 ,bartonella are transmitted by ticks4 7,b7 ,clinical outcomes research ,the ,secretary shall conduct or support clinical outcomes research to-- 7i7 establish epidemiological research objectives to determine the long-term course of illness for ,lyme disease and other tick-borne diseases and disorders2 7ii7 establish patient-centered treatment outcome objectives to allow for the comparative effectiveness of different treatment modalities2 and 7iii7 establish patient-centered research objectives to help elucidate promising treatment protocols for individuals suspected of harboring coinfections with more than one tick-transmitted pathogen4 7,c7 ,collaborative1 multidisciplinary research ,the ,secretary shall encourage the solicitation of proposals for collaborative1 multidisciplinary research that would-- 7i7 result in innovative approaches to study emerging scientific opportunities or eliminate gaps in research to improve the research portfolio1 including application of successful and promising advances in the study of other types of diseases1 such as upregulating or downregulating immune system cells or processes2 7ii7 outline key research questions1 methodologies1 and knowledge gaps2 7iii7 expand the number of research proposals that involve collaboration between #b or more national research institutes or national centers of the ,national ,institutes of ,health1 including proposals for research through the ,common ,fund pursuant to section #djb7;b77#g7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bhb7;b77#g77 to improve the research portfolio2 7iv7 expand the number of collaborative multi-institutional research grants related to tick-borne disease2 and 7v7 involve additional national research institutes and national centers of the ,national ,institutes of ,health in intramural and extramural research on tick-borne disease1 such as the ,national ,institute of ,neurological ,disorders and ,stroke conducting or sponsoring research on neurologic ,lyme disease4 7,d7 ,evaluation ,not later than #b years after the date of enactment of this ,act1 the ,secretary shall evaluate and make findings on-- 7i7 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 disorders2 7ii7 existing government or private biorepositories for ,lyme disease and other tick-borne diseases and disorders and whether-- 7,i7 specimens and samples are adequate and available to meet researcher needs2 or 7,,ii7 there are problems or challenges for researcher acquisition of samples and specimens2 and 7iii7 the scope and use of specimens and samples from cadavers1 the questions and answers such research may provide1 and the need for additional support of researchers using cadaver specimens4 7,e7 ,priority ,in carrying out this paragraph1 the ,secretary shall make it a priority to determine the extent of posttreatment persistence of ,borrelia burgdorferi and the clinical significance of such persistence4 7#b7 ,development of new and improved diagnostic tests 7,a7 ,in general ,the ,secretary1 in cooperation with the ,director of the ,office1 and acting through the ,directors of the ,centers for ,disease ,control and ,prevention and the ,director of the ,national ,institutes of ,health1 shall conduct and support research to-- 7i7 provide for the timely evaluation of promising new and improved diagnostic methods1 including direct-detection tests1 antibody-based tests1 and tests based on biosignature and biomarker profiles to make a specific diagnosis or aid in differential diagnoses2 7ii7 improve the sensitivity of ,lyme disease tests at all stages of disease progression2 7iii7 develop a ,lyme disease test capable of distinguishing between past and active infections2 7iv7 improve timely1 sensitive1 and specific diagnostic tools and tests for ,rocky ,mountain spotted fever2 and 7v7 improve the performance 7timeliness and accuracy7 of tools and tests for other tick-borne diseases found in the ,united ,states4 7,b7 ,strategies for expediting clearance ,the ,secretary shall direct the ,commissioner of ,food and ,drugs to design and propose or implement1 as appropriate within the authorities and public health priorities vested in the ,secretary by other provisions of law1 strategies for facilitating and expediting the clearance or approval of improved diagnostic tests for ,lyme disease and other tick-borne disease1 particularly where-- 7i7 there are no cleared diagnostic tests2 or 7ii7 cleared diagnostic tests lack a high level of specificity or sensitivity or are unable to confirm the presence or absence of active infection4 7#c7 ,ensuring safety and efficacy of vaccines ,the ,secretary shall-- 7,a7 ensure the safety and efficacy of any new1 renewed1 or modified human vaccine for ,lyme disease1 other tick-borne disease1 or a combination of such diseases2 and 7,b7 require the ,commissioner of ,food and ,drugs to submit to the ,secretary prior to final approval of the vaccine being reviewed1 a report1 with appropriate provisions for commercial confidentiality1 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 #bjjb and how those concerns with the withdrawn vaccine have been addressed or why they are not relevant4 7#d7 ,monitoring and understanding human cases of ,lyme disease and other tick-borne diseases 7,a7 ,in general ,the ,secretary shall-- 7i7 establish and maintain a statistically sound1 scientifically credible surveillance system to be known as the ,national ,tick-,borne ,disease ,surveillance ,system2 7ii7 enhance and expand infrastructure and activities to track the epidemiology of ,lyme disease and other tick-borne diseases and disorders2 and 7iii7 incorporate information obtained through such activities into the ,national ,tick-,borne ,disease ,surveillance ,system4 7,b7 ,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 disorders4 7,c7 ,content ,in carrying out subparagraph 7,a71 the ,secretary-- 7i7 shall provide for the collection and storage of information on the incidence and prevalence of tick-borne disease in the ,united ,states-- 7,i7 while continuing to support activities in the #ad ,states with the highest number of reported cases of ,lyme disease1 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 emerging2 7,,ii7 working with the ,states and treating physicians1 in consultation with the ,council of ,state and ,territorial ,epidemiologists 7in this clause referred to as the ,,cste71 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 ,prevention2 7,,iii7 in consultation with the ,,cste1 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 ,prevention2 7,,iv7 in consultation with the ,,cste1 working with the ,states to encourage and improve laboratory reporting of ,lyme disease and other tick-borne diseases1 and evaluate the feasibility of creating a national uniform reporting system including mandatory reporting by ,states and physicians and laboratories in each ,state2 7,v7 including in the surveillance system bartonellosis transmitted by any vector and1 if it is known1 by the vector of transmission2 and 7,,vi7 tracking incidence and prevalence data for tick-borne disorders2 and 7ii7 to the extent practicable1 shall provide for the collection and storage of other available information on ,lyme disease and other tick-borne diseases and disorders1 including information related to persons who have been diagnosed with and treated for tick-borne disease who choose to participate1 such as-- 7,i7 demographics1 such as age1 race1 sex1 geographic location1 and other information1 as appropriate2 7,,ii7 family history and experience with tick-borne disease or tick induced disorder2 7,,iii7 history of exposure and known tick bites2 7,,iv7 progression of signs and symptoms2 7,v7 diagnostic and treatment history and outcomes2 and 7,,vi7 additional screening conducted and related data1 such as biological markers4 7,d7 ,consultation ,in carrying out this paragraph1 the ,secretary shall consult with individuals with appropriate expertise1 which may include-- 7i7 epidemiologists with experience in disease surveillance or registries2 7ii7 representatives of national patient advocacy and research organizations that focus on tick-borne disease and have demonstrated experience in research1 data collection1 or patient access to care2 7iii7 health information technology experts or other information management specialists2 7iv7 clinicians with expertise in ,lyme disease or other tick-borne diseases or disorders2 and 7v7 research scientists with experience conducting translational research or utilizing surveillance systems for scientific research purposes4 7,e7 ,grants ,the ,secretary may award grants to1 or enter into contracts or cooperative agreements with1 public or private nonprofit entities to carry out activities under this paragraph4 7,f7 ,coordination with ,federal1 ,state1 and local agencies ,subject to subparagraph 7,h71 the ,secretary shall-- 7i7 establish agreements and mechanisms1 as appropriate1 for improved collecting and reporting of tick-borne disease surveillance data under subparagraphs 7,a71 7,b71 and clause 7i7 of subparagraph 7,c7 and other available information under clause 7ii7 of subparagraph 7,c7 from community health centers funded by the ,health ,resources and ,services ,administration and medical facilities of the ,indian ,health ,service2 7ii7 establish formal agreements1 as appropriate and may be worked out1 to provide for improved collection and reporting of surveillance data under subparagraphs 7,a71 7,b7 or clause 7i7 of subparagraph 7,c7 and other available information under clause 7ii7 of subparagraph 7,c71 obtained from hospitals and medical clinics run by other ,federal departments and agencies2 7iii7 make information and analysis in the ,national ,tick-,borne ,disease ,surveillance ,system available1 as appropriate1 to all components of the ,department of ,health and ,human ,services1 to other ,federal agencies1 and to ,state and local agencies2 and 7iv7 identify1 build upon1 leverage1 and coordinate among existing data and surveillance systems1 surveys1 registries1 and other ,federal public health infrastructure1 wherever practicable4 7,g7 ,public access ,subject to subparagraph 7,h71 the ,secretary shall ensure that information and analysis in the ,national ,tick-,borne ,disease ,surveillance ,system are available1 as appropriate1 to the public and other interested parties on the website of the ,department of ,health and ,human ,services4 7,h7 ,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 law1 and in a manner that protects personal privacy1 to the extent required by applicable ,federal and ,state privacy law1 at a minimum4 7#e7 ,education and prevention 7,a7 ,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 pamphlet1 available online and by hard copy1 addressing-- 7i7 ticks and tick-borne diseases common to the geographic area1 tick-borne disease that could be acquired while on domestic or international travel1 and ticks that1 while not common to the geographic area1 could migrate to the area2 7ii7 signs and symptoms of such tick-borne disease2 7iii7 tick removal instructions2 7iv7 the most effective actions individuals can take to reduce risk of exposure to ticks and risk of disease transmission2 and 7v7 additional community-based actions to reduce risk of exposure to ticks4 7,b7 ,coordination ,in carrying out subparagraph 7,a71 the ,secretary1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall coordinate with legally incorporated ,lyme disease or other tick-borne disease organizations4 7,c7 ,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-- 7i7 the consumer tick disease pamphlets developed under subparagraph 7,a72 or 7ii7 such other appropriate consumer tick disease pamphlets as the ,administration or ,service may develop or acquire4 7,d7 ,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 disorders1 including-- 7i7 the role of clinical diagnosis2 7ii7 the limitations of serological diagnostic tests2 7iii7 enhanced1 validated diagnostics available from laboratories certified under section #cec of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfc;a7 that may aid the physician2 7iv7 guidelines available on the ,national ,guideline ,clearinghouse2 7v7 the voluntary nature of clinical practice guidelines2 7vi7 the complexities presented by coinfections relating to symptomology1 diagnosis1 and treatment1 including prudently acting in the patient's interest in non- or low-incidence ,states2 and 7vii7 the identification of significant research gaps most impacting diagnosis and treatment1 and significant research being conducted to address those gaps4 7,e7 ,process for developing physician education program ,the ,secretary of ,health and ,human ,services shall-- 7i7 conduct a public meeting to solicit input for the design of the physician education program under subparagraph 7,d72 7ii7 give the public notice of such meeting at least #de days in advance2 7iii7 also solicit input on the design of the physician education program from the ,tick-,borne ,disease ,working ,group2 7iv7 publish a proposed syllabus for the physician education program not more than #abj days after the public meeting2 7v7 allow for a #fj-;day public comment period before publishing such syllabus in final form2 and 7vi7 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 7,d74 7#f7 ,monitoring1 understanding1 and controlling vectors and animal reservoirs of ,lyme disease and other tick-borne disease 7,a7 ,tick ,surveillance and ,testing ,the ,secretary1 in coordination with the ,director of the ,office1 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 appropriate1 shall-- 7i7 not later than #ahj days after the date of enactment of this ,act1 provide a report to the ,congress describing the tick surveillance and pathogen testing activities of the ,department and entities funded by the ,department1 including-- 7,i7 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-#ag-jje1 ,catalog of ,federal ,domestic ,assistance ,number #ic4jhd2 and 7,,ii7 within such description1 the roles of participating academic1 governmental1 and private institutions2 7ii7 not later than #b years after the date of enactment of this ,act1 in consultation and coordination with other ,federal agencies and ,state and local government agencies1 as appropriate1 and established academic or nonprofit tick-testing centers1 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 pathogenicity1 including a plan for a network of tick identification and testing laboratories2 7iii7 not later than #b years after the date of enactment of this ,act1 establish agreements and procedures for sharing data on surveillance and testing of ticks with other ,federal departments and agencies engaged in such activities2 and 7iv7 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 pathogens1 including geographic information from veterinary encounters4 7,b7 ,investigation ,in carrying out subparagraph 7,a71 the ,secretary1 in coordination with the ,director of the ,office1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 in consultation and coordination with other ,federal agencies that conduct or support tick surveillance or testing activities1 as appropriate1 and public and private laboratories1 shall-- 7i7 investigate and1 where appropriate1 promote the use of advanced new technologies1 such as tools to discover all known and all previously unidentified microorganisms in a vector2 and 7ii7 while being informed by previous surveillance studies1 allow for the possibility of rapid geographic migration of tick vectors and pathogens and unexpected findings4 7,c7 ,tick control and prevention ,the ,secretary1 in coordination with the ,director of the ,office1 acting through the ,director of the ,centers for ,disease ,control and ,prevention and the ,director of the ,national ,institutes of ,health1 shall1 as appropriate and pursuant to authorities vested in the ,secretary by other provisions of law1 support activities of and coordinate and share1 information with other ,federal1 ,state1 and local government agencies1 involved or interested in tick prevention and control activities on-- 7i7 the development of safer and more effective tick repellents1 both natural and chemical2 7ii7 the use of acaricides or other chemical interventions2 7iii7 nonchemical environmental measures to lessen human exposure to ticks2 7iv7 genetic therapies for vectors or animal hosts to interfere with the life cycle of pathogens2 and 7v7 the development of vector or reservoir host vaccines4 7,d7 ,leveraging existing tick management resources ,in carrying out this paragraph1 the ,secretary1 in coordination with the ,director of the ,office1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 shall identify1 build upon1 leverage1 and coordinate among existing tick surveillance1 testing1 and management resources and infrastructure wherever practicable4 7,e7 ,public access to data ,in carrying out this paragraph1 the ,secretary1 in coordination with the ,director of the ,office1 acting through the ,director of the ,centers for ,disease ,control and ,prevention1 in coordination and consultation with other ,federal agencies and ,state and local agencies as appropriate1 make data on tick surveillance1 testing1 control and prevention available to the public on the website of the ,department of ,health and ,human ,services4 7#g7 ,conferences1 symposia1 seminars1 and other public meetings 7,a7 ,sense of ,congress ,it is the sense of the ,congress that public meetings1 conferences1 symposia1 and seminars 7including webinars7 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 ,group4 7,b7 ,requirements ,the ,secretary and the ,director of the ,office1 in cooperation with the ,director of the ,centers for ,disease ,control and ,prevention1 the ,director of the ,national ,institutes of ,health1 and the ,tick-,borne ,disease ,working ,group1 shall-- 7i7 no later than #bd months after the date of enactment of this ,act1 sponsor a state-of-the-science conference on ,lyme disease and other tick-borne disease including identification of research gaps and top research priorities2 7ii7 for any scientific or medical conference on ,lyme disease or other tick-borne disease that is organized1 sponsored1 or paid for by the ,department of ,health and ,human ,services1 ensure that a controlling statement of work and significant modifications thereto1 whether in the contract or as a separate document1 issued to the vendor organizing or conducting the conference are in writing and made available to the public prior to the conference2 7iii7 not later than #abj days after the conclusion of the conference under clause 7i71 make available a final report on the conference to the ,tick-,borne ,disease ,working ,group and to the public2 7iv7 not later than #ah months after the date of enactment of this ,act1 working through the ,director of the ,agency for ,healthcare ,research and ,quality1 sponsor a symposium on the use of real-world evidence 7meaning data from sources other than randomized clinical trials1 such as observational studies1 comparative effectiveness and patient-centered outcomes research1 and patient clinical data or human subject data71 including the standards and methodologies for collection and analysis of real-world evidence in managing ,lyme disease and other tick-borne disease2 7v7 include in such symposium identification and analysis of existing data sources1 such as patient registries and human subjects' databases2 7vi7 sponsor a researcher workshop on challenges and solutions for clinical trial design and implementation for ,lyme disease to be held no later than #bd months after the date of enactment of this ,act1 which workshop may consider other tick-borne disease or coinfections with more than one tick-borne pathogen as may be feasible and practicable2 7vii7 not later than #i months after the date of enactment of this ,act1 in consultation with the ,tick-,borne ,disease ,working ,group1 design a survey instrument or instruments targeted to patients and patient advocates1 physicians and health care providers1 and researchers regarding recommended subjects and agendas for federally sponsored meetings1 conferences1 and seminars1 including webinars1 on ,lyme disease and other tick-borne disease2 7viii7 not later than #f months after the conduct of the survey1 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 #fj-;day public comment period2 and 7ix7 provide a final analysis and a proposed schedule and agenda for public meetings1 conferences1 and seminars1 including webinars1 for incorporation into the national strategy under section #c as appropriate and to the ,tick-,borne ,disease ,working ,group4 7#h7 ,common research bibliography ,the ,secretary1 in coordination with the ,director of the ,office1 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 ,states1 as well as for bartonellosis from whatever cause1 appropriately organized for use by the scientific community1 treating physicians1 and the public4 ,the bibliography should include literature relating to possible mechanisms of persistent infection with ,borrelia burgdorferi or other types of ,borrelia4 7c7 ,priority based on disease burden ,in conducting and supporting activities under this section1 the ,secretary shall give priority to ,lyme disease and other tick-borne diseases based on assessments of disease burden in the ,united ,states4 #e4 ,biennial reports 7a7 ,in general ,not later than #bd months after the date of the enactment of this ,act1 and biennially thereafter1 the ,secretary shall submit to the ,congress a report on the activities carried out under this ,act and the activities of the ,tick-,borne ,disease ,working ,group4 7b7 ,content ,reports under subsection 7a7 shall contain-- 7#a7 a scientifically qualified assessment of ,lyme disease and other tick-borne disease1 including a summary of prevalence1 geography1 important exposure characteristics1 disease stages and manifestations or symptoms of those stages1 based on a synthesis of the broad spectrum of empirical evidence of treating physicians1 as well as published peer-reviewed data1 to include for each tick-borne disease a state-of-the-science diagnosis and treatment2 7#b7 a description of all programs and activities funded by the ,department of ,health and ,human ,services that are related to the surveillance1 diagnosis1 treatment1 education1 or prevention of ,lyme disease or other tick-borne disease1 and an evaluation of progress and performance based on mission and purpose1 and discussion of significant challenges or barriers to performance1 to include-- 7,a7 for the initial report under this section1 a description of the intramural and extramural research portfolios of the ,centers for ,disease ,control and ,prevention1 the ,national ,institutes of ,health1 and other agencies and offices of the ,department of ,health and ,human ,services which conducted or contracted for research projects related to ,lyme disease or on other tick-borne disease or disorder1 including information on-- 7i7 the award amount1 institution1 primary investigator1 principal investigative question or questions1 and significant conclusions2 and 7ii7 studies that received ,federal funds and were terminated1 in progress1 or initiated in the fiscal year including the date of enactment of this ,act and the #e prior fiscal years2 7,b7 for reports in subsequent years1 all of the information described in subparagraph 7,a71 except the reference in subparagraph 7,a77ii7 to ,federal funds terminated1 in progress1 or awarded in the #f prior fiscal years shall be treated as reference to such funds in the #b prior fiscal years2 7,c7 a status and summary report on the ,national ,tick-,borne ,disease ,surveillance ,system1 including-- 7i7 the type of information collected and stored in the ,system2 7ii7 the use1 distribution1 and availability of such information1 including guidelines for such use2 and 7iii7 the use and coordination of surveillance and patient information databases2 and 7,d7 information on agreements1 partnerships1 cooperation1 coordination1 and data sharing with external entities1 such as ,state and local governments1 other ,federal agencies1 working groups1 and global entities2 7#c7 a description of major externally funded research1 surveillance1 education1 or other programs and initiatives impacting the management or science of tick-borne disease2 7#d7 recommendations for addressing research gaps in scientific understanding of ,lyme disease and other tick-borne diseases and disorders and relevant to development of effective diagnostic tools and treatment protocols for ,lyme disease and other tick-borne diseases and disorders2 7#e7 a description of clinical practice guidelines for any tick-borne disease published on the ,national ,guideline ,clearinghouse2 7#f7 recommendations for addressing research gaps in tick biology and tick management2 7#g7 a description of activities for the promotion of public awareness and physician education initiatives to improve the knowledge of health care providers and the public in support of clinical and behavioral decision making in relationship to ,lyme disease and other tick-borne disease2 and 7#h7 a copy of the most recent annual report issued by the ,tick-,borne ,disease ,working ,group and an assessment of progress in achieving recommendations of that ,working ,group4 7c7 ,biennial reports of ,,nih ,the ,secretary shall ensure that each biennial report under title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 or each triennial report under section #djc of such ,act 7#db ,u4,s4,c4 #bhc7 includes information on actions undertaken by the ,national ,institutes of ,health to carry out research with respect to ,lyme disease and other tick-borne disease4 #f4 ,definitions ,in this ,act3 7#a7 ,bartonellosis ,the term bartonellosis means disease caused by ,bartonella infection from any vector or source1 unless otherwise specified4 7#b7 ,disorder ,the term disorder means a disorder caused by ticks1 but not inducing human infection1 such as tick paralysis and ,alpha-,gal meat allergy4 7#c7 ,office ,the term ,office means the ,office of ,oversight and ,coordination for ,tick-,borne ,diseases established under section #b4 7#d7 ,other federal agency ,other ,federal agency means a ,federal ,department1 agency or office outside of the ,u4,s4 ,department of ,health and ,human ,services4 7#e7 ,secretary ,the term ,secretary means the ,secretary of ,health and ,human ,services4 7#f7 ,tick-borne disease ,the term tick-borne disease means a disease that is known to be transmitted by ticks in the ,united ,states1 unless otherwise specified1 or that may be discovered to be transmitted by ticks in the ,united ,states4 7#g7 ,tick-,borne ,disease ,working ,group ,the term ,tick-,borne ,disease ,working ,group means the ,tick-,borne ,disease ,working ,group established under section #bjfb of the #bast ,century ,cures ,act 7#db ,u4,s4,c4 #bhds74