SEC. 2. OFFICE OF OVERSIGHT AND COORDINATION FOR 
TICK-BORNE DISEASES. 
(a) ESTABLISHMENT.—The Secretary of Health and 
Human Services shall establish in the Office of the Sec-
retary the Office of Oversight and Coordination for Tick- 
Borne Diseases, to be headed by a director appointed by 
the Secretary— 
(1) to oversee the creation and updating of an 
integrated national strategy to overcome Lyme dis-
ease and other tick-borne diseases; and 
(2) 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 Services. 
(b) OBJECTIVE OF OFFICE.—In carrying out sub-
section (a), the Director of the Office shall facilitate and 
work to ensure accomplishment of the following activities: 
(1) Expansion and enhancement of epidemiolog-
ical research and basic, translational, and clinical bi-
ological and biomedical research. 
(2) Expansion and improvement of the surveil-
lance and reporting of Lyme disease and other tick- 
borne disease, including coinfections with agents of 
more than one tick-borne disease. 
(3) Development of effective diagnostic tests to 
accurately and timely diagnose Lyme disease and 
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other tick-borne disease, including direct detention 
tests. 
(4) Development of treatments to cure or im-
prove the lives of those who are infected with Lyme 
disease or other tick-borne disease or who suffer 
from a tick-induced disorder. 
(5) Design and conduct of clinical trials of suf-
ficient size and duration to support clinical rec-
ommendations. 
(6) Development and maintenance of one or 
more registries of patients and their experiences re-
lating to exposure to, diagnosis for, and treatment 
of tick-borne disease, including outcomes, which reg-
istries shall protect the confidentiality and safety of 
patient data. 
(7) Systematic documentation of the experi-
ences of health care professionals in diagnosing and 
treating tick-borne disease, including diagnostic and 
treatment outcomes. 
(8) Inclusion of individuals with chronic Lyme 
disease in clinical, research, and service efforts. 
(9) Coordination with international bodies to in-
tegrate and inform the fight against Lyme disease 
and tick-borne disease globally. 
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(c) INTEGRATION OF TICK-BORNE DISEASE WORK-
ING GROUP FINDINGS AND RECOMMENDATIONS.—In car-
rying out this section, the Director of the Office shall, as 
directed by the Secretary, with any modifications made by 
and as otherwise determined appropriate by the Secretary, 
oversee and coordinate integration and implementation, 
into the activities of the Office and the activities and pro-
grams of the agencies and offices of the Department of 
Health and Human Services, of the recommendations to 
the Secretary and the findings and conclusions in the lat-
est report of the Tick-Borne Disease Working Group sub-
mitted to the Secretary and congressional committees. 
(d) PRIORITY BASED ON DISEASE BURDEN.—In car-
rying out this section, 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 
States. 
SEC. 3. NATIONAL STRATEGY. 
(a) IN GENERAL.—The Secretary, in coordination 
with the Director of the Office, and in consultation with 
the Tick-Borne Disease Working Group, 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, shall— 
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(1) not later than 2 years after the date of en-
actment of this Act, develop and submit to the Con-
gress a national strategy for the conduct and sup-
port of Lyme disease and other tick-borne disease or 
disorder programs and activities; and 
(2) not less than every 2 years thereafter, up-
date such strategy. 
(b) CONTENTS.—The strategy under subsection (a) 
shall include— 
(1) proposed budgetary requirements; 
(2) an assessment of all federally funded pro-
grams and activities related to surveillance, diag-
nosis, treatment, education, or prevention with re-
spect to Lyme disease or other tick-borne disease, an 
evaluation of progress and performance based on 
mission and purpose, and a description of significant 
challenges or barriers to performance, including an 
assessment of Federal grants awarded; 
(3) a strategy for improving diagnosis, treat-
ment, and prevention, including increasing the im-
pact of grants awarded by the National Institutes of 
Health, the Centers for Disease Control and Preven-
tion, and other agencies and offices of the Depart-
ment of Health and Human Services; 
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(4) a strategy for improving outcomes of indi-
viduals with Lyme disease or another tick-borne dis-
ease or disorder, including progress related to chron-
ic or persistent symptoms and chronic or persistent 
infection and coinfections, including plans for evalu-
ating the potential value of and supporting the con-
duct of observational studies, comparative effective-
ness research, patient-centered outcomes research, 
or other real world evidence; 
(5) the appropriate benchmarks to measure 
progress in achieving the improvements described in 
paragraphs (3) and (4); 
(6) a strategy for improving interactions, co-
ordination, and partnerships with other Federal 
agencies, State and local governments, and global 
entities; and 
(7) 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 rec-
ommendations. 
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SEC. 4. 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 Cen-
ters 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 Di-
rector 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 de-
scribed in paragraphs (1) through (8) of subsection 
(b); and 
(2) the coordination of all programs and activi-
ties of the Department of Health and Human Serv-
ices 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
RE-
SEARCH.— 
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(A) IN GENERAL.—The Secretary shall ex-
pand and intensify epidemiological, basic, 
translational, and clinical research regarding 
Lyme disease and other tick-borne disease and 
disorders and bartonellosis to better under-
stand— 
(i) the pathophysiology of Borrelia 
burgdorferi and other tick-borne micro-
organisms that are human pathogens and 
of Bartonella; 
(ii) pathophysiological changes over 
time, including pathogen persistence pro-
files for patients with differing treatment 
histories; 
(iii) activation and deactivation of im-
mune 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 out-
comes 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; 
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(ii) establish patient-centered treat-
ment outcome objectives to allow for the 
comparative effectiveness of different treat-
ment modalities; and 
(iii) 
establish 
patient-centered 
re-
search objectives to help elucidate prom-
ising 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, multi-
disciplinary 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 be-
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tween 2 or more national research insti-
tutes 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 collabo-
rative multi-institutional research grants 
related to tick-borne disease; and 
(v) involve additional national re-
search institutes and national centers of 
the National Institutes of Health in intra-
mural and extramural research on tick- 
borne disease, such as the National Insti-
tute 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 Sec-
retary shall evaluate and make findings on— 
(i) the feasibility and potential value 
to the research community of establishing 
a deidentified human subjects database for 
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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 re-
searcher needs; or 
(II) there are problems or chal-
lenges 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 re-
searchers using cadaver specimens. 
(E) PRIORITY.—In carrying out this para-
graph, the Secretary shall make it a priority to 
determine the extent of posttreatment persist-
ence of Borrelia burgdorferi and the clinical sig-
nificance of such persistence. 
(2) DEVELOPMENT OF NEW AND IMPROVED DI-
AGNOSTIC TESTS.— 
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(A) IN GENERAL.—The Secretary, in co-
operation with the Director of the Office, and 
acting through the Directors of the Centers for 
Disease Control and Prevention and the Direc-
tor 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 dif-
ferential diagnoses; 
(ii) improve the sensitivity of Lyme 
disease tests at all stages of disease pro-
gression; 
(iii) develop a Lyme disease test capa-
ble of distinguishing between past and ac-
tive infections; 
(iv) improve timely, sensitive, and spe-
cific diagnostic tools and tests for Rocky 
Mountain spotted fever; and 
(v) improve the performance (timeli-
ness and accuracy) of tools and tests for 
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other tick-borne diseases found in the 
United States. 
(B) STRATEGIES FOR EXPEDITING CLEAR-
ANCE.—The Secretary shall direct the Commis-
sioner of Food and Drugs to design and pro-
pose or implement, as appropriate within the 
authorities and public health priorities vested in 
the Secretary by other provisions of law, strate-
gies for facilitating and expediting the clearance 
or approval of improved diagnostic tests for 
Lyme disease and other tick-borne disease, par-
ticularly 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 VAC-
CINES.—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 
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(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 con-
fidentiality, detailing the safety of the vaccine 
and contrasting its safety profile based on its 
mechanisms of action to safety concerns ex-
pressed 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 statis-
tically sound, scientifically credible surveil-
lance 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 
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(iii) incorporate information obtained 
through such activities into the National 
Tick-Borne Disease Surveillance System. 
(B) RESEARCH.—The Secretary shall en-
sure that the National Tick-Borne Disease Sur-
veillance 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 subpara-
graph (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 re-
ported cases cannot be affirmatively 
associated with out-of-State travel in 
order to better determine where the 
disease is emerging; 
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(II) working with the States and 
treating physicians, in consultation 
with the Council of State and Terri-
torial Epidemiologists (in this clause 
referred to as the ‘‘CSTE’’), to im-
prove 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 en-
courage and improve laboratory re-
porting of Lyme disease and other 
tick-borne diseases, and evaluate the 
feasibility of creating a national uni-
form reporting system including man-
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datory reporting by States and physi-
cians 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 prev-
alence data for tick-borne disorders; 
and 
(ii) to the extent practicable, shall 
provide for the collection and storage of 
other available information on Lyme dis-
ease and other tick-borne diseases and dis-
orders, 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; 
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(IV) progression of signs and 
symptoms; 
(V) diagnostic and treatment his-
tory and outcomes; and 
(VI) additional screening con-
ducted and related data, such as bio-
logical markers. 
(D) CONSULTATION.—In carrying out this 
paragraph, the Secretary shall consult with in-
dividuals 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 dem-
onstrated experience in research, data col-
lection, or patient access to care; 
(iii) health information technology ex-
perts or other information management 
specialists; 
(iv) clinicians with expertise in Lyme 
disease or other tick-borne diseases or dis-
orders; and 
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(v) research scientists with experience 
conducting translational research or uti-
lizing surveillance systems for scientific re-
search purposes. 
(E) GRANTS.—The Secretary may award 
grants to, or enter into contracts or cooperative 
agreements with, public or private nonprofit en-
tities to carry out activities under this para-
graph. 
(F) 
COORDINATION
WITH
FEDERAL, 
STATE, AND LOCAL AGENCIES.—Subject to sub-
paragraph (H), the Secretary shall— 
(i) establish agreements and mecha-
nisms, as appropriate, for improved col-
lecting 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 com-
munity health centers funded by the 
Health Resources and Services Administra-
tion and medical facilities of the Indian 
Health Service; 
(ii) establish formal agreements, as 
appropriate and may be worked out, to 
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provide for improved collection and report-
ing of surveillance data under subpara-
graphs (A), (B) or clause (i) of subpara-
graph (C) and other available information 
under clause (ii) of subparagraph (C), ob-
tained from hospitals and medical clinics 
run by other Federal departments and 
agencies; 
(iii) make information and analysis in 
the National Tick-Borne Disease Surveil-
lance System available, as appropriate, to 
all components of the Department of 
Health and Human Services, to other Fed-
eral agencies, and to State and local agen-
cies; and 
(iv) identify, build upon, leverage, and 
coordinate among existing data and sur-
veillance systems, surveys, registries, and 
other Federal public health infrastructure, 
wherever practicable. 
(G) PUBLIC ACCESS.—Subject to subpara-
graph (H), the Secretary shall ensure that in-
formation and analysis in the National Tick- 
Borne Disease Surveillance System are avail-
able, as appropriate, to the public and other in-
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terested parties on the website of the Depart-
ment 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
EDU-
CATION.—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 pam-
phlet, available online and by hard copy, ad-
dressing— 
(i) ticks and tick-borne diseases com-
mon to the geographic area, tick-borne dis-
ease that could be acquired while on do-
mestic or international travel, and ticks 
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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 individ-
uals can take to reduce risk of exposure to 
ticks and risk of disease transmission; and 
(v) additional community-based ac-
tions to reduce risk of exposure to ticks. 
(B) COORDINATION.—In carrying out sub-
paragraph (A), the Secretary, acting through 
the Director of the Centers for Disease Control 
and Prevention, shall coordinate with legally in-
corporated Lyme disease or other tick-borne 
disease organizations. 
(C) DISSEMINATION.—The Administrator 
of the Health Resources and Services Adminis-
tration and the Director of the Indian Health 
Service shall make available in rural health cen-
ters and clinics which they operate or fund— 
(i) the consumer tick disease pam-
phlets developed under subparagraph (A); 
or 
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(ii) such other appropriate consumer 
tick disease pamphlets as the Administra-
tion or Service may develop or acquire. 
(D) PHYSICIAN
EDUCATION.—The Sec-
retary shall carry out a physician education 
program that addresses the full spectrum of sci-
entific research related to Lyme disease and 
other tick-borne diseases and disorders, includ-
ing— 
(i) the role of clinical diagnosis; 
(ii) the limitations of serological diag-
nostic 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 Na-
tional Guideline Clearinghouse; 
(v) the voluntary nature of clinical 
practice guidelines; 
(vi) the complexities presented by co-
infections relating to symptomology, diag-
nosis, and treatment, including prudently 
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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 edu-
cation 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 
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Services a summary of the comments re-
ceived from the public under this subpara-
graph before conducting the first training 
program under subparagraph (D). 
(6) MONITORING, UNDERSTANDING, AND CON-
TROLLING
VECTORS
AND
ANIMAL
RESERVOIRS
OF 
LYME DISEASE AND OTHER TICK-BORNE DISEASE.— 
(A) TICK SURVEILLANCE AND TESTING.— 
The Secretary, in coordination with the Direc-
tor of the Office, acting through the Director of 
the Centers for Disease Control and Prevention 
and other agencies and offices of the Depart-
ment of Health and Human Services as appro-
priate, shall— 
(i) not later than 180 days after the 
date of enactment of this Act, provide a re-
port 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 activi-
ties of the Vector-Borne Disease Re-
gional Centers of Excellence as estab-
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lished under Funding Opportunity 
Announcement 
RFA–CK–17–005, 
Catalog of Federal Domestic Assist-
ance Number 93.084; and 
(II) within such description, the 
roles of participating academic, gov-
ernmental, and private institutions; 
(ii) not later than 2 years after the 
date of enactment of this Act, in consulta-
tion 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 implementa-
tion plan for a comprehensive nationwide 
strategy for the surveillance and testing of 
ticks for human pathogens and microorga-
nisms with unknown pathogenicity, includ-
ing a plan for a network of tick identifica-
tion 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 
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with other Federal departments and agen-
cies engaged in such activities; and 
(iv) consult and coordinate with the 
American Veterinary Medical Association 
and the Companion Animal Parasite Coun-
cil on obtaining and sharing data on the 
surveillance and testing of ticks and tick- 
borne pathogens, including geographic in-
formation from veterinary encounters. 
(B) INVESTIGATION.—In carrying out sub-
paragraph (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 coordina-
tion with other Federal agencies that conduct 
or support tick surveillance or testing activities, 
as appropriate, and public and private labora-
tories, shall— 
(i) investigate and, where appropriate, 
promote the use of advanced new tech-
nologies, 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 possi-
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bility of rapid geographic migration of tick 
vectors and pathogens and unexpected 
findings. 
(C) TICK CONTROL AND PREVENTION.— 
The Secretary, in coordination with the Direc-
tor 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 pro-
visions of law, support activities of and coordi-
nate and share, information with other Federal, 
State, and local government agencies, involved 
or interested in tick prevention and control ac-
tivities 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 meas-
ures to lessen human exposure to ticks; 
(iv) genetic therapies for vectors or 
animal hosts to interfere with the life cycle 
of pathogens; and 
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(v) the development of vector or res-
ervoir 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 coordi-
nate 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 consulta-
tion 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 De-
partment 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, con-
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ferences, symposia, and seminars (including 
webinars) sponsored by the Federal Govern-
ment are a valuable input to strategic and oper-
ational 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 Dis-
ease 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 includ-
ing identification of research gaps and top 
research priorities; 
(ii) for any scientific or medical con-
ference 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 con-
trolling statement of work and significant 
modifications thereto, whether in the con-
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tract or as a separate document, issued to 
the vendor organizing or conducting the 
conference are in writing and made avail-
able 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 evi-
dence (meaning data from sources other 
than randomized clinical trials, such as ob-
servational studies, comparative effective-
ness and patient-centered outcomes re-
search, and patient clinical data or human 
subject data), including the standards and 
methodologies for collection and analysis of 
real-world evidence in managing Lyme dis-
ease and other tick-borne disease; 
(v) include in such symposium identi-
fication and analysis of existing data 
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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 dis-
ease 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 consulta-
tion with the Tick-Borne Disease Working 
Group, design a survey instrument or in-
struments targeted to patients and patient 
advocates, physicians and health care pro-
viders, and researchers regarding rec-
ommended subjects and agendas for feder-
ally sponsored meetings, conferences, and 
seminars, including webinars, on Lyme dis-
ease and other tick-borne disease; 
(viii) not later than 6 months after 
the conduct of the survey, provide an anal-
ysis of the results of the survey to the 
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Tick-Borne Disease Working Group and 
publish such results in the Federal Reg-
ister for a 60-day public comment period; 
and 
(ix) provide a final analysis and a pro-
posed schedule and agenda for public 
meetings, conferences, and seminars, in-
cluding webinars, for incorporation into the 
national strategy under section 3 as appro-
priate 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 bib-
liography of peer-reviewed literature of tick-borne 
diseases and disorders in the United States, as well 
as for bartonellosis from whatever cause, appro-
priately organized for use by the scientific commu-
nity, treating physicians, and the public. The bibliog-
raphy 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 con-
ducting and supporting activities under this section, the 
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Secretary shall give priority to Lyme disease and other 
tick-borne diseases based on assessments of disease bur-
den in the United States. 
SEC. 5. BIENNIAL REPORTS. 
(a) IN GENERAL.—Not later than 24 months after 
the date of the enactment of this Act, and biennially there-
after, the Secretary shall submit to the Congress a report 
on the activities carried out under this Act and the activi-
ties of the Tick-Borne Disease Working Group. 
(b) CONTENT.—Reports under subsection (a) shall 
contain— 
(1) a scientifically qualified assessment of Lyme 
disease and other tick-borne disease, including a 
summary of prevalence, geography, important expo-
sure characteristics, disease stages and manifesta-
tions or symptoms of those stages, based on a syn-
thesis of the broad spectrum of empirical evidence of 
treating physicians, as well as published peer-re-
viewed data, to include for each tick-borne disease a 
state-of-the-science diagnosis and treatment; 
(2) a description of all programs and activities 
funded by the Department of Health and Human 
Services that are related to the surveillance, diag-
nosis, treatment, education, or prevention of Lyme 
disease or other tick-borne disease, and an evalua-
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tion of progress and performance based on mission 
and purpose, and discussion of significant challenges 
or barriers to performance, to include— 
(A) for the initial report under this section, 
a description of the intramural and extramural 
research portfolios of the Centers for Disease 
Control and Prevention, the National Institutes 
of Health, 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 disorder, including infor-
mation on— 
(i) the award amount, institution, pri-
mary investigator, principal investigative 
question or questions, and significant con-
clusions; and 
(ii) studies that received Federal 
funds and were terminated, in progress, or 
initiated in the fiscal year including the 
date of enactment of this Act and the 5 
prior fiscal years; 
(B) for reports in subsequent years, all of 
the information described in subparagraph (A), 
except the reference in subparagraph (A)(ii) to 
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Federal funds terminated, in progress, or 
awarded in the 6 prior fiscal years shall be 
treated as reference to such funds in the 2 prior 
fiscal years; 
(C) a status and summary report on the 
National Tick-Borne Disease Surveillance Sys-
tem, including— 
(i) the type of information collected 
and stored in the System; 
(ii) the use, distribution, and avail-
ability of such information, including 
guidelines for such use; and 
(iii) the use and coordination of sur-
veillance and patient information data-
bases; and 
(D) information on agreements, partner-
ships, cooperation, coordination, and data shar-
ing with external entities, such as State and 
local governments, other Federal agencies, 
working groups, and global entities; 
(3) a description of major externally funded re-
search, surveillance, education, or other programs 
and initiatives impacting the management or science 
of tick-borne disease; 
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