[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 220 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 220
To provide for a national strategy to address and overcome Lyme disease
and other tick-borne diseases, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
January 3, 2019
Mr. Smith of New Jersey (for himself, Mr. Peterson, Mr. Posey, Ms.
Stefanik, Mr. Fitzpatrick, Mr. Sires, Ms. Pingree, and Mrs. Hartzler)
introduced the following bill; 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 diseases, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``National Lyme and Tick-Borne
Diseases Control and Accountability Act of 2019''.
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 Secretary 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 disease 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 subsection (a), the
Director of the Office shall facilitate and work to ensure
accomplishment of the following activities:
(1) Expansion and enhancement of epidemiological research
and basic, translational, and clinical biological and
biomedical research.
(2) Expansion and improvement of the surveillance 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 other tick-borne disease,
including direct detention tests.
(4) Development of treatments to cure or improve the lives
of those who are infected with Lyme disease or other tick-borne
disease or who suffer from a tick-induced disorder.
(5) Design and conduct of clinical trials of sufficient
size and duration to support clinical recommendations.
(6) Development and maintenance of one or more registries
of patients and their experiences relating to exposure to,
diagnosis for, and treatment of tick-borne disease, including
outcomes, which registries shall protect the confidentiality
and safety of patient data.
(7) Systematic documentation of the experiences 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 integrate and
inform the fight against Lyme disease and tick-borne disease
globally.
(c) Integration of Tick-Borne Disease Working Group Findings and
Recommendations.--In carrying 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 programs 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 latest report
of the Tick-Borne Disease Working Group submitted to the Secretary and
congressional committees.
(d) Priority Based on Disease Burden.--In carrying 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--
(1) not later than 2 years after the date of enactment of
this Act, 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 activities; and
(2) not less than every 2 years thereafter, update such
strategy.
(b) Contents.--The strategy under subsection (a) shall include--
(1) proposed budgetary requirements;
(2) an assessment of all federally funded programs and
activities related to surveillance, diagnosis, treatment,
education, or prevention with respect 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, treatment, and
prevention, including increasing the impact of grants awarded
by the National Institutes of Health, the Centers for Disease
Control and Prevention, and other agencies and offices of the
Department of Health and Human Services;
(4) a strategy for improving outcomes of individuals with
Lyme disease or another tick-borne disease or disorder,
including progress related to chronic or persistent symptoms
and chronic or persistent infection and coinfections, including
plans for evaluating the potential value of and supporting the
conduct of observational studies, comparative effectiveness
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, coordination,
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 recommendations.
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 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.
SEC. 5. BIENNIAL REPORTS.
(a) In General.--Not later than 24 months after the date of the
enactment of this Act, and biennially thereafter, 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 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 exposure characteristics,
disease stages and manifestations or symptoms of those stages,
based on a synthesis of the broad spectrum of empirical
evidence of treating physicians, as well as published peer-
reviewed 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, diagnosis, treatment, education, or
prevention of Lyme disease or other tick-borne disease, and an
evaluation 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 information
on--
(i) the award amount, institution, primary
investigator, principal investigative question
or questions, and significant conclusions; 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 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 System, including--
(i) the type of information collected and
stored in the System;
(ii) the use, distribution, and
availability of such information, including
guidelines for such use; and
(iii) the use and coordination of
surveillance and patient information databases;
and
(D) information on agreements, partnerships,
cooperation, coordination, and data sharing with
external entities, such as State and local governments,
other Federal agencies, working groups, and global
entities;
(3) a description of major externally funded research,
surveillance, education, or other programs and initiatives
impacting the management or science of tick-borne disease;
(4) 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 disorders;
(5) a description of clinical practice guidelines for any
tick-borne disease published on the National Guideline
Clearinghouse;
(6) recommendations for addressing research gaps in tick
biology and tick management;
(7) 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 disease; and
(8) 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 Group.
(c) Biennial Reports of NIH.--The Secretary shall ensure that each
biennial report under title III of the Public Health Service Act (42
U.S.C. 241 et seq.) or each triennial report under section 403 of such
Act (42 U.S.C. 283) includes information on actions undertaken by the
National Institutes of Health to carry out research with respect to
Lyme disease and other tick-borne disease.
SEC. 6. DEFINITIONS.
In this Act:
(1) Bartonellosis.--The term ``bartonellosis'' means
disease caused by Bartonella infection from any vector or
source, unless otherwise specified.
(2) Disorder.--The term ``disorder'' means a disorder
caused by ticks, but not inducing human infection, such as tick
paralysis and Alpha-Gal meat allergy.
(3) Office.--The term ``Office'' means the Office of
Oversight and Coordination for Tick-Borne Diseases established
under section 2.
(4) Other federal agency.--Other Federal agency means a
Federal Department, agency or office outside of the U.S.
Department of Health and Human Services.
(5) Secretary.--The term ``Secretary'' means the Secretary
of Health and Human Services.
(6) Tick-borne disease.--The term ``tick-borne disease''
means a disease that is known to be transmitted by ticks in the
United States, unless otherwise specified, or that may be
discovered to be transmitted by ticks in the United States.
(7) Tick-borne disease working group.--The term ``Tick-
Borne Disease Working Group'' means the Tick-Borne Disease
Working Group established under section 2062 of the 21st
Century Cures Act (42 U.S.C. 284s).
<all>
National Lyme and Tick-Borne Diseases Control and Accountability Act of 2019
#220 | HR Congress #116
Policy Area: Health
Subjects: Congressional oversightDepartment of Health and Human ServicesExecutive agency funding and structureHealth information and medical recordsHealth programs administration and fundingHealth promotion and preventive careInfectious and parasitic diseasesMedical educationMedical researchMedical tests and diagnostic methodsResearch administration and fundingScientific communication
Last Action: Referred to the Subcommittee on Health. (1/25/2019)
Bill Text Source: Congress.gov
Summary and Impacts
Original Text