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113th Congress                                                   Report
                        HOUSE OF REPRESENTATIVES
 2d Session                                                     113-573

======================================================================



 
TICK-BORNE DISEASE RESEARCH ACCOUNTABILITY AND TRANSPARENCY ACT OF 2014

                                _______
                                

 September 8, 2014.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

  Mr. Upton, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 4701]

      [Including cost estimate of the Congressional Budget Office]

    The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 4701) to provide for scientific frameworks with 
respect to vector-borne diseases, having considered the same, 
report favorably thereon with amendments and recommend that the 
bill as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     2
Purpose and Summary..............................................     3
Background and Need for Legislation..............................     4
Hearings.........................................................     4
Committee Consideration..........................................     4
Committee Votes..................................................     4
Committee Oversight Findings.....................................     4
Statement of General Performance Goals and Objectives............     5
New Budget Authority, Entitlement Authority, and Tax Expenditures     5
Earmark, Limited Tax Benefits, and Limited Tariff Benefits.......     5
Committee Cost Estimate..........................................     5
Congressional Budget Office Estimate.............................     5
Federal Mandates Statement.......................................     7
Duplication of Federal Programs..................................     7
Disclosure of Directed Rule Makings..............................     7
Advisory Committee Statement.....................................     7
Applicability to Legislative Branch..............................     7
Section-by-Section Analysis of the Legislation...................     7
Changes in Existing Law Made by the Bill, as Reported............     8

                               Amendment

    The amendments are as follows:
    Strike all after the enacting clause and insert the 
following:

SECTION 1. SHORT TITLE.

  This Act may be cited as the ``Tick-Borne Disease Research 
Accountability and Transparency Act of 2014''.

SEC. 2. LYME DISEASE AND OTHER TICK-BORNE DISEASES.

  Title III of the Public Health Service Act (42 U.S.C. 241 et seq.) is 
amended by adding at the end the following new part:

          ``PART W--LYME DISEASE AND OTHER TICK-BORNE DISEASES

``SEC. 399OO. RESEARCH.

  ``(a) In General.--The Secretary shall conduct or support 
epidemiological, basic, translational, and clinical research regarding 
Lyme disease and other tick-borne diseases.
  ``(b) Biennial Reports.--The Secretary shall ensure that each 
biennial report under section 403 includes information on actions 
undertaken by the National Institutes of Health to carry out subsection 
(a) with respect to Lyme disease and other tick-borne diseases, 
including an assessment of the progress made in improving the outcomes 
of Lyme disease and such other tick-borne diseases.

``SEC. 399OO-1. WORKING GROUP.

  ``(a) Establishment.--The Secretary shall establish a permanent 
working group, to be known as the Interagency Lyme and Tick-Borne 
Disease Working Group (in this section and section 399OO-2 referred to 
as the `Working Group'), to review all efforts within the Department of 
Health and Human Services concerning Lyme disease and other tick-borne 
diseases to ensure interagency coordination, minimize overlap, and 
examine research priorities.
  ``(b) Responsibilities.--The Working Group shall--
          ``(1) not later than 24 months after the date of enactment of 
        this part, and every 24 months thereafter, develop or update a 
        summary of--
                  ``(A) ongoing Lyme disease and other tick-borne 
                disease research related to causes, prevention, 
                treatment, surveillance, diagnosis, duration of 
                illness, intervention, and access to services and 
                supports for individuals with Lyme disease or other 
                tick-borne diseases;
                  ``(B) advances made pursuant to such research;
                  ``(C) the engagement of the Department of Health and 
                Human Services with persons that participate at the 
                public meetings required by paragraph (5); and
                  ``(D) the comments received by the Working Group at 
                such public meetings and the Secretary's response to 
                such comments;
          ``(2) ensure that a broad spectrum of scientific viewpoints 
        is represented in each such summary;
          ``(3) monitor Federal activities with respect to Lyme disease 
        and other tick-borne diseases;
          ``(4) make recommendations to the Secretary regarding any 
        appropriate changes to such activities; and
          ``(5) ensure public input by holding annual public meetings 
        that address scientific advances, research questions, 
        surveillance activities, and emerging strains in species of 
        pathogenic organisms.
  ``(c) Membership.--
          ``(1) In general.--The Working Group shall be composed of a 
        total of 14 members as follows:
                  ``(A) Federal members.--Seven Federal members, 
                consisting of one or more representatives of each of--
                          ``(i) the Office of the Assistant Secretary 
                        for Health;
                          ``(ii) the Food and Drug Administration;
                          ``(iii) the Centers for Disease Control and 
                        Prevention;
                          ``(iv) the National Institutes of Health; and
                          ``(v) such other agencies and offices of the 
                        Department of Health and Human Services as the 
                        Secretary determines appropriate.
                  ``(B) Non-federal public members.--Seven non-Federal 
                public members, consisting of representatives of the 
                following categories:
                          ``(i) Physicians and other medical providers 
                        with experience in diagnosing and treating Lyme 
                        disease and other tick-borne diseases.
                          ``(ii) Scientists or researchers with 
                        expertise.
                          ``(iii) Patients and their family members.
                          ``(iv) Nonprofit organizations that advocate 
                        for patients with respect to Lyme disease and 
                        other tick-borne diseases.
                          ``(v) Other individuals whose expertise is 
                        determined by the Secretary to be beneficial to 
                        the functioning of the Working Group.
          ``(2) Appointment.--The members of the Working Group shall be 
        appointed by the Secretary, except that of the non-Federal 
        public members under paragraph (1)(B)--
                  ``(A) one shall be appointed by the Speaker of the 
                House of Representatives; and
                  ``(B) one shall be appointed by the Majority Leader 
                of the Senate.
          ``(3) Diversity of scientific perspectives.--In making 
        appointments under paragraph (2), the Secretary, the Speaker of 
        the House of Representatives, and the Majority Leader of the 
        Senate shall ensure that the non-Federal public members of the 
        Working Group represent a diversity of scientific perspectives.
          ``(4) Terms.--The non-Federal public members of the Working 
        Group shall each be appointed to serve a 4-year term and may be 
        reappointed at the end of such term.
  ``(d) Meetings.--The Working Group shall meet as often as necessary, 
as determined by the Secretary, but not less than twice each year.
  ``(e) Reporting.--Not later than 24 months after the date of 
enactment of this part, and every 24 months thereafter, the Working 
Group--
          ``(1) shall submit a report on its activities, including an 
        up-to-date summary under subsection (b)(1) and any 
        recommendations under subsection (b)(4), to the Secretary, the 
        Committee on Energy and Commerce of the House of 
        Representatives, and the Committee on Health, Education, Labor 
        and Pensions of the Senate;
          ``(2) shall make each such report publicly available on the 
        website of the Department of Health and Human Services; and
          ``(3) shall allow any member of the Working Group to include 
        in any such report minority views.

``SEC. 399OO-2. STRATEGIC PLAN.

  ``Not later than 3 years after the date of enactment of this section, 
and every 5 years thereafter, the Secretary shall submit to the 
Congress a strategic plan, informed by the most recent summary under 
section 399OO-1(b)(1), for the conduct and support of Lyme disease and 
tick-borne disease research, including--
          ``(1) proposed budgetary requirements;
          ``(2) a plan for improving outcomes of Lyme disease and other 
        tick-borne diseases, including progress related to chronic or 
        persistent symptoms and chronic or persistent infection and co-
        infections;
          ``(3) a plan for improving diagnosis, treatment, and 
        prevention;
          ``(4) appropriate benchmarks to measure progress on achieving 
        the improvements described in paragraphs (2) and (3); and
          ``(5) a plan to disseminate each summary under section 399OO-
        1(b)(1) and other relevant information developed by the Working 
        Group to the public, including health care providers, public 
        health departments, and other relevant medical groups.''.

    Amend the title so as to read:
    A bill to provide for research with respect to Lyme disease 
and other tick-borne diseases, and for other purposes.

                          Purpose and Summary

    H.R. 4701, the ``Tick-Borne Disease Research Accountability 
and Transparency Act of 2014'' was introduced on May 21, 2014, 
by Rep. Christopher Gibson (R-NY) and referred to the Committee 
on Energy and Commerce.
    The legislation would establish a working group at the 
Department of Health and Human Services to review Federal 
efforts concerning Lyme and other tick-borne diseases.

                  Background and Need for Legislation

    Lyme disease is caused by a bacterium and is transmitted to 
humans through the bite of an infected tick. Lyme symptoms can 
include a skin rash along with fever, headache, and fatigue. 
When left untreated, the infection can spread and affect the 
joints, heart, and nervous system.Diagnosis is based on 
physical symptoms, lab testing, and exposure.\1\ Approximately 10 to 
20% of patients treated for Lyme disease can have lingering symptoms 
beyond antibiotic treatment. The exact cause of these lingering 
symptoms is not known.\2\
---------------------------------------------------------------------------
    \1\http://www.cdc.gov/lyme/stats/index.html
    \2\http://www.cdc.gov/lyme/postLDS/index.html
---------------------------------------------------------------------------
    Prior to 2012, the Centers for Disease Control and 
Prevention (CDC) reported about 30,000 new cases each year in 
the U.S., with 95% of those cases in 13 States concentrated in 
the Northeast and upper Midwest. Using more indicators, 
including medical insurance claims, the CDC now estimates that 
around 300,000 people in the U.S. are diagnosed each year with 
Lyme disease, making it a substantial and vexing public health 
problem.\3\
---------------------------------------------------------------------------
    \3\http://www.cdc.gov/media/releases/2013/p0819-lyme-disease.html
---------------------------------------------------------------------------
    H.R. 4701, the ``Tick-Borne Disease Research Accountability 
and Transparency Act of 2014'' would help to accelerate 
improved methods for prevention, diagnosis, and treatment of 
Lyme disease. The bill would establish a working group to 
prepare a report that would summarize Federal research efforts 
related to Lyme disease and other tick-borne diseases. Informed 
by the report prepared by the working group, the Secretary of 
Health and Human Services (HHS) would develop a strategic plan 
to improve health outcomes.

                                Hearings

    The Committee on Energy and Commerce has not held hearings 
on the legislation.

                        Committee Consideration

    On June 19, 2014, the Subcommittee on Health met in open 
markup session and forwarded H.R. 4701, as amended, to the full 
Committee consideration, by a voice vote. On July 30, 2014, the 
Committee met in open markup session and approved H.R. 4701, as 
amended, by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. 
There were no record votes taken in connection with ordering 
approved H.R. 4701. A motion by Mr. Upton to order H.R. 4701 
reported to the House, with amendment, was agreed to by a voice 
vote.

                      Committee Oversight Findings

    Pursuant to clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee has not held hearings 
on this legislation.

         Statement of General Performance Goals and Objectives

    Pursuant to clause 3(c)(1) of rule XIII of the House of 
Representatives, the goal of the legislation is the 
continuation of research and the establishment of working group 
on Lyme disease and other tick-borne diseases.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    In compliance with clause 3(c)(2) of rule XIII of the Rules 
of the House of Representatives, the Committee finds that H.R. 
4701 would result in no new or increased budget authority, 
entitlement authority, or tax expenditures or revenues.

       Earmark, Limited Tax Benefits, and Limited Tariff Benefits

    In compliance with clause 9(e), 9(f), and 9(g) of rule XXI, 
the Committee finds that H.R. 4701 contains no earmarks, 
limited tax benefits, or limited tariff benefits.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate prepared 
by the Director of the Congressional Budget Office pursuant to 
section 402 of the Congressional Budget Act of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate 
provided by the Congressional Budget Office pursuant to section 
402 of the Congressional Budget Act of 1974:

H.R. 4701--Tick-Borne Disease Research Accountability and Transparency 
        Act of 2014

    Summary: H.R. 4701 would amend the Public Health Service 
Act to require the Secretary of the Department of Health and 
Human Services (HHS) to conduct or support research of Lyme and 
other tick-borne diseases. The National Institutes of Health 
(NIH) currently administers research programs related to such 
diseases. The authority for discretionary research programs at 
the NIH expired at the end of fiscal year 2009. For each year 
from 2010 through 2014, however, the Congress appropriated 
funds for the NIH to continue operating its discretionary 
programs across all areas of research.
    The bill also would require that the Secretary of HHS (in 
its biennial reports to the Congress) describe actions taken by 
NIH to support research of Lyme and other tick-borne diseases 
and report on the progress toward improving the outcomes of 
such diseases. In addition, the bill would require the 
Secretary to establish a permanent interagency working group on 
Lyme and tick-borne diseases and to periodically submit to the 
Congress a strategic plan for the conduct and support of tick-
borne disease research.
    CBO estimates that implementing H.R. 4701 would cost $338 
million over the 2015-2019 period, assuming appropriation of 
amounts similar to appropriations provided in recent years for 
NIH activities related to Lyme and other tick-borne diseases. 
Pay-as-you-go procedures do not apply to this legislation 
because it would not affect direct spending or revenues.
    H.R. 4701 contains no intergovernmental or private-sector 
mandates as defined in the Unfunded Mandates Reform Act (UMRA).
    Estimated cost to the Federal Government: The estimated 
budgetary effect of H.R. 4701 is shown in the following table. 
The costs of this legislation fall within budget function 550 
(health).

----------------------------------------------------------------------------------------------------------------
                                                                 By fiscal year, in millions of dollars--
                                                         -------------------------------------------------------
                                                            2015     2016     2017     2018     2019   2015-2019
----------------------------------------------------------------------------------------------------------------
                                  CHANGES IN SPENDING SUBJECT TO APPROPRIATION

Estimated Authorization Levela..........................       83       85       86       88       90       432
Estimated Outlays.......................................       24       65       78       84       88       338
----------------------------------------------------------------------------------------------------------------
Note: Numbers may not add to totals because of rounding.
a.The amounts shown in the table are roughly equivalent to estimated funding provided in recent years for NIH
  activities related to Lyme and other tick-borne diseases, with adjustments for anticipated inflation.

    Basis of estimate: For this estimate, CBO assumes that H.R. 
4701 will be enacted early in fiscal year 2015, that the 
necessary amounts will be appropriated each year, and that 
outlays will follow historical spending patterns for the 
affected programs.
    CBO estimates that implementing H.R. 4701 would cost $338 
million over the 2015-2019 period, assuming the appropriation 
of the necessary amounts. The NIH currently administers 
research programs related to Lyme and other tick-borne 
diseases. Authority for discretionary research programs at NIH 
expired at the end of fiscal year 2009. However, since 2009 the 
Congress has appropriated funds for NIH to continue operating 
its research programs. The Congress appropriated about $30 
billion to NIH for fiscal year 2014. CBO estimates that, of 
that total, NIH allocated $82 million for activities related to 
Lyme and other tick-borne diseases. The agency plans to 
allocate a similar amount to such activities in 2015.
    H.R. 4701 would direct NIH to conduct or support research 
activities related to Lyme and other tick-borne diseases. 
Because authority for discretionary research programs funded by 
NIH has expired under section 402A of the Public Service Act, 
estimated changes in discretionary costs associated with 
implementing H.R 4701 reflect the total costs of all NIH-funded 
research activities related to Lyme and tick-borne diseases for 
fiscal years 2015 through 2019, assuming the availability of 
appropriated funds. CBO estimates that the annual costs for 
such research activities in each of years 2015 through 2019 
would be similar to appropriated funds allocated for research 
on Lyme and tick-borne diseases at NIH in recent years. CBO 
expects that the bill would primarily affect research 
activities supported by NIH. However, the legislation could 
also affect programs administered by other HHS agencies, such 
as the Centers for Disease Control and Prevention.
    H.R. 4701 also would establish a permanent interagency 
working group on Lyme and tick-borne diseases by expanding an 
existing working group within HHS to consist of 14 individuals 
(including nonfederal members of the public). The working group 
would be required to meet at least twice a year and to submit a 
report to the Congress on its activities every 24 months. The 
bill would also require that the Secretary submit to the 
Congress a strategic plan for the conduct and support of 
research relating to Lyme and other tick-borne diseases every 
five years (starting the third year after the date of enactment 
of the bill). CBO estimates that those activities would cost 
about $1 million a year, subject to the availability of 
appropriated funds.
    Pay-As-You-Go considerations: None.
    Intergovernmental and private-sector impact: H.R. 4701 
contains no intergovernmental or private-sector mandates as 
defined in UMRA and would impose no costs on state, local, or 
tribal governments.
    Estimate prepared by: Federal costs: Jamease Miles; Impact 
on state, local, and tribal governments: J'nell L. Blanco; 
Impact on the private sector: Alexia Diorio.
    Estimate approved by: Peter H. Fontaine, Assistant Director 
for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates prepared by the Director of the Congressional Budget 
Office pursuant to section 423 of the Unfunded Mandates Reform 
Act.

                    Duplication of Federal Programs

    No provision of H.R. 4701 establishes or reauthorizes a 
program of the Federal government known to be duplicative of 
another Federal program, a program that was included in any 
report from the Government Accountability Office to Congress 
pursuant to section 21 of Public Law 111-139, or a program 
related to a program identified in the most recent Catalog of 
Federal Domestic Assistance.

                  Disclosure of Directed Rule Makings

    The Committee estimates that enacting H.R. 4701 would not 
specifically direct a rulemaking within the meaning of 5 U.S.C. 
551.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act were created by this 
legislation.

                  Applicability to Legislative Branch

    The Committee finds that the legislation does not relate to 
the terms and conditions of employment or access to public 
services or accommodations within the meaning of section 
102(b)(3) of the Congressional Accountability Act.

             Section-by-Section Analysis of the Legislation


Section 1. Short title

    Section 1 states the legislation may be cited as the 
``Tick-Borne Disease Research Accountability and Transparency 
Act of 2014''.

Section 2. Lyme disease and other tick-borne diseases

    Section 2 would authorize the Secretary of HHS to conduct 
or support research regarding Lyme disease and other tick-borne 
diseases and include information on Lyme disease in the 
National Institutes of Health (NIH) biennial report.
    The section would establish a permanent working group known 
as the Interagency Lyme and Tick-Borne Disease Working Group 
and include Federal and non-Federal members appointed by the 
Secretary of HHS and Congress. The working group would prepare 
a report that summarizes Federal activities related to Lyme 
disease and other tick-borne diseases and submit the results to 
the Secretary and Congress within 24 months.
    The Committee believes it is important to form an 
Interagency Lyme and Tick-Borne Disease Working Group to 
examine Lyme and tick-borne disease research that complies with 
Federal Advisory Committee Act (FACA) and facilitates an 
opportunity to ensure people work together to improve patient 
health outcomes. To that end, the Working Group should 
represent a balanced set of viewpoints. Members should be 
highly qualified Lyme disease experts whose interests do not 
conflict with the goals of the working group. The Committee 
intends that the non-Federal public physicians and other 
medical providers, scientists, or researchers appointed to 
serve on the Working Group shall have appropriate expertise, 
education, and scientific credentials to be qualified and 
experienced in diagnosing, treating, or researching Lyme 
disease and other tick-borne diseases.
    To ensure compliance with applicable conflict of interest 
requirements, the Committee expects that the Secretary will 
deem all non-Federal employee appointees to the Working Group 
as Special Government Employees (SGEs). As such, the Committee 
strongly urges the Secretary to identify a balanced and 
qualified working group and avoid conflicts of interest that 
would not improve health outcomes for patients with Lyme or 
other tick-borne diseases. In determining whether a potential 
appointee to the Working Group has a financial conflict of 
interest, the Committee strongly encourages the Secretary to 
examine issues related to significant financial gain from 
treating patients diagnosed with Lyme disease.
    The Committee intends that the Working Group examine Lyme 
disease and other tick-borne diseases, including Rocky Mountain 
Spotted Fever, ehrlichia, anaplasma, babesiosis, Borrelia 
miyamotoi, Ehrlichia muris, Rickettsia parkeri, and Powassan 
virus.
    The Committee would like the report of the Working Group to 
be shared with Congress at the same time that it is shared with 
the Secretary.
    The Committee supports the current research efforts at HHS 
and urges communication and coordination among all working 
groups at HHS that work on Lyme disease and other tick-borne 
diseases. Therefore, the Committee encourages HHS to review the 
work of any other Lyme working groups that operate at HHS and 
share that information with the working group established in 
this legislation.
    The section would authorize the Secretary of HHS to submit 
a strategic plan, informed by the report of the working group, 
to improve health outcomes for those suffering from Lyme 
disease and other tick-borne diseases.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (new matter is 
printed in italic and existing law in which no change is 
proposed is shown in roman):

                       PUBLIC HEALTH SERVICE ACT



           *       *       *       *       *       *       *
TITLE III--GENERAL POWERS AND DUTIES OF PUBLIC HEALTH SERVICE

           *       *       *       *       *       *       *


           PART W--LYME DISEASE AND OTHER TICK-BORNE DISEASES

SEC. 399OO. RESEARCH.

  (a) In General.--The Secretary shall conduct or support 
epidemiological, basic, translational, and clinical research 
regarding Lyme disease and other tick-borne diseases.
  (b) Biennial Reports.--The Secretary shall ensure that each 
biennial report under section 403 includes information on 
actions undertaken by the National Institutes of Health to 
carry out subsection (a) with respect to Lyme disease and other 
tick-borne diseases, including an assessment of the progress 
made in improving the outcomes of Lyme disease and such other 
tick-borne diseases.

SEC. 399OO-1. WORKING GROUP.

  (a) Establishment.--The Secretary shall establish a permanent 
working group, to be known as the Interagency Lyme and Tick-
Borne Disease Working Group (in this section and section 399OO-
2 referred to as the ``Working Group''), to review all efforts 
within the Department of Health and Human Services concerning 
Lyme disease and other tick-borne diseases to ensure 
interagency coordination, minimize overlap, and examine 
research priorities.
  (b) Responsibilities.--The Working Group shall--
          (1) not later than 24 months after the date of 
        enactment of this part, and every 24 months thereafter, 
        develop or update a summary of--
                  (A) ongoing Lyme disease and other tick-borne 
                disease research related to causes, prevention, 
                treatment, surveillance, diagnosis, duration of 
                illness, intervention, and access to services 
                and supports for individuals with Lyme disease 
                or other tick-borne diseases;
                  (B) advances made pursuant to such research;
                  (C) the engagement of the Department of 
                Health and Human Services with persons that 
                participate at the public meetings required by 
                paragraph (5); and
                  (D) the comments received by the Working 
                Group at such public meetings and the 
                Secretary's response to such comments;
          (2) ensure that a broad spectrum of scientific 
        viewpoints is represented in each such summary;
          (3) monitor Federal activities with respect to Lyme 
        disease and other tick-borne diseases;
          (4) make recommendations to the Secretary regarding 
        any appropriate changes to such activities; and
          (5) ensure public input by holding annual public 
        meetings that address scientific advances, research 
        questions, surveillance activities, and emerging 
        strains in species of pathogenic organisms.
  (c) Membership.--
          (1) In general.--The Working Group shall be composed 
        of a total of 14 members as follows:
                  (A) Federal members.--Seven Federal members, 
                consisting of one or more representatives of 
                each of--
                          (i) the Office of the Assistant 
                        Secretary for Health;
                          (ii) the Food and Drug 
                        Administration;
                          (iii) the Centers for Disease Control 
                        and Prevention;
                          (iv) the National Institutes of 
                        Health; and
                          (v) such other agencies and offices 
                        of the Department of Health and Human 
                        Services as the Secretary determines 
                        appropriate.
                  (B) Non-federal public members.--Seven non-
                Federal public members, consisting of 
                representatives of the following categories:
                          (i) Physicians and other medical 
                        providers with experience in diagnosing 
                        and treating Lyme disease and other 
                        tick-borne diseases.
                          (ii) Scientists or researchers with 
                        expertise.
                          (iii) Patients and their family 
                        members.
                          (iv) Nonprofit organizations that 
                        advocate for patients with respect to 
                        Lyme disease and other tick-borne 
                        diseases.
                          (v) Other individuals whose expertise 
                        is determined by the Secretary to be 
                        beneficial to the functioning of the 
                        Working Group.
          (2) Appointment.--The members of the Working Group 
        shall be appointed by the Secretary, except that of the 
        non-Federal public members under paragraph (1)(B)--
                  (A) one shall be appointed by the Speaker of 
                the House of Representatives; and
                  (B) one shall be appointed by the Majority 
                Leader of the Senate.
          (3) Diversity of scientific perspectives.--In making 
        appointments under paragraph (2), the Secretary, the 
        Speaker of the House of Representatives, and the 
        Majority Leader of the Senate shall ensure that the 
        non-Federal public members of the Working Group 
        represent a diversity of scientific perspectives.
          (4) Terms.--The non-Federal public members of the 
        Working Group shall each be appointed to serve a 4-year 
        term and may be reappointed at the end of such term.
  (d) Meetings.--The Working Group shall meet as often as 
necessary, as determined by the Secretary, but not less than 
twice each year.
  (e) Reporting.--Not later than 24 months after the date of 
enactment of this part, and every 24 months thereafter, the 
Working Group--
          (1) shall submit a report on its activities, 
        including an up-to-date summary under subsection (b)(1) 
        and any recommendations under subsection (b)(4), to the 
        Secretary, the Committee on Energy and Commerce of the 
        House of Representatives, and the Committee on Health, 
        Education, Labor and Pensions of the Senate;
          (2) shall make each such report publicly available on 
        the website of the Department of Health and Human 
        Services; and
          (3) shall allow any member of the Working Group to 
        include in any such report minority views.

SEC. 399OO-2. STRATEGIC PLAN.

  Not later than 3 years after the date of enactment of this 
section, and every 5 years thereafter, the Secretary shall 
submit to the Congress a strategic plan, informed by the most 
recent summary under section 399OO-1(b)(1), for the conduct and 
support of Lyme disease and tick-borne disease research, 
including--
          (1) proposed budgetary requirements;
          (2) a plan for improving outcomes of Lyme disease and 
        other tick-borne diseases, including progress related 
        to chronic or persistent symptoms and chronic or 
        persistent infection and co-infections;
          (3) a plan for improving diagnosis, treatment, and 
        prevention;
          (4) appropriate benchmarks to measure progress on 
        achieving the improvements described in paragraphs (2) 
        and (3); and
          (5) a plan to disseminate each summary under section 
        399OO-1(b)(1) and other relevant information developed 
        by the Working Group to the public, including health 
        care providers, public health departments, and other 
        relevant medical groups.