Text- 21st Century Cures Act
November 28, 2016
The bill's text (362 pages) is too large to fit on one page at this site. The bill language in its entirety can be found at this link- click here. A copy of the bill is also attached at the bottom of this page as a PDF file.
The portions specifically addressing Lyme disease (starting on page 354) are copied below. The line numbers do not match up with the text due to the PDF formatting.
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Referred in Senate (07/13/2015)
Subtitle C—Miscellaneous
SEC. 4061. LYME DISEASE AND OTHER TICK-BORNE DIS-
EASES.
(a) IN GENERAL.—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:
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‘‘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 dis- eases.
‘‘(b) BIENNIAL REPORTS.—The Secretary shall en- sure that each biennial report under section 403 includes information on actions undertaken by the National Insti- tutes 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 out- comes of Lyme disease and such other tick-borne diseases. ‘‘SEC. 399OO–1. WORKING GROUP.
‘‘(a) ESTABLISHMENT.—The Secretary shall estab- lish a permanent working group, to be known as the Inter- agency 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 Depart- ment of Health and Human Services concerning Lyme dis- ease and other tick-borne diseases to ensure interagency coordination, minimize overlap, and examine research pri- orities.
‘‘(b) RESPONSIBILITIES.—The Working Group shall—
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‘‘(1) not later than 24 months after the date of
enactment of this part, and every 24 months there- after, develop or update a summary of—
‘‘(A) ongoing Lyme disease and other tick- borne disease research related to causes, pre- vention, treatment, surveillance, diagnosis, diagnostics, duration of illness, intervention, and access to services and supports for individ- uals with Lyme disease or other tick-borne dis- eases;
‘‘(B) advances made pursuant to such re- search;
‘‘(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 Work- ing Group at such public meetings and the Sec- retary’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;
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‘‘(4) make recommendations to the Secretary
regarding any appropriate changes to such activities; and
‘‘(5) ensure public input by holding annual pub- lic meetings that address scientific advances, re- search questions, surveillance activities, and emerg- ing 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:
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‘‘(A) FEDERAL MEMBERS.—Seven Federal members, consisting of one or more representa- tives of each of—
‘‘(i) the Office of the Assistant Sec- retary for Health;
‘‘(ii) the Food and Drug Administra- tion;
‘‘(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 ap- propriate.
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‘‘(B) NON-FEDERAL PUBLIC MEMBERS.—
Seven non-Federal public members, consisting of representatives of the following categories:
‘‘(i) Physicians and other medical pro- viders with experience in diagnosing and treating Lyme disease and other tick-borne diseases.
‘‘(ii) Scientists or researchers with ex- pertise.
‘‘(iii) Patients and their family mem- bers.
‘‘(iv) Nonprofit organizations that ad- vocate for patients with respect to Lyme disease and other tick-borne diseases.
‘‘(v) Other individuals whose expertise is determined by the Secretary to be bene- ficial 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
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‘‘(B) one shall be appointed by the major-
ity leader of the Senate.
‘‘(3) DIVERSITY OF SCIENTIFIC PERSPEC- TIVES.—In making appointments under paragraph (2), the Secretary, the Speaker of the House of Rep- resentatives, 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) APPLICABILITY OF FACA.—The Working Group shall be treated as an advisory committee subject to the Federal Advisory Committee Act.
‘‘(f) 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, in- cluding an up-to-date summary under subsection (b)(1) and any recommendations under subsection
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(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 avail- able 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;
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‘‘(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 informa- tion developed by the Working Group to the public, including health care providers, public health depart- ments, and other relevant medical groups.’’.
(b) NO ADDITIONAL AUTHORIZATION OF APPRO-
PRIATIONS.—No additional funds are authorized to be ap- propriated for the purpose of carrying out this section and the amendment made by this section, and this section and such amendment shall be carried out using amounts other- wise available for such purpose.
