21st Century Cures Act

The 21st Century Cures Act, enacted in December 2016, authorizes the HHS Secretary to establish a Tick-Borne Disease Working Group to serve as a Federal Advisory Committee.  The Working Group is to comprise federal and public members with diverse disciplines and views pertaining to tick-borne diseases. The Act charges the Working Group to provide a report to Congress and the HHS Secretary on its findings and any recommendations every two years.  Working Group responsibilities include a review of ongoing research and resulting advances; Federal epidemiological and research efforts; and identification of research gaps.  The 21st Century Cures Act, Section 2062 Tick-Borne Diseases, is provided below.  You can access the legislation in its entirety at 21st Century Cures Act.


(a) IN GENERAL.—The Secretary of Health and Human Services (referred to in this section as ‘‘the Secretary’’) shall continue to conduct or support epidemiological, basic, translational, and clinical research related to vector-borne diseases, including tick-borne diseases.

(b) REPORTS.—The Secretary shall ensure that each triennial report under section 403 of the Public Health Service Act (42 U.S.C. 283) (as amended by section 2032) includes information on actions undertaken by the National Institutes of Health to carry out subsection (a) with respect to tick-borne diseases.


     (1) ESTABLISHMENT.—The Secretary shall establish a working group, to be known as the
          Tick-Borne Disease Working Group (referred to in this section as the ‘‘Working Group’’),
          comprised of representatives of appropriate Federal agencies and other non-Federal entities,
          to provide expertise and to review all efforts within the Department of Health and Human
          Services related to all tick-borne diseases, to help ensure interagency coordination and minimize
          overlap, and to examine research priorities.

     (2) RESPONSIBILITIES.—The working group shall—

           (A) not later than 2 years after the date of enactment of this Act, develop or update a summary
              (i) ongoing tick-borne disease research, including research related to causes, prevention,
                  treatment, surveillance, diagnosis, diagnostics, duration of illness, and intervention for
                 individuals with tick-borne diseases;
              (ii) advances made pursuant to such research;
              (iii) Federal activities related to tick-borne diseases, including—
                   (I) epidemiological activities related to tick-borne diseases; and
                   (II) basic, clinical, and translational tick-borne disease research related to the
                        pathogenesis, prevention, diagnosis, and treatment of tick-borne diseases;
              (iv) gaps in tick-borne disease research described in clause (iii)(II);
              (v) the Working Group’s meetings required under paragraph (4); and
              (vi) the comments received by the Working Group;

          (B) make recommendations to the Secretary regarding any appropriate changes or
                improvements to such activities and research; and

          (C) solicit input from States, localities, and nongovernmental entities, including organizations
                representing patients, health care providers, researchers, and industry regarding scientific
                advances, research questions, surveillance activities, and emerging strains in species of
                pathogenic organisms.

     (3) MEMBERSHIP.—The members of the working group shall represent a diversity of scientific
          disciplines and views and shall be composed of the following members:

          (A) FEDERAL MEMBERS.—Seven Federal members, consisting of one or more representatives
                of each of the following:
               (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.
               (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
                     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 tick-borne diseases.
                (v) Other individuals whose expertise is determined by the Secretary to be beneficial to the
                     functioning of the Working Group.

     (4) MEETINGS.—The Working Group shall meet not less than twice each year.

     (5) REPORTING.—Not later than 2 years after the date of enactment of this Act, and every 2 years
          thereafter until termination of the Working Group pursuant to paragraph (7), the Working Group

          (A) submit a report on its activities under paragraph (2)(A) and any recommendations under
               paragraph (2)(B) 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; and

          (B) make such report publicly available on the Internet website of the Department of Health and
                Human Services.

     (6) APPLICABILITY OF FACA.—The Working Group shall be treated as an advisory committee
          subject to the Federal Advisory Committee Act (5 U.S.C. App.).

     (7) SUNSET.—The Working Group under this section shall terminate 6 years after the date of
          enactment of this Act.

The Working Group will terminate on December 13, 2022

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