The Lyme Disease Association announced that early today, July 14, the US Department of Health & Human Services (HHS) released its intent to establish the Tick-Borne Disease (TBD) Working Group called for in Section 2062 of the 21st Century Cures Act.
The working group will assist HHS in its efforts to conduct and support epidemiological, basic, translational and clinical research related to vector-borne diseases, including tick-borne diseases. The working group will function as a Federal Advisory Committee and its activities will be overseen by HHS’s Office of the Assistant Secretary for Health.
Language to create the TBD Working Group was incorporated into the 21st Century Cures Act, thanks to the work of Congressman Chris Gibson, advocates, and Lyme Caucus Co-Chair Congressman Chris Smith who all carefully monitored the progress of the Lyme disease bill they supported that was introduced into the House in 2015 (HR 789 Gibson- NY). There was intense grassroots lobbying efforts to ensure the language in the bill was beneficial to patients. Subsequently, some of that language was incorporated into the 21st Century Cures Act passed by the House. The Senate, however, wanted to write its own Cures Act and weakened that Lyme language, and the Lyme community had to fight to get it back. Successful negotiations with House Leadership were led by LDA President Pat Smith and a team of advocates to have the stronger language reinstituted into 21st Century Cures, which enabled the Working Group to have a seat at the table for some of the most important stakeholders: patients/advocates and treating physicians.
The working group’s mission will be to review all the efforts within HHS related to tick-borne diseases, to examine research priorities, to help ensure interagency coordination and to minimize overlap. The working group will be made up of representatives from both federal and non-federal agencies and entities.
HHS is seeking nominations for non-federal members through August 15, 2017. Information is available in the Federal Register Notice:
In other information from Washington, DC, the House passed HR 2810 authorization for appropriations for fiscal year 2018 for military activities of the Department of Defense. It contained an amendment from US Representative Bill Keating (MA) that permits the DOD to partner with medical researchers and universities to test for tick-borne illnesses.
**For more on the bill language**
SEC. 2062. TICK-BORNE DISEASES.
(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.
(c) Tick-Borne Diseases Working Group.—
(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 of—
(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 shall—
(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.