The Charter defines how the Working Group will be structured and function in response to the charge provided by the 21st Century Cures Act. The charter for the Tick-Borne Disease Working Group was approved by the Secretary of Health and Human Services on August 10, 2017. The text of the Charter is provided below.
Tick-borne Disease Working Group
The Tick-borne Disease Working Group (hereafter referred to as the Working Group) is required under Section 2062 of the 21st Century Cures Act. The Working Group is governed by the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C. App), which sets forth standards for the formation and use of advisory committees.
Objectives and Scope of Activities
The Secretary of Health and Human Services (Secretary) is responsible for ensuring the conduct of or support for epidemiological, basic, translational, and clinical research related to vector-borne diseases, including tick-borne diseases. The Working Group will provide expertise and 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.
Description of Duties
The Working Group shall have the following responsibilities:
(A) Not later than two years after the date of enactment of the authorizing legislation, develop or update a summary of:
(1) 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;
(2) advances made pursuant to such research;
(3) federal activities related to tick-borne diseases, including:
(a) epidemiological activities related to tick-borne diseases; and
(b) basic, clinical, and translational tick-borne disease research related to the pathogenesis,
prevention, diagnosis, and treatment of tick-borne diseases.
(4) gaps in tick-borne disease research described in clause 3b;
(5) the Working Group's meetings; and 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 non-governmental entities, including organizations
representing patients, health care providers, researchers, and industry regarding scientific
advances, research questions, surveillance activities, and emerging strains in species of
Agency or Official to Whom the Working Group Reports
The Working Group will provide recommendations to the Secretary.
Not later than two years after the date of enactment of the authorizing legislation (December 13, 2016) and every two years thereafter until the Working Group is terminated pursuant to the stipulations of the authorizing legislation, the Working Group shall:
(A) submit a report on its activities and any recommendations, as stipulated under the Description of
Duties (A) and (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;
(B) make such report publicly available on the Internet website of the Department of Health and
Management and support services for the Working Group's activities will be provided by staff from within the Office of the Assistant Secretary for Health (OASH). OASH is a staff division within the Office of the Secretary in the Department of Health and Human Services.
Estimated Annual Operating Costs and Staff Years
Estimated annual cost for operating the Working Group, including compensation and travel expenses for members, but excluding staff support, is $349,440. Estimated person years of staff support required is 2.0, at an estimated annual cost of $250,560.
Designated Federal Officer (DFO)
The ASH will select the Designated Federal Officer (DFO) from among full-time or permanent part-time staff within OASH, who have knowledge of the subject matter and skills and experience necessary to manage the Working Group. The ASH may appoint an Alternate DFO who will carry out these duties in the event that the appointed DFO cannot fulfill the assigned responsibilities for the Working Group. In the absence of the appointed DFO or Alternate DFO, the ASH will temporarily appoint one or more permanent full-time or part-time program staff to carry out the assigned duties.
The DFO will schedule and approve all meetings of the Working Group and any subcommittees that may be established by the Working Group. The DFO will prepare and approve all meeting agendas. The DFO may collaborate with the Working Group Chair in this activity, and when deemed appropriate, with chairs of any existing subcommittees that have been established by the Working Group. The DFO, Alternate DFO, or designee will attend all meetings of the Working Group and all meetings of any subcommittees that have been established to assist the Working Group. The DFO has authority to adjourn meetings, when it is determined to be in the public interest, and the DFO can be directed by the Secretary or designee to chair meetings of the Working Group.
Estimated Number and Frequency of Meetings
The Working Group will meet not less than twice a year, and these may be conducted by teleconference or video conference at the discretion of the ASH. The meetings will be open to the public, except as determined otherwise by the Secretary, or other official to whom authority has been delegated, in accordance with the guidelines under Government in the Sunshine Act, 5 U.S.C. 552b(c). Notice of all meetings will be provided to the public in accordance with the FACA. Meetings will be conducted and records of the proceedings will be kept, as required by applicable laws and departmental policies. A quorum is required for the Working Group to meet to conduct business. A quorum will consist of a majority of the Working Group's voting members.
When the Secretary or designee determines that a meeting will be closed or partially closed to the public, in accordance with stipulations of Government in the Sunshine Act, 5 U.S.C. 552b(c), then a report will be prepared by the DFO that includes, at a minimum, a list of members and their business addresses, the Working Group's functions, date and place of the meeting, and a summary of the Working Group's activities and recommendations made during the fiscal year. A copy of the report will be provided to the Department Committee Management Officer.
Establishment of the Working Group was mandated under Section 2602 of the 21" Century Cures Act. The Working Group will operate pursuant to the stipulations in the authorizing legislation.
Unless extended by Congress, the Working Group will be terminated (on December 13, 2022) six years after the date of enactment of the authorizing legislation. Unless renewed by appropriate action, the charter for the Working Group will expire two years from the date it is filed.
Membership and Designation
The Working Group will consist of 14 voting members, including the Chair, who represent diverse scientific disciplines and views. The composition will include seven federal members and seven non-federal public members. The federal members will consist of one or more representatives of each of the following: OASH, the Food and Drug Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health. The non-federal public members will consist of representatives of the following categories: physicians and other medical providers with experience in diagnosing and treating tick-borne diseases; scientists or researchers with expertise; patients and their family members; nonprofit organizations that advocate for patients with respect to tick-borne diseases. One or more of the non-federal public members will be selected by the Secretary to serve as the Chair, Vice Chair, and/or Co-Chairs. Individuals who are appointed to represent federal entities will be classified as regular government employees. The non-federal public members will be classified as special government employees. Invitations of membership will be extended to other agencies and offices of the Department of Health and Human Services and other individuals as determined by the Secretary to be appropriate and beneficial to the functioning of the Working Group.
The federal members will be appointed to serve for the duration of time that the Working Group is authorized to operate. Participation of the appointed federal members will be at the discretion of the respective agency head. The non-federal public members will be invited to serve as special government employees for overlapping terms of up to four years. Any non-federal public member who is appointed to fill the vacancy of an unexpired term will be appointed to serve for the remainder of that term. A non-federal public member may serve after the expiration of their term until their successor has taken office, but no longer than 180 days.
Pursuant to advance written agreement, non-federal public members of the Working Group will receive no stipend for the advisory service that they render as members of the Working Group. However, non-federal public members will receive per diem and reimbursement for travel expenses incurred in relation to performing duties for the Working Group, as authorized by law under 5 U.S.C. 5703 for persons who are employed intermittently to perform services for the federal government and in accordance with federal travel regulations.
In carrying out its function, the Working Group may establish subcommittees composed of members of the Working Group, as well as other individuals who have expertise and knowledge about the topics and issues that are pertinent to the mission of the Working Group. The established subcommittee may consider issues in accordance with the mission of the Working Group, and will, as appropriate, make recommendations and/or reports to the Working Group for consideration. Recommendations and/or reports of the subcommittee that are provided to the Working Group will be discussed at an open public meeting that is held by the Working Group. No established subcommittee of the Working Group may report directly to the Secretary or another federal official unless there is specific statutory authority for such reporting. The Department Committee Management Officer will be notified upon establishment of each subcommittee, and will be given information regarding its name, membership, function, cost, and estimated frequency of meetings.
Records of the Working Group and any established subcommittees will be handled in accordance with the General Records Schedule 6.2, Federal Advisory Committee Records or other approved agency records disposition schedule. Applicable records will be made available to the public for inspection and copying, subject to the Freedom of Information Act, 5 U.S.C. 552.
August 10, 2017
Thomas E. Price
Secretary of Health and Human Services