Source: https://www.hhs.gov/ash/advisory-committees/tickbornedisease/notices/index.html
Timestamp: 2019-04-20 15:02:26+00:00

Document:
Federal Register Notice: Solicitation of Nominations for Appointment to the Tick-Borne Disease Working Group (Vol. 83, No. 222, 57739-57740). Notice published on Friday, November 16, 2018.
Federal Register Notice: Amendment extending the submission date for nominations of individuals who are interested in being considered for the Tick-Borne Disease Working Group (Vol. 82, No. 157, 38912). Notice published on Wednesday, August 16, 2017.
Federal Register Notice: Solicitation of nominations of individuals interested in being considered for appointment to the Tick-Borne Disease Working Group (Vol. 82, No. 135, 32711-32712). Notice published on Monday, July 17, 2017.
When are the Tick-Borne Disease Working Group’s records made available to the public?
The Tick-Borne Disease Working Group (“Working Group”) records are available to the public during the public meetings. Providing “contemporaneous availability” of those records is designed to “provide a meaningful opportunity [for the public] to comprehend fully the work undertaken by the advisory committee.” See GSA Federal Advisory Committee Management Final Rule, 41 C.F.R. § 102–3.170 and FACA § 10(b).
The Working Group will make those records available to the public in two ways. First, some of those records are available on the Working Group’s website during the public meeting. Second, when records are not available on the website during the meeting, the Working Group will make paper copies of those records available at the public meeting. Furthermore, as required by the Federal Advisory Committee Act (FACA), paper copies of records, which were made available to or prepared for or by the Working Group are available for public inspection and copying at: https://www.hhs.gov/ash/advisory-committees/tickbornedisease/index.html or at the offices of the Working Group.
How are public comments shared with the members of the Tick-Borne Disease Working Group and the public?
The public’s comments are important to the Tick-Borne Disease Working Group and those public comments are shared with the members of the Working Group.
The way those comments are shared with the Working Group depends on how those comments are submitted.
Verbal public comments: If a verbal public comment is provided to the Working Group during one of its public meetings, then the Working Group has the opportunity to listen to and consider that comment during the meeting. A transcript of those verbal public comments are also subsequently made available to the public on the Working Group’s website.
Written public comments: Written public comments can be submitted to tickbornedisease@hhs.gov. Those comments that relate to the substantive business upon which the Working Group provides advice and recommendations under the 21st Century Cures Act are posted to the Working Group’s website. The members of the Working Group are informed where those written public comments are posted on the Working Group’s website, so that they can review and consider those comments.
Although the FACA does not require that Federal Advisory Committees post public comments online, the written public comments related to the substantive business of the Working Group will be posted online in an effort to increase transparency.
The Tick Borne Disease Working Group greatly appreciates the time and effort that the public has devoted to sharing their comments and insights on this important topic.
How does the FACA affect subcommittees?
The subcommittees of the Tick-Borne Disease Working Group are not required to follow the transparency requirements of the FACA, because they are doing preparatory work for the Working Group and the final products of that preparatory work will be vetted by the Working Group at a public meeting.
Federal advisory committees are treated differently than subcommittees under FACA for two reasons. First, in general, the requirements of FACA “do not apply to subcommittees of advisory committees that report to a parent advisory committee and not directly to a Federal officer or agency.” See 41 C.F.R. § 102–3.35.
Second, the subcommittees of the Tick-Borne Disease Working Group are performing “preparatory work” and the FACA transparency requirements do not apply to preparatory work. See GSA Federal Advisory Committee Management Final Rule § 102–3.160(a). Preparatory work is defined as “[m]eetings of two or more advisory committee or subcommittee members convened solely to gather information, conduct research, or analyze relevant issues and facts in preparation for a meeting of the advisory committee, or to draft position papers for deliberation by the advisory committee.” See 41 C.F.R. at § 102–3.160(a).
How will the final products of the subcommittees’ preparatory work be made available to the public?
The final products of the preparatory work conducted by the subcommittees of the Tick-Borne Disease Working Group will be vetted at public meetings of that Working Group and will be made “available for public inspection and copying” under FACA § 10(b). The Working Group will make those final products available on the Working Group’s website.
The final products of the six current subcommittees are now available on the Working Group’s website on the Reports page and the Meeting page for the May 10, 2018 meeting.
Robert Sabatino, Founder and Executive Director of Lyme Society Inc., was named a public member of the Tick-Borne Disease Working Group. Lyme Society is the New York affiliate partner of Lyme Disease Association. As a patient and advocate, he continues to contribute to legislation, education, and awareness. From his own perspective as a patient, his focus is on the life and struggles of patients and treatments in society today. He retired from the New York Police Department that specialized in Drug Enforcement, Addiction Services, Community Outreach and Domestic Violence Awareness. He is a founding member of the Staten Island patients support group formed by the State Island Burroughs Presidents Office.
Sherill Franklin, a small business owner and patient advocate from Pennsylvania, will join the Access to Care Services and Support to Patients Subcommittee of the Tick-Borne Disease Working Group. Ms. Franklin has written extensively about her own 30-year experience with Lyme disease and has advocated for better diagnostic tools and definitive treatments for tick-borne disease. She will replace Dr. Enid Haller, who is departing.
Paula Jackson Jones, President of Midcoast Lyme Disease Support and Education, was named co-chair of the Access to Care Services and Support to Patients Subcommittee. She co-founded the Maine-based group in 2014 as a result of her own experiences as a patient with Lyme disease.
An updated listing of the co-chairs of the six subcommittees of the Tick-Borne Disease Working Group is provided below.
A member of the Tick-Borne Disease Working Group, Karen Vanderhoof-Forschner, resigned on March 6, 2018. Ms. Vanderhoof-Forschner also served as one of two co-chairs on the Access to Care Services and Support to Patients Subcommittee. Three non-federal subcommittee members were nominated by the other members to take on this leadership role. Early next week, subcommittee members will vote on their preference to replace Ms. Vanderhoof-Forschner. The results of the vote will be considered along with other information by the Chair and the Vice-Chair of the Working Group. A replacement for Ms. Vanderhoof-Forschner to serve on the Working Group will be appointed by Secretary Azar.
The Department of Health and Human Services announces changes to the composition of three of the six subcommittees of the Tick-Borne Disease Working Group (Working Group). The changes were made in response to three members who did not accept the invitations they received to be a part of a subcommittee. New members were selected from the list of existing nominees by the Co-Chairs of the affected subcommittees. The Chair and Vice-Chair of the Working Group provided input and approved the final changes.
Robert Bransfield, MD, a private practice physician and Associate Clinical Professor in the Department of Psychiatry at Rutgers-RWJ Medical School, has replaced Susan Green, JD, on the Access to Care and Support to Patients subcommittee. After careful consideration, Ms. Green withdrew her name.
David Roth, JD, has accepted a Co-Chair position on the Testing and Diagnostics Subcommittee, of which he is an existing member. Vanilla Singh, MD, was not able to accept the invitation to serve as Co-Chair because of additional duties she has been asked to perform in the Office of the Assistant Secretary for Health. Dr. Singh remains a federal member of the Tick-Borne Disease Working Group. Holly Ahern, MS, Associate Professor of Microbiology at SUNY Adirondack, has accepted a position on the Testing and Diagnostics Subcommittee.
David Walker, MD, who was selected for the Vaccine and Therapeutics subcommittee, withdrew his name for personal reasons. The subcommittee will proceed with the existing members.
The Department of Health and Human Services (HHS) announces the names of 53 individuals who have been selected to serve on one of six subcommittees of the Tick-Borne Disease Working Group (Working Group). After reviewing the nominations, selections were made by the co-chairs overseeing each of the subcommittees. The Chair and Vice-Chair of the Working Group provided input and approved the final selections. All of the individuals were notified today, but they have not yet confirmed their availability to serve on the subcommittee that they were chosen to join. The final list of subcommittee members will be updated if any of them are no longer able to join a subcommittee.
These subcommittees were established by the Working Group members during the December 12, 2017 meeting to assist them in identifying and reviewing information that provides the background, context, and evidence needed to develop the report to Congress and the HHS Secretary as required by the 21st Century Cures Act. The subcommittees will be led by members of the Working Group. The Chair and Vice-Chair of the Working Group will work in collaboration with the subcommittee Co-Chairs and the Designated Federal Officer to ensure that the work of the subcommittees is consistent with the needs of the Working Group and committee management laws and regulations. The roles of the subcommittees, the work they will be doing, and the reports that they will provide to the Working Group will discussed at the February 12, 2018 meeting.
The U.S. Department of Health and Human Services announced the appointment of Robert Smith, MD, MPH, to the Tick-Borne Disease Working Group. Dr. Smith will join Dr. Dennis Dixon as a co-chair to the Vaccine and Therapeutics Working Group Subcommittee.
Dr. Smith is Director of the Division of Infectious Diseases at Maine Medical Center, and Director and co-founder of the Vector-Borne Disease Laboratory at the Maine Medical Center Research Institute. He has also served as Medical Director of the HIV care program at Maine Medical Center since its inception in 1992. In 2009, he served as Chair of the external review panel of the Centers for Disease Control and Prevention’s Lyme disease program, and, in 2011, as an Invited Reviewer for the Institute of Medicine’s workshop report Critical Needs and Gaps in the Understanding, Prevention, and Resolution of Lyme and other Tick-borne Diseases. He is an author of more than 40 peer-reviewed journal articles and book chapters on tick-borne diseases, and has conducted more than 20 grant-supported studies of ticks and the diseases they transmit. His recent research includes investigations into the determinants of emergence of tick-transmitted diseases, the clinical spectrum of newly recognized infections, and interventions to lower human risk.
Co-chairs are currently reviewing the nominations for subcommittee members. The members of each subcommittee will be announced before the third meeting of the Working Group that takes place on February 12, 2018.
The Tick-Borne Disease Working Group (Working Group) is seeking nominations of federal employees and members of the public who are interested in being considered for appointment to one of six subcommittees that are being established to support the efforts of the Tick-Borne Disease Working Group. Each subcommittee will present a carefully reasoned, evidence-informed report to the Working Group for the Working Group’s deliberation. Nominations will be accepted until midnight on January 7, 2018.
The federal government has made significant investments that address tick-borne diseases and provide support to research, prevention, medical care and treatment, and other related services or activities. Congress established the Tick-Borne Disease Working Group in the 21st Century Cures Act 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. Key tasks include the development and implementation of a summary of federally funded projects focused on Lyme disease and other tick-borne diseases, reviews of the scientific literature, as well as information provided at subcommittee meetings by subject matter experts, and by patients and their families.
Disease Vectors, Surveillance and Prevention (includes epidemiology of tick-borne diseases).
Each subcommittee will be led by two subcommittee co-chairs. The co-chairs of each committee will work with the Working Group Chair, Vice Chair, the Designated Federal Official (DFO) and his alternate, and the other subcommittee co-chairs to align the work of the subcommittees with the goals and priorities of the Working Group and to conduct the work in a similar manner across subcommittees. It is expected that each subcommittee will have about 8-10 members, including two members who are members of the Working Group.
Invited presentations by nonfederal and federal experts on topics related to the work of the subcommittees including, but not limited to, current epidemiology impact of tick-borne diseases, current state-of-the-art practices, federal guidance and recommendations. Evidence-informed best practices, challenges and opportunities, and any other relevant issues.
Each subcommittee will create opportunities for public comments to be provided.
Nominations will only be considered from two sources: (1) nominations that are submitted by persons who would like to serve on the subcommittee and (2) follow up with persons who previously submitted their names for consideration as members of the full Working Group.
Persons who are interested in serving on a subcommittee are invited to nominate themselves by submitting an email with the information described below to tickbornedisease@hhs.gov.
All persons who had been previously nominated to serve on the Working Group should receive an email asking them if they would like to be considered for any of the subcommittees. If they do, they will have the option of using the materials they have already provided or submitting updated materials.
Detailed information about submitting nominations is provided in the supplemental information section below.
Nominations must be received no later than midnight on January 7, 2018. All of the nominations that are received will be acknowledged by email within 2 business days of receipt.
All nominations with the Tick-Borne Disease Working Group Subcommittee Nominations subject line must be sent to tickbornedisease@hhs.gov. Hard copies will not be accepted.
All inquiries should be sent to the Tick-Borne Disease Working Group at tickbornedisease@hhs.gov.
Additional information about the Working Group, including its charter, can be found on at the Tick-Borne Disease website.
Section 2062 of the 21st Century Cures Act authorizes establishment of the Tick-Borne Disease Working Group (Working Group). The Working Group will be governed by provisions of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), which sets forth standards for the formation and use of federal advisory committees.
The 21st Century Cures Act is intended to advance the research and development of new therapies and diagnostics and make substantial federal investments in a wide range of health priorities.
Estimated Number and Frequency of Meetings.
All subcommittee meetings will be held using virtual meeting technology that requires an internet connection. It is expected that subcommittees will do most of their work between the January 2018 and May 2018. All of the virtual meetings are expected to take place during business hours; subcommittees may meet 2-4 times per month. The total number of meetings from January to June 2018 is expected to be 11 to 21 per subcommittee. The subcommittee members will also be expected to participate virtually in one or two public meetings of the full Working Group. The full Working Group meetings will be open to the public, except as determined otherwise by the Secretary, or another official to whom authority has been delegated, in accordance with the guidelines under Government in the Sunshine Act, 5 U.S.C. 552b(c).
Please follow the instructions below that detail the information to be submitted. All nominations received of individuals who have the specified expertise and knowledge will be considered for appointment as subcommittee member. Those individuals selected to serve on subcommittees will be notified on, or soon after, January 18, 2018. All nominations will then be notified of the subcommittee member selection.
a. Contact information including: name, title and professional affiliation (if applicable); other relevant organizational affiliations (if applicable); physical address that correspondence should be sent to, email address; and one or two phone numbers that can be used to contact you during business hours.
a. Which of these stakeholder groups are you a member of?
b. Which subcommittee do you want to serve on and have relevant knowledge or expertise to serve effectively?
c. Are you a federal employee?
d. Were you nominated to serve as a full Working Group member in response to the Federal Register notice?
e. If Yes, do you want to provide updated information or use the information you provided previously to serve on the Working Group?

References: § 102
 § 10
 § 102
 § 102
 § 102
 § 10