After years of progress by the 14-member Tick-Borne Disease Working Group (TBDWG) and community-driven Lyme Innovation, HHS and partners are ushering in a new era for Lyme and tickborne-disease solutions with renewed focus on implementation. In consultation with the TBDWG, the Office of the Assistant Secretary for Health (OASH) and CDC are leading the development of a whole-of-government strategy for vector-borne diseases—with emphasis on implementation.
In November 2022, HHS published the DRAFT National Strategy with a request for information (“RFI”), entitled Input on the National Public Health Strategy for the Prevention and Control of Vector-Borne Diseases in Humans (Federal Register notice). Spanning both civilian agencies and defense departments, the National Strategy will:
- Assess gaps and any unnecessary duplication of federally funded programs.
- Identify strategic goals to address such diseases.
- Coordinate programs and federal activities to address such diseases.
Seventeen agencies and divisions worked with HHS to develop this DRAFT National Strategy, per the Kay Hagan Tick Act (P.L. 116-94) passed by Congress in 2019, because vector-borne diseases are a serious public health problem. Examples of vector-borne diseases include the Zika virus, West Nile virus, and tickborne diseases, including Lyme disease. These are diseases carried by mosquitoes, ticks, fleas, and biting insects.
Lyme disease is the fastest-growing vector-borne disease in the United States, accounting for over 70% of all vector-borne disease domestically. Lyme disease is the most common tickborne disease, yet there are at least 20 different infections that are transmitted by ticks in the United States. The CDC estimates that approximately 476,000 Americans are diagnosed and treated for Lyme disease each year. Due to climate change, habitat loss, and other land-use changes, humans face greater risk today than historically because of increased exposure risks to tick bites that transmit vector-borne diseases.
The DRAFT National Strategy RFI includes an informational crosswalk that maps the TBDWG 2018 Report and TBDWG 2020 Report recommendations to Congress with the goals and strategic priorities of the DRAFT National Strategy (see pages 70844–70848; entitled the HHS Tick-Borne Disease Working Group Cross Walk). It shows where and how the implementation is happening across HHS, CDC, NIH, FDA, CMS and federal agencies—with a one-to-one mapping between the DRAFT National Strategy and TBDWG recommendations made to HHS and Congress.
U.S. government will improve the National Strategy with your input. RFI responses will help HHS to finalize the National Strategy, due to Congress by December 2023.
Please submit your RFI comments on Regulations.gov before 12:00pm midnight Eastern Time (ET) on December 21, 2022.
Solutions to Lyme and vector-borne diseases will require all of us, and the National Strategy will be a future roadmap for implementing U.S. solutions. Implementation of the National Strategy will be enhanced by collaboration, both within and outside of government. Partnerships, like the LymeX Innovation Accelerator, can expedite progress.
Collaboration opportunities include community-driven Lyme Innovation events, placing Lyme patients and the lived experience at the center of the innovation process. For example, the HHS Health+ (pronounced “health plus”) collaboration synthesized almost 700 hours of research with diverse communities to co-create the Health+ Lyme Disease Human-Centered Design Report (2021, 123 pages). Other engagement avenues exist through the LymeX public-private partnership. For example, the LymeX Diagnostics Prize recently awarded $1 million dollars, announcing 10 Phase 1 winners developing Lyme disease diagnostics that each received $100,000 for breakthrough technologies. The LymeX Diagnostics Prize is a multi-year innovation challenge with ambitious plans for 2023, including 2023 LymeX events open to the public. Also in 2023, HHS expects to host Lyme and vector-borne-disease workshops and potentially also roundtables and virtual meetups.
For continued progress, HHS believes that ongoing, robust engagement with the patient-led community is essential. Multiple pathways will ensure continued transparency and collaborative communications between the federal government and external stakeholders.
If you have ideas to improve the DRAFT National Strategy, please share them with HHS. Submit your RFI comments on Regulations.gov before 12:00am midnight Eastern Time (ET) on December 21, 2022.