Understanding Persistent Signs and Symptoms Attributed to Post-Treatment Lyme Disease (R01 Clinical Trial Not Allowed) | RFA AI 22 046

Opportunity Information: Apply for RFA AI 22 046

The National Institutes of Health (NIH) is offering an R01 grant opportunity titled "Understanding Persistent Signs and Symptoms Attributed to Post-Treatment Lyme Disease (R01 Clinical Trial Not Allowed)," listed as Funding Opportunity Number RFA-AI-22-046 (CFDA 93.855). The main goal of this funding announcement is to support research that clarifies the underlying cause or causes of signs and symptoms that can continue even after a person has been diagnosed with Lyme disease and has completed antibiotic treatment. In other words, the focus is on the biological, physiological, and related mechanisms that may explain why some individuals experience ongoing problems after standard care, rather than on testing new clinical interventions in trial form, since clinical trials are not allowed under this specific FOA.

This is a discretionary federal funding opportunity using the "Grant" funding instrument, with a health-related funding activity category. The award ceiling is listed as $400,000, indicating the maximum amount that can be requested under the announcement (as provided in the source details). The original closing date for applications was November 8, 2022, and the FOA was created on July 20, 2022. While the number of expected awards is not specified in the provided information, the structure and labeling make clear it is intended to fund multiple investigator-initiated research projects that align with NIH priorities around post-treatment Lyme disease-related persistent symptoms.

Eligibility is broad and includes many types of U.S.-based organizations and government entities. Eligible applicants include state, county, city or township governments, and special district governments, as well as independent school districts. Higher education institutions are eligible, including public and state-controlled institutions of higher education and private institutions of higher education. Tribal eligibility includes federally recognized Native American tribal governments, public housing authorities/Indian housing authorities, and Native American tribal organizations that are not federally recognized tribal governments. The opportunity is also open to nonprofit organizations (both those with 501(c)(3) status and those without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses. NIH also highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

There are important limits related to non-U.S. participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply directly, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" are allowed as defined by the NIH Grants Policy Statement, meaning a U.S. applicant may include certain types of international involvement (for example, specific collaborations or performance sites) if they meet NIH's definition and requirements for a foreign component. This setup allows some global scientific collaboration while keeping the applicant organization and primary eligibility centered in the United States.

Overall, this FOA is designed to push the science forward on why persistent signs and symptoms occur after Lyme disease treatment, supporting mechanistic and explanatory research under the R01 mechanism while explicitly excluding clinical trial work. The intent is to strengthen the evidence base around post-treatment Lyme disease-related symptom persistence by funding rigorous studies that investigate potential causes, pathways, and contributing factors, using eligible U.S. institutions and organizations as the primary applicants.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Understanding Persistent Signs and Symptoms Attributed to Post-Treatment Lyme Disease (R01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
• This funding opportunity was created on 2022-07-20.
• Applicants must submit their applications by 2022-11-08. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $400,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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