Developing Salivary Components as Therapeutics for Oral Health (R21 Clinical Trial Not Allowed) | RFA DE 24 005

Opportunity Information: Apply for RFA DE 24 005

The National Institutes of Health (NIH) funding opportunity titled "Developing Salivary Components as Therapeutics for Oral Health (R21 Clinical Trial Not Allowed)" (Funding Opportunity Number: RFA-DE-24-005; CFDA: 93.121) supports early-stage, exploratory research aimed at turning key functional components of human saliva into therapeutic approaches for oral health. The central idea is to bring together interdisciplinary teams to identify, characterize, and harness saliva's protective and restorative functions in ways that can be translated into new treatments. A major expected outcome is progress toward creating more effective surrogate saliva products for clinical use, which is particularly relevant for people who suffer from reduced saliva production or impaired salivary function and experience downstream problems like tooth decay, oral infections, mucosal discomfort, and reduced quality of life.

This is an R21 mechanism, meaning it is designed for novel, high-impact, proof-of-concept work rather than large, definitive programs. The FOA explicitly states that clinical trials are not allowed under this announcement, so proposed studies should stay in the preclinical, mechanistic, formulation, and early translational space without enrolling human participants into clinical trial designs. In practice, this typically favors projects focused on the discovery and functional testing of salivary proteins, peptides, enzymes, glycoproteins, antimicrobial factors, immune modulators, or other bioactive constituents, along with work on how to stabilize them, deliver them effectively, or combine them into formulations that better replicate saliva's natural protective roles. The emphasis on "surrogate saliva" suggests interest in moving beyond simple lubricants toward biologically active substitutes that can meaningfully restore functions such as buffering acids, controlling microbial communities, protecting enamel, modulating inflammation, and supporting tissue repair.

The opportunity is categorized as discretionary grant funding in the health area and is offered by NIH (specifically within NIH's dental and craniofacial portfolio, as suggested by the "DE" identifier). The award ceiling listed is $275,000, indicating the maximum budget level expected for an individual award under this FOA. The original closing date was November 22, 2023, and the announcement was created on August 29, 2023. While the summary data does not specify the anticipated number of awards, the focus and structure indicate a competitive, investigator-initiated research program intended to seed innovative approaches and generate data that could later support larger-scale development and validation efforts under subsequent mechanisms.

Eligibility is broad and includes many types of U.S.-based organizations: state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits (both with and without 501(c)(3) status, as long as they are not institutions of higher education); for-profit organizations other than small businesses; and small businesses. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible agencies of the federal government, regional organizations, and U.S. territories or possessions. These eligibility statements underscore NIH's intent to encourage participation across a wide range of institution types and communities, including organizations that serve historically underrepresented populations.

Foreign eligibility is restricted in a specific way. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the primary applicant, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S. applicant organization can include certain well-justified international collaborations or performance sites as part of the project, provided they meet NIH requirements and are appropriately justified in terms of unique expertise, resources, populations, or technologies not available domestically. This creates room for international scientific input without allowing a non-U.S. institution to serve as the main awardee.

Overall, this FOA is best viewed as a targeted NIH initiative to catalyze creative, cross-disciplinary science that converts saliva biology into tangible therapeutic strategies for oral health, with particular interest in next-generation surrogate saliva that does more than moisturize by actively reproducing saliva's protective functions.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Developing Salivary Components as Therapeutics for Oral Health (R21 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): 93.121.
• This funding opportunity was created on 2023-08-29.
• Applicants must submit their applications by 2023-11-22. (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 $275,000.00 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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