Opportunity Information: Apply for RFA DE 24 004
The National Institutes of Health (NIH) is soliciting applications under Funding Opportunity Announcement (FOA) RFA-DE-24-004, titled "Developing Salivary Components as Therapeutics for Oral Health (R01 Clinical Trial Not Allowed)." This is a discretionary grant opportunity using the NIH R01 research project grant mechanism, focused on oral health research (CFDA 93.121). The central aim is to spur interdisciplinary work that identifies, characterizes, and harnesses functional components of saliva in ways that can be translated into therapeutic strategies. A key expectation is that funded projects will generate outcomes that move the field closer to producing highly effective surrogate saliva products intended for clinical use, especially for individuals who cannot produce adequate saliva naturally.
The scientific emphasis is on leveraging saliva's biologically active ingredients, such as protective proteins, peptides, enzymes, mucins, antimicrobial factors, minerals, and other molecular constituents that contribute to lubrication, buffering, remineralization, microbial control, and tissue protection in the mouth. The FOA is oriented toward research that can convert this growing knowledge of salivary biology into practical therapeutic approaches, which may include engineered formulations, biomimetic replacements, or component-based interventions designed to restore or replicate saliva's protective functions. Because the announcement explicitly states "Clinical Trial Not Allowed," proposed studies must stay within the boundaries of non-clinical-trial research, meaning applicants should not propose prospective human studies that assign participants to an intervention to evaluate health-related outcomes. Projects can still be translational and clinically relevant, but they need to be structured as preclinical, mechanistic, formulation, or other non-clinical-trial research consistent with NIH definitions.
In terms of funding details, the posted award ceiling is $500,000, and the original closing date listed for the opportunity was November 22, 2023. The opportunity is administered by NIH, and the activity category is Health. While the total number of expected awards is not specified in the provided source text, the presence of an award ceiling signals that budgets should be planned carefully and aligned with achievable milestones that advance surrogate saliva development and other saliva-component-based therapeutics.
Eligibility is broad and includes a wide range of domestic U.S. organizations. Eligible applicants include 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; public housing authorities/Indian housing authorities; and Native American tribal organizations other than federally recognized tribal governments. The FOA also permits applications from nonprofits (both 501(c)(3) and non-501(c)(3) organizations) other than institutions of higher education, as well as for-profit organizations (other than small businesses) and small businesses. It explicitly highlights additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). Faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions are also included among eligible applicants.
At the same time, the FOA places clear limits on foreign participation. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, 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, which generally means a U.S.-based applicant may include certain substantive project elements performed outside the United States when adequately justified, structured appropriately, and compliant with NIH policy.
Overall, this FOA is designed to push oral health research beyond describing saliva and toward building therapeutics that replicate or restore saliva's key functions. Competitive applications will likely bring together expertise across oral biology, microbiology, immunology, bioengineering, materials science, formulation chemistry, and translational research to develop component-informed or biomimetic solutions that can ultimately improve oral health outcomes for patients affected by salivary dysfunction, while staying squarely within the "no clinical trial" boundaries of the announcement.Apply for RFA DE 24 004
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Developing Salivary Components as Therapeutics for Oral Health (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): 93.121.
- 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 $500,000.00 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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FAQs: NIH FOA RFA-DE-24-004 (R01) - Developing Salivary Components as Therapeutics for Oral Health (Clinical Trial Not Allowed)
1) What is this funding opportunity?
This is a National Institutes of Health (NIH) discretionary grant opportunity under Funding Opportunity Announcement (FOA) RFA-DE-24-004 titled "Developing Salivary Components as Therapeutics for Oral Health (R01 Clinical Trial Not Allowed)." It uses the NIH R01 research project grant mechanism and is focused on oral health research.
2) What is the main goal of RFA-DE-24-004?
The goal is to spur interdisciplinary research that identifies, characterizes, and harnesses functional components of saliva in ways that can be translated into therapeutic strategies. A major expectation is that projects will generate outcomes that move the field closer to highly effective surrogate saliva products intended for clinical use, especially for people who cannot produce enough saliva naturally.
3) What kinds of salivary components does NIH want applicants to focus on?
The FOA emphasizes saliva's biologically active ingredients, including protective proteins, peptides, enzymes, mucins, antimicrobial factors, minerals, and other molecular constituents that support lubrication, buffering, remineralization, microbial control, and tissue protection in the oral cavity.
4) What types of therapeutic approaches are in scope?
The FOA is oriented toward practical, therapeutic approaches that convert knowledge of salivary biology into solutions. Examples described at a high level include engineered formulations, biomimetic replacements, and component-based interventions designed to restore or replicate saliva's protective functions.
5) What does "Clinical Trial Not Allowed" mean for this FOA?
It means applicants should not propose a prospective human study where participants are assigned to an intervention to evaluate health-related outcomes. Projects can still be translational and clinically relevant, but the research must be structured as non-clinical-trial work consistent with NIH definitions.
6) If clinical trials are not allowed, what kinds of studies can be proposed?
Based on the FOA description, studies may be preclinical, mechanistic, formulation-focused, or otherwise non-clinical-trial research. The emphasis is on building the scientific and technical foundation for saliva-component-based therapeutics and surrogate saliva products without crossing into prospective, intervention-assignment human clinical trial designs.
7) What is the activity code and mechanism for this opportunity?
The mechanism is an NIH R01 Research Project Grant.
8) What is the subject area or activity category?
The activity category listed is Health, with a focus on oral health research.
9) What is the CFDA (assistance listing) number associated with this opportunity?
The FOA is associated with CFDA 93.121.
10) How much funding is available per award?
The posted award ceiling in the provided information is $500,000. This signals that proposed budgets should be planned carefully and tied to realistic milestones that advance surrogate saliva development and related therapeutics.
11) When was the closing date for this opportunity?
The original closing date listed in the provided information is November 22, 2023.
12) Does the FOA specify how many awards NIH expects to make?
No. The provided information notes that the total number of expected awards is not specified.
13) Who is administering this funding opportunity?
The opportunity is administered by the National Institutes of Health (NIH).
14) Which U.S. organizations are eligible to apply?
Eligibility is broad and includes many domestic U.S. organization types, including:
- State governments, county governments, 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
- Public housing authorities/Indian housing authorities
- Native American tribal organizations other than federally recognized tribal governments
- Nonprofits (501(c)(3) and non-501(c)(3)) other than institutions of higher education
- For-profit organizations (other than small businesses) and small businesses
- Eligible federal agencies
- Regional organizations
- U.S. territories or possessions
- Faith-based or community-based organizations (if otherwise eligible)
15) Are minority-serving institutions specifically mentioned as eligible?
Yes. The FOA explicitly highlights eligibility that includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs).
16) Are foreign (non-U.S.) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply.
17) Can non-domestic components of U.S. organizations apply?
No. Non-domestic components of U.S. organizations are also not eligible to apply.
18) Are "foreign components" allowed at all under this FOA?
Yes. Although foreign organizations cannot apply, the FOA states that "foreign components" are allowed as defined in the NIH Grants Policy Statement. In general terms, this means a U.S.-based applicant may include certain substantive project elements performed outside the United States when adequately justified and compliant with NIH policy.
19) What is NIH looking for in terms of impact or outcomes?
The FOA is designed to push the field beyond describing saliva and toward building therapeutics that replicate or restore saliva's key functions. Funded projects are expected to generate results that move the field closer to surrogate saliva products intended for clinical use, particularly benefiting individuals with salivary dysfunction.
20) What scientific disciplines or expertise areas may be relevant for a competitive application?
The provided description suggests that competitive, interdisciplinary projects may integrate expertise from oral biology, microbiology, immunology, bioengineering, materials science, formulation chemistry, and translational research, with the common goal of developing component-informed or biomimetic solutions.
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