In utero Treatments of Congenital Dental and Craniofacial Disorders Using Precision Medicine Approaches (R01 Clinical Trial Not Allowed) | RFA DE 23 004

Opportunity Information: Apply for RFA DE 23 004

The funding opportunity titled "In utero Treatments of Congenital Dental and Craniofacial Disorders Using Precision Medicine Approaches (R01 Clinical Trial Not Allowed)" (Funding Opportunity Number RFA-DE-23-004) is a National Institutes of Health (NIH) discretionary grant initiative in the health research area (CFDA 93.121). It uses the R01 research project grant mechanism and specifically does not allow clinical trials, meaning proposed work should focus on preclinical and translational research rather than enrolling human participants in interventional studies.

The purpose of the initiative is to speed up research that develops in utero treatment strategies for congenital dental and craniofacial disorders, using animal models combined with precision medicine approaches. In practical terms, the program is aimed at supporting studies that can move the field beyond understanding these disorders toward testing and refining therapeutic concepts during fetal development, when interventions may prevent or reduce structural and functional problems before birth. A core emphasis is on using animal model systems as the main platform for developing, optimizing, and evaluating these prenatal interventions, including how they might be targeted, timed, delivered, and assessed for both safety and effectiveness in relevant developmental contexts.

A key theme is "precision medicine approaches," which generally refers to tailoring prevention or treatment strategies based on biological features that distinguish one condition, subtype, or affected individual from another. In the context of congenital dental and craniofacial disorders, that often implies research designs that account for genetic causes, molecular pathways, developmental timing, and variability in phenotype. The initiative is therefore positioned to support projects that connect underlying mechanisms to targeted prenatal therapeutic strategies, with the expectation that these strategies are informed by specific disease biology rather than one-size-fits-all treatment concepts.

Although the work is preclinical, the long-term goal is explicitly translational: to lay the groundwork for eventual delivery of in utero treatments in humans. That translates into an expectation that funded studies will generate the kind of evidence and practical know-how needed to make future human translation plausible, such as proof-of-concept efficacy in appropriate models, characterization of fetal and maternal safety considerations, development of feasible delivery methods, and identification of biomarkers or endpoints relevant to congenital craniofacial and dental outcomes. The program is essentially trying to build the scientific and technical foundation that could later support carefully designed human studies, even though those human clinical trials are outside the scope of this particular R01 announcement.

Eligibility is broad and includes many common applicant types across government, academia, nonprofit, and industry. 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; and public housing authorities/Indian housing authorities. Tribal eligibility is also expansive, covering federally recognized Native American tribal governments as well as Native American tribal organizations and tribal governments that are not federally recognized. The opportunity is open to nonprofits both with and without 501(c)(3) IRS status (when not institutions of higher education), as well as for-profit organizations (other than small businesses) and small businesses. In addition, the announcement explicitly calls out other eligible applicant categories, including 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); eligible federal agencies; faith-based or community-based organizations; U.S. territories or possessions; regional organizations; and non-domestic (non-U.S.) entities (foreign organizations), signaling an intent to encourage broad participation, including institutions that serve historically underrepresented populations and international collaborators.

Key administrative details provided in the source include a creation date of February 16, 2022, and an original closing date of June 14, 2022. The listing does not specify an award ceiling or the expected number of awards in the provided fields, so applicants typically would need to consult the full announcement for budget expectations, project period limits, and any additional constraints or review criteria not included in the abbreviated record. Overall, the opportunity is centered on preclinical, precision-guided prenatal intervention research for congenital dental and craniofacial conditions, with a clear throughline from animal-model development work toward future human applicability.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "In utero Treatments of Congenital Dental and Craniofacial Disorders Using Precision Medicine Approaches (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 2022-02-16.
• Applicants must submit their applications by 2022-06-14. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• 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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