Drug Repurposing for Conditions Affecting Neonates and Pregnant Women (R01 - Clinical Trial Optional) | PAR 18 506

Opportunity Information: Apply for PAR 18 506

The National Institutes of Health (NIH) funding opportunity titled "Drug Repurposing for Conditions Affecting Neonates and Pregnant Women (R01 - Clinical Trial Optional)" (Funding Opportunity Number PAR-18-506) supports research projects that take drugs already approved by the U.S. Food and Drug Administration and evaluate them for new uses in neonatal and obstetric care. The core idea is to speed up access to better treatments for newborns and pregnant women by building on medications with existing safety and manufacturing histories, rather than starting from scratch with entirely new drug development programs. Because neonates and pregnant patients are often excluded from traditional drug development pathways, this FOA is designed to help investigators overcome scientific, ethical, and practical barriers that slow progress in these populations and to encourage more evidence-based therapies for conditions specific to pregnancy and early life.

This opportunity uses the R01 grant mechanism and is labeled "clinical trial optional," meaning applicants may propose either preclinical and translational work that prepares a repurposed drug for a new indication, or a project that includes a clinical trial if that is appropriate for the research questions and readiness of the intervention. As an NIH discretionary grant in the health category (CFDA 93.865), the program is positioned for substantial, hypothesis-driven research that can establish whether an approved drug can be safely and effectively used for a different neonatal or obstetric indication, potentially including dosing, formulation considerations, pharmacokinetics, pharmacodynamics, and clinical outcome evaluation that are especially important in pregnancy and in newborns.

A wide range of applicant organizations are eligible. In addition to typical NIH-eligible entities such as public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, and various levels of government (state, county, city/township, special district), eligibility also extends to Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments), independent school districts, and public or Indian housing authorities. The FOA explicitly highlights additional categories of eligible applicants that NIH encourages to apply, 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, tribal governments that are not federally recognized, and U.S. territories or possessions.

The foreign eligibility rules are specific. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" are allowed when they meet the NIH Grants Policy Statement definition, meaning a U.S.-based applicant can include certain international elements in the project if justified and compliant with NIH policy, even though a foreign organization cannot be the primary applicant.

The FOA was created on December 18, 2017, and lists an original closing date of May 7, 2021. The publicly provided fields do not specify an award ceiling or the expected number of awards in the excerpted source data. Overall, the program is aimed at encouraging practical, clinically relevant research that can move faster than traditional drug development by repurposing approved therapies to address unmet needs in pregnancy and neonatal medicine, where evidence gaps and treatment limitations have historically been significant.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "Drug Repurposing for Conditions Affecting Neonates and Pregnant Women (R01 - Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865.
• This funding opportunity was created on 2017-12-18.
• Applicants must submit their applications by 2021-05-07. (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.

Apply for PAR 18 506

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