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.Apply for PAR 18 506
- 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.
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Frequently Asked Questions (FAQs)
What is the name and funding opportunity number of this NIH opportunity?
The opportunity is titled "Drug Repurposing for Conditions Affecting Neonates and Pregnant Women (R01 - Clinical Trial Optional)" and the Funding Opportunity Number is PAR-18-506.
What is the main goal of this funding opportunity?
The goal is to support research that evaluates drugs that are already approved by the U.S. Food and Drug Administration (FDA) for new uses in neonatal and obstetric care. The underlying intent is to speed up access to better treatments for newborns and pregnant women by leveraging medications with existing safety and manufacturing histories.
What types of drugs are in scope for the research?
This FOA focuses on repurposing drugs that are already FDA-approved. The research is centered on evaluating those approved drugs for different (new) neonatal or obstetric indications rather than developing entirely new drugs from scratch.
Which patient populations does the FOA focus on?
The FOA is focused on conditions affecting neonates (newborns) and pregnant women, targeting unmet needs in pregnancy and early life where evidence gaps and treatment limitations have historically been significant.
Why does NIH emphasize drug repurposing for neonates and pregnant patients?
Neonates and pregnant patients are often excluded from traditional drug development pathways, which can slow progress in developing evidence-based therapies for these populations. Repurposing FDA-approved drugs can help overcome scientific, ethical, and practical barriers by building on existing data and manufacturing experience.
What grant mechanism does this opportunity use?
This funding opportunity uses the NIH R01 grant mechanism, which is intended to support substantial, hypothesis-driven research projects.
What does "Clinical Trial Optional" mean for this FOA?
"Clinical Trial Optional" means applicants may propose either (1) preclinical and translational research that prepares a repurposed drug for a new indication, or (2) a project that includes a clinical trial, if a clinical trial is appropriate for the research questions and the readiness of the intervention.
Does an application have to include a clinical trial to be responsive?
No. The FOA is labeled clinical trial optional, so a clinical trial is not required. Applicants can propose preclinical or translational work, or include a clinical trial when appropriate.
What kinds of research activities are mentioned as relevant to repurposing in pregnancy and neonates?
The FOA highlights research that can establish whether an approved drug can be safely and effectively used for a different neonatal or obstetric indication. Examples of areas specifically noted include dosing considerations, formulation considerations, pharmacokinetics, pharmacodynamics, and evaluation of clinical outcomes, which are especially important in pregnancy and newborns.
What is the assistance listing / CFDA number and category?
The program is described as an NIH discretionary grant in the health category with CFDA 93.865.
Who is eligible to apply as an applicant organization?
A wide range of organization types are eligible, including 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 multiple levels of government (state, county, city/township, special district).
Are tribal governments and tribal organizations eligible to apply?
Yes. Eligibility includes Native American tribal governments (federally recognized) and tribal organizations (other than federally recognized tribal governments). The FOA also explicitly encourages tribal governments that are not federally recognized to apply.
Are independent school districts eligible?
Yes. Independent school districts are listed among eligible applicant organizations.
Are public housing authorities or Indian housing authorities eligible?
Yes. Public or Indian housing authorities are listed among eligible applicant organizations.
Which additional applicant categories does NIH explicitly encourage to apply?
The FOA explicitly highlights and encourages applications from 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.
Can a non-U.S. (foreign) organization apply as the primary applicant?
No. Non-domestic (non-U.S.) entities and non-domestic institutions are not eligible to apply as applicant organizations under this FOA.
Can a non-domestic component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are also not eligible to apply as the applicant.
Are foreign components allowed at all under this FOA?
Yes. Although foreign organizations cannot be the primary applicant, a U.S.-based applicant may include "foreign components" when they meet the NIH Grants Policy Statement definition and are justified and compliant with NIH policy.
When was this FOA created and what closing date is listed?
The FOA was created on December 18, 2017, and it lists an original closing date of May 7, 2021.
Does the provided information specify an award ceiling (maximum award amount)?
No. The excerpted information states that the publicly provided fields do not specify an award ceiling.
Does the provided information specify how many awards NIH expects to make?
No. The excerpted information notes that the expected number of awards is not specified in the publicly provided fields.
What is the overall program rationale in plain terms?
The program aims to move faster than traditional drug development by testing new uses for already-approved therapies in pregnancy and neonatal medicine, helping generate more evidence-based treatments for populations that have historically been underserved in clinical research.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 18 506) also looked into and applied for these:
| Funding Opportunity |
|---|
| Discovery of Molecular Targets for Pregnancy-Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (R01 - Clinical Trial Optional) Apply for PAR 18 511 Funding Number: PAR 18 511 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Human-Animal Interaction (HAI) Research (R21 - Clinical Trial Optional) Apply for PAR 18 650 Funding Number: PAR 18 650 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $200,000 |
| Human-Animal Interaction (HAI) Research (R03 - Clinical Trial Optional) Apply for PAR 18 649 Funding Number: PAR 18 649 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| Developmental Pharmacodynamics and Models of Drug Effects in Pediatrics (R03 Clinical Trial Optional) Apply for PA 18 687 Funding Number: PA 18 687 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| Innovative Therapies and Tools for Screenable Disorders (R01 Clinical Trial Optional) Apply for PAR 18 689 Funding Number: PAR 18 689 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Innovative Therapies and Tools for Screenable Disorders (R03 Clinical Trial Optional) Apply for PAR 18 690 Funding Number: PAR 18 690 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| Innovative Therapies and Tools for Screenable Disorders (R21 Clinical Trial Optional) Apply for PAR 18 691 Funding Number: PAR 18 691 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $200,000 |
| Developmental Pharmacodynamics and Models of Drug Effects in Pediatrics (R01 Clinical Trial Optional) Apply for PA 18 688 Funding Number: PA 18 688 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Reproductive Scientist Development Program (RSDP) (K12 Clinical Trial Not Allowed) Apply for RFA HD 18 103 Funding Number: RFA HD 18 103 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $920,000 |
| Small Research Grants for Establishing Basic Science-Clinical Collaborations to Understand Structural Birth Defects (R03 - Clinical Trial Not Allowed) Apply for PAR 18 734 Funding Number: PAR 18 734 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $75,000 |
| Small Research Grants for Analyses of Data for the Gabriella Miller Kids First Data Resource (R03 - Clinical Trial Not Allowed) Apply for PAR 18 733 Funding Number: PAR 18 733 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $200,000 |
| Identification and Management of Behavioral Symptoms and Mental Health Conditions in Individuals with Intellectual Disabilities (R01 - Clinical Trial Optional) Apply for PAR 18 766 Funding Number: PAR 18 766 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Patient Safety in the Context of Perinatal, Neonatal, and Pediatric Care (R01 - Clinical Trial Optional) Apply for PA 18 790 Funding Number: PA 18 790 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Patient Safety in the Context of Perinatal, Neonatal, and Pediatric Care (R03 - Clinical Trial Optional) Apply for PA 18 791 Funding Number: PA 18 791 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $50,000 |
| Rare Genetic Syndromes as a Window into the Genetic Architecture of Mental Disorders (Collaborative U01 Clinical Trial Not Allowed) Apply for RFA MH 19 201 Funding Number: RFA MH 19 201 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Rare Genetic Syndromes as a Window into the Genetic Architecture of Mental Disorders (U01 Clinical Trial Not Allowed) Apply for RFA MH 19 200 Funding Number: RFA MH 19 200 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| Immune Mechanisms at the Maternal-Fetal Interface (R01 Clinical Trial Optional) Apply for RFA AI 18 023 Funding Number: RFA AI 18 023 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: Case Dependent |
| The Role of Epitranscriptomics in Development and Disease (R21 - Clinical Trial Not Allowed) Apply for PAR 18 831 Funding Number: PAR 18 831 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $200,000 |
| Development of Novel Nonsteroidal Contraceptive Methods (R61/R33 - Clinical Trial Not Allowed) Apply for RFA HD 19 015 Funding Number: RFA HD 19 015 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $500,000 |
| Enhancing Developmental Biology Research at Academic Research Enhancement Award Eligible Institutions (R15 - Clinical Trial Not Allowed) Apply for PAR 18 834 Funding Number: PAR 18 834 Agency: National Institutes of Health Category: Health, Income Security and Social Services Funding Amount: $300,000 |
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