Translational Research in Maternal and Pediatric Pharmacology and Therapeutics (R01 Clinical Trial Optional)
Can you apply?
This grant is for researchers conducting translational and clinical research in maternal and pediatric pharmacology and therapeutics. Eligible applicants include academic institutions (HBCUs, Hispanic-serving institutions, tribal colleges), federal agencies, faith-based and community-based organizations, and non-domestic entities. The work must advance precision medicine for pregnant women, lactating women, neonates, and children through novel tools, improved therapeutics, or better understanding of drug mechanisms.
Research may be conducted nationally and internationally. Clinical trials are optional but supported. The grant supports development of novel technologies and therapeutics to improve medication safety and efficacy in vulnerable populations including those with disabilities.
This grant is for researchers conducting translational and clinical research in maternal and pediatric pharmacology and therapeutics. Eligible applicants include academic institutions (HBCUs, Hispanic-serving institutions, tribal colleges), federal agencies, faith-based and community-based organizations, and non-domestic entities. The work must advance precision medicine for pregnant women, lactating women, neonates, and children through novel tools, improved therapeutics, or better understanding of drug mechanisms.
Research may be conducted nationally and internationally. Clinical trials are optional but supported. The grant supports development of novel technologies and therapeutics to improve medication safety and efficacy in vulnerable populations including those with disabilities.
Program description
The purpose of this notice of funding opportunity (NOFO) is to support translational and clinical research to (1) advance precision medicine in pregnant women, lactating women, and children through the development of novel tools, models, and other technologies that could have a direct clinical or health impact; (2) enhance the understanding of the underlying mechanisms of drug action, including the role of pediatric ontogeny and the dynamic physiological changes that occur during pregnancy and lactation; and (3) discover and develop novel therapeutics or enhance the usage of existing drugs or drug repurposing for safer and more effective medications in pregnant and lactating women, neonates, and children. The overall goal is to improve safe and effective precision therapeutics for pregnant and lactating women, fetuses, neonates, and children, including those with disabilities.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Faith-based Organization
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
Details
This grant is for researchers conducting translational and clinical research in maternal and pediatric pharmacology and therapeutics. Eligible applicants include academic institutions (HBCUs, Hispanic-serving institutions, tribal colleges), federal agencies, faith-based and community-based organizations, and non-domestic entities. The work must advance precision medicine for pregnant women, lactating women, neonates, and children through novel tools, improved therapeutics, or better understanding of drug mechanisms.
Research may be conducted nationally and internationally. Clinical trials are optional but supported. The grant supports development of novel technologies and therapeutics to improve medication safety and efficacy in vulnerable populations including those with disabilities.
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) Application for Federal Assistance
- Project Narrative/Research Strategy
- Budget and Budget Justification
- Biographical Sketches (Key Personnel)
- Supporting Documents (letters of support, preliminary data, etc.)
- Facilities and Resources
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.279 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
-
$128,078,833
-
$126,585,435
-
$79,333,238
-
$78,351,755
-
$74,806,844
-
$71,588,047
-
$61,578,651
-
$50,344,757
-
$41,820,011
-
$39,479,041
Top States by Funding
- NY 4 awards $260.8M
- CT 2 awards $155.8M
- CA 3 awards $90.2M
- KY 1 awards $79.3M
- MA 1 awards $78.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
FAQ
Can international organizations apply?
Yes, non-domestic (non-U.S.) entities are eligible to apply for this grant.
What types of research activities are supported?
The grant supports translational research, clinical trials (optional), drug development, drug repurposing, and mechanistic studies of drug action in pregnancy, lactation, and pediatric populations.
Can I include clinical trial activities?
Yes, clinical trials are optional components. You can design your project to include or exclude clinical trial activities.
What makes a competitive application?
Strong applications clearly demonstrate how the research advances precision medicine, addresses specific gaps in drug safety or efficacy, and has potential clinical impact for the target populations.
Is there a specific funding amount I should request?
Award amounts are not specified in the NOFO. Follow standard NIH R01 guidance for your budget request.
💡 Tips for applicants
- Clearly explain how your research translates to clinical or health impact for pregnant women, lactating women, or children.
- Address the underlying mechanisms of drug action and how pediatric development or pregnancy/lactation physiology affects treatment outcomes.
- Consider whether a clinical trial component strengthens your proposal, even if optional.
- Use preliminary data to demonstrate feasibility and proof-of-concept for your novel tools or therapeutic approaches.
- Align your work with precision medicine principles and highlight how it improves medication safety and effectiveness.
⚠️ Common mistakes
Failing to clearly articulate clinical or health impact and relevance to the target populations. Insufficient preliminary data or inadequate justification for the proposed mechanisms of action. Neglecting to address how the research accounts for the unique physiological changes in pregnancy, lactation, or pediatric development.
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