RFA-HD-26-010
Maternal Medications and Human Milk Research Center (M2HMRC)
Summary
Maternal Medication and Human Milk Research Center (M2HMRC)
This is a Notice of Intent only — applications are not currently being accepted. NICHD plans to release a formal funding opportunity to establish a research center investigating how maternal medications alter human milk composition and affect neonatal and infant health outcomes. The center will operate as part of NICHD's Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub, integrating clinical, translational, and data science approaches to address critical gaps in pregnancy pharmacology and lactation pharmacology.
The M2HMRC will pursue four core aims: mapping knowledge gaps in medication safety during pregnancy and lactation; synthesizing real-world evidence with bioanalytical chemistry and chemical analysis data; creating tools to optimize medication safety and efficacy for nursing mothers and infants; and translating findings to clinicians and the public. Research will span maternal medications, human milk composition, neonatal health outcomes, and infant health outcomes, drawing on clinical translational research methods and real-world evidence frameworks. The center will coordinate closely with MPRINT's Knowledge and Research Coordinating Center to conduct large-scale, multi-institutional research.
- Who can apply: Institutions capable of managing cooperative agreements with complex, large-scale research structures (details on specific eligibility to follow in formal NOFO).
- Funding & project length: Not stated in this notice.
- Award mechanism: Cooperative agreement (U01).
- Key dates: Formal NOFO release date not specified; this notice allows time for collaboration development.
- Best fit for: Maternal-fetal medicine, pediatrics, pharmacology, and bioanalytical chemistry researchers with infrastructure for multi-site clinical and translational studies on medication safety in lactation.
Insights (6)
U01 Cooperative Agreement Demands Substantial Infrastructure and Multi-Disciplinary Integration
This is a U01 mechanism requiring a Maternal Medication and Human Milk Research Center with formal collaboration to NICHD's MPRINT Hub. Success requires demonstrated capacity in clinical research, bioanalytical chemistry, real-world evidence synthesis, and data science—not just single-discipline expertise. Applicants should position themselves as hub leaders capable of coordinating complex, multi-site activities and integrating diverse methodologies.
Mandatory Partnership with KRCC Creates Dependency and Coordination Requirements
The Center must collaborate with MPRINT's Knowledge and Research Coordinating Center (KRCC) for clinical, translational, and data science research. This is not optional collaboration but a structural requirement, meaning governance, data-sharing, and research prioritization will be negotiated with an external coordinating entity. Early engagement with KRCC leadership during the NOI phase is strategically essential.
NOI Status Means No Applications Currently Accepted; Timeline Remains Undefined
This is explicitly a Notice of Intent, not an active solicitation. The actual NOFO has not been published, and no applications are being accepted now. The stated purpose is to allow time for collaboration development, but no target publication date or application deadline is provided. Applicants should treat this as a 6–12 month planning window with significant uncertainty about final scope and requirements.
Real-World Evidence and Bioanalytical Chemistry Are Core Competitive Differentiators
The Center's mission explicitly integrates real-world evidence with chemical and bioanalytic data to address medication safety in lactation. Applicants with established capacity in pharmacokinetic analysis, milk composition measurement, or observational/registry-based clinical data will be more competitive than those relying solely on traditional RCT designs. Preliminary data demonstrating integration of these approaches strengthens positioning.
Large-Scale Cooperative Mechanism Suggests Limited Number of Awards
U01 cooperative agreements for research centers are typically high-budget, complex awards with small numbers of funded applications (often 1–3 nationally). The emphasis on 'large-scale research activities' and hub integration suggests this is a flagship initiative, not a broad-based program. Competition will be intense and limited to institutions with substantial research infrastructure.
Center Leadership Role Favors Established, Independently Funded Researchers
A U01 Center award requires demonstrated leadership capacity, existing research funding, and institutional support. Early-stage investigators (ESI) are unlikely to be competitive as principal investigators, though they may be valuable as co-investigators or project leaders within a larger team. This is a portfolio-building opportunity for mid-to-senior career researchers seeking to establish a research center.
Key Facts
Deadline
—
Posted
Mon, September 15, 2025
Expected Awards
1
Keywords
Research Areas
Gotchas (3)
This is a Notice of Intent (NOI) for a future funding opportunity, not an active solicitation. Applications are explicitly not being solicited at this time.
95%
Source Text
“Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.”
The mechanism will be a cooperative agreement, not a standard grant. This implies different award terms, reporting requirements, and potentially more intensive NIH involvement than typical R01/R21 mec
90%
Source Text
“This NOFO will support cooperative agreements involving large-scale research activities with complex structures.”
The Center must collaborate with MPRINT's Knowledge and Research Coordinating Center (KRCC). This is a mandatory partnership requirement that may constrain project design and governance.
85%
Source Text
“The Center will collaborate with MPRINT's Knowledge and Research Coordinating Center (KRCC) to conduct cutting-edge clinical, translational, and data science research.”