Natural History of Disorders Screenable in the Newborn Period (R01 Clinical Trial Optional)
Can you apply?
This grant is for research expanding knowledge of disorders screened in newborn screening programs. Eligible applicants include 501(c)(3) nonprofits, research institutions, HBCUs, tribal organizations, and federal agencies. Projects must focus on the natural history of conditions currently or potentially included in statewide newborn screening. Both domestic and foreign organizations may apply with appropriate sponsorship or partnerships.
This grant is for research expanding knowledge of disorders screened in newborn screening programs. Eligible applicants include 501(c)(3) nonprofits, research institutions, HBCUs, tribal organizations, and federal agencies. Projects must focus on the natural history of conditions currently or potentially included in statewide newborn screening. Both domestic and foreign organizations may apply with appropriate sponsorship or partnerships.
Program description
The purpose of this Notice of Funding Opportunity (NOFO) encourages applications that will expand knowledge of the natural history of disorders that currently are, or may become, part of statewide newborn screening programs. A comprehensive understanding of the natural history of a condition is necessary to facilitate appropriate interventions for infants identified by newborn screening. Characterization of the sequence and timing of symptom development provides information crucial for developing targeted, age-appropriate treatments and for establishing a baseline against which to assess novel interventions. In addition, for some conditions, establishment of genotype-phenotype correlations may facilitate prediction of the clinical course; for others, identification of modifying genetic, epigenetic, or environmental factors may enhance understanding of clinical outcomes. Comprehensive data on the natural history of a condition will facilitate the fields ability to: 1) identify the underlying biological mechanisms; 2) understand the genetic and clinical heterogeneity and phenotypic expression of the condition; 3) improve diagnostic accuracy; 4) facilitate clinical trials by providing comprehensive natural history data; 5) prevent, manage, and treat symptoms and complications of the condition; 6) furnish physicians and families with needed support and predictive information about the condition; and 7) establish data collection systems or patient registries to collect longitudinal data (e.g., child/family outcomes following newborn screening).
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Small Business (SBA-defined)
- Special District
- State Government
- TCU (Tribal Colleges)
- Tribal Nation
- Tribal Organization
Demographic focus
Details
This grant is for research expanding knowledge of disorders screened in newborn screening programs. Eligible applicants include 501(c)(3) nonprofits, research institutions, HBCUs, tribal organizations, and federal agencies. Projects must focus on the natural history of conditions currently or potentially included in statewide newborn screening. Both domestic and foreign organizations may apply with appropriate sponsorship or partnerships.
How to apply
Application links
Required documents
- SF-424 R&R (NIH Application Form)
- Project Narrative/Research Strategy
- Specific Aims
- Significance and Innovation sections
- Research Design and Methods
- Budget and Budget Justification
- Biographical Sketches (Key Personnel)
- NIH Biographical Sketch Form (SciENcv)
- Letters of Support (from collaborating institutions/programs)
- Data Management and Sharing Plan
- Clinical Trial Protocol (if applicable)
Program contact
- 👤 National Institutes of Health
- 📧 grantsinfo@nih.gov
- 📞 301-402-2541
Funding track record
Recent awards under CFDA 93.865 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$1,059,454,555
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$719,372,575
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$276,059,721
-
$155,556,396
-
$155,482,198
-
$103,665,364
-
$74,151,078
-
$71,490,911
-
$52,238,426
-
$47,450,377
Top States by Funding
- WA 1 awards $1,059.5M
- NC 7 awards $921.5M
- MD 4 awards $493.9M
- MA 3 awards $190.0M
- PA 3 awards $145.1M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.865). How funding has trended year over year.
| 2024 | $1,282,226,682 | |
| 2025 | $1,333,391,690 | |
| 2026 est. | $184,920,723 |
FAQ
What types of research does this grant support?
Studies examining the natural history of newborn screening disorders, including symptom development, genotype-phenotype correlations, and identification of modifying factors. Clinical trials are optional.
Who is eligible to apply?
Research institutions, nonprofits, HBCUs, tribal colleges, faith-based organizations, federal agencies, and designated minority-serving institutions. Foreign organizations may apply under certain conditions.
When is the deadline?
The fixed deadline is January 7, 2028. Applicants should submit well in advance to allow processing time.
What must a competitive application include?
Clear research aims addressing natural history gaps, longitudinal data collection plans, established registries or cohorts, and clinical significance for newborn screening programs.
What is the typical funding level?
NIH R01 grants typically range from $250,000 to $500,000+ annually, but award amounts vary by project scope and review outcomes.
💡 Tips for applicants
- Clearly identify which newborn screening disorder(s) your project addresses and explain current knowledge gaps in their natural history.
- Design longitudinal data collection systems or build on existing patient registries to strengthen your application competitively.
- Include multidisciplinary teams with expertise in genetics, clinical care, family support, and data management.
- Emphasize how your natural history findings will directly facilitate clinical trials and intervention development for affected infants.
- Demonstrate partnerships with state newborn screening programs and family advocacy organizations to ensure real-world relevance.
⚠️ Common mistakes
Proposing descriptive studies without clear mechanisms to improve clinical outcomes or intervention development. Failing to establish longitudinal follow-up plans or partnerships with screening programs that limit the scope and impact of findings. Underestimating the complexity of genotype-phenotype correlation analyses or failing to account for genetic and environmental heterogeneity.
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