Innovative Screening Approaches and Therapies for Screenable Disorders in Newborns (R01 – Clinical Trial Optional)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Jul 16, 2026
Can you apply?
This grant is for NIH-funded research on innovative screening and therapeutic approaches for newborn screenable disorders. Eligible applicants include doctoral-degree-holding researchers, established research institutions (universities, medical centers, independent research institutes), and organizations with DUNS numbers and active NIH institutional infrastructure. Research projects must focus on developing, validating, or improving screening methodologies or therapeutic interventions for genetic, metabolic, functional, or other conditions detectable through newborn screening. Applicants must demonstrate institutional support, access to research facilities, and capability to conduct the proposed research. The geographic scope is nationwide, and both domestic and some international research sites may be included. Grant funding supports direct research costs including personnel, equipment, supplies, and clinical trial expenses if applicable.
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Program description
This FOA encourages research relevant to the development of novel screening approaches and/or therapeutic interventions for potentially fatal or disabling conditions that have been identified through newborn screening, as well as for “high priority” genetic conditions where screening may be possible in the near future.Having an accurate screening test, as well as demonstrating the benefits of early intervention or treatment, are important criteria for including a condition on a newborn screening panel. This FOA defines a “high priority” condition as one where screening is not currently recommended, but infants with the condition would significantly benefit from early identification and treatment.
Who can apply
Eligible applicants
- 501(c)(3) Public Charity
- City / Municipal Government
- County Government
- Hospital
- Nonprofits
- Private University
- Public Authority
- Public K-12 School
- Public University
- Researcher (independent)
- Small Business (SBA-defined)
- Special District
- State Government
- Tribal Nation
- Tribal Organization
Demographic focus
How to apply
Application links
Required documents
- SF-424 (R&R) form and SF-424 Cover Sheet
- Project Narrative (specific aims, background, significance, innovation, approach, timeline)
- Budget and Budget Justification (direct costs, personnel, equipment, supplies, travel)
- Biographical Sketches (4-5 pages per key personnel, emphasis on PI)
- Institutional Support Letter and Facilities/Equipment Description
- IRB/IACUC Approval letters (if human subjects or animal research involved)
- Letters of Collaboration/Support from partner institutions
- Data Management and Sharing Plan
- Publication Plan (if applicable)
- Vertebrate Animals section (if applicable)
- Research Strategy (aims, background, innovation, approach sections)
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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$1,073,967,938
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$719,372,575
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$276,059,721
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$155,556,396
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$155,482,198
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$103,665,364
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$74,151,078
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$72,701,366
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$52,238,426
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$47,450,377
Top States by Funding
- WA 1 awards $1,074.0M
- NC 7 awards $925.9M
- MD 4 awards $501.6M
- 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
Who is eligible to apply for this R01 grant?
Eligible applicants include domestic and foreign research institutions, public/private non-profit organizations, for-profit organizations, small businesses, and state/local government entities. Principal Investigators must have a doctoral degree (Ph.D., M.D., or equivalent) and demonstrated research experience in the relevant field.
What types of research are supported?
This grant supports innovative research on screening approaches and therapies for newborn-detectable disorders, including development of screening methodologies, therapeutic interventions, diagnostic improvements, and clinical trials related to these conditions.
What is the typical funding range and project duration?
R01 grants typically support 3-5 year projects. Funding amounts vary but commonly range from $100,000-$500,000+ in direct costs depending on the project scope and complexity.
What is the application deadline?
The next fixed deadline is November 16, 2027, with applications accepted starting December 2, 2024. Multiple submission windows may be available; check NIH Grants.gov for rolling deadlines.
How competitive is this funding?
NIH R01s are highly competitive with success rates typically 15-25%. Strong preliminary data, clear innovation, experienced teams, and rigorous methodology significantly strengthen applications.
💡 Tips for applicants
- Establish strong preliminary data demonstrating feasibility of your screening or therapeutic approach before submission; reviewers expect proof-of-concept results for innovative work.
- Build a multidisciplinary team with complementary expertise in screening science, pediatrics, molecular/genetic testing, and clinical outcomes to strengthen your application's credibility.
- Clearly articulate the unmet clinical need and public health impact of your proposed approach; explain why current screening or therapeutic methods are insufficient.
- If proposing a clinical trial component, develop a robust protocol with appropriate statistical power, recruitment feasibility, and outcome measures that align with current NIH clinical trial standards.
- Address potential barriers to implementation and dissemination early in your narrative; reviewers want to understand how your innovation will translate into clinical or public health practice.
⚠️ Common mistakes
Many R01 applications for screening research lack sufficient preliminary data or proof-of-concept results, leading to reviewer concerns about feasibility. Applications often underestimate the complexity of clinical trial implementation or fail to provide adequately detailed protocols for proposed clinical studies. Weak sections on innovation or public health significance—failing to clearly explain why the proposed approach is better than existing methods—are common reasons for rejection in this competitive funding mechanism.
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