Opportunity Information: Apply for RFA HG 27 013
Apply for RFA HG 27 013
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "GREGoRi Innovation Projects (U01 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.172.
- This funding opportunity was created on 2026-06-18.
- Applicants must submit their applications by 2026-10-30. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $500,000.00 in funding.
- The number of recipients for this funding is limited to 10 candidate(s).
- 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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Opportunity Summary:
The GREGoRi Innovation Projects (U01 Clinical Trial Optional) funding opportunity (RFA-HG-27-013) is a National Institutes of Health (NIH) cooperative agreement designed to push rare disease diagnosis forward in a major way. It sits under the Genomics Research to Elucidate the Genetics of Rare Diseases innovation (GREGoRi) initiative, which is focused on speeding up a real shift in how researchers and clinicians pinpoint the underlying genetic causes of rare disorders. Instead of making incremental improvements to existing workflows, this NOFO emphasizes rethinking the core tools, molecular technologies, and analytical methods used to identify the causal gene(s) and/or variant(s) responsible for rare genetic disease. The central idea is to support projects that could noticeably change what is considered possible or practical in the current state of the art for rare disease diagnosis.
The program is specifically aimed at the development and testing of highly innovative experimental and/or computational approaches. In practice, that means applicants are expected to propose methods that go beyond routine sequencing-and-interpretation pipelines and could meaningfully improve diagnostic yield, accuracy, speed, or interpretability for rare disease cases that remain unsolved. The opportunity also allows for clinical trial activity if relevant, but a clinical trial is not required (as indicated by the "Clinical Trial Optional" designation). Because the award mechanism is a U01 cooperative agreement, recipients should anticipate a more collaborative and interactive relationship with NIH compared with standard research project grants, typically involving substantial federal involvement in project oversight, milestones, and coordination.
Eligibility is broad and includes many types of U.S. domestic organizations as well as international applicants. Eligible applicants listed in the opportunity include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities, excluding institutions of higher education in those specific nonprofit categories as stated); for-profit organizations other than small businesses; small businesses; and other entities. Importantly, non-U.S. participation is explicitly permitted: non-domestic (non-U.S.) entities (foreign organizations) may apply, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement. Applicants are directed to consult Section III (Eligibility Information) of the full NOFO for the official requirements and any conditions or documentation expectations.
From a funding and timing standpoint, the opportunity is categorized as discretionary funding and falls under the health activity category, with CFDA number 93.172. NIH expects to make around 10 awards under this announcement. The award ceiling is listed as $500,000, which indicates the maximum amount of funding anticipated per award (with exact budgets depending on NIH policies and the specific project scope as proposed and negotiated). The original application closing date is October 30, 2026, and the opportunity record shows a creation date of June 18, 2026, which helps situate it in the NIH funding calendar.
Overall, this NOFO is best viewed as a call for bold, testable ideas that could materially improve rare disease gene and variant discovery, especially in the difficult-to-diagnose cases that persist even after standard genomic testing. It is positioned to support projects that combine creativity with a clear plan for development and validation, with the goal of producing diagnostic approaches that could ultimately be adopted or adapted broadly across the rare disease research and clinical diagnostic landscape.
GREGoRi Innovation Projects (U01 Clinical Trial Optional) (RFA-HG-27-013) - FAQs
What is this funding opportunity?
This opportunity is the GREGoRi Innovation Projects (U01 Clinical Trial Optional) funding opportunity announcement (NOFO), RFA-HG-27-013, issued by the National Institutes of Health (NIH). It is a cooperative agreement intended to drive major advances in rare disease diagnosis by supporting highly innovative projects.
What does GREGoRi stand for and what is the initiative about?
GREGoRi refers to Genomics Research to Elucidate the Genetics of Rare Diseases innovation. The initiative focuses on speeding up a real shift in how researchers and clinicians identify the underlying genetic causes of rare disorders, especially for cases that remain unsolved after standard approaches.
What is the main goal of the program?
The main goal is to support projects that could materially improve what is currently possible or practical in rare disease diagnosis by rethinking core tools, molecular technologies, and analytical methods used to identify causal gene(s) and/or variant(s).
What kinds of projects is NIH looking for under this NOFO?
The NOFO emphasizes development and testing of highly innovative experimental and/or computational approaches. Applicants are expected to propose methods that go beyond routine sequencing-and-interpretation pipelines and that could meaningfully improve diagnostic yield, accuracy, speed, or interpretability for rare disease cases that remain unsolved.
Is incremental improvement of existing workflows a good fit?
Based on the description, the emphasis is on rethinking and redesigning core approaches rather than making incremental improvements to existing workflows. Projects should aim for noticeable, meaningful advances beyond the current state of the art.
Are clinical trials required for this opportunity?
No. The NOFO is labeled "Clinical Trial Optional," meaning clinical trial activity is allowed if relevant, but a clinical trial is not required.
What does "U01 cooperative agreement" mean for awardees?
A U01 is a cooperative agreement mechanism. Recipients should expect a more collaborative and interactive relationship with NIH than with standard research project grants, typically including substantial federal involvement in project oversight, milestone expectations, and coordination activities.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. domestic organizations as well as international applicants. Eligible applicants listed include: state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations (including both 501(c)(3) and non-501(c)(3) entities, excluding institutions of higher education in those specific nonprofit categories as stated); for-profit organizations other than small businesses; small businesses; and other entities.
Are non-U.S. (foreign) organizations allowed to apply?
Yes. Non-domestic (non-U.S.) entities (foreign organizations) may apply. In addition, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed as defined in the NIH Grants Policy Statement.
Where should applicants confirm official eligibility requirements?
Applicants are directed to consult Section III (Eligibility Information) of the full NOFO for the official requirements, including any conditions and documentation expectations.
What is the program trying to improve in rare disease diagnosis?
The program aims to improve rare disease diagnosis in ways that can increase diagnostic yield, accuracy, speed, and interpretability, particularly for difficult-to-diagnose cases that persist even after standard genomic testing.
What is the activity category and assistance listing information provided?
The opportunity is categorized as discretionary funding and falls under the health activity category. The CFDA number listed is 93.172.
How many awards does NIH expect to make?
NIH expects to make around 10 awards under this announcement.
What is the maximum award amount?
The award ceiling is listed as $500,000, indicating the maximum amount of funding anticipated per award. Exact budgets depend on NIH policies and the project scope as proposed and negotiated.
When is the application due?
The original application closing date is October 30, 2026.
When was the opportunity record created?
The opportunity record shows a creation date of June 18, 2026.
What is the best overall way to interpret the intent of this NOFO?
This NOFO is best viewed as a call for bold, testable ideas that could materially improve rare disease gene and variant discovery, especially for unsolved cases after standard genomic testing. It is positioned to support projects that combine creativity with a clear plan for development and validation, with the aim that successful diagnostic approaches could ultimately be adopted or adapted broadly across rare disease research and clinical diagnostic landscapes.
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| Model-to-Clinic (M2C) for Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) (UG3/UH3, Clinical Trial Optional) Apply for RFA RM 27 013 Funding Number: RFA RM 27 013 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
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