GREGoRi Technology Integration Center (U01, Clinical Trials Optional) | Apply Online

Frequently Asked Questions (FAQs)

What is the GREGoRi Technology Integration Center funding opportunity?

The GREGoRi Technology Integration Center opportunity is an NIH cooperative agreement (U01; clinical trials optional) that supports the creation of a single, centralized Center to modernize and standardize how rare disease researchers and clinicians identify the gene(s) and variant(s) responsible for rare genetic conditions.

What initiative is this opportunity part of?

This opportunity sits within the broader Genomics Research to Elucidate the Genetics of Rare Diseases innovation initiative (GREGoRi). The initiative is focused on creating a step-change in diagnostic capability for rare diseases by rethinking and validating tools, molecular technologies, and analytical methods used in rare disease genomics.

What is the main purpose of establishing a Technology Integration Center?

The central purpose is to establish one GREGoRi Technology Integration Center that acts as a hub for developing standards and best practices for using new and emerging molecular methods in rare disease diagnosis. The Center is expected to address the integration work that often slows adoption of promising technologies, including defining data generation practices, quality assessment approaches, analysis and comparison methods, and result interpretation practices that support diagnosis.

How many awards does this NOFO expect to make?

The NOFO anticipates making one award, reflecting the goal of building a single, well-resourced Center that can deliver field-wide value through coordination, standard-setting, and resource generation.

What is the maximum award amount (award ceiling)?

The award ceiling is $2,250,000.

What is the application deadline?

The application closing date is October 30, 2026.

What is the NOFO number for this opportunity?

The opportunity is listed as RFA-HG-27-012.

Which NIH activity type is used for this award?

This funding opportunity uses a U01 cooperative agreement mechanism, with clinical trials optional.

What does it mean that this is a cooperative agreement (U01)?

Because the mechanism is a cooperative agreement (U01), NIH will have substantial programmatic involvement. Awardees should expect active coordination with NIH staff, milestone-driven progress expectations, and collaboration patterns typical of large, community-facing infrastructure efforts.

Are clinical trials required?

No. Clinical trials are optional under this opportunity.

What kinds of outputs or deliverables are required?

A major required deliverable is a multidimensional dataset intended to serve as a resource for method development and benchmarking. In addition, the Center is expected to develop standards and best practices that enable consistent and reliable application of new molecular and analytical approaches across the rare disease genomics field.

What is the purpose of the required multidimensional dataset?

The dataset is intended to help the broader community develop and fairly compare novel tools and strategies that improve rare disease diagnosis, particularly for cases that remain unresolved or are not well served by standard approaches.

What does "benchmarking-ready dataset" imply about the dataset quality and structure?

The emphasis on a benchmarking-ready dataset signals that the data should be scientifically valuable and also structured and curated well enough for repeated use in evaluating performance, reproducibility, and real-world utility of emerging diagnostic approaches.

What types of methods or technologies is the Center expected to focus on?

The Center is expected to focus on new and emerging molecular methods and the associated analytical methods used in rare disease diagnosis, including how those methods are validated, compared, and interpreted so they can be used consistently and reliably across the field.

Is the program aiming for incremental improvements or major advances?

The GREGoRi initiative is explicitly focused on creating a step-change in diagnostic capability, not just incremental improvement, by rethinking and validating tools and approaches used in rare disease genomics.

Who is eligible to apply?

Eligibility is broad across many U.S.-based organization types, including 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; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other eligible entities described in the NOFO.

Can non-U.S. (foreign) organizations apply?

No. Non-U.S. entities (foreign organizations) cannot apply under this opportunity.

Can a U.S. organization apply if it has non-U.S. components?

Non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components (as defined in the NIH Grants Policy Statement) are allowed, which generally means a U.S. applicant may include well-justified international collaborations or elements consistent with NIH policy, as long as they are appropriately described and budgeted.

What is the CFDA number and classification listed for this opportunity?

The opportunity is listed with CFDA 93.172 and described as a discretionary funding category with a health-related activity classification.

How will success for the Center be measured, based on the NOFO description?

Success is framed around both scientific and practical outcomes: producing clear best practices and standards that enable community adoption and trust of emerging approaches, and generating a high-value benchmarking dataset that accelerates tool-building, comparison, and improved diagnostic yield for patients with rare genetic disorders.

What problem is the Center intended to solve for the field?

The Center is intended to solve the "integration gap" that often slows uptake of promising technologies by defining consistent approaches for data generation, quality assessment, analysis, comparison, and interpretation so newer methods can be applied reliably across rare disease genomics research and diagnosis.

Why does the NOFO emphasize standards and best practices?

The emphasis reflects the goal of making newer molecular and analytical approaches usable in routine diagnostic contexts by creating consistent, reliable practices for generating and evaluating data and for interpreting results in ways that support diagnosis.