Development of Standard Core Clinical Outcomes Assessments (COAs) and Endpoints (UG3/UH3 Clinical Trial Optional) | RFA FD 19 006

Opportunity Information: Apply for RFA FD 19 006

This grant opportunity, RFA-FD-19-006, comes from the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), and is aimed at improving how clinical trials measure and interpret patient outcomes. The core goal is to fund projects that develop publicly available, standardized core set(s) of Clinical Outcomes Assessments (COAs) and their related endpoints for specific disease indications. In practical terms, the FDA is seeking efforts that bring order and consistency to outcome measurement by defining which assessments should be used in a given disease area and how those assessments translate into well-defined endpoints that can be used across studies. By making these tools publicly available, the program is designed to help researchers, sponsors, clinicians, and regulators align on common measures, making results easier to compare and potentially speeding up clinical development and regulatory evaluation.

The funding mechanism is a cooperative agreement, meaning awardees should expect substantial involvement from the FDA during the life of the project. The program uses a two-phase UG3/UH3 structure, sometimes described as a planning-to-implementation pathway. The UG3 phase is the initial stage and lasts 1 to 2 years, focused on planning activities. This phase is meant to support foundational work such as organizing collaborations, refining the scientific approach, confirming feasibility, and building the detailed framework needed to successfully produce a credible core outcome set. A key feature is that the UG3 phase is milestone-driven: applicants propose concrete scientific milestones and feasibility benchmarks that must be met before moving forward.

If the UG3 planning phase is successful, projects can transition to the UH3 phase, which supports full implementation for an additional 3 to 4 years. Progression is not automatic. UH3 funding is contingent on an administrative review of the UG3 award’s performance, specifically whether the project met the proposed milestones and demonstrated the feasibility required to carry out the larger implementation plan. This structure is meant to reduce the risk of funding long projects that are not ready for execution by requiring early proof that the team, methods, and partnerships can deliver.

Applicants must submit a single application that covers both phases, with attention to the specific instructions for each phase described in the announcement. Even though it is one submission, the application is expected to clearly separate what will be done during the UG3 planning period versus what will be executed during the UH3 implementation period, including timelines and milestone criteria that define a successful transition. The total project period cannot exceed five years across both phases combined.

The opportunity is categorized under discretionary funding and falls broadly within food and nutrition, health, science and technology, and other research and development. The CFDA listing provided is 93.103. The FDA anticipated making around three awards, depending on available funds. The award ceiling listed is $1,400,000, indicating the maximum funding level expected per award under the program parameters.

Eligibility is intentionally broad, spanning many types of organizations that can credibly lead multi-stakeholder clinical measurement development efforts. Eligible applicants 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 both with and without 501(c)(3) status (as long as they are not institutions of higher education in those categories); for-profit organizations other than small businesses; small businesses; and other entities as allowed under the additional eligibility language referenced in the announcement.

Administratively, the announcement was created on February 20, 2019, with an original closing date of May 31, 2019. In summary, this FOA is essentially about building shared, disease-specific measurement standards for clinical research: selecting and validating core COAs, defining their associated endpoints, and ensuring those outputs are public and usable across trials. The two-step UG3/UH3 design emphasizes careful upfront planning and milestone-based readiness before committing to a longer implementation phase, while the cooperative agreement format signals an expectation of close coordination with the FDA throughout the project.

• The Department of Health and Human Services, Food and Drug Administration in the food and nutrition, health, science and technology and other research and development sector is offering a public funding opportunity titled "Development of Standard Core Clinical Outcomes Assessments (COAs) and Endpoints (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
• This funding opportunity was created on Feb 20, 2019.
• Applicants must submit their applications by May 31, 2019. (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 $1,400,000.00 in funding.
• The number of recipients for this funding is limited to 3 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 (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA FD 19 006

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: