Opportunity Information: Apply for RFA FD 21 004
This grant opportunity from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA) seeks proposals to create standardized, publicly available core sets of Clinical Outcome Assessments (COAs) and the endpoints derived from those COAs. The intent is to improve consistency in how clinical benefit is measured in studies, especially for specific disease indications and for disease impacts that show up across multiple rare diseases with similar phenotypes. In practical terms, the funding supports efforts to define which outcomes should be measured, how they should be measured, and how those measures should be translated into credible endpoints that can be used across studies so results are comparable and more useful for decision-making.
The award mechanism is a UG3/UH3 cooperative agreement, meaning funded teams should expect substantial scientific and programmatic involvement from the FDA compared with a typical grant. The project is structured in two connected phases that are submitted together as a single application. The first phase, UG3, lasts 1 to 2 years and is focused on planning and laying the groundwork. This stage is meant for preparatory activities such as building stakeholder alignment, refining the conceptual framework for what should be measured, selecting or refining candidate COAs, determining data standards, and setting clear, measurable milestones that demonstrate readiness to move into full implementation. The second phase, UH3, lasts 3 to 4 years and supports projects that successfully complete the UG3 planning work and meet the predefined milestones. Transition to UH3 is not automatic; it depends on an administrative review confirming that the UG3 milestones were met and that the proposed implementation is feasible and scientifically justified. The total project period across both phases cannot exceed five years.
The overall deliverable emphasized by the announcement is a core outcome set (or sets) that is publicly accessible and that includes not only the COAs themselves but also their associated endpoints. This focus on standardization and public availability is meant to reduce fragmentation across trials, strengthen evidence quality, and speed progress by giving researchers and developers a shared toolkit for measuring outcomes in a way that is meaningful and reproducible. While the funding language is oriented toward rare diseases and cross-cutting impacts across rare conditions, the key theme is creating harmonized measurement approaches that can be broadly adopted by the field.
The opportunity is listed as discretionary funding under the category of consumer protection, health, science and technology, and other research and development (CFDA 93.103). Eligibility is broad and includes state, county, and special district governments; public and private institutions of higher education; federally recognized 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 entities as described in the announcement’s additional eligibility guidance. This wide eligibility suggests the FDA is open to applications from academic consortia, nonprofit research groups, patient-focused organizations, and industry or mixed partnerships, provided the proposed work is aligned with the FOA’s goal of producing standardized COAs and endpoints.
Key administrative details include the funding opportunity number RFA-FD-21-004, a creation date of July 9, 2020, and an original closing date of October 14, 2020. The stated award ceiling is $1,400,000, and the FDA anticipated making about three awards, although the final number is explicitly dependent on the availability of funds. Overall, the program is designed to fund a small number of milestone-driven projects that can deliver field-ready, public standards for outcome measurement, with a built-in go/no-go transition between planning and implementation to ensure that only well-validated, feasible projects move into the later phase.Apply for RFA FD 21 004
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, 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 Jul 09, 2020.
- Applicants must submit their applications by Oct 14, 2020. (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, 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).
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| Physiologically-based pharmacokinetic (PBPK) models to aid the development of generic dermatological products (U01) Clinical Trials Optional Apply for RFA FD 21 013 Funding Number: RFA FD 21 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Development of Methods to Evaluate the Impact of Design Differences to the User Interface of Generic Drug-Device Combination Products in Comparison to their Reference Listed Drugs (U01) Clinical Trials Optional Apply for RFA FD 21 014 Funding Number: RFA FD 21 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Cutaneous pharamcokinetic-based approaches to establish bioequivalence of topically applied drug products Apply for RFA FD 22 017 Funding Number: RFA FD 22 017 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $1,500,000 |
| Investigating the in vivo behavior and in vitro characteristics purportedly gastro-retentive extended release formulation to enhance the regulatory standard of such products Apply for RFA FD 22 018 Funding Number: RFA FD 22 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery (U01) Clinical Trial Optional Apply for RFA FD 22 016 Funding Number: RFA FD 22 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $600,000 |
| In Vitro Based Approaches to Evaluate the Bioequivalence of Generic Rectal and Vaginal Products Apply for RFA FD 22 014 Funding Number: RFA FD 22 014 Agency: Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Development of advanced analytical methods for the characterization of complex generics Apply for RFA FD 22 013 Funding Number: RFA FD 22 013 Agency: Food and Drug Administration Category: Consumer Protection, Health, Science and Technology and other Research and Development Funding Amount: $300,000 |
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