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.Apply for RFA FD 19 006
- 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).
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Frequently Asked Questions (FAQs)
What is the name and identifier of this grant opportunity?
This opportunity is titled RFA-FD-19-006 and is issued by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
What is the main purpose of RFA-FD-19-006?
The 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. The intent is to improve consistency in how clinical trials measure and interpret patient outcomes so results can be compared more easily across studies.
What problem is the FDA trying to solve through this funding?
The program aims to bring order and consistency to outcome measurement in clinical research by defining which assessments should be used in a given disease area and how those assessments translate into well-defined endpoints. This alignment can make results more comparable across trials and may help speed clinical development and regulatory evaluation.
What are Clinical Outcomes Assessments (COAs) in the context of this opportunity?
Within the scope of this announcement, COAs refer to standardized assessments used to measure patient outcomes in clinical trials. The FOA focuses on identifying and developing core sets of COAs for particular disease indications and linking them to clear endpoints that can be used across studies.
What does it mean to develop a "core set" of COAs?
It means establishing a standardized, disease-specific set of outcome assessments that multiple studies can use consistently. The core set is intended to define what should be measured in a given disease area and to support shared expectations across researchers, sponsors, clinicians, and regulators.
What are "related endpoints" and why are they important here?
Endpoints are the defined outcomes used in clinical trials to evaluate results. This FOA emphasizes connecting COAs to well-defined endpoints so that the assessments translate into consistent, interpretable outcomes that can be used across studies in the same disease indication.
Are the outputs required to be publicly available?
Yes. A core feature of this program is developing tools (the standardized core COA set(s) and associated endpoints) that are publicly available and usable across trials.
Who is expected to benefit from the work supported by this program?
The FOA is designed to help researchers, sponsors, clinicians, and regulators align on common measures in specific disease areas, making study results easier to compare and potentially improving the efficiency of clinical development and regulatory evaluation.
What type of funding mechanism is used?
The funding mechanism is a cooperative agreement. This means awardees should expect substantial involvement from the FDA during the life of the project.
What does "substantial involvement from the FDA" imply for awardees?
Because this is a cooperative agreement, the FDA is expected to be actively involved with the project over time. Applicants should plan for close coordination with the FDA throughout the project period.
What is the UG3/UH3 structure described in this announcement?
This FOA uses a two-phase UG3/UH3 approach, often described as a planning-to-implementation pathway. The UG3 phase supports planning and feasibility work, and the UH3 phase supports full implementation if the UG3 phase is successful and approved to transition.
How long is the UG3 phase?
The UG3 phase lasts 1 to 2 years and focuses on planning activities.
What kinds of activities are expected during the UG3 (planning) phase?
The UG3 phase is intended to support foundational work such as organizing collaborations, refining the scientific approach, confirming feasibility, and building a detailed framework needed to produce a credible core outcome set.
Is the UG3 phase milestone-driven?
Yes. The UG3 phase is milestone-driven. Applicants propose concrete scientific milestones and feasibility benchmarks that must be met before the project can move forward to the UH3 phase.
How long is the UH3 phase?
The UH3 phase supports full implementation for an additional 3 to 4 years.
Is transition from UG3 to UH3 automatic?
No. Progression to UH3 is not automatic. UH3 funding depends on an administrative review of UG3 performance, including whether the proposed milestones were met and whether feasibility was demonstrated for the larger implementation plan.
What review determines whether a project can move from UG3 to UH3?
An administrative review is used to assess the UG3 award's performance. The review focuses on whether the project met the proposed milestones and demonstrated feasibility for successful implementation.
Why does this FOA use a two-phase design?
The two-phase design is meant to reduce the risk of funding long projects that are not ready for execution by requiring early proof (during UG3) that the team, methods, and partnerships can deliver before committing to the longer UH3 implementation phase.
Do applicants submit one application or separate applications for UG3 and UH3?
Applicants must submit a single application that covers both phases.
How should applicants present UG3 versus UH3 work in the application?
The application should 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.
What is the maximum total project period?
The total project period cannot exceed five years across both phases combined.
What is the CFDA listing for this opportunity?
The CFDA listing provided for this opportunity is 93.103.
How many awards did the FDA anticipate making?
The FDA anticipated making around three awards, depending on available funds.
What is the award ceiling for this program?
The award ceiling listed is $1,400,000, which indicates the maximum funding level expected per award under the program parameters.
What broad subject areas does this funding fall under?
The opportunity is categorized under discretionary funding and falls broadly within food and nutrition, health, science and technology, and other research and development.
Who is eligible to apply?
Eligibility is broad and includes: 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 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.
Are small businesses eligible?
Yes. Small businesses are explicitly listed as eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed separately as eligible.
Are nonprofits without 501(c)(3) status eligible?
Yes. Nonprofit organizations without 501(c)(3) status are listed as eligible, as long as they are not institutions of higher education in those categories.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized Native American tribal governments and other tribal organizations are included in the eligible applicant categories.
Are institutions of higher education eligible?
Yes. Both public and state-controlled institutions of higher education and private institutions of higher education are eligible.
What was the posting (created) date for the announcement?
The announcement was created on February 20, 2019.
What was the original closing date?
The original closing date listed was May 31, 2019.
In simple terms, what is this FOA asking teams to produce?
It is asking teams to build shared, disease-specific measurement standards for clinical research by selecting and validating core COAs, defining the associated endpoints, and making those outputs public and usable across clinical trials.
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