Opportunity Information: Apply for RFA FD 23 025
The FDA funding opportunity titled "Supporting the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional" (Funding Opportunity Number RFA-FD-23-025) is a discretionary research and development grant that uses a cooperative agreement mechanism (U01). Its central aim is to support work that advances the FDA Real-World Evidence (RWE) Program by exploring, testing, and demonstrating how real-world data (RWD) can be used to generate reliable real-world evidence that the FDA can consider in regulatory decision-making. In practical terms, the opportunity is designed to help the FDA evaluate when and how data generated outside traditional randomized clinical trials can be transformed into evidence strong enough to inform regulatory questions, such as product safety, effectiveness, or use in specific populations, depending on the study design and regulatory context.
A key feature of this announcement is the emphasis on the FDA being able to "assess the potential utility" of RWD for RWE purposes. That framing signals that projects should not only use real-world sources of data, but also directly address the methodological and operational challenges that determine whether those data can credibly support regulatory conclusions. Examples of the kinds of underlying issues this type of program commonly targets include data quality and completeness, outcome and exposure definition, bias and confounding control, missing data, record linkage, reproducibility, validation approaches, and transparency in analytic decision-making. Because the award is a cooperative agreement, applicants should expect substantial FDA involvement during the project period, such as collaboration on project direction, milestones, deliverables, and coordination to ensure the outputs are useful for the agency's learning objectives.
The eligible applicant pool is broad and includes higher education institutions (public/state-controlled and private), nonprofits (with or without 501(c)(3) status, excluding institutions of higher education in those categories), for-profit organizations (including small businesses and other for-profits), and many levels of government and quasi-governmental entities. Eligible government applicants include state governments, county governments, city or township governments, special district governments, independent school districts, public housing authorities/Indian housing authorities, U.S. territories or possessions, and Indian/Native American tribal governments (federally recognized and other than federally recognized), as well as Native American tribal organizations that are not federally recognized tribal governments. The announcement also explicitly encourages applications from institutions that are often underrepresented in federal funding, including Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs). It also allows faith-based or community-based organizations and regional organizations, reflecting an interest in diverse settings where real-world data are generated and maintained.
From an administrative standpoint, the opportunity is run by the Food and Drug Administration under CFDA number 93.103, categorized under science and technology and other research and development. The FOA was created on 2022-12-13, with an original closing date of 2023-02-28. The instrument type is a cooperative agreement rather than a standard grant, which generally means the FDA anticipates being an active partner rather than a hands-off funder. The listing notes an award ceiling of $6,750,000, indicating that projects could be funded at a relatively substantial scale, potentially supporting multi-site collaborations, major data infrastructure work, or large analytic efforts, depending on how an individual application is scoped. The posting also indicates expected awards are not specified in the excerpt provided.
Finally, the "Clinical Trials Optional" designation means that proposed studies may include clinical trial components if scientifically justified, but they do not have to. That flexibility fits the RWE focus, since many RWE efforts rely on observational designs using sources like electronic health records, claims and billing data, registries, pharmacy data, device data, or other routinely collected information. Overall, the opportunity is best understood as a way to fund rigorous, regulator-relevant demonstrations and methodological work that help clarify when real-world data can be trusted to support real-world evidence for FDA decisions, and what standards, practices, and validation steps are needed to make those approaches credible and repeatable.Apply for RFA FD 23 025
- The Food and Drug Administration in the science and technology and other research and development sector is offering a public funding opportunity titled "Supporting the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials 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 2022-12-13.
- Applicants must submit their applications by 2023-02-28. (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 $6,750,000.00 in funding.
- 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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FAQs: Supporting the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) - Clinical Trials Optional (RFA-FD-23-025)
What is the name of this FDA funding opportunity?
The opportunity is titled "Supporting the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials Optional."
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-FD-23-025.
What agency is offering this grant?
The grant is administered by the U.S. Food and Drug Administration (FDA).
What type of funding mechanism is used?
This opportunity uses a cooperative agreement mechanism (U01), which generally indicates substantial FDA involvement during the project period.
How is a cooperative agreement (U01) different from a standard grant?
Based on the description provided, the FDA expects to be an active partner rather than a hands-off funder. Applicants should anticipate collaboration with FDA on items like project direction, milestones, deliverables, and coordination so project outputs align with the agency's learning objectives.
What is the primary purpose of this funding opportunity?
The central aim is to advance the FDA Real-World Evidence (RWE) Program by exploring, testing, and demonstrating how real-world data (RWD) can be used to generate reliable real-world evidence that the FDA can consider in regulatory decision-making.
What does the FDA mean by real-world data (RWD) in this context?
The opportunity focuses on data generated outside traditional randomized clinical trials, such as routinely collected information from real-world settings.
What is real-world evidence (RWE) in the context of this opportunity?
RWE refers to evidence generated from real-world data that is reliable enough to be considered by the FDA in regulatory decision-making, depending on the study design and regulatory context.
What kinds of regulatory questions could these projects help inform?
The description notes that projects may help inform regulatory questions such as product safety, effectiveness, or product use in specific populations, depending on study design and context.
What does it mean that the FDA wants to "assess the potential utility" of RWD?
It signals that projects should do more than simply analyze real-world data. They should directly address the methodological and operational issues that determine whether the data can credibly support regulatory conclusions.
What kinds of challenges or issues are projects expected to address?
Examples mentioned include data quality and completeness, defining outcomes and exposures, controlling bias and confounding, handling missing data, record linkage, reproducibility, validation approaches, and transparency in analytic decision-making.
Does this opportunity require a clinical trial?
No. The opportunity is labeled "Clinical Trials Optional," meaning clinical trial components may be included if scientifically justified, but they are not required.
Why does "Clinical Trials Optional" fit this program?
Because many real-world evidence efforts rely on observational designs using routinely collected data rather than traditional randomized clinical trials.
What real-world data sources are commonly relevant to this type of work?
The description lists examples such as electronic health records, claims and billing data, registries, pharmacy data, device data, and other routinely collected information.
Who is eligible to apply?
The eligible applicant pool is broad and includes higher education institutions (public/state-controlled and private), nonprofits (with or without 501(c)(3) status, excluding institutions of higher education in those categories), for-profit organizations (including small businesses and other for-profits), and various government and quasi-governmental entities.
Which types of higher education institutions are eligible?
Public/state-controlled institutions of higher education and private institutions of higher education are eligible.
Are nonprofit organizations eligible?
Yes. Nonprofits with or without 501(c)(3) status are eligible, with the note that the nonprofit categories referenced exclude institutions of higher education in those categories.
Are for-profit organizations eligible?
Yes. For-profit organizations, including small businesses and other for-profits, are eligible.
Are state and local governments eligible?
Yes. Eligible government applicants include state governments, county governments, city or township governments, special district governments, and independent school districts.
Are U.S. territories eligible?
Yes. U.S. territories or possessions are listed as eligible applicants.
Are tribal governments and tribal organizations eligible?
Yes. The announcement includes Indian/Native American tribal governments (federally recognized and other than federally recognized), as well as Native American tribal organizations that are not federally recognized tribal governments.
Are public housing authorities eligible?
Yes. Public housing authorities and Indian housing authorities are included among eligible government applicants.
Are faith-based or community-based organizations eligible?
Yes. The opportunity allows faith-based or community-based organizations.
Are regional organizations eligible?
Yes. The opportunity allows regional organizations.
Does the announcement encourage applications from certain institution types?
Yes. It explicitly encourages applications from institutions that are often underrepresented in federal funding, including Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), and others described as underrepresented in federal funding.
What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.103.
How is this opportunity categorized?
It is categorized under science and technology and other research and development.
When was this funding opportunity created?
The FOA was created on 2022-12-13.
What was the original closing date?
The original closing date listed is 2023-02-28.
What is the maximum award amount (award ceiling)?
The listing notes an award ceiling of $6,750,000.
How should applicants interpret the award ceiling?
The description suggests this ceiling indicates projects could be supported at a substantial scale, potentially enabling multi-site collaborations, significant data infrastructure work, or large analytic efforts, depending on how a project is scoped.
How many awards will be made?
The excerpt provided states that expected awards are not specified.
What kinds of projects are a good fit for this opportunity?
Projects that rigorously demonstrate and test when and how real-world data can be transformed into credible, regulator-relevant real-world evidence, including work that clarifies standards, practices, and validation steps needed for reliability and repeatability.
What is the overarching goal for FDA learning or impact?
The opportunity is intended to produce outputs that help the FDA understand when real-world data can be trusted for real-world evidence in regulatory decisions, and what methodological practices and validation approaches support credible conclusions.
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