Opportunity Information: Apply for RFA FD 26 007
Apply for RFA FD 26 007
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Pathways for Regulatory Innovation and Strategic Modernization (PRISM)" 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 2026-03-31.
- Applicants must submit their applications by 2026-04-30. (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 $1,300,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others.
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Opportunity Summary:
The Pathways for Regulatory Innovation and Strategic Modernization (PRISM) opportunity is a Food and Drug Administration (FDA) cooperative agreement focused on improving public health by modernizing the scientific and operational groundwork that supports regulatory oversight. The core idea is that medical products, diagnostics, foods, and digital health tools are changing quickly, and the regulatory science behind oversight has to keep pace so people can get timely access to products that are safe, effective, and high quality. PRISM is positioned as a forward-looking vehicle to strengthen how the FDA and partners learn, test, and apply new methods for evaluating emerging technologies and new types of evidence, while also improving the overall clarity and consistency of regulatory pathways.
A central feature of PRISM is collaboration that is explicitly described as non-regulatory in nature. In practice, that means the work is meant to generate applied scientific knowledge, tools, and approaches that can inform and support modernization, rather than carrying out enforcement or decision-making functions. The program emphasizes bringing together perspectives from patients and consumers, industry, academia, and the healthcare workforce. By building structured engagement with these groups, PRISM aims to produce insights and practical outputs that make the regulatory environment more predictable, efficient, and transparent, especially as innovation introduces unfamiliar product types and fast-moving development cycles.
PRISM also highlights the growing importance of real-world data and real-world evidence as complements to traditional evidence sources. The opportunity frames this as part of a broader effort to bridge the gap between innovation and regulation by leveraging independent expertise and practical, real-world insights. The intended result is smoother uptake and evaluation of emerging technologies and better alignment between evolving consumer needs and the methods used to assess product performance, safety, and quality. Overall, PRISM is described as flexible and scalable, suggesting it can support a range of activities and engagement models depending on the specific modernization priorities being addressed.
From a funding and administrative standpoint, this is a discretionary cooperative agreement under FDA, with a single expected award. The funding opportunity number is RFA-FD-26-007, and it is listed under CFDA 93.103. The award ceiling is $1,300,000, with an application closing date of April 30, 2026. Eligibility is limited to a single source applicant: the Reagan-Udall Foundation for the Food and Drug Administration. This means the opportunity is not broadly open competition; it is structured for that specific organization to carry out the collaborative modernization work described in the announcement.
PRISM (Pathways for Regulatory Innovation and Strategic Modernization) Grant Opportunity FAQs
What is the PRISM opportunity?
PRISM stands for Pathways for Regulatory Innovation and Strategic Modernization. It is a Food and Drug Administration (FDA) cooperative agreement focused on improving public health by modernizing the scientific and operational groundwork that supports regulatory oversight.
What is the main goal of PRISM?
The core goal is to help regulatory science keep pace with rapidly changing medical products, diagnostics, foods, and digital health tools so that people can get timely access to products that are safe, effective, and high quality. PRISM is intended to strengthen how FDA and partners learn, test, and apply new methods for evaluating emerging technologies and new types of evidence, and to improve clarity and consistency across regulatory pathways.
Which agency is offering this opportunity?
The opportunity is offered by the U.S. Food and Drug Administration (FDA).
What type of award is PRISM?
PRISM is a discretionary cooperative agreement. A cooperative agreement generally indicates a substantial level of involvement and collaboration between the funding agency and the award recipient compared with a standard grant.
How many awards does FDA expect to make under this opportunity?
The announcement indicates a single expected award.
What is the maximum funding amount (award ceiling)?
The award ceiling is $1,300,000.
When is the application due?
The application closing date is April 30, 2026.
What is the funding opportunity number?
The funding opportunity number is RFA-FD-26-007.
What is the CFDA number listed for this opportunity?
The opportunity is listed under CFDA 93.103.
Who is eligible to apply?
Eligibility is limited to a single source applicant: the Reagan-Udall Foundation for the Food and Drug Administration. The opportunity is not an open competition for the general public, companies, universities, or other organizations.
Is this opportunity open to other organizations besides the Reagan-Udall Foundation?
No. Based on the information provided, eligibility is restricted to the Reagan-Udall Foundation for the Food and Drug Administration, and no other applicants are eligible under this announcement.
What does it mean that PRISM collaboration is "non-regulatory in nature"?
It means the collaboration is intended to generate applied scientific knowledge, tools, and approaches that can inform and support modernization efforts, rather than performing enforcement activities or making regulatory decisions. The work is meant to support modernization by building evidence, methods, and practical outputs.
What kinds of products or areas does PRISM relate to?
PRISM is framed around innovation across medical products, diagnostics, foods, and digital health tools, particularly where rapid change creates new evaluation challenges for regulatory science and oversight methods.
What problem is PRISM trying to address?
The opportunity is designed around the idea that innovation is moving quickly and can introduce unfamiliar product types and fast-moving development cycles. PRISM aims to help the underlying scientific and operational foundations for oversight evolve so regulatory pathways remain predictable, efficient, and transparent while still supporting safety, effectiveness, and quality.
What kinds of activities does PRISM support?
Based on the description, PRISM supports collaborative modernization work that strengthens the ability to learn, test, and apply new evaluation methods for emerging technologies and new evidence types. It also supports efforts to improve the clarity and consistency of regulatory pathways and to build engagement models that produce practical outputs.
What role do stakeholders play in PRISM?
PRISM emphasizes structured engagement and bringing together perspectives from patients and consumers, industry, academia, and the healthcare workforce. The intent is to use these perspectives to produce insights and practical outputs that improve predictability, efficiency, and transparency as innovation evolves.
How does PRISM address emerging technologies and new evidence?
PRISM is positioned as a forward-looking vehicle to strengthen methods for evaluating emerging technologies and new types of evidence. It focuses on applied work that can inform modernization of evaluation approaches and improve the consistency of regulatory pathways as innovation introduces new challenges.
What is PRISM's position on real-world data (RWD) and real-world evidence (RWE)?
PRISM highlights the growing importance of real-world data and real-world evidence as complements to traditional evidence sources. The opportunity frames this as part of a broader effort to bridge the gap between innovation and regulation by leveraging independent expertise and practical, real-world insights.
Why does PRISM emphasize real-world data and evidence?
The description suggests that using real-world data and real-world evidence can help improve uptake and evaluation of emerging technologies and better align evolving consumer needs with the methods used to assess product performance, safety, and quality.
How is PRISM intended to improve the regulatory environment?
By producing applied scientific knowledge, tools, approaches, and stakeholder-informed insights, PRISM aims to make the regulatory environment more predictable, efficient, and transparent, especially for unfamiliar product types and fast-moving development cycles.
Does PRISM involve enforcement or regulatory decision-making?
No. The collaboration is explicitly described as non-regulatory in nature, meaning it is focused on modernization-supporting science and methods rather than enforcement activities or regulatory decisions.
What is meant by PRISM being "flexible and scalable"?
The opportunity describes PRISM as flexible and scalable, suggesting it can support a range of activities and engagement models depending on the specific modernization priorities being addressed.
What is the intended public health impact of PRISM?
The stated public health purpose is to improve the scientific and operational foundations that support oversight so that people can have timely access to medical products, diagnostics, foods, and digital health tools that are safe, effective, and high quality.
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