Opportunity Information: Apply for RFA FD 23 004
The Centers of Excellence in Regulatory Science and Innovation (CERSI) opportunity (RFA FD 23 004) is a U.S. Food and Drug Administration (FDA) cooperative agreement funding program designed to strengthen and modernize regulatory science. Regulatory science, in this context, is the applied research and scientific capability that supports how FDA evaluates the safety, effectiveness, quality, and performance of FDA-regulated products and technologies. Through CERSI, FDA aims to build a network of organizations that can develop robust, innovative approaches to regulatory challenges while also sharing knowledge and methods across the broader FDA-regulatory science community.
A central feature of the program is collaboration. The CERSIs are expected to advance regulatory science both individually, by pursuing their own research strengths, and synergistically, by working as part of a coordinated program led by FDA's Office of Regulatory Science and Innovation (ORSI). Rather than operating as isolated research awards, these cooperative agreements emphasize ongoing interaction with FDA scientific experts and relevant FDA funding offices. The intent is to create practical, regulator-informed research and information sharing that can directly improve the tools, standards, data approaches, and evaluation frameworks used in regulatory decision-making.
The opportunity supports collaborative research with FDA and also supports regulatory science information sharing activities, contingent on the availability of FDA funding. In practice, this can include joint scientific projects aligned with FDA priorities, structured engagements with FDA subject-matter experts, and activities that help diffuse lessons learned, methods, and best practices. While the notice does not list specific topic areas in the text provided, the program framing suggests projects should be tightly connected to real-world regulatory questions and should produce outputs that are useful for FDA's mission in consumer protection and science-based oversight.
Administratively, this is a discretionary funding opportunity from the Department of Health and Human Services (HHS), FDA, using a cooperative agreement mechanism. Cooperative agreements typically mean the federal agency expects to have substantial involvement during the project period, which aligns with the program's emphasis on close FDA collaboration. The funding activity category spans consumer protection, food and nutrition, science and technology, and other research and development, and it is associated with CFDA number 93.103.
The eligible applicant pool is broad and includes many types of governmental entities (state, county, city or township, special districts, and independent school districts), public and state-controlled institutions of higher education, private institutions of higher education, tribal governments and tribal organizations, public housing/Indian housing authorities, nonprofit organizations (both with and without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses. This range signals that FDA is open to partnering with universities as well as other capable research and innovation organizations that can contribute meaningfully to regulatory science.
Key dates and scale details from the notice include a creation date of October 12, 2022, and an original closing date of December 22, 2022. The award ceiling is listed as $1,000,000, with an expectation of about five awards. Overall, the opportunity is best understood as a structured partnership vehicle: FDA is seeking a small set of well-resourced collaborators to conduct regulator-relevant research and to participate in an ongoing, networked program that improves the scientific foundations and tools behind FDA regulatory oversight.Apply for RFA FD 23 004
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, food and nutrition, science and technology and other research and development sector is offering a public funding opportunity titled "Centers of Excellence in Regulatory Science and Innovation (CERSI)" 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 Oct 12, 2022.
- Applicants must submit their applications by Dec 22, 2022. (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 $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 5 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.
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Centers of Excellence in Regulatory Science and Innovation (CERSI) (RFA FD 23 004) - FAQs
What is the CERSI opportunity (RFA FD 23 004)?
CERSI (Centers of Excellence in Regulatory Science and Innovation) is an FDA cooperative agreement funding program intended to strengthen and modernize regulatory science. It supports organizations that can help develop and share practical, regulator-informed approaches to FDA regulatory challenges.
What does FDA mean by "regulatory science" in this program?
In this context, regulatory science refers to applied research and scientific capability that supports how FDA evaluates the safety, effectiveness, quality, and performance of FDA-regulated products and technologies. The emphasis is on science that directly informs regulatory evaluation and decision-making.
What is the main goal of the CERSI program?
The goal is to build a network of organizations that can develop robust and innovative approaches to regulatory challenges and share knowledge and methods across the broader FDA-regulatory science community, improving tools, standards, data approaches, and evaluation frameworks used by FDA.
Is this funding a grant or a cooperative agreement?
This opportunity uses a cooperative agreement mechanism. That structure generally means FDA expects substantial involvement during the project period, consistent with the program's strong focus on ongoing collaboration with FDA scientific experts and relevant FDA funding offices.
How does collaboration with FDA work under CERSI?
CERSIs are expected to pursue their own research strengths while also working synergistically as part of a coordinated program led by FDA's Office of Regulatory Science and Innovation (ORSI). The model emphasizes ongoing interaction with FDA scientific experts so the work remains closely connected to real regulatory needs.
What is ORSI and what is its role in the program?
ORSI is FDA's Office of Regulatory Science and Innovation. Under this program framing, ORSI leads the coordinated, networked effort across CERSIs so that individual centers contribute to shared learning and aligned progress on regulatory science challenges.
What kinds of activities can be supported through CERSI?
The opportunity supports collaborative research with FDA and also supports regulatory science information sharing activities (subject to the availability of FDA funding). Examples described in the notice include joint scientific projects aligned with FDA priorities, structured engagements with FDA subject-matter experts, and activities that spread lessons learned, methods, and best practices.
Does the opportunity list specific research topic areas?
No specific topic areas are listed in the information provided. The program description indicates that projects should be tightly connected to real-world regulatory questions and produce outputs useful to FDA's consumer protection mission and science-based oversight.
What makes this program different from a typical stand-alone research award?
Rather than operating as isolated awards, CERSI cooperative agreements emphasize ongoing interaction with FDA and participation in a coordinated network. The intent is practical, regulator-informed research plus active information sharing that can directly improve FDA's tools and evaluation frameworks.
Which federal department and agency sponsor this opportunity?
This is a discretionary funding opportunity from the U.S. Department of Health and Human Services (HHS), specifically the U.S. Food and Drug Administration (FDA).
What is the CFDA number associated with this program?
The opportunity is associated with CFDA number 93.103.
What funding activity categories does the opportunity cover?
The funding activity category spans consumer protection, food and nutrition, science and technology, and other research and development.
Who is eligible to apply?
The eligible applicant pool is broad. Eligible entities include state governments, county governments, city or township governments, special district governments, independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, tribal governments and tribal organizations, public housing/Indian housing authorities, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (other than small businesses), and small businesses.
Does FDA appear open to partnering with universities and non-university organizations?
Yes. The eligibility list includes both public and private institutions of higher education as well as governmental entities, nonprofits, for-profits (other than small businesses), and small businesses, suggesting FDA is open to partnering with a wide range of capable organizations that can contribute to regulatory science.
What is the award ceiling for this opportunity?
The award ceiling listed in the notice is $1,000,000.
How many awards does FDA expect to make?
The notice indicates an expectation of about five awards.
What are the key dates mentioned in the notice?
The notice lists a creation date of October 12, 2022, and an original closing date of December 22, 2022.
What are "information sharing activities" in the CERSI context?
Based on the description provided, information sharing activities are efforts to diffuse lessons learned, methods, and best practices across the FDA-regulatory science community. These activities are supported contingent on the availability of FDA funding.
What types of outputs is FDA likely looking for from CERSIs?
The program description emphasizes outputs that can directly improve regulatory decision-making, including improvements to tools, standards, data approaches, and evaluation frameworks used in assessing FDA-regulated products and technologies.
What is the overall intent of the CERSI network model?
The intent is to create a small set of well-resourced collaborators that conduct regulator-relevant research and participate in an ongoing, coordinated program that strengthens the scientific foundations behind FDA regulatory oversight.
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