Opportunity Information: Apply for RFA FD 21 017
This grant opportunity (RFA FD 21 017) is a discretionary funding announcement from the U.S. Department of Health and Human Services, Food and Drug Administration (FDA), focused on renewing support for the existing UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI). It is issued under the FDA's Advancing Regulatory Science Initiative and is designed to strengthen and modernize the scientific tools and evidence approaches the FDA relies on to evaluate products it regulates. In practical terms, the opportunity is meant to fund work that improves how the FDA and its partners assess safety, effectiveness, quality, and overall performance across FDA-regulated products by developing and validating new tools, standards, and methods that can be used in real regulatory decision-making.
The funding mechanism is a U01 cooperative agreement, which typically means the FDA expects to be substantially involved in the scientific direction and execution of the work, rather than simply providing funds and receiving reports. The announcement is labeled "Clinical Trials Optional," indicating that while clinical trials are not required, they are not prohibited if they are scientifically justified and aligned with the project goals. The overall emphasis is on collaborative, cutting-edge regulatory science research conducted with FDA involvement, reflecting the idea that the center functions as a close partner to the Agency to solve high-priority regulatory science problems.
This is a renewal opportunity specifically intended to support the already-established CERSI at the University of California, San Francisco in partnership with Stanford University, rather than a broadly competitive program aimed at creating a new center at a different institution. The announcement notes that funding is dependent on the availability of FDA funds, reinforcing that the award is contingent upon appropriations and internal FDA budget decisions. Alongside research, the center may also provide regulatory science training, which can include educational activities that build workforce capability and disseminate best practices in regulatory science, although the core purpose remains advancing FDA regulatory science goals through collaborative research.
Administratively, the opportunity is categorized under consumer protection and science and technology/research and development, and it is associated with CFDA (now typically referred to as Assistance Listing) number 93.103. The award ceiling is listed as $16,000,000, with an expectation of a single award, consistent with the renewal of one existing center. The opportunity was created on February 18, 2021, with an original closing date of May 25, 2021. Eligibility is noted as "Others (see text field entitled Additional Information on Eligibility for clarification)," which commonly signals that eligibility is limited or specialized for this renewal and that the detailed eligibility rules are provided in the full announcement, but the context makes clear it is centered on the UCSF-Stanford CERSI.
Overall, the grant is best understood as targeted federal support for a specialized academic-government partnership meant to generate practical regulatory science outputs: new evaluation methods, data standards, testing approaches, and other innovations that can directly improve the FDA's ability to regulate products based on strong, modern scientific evidence, while also helping train the next generation of regulatory scientists through center activities.Apply for RFA FD 21 017
- The Department of Health and Human Services, Food and Drug Administration in the consumer protection, science and technology and other research and development sector is offering a public funding opportunity titled "Renewal : UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (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 Feb 18, 2021.
- Applicants must submit their applications by May 25, 2021. (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 $16,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQ)
What is the name and identifier of this grant opportunity?
This opportunity is titled RFA FD 21 017. It is a discretionary funding announcement from the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
Which federal agency is offering this funding?
The funding is offered by the U.S. Food and Drug Administration (FDA) within HHS.
What is the main purpose of this award?
The purpose is to renew support for the existing UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) and to advance FDA regulatory science by strengthening and modernizing the scientific tools and evidence approaches used in FDA product evaluations.
What is meant by "Advancing Regulatory Science Initiative" in this context?
The opportunity is issued under FDA's Advancing Regulatory Science Initiative and focuses on developing and validating tools, standards, and methods that can be used in real regulatory decision-making to improve how FDA evaluates regulated products.
Is this a new center competition or a renewal?
This is a renewal opportunity specifically intended to support the already-established CERSI at the University of California, San Francisco (UCSF) in partnership with Stanford University, rather than a broadly competitive program to create a new center at another institution.
Who is this funding intended to support?
Based on the description provided, the funding is intended to support the existing UCSF-Stanford CERSI partnership, reflecting a targeted renewal rather than an open, general competition.
What type of funding mechanism is used?
The mechanism is a U01 cooperative agreement.
What does a U01 cooperative agreement imply for how the project will be run?
A U01 cooperative agreement generally indicates substantial FDA involvement in the scientific direction and execution of the work, rather than a model where the government simply provides funds and receives periodic reports.
Are clinical trials required under this opportunity?
No. The announcement is labeled "Clinical Trials Optional," meaning clinical trials are not required.
Are clinical trials allowed if they make scientific sense?
Yes. "Clinical Trials Optional" also indicates clinical trials are not prohibited if they are scientifically justified and aligned with the project goals.
What kinds of activities or outputs is the FDA seeking through this award?
The emphasis is on collaborative, cutting-edge regulatory science research that improves assessment of safety, effectiveness, quality, and overall performance of FDA-regulated products. Examples of intended outputs include new evaluation methods, validated tools, data standards, testing approaches, and other innovations that can be used directly in regulatory decision-making.
How does this work support the FDA in practical terms?
The funded work is meant to improve how FDA and its partners evaluate products the FDA regulates by producing modern scientific tools and evidence approaches that strengthen regulatory evaluations.
Does the opportunity include training or education components?
Yes. Alongside research, the center may provide regulatory science training, including educational activities that build workforce capability and help disseminate best practices in regulatory science, while the core purpose remains advancing FDA regulatory science goals through collaborative research.
What are the program focus areas or categories associated with this funding?
Administratively, the opportunity is categorized under consumer protection and science and technology/research and development.
What is the Assistance Listing (CFDA) number associated with this opportunity?
The opportunity is associated with CFDA (Assistance Listing) number 93.103.
What is the maximum award amount (award ceiling)?
The award ceiling is listed as $16,000,000.
How many awards does the announcement expect to make?
The announcement indicates an expectation of a single award, consistent with renewing one existing center.
Is the award guaranteed once an application is submitted?
No. Funding is dependent on the availability of FDA funds, meaning the award is contingent upon appropriations and internal FDA budget decisions.
When was this opportunity created?
The opportunity was created on February 18, 2021.
What was the original closing date for submissions?
The original closing date was May 25, 2021.
What does the eligibility statement mean if it says "Others (see text field entitled Additional Information on Eligibility for clarification)"?
This phrasing commonly signals that eligibility is limited or specialized and that detailed eligibility rules are provided in the full announcement. In this case, the context indicates the opportunity is centered on renewing support for the UCSF-Stanford CERSI.
What is the overall goal of renewing the UCSF-Stanford CERSI through this award?
The overall goal is to provide targeted federal support for a specialized academic-government partnership that produces practical regulatory science innovations and helps train regulatory scientists, with FDA collaboration to address high-priority regulatory science needs.
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| Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks and Pediatric Anesthesia Safety Initiative (ACTTION/PASI) (U01) Clinical Trial Not Allowed) Apply for RFA FD 22 023 Funding Number: RFA FD 22 023 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $3,000,000 |
| Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional Apply for RFA FD 22 026 Funding Number: RFA FD 22 026 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for FOR FD 23 007 Funding Number: FOR FD 23 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $650,000 |
| Designing and performing a virtual bioequivalence trial for physiologically-based pharmacokinetic and other mechanism-based models Apply for RFA FD 23 016 Funding Number: RFA FD 23 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 23 012 Funding Number: RFA FD 23 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,200,000 |
| Evaluation of oral modified release drug tablet to support the approval of additional strengths Apply for RFA FD 23 013 Funding Number: RFA FD 23 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $450,000 |
| Novel approaches to support therapeutic development in ultra-rare cancers Apply for RFA FD 23 008 Funding Number: RFA FD 23 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,500,000 |
| In Vitro Based Approaches to Evaluate the Bioequivalence of Prospective Generic Rectal and Vaginal Products (U01) Clinical Trial Not Allowed Apply for RFA FD 23 014 Funding Number: RFA FD 23 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $1,000,000 |
| Applied Regulatory Science Research to Understand Factors that Affect the Safety and Efficacy of Underrepresented Populations in Oncology Therapeutic Development (U01) Clinical Trial Optional Apply for RFA FD 23 006 Funding Number: RFA FD 23 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,500,000 |
| Site Selection in Oncology Clinical Trials: Considerations for Selecting Sites in Limited Geographic Regions or Areas of Political Unrest, Limiting Inspection Capabilities (U13) Clinical Trial not allowed. Apply for RFA FD 23 007 Funding Number: RFA FD 23 007 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $300,000 |
| Development and Validation of a Multi-functional, Multi-purpose Quantitative Tool for Dermal Physiologically-Based Pharmacokinetic (PBPK) Modeling (U01) Clinical Trial Optional Apply for RFA FD 23 015 Funding Number: RFA FD 23 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $750,000 |
| Pediatric Device Consortia Grants Program (P50) Clinical Trials Optional Apply for RFA FD 23 024 Funding Number: RFA FD 23 024 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $5,000,000 |
| Natural History and Biomarker Studies of Rare Neurodegenerative Diseases (U01) Clinical Trials Optional Apply for RFA FD 23 028 Funding Number: RFA FD 23 028 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
| Education and Training Program for Outsourcing Facility Industry (UE5) Clinical Trials Not Allowed Apply for RFA FD 23 029 Funding Number: RFA FD 23 029 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $5,500,000 |
| Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01) Clinical Trials Required Apply for RFA FD 23 001 Funding Number: RFA FD 23 001 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $650,000 |
| Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed Apply for RFA FD 23 017 Funding Number: RFA FD 23 017 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $500,000 |
| Biosimilar User Fee Act (BsUFA) Research Grant (U01) Clinical Trials Optional Apply for RFA FD 23 026 Funding Number: RFA FD 23 026 Agency: Food and Drug Administration Category: Consumer Protection, Science and Technology and other Research and Development Funding Amount: $2,000,000 |
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