Opportunity Information: Apply for RFA FD 24 029
The funding opportunity "Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional" (RFA-FD-24-029) is a cooperative agreement from the U.S. Food and Drug Administration (FDA) designed to strengthen the agency's Critical Path Initiative by building and running public-private partnerships and other structured collaborative efforts. The main idea is that FDA and the selected awardees do not operate in parallel; they actively work together to plan and carry out projects that FDA identifies as priorities. These projects are meant to advance regulatory science and make drug development more efficient and more reliable, while also improving how drug products are evaluated for safety, effectiveness, quality, and performance. Although clinical trials are allowed under this program, they are optional, meaning an application can focus on other forms of research, education, tool development, or outreach that support FDA's regulatory science and drug development goals.
At the program level, the NOFO focuses on four broad outcomes. First, it aims to accelerate drug product development by supporting new approaches that improve the speed and predictability of development pathways. Second, it supports advanced manufacturing approaches, reflecting FDA's interest in modernizing how drugs are made and controlled, including methods that can increase consistency, quality assurance, and supply reliability. Third, it emphasizes better translation of basic science into therapeutics, addressing the common gap between early discoveries and real-world medical products. Fourth, it seeks to enhance the overall safety, efficacy, quality, and performance of drug products by enabling better tools and evidence-generation methods to understand benefits and risks throughout the product lifecycle.
Because this is a cooperative agreement, the structure implies substantial FDA involvement in shaping, guiding, and coordinating the work. The awardee is expected to support, manage, and facilitate collaborations, not just conduct a standalone research project. In practice, that means building mechanisms that bring multiple stakeholders to the table, keeping projects organized, maintaining momentum across partners, and ensuring the outputs are useful for regulatory science and the drug development ecosystem. The NOFO also notes that multiple awards may be made, but the final number and scope depend on FDA's current drug development priorities and the availability of funds.
Eligibility is limited to organizations that can credibly serve as a hub for complex biomedical collaborations. Specifically, eligible applicants include private institutions of higher education, consortia of such institutions, and nonprofits that are 501(c)(3) organizations exempt under 501(a). Beyond formal eligibility status, applicants are expected to have experienced personnel and strong clinical and technical expertise in biomedical sciences. The announcement also highlights that this expertise can include graduate training programs aligned with Critical Path priorities, signaling that FDA values environments with deep scientific infrastructure and workforce development capabilities.
The NOFO lays out capability expectations that go beyond scientific competence. Applicants must be able to develop and critically evaluate tools, methods, and processes that improve the efficiency, predictability, and productivity of medical product development, while also improving how benefits and risks are identified for both new and existing products. This points to deliverables like validation frameworks, decision-support tools, new measurement methods, data standards, model-informed development approaches, or other platform-like solutions that can be used broadly rather than only within a single study. In addition, applicants must demonstrate the ability to establish wide-ranging partnerships across the healthcare and product development landscape, including clinicians and other providers, pharmacists, pharmacy benefit managers, purchasers, managed care organizations, insurers, government agencies, patients and consumers, manufacturers (including drugs, biologics, diagnostics, and devices), and academic scientists. This breadth reflects the real-world complexity of drug development and regulation, where evidence, implementation, reimbursement, and patient experience all influence whether innovations translate into better products and outcomes.
Another defining expectation is resource mobilization. The NOFO explicitly states that the entity must be capable of securing funding for Critical Path public-private partnership projects from federal and nonfederal governmental sources, foundations, and private individuals. That is an important signal that FDA is looking for an organization that can sustain and expand a portfolio of collaborative projects over time, leveraging the cooperative agreement as a foundation while building a diversified funding base to support longer-term or larger-scale efforts.
From the administrative details provided, the opportunity is categorized as discretionary and uses the cooperative agreement instrument. It is listed under the FDA with CFDA number 93.103 and falls within the broad activity category labeled Agriculture, Consumer Protection, Food and Nutrition, which is how some FDA programs are grouped in federal assistance listings. The application closing date shown is 2024-04-02, the award ceiling is $5,000,000, and FDA anticipates up to 6 awards. The posting date is 2024-01-04. Overall, the program is best understood as funding an organizational backbone for FDA-prioritized collaborations that generate practical, scalable outputs in regulatory science and drug development, with room for clinical trials when they are needed to achieve those outputs but no requirement that trials be the centerpiece of every project.Apply for RFA FD 24 029
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Collaborations to Enhance Drug Development and Regulatory Science - 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 2024-01-04.
- Applicants must submit their applications by 2024-04-02. (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 $5,000,000.00 in funding.
- The number of recipients for this funding is limited to 6 candidate(s).
- Eligible applicants include: Private institutions of higher education, Others.
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Frequently Asked Questions (FAQs)
1) What is the name of this funding opportunity?
The opportunity is titled "Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional" (RFA-FD-24-029).
2) Which federal agency is offering this grant?
The program is offered by the U.S. Food and Drug Administration (FDA).
3) What type of funding mechanism is this?
This opportunity uses a cooperative agreement. That structure is designed for situations where FDA expects substantial involvement in shaping, guiding, and coordinating the funded work, rather than simply funding an independent project that runs in parallel with the agency.
4) What is the main purpose of the program?
The goal is to strengthen FDA's Critical Path Initiative by building and running public-private partnerships and other structured collaborative efforts. These collaborations are intended to advance regulatory science and improve drug development so it becomes more efficient and more reliable, while also improving evaluation of drug products for safety, effectiveness, quality, and performance.
5) What does it mean that FDA and awardees "do not operate in parallel"?
It means FDA and the selected awardees actively work together to plan and carry out projects that FDA identifies as priorities. The funded organization is expected to help organize and facilitate this joint work across multiple stakeholders, rather than acting as a standalone research team.
6) Are clinical trials required under this opportunity?
No. Clinical trials are allowed but optional. An application may focus on other activities such as research approaches that do not involve trials, education, tool development, or outreach, as long as the work supports FDA's regulatory science and drug development goals.
7) What major outcomes is the NOFO trying to achieve?
The NOFO describes four broad outcomes: (1) accelerating drug product development by improving the speed and predictability of development pathways; (2) supporting advanced manufacturing approaches to modernize how drugs are made and controlled; (3) improving translation of basic science into therapeutics; and (4) enhancing the safety, efficacy, quality, and performance of drug products through better tools and evidence-generation methods across the product lifecycle.
8) What kinds of projects or activities does this program support?
The emphasis is on collaborations and structured partnership efforts that generate practical outputs for regulatory science and drug development. Examples of the kinds of deliverables described include tools, methods, and processes that improve development efficiency and predictability, and that improve how benefits and risks are identified for new and existing products. The program also allows research, education, tool development, and outreach aligned to FDA priorities, with clinical trials included only when needed.
9) Is this funding intended for a single research project or for managing a broader collaboration?
Based on the description, it is intended to fund an organizational backbone that supports, manages, and facilitates collaborations. The awardee is expected to build mechanisms to bring multiple stakeholders together, keep projects organized, maintain momentum across partners, and ensure outputs are useful for regulatory science and the broader drug development ecosystem.
10) Who is eligible to apply?
Eligibility is limited to: private institutions of higher education, consortia of private institutions of higher education, and nonprofit organizations that are 501(c)(3) and exempt under 501(a).
11) What capabilities are expected beyond basic eligibility?
Applicants are expected to have experienced personnel and strong clinical and technical expertise in biomedical sciences. The announcement also signals interest in environments that include graduate training programs aligned with Critical Path priorities, reflecting the value placed on scientific infrastructure and workforce development.
12) What specific technical or programmatic abilities should applicants demonstrate?
Applicants must be able to develop and critically evaluate tools, methods, and processes that improve the efficiency, predictability, and productivity of medical product development, while also improving how benefits and risks are identified for both new and existing products. The description points toward scalable, broadly useful outputs (for example, platform-like tools or approaches) rather than results usable only within a single study.
13) What partnership and stakeholder engagement expectations are included?
The NOFO expects the applicant to be able to establish wide-ranging partnerships across the healthcare and product development landscape. The listed stakeholder types include clinicians and other providers, pharmacists, pharmacy benefit managers, purchasers, managed care organizations, insurers, government agencies, patients and consumers, manufacturers (including drugs, biologics, diagnostics, and devices), and academic scientists.
14) Does the NOFO expect applicants to raise additional resources outside of the award?
Yes. The NOFO explicitly states the entity must be capable of securing funding for Critical Path public-private partnership projects from federal and nonfederal governmental sources, foundations, and private individuals. This indicates FDA is looking for an organization that can sustain and expand a portfolio of collaborative projects over time.
15) How many awards does FDA expect to make?
FDA anticipates up to 6 awards. The NOFO also notes that multiple awards may be made, but the final number and scope depend on FDA priorities and the availability of funds.
16) What is the maximum award amount listed?
The listed award ceiling is $5,000,000.
17) What is the application deadline?
The application closing date shown is 2024-04-02.
18) When was this opportunity posted?
The posting date shown is 2024-01-04.
19) What is the CFDA number associated with this opportunity?
The CFDA number listed is 93.103.
20) How is this opportunity categorized in federal assistance listings?
It is categorized as discretionary and is listed within the broad activity category "Agriculture, Consumer Protection, Food and Nutrition," which is how some FDA programs are grouped in federal assistance listings.
21) What is the role of advanced manufacturing in this program?
Advanced manufacturing is one of the four stated outcomes. The program reflects FDA's interest in modernizing how drugs are made and controlled, including approaches that can increase consistency, strengthen quality assurance, and improve supply reliability.
22) What does "translation of basic science into therapeutics" mean in this context?
It refers to closing the gap between early scientific discoveries and real-world medical products, so that insights from basic science are more likely to lead to usable therapies.
23) What does the program mean by improving evaluation of drug products "throughout the product lifecycle"?
It points to strengthening tools and evidence-generation methods used to understand benefits and risks not only during development, but also as products are evaluated over time for safety, efficacy, quality, and performance.
24) What kinds of outputs does FDA appear to value under this NOFO?
The description emphasizes practical, scalable outputs that can be used broadly across drug development and regulatory science. It highlights tools, methods, processes, and other platform-like solutions that help improve efficiency, predictability, and risk-benefit evaluation for both new and existing products.
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| Funding Opportunity |
|---|
| Critical Path Public Private Partnerships Clinical Trials Optional Apply for RFA FD 24 027 Funding Number: RFA FD 24 027 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $20,000,000 |
| Utilizing Real-World Data and Algorithmic Analyses to Assess Post-Market Clinical Outcomes in Patients Switching Amongst Therapeutically Equivalent Complex Generic Drug Products and Reference Listed Drugs (U01) Clinical Trial Not Allowed Apply for RFA FD 24 007 Funding Number: RFA FD 24 007 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Developing PBPK Model-Based Mechanistic IVIVCs for Long Acting Injectable Suspensions and Implants (U01) Clinical Trial Optional Apply for RFA FD 24 006 Funding Number: RFA FD 24 006 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required) Apply for RFA FD 24 008 Funding Number: RFA FD 24 008 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Integrating Machine Learning with Computational Fluid Dynamics Models of Orally Inhaled Drug Products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 005 Funding Number: RFA FD 24 005 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed Apply for RFA FD 24 011 Funding Number: RFA FD 24 011 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed Apply for RFA FD 24 010 Funding Number: RFA FD 24 010 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Novel Approaches to Support Therapeutic Development in Ultra-Rare Cancers (U01) Clinical Trial Optional Apply for RFA FD 24 038 Funding Number: RFA FD 24 038 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies (U19) Clinical Trials Not Allowed Apply for RFA FD 24 033 Funding Number: RFA FD 24 033 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $15,000,000 |
| Development and Maintenance of Human and Animal Food Rapid Response Teams (U2F) Clinical Trials Not Allowed Apply for RFA FD 24 032 Funding Number: RFA FD 24 032 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $360,000 |
| Flexible Funding Model-Infrastructure Development and Maintenance for State Manufactured Food Regulatory Programs (U19) Clinical Trials Not Allowed Apply for RFA FD 24 039 Funding Number: RFA FD 24 039 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $340,000 |
| Drug Development Tools Research Grants (U01) Clinical Trials Optional Apply for RFA FD 24 030 Funding Number: RFA FD 24 030 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $500,000 |
| Cooperative Agreement for Long Term Data Collection on Antimicrobial Use in Animals (U01) Clinical Trial Not Allowed Apply for RFA FD 24 031 Funding Number: RFA FD 24 031 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $200,000 |
| Alliance to Support the Activities of the Integrated Food Safety System (IFSS), including the Grade “A” Milk Safety and National Shellfish Sanitation Programs (U01) Clinical Trials Not Allowed Apply for RFA FD 24 034 Funding Number: RFA FD 24 034 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $6,000,000 |
| Cooperative Agreement to Support the World Trade Organization's (WTO) Standards and Trade Development Facility (STDF) (U01) Clinical Trials Not Allowed Apply for RFA FD 24 016 Funding Number: RFA FD 24 016 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Use of Digital Health Technologies in Clinical Investigations to Support Drug and Biological Product Development (U01) Clinical Trials Optional Apply for RFA FD 24 037 Funding Number: RFA FD 24 037 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,100,000 |
| Development and Maintenance of the Animal Food Regulatory Program Standards (U19) Clinical Trial Not Allowed Apply for RFA FD 24 035 Funding Number: RFA FD 24 035 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $300,000 |
| Convener and Organizer of Activities and Engagements Related to Processes, Surveillance, and Policy Development of Medical Products for Ongoing Public Health Activities, U01 Clinical Trial Not Allowed Apply for RFA FD 24 036 Funding Number: RFA FD 24 036 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $700,000 |
| FY 2024 SNAP Fraud Framework Implementation Grant Apply for USDA FNS SNAP FFIG 2024 Funding Number: USDA FNS SNAP FFIG 2024 Agency: Food and Nutrition Service Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Renewal Application: Increasing the Quality and Efficiency of Clinical Trials (U18) Clinical Trials Optional Apply for RFA FD 24 040 Funding Number: RFA FD 24 040 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $7,500,000 |
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