Opportunity Information: Apply for RFA FD 24 027
The funding opportunity titled "Critical Path Public Private Partnerships Clinical Trials Optional" (RFA-FD-24-027) is a discretionary cooperative agreement offered by the U.S. Food and Drug Administration (FDA) to support the continued operation of public-private partnership consortia originally convened and established by the Critical Path Institute (C-Path). This announcement is specifically framed as a renewal of an existing cooperative agreement, #5U18FD005320, and it sits within the broader FDA Critical Path Initiative, which was authorized in Section 566 of the Federal Food, Drug, and Cosmetic Act. In practical terms, the FDA is looking for an applicant capable of maintaining and managing the current network of consortia groups and continuing their collaborative work rather than creating an entirely new program from scratch.
The central purpose of the award is to sustain and advance collaborative projects that help modernize and speed up the development of medical products by improving the tools, methods, and evidence-generation approaches used across the product lifecycle. The scope described emphasizes research, education, and outreach activities designed to foster drug product innovation and to enable faster and more efficient development, manufacturing, and translational therapeutics. The work is also intended to strengthen the foundations of regulatory science by enhancing the safety, efficacy, quality, and overall performance of drug products. Although the title references "Clinical Trials Optional," the description is broader than clinical trials alone and points to a range of activities that can support development and evaluation, including coordination of multi-stakeholder consortia and development of innovative approaches that can be shared across industry, academia, and regulators.
This opportunity uses the cooperative agreement mechanism, meaning FDA anticipates substantial involvement in the funded effort compared to a more hands-off grant. The activity category is listed under agriculture/consumer protection/food and nutrition (CFDA 93.103), reflecting FDA's broader public health mission and regulatory responsibilities. Eligibility is categorized as "Others," and the announcement indicates an expectation of a single award, which aligns with the renewal nature of the effort and the focus on continuing work tied to C-Path-established consortia.
Key logistics included in the notice are a creation date of January 4, 2024, and an original closing date of March 4, 2024. The award ceiling is up to $20,000,000, with one expected award, and the agency notes that actual support is dependent on the availability of FDA funding. Overall, the grant is designed to keep established consortia functioning effectively, continue cross-sector coordination, and produce collaborative outputs that help accelerate therapeutic innovation while improving evidence quality and public health protections.Apply for RFA FD 24 027
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Critical Path Public Private Partnerships 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 2024-03-04. (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 $20,000,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others.
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Frequently Asked Questions (FAQs)
1) What is the title and number of this funding opportunity?
The opportunity is titled "Critical Path Public Private Partnerships Clinical Trials Optional" and the funding opportunity number is RFA-FD-24-027.
2) Which federal agency is offering this opportunity?
This opportunity is offered by the U.S. Food and Drug Administration (FDA).
3) What type of funding mechanism is being used?
The mechanism is a discretionary cooperative agreement. Compared with a traditional grant, FDA expects substantial involvement in the funded effort.
4) Is this a new program or a continuation of an existing effort?
It is framed as a renewal of an existing cooperative agreement (identified as #5U18FD005320). The intent is to continue operating and managing an existing network of public-private partnership consortia rather than creating a brand-new program.
5) What is the overall purpose of the award?
The central purpose is to sustain and advance collaborative projects that modernize and speed up medical product development by improving tools, methods, and evidence-generation approaches used across the product lifecycle.
6) What kinds of activities does the scope emphasize?
The scope emphasizes research, education, and outreach activities intended to foster drug product innovation and support faster, more efficient development, manufacturing, and translational therapeutics.
7) How does this opportunity relate to FDA's Critical Path Initiative?
The opportunity sits within the broader FDA Critical Path Initiative, which was authorized in Section 566 of the Federal Food, Drug, and Cosmetic Act.
8) What role do public-private partnership consortia play in this opportunity?
The award is intended to support the continued operation of public-private partnership consortia that were originally convened and established by the Critical Path Institute (C-Path). The funded applicant is expected to maintain and manage the current network of consortia groups and continue their collaborative work.
9) Is the focus limited to clinical trials?
No. While the title includes "Clinical Trials Optional," the description is broader than clinical trials alone and includes activities that support development and evaluation more generally, such as coordination of multi-stakeholder consortia and development of innovative approaches that can be shared across industry, academia, and regulators.
10) What is meant by "clinical trials optional" in this context?
Based on the description provided, clinical trials may be part of the work but are not the only focus. The opportunity also highlights broader collaboration, tool and method development, and evidence-generation improvements across the medical product lifecycle.
11) What outcomes is FDA seeking from the funded work?
The work is intended to produce collaborative outputs that help accelerate therapeutic innovation while improving evidence quality and strengthening public health protections, including enhancing the safety, efficacy, quality, and overall performance of drug products.
12) What does FDA's "substantial involvement" imply for applicants?
Because this is a cooperative agreement, FDA anticipates being substantially involved in the funded effort. This generally indicates more ongoing collaboration and engagement by the agency than would be expected under a more hands-off grant mechanism.
13) What is the assistance listing or CFDA number provided?
The activity category is listed under agriculture/consumer protection/food and nutrition, with CFDA 93.103.
14) Who is eligible to apply?
Eligibility is categorized as "Others" in the notice.
15) How many awards does FDA expect to make?
The announcement indicates an expectation of a single award.
16) Why is only one award expected?
The notice aligns the single expected award with the renewal nature of the effort and the focus on continuing work tied to the existing C-Path-established consortia network.
17) What is the maximum award amount?
The award ceiling is up to $20,000,000.
18) Is the full amount guaranteed?
No. The agency notes that actual support is dependent on the availability of FDA funding.
19) What are the key dates listed in the notice?
The creation date is January 4, 2024, and the original closing date is March 4, 2024.
20) What is the applicant expected to do operationally?
The applicant is expected to maintain and manage the current network of consortia groups and continue cross-sector coordination so established consortia can keep functioning effectively and advancing shared projects.
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| 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 |
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| 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 |
| Renewal Application: Kidney Health Initiative (R18) Clinical Trials Optional Apply for RFA FD 24 041 Funding Number: RFA FD 24 041 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $350,000 |
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