Opportunity Information: Apply for RFA FD 24 026
This FDA cooperative agreement (RFA-FD-24-026) supports a single, targeted effort to strengthen how national regulatory authority (NRA) inspectorates around the world oversee the manufacturing quality of human and veterinary pharmaceutical products. The focus is on improving good manufacturing practice (GMP) inspection approaches in a way that is data-driven, science-based, and aligned with FDA priorities for integrating inspection activities with modern risk assessment methods, including data modeling that can inform risk-based inspection planning, prioritization, and workplans. Clinical trials are not allowed under this opportunity, since the work is centered on regulatory oversight capacity and inspectional systems rather than clinical research.
The core purpose is to leverage an institution that already has deep, globally recognized expertise in GMP inspectorate quality standards and training, and use that platform to build broader international alignment. The funded work is expected to catalyze efforts to build global consensus on what "optimal" GMP inspections look like, what competencies inspectors and investigators should have, and how inspection programs should plan and prioritize inspections based on well-informed risk assessments. This matters because pharmaceutical manufacturing and supply chains are increasingly complex, innovative, and internationally distributed, which raises the stakes for consistent inspection quality and comparable decision-making across jurisdictions.
A major theme of the award is systems-level harmonization. Rather than producing isolated training materials or one-off workshops, the project is intended to help drive sustainable alignment across multiple NRA inspectorates by promoting common standards, shared practices, and interoperable approaches to inspection planning and execution. In practical terms, the opportunity points toward coordinated inspector training and regulatory expert development, strengthened networking among inspectorates, and approaches that increase mutual confidence in GMP inspection outcomes across countries. The end goal is stronger, more consistent oversight of pharmaceutical supply chains globally, supported by shared expectations for inspector competency and a common understanding of risk-based inspection strategies.
Eligibility is extremely limited. Only the Pharmaceutical Inspection Cooperation Scheme (PIC/S) is eligible to apply. The solicitation also spells out the type of capabilities the applicant must demonstrate: strong institutional linkages with inspectorates worldwide; broad knowledge of GMP procedures and regulatory systems across regions for both human and veterinary medicinal products; leadership in the international development and maintenance of harmonized GMP standards and quality systems; a proven track record working across a diverse range of NRA inspectorates to harmonize and better align inspection procedures through common standards and capacity-building; and demonstrated experience designing competency- and capacity-building programs that strengthen inspector skills and support harmonized inspection procedures.
From an administrative standpoint, the award mechanism is a cooperative agreement (U01), which typically means FDA expects substantial involvement during the project period compared with a standard grant. The opportunity is listed under CFDA 93.103, with an activity category covering areas such as consumer protection and related regulatory public health functions. The agency anticipates making one award, with an award ceiling of $150,000. The opportunity was created on December 21, 2023, and the original application due date was February 27, 2024.
Foreign participation is explicitly permitted in the sense that non-U.S. entities may apply when eligible, non-domestic components of U.S. organizations are eligible, and foreign components (as defined in HHS grants policy) are allowed. In this case, because PIC/S is the only eligible applicant and it is an international cooperation scheme, the design of the program inherently supports global engagement and cross-border collaboration among regulatory authorities.Apply for RFA FD 24 026
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed" 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 2023-12-21.
- Applicants must submit their applications by 2024-02-27. (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 $150,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others.
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| Funding Opportunity |
|---|
| OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 023 Funding Number: RFA FD 24 023 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Cooperative Agreement to Support a Human Abuse Potential Study of Botanical Kratom (U01 Clinical Trial Required) Apply for RFA FD 24 025 Funding Number: RFA FD 24 025 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Collaborations to Enhance Drug Development and Regulatory Science - Clinical Trials Optional Apply for RFA FD 24 029 Funding Number: RFA FD 24 029 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| 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 |
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