Opportunity Information: Apply for RFA FD 24 020
This funding opportunity is a U.S. Food and Drug Administration (FDA) cooperative agreement (U01) issued through the Center for Drug Evaluation and Research (CDER), Office of New Drugs (OND), focused on identifying and evaluating practical ways to address nitrosamine impurities in human drug products. Nitrosamines are chemical impurities that can arise during manufacturing, formulation, packaging, or storage, and some are considered probable or known carcinogens. The overall purpose of the award is to directly support FDA's public health mission by reducing unacceptable nitrosamine-related risks while also helping maintain reliable access to important medicines. The work is intended to move beyond purely theoretical research and instead generate translational, implementable approaches that can be used in real-world drug development and manufacturing settings to prevent, detect, assess, and control nitrosamine impurity liabilities.
The FOA emphasizes that, even though FDA and stakeholders have already undertaken substantial experimental work and regulatory or policy efforts in this area, there is still a gap in methods and practices that can be broadly adopted across the drug supply chain. The project is therefore aimed at developing and refining approaches that can be put into practice by manufacturers and other stakeholders, with the ultimate goal of improving the safety profile of marketed and pipeline drugs that may be vulnerable to nitrosamine formation or contamination. A notable requirement is forward-looking sustainability: in addition to the core research and practices development, the awardee must evaluate and propose how the resulting work can continue after the FDA-funded period ends, including mechanisms for ongoing collaboration and upkeep among industry, nonprofit organizations, and academic institutions. In other words, the FDA is not just funding a one-time study; it is looking for work that can be carried forward and maintained as an active, evolving body of practice once the cooperative agreement concludes.
From an administrative and eligibility standpoint, this is a discretionary grant mechanism under a cooperative agreement structure, meaning the FDA is expected to have substantial involvement during the project period compared with a standard grant. The opportunity is labeled "Clinical Trials Not Allowed," indicating that applicants should not propose clinical trials as part of the scope; the work is expected to center on impurity science, analytical methods, risk assessment approaches, manufacturing controls, or other non-clinical translational practices relevant to nitrosamine impurities in drugs. The funding opportunity number is RFA-FD-24-020, associated with CFDA number 93.103, and it falls within the broad activity category of agriculture/consumer protection/food and nutrition, consistent with FDA's public health regulatory mission.
The applicant pool is intentionally broad and includes government entities (state, county, city/township, special districts), public and private institutions of higher education, federally recognized Native American tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofit organizations with or without 501(c)(3) status, for-profit organizations (including those other than small businesses), small businesses, and essentially unrestricted applicants. The FOA anticipates making a single award (Expected Awards: 1), with an award ceiling of $350,000. The original application closing date listed is February 27, 2024, and the opportunity was created on December 21, 2023. Taken together, these details point to a single, targeted project designed to generate usable, durable practices that strengthen FDA and stakeholder capability to manage nitrosamine impurity risks across human drugs, without involving clinical trial activities.Apply for RFA FD 24 020
- The Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Identification and Evaluation of Possible Approaches to Addressing Nitrosamine Impurities in Drugs (U01) Here and Clinical Trial Designator - 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 $350,000.00 in funding.
- The number of recipients for this funding is limited to 1 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, Unrestricted.
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| Funding Opportunity |
|---|
| Strengthening Global Competency and Capacity in Inspectional Approaches for the Oversight of Human and Animal Pharmaceutical Products (U01) Clinical Trials Not Allowed Apply for RFA FD 24 026 Funding Number: RFA FD 24 026 Agency: Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $150,000 |
| 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 |
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