Opportunity Information: Apply for RFA FD 16 021
Apply for RFA FD 16 021
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "FDA Drug Residue Cooperative Agreement Program (U18)" 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 Mar 14, 2016 and posted on Mar 14, 2016.
- Applicants must submit their applications by May 16, 2016. (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 $125,000.00 in funding.
- The number of recipients for this funding is limited to 4 candidate(s).
- Eligible applicants include: State governments.
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Opportunity Summary:
The FDA Drug Residue Cooperative Agreement Program (U18) is a discretionary cooperative agreement opportunity from the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), designed to strengthen and expand state-level efforts to prevent illegal drug residues in foods derived from animals. The core purpose is consumer protection: helping states build and improve drug residue prevention programs so that edible products from food animals (such as meat and other animal-derived foods) are less likely to contain unsafe or unlawful drug residues. The program is structured around practical, prevention-focused work, emphasizing that stopping residue problems upstream through better practices, education, and program management is more effective than reacting after violations occur.
A major focus of the opportunity is to provide targeted assistance to state tissue residue programs that need a stronger foundation. The funding is meant to support educational outreach and training that improves understanding of proper drug use in food animals, including correct dosing, adherence to withdrawal times, and other husbandry and management practices that reduce the risk of residues entering the food supply. In addition to direct training, the program stresses the importance of clear communication and promotion of effective best practices for drug residue prevention. In other words, states are expected not only to know what works, but also to actively disseminate that information to relevant stakeholders such as producers, veterinarians, and others involved in raising and marketing food animals.
Because this is a cooperative agreement (rather than a standard grant), it implies a more collaborative relationship with the FDA during the project period. The opportunity is also intended to help states assess how well their current prevention systems are working. That includes measuring the performance of existing state drug residue prevention programs, identifying gaps or weaknesses, and then using those findings to improve current programs or develop new ones where needed. The overall outcome FDA is aiming for is a better-directed, more effective state capability to reduce illegal residue events in animal-derived foods, thereby lowering consumer exposure and improving compliance with applicable drug use and food safety requirements.
Eligibility is limited to state governments. The funding opportunity number is RFA-FD-16-021 (CFDA 93.103). FDA anticipated making up to 4 awards, with an award ceiling of $125,000 per award. The opportunity was posted on March 14, 2016, with an application closing date of May 16, 2016.
FDA Drug Residue Cooperative Agreement Program (U18) - FAQs
What is the FDA Drug Residue Cooperative Agreement Program (U18)?
The FDA Drug Residue Cooperative Agreement Program (U18) is a discretionary cooperative agreement opportunity from the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). It is designed to strengthen and expand state-level efforts to prevent illegal drug residues in foods derived from animals.
What problem is this program intended to address?
The program focuses on preventing illegal or unsafe drug residues from appearing in edible products from food animals, such as meat and other animal-derived foods. The goal is to reduce the likelihood that these foods contain unlawful or unsafe drug residues.
What is the main purpose of this funding opportunity?
The core purpose is consumer protection. FDA aims to help states build and improve drug residue prevention programs so state systems are better able to reduce illegal residue events and lower consumer exposure.
Why does the program emphasize prevention rather than reacting to violations?
The opportunity is described as prevention-focused, emphasizing that stopping residue problems upstream through better practices, education, and program management is more effective than reacting after violations occur.
What kinds of activities does the program support?
The funding is meant to support practical, prevention-focused work, including educational outreach and training to improve understanding of proper drug use in food animals and the husbandry and management practices that reduce residue risks.
What topics are expected to be covered through training and outreach?
The opportunity highlights improving understanding of proper drug use in food animals, including correct dosing, adherence to withdrawal times, and other practices that reduce the risk of residues entering the food supply.
Who are states expected to reach through communication and best-practice promotion?
States are expected to disseminate effective best practices and communicate clearly with relevant stakeholders such as producers, veterinarians, and others involved in raising and marketing food animals.
What does it mean that this is a cooperative agreement rather than a standard grant?
Because it is a cooperative agreement, it implies a more collaborative relationship with the FDA during the project period, rather than a more hands-off funding relationship typical of some standard grants.
Does the program focus on building new programs or improving existing ones?
Both. The opportunity is intended to help states strengthen the foundation of tissue residue prevention programs that need improvement, and it also supports improving current programs or developing new ones where needed based on identified gaps.
How does the program expect states to evaluate their current drug residue prevention systems?
The opportunity indicates states should assess how well their current prevention systems are working by measuring performance of existing state drug residue prevention programs, identifying gaps or weaknesses, and using those findings to guide improvements.
What outcomes is FDA aiming for through this program?
FDA is aiming for better-directed and more effective state capability to reduce illegal residue events in animal-derived foods, thereby lowering consumer exposure and improving compliance with applicable drug use and food safety requirements.
Who is eligible to apply for this opportunity?
Eligibility is limited to state governments.
What is the funding opportunity number and CFDA number?
The funding opportunity number is RFA-FD-16-021, and the CFDA number is 93.103.
How many awards did FDA anticipate making under this opportunity?
FDA anticipated making up to 4 awards.
What is the maximum award amount (award ceiling)?
The award ceiling was $125,000 per award.
When was this opportunity posted and when was the application due?
The opportunity was posted on March 14, 2016, and the application closing date was May 16, 2016.
Which federal agencies sponsor and administer this opportunity?
The opportunity is from the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
What type of state programs are specifically mentioned as a focus area?
The opportunity specifically mentions targeted assistance to state tissue residue programs that need a stronger foundation.
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| Development, Implementation, and Management of a Funding System to support the Grade “A” Milk Safety Program and Molluscan Shellfish Program (U18) Apply for RFA FD 16 023 Funding Number: RFA FD 16 023 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $900,000 |
| Architectural review of the BRIDG model (U01) Apply for RFA FD 16 015 Funding Number: RFA FD 16 015 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $225,000 |
| Investigation of Peptide-Polymer Interaction in Poly(lactide-co-glycolide) Microspheres (U01) Apply for RFA FD 16 012 Funding Number: RFA FD 16 012 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $250,000 |
| Assessment of Intersubject Variability in Small Airway Delivery with Oral Inhalation Drug Products (U01) Apply for RFA FD 16 024 Funding Number: RFA FD 16 024 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $200,000 |
| Implementing Population Pharmacokinetic Modeling Algorithm in Physiologically-based Pharmacokinetic Models to Allow Parameter Estimation at Individual Data Level (U01) Apply for RFA FD 16 026 Funding Number: RFA FD 16 026 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $250,000 |
| Development, Implementation, and Management of a Funding System to Advance Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) (U18) Apply for RFA FD 16 016 Funding Number: RFA FD 16 016 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $2,420,000 |
| Evaluation of Aberrant Observations and Their Impact on Bioequivalence Assessment (U01) Apply for RFA FD 16 018 Funding Number: RFA FD 16 018 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $200,000 |
| Therapeutic Areas for Data Standards Development (U01) Apply for RFA FD 16 020 Funding Number: RFA FD 16 020 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $225,000 |
| Bioequivalence of Topical Products: Comparing Dermal Pharmacokinetics by Microdialysis or Microperfusion Techniques (U01) Apply for RFA FD 16 028 Funding Number: RFA FD 16 028 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $500,000 |
| Integrating Supersaturation-precipitation Mechanisms in Mechanistic Oral Absorption Models for Predicting In- vivo Performance of Associated Formulations (U01) Apply for RFA FD 16 025 Funding Number: RFA FD 16 025 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $250,000 |
| Study of Fluid Amounts Taken with Oral Drug Products (U01) Apply for RFA FD 16 033 Funding Number: RFA FD 16 033 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $300,000 |
| Refine, Complete, and Publish Data Standards for Animal Efficacy Studies and Natural History Studies for Animal Rule Applications (U01) Apply for RFA FD 16 008 Funding Number: RFA FD 16 008 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $250,000 |
| Bioequivalence of Topical Products: Comparing Epidermal Pharmacokinetics by Spectroscopic Imaging Techniques (U01) Apply for RFA FD 16 029 Funding Number: RFA FD 16 029 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $250,000 |
| Analgesic, Anesthetic and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) (U01) Apply for RFA FD 16 047 Funding Number: RFA FD 16 047 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $800,000 |
| Pediatric Anesthesia Safety Initiative (PASI) (U01) Apply for RFA FD 16 037 Funding Number: RFA FD 16 037 Agency: HHS-FDA Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $800,000 |
| FDA Drug Residue Prevention Program (U18) Apply for RFA FD 18 006 Funding Number: RFA FD 18 006 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $175,000 |
| Development, Implementation, and Management of a Funding System to support the Grade “A” Milk Safety Program and National Shellfish Sanitation Program (U18) Apply for RFA FD 19 004 Funding Number: RFA FD 19 004 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $3,000,000 |
| National Project to Support and Promote Consistent Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (U18) Apply for RFA FD 19 023 Funding Number: RFA FD 19 023 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $1,500,000 |
| Revision Applications - FSMA Human Foods Preventive Controls Implementation Expansion Supplement to RFA-FD-18-001 (U18 Clinical Trials Not Allowed) Apply for PAR 20 091 Funding Number: PAR 20 091 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $300,000 |
| CFD Models to aid the development of generic inhalation products Apply for FOR FD 20 023 Funding Number: FOR FD 20 023 Agency: Department of Health and Human Services, Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: Case Dependent |
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