Opportunity Information: Apply for RFA FD 16 023
Apply for RFA FD 16 023
- The HHS-FDA in the consumer protection, food and nutrition, health sector is offering a public funding opportunity titled "Development, Implementation, and Management of a Funding System to support the Grade “A” Milk Safety Program and Molluscan Shellfish 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 $900,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- Eligible applicants include: 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.
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Opportunity Summary:
The Development, Implementation, and Management of a Funding System to support the Grade "A" Milk Safety Program and Molluscan Shellfish Program (U18) is a discretionary federal funding opportunity released by the U.S. Department of Health and Human Services, Food and Drug Administration (HHS-FDA). It was offered as a cooperative agreement, meaning the FDA would likely remain actively involved with the recipient(s) during the project rather than simply providing funds with minimal interaction. The opportunity was posted and created on March 14, 2016, with an application closing date of May 16, 2016. The program falls under the Consumer Protection, Food and Nutrition, and Health activity category and is associated with CFDA number 93.103.
The main purpose of the award is to build and run a structured funding system that can distribute (subaward) money to government regulatory programs responsible for two key public health areas: the Grade "A" Milk Safety Program and the National Shellfish Sanitation Program (NSSP), which covers molluscan shellfish safety. Instead of awarding funds directly to every state, tribal, or territorial regulatory agency, the FDA intended to fund up to two nonprofit associations or organizations that would serve as the administrators of the funding system. These nonprofits would then accept applications from eligible state, tribal, and territorial regulatory programs and make subawards to support improvements in training, equipment, and overall program implementation.
The work described centers on practical capacity-building. Subawarded funds are meant to help regulatory agencies purchase equipment and obtain technical training that strengthens inspection, monitoring, compliance, and other core functions tied to milk safety oversight and shellfish sanitation controls. The broader goal is to improve how well these regulatory programs carry out and sustain the standards and practices required under the Grade "A" Milk Safety Program and the NSSP, ultimately supporting safer food systems and stronger public health protections.
Eligibility for the prime award was limited to nonprofit organizations, including both nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status, as long as they were not institutions of higher education. The FDA expected to make up to two awards under this announcement, with an award ceiling of $900,000. In practice, that ceiling indicates the maximum amount available per award, and the structure suggests that each selected nonprofit would be responsible for administering a funding pipeline, including designing the application process for subawards, managing review and selection procedures, handling distribution of funds, and overseeing basic governance and accountability for how subrecipients use the money.
In short, this FOA (RFA FD 16 023) was designed to create an organized, nonprofit-run grantmaking mechanism that channels federal resources to frontline state, tribal, and territorial regulators. By focusing subawards on training and equipment and by strengthening implementation of the Grade "A" Milk Safety Program and the National Shellfish Sanitation Program, the opportunity aims to modernize and reinforce regulatory capacity where it directly affects the safety of milk and molluscan shellfish in U.S. commerce.
Frequently Asked Questions (FAQs)
What is the name of this grant opportunity?
The opportunity is titled "The Development, Implementation, and Management of a Funding System to support the Grade 'A' Milk Safety Program and Molluscan Shellfish Program (U18)."
Which federal agency released this funding opportunity?
It was released by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
What type of federal funding mechanism is this?
This was offered as a cooperative agreement (U18), which generally indicates that FDA would likely stay actively involved with the recipient(s) during the project rather than only providing funds with minimal interaction.
Is this a discretionary or formula funding opportunity?
This is described as a discretionary federal funding opportunity.
When was the opportunity posted and when did it close?
The opportunity was posted and created on March 14, 2016. The application closing date was May 16, 2016.
What is the primary purpose of the award?
The main purpose is to build and operate a structured funding system that can distribute funds as subawards to government regulatory programs responsible for the Grade "A" Milk Safety Program and the National Shellfish Sanitation Program (NSSP) for molluscan shellfish safety.
What public health programs does the funding system support?
The funding system supports two key areas: (1) the Grade "A" Milk Safety Program and (2) the National Shellfish Sanitation Program (NSSP), which covers molluscan shellfish safety.
Who was FDA intending to fund directly under this announcement?
Rather than funding each state, tribal, or territorial agency directly, FDA intended to fund up to two nonprofit associations or organizations that would administer the funding system and then make subawards to eligible regulatory programs.
Who is eligible to apply for the prime (direct) award?
Eligibility for the prime award was limited to nonprofit organizations, including nonprofits with 501(c)(3) status and nonprofits without 501(c)(3) status, as long as they were not institutions of higher education.
Are institutions of higher education eligible to apply as the prime recipient?
No. The eligibility description specifies nonprofits (with or without 501(c)(3) status) that are not institutions of higher education.
How many awards did FDA expect to make?
FDA expected to make up to two awards under this announcement.
What is the maximum award amount (award ceiling)?
The award ceiling was $900,000, which indicates the maximum amount available per award.
What would the prime award recipients be responsible for doing?
The selected nonprofit(s) would be responsible for administering a funding pipeline. This includes designing the application process for subawards, managing review and selection procedures, distributing funds, and providing basic governance and accountability for how subrecipients use the money.
Who would be eligible to receive subawards from the funding system?
Subawards were intended for eligible state, tribal, and territorial government regulatory programs responsible for implementing and maintaining the Grade "A" Milk Safety Program and/or the NSSP.
What kinds of activities were subawarded funds meant to support?
Subawarded funds were meant to support practical capacity-building, including purchasing equipment and obtaining technical training to strengthen inspection, monitoring, compliance, and other core regulatory functions tied to milk safety oversight and shellfish sanitation controls.
What is the overall goal of providing training and equipment to regulatory agencies?
The broader goal is to improve how well regulatory programs carry out and sustain the standards and practices required under the Grade "A" Milk Safety Program and the NSSP, supporting safer food systems and stronger public health protections.
What activity category is associated with this opportunity?
The program falls under the Consumer Protection, Food and Nutrition, and Health activity category.
What CFDA number is associated with this opportunity?
The opportunity is associated with CFDA number 93.103.
What is the FOA or RFA identifier mentioned for this opportunity?
The announcement is referenced as RFA FD 16 023.
Does this opportunity fund improvements directly at the local regulatory level?
Yes, but indirectly. The FDA funds up to two nonprofit administrators, and those administrators then provide subawards to state, tribal, and territorial regulatory programs to support improvements such as training and equipment.
Why use nonprofit administrators instead of awarding funds directly to states, tribes, and territories?
Based on the description, the intent was to create an organized, nonprofit-run grantmaking mechanism that could accept applications from eligible regulatory programs and distribute funds through subawards, rather than having FDA issue direct awards to each individual regulatory agency.
What food products are directly tied to the safety programs named in this opportunity?
The Grade "A" Milk Safety Program is tied to milk safety, and the NSSP component is tied to molluscan shellfish safety.
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| 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 |
| Collaborating Centers of Excellence in Regulatory Science and Innovation (U01) Apply for RFA FD 16 036 Funding Number: RFA FD 16 036 Agency: Food and Drug Administration Category: Consumer Protection, Food and Nutrition, Health Funding Amount: $5,000,000 |
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