Opportunity Information: Apply for RFA FD 16 017

  • The HHS-FDA in the consumer protection, food and nutrition, health, science and technology and other research and development sector is offering a public funding opportunity titled "Manufactured Food Regulatory Program Alliance (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 Apr 14, 2016 and posted on Apr 14, 2016.
  • Applicants must submit their applications by Jul 02, 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 $2,943,750.00 in funding.
  • The number of recipients for this funding is limited to 1 candidate(s).
  • Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
Apply for RFA FD 16 017

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Opportunity Summary:

The Manufactured Food Regulatory Program Alliance (U18) is an FDA cooperative agreement opportunity designed to strengthen the national food safety system over the long term by building closer, more effective partnerships across federal, state, local, tribal, and other food safety stakeholders. Run through HHS-FDA (specifically FDA/ORA), the program focuses on improving how manufactured food regulatory programs operate and coordinate, enhancing surveillance and regulatory protection for manufactured foods, supporting applied research, and expanding awareness and adoption of the Manufactured Food Regulatory Program Standards (MFRPS). The overall intent is to move food protection efforts toward a more consistent, prevention-oriented system that reduces foodborne illness risks in facilities that manufacture, process, pack, or hold food.

A key driver behind this funding is the FDA Food Safety Modernization Act (FSMA), which shifted FDA's mandate from reacting to outbreaks to preventing them. FSMA covers both human and animal food, including pet food, and it directs the establishment and adoption of modern preventive controls and safety practices across the food supply chain, from growing and processing through transportation and storage. Congress also explicitly recognized that food safety in the United States is not handled by FDA alone; it is distributed across more than 3,000 state, local, tribal, and other government agencies. Because those agencies conduct inspections, investigations, sampling, compliance activities, and other frontline work, the grant emphasizes integrating their efforts with FDA so that everyone is working toward the same prevention and risk-based goals. This is the broader vision often described as a National Integrated Food Safety System, where responsibilities are shared but standards, training, quality, and outcomes are aligned.

The grant places strong emphasis on resource leveraging and harmonization, meaning it is not just about funding isolated projects. Instead, award activities are expected to involve extensive cooperation and coordination with FDA, national organizations and initiatives, state and local regulatory programs, and other major stakeholders involved in food safety. The cooperative agreement structure signals that FDA expects to be substantially involved during the period of performance, typically through joint planning, technical input, coordination of priorities, and alignment with national strategies rather than a hands-off pass-through of funds. In practical terms, the opportunity aims to help partners work from a common playbook, reduce duplication, and raise the overall performance and consistency of manufactured food oversight across jurisdictions.

Central to the opportunity are the Manufactured Food Regulatory Program Standards (MFRPS). These standards serve as a uniform foundation for how state programs that regulate food plants should be designed, managed, and continuously improved. The standards outline best practices associated with a high-quality regulatory program, helping programs assess their current capabilities, identify gaps, and build toward a more mature and reliable system. Conformance with MFRPS is meant to improve how both federal and state agencies target their regulatory efforts, especially by focusing on the hazards and conditions most associated with foodborne illness in manufactured food environments. By promoting and supporting implementation of MFRPS, the program aims to increase program quality, consistency, and effectiveness nationwide, which in turn supports better prevention, faster detection of problems, and more coordinated responses when issues arise.

From an administrative standpoint, this opportunity is listed as RFA-FD-16-017 under CFDA 93.103, offered as a discretionary Cooperative Agreement (U18). At the time of posting, FDA anticipated making a single award, with an award ceiling of $2,943,750. The opportunity was created and posted on April 14, 2016, with a closing date of July 2, 2016. Eligibility is noted broadly as "Others" with additional clarification referenced in the full announcement, indicating that applicants likely needed to fit specific categories described in the eligibility section of the official funding notice.

In short, the Manufactured Food Regulatory Program Alliance (U18) is aimed at building a more unified, prevention-centered food safety system by investing in collaboration, capability building, and consistent regulatory quality for manufactured food programs, using MFRPS as the core framework and FSMA as the policy foundation guiding the work.

Manufactured Food Regulatory Program Alliance (U18) - FAQ

What is the Manufactured Food Regulatory Program Alliance (U18)?

The Manufactured Food Regulatory Program Alliance (U18) is an FDA cooperative agreement opportunity intended to strengthen the national food safety system over the long term. It does this by building closer, more effective partnerships among federal, state, local, tribal, and other food safety stakeholders, with an emphasis on manufactured food regulatory programs.

Which federal agency runs this funding opportunity?

This opportunity is run through HHS-FDA, specifically the FDA Office of Regulatory Affairs (FDA/ORA).

What is the main purpose of the program?

The program focuses on improving how manufactured food regulatory programs operate and coordinate, enhancing surveillance and regulatory protection for manufactured foods, supporting applied research, and expanding awareness and adoption of the Manufactured Food Regulatory Program Standards (MFRPS). The overall intent is to support a more consistent, prevention-oriented system that reduces foodborne illness risks in facilities that manufacture, process, pack, or hold food.

What types of facilities are in scope for the program's food protection goals?

The opportunity targets food protection efforts related to facilities that manufacture, process, pack, or hold food (manufactured food environments). The description also notes that FSMA covers human and animal food, including pet food.

What is FSMA and why is it important to this grant?

The FDA Food Safety Modernization Act (FSMA) is identified as a key driver for this funding. FSMA shifted FDA's mandate from reacting to outbreaks to preventing them. It directs the establishment and adoption of modern preventive controls and safety practices across the food supply chain, from growing and processing through transportation and storage.

How does this opportunity relate to a National Integrated Food Safety System?

The grant supports the broader vision often described as a National Integrated Food Safety System, where food safety responsibilities are shared across jurisdictions but standards, training, quality, and outcomes are aligned. The opportunity emphasizes integrating the work of state, local, tribal, and other agencies with FDA so that everyone works toward the same prevention and risk-based goals.

Why does the grant emphasize partnerships beyond FDA?

Congress recognized that food safety in the United States is not handled by FDA alone and is distributed across more than 3,000 state, local, tribal, and other government agencies. Because these agencies conduct inspections, investigations, sampling, compliance activities, and other frontline work, the program emphasizes coordination and alignment with FDA to support prevention-focused and risk-based oversight.

What does "resource leveraging and harmonization" mean in this context?

Resource leveraging and harmonization means the program is not designed to fund isolated, stand-alone projects. Instead, award activities are expected to involve extensive cooperation and coordination with FDA, national organizations and initiatives, state and local regulatory programs, and other major food safety stakeholders. The aim is to work from a common playbook, reduce duplication, and raise consistency across jurisdictions.

What is a cooperative agreement (U18) and how is it different from a typical grant?

This opportunity is a discretionary Cooperative Agreement (U18). The cooperative agreement structure indicates that FDA expects to be substantially involved during the period of performance, typically through joint planning, technical input, coordination of priorities, and alignment with national strategies rather than operating as a hands-off pass-through of funds.

What are the Manufactured Food Regulatory Program Standards (MFRPS)?

MFRPS are described as a uniform foundation for how state programs that regulate food plants should be designed, managed, and continuously improved. They outline best practices associated with a high-quality regulatory program and help programs assess current capabilities, identify gaps, and build toward a more mature and reliable system.

Why are MFRPS central to this funding opportunity?

The opportunity places MFRPS at the center because promoting and supporting implementation of these standards is intended to increase regulatory program quality, consistency, and effectiveness nationwide. Conformance with MFRPS is meant to improve how federal and state agencies target regulatory efforts, especially by focusing on hazards and conditions most associated with foodborne illness in manufactured food environments.

What kinds of outcomes is the program trying to improve?

Based on the description, the program aims to improve prevention of food safety problems, strengthen surveillance and regulatory protection, support faster detection of problems, and enable more coordinated responses when issues arise. It also aims to improve overall performance and consistency of manufactured food oversight across jurisdictions.

What kinds of activities does the opportunity highlight?

The opportunity highlights improving program operations and coordination, enhancing surveillance and regulatory protection for manufactured foods, supporting applied research, and expanding awareness and adoption of MFRPS. It also emphasizes broad cooperation and alignment with FDA and other stakeholders.

What is the program's approach to prevention and risk-based oversight?

The opportunity reflects FSMA's prevention-oriented approach, aiming to reduce foodborne illness risks by strengthening regulatory programs and aligning oversight around prevention and risk-based priorities, particularly in manufactured food facilities.

What is the funding opportunity number and program listing information?

The opportunity is listed as RFA-FD-16-017 under CFDA 93.103.

How many awards did FDA anticipate making?

At the time of posting, FDA anticipated making a single award.

What was the award ceiling?

The award ceiling listed for the opportunity was $2,943,750.

When was the opportunity posted and when did it close?

The opportunity was created and posted on April 14, 2016, and it had a closing date of July 2, 2016.

Who was eligible to apply?

Eligibility is noted broadly as "Others," with additional clarification referenced in the full announcement. This suggests applicants needed to fit specific categories described in the eligibility section of the official funding notice.

Does the description specify exactly which organizations qualify under "Others"?

No. The description provided notes "Others" and indicates that additional clarification is referenced in the full announcement, but the specific categories are not included in the text provided.

What does the opportunity say about coordination with national organizations and initiatives?

The opportunity states that award activities are expected to involve extensive cooperation and coordination not only with FDA but also with national organizations and initiatives, state and local regulatory programs, and other major food safety stakeholders.

Is the program intended to reduce duplication across jurisdictions?

Yes. The description explicitly notes goals such as working from a common playbook, reducing duplication, and improving consistency and performance of manufactured food oversight across jurisdictions.

How does the opportunity describe the role of state, local, and tribal agencies?

It highlights that state, local, tribal, and other agencies perform frontline work such as inspections, investigations, sampling, and compliance activities. Because of that, the grant emphasizes integrating their efforts with FDA toward shared prevention and risk-based goals.

What is the long-term intent of investing in this alliance?

The long-term intent is to strengthen the national food safety system by investing in collaboration, capability building, and consistent regulatory quality for manufactured food programs, using MFRPS as the core framework and FSMA as the policy foundation.

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