Opportunity Information: Apply for RFA FD 12 025
Apply for RFA FD 12 025
- The Food Drug Administration in the consumer protection food and nutrition health sector is offering a public funding opportunity titled "Building an Integrated Laboratory System to Advance the Safety of Food and Animal Feed (U18)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch.
- This funding opportunity was created on Jun 8, 2012 and posted on Jun 8, 2012.
- Applicants must submit their applications by Jul 16, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,500,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
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Opportunity Summary:
Building an Integrated Laboratory System to Advance the Safety of Food and Animal Feed (U18) is an FDA Office of Regulatory Affairs (ORA) cooperative agreement opportunity designed to strengthen the national system that supports food and animal feed safety. The program is framed as a limited-competition award, meaning it is not broadly competed across all organization types, and it is structured as a cooperative agreement (U18). That matters because a cooperative agreement typically involves substantial federal involvement beyond what is common in a standard grant, with the FDA working closely with the recipient to shape, coordinate, and advance the project goals. The central public health objective is to create long-term, durable improvements by building stronger, more consistent connections among laboratories that test food and animal feed and by improving the comparability and reliability of results across jurisdictions.
A core focus of the announcement is advancing ISO/IEC 17025:2005 accreditation for regulatory laboratories that handle food and animal feed testing. ISO/IEC 17025 is the key international standard for testing and calibration laboratories, and the FOA treats progress toward this accreditation as a foundational building block for an integrated laboratory system. In practical terms, emphasizing this standard signals a push for consistent quality management systems, validated methods, competency assurance, documentation, traceability, and reliable reporting practices across participating labs. The broader intent is that when laboratories operate under comparable quality systems, their analytical results become more equivalent and more readily accepted by other agencies, which is essential during routine regulatory work and especially during outbreaks or contamination events where time-sensitive decisions depend on trusted data.
Beyond accreditation, the opportunity also aims to establish a formal platform for an "integrated laboratory community" that brings together state and local food regulatory laboratories and regulatory program managers. The language highlights collaboration that is multidisciplinary and focused on equivalency and harmonization, not simply information sharing. The idea is to create a structured community where labs can coordinate around methods, quality practices, proficiency approaches, and mutual expectations so that results can be shared, compared, and accepted with greater confidence. By building this kind of community, the program is aiming to reduce duplication, speed up response efforts, and improve how laboratory evidence supports public health and regulatory actions.
The announcement also stresses leveraging resources and aligning efforts with other relevant initiatives. This includes coordination with federal partners and national initiatives and associations, as well as state and local partners. The intent is to avoid building a parallel system and instead connect existing efforts into a more coherent national approach. This emphasis on harmonization suggests the funded work is expected to operate as a convening and coordinating mechanism, helping different laboratories and programs move in the same direction on standards, quality expectations, and acceptability of results, rather than each jurisdiction solving the same problems independently.
Administratively, this FOA is identified as Funding Opportunity Number RFA-FD-12-025, with the title listed as Building an Integrated Laboratory System to Advance the Safety of Food and Animal Feed (U18). It falls under discretionary funding and is categorized under consumer protection, food and nutrition, and health. The FDA anticipated a single award, with an estimated total funding amount of $1,500,000, which is also listed as both the award ceiling and award floor, indicating the expectation of one award at that level. There is no cost-sharing or matching requirement. Eligible applicants are limited to nonprofits with 501(c)(3) status, excluding institutions of higher education. Key dates in the notice show it was posted on June 8, 2012, with an original and current closing date of July 16, 2012, and an archive date of August 15, 2012, indicating the opportunity is no longer open.
For applicants or interested parties who needed access to the full announcement at the time, the FOA referenced an additional information link to the full announcement in the NIH Guide, and it provided a grants management contact at FDA: Daniel Lukash, Grants Management Specialist (phone 301-827-6771, email daniel.lukash@fda.hhs.gov). Overall, the opportunity is best understood as a targeted FDA investment in laboratory system integration, using ISO/IEC 17025:2005 accreditation advancement and structured community-building among state and local regulatory labs as the primary mechanisms to improve the credibility, consistency, and interoperability of laboratory results that underpin food and animal feed safety decisions nationwide.
Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled Building an Integrated Laboratory System to Advance the Safety of Food and Animal Feed (U18).
Which agency is offering this cooperative agreement?
It is offered by the U.S. Food and Drug Administration (FDA), specifically the Office of Regulatory Affairs (ORA).
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-FD-12-025.
What type of funding mechanism is this (and what does U18 mean)?
This opportunity is a cooperative agreement (U18). A cooperative agreement typically includes substantial federal involvement compared with a standard grant, meaning FDA is expected to work closely with the recipient to shape, coordinate, and advance the project goals.
Is this a competitive opportunity open to all applicant types?
No. The announcement describes it as a limited-competition award, meaning it is not broadly competed across all organization types.
What is the public health goal of the program?
The central objective is to strengthen the national system supporting food and animal feed safety by creating durable improvements in how laboratories connect and by improving the comparability, reliability, and acceptability of test results across jurisdictions.
What is the main focus area emphasized in the announcement?
A core focus is advancing ISO/IEC 17025:2005 accreditation for regulatory laboratories that perform food and animal feed testing.
Why does ISO/IEC 17025:2005 matter in this program?
The FOA treats progress toward ISO/IEC 17025:2005 as foundational for an integrated laboratory system because it supports consistent laboratory quality practices such as quality management systems, validated methods, competency assurance, documentation, traceability, and reliable reporting. When labs operate under comparable quality systems, results are more equivalent and more readily accepted by other agencies.
What does the program mean by an "integrated laboratory system"?
Based on the announcement, it refers to stronger and more consistent connections among laboratories that test food and animal feed, with improved equivalency and harmonization so results can be shared, compared, and accepted with greater confidence across different jurisdictions.
Who is the program trying to bring together through the "integrated laboratory community"?
The program emphasizes bringing together state and local food regulatory laboratories and regulatory program managers into a formal platform for ongoing coordination and collaboration.
Is the community-building component just information sharing?
No. The language emphasizes collaboration that is multidisciplinary and focused on equivalency and harmonization, not simply sharing updates. The intent is structured coordination around methods, quality practices, proficiency approaches, and mutual expectations.
How is this expected to help during outbreaks or contamination events?
By improving the consistency and credibility of laboratory results, agencies can make time-sensitive decisions with greater confidence. Comparable quality systems also make it more feasible for results to be accepted across agencies during urgent response situations.
Does the opportunity expect applicants to coordinate with other initiatives?
Yes. The announcement stresses leveraging resources and aligning efforts with other initiatives, including coordination with federal partners, national initiatives and associations, and state and local partners.
What is the intent behind aligning with other partners and initiatives?
The stated intent is to avoid creating a parallel system and instead connect existing efforts into a more coherent national approach, reducing duplication and helping jurisdictions move in the same direction on standards and acceptance of results.
What funding category does this opportunity fall under?
The notice categorizes it under consumer protection, food and nutrition, and health, and identifies it as discretionary funding.
How many awards did FDA anticipate making?
FDA anticipated a single award.
What was the estimated total funding amount?
The estimated total funding amount was $1,500,000.
What were the award floor and award ceiling?
Both the award floor and award ceiling were listed as $1,500,000, indicating the expectation of one award at that level.
Is cost sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement.
Who was eligible to apply?
Eligible applicants were limited to nonprofits with 501(c)(3) status, excluding institutions of higher education.
When was the opportunity posted?
The notice was posted on June 8, 2012.
What was the application closing date?
The original and current closing date listed was July 16, 2012.
Is this funding opportunity still open?
No. The notice lists an archive date of August 15, 2012, indicating the opportunity is no longer open.
Where did the notice point applicants to find the full announcement?
It referenced an additional information link to the full announcement in the NIH Guide.
Who was the grants management contact listed in the announcement?
The grants management contact listed was Daniel Lukash, Grants Management Specialist, FDA. Phone: 301-827-6771. Email: daniel.lukash@fda.hhs.gov.
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