Opportunity Information: Apply for PAR 17 141
The CVM Vet-LIRN Veterinary Diagnostic Laboratory Program (U18) is an FDA cooperative agreement funding opportunity run through the Center for Veterinary Medicine (CVM) to strengthen the national network of veterinary diagnostic laboratories that support investigations of animal food and animal drug safety issues. The core idea is to provide participating Vet-LIRN laboratories across the United States with resources such as equipment, supplies, personnel support, and training so they can rapidly test animal diagnostic samples and animal food or drug products when FDA needs additional investigative capacity. This support is designed for situations involving microbiological or chemical contamination, whether the contamination happens accidentally (for example, manufacturing or supply chain failures) or intentionally (including potential food defense and terrorism-related scenarios). A major emphasis is building surge capacity so that, during large or fast-moving events, Vet-LIRN labs can supplement FDA's standard regulatory testing system and prevent bottlenecks in sample analysis.
The program is closely tied to the Food Safety Modernization Act (FSMA), particularly provisions focused on building domestic capacity through stronger surveillance systems and laboratory networks that can quickly detect and respond to outbreaks. In practical terms, FDA is using this cooperative agreement mechanism to push the network toward more consistent, higher-throughput, and more defensible testing. That includes modernizing labs so they can adopt rapid analytical techniques, expanding the types of sample "matrices" they can handle (clinical samples, post-mortem samples, environmental swabs, feed ingredients, water, and more), and improving coordination among federal, state, local, and tribal partners. The intended outcome is a more connected and capable laboratory system that can investigate animal illness events linked to contaminated food or drugs and, when necessary, generate results that can support regulatory actions such as recalls.
The opportunity also reflects lessons learned from past crises, especially the 2007 pet food recall caused by melamine-adulterated ingredients and the subsequent 2008 melamine infant formula incident. Those events highlighted how tightly connected animal and human food ingredient supply chains can be, and why veterinary diagnostic findings can serve as an early warning signal for broader food safety risks. While FDA's Office of Regulatory Affairs (ORA) traditionally leads inspection and regulatory sample testing, Vet-LIRN fills a gap by focusing on veterinary diagnostic specimens from sickened animals. Testing these diagnostic samples can speed detection of adulteration or contamination and improve FDA's ability to understand what is happening biologically in affected animals, which can be critical for tracing sources and assessing risk.
Projects funded under this program are expected to support real-world FDA and Vet-LIRN operational needs. Labs may be tasked with testing surveillance samples assigned by the Vet-LIRN Program Office (VPO), analyzing samples during animal food or drug outbreak investigations, and providing surge support during large-scale emergency events that exceed FDA's internal analytical capacity. The solicitation notes FDA may require analysis of up to about 300 samples, with scheduling and sample flow coordinated by the VPO in collaboration with grantees. Samples can come from multiple sources, including government sampling assignments, shipments from other Vet-LIRN labs, or clinical cases coordinated through the VPO and veterinarians engaged in case investigations. In addition, bacterial isolates generated during testing may be forwarded to other Vet-LIRN laboratories for additional characterization, reinforcing the networked model where different labs contribute complementary expertise.
A central requirement is that participating labs produce analytical data suitable for potential regulatory use. That means using standardized methods, aligned equipment platforms when feasible, and consistent reporting tools such as standardized worksheets and electronic reporting formats. Grantees are expected to participate in proficiency testing and method training organized by the VPO, and to implement standardized quality management systems as determined by the program. Laboratories may also be asked to help investigate consumer complaint cases routed through the VPO, which can be an important mechanism for detecting emerging issues before they become widespread.
Beyond routine readiness and event response, the program anticipates ongoing technical advancement. Awardees may be asked to participate in additional projects such as small-scale method development, method validation, or matrix extension work, depending on evolving regulatory science needs. The announcement notes that post-award supplemental funding may be available for certain projects, particularly those responding to urgent or novel public health needs that were not known at the time of the original award. Some of this work may be collaborative across Vet-LIRN laboratories or coordinated with other federal networks, and in certain cases may involve joint efforts with FDA scientists (with FDA internal support handled separately from the external award).
Administratively, the opportunity is a discretionary cooperative agreement (meaning FDA anticipates substantial involvement in coordination, standards, and priorities, rather than simply issuing funds and stepping back). The funding opportunity number is PAR 17-141 under CFDA 93.103. The listing indicates an award ceiling of $75,000 and an expected number of awards around 35. The overall purpose is to upgrade and harmonize veterinary diagnostic laboratory capacity nationwide so the United States can detect and respond faster to animal food and drug contamination events, reduce foodborne illness risks, strengthen food defense preparedness, and improve intergovernmental coordination across the food safety system.Apply for PAR 17 141
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "CVM Vet-LIRN Veterinary Diagnostic Laboratory 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 Jan 30, 2017.
- Applicants must submit their applications by Feb 16, 2019. (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 $75,000.00 in funding.
- The number of recipients for this funding is limited to 35 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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FAQs: CVM Vet-LIRN Veterinary Diagnostic Laboratory Program (U18)
What is the CVM Vet-LIRN Veterinary Diagnostic Laboratory Program (U18)?
It is an FDA cooperative agreement funding opportunity run through the Center for Veterinary Medicine (CVM) to strengthen the national network of veterinary diagnostic laboratories (Vet-LIRN) that support investigations of animal food and animal drug safety issues.
What problem is this program designed to address?
The program is designed to improve the nation's ability to rapidly test animal diagnostic samples and animal food or drug products when FDA needs additional investigative capacity, especially during large or fast-moving events that could otherwise create bottlenecks in sample analysis.
What is the overall purpose of the funding?
The purpose is to upgrade and harmonize veterinary diagnostic laboratory capacity across the United States so the country can detect and respond faster to animal food and drug contamination events, reduce foodborne illness risks, strengthen food defense preparedness, and improve coordination across federal, state, local, and tribal partners.
Which FDA center runs this opportunity?
The opportunity is run through FDA's Center for Veterinary Medicine (CVM).
What does "Vet-LIRN" refer to in this context?
Vet-LIRN refers to a national network of veterinary diagnostic laboratories that can support FDA by performing testing linked to animal food and animal drug safety investigations, including surge testing during emergencies.
What type of award mechanism is this?
This is a discretionary cooperative agreement (U18). It is structured for substantial FDA involvement in coordination, standards, and priorities, rather than a hands-off grant.
What does "cooperative agreement" mean for participating labs?
It means FDA anticipates substantial involvement in program coordination and expectations, such as aligning on methods, reporting tools, proficiency testing, training, and prioritization of testing needs coordinated through the Vet-LIRN Program Office (VPO).
What is the role of the Vet-LIRN Program Office (VPO)?
The VPO coordinates scheduling and sample flow with grantees, assigns surveillance samples, organizes proficiency testing and method training, and supports consistent network operations including standardized reporting expectations.
What kinds of resources can the award support for Vet-LIRN labs?
The program is intended to provide participating laboratories with resources such as equipment, supplies, personnel support, and training to increase readiness and analytical capacity for FDA-related investigations.
What kinds of contamination events is this program intended to support?
It supports investigations involving microbiological or chemical contamination that may be accidental (such as manufacturing or supply chain failures) or intentional (including potential food defense and terrorism-related scenarios).
What is meant by "surge capacity" in this program?
Surge capacity is the ability for Vet-LIRN laboratories to rapidly increase testing throughput during major or fast-moving events so they can supplement FDA's standard regulatory testing system and reduce bottlenecks in sample analysis.
How is this opportunity connected to the Food Safety Modernization Act (FSMA)?
The opportunity aligns with FSMA provisions focused on building domestic capacity through stronger surveillance systems and laboratory networks that can quickly detect and respond to outbreaks.
What testing improvements is FDA trying to drive through this program?
FDA aims to make the network more consistent, higher-throughput, and more defensible by modernizing laboratories, supporting adoption of rapid analytical techniques, expanding the types of sample matrices labs can handle, and improving coordination across partners.
What are "sample matrices" in the context of this program?
Sample matrices refer to different sample types that may require different preparation and analytical approaches. The opportunity mentions matrices such as clinical samples, post-mortem samples, environmental swabs, feed ingredients, water, and more.
What types of samples might participating labs be asked to analyze?
Labs may be tasked with testing surveillance samples assigned by the VPO, analyzing samples during animal food or drug outbreak investigations, and providing surge support during large-scale emergency events. Samples may include animal diagnostic specimens and animal food or drug products.
How many samples might FDA require labs to analyze?
The solicitation notes FDA may require analysis of up to about 300 samples, with scheduling and sample flow coordinated by the VPO in collaboration with grantees.
Where can samples come from?
Samples can come from multiple sources, including government sampling assignments, shipments from other Vet-LIRN laboratories, or clinical cases coordinated through the VPO and veterinarians engaged in case investigations.
Why does this program emphasize veterinary diagnostic specimens from sick animals?
Vet-LIRN fills a gap by focusing on veterinary diagnostic specimens from sickened animals, which can speed detection of adulteration or contamination and help FDA understand what is happening biologically in affected animals. This can be critical for tracing sources and assessing risk.
How does Vet-LIRN relate to FDA's Office of Regulatory Affairs (ORA)?
ORA traditionally leads inspection and regulatory sample testing, while Vet-LIRN supports FDA by focusing on veterinary diagnostic specimens and providing additional investigative capacity when needed.
What past events influenced the design and emphasis of this program?
The opportunity reflects lessons from the 2007 pet food recall involving melamine-adulterated ingredients and the subsequent 2008 melamine infant formula incident, which highlighted interconnected animal and human ingredient supply chains and the early-warning value of veterinary diagnostic findings.
What are the expectations for data quality and regulatory usability?
A central requirement is that laboratories produce analytical data suitable for potential regulatory use. This includes using standardized methods, aligned equipment platforms when feasible, and consistent reporting tools such as standardized worksheets and electronic reporting formats.
Are labs expected to participate in proficiency testing and training?
Yes. Grantees are expected to participate in proficiency testing and method training organized by the VPO.
Are labs expected to follow a quality management system?
Yes. Laboratories are expected to implement standardized quality management systems as determined by the program.
Can participating labs be asked to help with consumer complaint investigations?
Yes. Laboratories may be asked to help investigate consumer complaint cases routed through the VPO, which can help detect emerging issues before they become widespread.
Will labs only do routine testing, or are there additional technical projects?
Beyond readiness and event response, awardees may be asked to participate in additional projects such as small-scale method development, method validation, or matrix extension work depending on evolving regulatory science needs.
Can labs collaborate with other Vet-LIRN laboratories under this program?
Yes. The program describes a networked model where laboratories can contribute complementary expertise, including forwarding bacterial isolates generated during testing to other Vet-LIRN labs for additional characterization.
Is supplemental funding mentioned for work that emerges after the award is made?
Yes. The announcement notes that post-award supplemental funding may be available for certain projects, particularly those responding to urgent or novel public health needs that were not known at the time of the original award.
Could projects involve coordination with other federal laboratory networks?
Yes. Some work may be collaborative across Vet-LIRN laboratories or coordinated with other federal networks.
Could awardees work jointly with FDA scientists?
In certain cases, joint efforts with FDA scientists may occur, with FDA internal support handled separately from the external award.
What is the funding opportunity number and CFDA listing provided?
The funding opportunity number is PAR 17-141 under CFDA 93.103.
What is the award ceiling noted in the listing?
The listing indicates an award ceiling of $75,000.
How many awards are expected?
The listing indicates an expected number of awards around 35.
What outcomes is FDA aiming for through this network investment?
FDA is aiming for a more connected and capable laboratory system that can investigate animal illness events linked to contaminated food or drugs and, when necessary, generate results that can support regulatory actions such as recalls.
How does this program support food defense?
The program explicitly includes support for intentional contamination scenarios (including potential terrorism-related scenarios) and focuses on readiness and surge testing capacity to respond quickly when suspicious or high-impact events occur.
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