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Grant Analysis

Purpose & Target

This grant, PAR-23-202, aims to fund veterinary diagnostic laboratories within the Vet-LIRN network for projects and equipment. The core objectives include supporting the development and validation of new methods related to animal food safety and antimicrobial resistance (AMR), conducting short-term monitoring, developing AMR stewardship projects, contributing to Vet-LIRN's AMR monitoring, and supporting One Health initiatives (e.g., emerging diseases, emergency surge capacity). This is a SECTOR-SPECIFIC grant primarily targeting established veterinary diagnostic laboratories. While not explicitly stated, the funding body (U.S. FDA) implies a U.S. geographic scope.

Financial Structure

Funding Details

Budget Range: Not specified in the grant materials. There are no minimum or maximum funding amounts per application mentioned.
Currency: USD (United States Dollar), as the funding organization is the U.S. FDA.
Funding Rate: Not specified.
Eligible Costs: The grant will fund 'projects and equipment' associated with the stated objectives. This implies costs related to:
- Development, adaptation, verification/validation of new methods.
- Short-term monitoring efforts.
- Purchase of equipment for testing or developing tests.
- Projects related to antimicrobial stewardship.
- Work contributing to AMR monitoring (e.g., sequencing isolates).
- Support for One Health initiatives and emergency surge capacity testing.
Ineligible Costs: Not specified.
Matching Fund Requirements: Not specified. There are no mentions of co-financing or cost-sharing requirements.
Financial Guarantees: Not specified.
Financial Reporting: Implied by the nature of grant funding from a federal agency, but specific reporting requirements are not detailed in this document.

Eligibility Requirements

Organizational Eligibility

Eligible Organization Type: Only veterinary diagnostic laboratories that are part of the Vet-LIRN network are eligible to apply. The term 'Vet-LIRN network' is not further defined within this document, but implies a pre-existing affiliation or qualification.
Organizational Size: Not specified in the grant materials.
Geographic Location: While not explicitly stated, the funding organization (U.S. Food and Drug Administration - FDA) indicates that applicants must be located within the United States.
Qualifications/Certifications: Applicants must possess the technical capabilities required for method development, verification/validation, monitoring, and potentially sequencing, as implied by the grant's objectives. Being a 'veterinary diagnostic laboratory' inherently suggests a certain level of qualification and infrastructure.

Application Process

Key Dates and Deadlines

Open Date (Earliest Submission): January 15, 2024, 2025, 2026, 2027, 2028
Letter of Intent Due Date(s): February 15, 2024, 2025, 2026, 2027, 2028
Application Due Date(s): April 15, 2028, by 11:59 PM Eastern Time (latest deadline)
- Note: Earlier deadlines are April 15, 2024, 2025, 2026, 2027.
Scientific Merit Review: May of each year (2024-2028)
Earliest Start Date: August 2024 (implies an annual award cycle)

Application Procedure

Required Documentation: Applicants must follow the Research (R) Instructions in the SF424 (R&R) Application Guide, unless specific instructions in this Funding Opportunity Announcement (FOA) or NIH Notices state otherwise. Program-specific instructions in Section IV of the full announcement take precedence.
Submission Format and Platform: Applications can be submitted through:
- NIH ASSIST system (online preparation, submission, and tracking)
- Institutional system-to-system (S2S) solution (for institutions with this capability)
- Grants.gov Workspace (preparation and submission, with eRA Commons for tracking)
Late Applications: Will not be accepted.
Error Correction: Applicants are strongly encouraged to submit early to allow time for correcting any errors found during the submission process (Grants.gov and eRA Commons errors) by the due date. On-time submission means an error-free application by the deadline.
Types of Support Offered: This grant provides funding for both specific projects and the acquisition of equipment.

Evaluation Criteria

The grant document explicitly states: 'The FDA does not follow the NIH Review Criteria.' Applicants are strongly encouraged to consult with FDA Agency Contacts for specific information regarding the 'FDA Objective Review Process.' This indicates that detailed scoring factors or evaluation criteria are not provided in this funding opportunity announcement and must be sought directly from the agency.

Compliance & Special Requirements

Regulatory and Ethical Compliance

Regulatory Compliance: As a grant from the U.S. Food and Drug Administration (FDA) and Center for Veterinary Medicine (CVM), projects are expected to adhere to all relevant FDA regulations and guidelines, particularly concerning animal food issues and antimicrobial resistance. This implies strict adherence to quality standards in diagnostic testing and method development.
Ethical Standards: The 'U18 Research Demonstration / Cooperative Agreements' activity code suggests that projects may involve research components. Therefore, adherence to ethical standards applicable to research, especially involving animals, is implied.

Unique Aspects and Considerations

Program Context: This grant is part of the Vet-LIRN network, emphasizing its role in strengthening and expanding the capabilities of veterinary diagnostic laboratories in the U.S.
Strategic Alignment: Projects must align with the CVM mission and key initiatives, including contributions to AMR monitoring and antimicrobial stewardship.
One Health Focus: The grant specifically mentions supporting work associated with One Health, including emerging diseases (e.g., COVID-19), highlighting a broader public health relevance.
Emergency Response: A unique objective is to support emergency surge capacity testing during large-scale animal food/feed emergency events.
Funder-Specific Guidelines: Applicants should note that the FDA's policies and guidelines may differ from those used by the NIH. It is crucial to follow the specific instructions in this FOA over general grant application guides, and to consult FDA contacts for details on page limits and review processes.

Grant Details