Laboratories meeting all of the eligibility requirements of Competition A and B may apply for both.
Competition A: ISO/IEC 17025 Accreditation Maintenance and Enhancement
Governments
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
This opportunity is only available to State-authorized food testing laboratories and Higher Education Institutions and State Governments that meet each of the following criteria:
1) Laboratories that have successfully achieved ISO/IEC 17025 accreditation or have submitted an application for ISO/IEC 17025 accreditation. ISO/IEC 17025 accreditation, including methods of interest to the FDA, shall be maintained throughout the project period of this cooperative agreement;
2) Laboratories that are the primary servicing laboratory for conducting microbiological and chemical food analyses on behalf of a State agency enrolled in the Manufactured Food Regulatory Program Standards (MFRPS), or a State that has agreed to enroll in MFRPS at the earliest date. Enrollment in MFRPS shall be maintained throughout the entire project period of the cooperative agreement;
3) Laboratory is the primary servicing laboratory for their State manufactured food regulatory program. For purposes of the cooperative agreement, "primary servicing laboratory" is defined as the laboratory that performs greater than or equal to 51% of the microbiological and chemical food analyses. This percentage shall be maintained throughout the entire project period of the cooperative agreement;
4) The State maintains a current human food safety inspection contract with FDA, or agrees to apply for a human food safety inspection contract at the earliest possible date. The human food safety inspection contract shall be maintained with FDA throughout the entire project period of this cooperative agreement;
5) Eligible laboratories shall also participate, or enroll within thirty (30) days of the award in FERN;
6) Laboratories that agree to and have a written agreement from their State manufactured food regulatory program to participate in the Sample Collection and Analysis Project; and
7) Laboratories that agree to enter surveillance and emergency response samples and share the results through eLEXNET. This will serve to increase the food safety surveillance, detection, and response efforts of the FDA and other regulatory agencies.
Failure to maintain any of the eligibility requirements at any stage in cooperative agreement project period may result in termination of the award.
Competition B: Whole Genome Sequencing
Governments
- State Governments
- Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
1) Laboratories that currently have a Research Collaboration Agreement with CFSAN for the Genome Trackr network, have been provided with a sequencing device by FDA, and are being supported by FDA's CFSAN or ORS; and
2) Laboratories that agree to sequence a mixture of four hundred (400) or more Salmonella, Listeria monocytogenes, shiga toxin-producing Escherichia coli (STEC) and other foodborne related bacterial, viral and parasite pathogen isolates and deposit results, including the metadata, in real-time to NCBI-NIH curated national database for enteric pathogen genomes, in coordination with FDA CFSAN.
Competition C: ISO/IEC 17025 Accreditation and Whole Genome Sequencing Support Services
This opportunity is only available to non-profit, national associations/organizations that represent State and local laboratories that conduct food and/or animal feed testing on behalf of State and local regulatory programs.