Notice of Intent to Publish a Funding Opportunity Announcement for the Laboratory Flexible Funding Model (LFFM) (U18) Clinical Trial Not Allowed
Notice Number:
NOT-FD-20-004

Key Dates

Release Date:

December 16, 2019

Related Announcements

None

Issued by

FOOD AND DRUG ADMINISTRATION (FDA)

Purpose

The U.S. Food and Drug Administration, Office of Regulatory Affairs (ORA), Center for Veterinary Medicine (CVM) and Center for Food Safety and Applied Nutrition (CFSAN) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a new laboratory flexible funding model cooperative agreement. This cooperative agreement is intended to enhance the capacity and capabilities of eligible human and animal food testing laboratories in support of an integrated food safety system, specifically, through sample testing in the areas of microbiology, chemistry, and radiochemistry, and the development of special projects that would support and expand that testing. This project will strengthen and improve the collaboration of surveillance and emergency response testing activities between the FDA and our laboratory partners to continue building a nationally integrated laboratory science system.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in early 2020 with an expected application due date sixty days (60) after publication.

This FOA will utilize the U18 (Research Demonstration - Cooperative Agreement) activity code. Details of the planned FOA are provided below.

Details

The proposed FOA will support the risk-informed and preventive approach to food safety that is outlined in the Food Safety Modernization Act (FSMA) through sample analysis of human and animal food products. Market samples as well as in-process and raw ingredient samples will be analyzed to ensure they do not reach consumers, pets, and livestock with harmful contaminants, or to verify they contain ingredients at levels as declared on product labeling. This project will produce a large quantity of sample outputs that will advance public health and equip our partner laboratories with additional resources that can be employed to build and increase sample throughput capacity within their state. Laboratories may conduct testing for surveillance, targeted assignments, emergency response, and emerging issues. Whole genome sequencing may also be performed on positive isolates.

Eligible organizations for the LFFM FOA may include:

Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)
  • U.S. Territory or Possession 

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)

The preferred sampling organizations for this project are the state manufactured food regulatory program and the animal food regulatory program. Other acceptable sampling organizations include any state or local government agencies that meet the guidelines as outlined in the Human and Animal Food Testing Laboratories Best Practices Manual.

For applicant laboratories identified as the primary servicing laboratory for a program enrolled in the Manufactured Food Regulatory Program Standards (MFRPS) and/or Animal Food Regulatory Program Standards (AFRPS), enrolled regulatory program must collect a minimum of 15% of the samples under the Microbiology and/or Chemistry Analytical Tracks.

The sampling organization selected must be:

a. State Government;

b. County Government;

c. City or Township Government;

d. Special District Government;

e. Indian/Native American Tribal Government; or

f. U.S. Territory or Possession.

Any personnel performing the collection on behalf of the sampling organization must be trained and have demonstrated competency in sample collection, including but not limited to: maintaining sample integrity, aseptic sampling, and proper chain of custody.

Samples analyzed under this cooperative agreement could derive from a variety of sources including but not limited to: an approved sample plan, emergency outbreak situations, national special security exercises, or an FDA assignment. Laboratories may be requested to participate in national special security exercises and FDA assignments. Samples may be collected by other organizations (e.g., FDA or a 3rd party) and submitted to participating laboratories for analysis.

Applicants have the option to apply for multiple analytical tracks under multiple disciplines, as outlined below.

Overarching Program Structure:

Discipline A: Microbiology

Analytical Track 1: Food Defense

The purpose of this analytical track is to ensure laboratory surge capacity for the analysis of foods and food products related to microbiological contamination, through intentional means, and to enhance the network capacity and readiness of state BSL2+ and BSL3 laboratories. These samples may consist of, but are not limited to, the following: Vegetables and fruits (fresh and packaged); juices (concentrate and diluted); grains and grain products; seafood and other fish products; milk and other dairy products; infant formula; baby foods; bottled water; condiments; and alcoholic products (beer, wine, scotch).

To be considered for this analytical track, laboratories must have:

1. The ability to analyze human or animal food for:

a. Bacillus anthracis

b. Yersinia pestis; and

2. A BSL2+ facility, with personal protective equipment and safeguards in place.

Analytical Track 2: Human Food Product Testing

The purpose of this analytical track is to improve food testing surveillance programs through the microbiological analysis of food products and environmental samples. The test results generated by these laboratories can be used to remove adulterated food from commerce and aide regulatory inspection programs in conducting investigations.

To be considered for this analytical track, laboratories must have:

1. The ability to analyze human food and/or environmental samples for:

a. Listeria monocytogenes;

b. Salmonella species; and

c. Shiga toxin-producing E. coli (STEC).

Analytical Track 3: Animal Food Product Testing

The purpose of this analytical track is to improve animal food testing surveillance programs through the microbiological analysis of animal food products. The test results generated by these laboratories can be used to remove adulterated animal food from commerce and aide regulatory inspection programs in conducting investigations.

To be considered for this analytical track, at a minimum, laboratories must have the ability to analyze animal food and/or environmental samples for Salmonella species.

Analytical Track 4: Whole Genome Sequencing

The purpose of this analytical track is to enhance the GenomeTrakr network by capturing the current and evolving genomic diversity of non-clinical pathogens across FDA-relevant areas in human or animal food, environmental, and water samples. The data generated through this analytical track, which will be housed in public databases at the National Center for Biotechnology Information (NCBI), can be accessed by researchers and public health officials for real time comparison and analysis that promises to speed foodborne illness outbreak investigations and reduce foodborne illnesses and deaths.

To be considered for this analytical track, laboratories must have:

1. The ability to sequence human or animal food, and environmental isolates for

a. Listeria monocytogenes;

b. Salmonella; and

c. Shiga toxin-producing E. coli (STEC).

Analytical Track 5: Microbiology Capability/Capacity Development

The purpose of this analytical track is to build additional capability and expand the national capacity in microbiological areas of emerging technology and/or where FDA has identified a specific need.

Discipline B: Chemistry

Analytical Track 1: Food Defense

The purpose of this analytical track is to ensure laboratory surge capacity in the analyses of foods and food products for analyses related to chemical contamination, through intentional means. These samples may consist of, but are not limited to, the following: Vegetables and fruits (fresh and packaged); juices (concentrate and diluted); grains and grain products; seafood and other fish products; milk and other dairy products; infant formula; baby foods; bottled water; condiments; and alcoholic products (beer, wine, scotch).

To be considered for this analytical track, laboratories must have the ability to analyze human or animal food for poisons/toxins and toxic metals.

Analytical Track 2: Human Food Product Testing

The purpose of this analytical track is to improve food testing surveillance programs through the chemical analysis of food products. The test results generated by these laboratories can be used to remove adulterated food from commerce and aide regulatory inspection programs in conducting investigations.

To be considered for this analytical track, laboratories must have the ability to analyze human food for one or more of the following: pesticides, mycotoxins, veterinary drug residues, toxic elements, nutrition, filth, decomposition, new dietary ingredients, allergens, and/or other emerging food safety issues.

Analytical Track 3: Animal Food Product Testing

The purpose of this analytical track is to improve animal food testing surveillance programs through the chemical analysis of animal food products. The test results generated by these laboratories can be used to remove adulterated animal food from commerce and aide regulatory inspection programs in conducting investigations.

To be considered for this analytical track, laboratories must have the ability to analyze animal food for one or more of the following: pesticides, mycotoxins, toxic elements, nutrition deficiency or toxicity analysis, and/or other emerging animal food safety issues.

Analytical Track 4: Chemistry Capability /Capacity Development

The purpose of this analytical track is to build additional capability and expand the national capacity in chemical areas of emerging technology and/or where FDA has identified a specific need.

Discipline C: Radiochemistry

Analytical Track 1: Food Defense

The purpose of this analytical track is to prove presence or absence of radioactive contamination and identify the identities of radionuclides present in human or animal food samples through screening. The data generated will be used to characterize the extent of food contamination, for following trends, and for calculating intakes.

To be considered for this analytical track, laboratories must have the ability to analyze human or animal food for the detection of gamma emitters, for example: Cs-137 and I-131.

Analytical Track 2: Radiochemistry Capacity/Capability Development

The purpose of this analytical track is to build additional capability and expand the national capacity in radiochemical areas of emerging technology and/or where FDA has identified a specific need.

Discipline D: Special Projects

Analytical Track 1: Sample Collection

The purpose of this track is to assist laboratories in obtaining the samples needed to meet the goals of this cooperative agreement. Funds provided under this track must be utilized to: compensate the sampling organization for collecting samples, purchase supplies for the sampling organization to utilize during sample collection, pay for shipping costs, or to pay for samples purchased at the manufacturer or retail location.

Only applicants receiving the Human and/or Animal Food Testing Tracks are eligible to receive funding under this track.

Analytical Track 2: National Food Safety Data Exchange (NFSDX) Integration and ORA Partner Portal (ORAPP) Adoption

The purpose of this track is to assist laboratories in enhancing their current data systems to enable them to electronically submit Sample Analysis data to FDA. This funding is only available for one (1) year. Applicants have the ability to select which year they prefer to complete this project.

Analytical Track 3: Method Development and Method Validation

The purpose of this track is to conduct preliminary, short-term or exploratory investigations that focus on the feasibility of a new method and/or technology. These projects could include proof of concept for new analytical approaches, method development for representative food matrices, single laboratory validations of methods, matrix or platform extensions or multi-laboratory validations. Projects will be one-year in duration but can be renewed for additional years upon demonstration of appropriate progress. Multiple-year sequential efforts may be proposed but will be approved on a year-by-year basis. Project opportunities may change annually, as requested by FDA.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:
Kiara Fowler
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-3099
Email: kiara.fowler@fda.hhs.gov


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices