Part 1. Overview Information

Key Dates

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The Food Safety Modernization Act (FSMA) outlines a new approach to food safety that is risk-informed and preventive in focus. In order to develop prevention-based systems, sample data and other information are needed to help identify and address hazards. There are different types of sample analyses that will be the focus of this project: routine human and animal food product testing, whole genome sequencing, and emergency response/emerging issues testing.

The LFFM mission is to enhance the capacity and capabilities of state human and animal food testing laboratories in support of an integrated food safety system (IFSS). This is achieved through prioritized sample testing and food defense preparedness in the areas of microbiology, chemistry, and radiochemistry, as well as method development and capacity/capability development projects that support and expand food safety and food defense testing.

The LFFM vision is that our nation’s state human and animal food (HAF) testing laboratories are prepared, equipped, and continuously exercised for response to microbiological, chemical, and radiochemical food safety hazards requiring multi-state response and national coordination/support.

Human and animal food finished products as well as in-process and raw ingredient samples are analyzed to ensure they do not reach consumers with harmful contaminants, or to verify they contain ingredients at levels as declared on product labeling. Analysis of environmental swabs from food production facilities may also be analyzed as part of for-cause facility investigations in response to positive product samples.

Emergency response and emerging issue testing can take the form of either environmental (e.g., water, sediment, soil amendments, other complex environmental samples) or product testing and could include both.  Emergency response testing is routinely conducted in response to outbreaks of foodborne illness to help identify the source of the disease-causing pathogen. Emerging issues testing allows the agency to gather information about potential food safety issues based on trends or intelligence the Agency or grantee might have.

This project will produce a large quantity of sample outputs that will drive a risk-based and prevention focused food safety system that both the FDA and our State partners can utilize for tracking and trending, early identification of emerging issues, and evaluation for future sampling initiatives and areas of focus. Participating laboratories will be equipped with additional resources that can be employed to build and increase sample throughput capacity and capability within their state.

The LFFM is a cooperative agreement program, and therefore the work accomplished within the Tracks is public health oriented and of mutual benefit to FDA and state partners. Specifically, within the Product Testing Tracks, FDA sets priorities for commodity-hazard pairs and LFFM labs select what work aligns with their goals, capabilities, and interests, in collaboration with State Regulatory Program (SRP) partners. Samples collected and analyzed under the LFFM HAF Product Testing Tracks may be for a variety of purposes: regulatory, surveillance, blinded studies, Total Diet Study (TDS), signals evaluation surveillance, baseline prevalence data, etc. 

Samples collected and analyzed under this cooperative agreement may derive from a variety of sources including but not limited to: an approved sample plan, emergency response and outbreak situations, national special security exercises, or an FDA assignment. Grantees may be invited to participate in FDA-issued assignments, which may have more stringent requirements regarding sampling, methodology, etc., as outlined in detailed planning and instruction documents. Outside of these FDA-issued assignments, states will have flexibility to utilize equivalent methodology, procedures, etc. Apart from FDA assignments and other FDA-directed samples (such as those collected by FDA or a 3rd party and submitted to a participating laboratory for analysis), the samples collected and analyzed under the LFFM Product Testing Tracks are state samples (collected by state regulatory program inspectors or laboratory analysts; and analyzed by state laboratories). These samples cannot be collected under FDA authority, and neither FDA credentials nor commissions can be used for collection activities. 

Program Goals:

The LFFM mission is to enhance the capacity and capabilities of state human and animal food testing laboratories in support of an integrated food safety system (IFSS). This is achieved through prioritized sample testing and food defense preparedness in the areas of microbiology, chemistry, and radiochemistry, as well as method development and capacity/capability development projects that support and expand food safety and food defense testing.

The LFFM vision is that our nation’s state human and animal food (HAF) testing laboratories are prepared, equipped, and continuously exercised for response to microbiological, chemical, and radiochemical food safety hazards requiring multi-state response and national coordination/support.

 Table 1: Overarching Program Structure

 Table 2: Required Aims per Track:

Note: The Sample Guide will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed.

Discipline A: Microbiology

Table 3: Microbiology Funding Table

Use the table below to determine the amount of funding available based on the work selected. 

Analytical Track A1: Microbiology Human Food Product Testing

The purpose of this analytical track is to support and strengthen state surveillance programs for microbiological contamination of human food products and environmental samples from human food production or handling facilities. Participation in this track requires support of a state regulatory program with jurisdiction over the commodities being collected and analyzed. Collection and analysis of products produced within the state is encouraged (regardless of whether those products are collected at the manufacturer, distributor, or retail level). The test results generated from this sampling can be used to remove adulterated food from commerce and aid regulatory inspection programs in conducting investigations. Sample results may be used by state regulatory programs and FDA to support follow-up regulatory and enforcement actions and outbreak response (if applicable). Additionally, aggregate data from this Track can be used for risk assessment, future policy development, knowledge gap filling, and to inform future surveillance activities.

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

(1) ISO 17025 accreditation for at least one method applicable to microbiological analysis of human or animal food

(2) Letter of support from manufactured food state regulatory program, as well as other state regulatory program (SRP) components, if other commodities will be collected/analyzed (e.g., produce from farms, dairy not covered by manufactured food program, etc.). Must include affirmative statement that the SRP is willing to follow the LFFM Sample Guide and is willing to collect at least 15% of planned samples for which they have jurisdiction, annually.

(3) Affirmative statement that the laboratory is willing to accept and analyze samples collected by FDA or other states in the event of an emergency requiring surge capacity coordinated by FDA/FERN (if the laboratory has the capability to perform requested analyses)

(4) Affirmative statement that the laboratory and SRP are willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting, and following up on LFFM samples

(5) Implemented use of GFP-tagged control strains for major foodborne pathogens aligned with the laboratory's testing capabilities (specifically: Salmonella spp., Listeria monocytogenes, E. coli, Cronobacter sakazakii)

The commodity-hazard pairs available for surveillance under this track are pre-determined by FDA on an annual basis, and laboratories may submit a proposal to participate in the commodity-hazard pairs of their choice each year. States are encouraged to participate in FDA’s annual work planning request and prioritization process to suggest commodity-hazard pairs for inclusion under LFFM.

The LFFM Sample Guide and the list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time. Development of the sample plan for the year is a collaborative process that follows the LFFM Sample Guide and will be done after applications are reviewed and scored but before the project period starts.

Analytical Track A2: National Antimicrobial Monitoring System (NARMS) Testing

The purpose of this analytical track is to support and strengthen state surveillance programs for microbiological contamination of retail raw meat samples in support of the NARMS Program. NARMS Track surveillance is non-regulatory in scope and does not require regulatory or enforcement follow-up from state partners. The NARMS program helps promote and protect public health by providing information about emerging bacterial antimicrobial resistance (AMR), how resistant infections differ from susceptible infections, and the impact of interventions designed to limit the spread of AMR. NARMS data are used by FDA to help inform regulatory decisions designed to preserve the effectiveness of antibiotics for humans and animals.

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

(1) Affirmative statement that the laboratory (and any other group responsible for sample collections, i.e., if partnering with inspectional staff to collect samples) is willing to collect samples from a wide variety of retail grocery stores and follow a randomized collection schedule set by the NARMS program, which pulls from a list of zip codes that the laboratory (or other collection partners) is willing/able to collect from.

(2) Affirmative statement that the laboratory is willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting of NARMS samples.

(3) Laboratory cannot be a recipient of the standalone NARMS cooperative agreement PAR-20-124 "NARMS Cooperative Agreement Program to Strengthen Antibiotic Resistance Surveillance in Retail Food Specimens", or any subsequent NARMS cooperative agreement managed and funded by the FDA

The commodity-hazard pairs available for surveillance under this track are pre-determined by FDA on an annual basis, and laboratories may submit a proposal to participate in the commodity-hazard pairs of their choice each year.

The LFFM Sample Guide and the list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time. Development of the sample plan for the year is a collaborative process that follows the LFFM Sample Guide and will be done after applications are reviewed and scored but before the project period starts.

Analytical Track A3: Microbiology Animal Food Product Testing

The purpose of this analytical track is to support and strengthen state surveillance programs for microbiological contamination of animal food products or ingredients intended for use in manufacturing animal food. Participation in this track requires support of a state regulatory program with jurisdiction over the commodities being collected and analyzed. Collection and analysis of products produced within the state is encouraged (regardless of whether those products are collected at the manufacturer, distributor, or retail level). The test results generated from this sampling can be used to remove adulterated food from commerce and aid regulatory inspection programs in conducting investigations. Sample results may be used by state regulatory programs and FDA to support follow-up regulatory and enforcement actions and human or animal illness outbreak response (if applicable). Additionally, aggregate data from this Track can be used for risk assessment, future policy development, knowledge gap filling, and to inform future surveillance activities.

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

(1) ISO 17025 accreditation for at least one method applicable to microbiological analysis of human or animal food

(2) Letter of support from animal food state regulatory program. Must include affirmative statement that the SRP is willing to follow the LFFM Sample Guide and is willing to collect at least 15% of planned samples for which they have jurisdiction, annually. Must include affirmative statement that the SRP has the capability and willingness to collect at least a portion of samples from manufacturer and distributor level.

(3) Affirmative statement that the laboratory is willing to accept and analyze samples collected by FDA or other states in the event of an emergency requiring surge capacity coordinated by FDA/FERN (if the laboratory has the capability to perform requested analyses)

(4) Affirmative statement that the laboratory and SRP are willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting, and following up on LFFM samples

(5) Implemented use of GFP-tagged control strains for major foodborne pathogens aligned with the laboratory's testing capabilities (specifically: Salmonella spp., Listeria monocytogenes, E. coli)

The commodity-hazard pairs available for surveillance under this track are pre-determined by FDA on an annual basis, and laboratories may submit a proposal to participate in the commodity-hazard pairs of their choice each year. States are encouraged to engage with CVM to suggest commodity-hazard pairs for inclusion under LFFM.

The LFFM Sample Guide and the list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time. Development of the sample plan for the year is a collaborative process that follows the LFFM Sample Guide and will be done after applications are reviewed and scored but before the project period starts.

Analytical Track A4: Microbiology Whole Genome Sequencing – Maintenance

The objective of Analytical Track 4 is to allocate funds to GenomeTrakr laboratories for the sequencing of foodborne pathogen genomes sourced from LFFM product testing tracks, specifically from Micro Human or Animal Food Product Testing and/or NARMS Tracks (M-HAF Product Testing Tracks). Participating laboratories are required to sequence all isolates obtained from their LFFM M-HAF product testing and submit the resulting whole genome sequence (WGS) data, along with associated contextual data, to the National Center for Biotechnology Information (NCBI) in accordance with current protocols issued by the FDA’s GenomeTrakr Program Coordinators.

This track aims not only to cover sequencing for the M-HAF testing but also to facilitate the sequencing of isolates from broader state-conducted human and animal food product surveillance, outbreak investigations, and emergency response testing. Additionally, there may be occasions where laboratories will need to assist with sequencing for other states that do not have WGS capabilities.

To be considered for this analytical track, laboratories must:

(1) Participate in either LFFM Micro Human Food, Micro NARMS, or Micro Animal Food Product Testing Track

(2) Have WGS capabilities for enteric pathogens, including ability to submit genomic data to NCBI

(3) Affirmative statement that the laboratory will follow current protocols issued by the FDA’s GenomeTrakr Program Coordinators, which include completing “sequenced_by” and “project_name” fields in a manner that supports querying NCBI to determine isolate accomplishments.

Analytical Track A5: Microbiology Whole Genome Sequencing – Throughput

The objective of Analytical Track 5 is to allocate funds to GenomeTrakr laboratories for sequencing foodborne pathogens isolated from environmental, food, and animal samples (see target list for priority pathogens and sample types). Participating laboratories are required to submit the resulting whole genome sequence (WGS) data, along with associated contextual data, to the National Center for Biotechnology Information (NCBI) in accordance with current protocols issued by the FDA’s GenomeTrakr Program Coordinators.

This track aims to provide a baseline signal to the GenomeTrakr database, either by sequencing historical isolate collections, or by sequencing pathogens isolated from routinely collected environmental samples.

Laboratories may choose between two options:

1. Sequence isolates: Laboratories focused exclusively on sequencing should process and upload data for at least 400 enteric pathogens each funding year.

2. Environmental sample collection and analysis: Alternatively, laboratories can use the funds to cover the full scope of work for environmental pathogen surveillance, including the collection, microbiological analysis, isolation, and sequencing of enteric pathogens from routine samples, like water, in agricultural growing regions. While there is no annual minimum number of sequences for this option, sampling plans should include weekly sampling, or another routine schedule, throughout the year or during applicable growing seasons, depending on the location. All positive samples should be sequenced.

Please note that grantees will be responsible for establishing their own collaborations to obtain the necessary isolates or environmental samples.

If the laboratory is also participating in a Micro Human or Animal Food Product Testing and/or NARMS Tracks, the laboratory is required to sequence all isolates obtained from their LFFM M-HAF product testing and submit the resulting WGS data, along with associated contextual data, to NCBI in accordance with current protocols issued by the FDA’s GenomeTrakr Program Coordinators.

Laboratories may also be asked to support sequencing of LFFM M-HAF product testing track isolates from other states lacking WGS capacity.

• Priority foodborne bacterial pathogens for Analytical Track 5:
• Salmonella enterica
• Listeria monocytogenes
• E. coli (specifically Shiga toxin-producing strains, STECs)
• Cronobacter species
• Vibrio parahaemolyticus
• Campylobacter jejuni
• Other emerging foodborne pathogens as determined by GenomeTrakr coordinators

Priority samples sources for Analytical Track 5:

• Collections from locations involved in the production, packaging, and handling of foods overseen by the FDA, which includes facilities, restaurants, and farms.
• Environmental samples from agricultural growing regions, such as compost, manure, water sources like irrigation ditches or ponds, soil amendments (including animal by-products), sediment, dust, air, along with samples from wastewater treatment plants.
• FDA-regulated food products, including dietary supplements
• Animal sources, specifically wildlife associated with agriculture, such as wild birds and other animals that may encroach on agricultural spaces.
• Both domestic and international collaborations to source isolates are acceptable

To be considered for this analytical track, laboratories must:

(1) Have WGS capabilities for enteric pathogens, including ability to submit genomic data to NCBI

(2) Have sufficient partnerships and network to support sourcing approximately 400 enteric pathogen isolates per year or to establish routine environmental samples, demonstrated by letters of support.

(3) Affirmative statement that the laboratory will follow current protocols issued by the FDA’s GenomeTrakr Program Coordinators, which include completing “sequenced_by” and “project_name” fields in a manner that supports querying NCBI to determine isolate accomplishments.

(4) Affirmative statement that the laboratory will prioritize sequencing of M-HAF product testing track isolates, if the laboratory is also applying to those tracks.

Analytical Track A6: Microbiology Food Defense

The purpose of this analytical track is to support and maintain geographically diverse national capacity, capability, and readiness for intentional or unintentional microbiological contamination of human and animal foods using BSL2+ and BSL3 laboratories. Specifically, laboratories in this track will maintain readiness, demonstrate competency, and respond to FDA’s requests for testing.

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

(1) A BSL2+ facility, with personal protective equipment and safeguards in place.

Analytical Track A7: Microbiology Method Development and Method Validation

The purpose of this analytical 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 extensions, alternative instrument platform extensions, or multi-laboratory validations.

Generally, projects will be one-year in duration but can be renewed for additional years upon demonstration of appropriate progress with tangible results.  Multiple-year sequential efforts may be proposed but will be approved on a year-by-year basis.  Under this track, laboratories can either propose their own method development or method validation project aligned with the FERN mission or choose to participate in one of the FDA pre-determined projects.

During the Objective Review of applications under this announcement, laboratories that are approved for a Microbiology Human Food Product Testing Track, Microbiology Animal Food Product Testing Track, Microbiology Food Defense, or the Whole Genome Sequencing tracks will automatically be eligible to participate in the Microbiology Method Development and Validation Track.

The list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time. This is also the time that laboratories will have the opportunity to propose additional projects, not included on the FDA pre-determined list.

Laboratories have the option to opt-out of this track annually if there are not any projects being offered that are of interest to them.

Analytical Track A8: Microbiology Capability/Capacity Development

The purpose of this analytical track is to assist laboratories in implementing new capabilities (i.e., methods, equipment) to support microbiological testing related to human and animal foods.

Capabilities developed under this track are expected to be operationalized in subsequent years under a human or animal food product testing, WGS, or food defense track. An example would be implementing BAM Ch4A qPCR for Shiga-toxin producing E. coli in foods, and then conducting surveillance under the Microbiological Human or Animal Food Product Testing Track the following year.

Generally, projects will be one-year in duration but can be renewed for additional years upon demonstration of appropriate progress with tangible results.  Multiple-year sequential efforts may be proposed but will be approved on a year-by-year basis.  Under this track, laboratories can either propose their own capability/capacity development project aligned with the FERN mission or choose to participate in one of the FDA pre-determined projects.

During the Objective Review of applications under this announcement, laboratories that are approved for a Microbiology Human Food Product Testing Track, Animal Food Product Testing Track, Microbiology Food Defense, or the Whole Genome Sequencing tracks will automatically be eligible to participate in the Microbiology Capability/Capacity Development Track.

The list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time.

Laboratories have the option to opt-out of this track annually if there are not any projects being offered that are of interest to them. 

Discipline B: Chemistry

Table 3: Chemistry Funding Table

Use the table below to determine the amount of funding available based on the work selected. 

Analytical Track B1: Chemistry Human Food Product Testing

The purpose of this analytical track is to support and strengthen state surveillance programs for chemical contamination of human food product samples. Participation in this track requires support of a state regulatory program with jurisdiction over the commodities being collected and analyzed. Collection and analysis of products produced within the state is encouraged (regardless of whether those products are collected at the manufacturer, distributor, or retail level). The test results generated from this sampling can be used to remove adulterated food from commerce and aid regulatory inspection programs in conducting investigations. Sample results may be used by state regulatory programs and FDA to support follow-up regulatory and enforcement actions and outbreak response (if applicable). Additionally, aggregate data from this Track can be used for risk assessment, future policy development, knowledge gap filling, and to inform future surveillance activities.

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

(1) ISO 17025 accreditation for at least one method applicable to chemical analysis of human or animal food

(2) Letter of support from manufactured food state regulatory program, as well as other state regulatory program (SRP) components, if other commodities will be collected/analyzed (e.g., produce from farms, dairy not covered by manufactured food program, etc.). Must include affirmative statement that the SRP is willing to follow the LFFM Sample Guide and is willing to collect at least 15% of planned samples for which they have jurisdiction, annually.

(3) Affirmative statement that the laboratory is willing to accept and analyze samples collected by FDA or other states in the event of an emergency requiring surge capacity coordinated by FDA/FERN (if the laboratory has the capability to perform requested analyses)

(4) Affirmative statement that the laboratory and SRP are willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting, and following up on LFFM samples

The commodity-hazard pairs available for surveillance under this track are pre-determined by FDA on an annual basis, and laboratories may submit a proposal to participate in the commodity-hazard pairs of their choice each year. States are encouraged to participate in FDA’s annual work planning request and prioritization process to suggest commodity-hazard pairs for inclusion under LFFM.

The LFFM Sample Guide and the list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time. Development of the sample plan for the year is a collaborative process that follows the LFFM Sample Guide and will be done after applications are reviewed and scored but before the project period starts.

Analytical Track B2: Chemistry Animal Food Product Testing

The purpose of this analytical track is to support and strengthen state surveillance programs for chemical contamination of animal food products or ingredients intended for use in manufacturing animal food. Participation in this track requires support of a state regulatory program with jurisdiction over the commodities being collected and analyzed. Collection and analysis of products produced within the state is encouraged (regardless of whether those products are collected at the manufacturer, distributor, or retail level). The test results generated from this sampling can be used to remove adulterated food from commerce and aid regulatory inspection programs in conducting investigations. Sample results may be used by state regulatory programs and FDA to support follow-up regulatory and enforcement actions and human or animal adverse event response (if applicable). Additionally, aggregate data from this Track can be used for risk assessment, future policy development, knowledge gap filling, and to inform future surveillance activities.

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

(1) ISO 17025 accreditation for at least one method applicable to chemical analysis of human or animal food

(2) Letter of support from animal food state regulatory program. Must include affirmative statement that the SRP is willing to follow the LFFM Sample Guide and is willing to collect at least 15% of planned samples for which they have jurisdiction, annually. Must include affirmative statement that the SRP has the capability and willingness to collect at least a portion of samples from manufacturer and distributor level.

(3) Affirmative statement that the laboratory is willing to accept and analyze samples collected by FDA or other states in the event of an emergency requiring surge capacity coordinated by FDA/FERN (if the laboratory has the capability to perform requested analyses)

(4) Affirmative statement that the laboratory and SRP are willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting, and following up on LFFM samples

The commodity-hazard pairs available for surveillance under this track are pre-determined by FDA on an annual basis, and laboratories may submit a proposal to participate in the commodity-hazard pairs of their choice each year. States are encouraged to engage with CVM to suggest commodity-hazard pairs for inclusion under LFFM.

The LFFM Sample Guide and the list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time. Development of the sample plan for the year is a collaborative process that follows the LFFM Sample Guide and will be done after applications are reviewed and scored but before the project period starts.

Analytical Track B3: Chemistry Food Defense

The purpose of this analytical track is to support and maintain geographically diverse national capacity, capability, and readiness for intentional or unintentional chemical contamination of human and animal foods. Specifically, laboratories in this track will maintain readiness, demonstrate competency, and respond to FDA’s requests for testing.

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

(1) Ability to conduct non-targeted screening

(2) Ability to perform FERN food defense methods CHE-0008 or CHE-0008A, CHE-0006, CHE-0009 or EAM 4.7

Analytical Track B4: Chemistry Method Development and Method Validation

The purpose of this analytical 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, verify an existing non-food method for food analysis, method development for representative food matrices, single laboratory validations of methods, matrix extensions, alternative instrument platform extensions, or multi-laboratory validations.

Generally, projects will be one-year in duration but can be renewed for additional years upon demonstration of appropriate progress with tangible results.  Multiple-year sequential efforts may be proposed but will be approved on a year-by-year basis.  Under this track, laboratories can either propose their own method development or method validation project aligned with the FERN mission or choose to participate in one of the FDA pre-determined projects.

During the Objective Review of applications under this announcement, laboratories that are approved for a Chemistry Food Defense track will automatically be eligible to participate in the Chemistry Method Development and Validation Track.

The list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time. This is also the time that laboratories will have the opportunity to propose additional projects, not included on the FDA pre-determined list.

Laboratories have the option to opt-out of this track annually if there are not any projects being offered that are of interest to them.

Analytical Track B5: Chemistry Capability/Capacity Development

The purpose of this analytical track is to assist laboratories in implementing new capabilities (i.e., methods, equipment) to support chemistry testing related to human and animal foods.

Capabilities developed under this track are expected to be operationalized in subsequent years under the chemistry human or animal food product testing track or the chemistry food defense track (i.e., maintain readiness, utilize the capability during emergency response situations, etc.).

Generally, 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. Under this track, laboratories can either propose their own capability/capacity development project aligned with FERN mission or choose to participate in one of the FDA pre-determined projects.

During the Objective Review of applications under this announcement, laboratories that are approved for a Chemistry Human or Animal Food Product Testing Track, or Chemistry Food Defense track will automatically be eligible to participate in the Chemistry Capability/Capacity Development Track.

The list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time.

Laboratories have the option to opt-out of this track annually if there are not any projects being offered that are of interest to them. 

Discipline C: Radiochemistry

Table 4: Radiochemistry Funding Table

Use the table below to determine the amount of funding available based on the work selected. 

Analytical Track C1: Radiochemistry Food Defense

The purpose of this analytical track is to support and maintain geographically diverse national capacity, capability, and readiness for radiochemical testing of human and animal foods. Specifically, Laboratories in this track assess radiological food safety by detecting radioactive contamination, identify the specific radionuclides present, and quantify their levels through laboratory testing.  These activities aim to maintain competency and preparedness, support emergency response efforts, and enhance surveillance measures. 

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-134, Cs-137, and I-131.  Laboratories participating in this track may also have the ability to analyze human or animal food for the detection of alpha emitters, for example Am/Pu, and beta emitters, for example Sr-90.

Analytical Track C2: Radiochemistry Method Development and Method Validation

The purpose of this analytical 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, verify an existing non-food method for food analysis, method development for representative food matrices, single laboratory validations of methods, matrix extensions, alternative instrument platform extensions, or multi-laboratory validations.

Generally, projects will be one-year in duration but can be renewed for additional years upon demonstration of appropriate progress with tangible results.  Multiple-year sequential efforts may be proposed but will be approved on a year-by-year basis.  Under this track, laboratories can either propose their own method development or method validation project aligned with the FERN mission or choose to participate in one of the FDA pre-determined projects.

During the Objective Review of applications under this announcement, laboratories that are approved for a Radiochemistry Food Defense track will automatically be eligible to participate in the Radiochemistry Method Development and Validation Track.

The list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time. This is also the time that laboratories will have the opportunity to propose additional projects, not included on the FDA pre-determined list.

Laboratories have the option to opt-out of this track annually if there are not any projects being offered that are of interest to them.

Analytical Track C3: Radiochemistry Capacity/Capability Development

The purpose of this analytical track is to assist laboratories in implementing new capabilities (i.e., methods, equipment) to support radiochemistry testing related to human and animal foods.

Capabilities developed under this track are expected to be operationalized in subsequent years under the radiochemistry food defense track (i.e., maintain readiness, utilize the capability during emergency response situations, etc.)

Generally, 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. Under this track, laboratories can either propose their own capability/capacity development project aligned with FERN mission or choose to participate in one of the FDA pre-determined projects.

During the Objective Review of applications under this announcement, laboratories that are approved for a Radiochemistry Food Defense track will automatically be eligible to participate in the Radiochemistry Capability/Capacity Development Track.

The list of the 2024-2025 projects will be provided to prospective applicants after submitting a Letter of Intent and eligibility is confirmed as an example of the types of projects conducted under this track. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time.

Laboratories have the option to opt-out of this track annually if there are not any projects being offered that are of interest to them. 

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

HHS grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

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

Additional Eligibility Requirements:

Accreditation and Information Sharing Agreement

Applicant organizations applying for product testing tracks must be accredited to ISO 17025 in at least one human or animal food testing method applicable to the discipline for which they are applying.

Applicant organizations applying for tracks other than product testing must be accredited to ISO 17025 or have a quality system that ensures quality assurance and quality control of laboratory testing including but not limited to: validated methods, document control, training programs, and analyst competency requirements.

Applicant organizations applying to any track other than Whole Genome Sequencing must have a valid 20.88 agreement with FDA prior to the time of application.

Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the HHS Grants Policy Statement for additional information.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply - Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the HHS Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The FDA will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the FDA will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most FDA opportunities. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Participating institution(s)
• Number and title of this funding opportunity
• Title of each analytical track, and sample load (if applicable), per discipline of which there is interest

The letter of intent should be sent to:

Danielle Head
Office of Acquisitions and Grants Services
Email: [email protected] 

A copy of the LFFM Sample Guide, an example SRP letter of support, and the list of the 2024-2025 commodity-hazard pairs, capacity and capability, and method development and validation projects will be provided to prospective applicants following receipt of the Letter of Intent and eligibility is confirmed. These are only provided as examples for potential applicants of the types of projects conducted under these tracks. The list of 2025-2026 projects will be available in March 2025 and will be provided to approved applicants at that time. Development of the sample plan for the year is a collaborative process that follows the LFFM Sample Guide and will be done after applications are reviewed and scored but before the project period starts.

A technical session will be held for prospective applicants a month prior to each application due date.  The conference call information will be provided to prospective applicants that submit a letter of intent.  The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process.  Participation in the technical session is optional, but strongly encouraged. 

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: Required
• Projects: Required (at least one)

Overall Component

When preparing the application, use Component Type “Overall.”

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims:

Describe the overall objective of the proposed multi-project application, and how the individual projects contribute to the overall objective.

Research Strategy:

Focusing on the project as a whole, describe the strategy to accomplish the overarching aims of the overall project. This should include how your personnel, resources, and organizational infrastructure are well suited to meet the goals of the project through appropriate training and experience.

Resource Sharing Plan:
Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s): 

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply - Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

PHS Assignment Request Form (Overall)

All instructions in the How to Apply- Application Guide must be followed.

Project A1: Microbiology Human Food Product Testing

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted. 

SF424 (R&R) Cover (Project A1: Microbiology Human Food Product Testing)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Title of Applicant's Project - Project A1: Microbiology Human Food Product Testing
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project A1: Microbiology Human Food Product Testing)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project A1: Microbiology Human Food Product Testing)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project A1: Microbiology Human Food Product Testing)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project A1: Microbiology Human Food Product Testing)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project A1: Microbiology Human Food Product Testing)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project A1: Microbiology Human Food Product Testing)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:

(1) Maintain ISO 17025 accreditation for the duration of the award

(a) If ISO 17025 accreditation scope does not include methods utilized in this LFFM Product Testing Track, a plan must be developed by the end of the 1st year to expand the scope of ISO 17025 accreditation

(b) By the end of the 3rd year at least 1 method used in this track must be on the ISO 17025 accreditation scope

(2) Submit one or more data packages per year conducted under the Track (either spot check or potentially violative samples), per annual spot check schedule issued by LFFM Staff

(3) Use of FDA 431 or equivalent information provided in Spot Check and potentially violative data package submissions

(4) Collect, analyze, and report sample data in accordance with annual approved sample plan (commodity-hazard pairs). The percent completion rate for overall sampling and by commodity-hazard pair will be assessed annually. The timeliness and accuracy of data reported will be assessed annually.

Research Strategy:

Salmonella

1. Describe the laboratory’s ability to analyze human food samples for Salmonella, including screening and confirmatory testing. Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year.

2. Describe control strain(s) used to detect Salmonella. Include information that demonstrates the validity of the results, such as green fluorescence protein (GFP) tagged controls.

3. Describe the laboratory’s experience testing FDA-regulated human food matrices for Salmonella.

4. Describe the laboratory’s capability to test dead-end ultrafiltration (DEUF) filters from agriculture water samples for Salmonella.

5. Describe capability of SRP(s) to collect environmental swabs at manufacturing/processing facilities for Salmonella analysis.

6. Describe the laboratory’s capability to test environmental swabs for Salmonella.

STECs

1. Describe the laboratory’s ability to analyze human food samples for Shiga toxin-producing E. coli (STECs), including screening and confirmatory testing. Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year.

2. Describe control strain(s) used to detect STECs. Include information that demonstrates the validity of the results, such as green fluorescence protein (GFP) tagged controls.

3. Describe the laboratory’s experience testing FDA-regulated human food matrices for STECs.

4. Describe the laboratory’s capability to test dead-end ultrafiltration (DEUF) filters from agriculture water samples for STECs.

Listeria

1. Describe the laboratory’s ability to analyze human food samples for Listeria, including screening and confirmatory testing. Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year.

2. Describe the laboratory’s capability to perform enumeration.

3. Describe control strain(s) used to detect Listeria. Include information that demonstrates the validity of the results, such as green fluorescence protein (GFP) tagged controls.

4. Describe the laboratory’s experience testing FDA-regulated human food matrices for Listeria spp.

5. Describe capability of SRP(s) to collect environmental swabs and manufacturing/processing facilities for Listeria analysis.

6. Describe the laboratory’s capability to test environmental swabs.

Cyclospora

1. Describe the laboratory’s ability to analyze human food samples for Cyclospora. Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year.

2.Describe the laboratory’s capability to test dead-end ultrafiltration (DEUF) filters from agriculture water samples for Cyclospora.

Other

1. Describe the laboratory’s ability to test for the following additional pathogens in human food samples.

Please identify the pathogens that the laboratory can test, including screening and confirmatory testing. For each pathogen, describe the instruments available on-site, number of trained analysts, specific methods used, and any related proficiency testing completed within the past year. Describe any green fluorescence protein (GFP) tagged control strains used to detect these pathogens.

2. Provide links to recalls of inter-state distributed product resulting from violative sample analyzed by the laboratory in the last 3 years relevant to this track (microbiological analysis of human foods)

Letters of Support and Eligiblity Documentation:

1. Provide laboratory’s certificate(s) of ISO 17025 accreditation and accreditation scope(s).

2. Affirmative statement that the laboratory is willing to accept and analyze samples collected by FDA or other states in the event of an emergency requiring surge capacity coordinated by FDA/FERN (if the laboratory has the capability to perform requested analyses).

3. Affirmative statement that the laboratory and SRP are willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting, and following up on LFFM samples.

4. Provide letter of support from manufactured food state regulatory program, as well as other state regulatory program (SRP) components, if other commodities will be collected/analyzed (e.g., produce from farms, dairy not covered by manufactured food program, etc.). Must include affirmative statement that the SRP is willing to follow the LFFM Sample Guide. Please note retail food is not considered a separate program for the purposes of this scoring this application. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: 

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project A1: Microbiology Human Food Product Testing)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project A2: National Antimicrobial Monitoring System (NARMS) Testing

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project A2: National Antimicrobial Monitoring System (NARMS) Testing)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Title of Applicant's Project - Project A2: National Antimicrobial Monitoring System (NARMS) Testing
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project A2: National Antimicrobial Monitoring System (NARMS) Testing)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project A2: National Antimicrobial Monitoring System (NARMS) Testing)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project A2: National Antimicrobial Monitoring System (NARMS) Testing)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project A2: National Antimicrobial Monitoring System (NARMS) Testing)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project A2: National Antimicrobial Monitoring System (NARMS) Testing)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project A2: National Antimicrobial Monitoring System (NARMS) Testing)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Collect, analyze, and report sample data in accordance with annual approved sample plan (commodity-hazard pairs). The percent completion rate for overall sampling and by commodity-hazard pair will be assessed annually.

(2) Ship isolates recovered from product samples to FDA CVM for additional testing

Research Strategy:

Salmonella

1. Describe the laboratory’s ability to analyze retail raw meat samples for Salmonella, including screening and confirmatory testing. Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed and intended for use for NARMS, and any related proficiency testing conducted within the past year.

2. Describe control strain(s) used to detect Salmonella. Include information that demonstrates the validity of the results, such as green fluorescence protein (GFP) tagged controls.

Campylobacter

1. Describe the laboratory’s ability to analyze animal food samples for Campylobacter, including screening and confirmatory testing. Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed and intended for use for NARMS, and any related proficiency testing conducted within the past year.

2. Describe control strain(s) used to detect Campylobacter. Include information that demonstrates the validity of the results, such as green fluorescence protein (GFP) tagged controls.

Generic E. coli

1. Describe the laboratory’s ability to analyze animal food samples for E. coli (generic). Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed and intended for use for NARMS, and any related proficiency testing conducted within the past year.

Other

1. Provide the total number of zip codes in your state and a list of all the zip codes from which you are willing to sample.

Letters of Support and Eligiblity Documentation:

1. Affirmative statement that the laboratory (and any other group responsible for sample collections, i.e., if partnering with inspectional staff to collect samples) is willing to collect samples from a wide variety of retail grocery stores and follow a randomized collection schedule set by the NARMS program, which pulls from a list of zip codes that the laboratory (or other collection partners) is willing/able to collect from.

2. Affirmative statement that the laboratory is willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting of NARMS samples.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project A2: National Antimicrobial Monitoring System (NARMS) Testing)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project A3: Microbiology Animal Food Product Testing

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project A3: Microbiology Animal Food Product Testing)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Title of Applicant's Project - Project A3: Microbiology Animal Food Product Testing
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project A3: Microbiology Animal Food Product Testing)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project A3: Microbiology Animal Food Product Testing)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project A3: Microbiology Animal Food Product Testing)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project A3: Microbiology Animal Food Product Testing)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project A3: Microbiology Animal Food Product Testing)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project A3: Microbiology Animal Food Product Testing)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:

(1) Maintain ISO 17025 accreditation for the duration of the award

(a) If ISO 17025 accreditation scope does not include methods utilized in this LFFM Product Testing Track, a plan must be developed by the end of the 1st year to expand the scope of ISO 17025 accreditation

(b) By the end of the 3rd year at least 1 method used in this track must be on the ISO 17025 accreditation scope

(2) Submit one or more data packages per year conducted under the Track (either spot check or potentially violative samples), per annual spot check schedule issued by LFFM Staff

(3) Use of FDA 431 or equivalent information provided in Spot Check and potentially violative data package submissions

(4) Collect, analyze, and report sample data in accordance with annual approved sample plan (commodity-hazard pairs). The percent completion rate for overall sampling and by commodity-hazard pair will be assessed annually. The timeliness and accuracy of data reported will be assessed annually.

Research Strategy:

Salmonella

1. Describe the laboratory’s ability to analyze animal food samples for Salmonella, including screening and confirmatory testing. Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year.

2. Describe control strain(s) used to detect Salmonella. Include information that demonstrates the validity of the results, such as green fluorescence protein (GFP) tagged controls. 

3. Describe the laboratory experience testing FDA-regulated animal food matrices (including animal food ingredients)

4. Describe capability of SRP to collect environmental swabs at manufacturing/processing facilities for Salmonella analysis.

5. Describe the laboratory’s capability to test environmental swabs for Salmonella.

Shiga toxin-producing E. coli (STECs)

1. Describe the laboratory’s ability to analyze animal food samples for STECs, including screening and confirmatory testing. Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year.

2. Describe control strain(s) used to detect STECs. Include information that demonstrates the validity of the results, such as green fluorescence protein (GFP) tagged controls.

3. Describe the laboratory experience testing FDA-regulated animal food matrices (including animal food ingredients)

Other

1. Describe the laboratory’s ability to test for the following additional pathogens in animal food samples, including screening and confirmatory testing.

Please identify the pathogens that the laboratory can test. For each pathogen, describe the instruments available on-site, the number of trained analysts, specific methods used, and any related proficiency testing completed within the past year.

a. Campylobacter

b. Clostridium botulinum (type C & D)

c. Listeria monocytogenes

d. Aerobic Plate Counts

e. Coliform (MPN)

f. Generic E. coli (MPN)

2. Provide a narrative description of the SRP’s ability to collect animal food product and animal food ingredients at manufacturers. This information should include a summary of the SRP’s sample collections in the past 3 years, including: numbers of samples, types of commodities, form of product sampled (e.g., bulk, bagged), number of facilities where sampling occurred.

3. Provide links to recalls of inter-state distributed product resulting from violative sample analyzed by the laboratory in the last 3 years relevant to this track (microbiological analysis of animal foods)

Letters of Support and Eligiblity Documentation:

1. Provide laboratory’s certificate(s) of ISO 17025 accreditation and accreditation scope(s).

2. Affirmative statement that the laboratory is willing to accept and analyze samples collected by FDA or other states in the event of an emergency requiring surge capacity coordinated by FDA/FERN (if the laboratory has the capability to perform requested analyses).

3. Affirmative statement that the laboratory and SRP are willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting, and following up on LFFM samples.

4. Provide letter of support from animal food state regulatory program. Must include affirmative statement that the SRP is willing to follow the LFFM Sample Guide. Must include affirmative statement that the SRP has the capability and willingness to collect at least a portion of samples from manufacturer and distributor level.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project A3: Microbiology Animal Food Product Testing)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project A4: Microbiology Whole Genome Sequencing – Maintenance

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project A4: Microbiology Whole Genome Sequencing – Maintenance)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Title of Applicant's Project - Project A4: Microbiology Whole Genome Sequencing – Maintenance
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project A4: Microbiology Whole Genome Sequencing – Maintenance)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project A4: Microbiology Whole Genome Sequencing – Maintenance)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project A4: Microbiology Whole Genome Sequencing – Maintenance)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project A4: Microbiology Whole Genome Sequencing – Maintenance)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project A4: Microbiology Whole Genome Sequencing – Maintenance)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project A4: Microbiology Whole Genome Sequencing – Maintenance)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims:

(1) Sequence and upload WGS data for enteric pathogen genomes, following current protocols issued by the FDA’s GenomeTrakr Program Coordinators, summarized here on protocols.io: GenomeTrakr WGS Protocol Collection and Workflow for MiSeq. Modifications to the laboratory workflow are allowed as long as WGS data meet the GenomeTrakr quality thresholds.

(a) The number of isolates sequenced and uploaded to NCBI will be assessed annually by querying NCBI using the following metadata fields: “sequenced_by” and “project_name”.

(b) For isolates recovered from LFFM M-HAF product testing or high priority state food product testing (e.g., outbreak), WGS data should be submitted to NCBI within 7 days of isolate confirmation.

Research Strategy:

1. Describe the laboratory’s ability to conduct WGS on isolates of foodborne pathogens from food and environmental sources. Provide details regarding instruments available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year.

2. Describe engagement with the Genome Trakr program, including details of previous meeting participation, participation in the annual GenomeTrakr PT, and other relevant activities.

3. Describe submission of foodborne pathogen isolates from food and environmental sources (related to FDA-regulated products or facilities) to NCBI over the past 5 years. Isolates may originate from surveillance, outbreak response, or other sources (FDA-regulated products).

4. Describe the volume of microbiological testing of FDA-regulated products or facilities conducted by the laboratory in the past 5 years. Samples may originate from surveillance, outbreak response, or other sources.

5. Describe any instances where your laboratory isolated and identified an outbreak strain in an FDA-regulated food product.

Letters of Support and Eligiblity Documentation: 

1. Affirmative statement that the laboratory will follow current protocols issued by the FDA’s GenomeTrakr Program Coordinators, which include completing “sequenced_by” and “project_name” fields in a manner that supports querying NCBI to determine isolate accomplishments.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project A4: Microbiology Whole Genome Sequencing – Maintenance)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project A5: Microbiology Whole Genome Sequencing – Throughput

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project A5: Microbiology Whole Genome Sequencing – Throughput)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - Project A5: Microbiology Whole Genome Sequencing – Throughput
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project A5: Microbiology Whole Genome Sequencing – Throughput)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project A5: Microbiology Whole Genome Sequencing – Throughput)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project A5: Microbiology Whole Genome Sequencing – Throughput)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project A5: Microbiology Whole Genome Sequencing – Throughput)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project A5: Microbiology Whole Genome Sequencing – Throughput)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project A5: Microbiology Whole Genome Sequencing – Throughput)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Sequence and upload WGS data for enteric pathogen genomes, following current protocols issued by the FDA’s GenomeTrakr Program Coordinators, summarized here on protocols.io: GenomeTrakr WGS Protocol Collection and Workflow for MiSeq. Modifications to the laboratory workflow are allowed as long as WGS data generated meet the GenomeTrakr quality thresholds.

(a) The number of isolates sequenced and uploaded to NCBI will be assessed annually by querying the following metadata fields: “sequenced_by” and “project_name”. Laboratories unable to meet the expectations of the track (400 isolates/year for historical isolate projects, or continuous participation in surveillance of environmental samples) may be removed from the track.

(b) Submit WGS data for isolates recovered from LFFM M-HAF Product Testing tracks to NCBI within 7 days of isolate confirmation.

Research Strategy:

1. Describe the laboratory’s ability to conduct WGS on isolates of foodborne pathogens from food and environmental sources. Provide details regarding instruments available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year.

2. Describe engagement with the Genome Trakr program, including details of participation in the annual GenomeTrakr PT in each of the past 3 years.

3. Describe all planned collaborations or other projects that will yield isolates for sequencing under this track. Specifically for each collaboration/project:

a. Describe the collaboration/project: whether the laboratory will be receiving sets of historical isolates or conducting environmental pathogen surveillance, including the collection, microbiological analysis, isolation, and sequencing of enteric pathogens from routine samples, like water, in agricultural growing regions

b. Provide letters of support from each collaborator (source of samples and/or isolates) demonstrating commitment for obtaining and sending samples/isolates to the laboratory

c. List the pathogens to be analyzed and/or sequenced

d. Describe the source of the samples that yielded the isolates (see list of sample sources in NOFO)

e. Provide the approximate number of samples/isolates (in total, by pathogen, and by sample source)

f. Describe whether the collaboration/project will yield domestic or international isolates and estimate the percentage of each.

4. Describe the volume of submission of WGS data for foodborne pathogen isolates from food and environmental sources (related to FDA-regulated products or facilities) to NCBI over the past 3 years. Isolates may originate from surveillance, outbreak response, or other sources.

5. Describe the laboratory’s ability to and willingness to organize and support a continuous and routine surveillance project of environmental samples from agricultural growing regions.

Letters of Support and Eligiblity Documentation:

1. Affirmative statement that the laboratory will follow current protocols issued by the FDA’s GenomeTrakr Program Coordinators, which include completing “sequenced_by” and “project_name” fields in a manner that supports querying NCBI to determine isolate accomplishments.

2. Affirmative statement that the laboratory will prioritize sequencing of M-HAF product testing track isolates, if the laboratory is also applying to those tracks.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project A5: Microbiology Whole Genome Sequencing – Throughput)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project A6: Microbiology Food Defense

When preparing your application, use Component Type “Project”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project A6: Microbiology Food Defense)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - Project A6: Microbiology Food Defense
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project A6: Microbiology Food Defense)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project A6: Microbiology Food Defense)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project A6: Microbiology Food Defense)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project A6: Microbiology Food Defense)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project A6: Microbiology Food Defense)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project A6: Microbiology Food Defense)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Maintain readiness to receive and analyze human and animal food samples for food defense microbiological contamination. This includes:

(a) maintain equipment

(b) maintain trained staff

(c) maintain validated methods/quality system

(d) maintain reagents, supplies, and controls

(2) Participate in FERN annual Triage exercise or annual FERN B. anthracis/Y. pestis Proficiency Test

(3) Participate in any other FERN PTs involving food defense microbiological analytes aligned with the laboratory’s capabilities

(4) Provide analytical testing support to FDA or other states (coordinated by FDA/FERN) in response to a planned event or emergency response incident involving microbiological contamination of human or animal food. This may include participation in national security event exercises, as available and requested.

(5) Maintain certification of BSL2+ or BSL3 facilities

Research Strategy:

1. Describe the laboratory’s ability to test Bacillus anthracis in human and animal foods. Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year.

2. Describe the laboratory’s ability to test Yersinia pestis in human and animal foods. Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year.

3. Describe the laboratory’s ability to test Ricin in human and animal foods. Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year.

4. Describe the laboratory’s ability to test Staphylococcal Enterotoxin (SET) in human and animal foods. Provide details regarding the instruments available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year.

5. Describe the laboratory’s ability to test C. botulinum toxin in human and animal foods. Include information on the MALDI-TOF mass spectrometry available on-site, number of trained analysts, specific methods employed, completed validation and ability to purchase required antibodies (MTA).

6. Provide copy of BSL3 laboratory certification.

7. Provide copy of LRN Laboratory registration and confirm compliance with Select Agent Regulations.

8. Describe the laboratory’s participation in either BA/YP FERN Proficiency Test or FERN Triage Exercise in each of the past 3 years.

9. Describe circumstances in which the laboratory analyzed samples to support emergency response, outbreak investigations, or other unique needs for the FDA or other states.

Letters of Support and Eligiblity Documentation:

1. Documentation that the laboratory is a BSL2+ facility, such as a safety plan that ensures analysts are trained to use food defense methods with appropriate personal protective equipment and safeguards in place.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project A6: Microbiology Food Defense)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project A7: Microbiology Method Development and Method Validation

When preparing your application, use Component Type “Project”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project A7: Microbiology Method Development and Method Validation)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - Project A7: Microbiology Method Development and Method Validation
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project A7: Microbiology Method Development and Method Validation)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project A7: Microbiology Method Development and Method Validation)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project A7: Microbiology Method Development and Method Validation)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project A7: Microbiology Method Development and Method Validation)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project A7: Microbiology Method Development and Method Validation)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project A7: Microbiology Method Development and Method Validation)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Follow FDA guidelines for the Validation of Analytical Methods (Foods Program Methods Validation Processes and Guidelines - FDA)

(2) Complete planned project and provide detailed description of progress/status in mid-year and end-of-year progress reports.

(3) Participate in check-in calls and general communications with LFFM staff regarding the project

(4) If participating in an FDA-led multi-laboratory project, analyze study samples and submit data following study protocol and in accordance with study timeline and due dates (will vary by project). The project lead is responsible for writing and submitting the validation report.

(5) If conducting a state-led project, successful completion of the project involves completion of at least a Level 2 single lab validation report consisting of standard operating procedure (SOP) of the method, a report detailing the method development, validation, performance characteristics with supporting data, as outlined in the Guidelines for the Validation of Microbiological Methods for the Foods Program. The project lead is responsible for writing and submitting the validation report.

Research Strategy:

A written research strategy is not required for this track. In this section, please include the following statement: ‘Laboratories approved for a Microbiology Human Food Product Testing Track, Microbiology Animal Food Product Testing Track, Microbiology Food Defense, or the Whole Genome Sequencing tracks will automatically qualify to participate in the Microbiology Method Development and Validation Track.’

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project A7: Microbiology Method Development and Method Validation)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project A8:Microbiology Capacity/Capability Development

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project A8:Microbiology Capacity/Capability Development)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - Project A8:Microbiology Capacity/Capability Development
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project A8:Microbiology Capacity/Capability Development)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project A8:Microbiology Capacity/Capability Development)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project A8:Microbiology Capacity/Capability Development)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project A8:Microbiology Capacity/Capability Development)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project A8:Microbiology Capacity/Capability Development)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project A8:Microbiology Capacity/Capability Development)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Complete implementation of the planned capability including the purchase of necessary equipment, training of personnel, and demonstrating competency through a proficiency test offered by a suitable proficiency testing program, as available. A summary report will be generated at the end of the project and submitted to LFFM Staff.

(2) Operationalize the capability in a subsequent year through the chemistry human or animal food product testing track or chemistry food defense track.

(3) Highlight impact of developed capabilities on LFFM or state activities in mid-year and end-of-year progress reports, and through presentations at meetings. 

Research Strategy:

A written research strategy is not required for this track. In this section, please include the following statement: 'Laboratories approved for a Microbiology Human Food Product Testing Track, Microbiology Animal Food Product Testing Track, Microbiology Food Defense, or the Whole Genome Sequencing tracks will automatically qualify to participate in the Microbiology Capacity/Capability Track. ' 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project A8:Microbiology Capacity/Capability Development)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project B1: Chemistry Human Food Product Testing

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project B1: Chemistry Human Food Product Testing)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - Project B1: Chemistry Human Food Product Testing
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project B1: Chemistry Human Food Product Testing)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project B1: Chemistry Human Food Product Testing)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project B1: Chemistry Human Food Product Testing)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project B1: Chemistry Human Food Product Testing)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project B1: Chemistry Human Food Product Testing)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project B1: Chemistry Human Food Product Testing)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Maintain ISO 17025 accreditation for the duration of the award

(a) If ISO 17025 accreditation scope does not include methods utilized in this LFFM Product Testing Track, a plan must be developed by the end of the 1st year to expand the scope of ISO 17025 accreditation

(b) By the end of the 3rd year at least 1 method used in this track must be on the ISO 17025 accreditation scope

(2) Submit one or more data packages per year conducted under the Track (either spot check or potentially violative samples), per annual spot check schedule issued by LFFM Staff

(3) Use of FDA 431 or equivalent information provided in Spot Check and potentially violative data package submissions

(4) Collect, analyze, and report sample data in accordance with annual approved sample plan (commodity-hazard pairs). The percent completion rate for overall sampling and by commodity-hazard pair will be assessed annually. The timeliness and accuracy of data reported will be assessed annually.

Research Strategy:

1. Describe the laboratory’s equipment available for human food testing. Provide details regarding the following instruments, including the number available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year. Include breadth of validated/verified analytes and method testing capabilities (relevant to the track).

a. ICP-MS

b. HPLC-ICP-MS

c. LC-MS/MS

d. LC-HRMS

e. ICP-OES

f. GC-MS/MS

g. GC-HRMS

2. Describe the laboratory’s equipment available for allergen testing. Provide details regarding the following instruments (e.g., MAGPIX or ELISA) available on-site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year. Incorporate the breadth of analyte testing capabilities.

3. Provide links to recalls of inter-state distributed product resulting from violative sample analyzed by the laboratory in the last 3 years relevant to this track (chemistry analysis of human foods)

Letters of Support and Eligiblity Documentation:

1. Provide laboratory’s certificate(s) of ISO 17025 accreditation and accreditation scope(s).

2. Affirmative statement that the laboratory is willing to accept and analyze samples collected by FDA or other states in the event of an emergency requiring surge capacity coordinated by FDA/FERN (if the laboratory has the capability to perform requested analyses).

3. Affirmative statement that the laboratory and SRP are willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting, and following up on LFFM samples.

4. Provide letter of support from manufactured food state regulatory program, as well as other state regulatory program (SRP) components, if other commodities will be collected/analyzed (e.g., produce from farms, dairy not covered by manufactured food program, etc.). Must include affirmative statement that the SRP is willing to follow the LFFM Sample Guide. Please note retail food is not considered a separate program for the purposes of this scoring this application. 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project B1: Chemistry Human Food Product Testing)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project B2: Chemistry Animal Food Product Testing

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project B2: Chemistry Animal Food Product Testing)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - Project B2: Chemistry Animal Food Product Testing
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project B2: Chemistry Animal Food Product Testing)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project B2: Chemistry Animal Food Product Testing)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project B2: Chemistry Animal Food Product Testing)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project B2: Chemistry Animal Food Product Testing)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project B2: Chemistry Animal Food Product Testing)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project B2: Chemistry Animal Food Product Testing)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Maintain ISO 17025 accreditation for the duration of the award

(a) If ISO 17025 accreditation scope does not include methods utilized in this LFFM Product Testing Track, a plan must be developed by the end of the 1st year to expand the scope of ISO 17025 accreditation

(b) By the end of the 3rd year at least 1 method used in this track must be on the ISO 17025 accreditation scope

(2) Submit one or more data packages per year conducted under the Track (either spot check or potentially violative samples), per annual spot check schedule issued by LFFM Staff

(3) Use of FDA 431 or equivalent information provided in Spot Check and potentially violative data package submissions

(4) Collect, analyze, and report sample data in accordance with annual approved sample plan (commodity-hazard pairs). The percent completion rate for overall sampling and by commodity-hazard pair will be assessed annually. The timeliness and accuracy of data reported will be assessed annually.

Research Strategy:

1. Describe the laboratory’s equipment available for animal food testing. Provide details regarding the following instruments, including the number available on site, number of trained analysts, specific methods employed, and any related proficiency testing conducted within the past year. Include breadth of validated/verified analytes and method testing capabilities (relevant to the track).

a. ICP-MS

b. LC-MS/MS

c. LC-HRMS

d. ICP-OES

e. GC-MS/MS

f. GC-HRMS

2. Provide links to recalls of inter-state distributed product resulting from violative sample analyzed by the laboratory in the last 3 years relevant to this track (chemistry analysis of animal foods)

Letters of Support and Eligiblity Documentation:

1. Provide laboratory’s certificate(s) of ISO 17025 accreditation and accreditation scope(s).

2. Affirmative statement that the laboratory is willing to accept and analyze samples collected by FDA or other states in the event of an emergency requiring surge capacity coordinated by FDA/FERN (if the laboratory has the capability to perform requested analyses).

3. Affirmative statement that the laboratory and SRP are willing to follow the LFFM Sample Guide for planning, collecting, analyzing, reporting, and following up on LFFM samples.

4. Provide letter of support from animal food state regulatory program. Must include affirmative statement that the SRP has the capability and willingness to collect at least a portion of samples from manufacturer and distributor level.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project B2: Chemistry Animal Food Product Testing)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project B3: Chemistry Food Defense

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project B3: Chemistry Food Defense)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - Project B3: Chemistry Food Defense
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project B3: Chemistry Food Defense)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project B3: Chemistry Food Defense)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project B3: Chemistry Food Defense)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project B3: Chemistry Food Defense)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project B3: Chemistry Food Defense)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project B3: Chemistry Food Defense)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Maintain readiness to receive and analyze human and animal food samples for food defense chemical contamination. This includes:

(a) maintain equipment

(b) maintain trained staff

(c) maintain validated methods/quality system

(d) maintain reagents, supplies, and controls

(2) Participate in FERN annual unknown poison/toxin screen exercise

(3) Participate in any other FERN PTs involving food defense chemical analytes aligned with the laboratory’s capabilities.

(4) Participate in Integrated Consortium of Laboratory Networks (ICLN) exercises on behalf of FERN, as available and aligned with the laboratory’s capabilities

(5) Provide analytical testing support to FDA or other states (coordinated by FDA/FERN) in response to a planned event or emergency response incident involving chemical contamination of human or animal food. This may include participation in national security event exercises, as available and requested.

Research Strategy:

1. Describe participation in FERN Food Defense PTs (PTs using CHE0006, CHE0008 or CHE0008A, or CHE0009 or EAM 4.7) and FERN Unknown Poison/Toxin Exercise in past 3 years, including whether the lab was successful for target analytes.

2. Describe circumstances in which the laboratory analyzed samples to support emergency response, outbreak investigations, or other unique needs for the FDA or other states.

3. Describe instances where FERN food defense methods were utilized to support an emergency response event within the state.

4. Describe any mentorship support the laboratory provided to another laboratory as part of the LFFM.

5. Describe past experience and participation in LFFM chemistry food defense special projects.

6. Describe the laboratory's capability to identify unknowns in a suspect sample by LC-MS and/or GC-MS.

7. Describe the laboratory’s ability to analyze samples using the following, including details regarding the number of instruments available on-site, number of trained analysts, and any related proficiency testing conducted within the past year:

a. CHE0006 (GC-MS)

b. CHE0008 and/or CHE0008A

c. CHE0009 and/or EAM 4.7

d. other food defense related methods or equipment utilized by the laboratory

8. Indicate if the laboratory is part of a state Rapid Response Team (RRT), whether funded or voluntary.

Letters of Support and Eligiblity Documentation:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project B3: Chemistry Food Defense)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project B4: Chemistry Method Development and Method Validation

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project B4: Chemistry Method Development and Method Validation)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - Project B4: Chemistry Method Development and Method Validation
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project B4: Chemistry Method Development and Method Validation)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project B4: Chemistry Method Development and Method Validation)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project B4: Chemistry Method Development and Method Validation)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project B4: Chemistry Method Development and Method Validation)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project B4: Chemistry Method Development and Method Validation)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project B4: Chemistry Method Development and Method Validation)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Follow FDA guidelines for the Validation of Analytical Methods (Foods Program Methods Validation Processes and Guidelines - FDA)

(2) Complete planned project and provide detailed description of progress/status in mid-year and end-of-year progress reports.

(3) Participate in check-in calls and general communications with LFFM staff regarding the project

(4) If participating in an FDA-led multi-laboratory project, analyze study samples and submit data following study protocol and in accordance with study timeline and due dates (will vary by project). The project lead is responsible for writing and submitting the validation report.

(5) If conducting a state-led project, successful completion of the project involves completion of at least a Level 2 single lab validation report consisting of standard operating procedure (SOP) of the method, a report detailing the method development, validation, performance characteristics with supporting data, as outlined in the Guidelines for the Validation of Chemical Methods for the Foods Program. The project lead is responsible for writing and submitting the validation report.

Research Strategy:

A written research strategy is not required for this track. In this section, please include the following statement: ‘ Laboratories approved for a Chemistry Human Food Product Testing Track, Chemistry Animal Food Product Testing Track, or Chemistry Food Defense will automatically qualify to participate in the Chemistry Method Development and Validation Track.’

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project B4: Chemistry Method Development and Method Validation)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project B5: Chemistry Capability/Capacity Development

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project B5: Chemistry Capability/Capacity Development)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - Project B5: Chemistry Capability/Capacity Development
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project B5: Chemistry Capability/Capacity Development)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project B5: Chemistry Capability/Capacity Development)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project B5: Chemistry Capability/Capacity Development)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project B5: Chemistry Capability/Capacity Development)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project B5: Chemistry Capability/Capacity Development)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project B5: Chemistry Capability/Capacity Development)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Complete implementation of the planned capability including the purchase of necessary equipment, training of personnel, and demonstrating competency through a proficiency test offered by a suitable proficiency testing program, as available. A summary report will be generated at the end of the project and submitted to LFFM Staff.

(2) Operationalize the capability in a subsequent year through the chemistry human or animal food product testing track or chemistry food defense track.

(3) Highlight impact of developed capabilities on LFFM or state activities in mid-year and end-of-year progress reports, and through presentations at meetings. 

Research Strategy:

A written research strategy is not required for this track. In this section, please include the following statement: 'Laboratories approved for a Chemistry Human Food Product Testing Track, Chemistry Animal Food Product Testing Track, or Chemistry Food Defense will automatically qualify to participate in the Chemistry Capacity/Capability Track.' 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project B5: Chemistry Capability/Capacity Development)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project C1: Radiochemistry Food Defense

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project C1: Radiochemistry Food Defense)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - Project C1: Radiochemistry Food Defense
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project C1: Radiochemistry Food Defense)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project C1: Radiochemistry Food Defense)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project C1: Radiochemistry Food Defense)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project C1: Radiochemistry Food Defense)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project C1: Radiochemistry Food Defense)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project C1: Radiochemistry Food Defense)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Maintain readiness to receive and analyze human and animal food samples for alpha, beta, and gamma emitters. This includes:

(a) Maintain equipment in good working order and equipment has valid calibrations

(b) Maintain trained and proficient staff

(c) Maintain validated methods/quality control

(d) Maintain reagents/standards/supplies

(e) Ability to utilize semi-quantitative results to determine whether contamination level is well above or well below regulatory limits

(f) Ability to document sample reception/analysis and correctly submit analytical results for determining whether additional analysis is warranted

(2) Participate in FERN annual radiochemistry exercise, other FDA-requested exercises, and/or surveillance activities to demonstrate proficiency and sustained preparedness.

(3) Provide analytical testing support to detect gamma, alpha, or beta emitters in human or animal food to FDA or other states (coordinated by FDA/FERN) during planned events or emergency response incidents which may involve joining national security exercises upon availability and request.

(4) Participate in small-scale survey of human or animal food to test for radionuclides of interest, as outlined/coordinated by FDA with the potential for future surveillance activities based on the outcomes of the preliminary survey.

Research Strategy:

1. Provide laboratory’s certificate(s) of ISO 17025 accreditation and accreditation scope(s).

2. Describe the laboratory’s association with a human or animal food regulatory program. Provide copy of written agreement between lab and regulatory program, if applicable.

3. Describe the laboratory’s and associated regulatory program's ability to collect a variety of human and/or animal food samples, including perishable items, across a broad geographic area. This includes the ability to generate a collection report and other appropriate documentation, as necessary. Please describe any training/procedures for sample collection, chain of custody, and maintaining sample integrity.

4. Describe participation in emergency response events and readiness activities in the last 5 years. Include any commodity area, but emphasize activities related to human and animal food. (e.g., ingestion pathway exercises, state/national exercises, or others).

5. Describe participation in FERN radiochemistry special projects within the last 5 years.

6. Describe participation in FERN radiochemistry challenge sample exercises within the last five years.

7. Provide a list of nuclear facilities in the state or close to the state border, including the name of the installation and addresses.

8. Describe the laboratory’s alpha testing capabilities supported by current laboratory infrastructure and validated methods for analysis of alpha emitters. Provide details regarding the number of instruments available on-site, age of instruments, acid fume hoods for sample digestion and radiochemical separation, number of trained analysts, analyst years of experience, specific methods employed (including validation and implementation status, and matrices covered), and any related proficiency testing conducted within the past year. Describe the breadth of human and animal foods tested using validated, implemented methods.

9. Describe the laboratory’s beta testing capabilities supported by current laboratory infrastructure and validated methods for analysis of beta emitters. Provide details regarding the number of instruments available on-site, age of instruments, number of trained analysts, analyst years of experience, specific methods employed (including validation and implementation status, and matrices covered), and any related proficiency testing conducted within the past year. Describe the breadth of human and animal foods tested using validated, implemented methods.

10. Describe the laboratory’s gamma testing capabilities supported by current laboratory infrastructure and validated methods for analysis of gamma emitters. Provide details regarding the number of instruments available on-site, age of instruments, number of trained analysts, analyst years of experience, specific methods employed (including validation and implementation status, and matrices covered), and any related proficiency testing conducted within the past year. Describe the breadth of human and animal foods tested using validated, implemented methods.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project C1: Radiochemistry Food Defense)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project C2: Radiochemistry Method Development and Method Validation

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project C2: Radiochemistry Method Development and Method Validation)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - Project C2: Radiochemistry Method Development and Method Validation
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project C2: Radiochemistry Method Development and Method Validation)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project C2: Radiochemistry Method Development and Method Validation)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project C2: Radiochemistry Method Development and Method Validation)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project C2: Radiochemistry Method Development and Method Validation)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project C2: Radiochemistry Method Development and Method Validation)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project C2: Radiochemistry Method Development and Method Validation)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Follow FDA guidelines for the Validation of Analytical Methods (Foods Program Methods Validation Processes and Guidelines - FDA)

(2) Complete planned project and provide detailed description of progress/status in mid-year and end-of-year progress reports.

(3) Participate in check-in calls and general communications with LFFM staff regarding the project

(4) If participating in an FDA-led multi-laboratory project, analyze study samples and submit data following study protocol and in accordance with study timeline and due dates (will vary by project). The project lead is responsible for writing and submitting the validation report.

(5) If conducting a state-led project, successful completion of the project involves completion of at least a Level 2 single lab validation report consisting of standard operating procedure (SOP) of the method, a report detailing the method development, validation, performance characteristics with supporting data, as outlined in the Guidelines for the Validation of Chemical Methods for the Foods Program. The project lead is responsible for writing and submitting the validation report.

Research Strategy:

A written research strategy is not required for this track. In this section, please include the following statement: 'Laboratories approved for the Radiochemistry Food Defense track will automatically qualify to participate in the Radiochemistry Method Development and Validation Track.' 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project C2: Radiochemistry Method Development and Method Validation)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

Project C3: Radiochemistry Capacity/Capability Development

When preparing your application, use Component Type “Project.”

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project C3: Radiochemistry Capacity/Capability Development)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant's Project - Project C3: Radiochemistry Capacity/Capability Development.
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project C3: Radiochemistry Capacity/Capability Development)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project C3: Radiochemistry Capacity/Capability Development)

Human Subjects: Answer only the “Are Human Subjects Involved?” and "Is the Project Exempt from Federal regulations?" questions.

Vertebrate Animals: Answer only the “Are Vertebrate Animals Used?” question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project C3: Radiochemistry Capacity/Capability Development)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project C3: Radiochemistry Capacity/Capability Development)

• In the Project Director/Principal Investigator section of the form, use Project Role of “Other” with Category of “Project Lead” and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project C3: Radiochemistry Capacity/Capability Development)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project C3: Radiochemistry Capacity/Capability Development)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

The most commonly referenced Research Plan attachments are listed below for your convenience. NOFO specific instructions are required for the Specific Aims and the Research Strategy in each component. NOFO-specific instructions are optional for Letters of Support. Delete Letters of Support if there are no NOFO-specific instructions.

Specific Aims:

(1) Complete implementation of the planned capability including the purchase of necessary equipment, training of personnel, and demonstrating competency through a proficiency test offered by a suitable proficiency testing program, as available. A summary report will be generated at the end of the project and submitted to LFFM Staff.

(2) Operationalize the capability in a subsequent year through the radiochemistry food defense track.

(3) Highlight impact of developed capabilities on LFFM or state activities in mid-year and end-of-year progress reports, and through presentations at meetings. 

Research Strategy:

A written research strategy is not required for this track. In this section, please include the following statement: ‘ Laboratories approved for the Radiochemistry Food Defense track will automatically qualify to participate in the Radiochemistry Capacity/Capability Track.’

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide, with the following modification:

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• A Data Management and Sharing Plan is not applicable for this NOFO.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Project C3: Radiochemistry Capacity/Capability Development)

When involving human subjects research, clinical research, and/or FDA-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the How to Apply- Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA's electronic system for grants administration. FDA and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the FDA Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in How to Apply- Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

1. Facilities and work reimbursed under the FDA human or animal food safety inspection contract or other funding mechanisms such as the Manufactured Food Regulatory Program Standards, Animal Food Regulatory Program Standards, Produce Safety, or Rapid Response Teams cooperative agreements must remain distinct and separate from this cooperative agreement.

2. Vehicle purchases are not permitted.

3. Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.

4. Cooperative agreement funds may not be utilized for clothing and uniforms with the exception of personal protective equipment (PPE).  PPE is defined as protective clothing or other outerwear required to mitigate a defined workplace hazard.

Additional funding restrictions may be part of the Notice of Award

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply - Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to the FDA.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in How to Apply - Application Guide. 

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the assigned FDA Grants Management Specialist and responsiveness by components of participating organizations. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy.

Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review. Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the FDA in support of the FDA mission are evaluated for scientific and technical merit through the FDA objetive review system.

Scored Review Criteria - A1: Microbiology Human Food Product Testing

Scored Review Criteria - A2: National Antimicrobial Monitoring System (NARMS) Testing

Scored Review Criteria - A3: Microbiology Animal Food Product Testing

Scored Review Criteria - A4: Microbiology Whole Genome Sequencing – Maintenance

Scored Review Criteria - A5: Microbiology Whole Genome Sequencing – Throughput

Scored Review Criteria - A6: Microbiology Food Defense

Scored Review Criteria - B1: Chemistry Human Food Product Testing

Scored Review Criteria - B2: Chemistry Animal Food Product Testing

Scored Review Criteria - B3: Chemistry Food Defense

Scored Review Criteria - C1: Radiochemistry Food Defense

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Committee convened by the FDA, using the stated review criteria. Assignment to an Objective Review Committee will be shown in eRA Commons.

As part of the objective review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this NOFO will be subject to terms and conditions found on the Award Conditions and Information for FDA Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

If a recipient receives and award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that FDA research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. The FDA will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all FDA grants and cooperative agreements except fellowships.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial FDA programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and FDA as defined below.

Project Director/Principal Investigator Rights and Responsibilities:

The Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA/ORA staff being substantially involved as a partner with the PD/PI, as described below.

The PD/PI will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff have the necessary training and clearance to work on this project. This individual will work closely with designated officials within the recipient organization and with partner organizations to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal, regulatory, and organizational requirements.

FDA staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The Grants Project Team may consist of a Grants Management Specialist, Program Official (PO), and Technical Advisor.  The Grants Project Team collaborates to review the progress of the grantee.  The Grants Project Team may utilize the grantee’s progress reports, site visits, audit reports and other supporting documentation to determine if the condition of the award was met and satisfactory progress is being made.  Each team member works in consultation with each other, as needed, throughout the duration of the project. A description of each team member involved with the program are described below.

An FDA Grants Management Specialist (GMS) will be assigned and named in the Notice of Award.  The GMS oversees the administrative, financial, business and other non-programmatic aspects of the program.  These activities include, but are not limited to the following:

• Provides guidance on administrative, business, fiscal aspects of grants management to grantees and FDA program staff
• Monitors and manages applications and required reports on eRA Commons
• Monitors administrative and financial aspects of grantee activities
• Maintains the official grantee file

An FDA Program Official (PO) will be assigned and named in the Notice of Award.  The PO is accountable for the programmatic oversight of the grant to include coordination, with the Project Manager, on the technical aspects of the grant.  S/he ensures the budget of grantees are reasonable and costs are allowable and allocable.  The PO reviews the progress reports to verify the budget proposed includes only allowable expenses that support the project goals and objectives.   The PO also assists with post-award monitoring and establishing a corrective action plan, if necessary.

An FDA Technical Advisor(s) will be assigned to each track. The Advisor will work cooperatively with the PO to help monitor and report grantee status/progress including sharing of information and historical backgrounds.

The PO and Technical Advisor(s) will have substantial involvement that is above and beyond the normal stewardship role in the design, implementation, and evaluation of program activities, and dissemination of program results and outcomes, above and beyond routine grant monitoring.

Substantial involvement by the FDA includes, but is not limited to, the following:

• Provide guidance, and technical assistance in project planning, implementation, and evaluation;
• Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;
• Actively monitor the supported program via telephone conversations, webinars, e-mails, written correspondence, or periodic site visits;
• Evaluate the supported program, including development of program-level performance measures, consistent data collection, and reporting procedures and protocols;
• Convene trainings, meetings, conference calls, and site visits with grantee to facilitate collaboration and information sharing;
• Participate in data analysis, interpretation of findings, and where appropriate, co-authorship of publications;
• Development of programs to meet the FDA mission;
• Provision of programmatic technical assistance;
• Post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the FDA. 

Unless another governance structure is mutually agreed upon, the PO will serve as the primary point of contact for the dissemination of FDA policy and milestones/objectives work planning.

Monitoring Activities

Periodic program monitoring will be conducted by the FDA on an ongoing basis which may include, but is not limited to, telephone conversations, emails, on-site visits, review of quarterly sample reports, progress reports, audit assessments, financial reports, etc.

In addition, performance evaluations will include monitoring to ensure:

• Completion of at least 90% of planned sampling for product testing tracks
• Successful sequencing of isolates yielded from microbiology human and animal food product testing tracks
• Acceptable progress on Capacity/Capability and Method Development Validation projects
• Readiness for food defense methods outlined notice of funding opportunity and successfully demonstrate competency via FERN exercises and/or PTs
• Timely submission of spot check packages and acceptable findings during spot check reviews
• Timely submission of quarterly sample data for product testing track with minimal or minor corrections needed
• Timely and complete submission of progress reports and annual sample and activity plan proposals

The Program Official and Technical Advisor(s) conduct the monitoring of the grantee’s performance, provide technical advice and assistance and, when necessary, investigate problems or deficiencies identified during review of reports.

The Grants Project Team (Grant Management Specialist, Program Official, and Technical Advisor(s)) reviews the progress report to verify the satisfactory progress is being made toward the project objectives and goals in the project, proposed activities are allowable and within the guidelines of the NOFO and budget proposed includes only allowable expenses that support project goals and objectives. When necessary, the Grants Project Team will investigate problems or deficiencies identified during review of reports and determine the corrective actions required.  Performance deficiencies may be addressed by requiring a revised progress report, submission of a corrective action plan, increased reporting requirements and monitoring activities, funding restrictions, and other methods, including up to suspension or termination of the award. 

Areas of Joint Responsibility include:

• None; all responsibilities are divided between recipients and FDA staff as described above.

The grantee organization must comply with all special terms and conditions of the cooperative agreement. Future funding will be dependent on recommendations from the Project Manager and Program Official.  The scope of the recommendation will confirm an acceptable level of performance and continued compliance with all FDA regulatory requirements and conditions of the award. Specific project milestones, reporting requirements, and other project deliverables may be included as a condition of your award. If FDA determines that the grantee is unable to make adequate progress, FDA may place them in special condition status and may require a corrective action plan.

Additional Terms and Conditions:

• Grantees will meet required aims per track as outlined in the NOFO.
• If a recipient of multiple FDA awards (cooperative agreements, grants, contracts), the State must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, under those funding mechanisms and this cooperative agreement.
• A rebudgeting request covers reallocation of cooperative agreement funds and change of planned expenditures (compared to the existing budget on record for the grantee) either between budget categories (personnel, equipment, supplies, etc.) or within a single budget category.
• All rebudgeting requests that involve moving cooperative agreement funds between budget categories in excess of 10% of the total track award must be submitted and approved by FDA. Although Prior Approval is not required for rebudgeting of less than 10%, the FDA must be notified via email.
• Rebudgeting requests within a single budget category must be submitted and approved by OP/OAGS when they reach a cumulative (during a single budget period) total of $10,000 or more.
• Rebudgeting requests up to 25% can be submitted to the FDA via email. Rebudgeting requests over 25% must be submitted in the Prior Approval module in eRA.
• A new NGA will only be issued when rebudgeting requests reach a cumulative total (during a single budget period) of 25% of the total award or more.
• LFFM laboratories must utilize the most recent version of the LFFM Sample Guide.
• FDA reserves a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use for federal purposes any copyrighted works that are outcomes from these funding tracks, including curriculum, course content, objectives, learning outcomes, presentations, manuals, scripts, exercises, handouts, reports, documents or other tangible materials produced by the awardee.  FDA may authorize others to reproduce, publish, or otherwise use such works for Federal purposes. 

FDA Records and FDA Directed Assignments:  

Any information received under this cooperative agreement or generated under an FDA directed assignment that 1) has been provided to the awardees by the FDA, or 2) was generated through sample analysis by the awardee shall not be released, published, disclosed or made known in any manner to any persons outside of the awardee organization or designated partner regulatory agency without prior authorization from the FDA.  Examples of this information includes FDA assignment documents and laboratory results.    

The awardee must notify the Program Official (PO) of any Freedom of Information Act (FOIA) or any other information access requests received that would include any work performed or documents received under this cooperative agreement.  FDA will determine if the requested records may be released at the awardee level or if the awardee must refer the requester to FDA's Division of Freedom of Information at https://www.fda.gov/regulatory-information/freedom-information/how-make-foia-request for access to the records. 

Other Information Generated under the Cooperative Agreement:  

Any other information generated under this cooperative agreement that has been collected by the awardee or designated partner regulatory agency, or generated through sample analysis by the awardee under their own state authority (and not related to an FDA directed assignment) will not be released, published, disclosed or made known in any manner to any persons outside of the awardee organization or designated partner regulatory agency without prior timely advance notification to the FDA.  Examples of this information includes sample collection reports, and laboratory results.    

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and FDA may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without FDA staff voting, one FDA designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.

3. Data Management and Sharing

Consistent with the FDA Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the HHS Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described. 

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the HHS Grants Policy Statement.

In addition to completing the RPPR in eRA Commons, awardees must also upload a completed copy of the most recent version of the LFFM Reporting Document, which will be provided by FDA, a pdf version of samples submitted in the FERN website during the reporting period, and the proposed sample plan for the upcoming year for FDA review and approval. 

A detailed quarterly summary of all samples collected and analyzed must be submitted using the appropriate discipline's Quarterly Sample Summary form (OMB #0910-0909) through the FERN website, or other FDA approved system. 

A Mid-Year Progress Report is required no later than fifteen (15) days after the six (6) month mark of each budget year, annually. Awardees must email to the PO and [email protected] a completed copy of the most recent version of the LFFM Program Report (OMB #0910-0909), which will be provided by FDA prior to the progress report due date. 

An End-of-Year Progress Report is required at the same time as the RPPR, annually. Awardees must email to the PO and [email protected] a completed copy of the most recent version of the LFFM Program Report (OMB #0910-0909), which will be provided by FDA prior to the report due date.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement. FDA NOFOs outline intended research goals and objectives. Post award, the FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the HHS Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to  2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 2 CFR Part 200 â?“ Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help  (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Janna Hutchinson

FDA - Office of Domestic Partnerships
Telephone: 240-402-5353
Email: [email protected] 

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Danielle Head
Office of Acquisitions and Grants Services
Email: [email protected]  

Section VIII. Other Information

Recently issued policy notices may affect your application submission. A full list of policy notices is provided in the Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.