2024 CAP Program Competitive Announcement final.pdf

FSIS FERN Cooperative Agreement Program Announcement

A. PROGRAM DESCRIPTION

The Food Emergency Response Network (FERN) currently comprises federal, state, and local government regulatory laboratories with varying capacities to perform threat agent testing. The

Contaminants and Threat Agents Group (CTAG) within the Laboratory Quality Assurance, Response and Coordination Staff (LQARCS) in USDA’s Food Safety and Inspection Service

(FSIS) is seeking to award new cooperative agreements thereby continuing its program of providing surge capacity and capability for food defense and food safety testing to FSIS. The agreements enhance the ability to analyze meat, poultry, and meat and egg products for microbiological, chemical, and radiological agents utilizing approved FERN methods to improve laboratory capacities for food defense initiatives, outbreak response, and other food testing projects. The agreements support the FERN program testing initiatives, method proficiency training, method-required supply and equipment purchases, and reimbursement of personnel expenses. All cooperative agreements are awarded yearly and part of a 5-year cycle. This announcement will constitute the 1st year of a 5-year cycle. Yearly awards are contingent upon continued Agency funding and a review of each laboratory participant’s past performance where possible.

History

The FSIS FERN Cooperative Agreement Program (CAP) provides funding to state meat, poultry, and meat and egg products testing laboratories with the objective of increasing FSIS’ capacity and capability to respond to both intentional and unintentional contaminated food events.

Laboratories that are members of the network have access to the FERN Communication, Collaboration and Management (CCM) Portal (www.fernlab.org). This system maintains information on member laboratories’ capacity and capability for meat, poultry, and meat and egg products testing including laboratory space, equipment, select agent registration, and personnel.

The FERN CCM Portal is used to communicate with individual laboratories as well as workgroups, FERN regions, and participants in training and proficiency testing activities. The

FERN CCM Portal is also used to plan, coordinate, and perform surveillance activities including the sharing of sample results, situation reports (SITREPS) for exercises, and after-action reports.

The FERN CAP supports the development and validation of new methods for microbiology, chemistry, and radiochemistry analyses of meat, poultry, and meat and egg products. Single and multi-laboratory validations and method extensions create a robust set of methods for FERN laboratories. Proficiency and check sample programs are offered that utilize FERN methods and provide opportunities for laboratories to demonstrate their readiness to respond to the needs of

FSIS. The FERN CAP also targets food defense surveillance by analyzing meat, poultry, and meat and egg products purchased at retail for food defense analytes. FERN member laboratories have the opportunity to test samples related to food borne outbreaks and food defense assignments, e.g., national special security events (NSSEs) such as the Super Bowl, Kentucky

Derby, National Political Conventions, and the U.S. Presidential Inauguration.

Goals

The FSIS FERN CAP laboratories will test FSIS regulated products in a variety of food defense and food safety activities providing additional meat, poultry, and meat and egg products testing http://www.fernlab.org/ capacity and capability to the FSIS Field Service Laboratories. These activities support FSIS’s mission to protect the public's health by ensuring that meat, poultry and egg products are safe, wholesome and properly labeled. The FERN CAP initiatives allow the selected laboratories to provide surge capacity and special project testing for food defense and food safety topics.

Laboratories will be involved in on-going testing of meat matrices for food safety and food defense analytes, method development, method validation, and special directed projects that meet FSIS data gathering needs. Long term planning is not always possible for these activities, so laboratories with the capability to respond quickly and with the greatest variety of capabilities are preferred.

B. FEDERAL AWARD INFORMATION

Funding Amount: Total funding for this program is approximately $1,985,000 per year

Anticipated number of awards: The number of awards will be determined through the review process and may include up to 8 awards.

Expected amount of individual awards: Individual award amounts are expected to be

$246,875 per laboratory.

Anticipated Effective Dates of the Award: September 30, 2024 through September 29, 2025

Period of Performance: Each award is a 1-year award with a potential for non-competitive renewal for an additional 4 years. This yearly award is dependent upon annual appropriations and approved performance for a total of 5 years.

Award type: This award is a cooperative agreement involving substantial involvement by the awarding Agency. Awardees should expect to have an assigned FSIS project officer for regular discussions and to assist, guide, and coordinate project activities.

C. ELIGIBILITY INFORMATION

Eligible Applicants – Only FERN member laboratories with active status in the FERN CCM

Portal (www.fernlab.org ) are eligible for funding. This includes Public or State Higher

Education Institutions, State Governments, County Governments and Federally Recognized

Indian and Native American Tribal Governments. Submissions from laboratories that are not

FERN members or FERN members with an inactive status on the proposal submission due date, April 22, 2024, will not be reviewed and will not be eligible for funding.

Cost Sharing or Matching – Not required.

D. APPLICATION AND SUBMISSION INFORMATION

Applicants can download the appropriate associated forms with this funding opportunity following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in this announcement. Compliance with the application requirements is required and strictly enforced. Applications that are not in compliance with these instructions will not be accepted for review.

Instructions for Application Submission

The following documents must be submitted as a complete application. Applications received by the April 22, 2024 deadline will be reviewed and scored. Applications received after the deadline, missing a section, or without all required documents will not be reviewed.

All applications must be submitted electronically to the FSIS FERN email address, FSIS.FERNHeadquarters@usda.gov. All applications received before 11:59 pm on the due date will be acknowledged by email as received within 48 hours of receipt.

Page Limitations

For this specific funding announcement, the Facility Description and the Project Summary sections are both limited to 10 pages each. The following guidelines are required for these sections: 8.5” x 11” paper size, 1” top and bottom margins, 0.75” left and right margins, minimum font size of 11, Calibri font.

Detailed Proposal

Submitted proposals must include the following sections and required forms which are available at Grants.gov. All forms (SF424, SF424A, SF424B) must have signatures from the proper officials at the submitting location.

• SF424 Application for Federal Assistance

• SF424A Budget Information for Non-Construction Programs

• SF424B Assurances for Non-Construction Programs

• Curriculum Vitae for the Principal Investigator and laboratory personnel with a significant role in the cooperative agreement project

• Facility Description (Limited to 10 pages) o Laboratory or facility infrastructure (e.g., size of the laboratory, secure receiving facility, biosafety level II and III room availability, meat, poultry, and meat and egg products testing personnel, accreditations, LIMS, SOPs).

o Laboratory role in food safety testing [e.g., routine meat, poultry, and meat and egg products testing; outbreak sample testing; number of meat, poultry, and meat and egg product samples tested annually; current regulatory program activities involving programs such as the Meat and Poultry Inspection (MPI; “at least equal to” FSIS)

Program, Cooperative Interstate Shipment (CIS; “same as” FSIS) Program, Accredited

Laboratory Program (ALP), Manufactured Food Regulatory Program Standards https://grants.gov/ mailto:FSIS.FERNHeadquarters@usda.gov https://grants.gov/

(MFRPS), Animal Food Regulatory Program Standards (AFRPS) or others; and the ability to currently run or adopt the FSIS Microbiology, Chemistry, or Pathology

Laboratory Guidebook methods].

o Specific information will be included on the laboratory’s participation in federal programs. For example, a description of the analyte method and meat matrix tested, along with the analytical methods on the laboratory’s current scope of accreditation.

o Laboratory role in food defense or bio-threat testing in their state.

o Current food defense testing capabilities (microbiological analytes, chemical analytes, radiological analytes, instrumentation, emergency sample throughput capacity)

• Project Summary (Limited to 10 pages) o Each proposal will include a detailed description of the laboratory’s ability to meet the 11 program requirements below.

o The laboratory will describe how it plans to meet the objectives for the chosen individual projects. This can include identifying the personnel involved, analyst competencies, and training or proficiency work required prior to starting the project. The laboratory will explain its choice for the specific project and how the project will increase its capacity and capability.

o The laboratory will estimate the costs and time required for performing the selected projects. Each project will include costs for reagents, standards, consumables, and meat, poultry, and meat and egg products required to complete the activity. A separate budget sheet will be provided for each project (mandatory and additional).

o For each project, the laboratory will present a separate timetable describing the start and completion of the proposed work.

• Program Requirements

1) The laboratory must be a FERN member in good standing to include at least two of the three disciplines (microbiology, chemistry, or radiochemistry) prior to application submission.

2) The laboratory will provide a detailed project plan, that will include all mandatory projects and 2 or more additional projects during the award year. The additional project must be in the laboratory’s FERN approved disciplines.

3) Ability to perform and demonstrate verification of at least 2 FSIS Microbiology

Laboratory Guidebook (MLG) methods (including screen and confirmation). These methods include: MLG 4 (Salmonella), MLG 5C (STEC, all 7 O groups), MLG 8

(Listeria monocytogenes), or MLG 41 (Campylobacter). If the laboratory is unable to use the current FSIS screening and confirmation technologies (3M™ or Bruker MALDI

Biotyper® System), the laboratory may substitute technology that FSIS has previously validated and determined appropriate (e.g., BAX® System or VITEK® 2). Acceptance of the method(s) will be determined by LQARCS.

4) Ability to perform FSIS or FERN method screening assays for the following microbiology food defense analytes in meat, poultry, and meat and egg products:

Bacillus anthracis Yersinia pestis Francisella tularensis

Brucella spp. Burkholderia spp. Shigella dysenteriae

Ricin toxin Staphylococcal enterotoxins Abrin toxin

Alpha amanitin toxin Clostridium botulinum toxin

5) Ability to perform the FSIS Chemistry Laboratory Guidebook (CLG) or FERN chemistry methods in the following areas:

• GC/MS assays (FERN CHE0006.01)

• LC/MS assays (FERN CHE0008.00, FERN CHE0008.00A)

• Screening for metals (FERN CHE0009.01 (based on EAM 4.7) or FSIS CLG

TM3.06)

Upon request:

• T2 toxin (CLG-T2.01)

• Cyanide/Azide screen (FERN-CHE0010, CHE0011, CHE0012 or CLG-SAZCN1.03)

• Aflatoxin screen (CLG-AFL.03)

6) Ability to perform FERN radiochemistry screening assays and related methods in the following areas:

• Gross alpha emitters (FERN-RAD.0003.00, FERN Rapid Prep for Gross Alpha

Analysis)

• Gross beta emitters

• Gamma emitters (General Guidelines for Determining Gamma Emitting

Radionuclides, FERN interim method)

• Radiostrontium (FERN RAD0005.00, FERN RAD0007.00)

7) The laboratory will have proper facilities to work with stated agents and agrees to accept unknown samples for testing.

8) The laboratory will regularly:

• Participate in all FERN PTs in the approved discipline.

• Participate in appropriate FERN training courses when offered.

• Participate in FERN workgroups through attending monthly calls, sharing of expertise, and sample testing.

• Participate in FERN Regional calls, FERN-wide conference calls, and associated activities.

• Present project progress and milestones to FSIS personnel and other participants in the FSIS FERN CAP by webinar or face-to-face.

https://www.fsis.usda.gov/news-events/publications/chemistry-laboratory-guidebook

9) Select Agent Registration (SAR) preferred

If not “Select Agent Registered,” labs will include an MOU or protocol for transfer of

“cannot rule out” isolates to a SAR facility for microbiological agent confirmation.

10) Current BSL3 capable laboratory preferred.

11) Current ISO 17025 accreditation for meat, poultry, and meat and egg product analyses preferred.

Unique entity identifier and System for Award Management (SAM)

Each applicant (unless excepted) is required to be registered in the System for Award

Management (SAM) before submitting its application. The application must include a valid unique entity identifier and the applicant must continue to maintain an active SAM registration with current information at all times during the award period. The status of an applicant’s SAM registration may be considered in the determination of an award.

Submission Dates and Times

• Application Post Date to Grants.gov: March 15, 2024

• Open Date (Earliest Submission Date): March 15, 2024

• Application Due Date: All applications are to be submitted electronically and must be completed and received by 11:59 pm eastern daylight time, Friday, April 22, 2024.

Applications received after this deadline or with missing documents will not be reviewed and will not be eligible for funding.

Intergovernmental Review

This initiative is not subject to intergovernmental review.

Funding Restrictions

• Indirect costs are limited to 10% of the total award

• No construction costs are allowed

• No pre-Federal award costs are allowed

Other Submission Requirements

None

E. APPLICATION REVIEW INFORMATION

Criteria

The review criteria listed below will be considered in the evaluation process of complete applications.

Reviewers will consider the information provided below when scoring. These items must be addressed in your application as described in Section D.

• Information concerning food defense and food safety testing demonstrating that the laboratory possesses the capability, resources, infrastructure and personnel to be successful in the program.

• Documentation of expertise in the techniques and technologies described by the laboratories.

• Description of current meat, poultry, meat and egg product or environmental testing programs including the sample number analyzed by the laboratory. Specific information will be included about the laboratory’s participation in federal programs. For example, the analyte method description, meat matrix tested, and analyte method(s) on the laboratory’s current scope of accreditation.

• Information on laboratory standard practices and procedures, including ISO 17025 accreditation concerning quality control, quality assurance, and meat, poultry, meat and egg products, and environmental samples analyzed by the laboratory.

• Information that demonstrates the laboratory’s ability to respond to emergency samples or analysis including personnel staff working the weekend.

• Documentation of responding quickly to data requests from FERN including results (e.g., providing a response to a FSIS Directive 10,000.1 Information Request).

• Participation in programs such as method development, food defense activities, training, and proficiency testing through the FERN CCM Portal.

• Redirection of activities to priority projects for FERN and FSIS where budget, time, and resources allow.

A review panel will score all applications received by the deadline as stated in Section D.

Reviewers will provide an overall score to reflect their assessment of the proposal. Final panel scores will be forwarded to the selection official for ranking and selection. Reviewers will consider each of the areas below:

• Adequate Facilities – 20 Points

• Competent Personnel – 20 Points

• Adequate Testing Capacity – 20 Points

• Demonstrated Technical Capability - 20 Points

• Comprehensive Laboratory Procedures and Policies – 20 points

• Comprehensive, Clear Plan for the laboratory to successfully complete proposed projects, including timelines, budget, and personnel considerations – 20 points

Review and Selection Process

Applications will be ranked using panel scores. Selecting officials may also consider additional factors below when making final selection of applications for Federal award:

• Diversity of testing capability – screening ability for select agents, toxic chemicals and drugs, radiochemistry analyses

• Geographic diversity

• Multiple disciplines per laboratory (e.g., three per lab preferred)

• Past Performance in FERN programs (CAP, PTs, Training, etc.)

• FSIS method capability and capacity https://www.fsis.usda.gov/wps/wcm/connect/125da540-2daa-4e3a-86ab-c6cc4b127f61/10000.1.pdf?MOD=AJPERES

Scores and recommendations by the technical review panel are only advisory. The agency is not bound to award applications solely based on the highest scores.

Anticipated Announcement and Federal Award Dates

• Announcement Date – March 15, 2024

• Deadline for Submission of Proposal – April 22, 2024

• Notification of Intent to Award – May 13, 2024

• Deadline for Submission of Final Paperwork – June 25, 2024

F. FEDERAL AWARD ADMINISTRATION INFORMATION

Federal Award Notices

After review of all submissions, FSIS LQARCS CTAG will notify program selectees. The notification of intent to award will include a request to submit your final proposal with updates and changes, along with all completed and signed forms. After review, FSIS LQARCS CTAG will send all completed and signed forms to the FSIS Administrative Services Division. The notification of intent to award is not binding and awards will still be subject to approval by FSIS management.

Applicants that receive a notification of intent to make a Federal award will be required to make any suggested updates or changes to the proposal and submit the following additional required forms (available on the Grants.gov website).

GG Lobbying Form Certification Regarding Lobbying

SF-LLL Disclosure of Lobbying Activities (if required)

An official and binding notice of award signed by a representative of FSIS’ Administrative

Services Division will be provided following receipt of the final proposal and supporting documents. The notice of award will also include specific start and end dates of the award.

Administrative and National Policy Requirements

These cooperative agreements will be administered under the guidance of the Uniform

Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (2

CFR Part 200). Listed below are some of the pertinent rules to follow.

Cooperative Agreement Terms and Conditions of Award

Program monitoring of recipients will be conducted on an ongoing basis and written reports will be reviewed and evaluated quarterly by the Project Officer (PO). Project monitoring may also be in the form of telephone or videocall conversations between the project officer or grants management specialist and the project director or principal investigator.

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 FSIS programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, FSIS’ purpose is to support and stimulate the recipients’ activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.

An assigned PO will have substantial programmatic involvement that is above and beyond the normal stewardship role. The assigned PO is the official responsible for the programmatic, scientific, and technical aspects of assigned applications and grants. The assigned PO’s responsibilities include, but are not limited to, post-award monitoring of project or program performance, reviewing progress reports and making site visits.

FSIS will have substantial involvement in the program activities of the project funded by the cooperative agreement. Substantive involvement includes, but is not limited to, the following: (1) sampling frequency, (2) number of samples obtained, either at retail or through FSIS regulatory processes, (3) direction on how tests should be executed, (4) on-site monitoring, (5) enhancement and extension of analytical methodology, and (6) the IT system through which the data are reported.

Awardees are required to participate in all aspects of the FERN Cooperative Agreement Program

(CAP), which may include workgroups, monthly oversight calls, specific analyte checks or proficiency testing (PT) samples, and attendance at the yearly meeting organized by the FSIS

LQARCS CTAG for the specific purpose of ensuring the adequate oversight and successful completion of proposed projects.

It should be emphasized that for all projects, there is a particular desire to promote reliable capability and capacity for laboratory sample analyses of meat, poultry, or meat and egg products for the rapid detection and identification of pathogenic organisms, toxins, metals, chemicals and radioisotopes. Sample analyses should be completed in an appropriate timeframe as determined by FSIS LQARCS CTAG. The results will be reported in the format and reporting media established by FSIS LQARCS CTAG. Shorter timeframes may be sought for special testing such as PTs or special assignments.

Recommended support beyond the first year will depend on the availability of funds and sustained laboratory performance. The evaluation of performance includes, but is not limited to:

technical meeting attendance, PT participation, available method training (including out of state travel), responsiveness to FSIS, conference call participation, and the progress of cooperative agreement deliverables as determined by the FSIS LQARCS CTAG.

Reporting

Performance Reports

• Required to be submitted by the Cooperator (i.e., participating laboratory) electronically to their PO and the FSIS.FERNHeadquarters@usda.gov.

• Required 30 days after the end of each quarter

• Required Final Report for the complete award year is due 90 days after the end of the award year

Quarterly Report Due Dates:

o January 30, 2025 o April 30, 2025 o July 30, 2025 o October 30, 2025

Final Report Due Date:

o December 30th, 2025

Financial status (SF-425)

• Required to be submitted by the Cooperator (i.e., participating laboratory) using the Payment

Management System (PMS) and submitted electronically to Tracey Hardy, tracey.hardy@usda.gov

• Required 30 days after the end of each quarter

• Required Final Financial Report is due 90 days after the award year

Quarterly Report Due Dates:

o January 30, 2025 o April 30, 2025 o July 30, 2025 o October 30, 2025

Final Financial Report Due Date:

o December 30th, 2025

G. FEDERAL AWARDING AGENCY CONTACT(S)

For further information or assistance concerning this funding opportunity, please use the following:

Email: FSIS.FERNHeadquarters@usda.gov

Phone: 706-713-5681

For more information about the Food Safety Inspection Service (FSIS) or the Food Emergency

Response Network (FERN) please visit:

• http://www.fsis.usda.gov/

• http://www.fernlab.org/ mailto:tracey.hardy@usda.gov http://www.fsis.usda.gov/