FY21 CAP Program Announcement 03022020.pdf

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 FERN Staff 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 will enhance the ability to analyze for microbiological, radiological and chemical threat agents utilizing approved FERN methods to improve laboratory capacities for food defense assignments, outbreak response, and other food testing projects. The agreements will support FERN sample testing, method training, supplies required by the approved methods and the possible purchase of equipment and reimbursement of personnel expenses. All cooperative agreements are on a 1 year funding cycle and this announcement will constitute the 1st year of a 5 year cycle. All funding is contingent on continued Agency funding of the program and a review of past performance of the participant laboratory where possible.

History – The FSIS FERN cooperative agreement program (CAP) has provided funding to state food testing laboratories with the objective of increasing FSIS’ capacity and capability to respond to 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 food testing including laboratory space, equipment, select agent registration, and personnel. The CCM is used to communicate with individual laboratories as well as to workgroups, FERN regions, and participants in training and proficiency testing activities.

The CCM is also used to plan, coordinate, and conduct surveillance activities including the sharing of sample results, SITREPs, and after-action reports. The FERN program has supported the development and validation of new methods for microbiology, chemistry, and radiochemistry analysis of foods. Single laboratory and multi-laboratory validations and method extensions have created a robust set of methods for FERN laboratories. Proficiency and check samples programs have been offered that utilize FERN methods and provide opportunities for laboratories to demonstrate their readiness to respond to the needs of FSIS. The FSIS/FERN program has also been performing targeted food defense surveillance by analyzing foods purchased at retail for food defense analytes. FERN member laboratories have also had the opportunity to test samples related to food borne outbreaks and food defense assignments.

These have included the analysis of samples for such high-profile events as the Super Bowl, National Political Conventions and the Presidential Inauguration.

Goals – The FSIS FERN Cooperative Agreement program provides FSIS food defense capacity and supports the agency’s mission of food safety in the event of a national emergency. Any or all of the CAP initiatives may allow the selected laboratories to provide surge capacity testing for food defense events and special project testing for food defense and/or food safety topics. Laboratories will be involved in on-going testing of food matrices for food defense analytes, method development, method validation, and special directed projects that meet FSIS food safety 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 will be necessary to support the needs of FSIS.

http://www.fernlab.org/

B. FEDERAL AWARD INFORMATION

Funding Amount: total funding for this program is approximately $2,585,000 per year

Anticipated number of awards: the number of awards will be determined through the review process but could include up to 10 awards.

Expected amount of individual awards: individual award amounts are expected to be $230,000 per laboratory.

Anticipated Start Date: September 30, 2020

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

Award type: This award is a cooperative agreement involving substantial involvement of the awarding Agency. Awardee should expect to have a project officer assigned to them for regular discussions and to assist, guide, coordinate, or participate in the 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 Higher Education Institutions (Public/State controlled), State Governments, County Governments and Federally Recognized Indian/Native American Tribal Governments. Submissions from laboratories that are either not FERN members or FERN members with an inactive status on the proposal submission due date, April 10, 2020, will not be reviewed and will not be eligible for funding.

Cost Sharing or Matching – Not required.

D. APPLICATION AND SUBMISSION INFORMATION

Applicants may download the SF424 and other forms associated with this funding opportunity using or 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 out of compliance with these instructions may not be accepted for review.

Instructions for Application Submission The following narrative and documents must be submitted for a complete application. Application received by the April 10, 2020 deadline missing a section or required document will not be reviewed.

All proposals should be submitted electronically to the FSIS FERN email address, FSIS.FERNHeadquarters@fsis.usda.gov . All proposals received before 11:59pm on the due date will be mailto:FSIS.FERNHeadquarters@fsis.usda.gov acknowledged by email as received and will be considered for scoring. Proposal received after April 10, 2020 or missing required information will not be reviewed.

Page Limitations

For this specific funding announcement, the Facility Description section is limited to 10 pages and the Project Narrative section is limited to 20 pages. 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 should include the following sections and required forms which are available on the Grants.gov website. All forms (SF424, SF424A, SF424B, Senior/Key Personnel Profile) 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

• Senior/Key Personnel Profile (R&R Form)

• Facility Description (Limit 10 pages) o Laboratory/facility infrastructure (e.g. size of the laboratory, secure receiving facility, biosafety level II and III room availability, food testing personnel, accreditations, LIMS, SOPs) o Laboratory role in food testing (e.g. routine food testing, outbreak sample testing, number of food samples tested annually, current regulatory program activities such as state program, MPI, ALP, MFRPS, AFRPS or others) o Laboratory role in food defense or bio-threat testing in their state o Current testing capabilities (microbiological analytes, chemical analytes, radiological analytes, instrumentation, emergency sample throughput capacity)

• Project Description (Limit 20 pages)

These CAP awards are for enhancing and expanding the capacity and capability of the participating laboratory to analyze various food matrices for microbiological, chemical and radiochemical threat agents; thereby, allowing them to quickly and accurately respond to any potential threats to the nation’s food supply. The FERN program also provides support to FSIS and the mission of protecting the public’s health by ensuring the safety of meat, poultry, and processed egg products. To this end, each applicant should provide a detailed description of their laboratory’s ability to meet the requirements of the 10 points below. Laboratories should also include a detailed project plan that includes the mandatory projects described and 2 or more of the additional projects listed in the project summary document.

Laboratories should describe how they plan to meet the objectives for the individual projects in which they want to be involved. This could include identifying the personnel involved and their competencies; any training or proficiency work that would be performed at the laboratory before work begins. Laboratories should explain why they wish to work on a specific project and how it will increase their capacity and/or capability.

Laboratories should estimate the cost and time for performing the selected projects including costs for reagents, standards, consumables and foods should also be estimated.

For each project, laboratories should present a separate timetable describing when they expect the work to be performed and a budget.

No travel should be included in the proposal. The FSIS FERN NPO has arranged to have all travel associated with FERN training courses to be provided by the host site.

1) Laboratory must be FERN approved in at least two of the three disciplines (microbiology, chemistry, and/radiochemistry) prior to application submission.

2) Labs will propose and perform mandatory projects and additional projects in their approved disciplines during the award year.

3) Ability to perform screening assays/FERN methods for the following microbiology food defense analytes in foods:

Bacillus anthracis, Yersinia pestis, Francisella tularensis, Brucella spp., Burkholderia spp., Shigella dysenteriae, Clostridium botulinum toxin, Ricin toxin, staphylococcal enterotoxins, Abrin toxin, Alpha amanitin toxin

4) Ability to perform screening assays/FERN chemistry methods in the following areas:

GC/MS assays (FERN CHE0006.01);

LC/MS assays (FERN CHE0008.00);

Screening for metals (FERN CHE0009.01 (based on EAM4.7)/FSIS MLG TM3.06);

5) Ability to perform screening assays/FERN radiochemistry 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 (Interim)

6) Select Agent Registration (SAR) preferred; if not SAR then MOU for “cannot rule out” isolates with transfer protocol in place to SAR facility and/or LRN site. If not select agent registered, labs should include an MOU and/or protocol for transfer to the SAR facility for confirmation of microbiological agents.

7) Current BSL3 capable laboratory preferred.

8) Accredited to ISO 17025 for food analysis preferred.

9) Lab has proper facilities to work with stated agents and agrees to accept unknown samples for testing.

10) Laboratories choosing to participate in the program at this level will be expected to regularly perform the following activities:

• Participate in all FERN PTs in the approved discipline.

• Participate in appropriate FERN training courses.

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

• Participate in FERN Regional and FERN wide conference calls and activities.

• Presentation of project progress and milestones to FSIS personnel by webinar.

Project Summary See project summary document for detailed description of mandatory and additional projects.

Unique entity identifier and System for Award Management (SAM)

Each applicant (unless excepted) is required to be registered in the SAM (System for Award Management) 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 used in the determination of an award.

Submission Dates and Times

Posted Date: March 2, 2020 Open Date (Earliest Submission Date): March 16, 2020 Application Due Date: All proposals are to be submitted electronically and must be received and complete by 11:59pm eastern daylight time, Friday, April 10, 2020. Proposal 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 total award No construction costs are allowed No pre-Federal award costs allowed

Other Submission Requirements None

E. APPLICATION REVIEW INFORMATION

Criteria Only the review criteria listed below will be considered in the evaluation process of complete proposals.

Reviewers will consider the provided information for the following when scoring the application and incorporate these into their scores. The items indicated below should be addressed in your application as described in Section D.

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

• Documented expertise in the use of the techniques/technologies described by the laboratories.

• Description of the current food or environmental testing programs including the variety and number of samples analyzed by the laboratory.

• Information on the standard practices and procedures of the laboratory concerning quality control, quality assurance, and facilities associated with food and environmental sample analysis by the laboratory.

• Information that demonstrates the laboratories ability to respond to emergency samples or analysis including possible recall of personnel and extended work weeks.

• The ability to quickly respond to data requests from FERN including documented results, (e.g.

provide response to FSIS 10,000.1 Information Request).

• Agreement to participate in programs such as method development, food defense activities, training, proficiency testing through the FERN.

• Agreement to redirect activities to priority projects for FERN and the USDA Food Safety and Inspection Service where budget, time, and resources allow.

A group of reviewers will be utilized to 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:

• Facilities – 20 Points

• Personnel – 20 Points

• Testing Capacity – 20 Points

• Demonstrated Capability - 20 Points

• Laboratory Procedures, Policies, Support, Management – 20 points

Review and Selection Process Applications will be ranked using panel scores. The FSIS FERN selecting official will also include other factors when making the final selection of applications for Federal award based on program policy and need to support overall FSIS activities.

Areas to be considered in selection of laboratories:

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

• Geographic diversity

• Multiple disciplines per laboratory (i.e., preferred 3 per lab)

• Forensic analysis including: product tampering, packaging, photo documentation, and testimony

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

Note: scores and recommendations by the technical review panel are only advisory. The agency is not bound to award to those with highest scores.

Simplified Acquisition Threshold

i. That the Federal awarding agency, prior to making a Federal award with a total amount of Federal share greater than the simplified acquisition threshold, is required to review and consider any information about the applicant that is in the designated integrity and performance system accessible through SAM (currently FAPIIS) (see 41 U.S.C. 2313);

ii. That an applicant, at its option, may review information in the designated integrity and performance systems accessible through SAM and comment on any information about itself that a Federal awarding agency previously entered and is currently in the designated integrity and performance system accessible through SAM;

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

iii. That the Federal awarding agency will consider any comments by the applicant, in addition to the other information in the designated integrity and performance system, in making a judgment 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 §200.205 Federal awarding agency review of risk posed by applicants.

Anticipated Announcement and Federal Award Dates Announcement Date – March 2, 2020 Deadline for Submission of Proposal – April 10, 2020 Notification of Intent to Award – May 15, 2020 Deadline for Submission of Final Paperwork – June 29, 2020

F. FEDERAL AWARD ADMINISTRATION INFORMATION

Federal Award Notices After review of all submissions, program selectees will be notified by the FSIS FERN staff. The notification of intent to award will include a request to submit your final proposal with updates and changes, completed and signed forms to the FSIS Administrative Services Division. This notification 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 additional required Forms (available on the Grants.gov website).

USDA AD-1047 Certification Regarding Debarment, Suspension, and Other Responsibility Matters USDA AD-1049 Certification Regarding Drug-Free Workplace Requirements GG Lobbying Form Certification Regarding Lobbying SFLLL 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.

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 (OMB Uniform Guidance 2014, available at Grants.gov). Below are listed some of the pertinent rules that will be followed.

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. Project monitoring may also be in the form of telephone conversations between the project officer/grants management specialist and the project director/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.

A Project Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below. The PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO ’s responsibilities include, but are not limited to, post-award monitoring of project/program performance, including 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) How often samples will be sent, (2) how samples are obtained, either at retail or through FSIS regulatory processes, (3) directions on how tests should be executed, (4) on-site monitoring, (5) enhancement and extension of analytical methodology, and (6) the IT systems 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 check samples, and attendance at a yearly face-to-face meeting organized by the NPO for the specific purpose of ensuring the adequate oversight and successful completion of proposed projects.

It should be emphasized that in all of the projects, there is a particular desire to promote a continuing, reliable capability and capacity for laboratory sample analyses of foods and food 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 FERN NPO, and the results will be reported to FERN. The format and reporting media will be established by FERN. Shorter timeframes may be sought for special testing such as proficiency tests or special assignments.

Recommended support beyond the first year will depend on the availability of funds and approved performance. The evaluation of performance includes, but is not limited to: technical meeting attendance, PT participation, training (including out of state travel), responsiveness to FSIS, conference call participation, and the progress of cooperative agreement deliverables as determined by the FERN

NPO.

Reporting Performance reports are to be submitted electronically 30 days after the end of each quarter (due dates January 30, 2021; April 30, 2021; July 30, 2021; Oct. 30, 2021). Financial status (SF-425) are to be submitted on a quarterly basis (January 30, 2021, April 30, 2021, July 30, 2021, and Oct 30, 2021).

Financial reports will be reported electronically through the Payment Management System (PMS).

Additionally, a final performance and financial report is required within 90 days of the end of the award period (December 30th, 2021). The award period will run from September 30, 2020 to September 29, 2021.

G. FEDERAL AWARDING AGENCY CONTACT(S)

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

Email: FSIS.FERNHeadquarters@fsis.usda.gov Phone: 706-546-3578

For more information about the Food Safety Inspection Service (FSIS) or the Food Emergency Response Network (FERN) please visit:

http://www.fsis.usda.gov/

H. OTHER INFORMATION—OPTIONAL

mailto:FSIS.FERNHeadquarters@fsis.usda.gov http://www.fsis.usda.gov/ http://www.fernlab.org/