Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

U.S. Food and Drug Administration (FDA)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

The FDA does not follow the NIH Page Limitation Guidelines or the NIH Review Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Objective Review Process.

Components of Participating Organizations

Center for Food Safety and Applied Nutrition (CFSAN)
Office of Regulatory Affairs (ORA)

Funding Opportunity Title

Maintenance and Enhancement of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State Food Testing Laboratories (U18 Clinical Trial Not Allowed)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-19-018

Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103

Funding Opportunity Purpose

The intended outcome of this cooperative agreement is to advance the goal of a national food safety system by supporting and enhancing state food laboratories tasked with investigation of foodborne disease outbreaks in activities including:

1.   Ensuring microbiological and chemical food analyses performed on behalf of the State manufactured food regulatory programs are conducted within the scope of an International Organization for Standardization (ISO)/ International Electrotechnical Commission (IEC) 17025 accredited laboratory;

2.   Strengthening the collaboration between the laboratories and State manufactured food regulatory programs;

3.   Increasing the number of State samples collected and analyzed

      for surveillance purposes annually;  

4.   Developing a stronger international rapid surveillance system for pathogen traceback through the GenomeTrakr network using a minimum set of metadata fields for all food and environmental isolates; and

5.   Providing additional support to the State food laboratories through an outside association to offer trainings, workshops, and educational resources to both awardees under this cooperative agreement and to unfunded laboratories seeking ISO/IEC 17025 accreditation. 

Key Dates

 

Posted Date

March 19, 2019

Open Date (Earliest Submission Date)

March 22, 2019

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

May 21, 2019, by 11:59 PM Eastern Time.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. 

Late applications will not be accepted for this FOA.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June 2019

Advisory Council Review

Not Applicable

Earliest Start Date

July 2019

Expiration Date

May 22, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the 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.
  4. Table of Contents

    Part 1. Overview Information
    Part 2. Full Text of the Announcement

    Section I. 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. Funding Opportunity Description

    Performance Measures

    Due to the need for accountability as required by the Uniform Guidance 2 CFR 200, an emphasis will be placed on the applicant’s ability to measure progress and track performance using objective, proven and measurable data.  As such, applicants shall propose how they will develop and implement a performance measurement system, plan, and/or process and shall carefully consider the Scored Review Criteria listed in Section V of this announcement when submitting their application. 

    Background

    Over the past several years, the food safety system has continually encountered risks and emergencies of significant national concern. Multiple efforts have been undertaken at all levels, including consumers, industry, regulators, and even international organizations, to identify and implement improvements to the food safety system.

    a. President’s Food Safety Working Group

    An indication of the significant, national interest in food safety is the President’s Food Safety Working Group (FSWG), initiated in March of 2009 (http://www.foodsafetyworkinggroup.gov/Home.htm). The charge of the FSWG is the following: “To have safe food that does not cause us harm and to enhance our food safety systems by fostering coordination throughout the government including enhancing our food safety laws for the 21st century. These laws will be designed to keep the American people safe

    and will be enforced.” Chaired by the Secretary of Health and Human Services and the Secretary of Agriculture, the FSWG recommends a public health-focused approach to food safety that prioritizes

    prevention, strengthens surveillance and enforcement, and improves response and recovery.

    b. National Integrated Food Safety System

    FDA is continuing to work with its state partners to create a national, fully integrated food safety system that is characterized by effective communication and efficient processes among federal, state, and local partners in the food safety system.  Various initiatives, such as the Food Safety Task Force Program, Innovative Food Defense Program, and the programs supported by these cooperative agreements, work to engage partners across multiple sectors of the food safety system to collaborate to identify means to improve and optimize the nation’s food safety system.

    The Partnership for Food Protection (http://www.fda.gov/ForFederalStateandLocalOfficials/Meetings/ucm249828.htm) is a

    major driving force in the establishment of a national integrated food safety system.

    In alignment with this concept, these cooperative agreements work to engage partners across multiple sectors of the food safety system to collaborate to identify means of improving and optimizing the nation’s food safety system.

    c. Food Safety Modernization Act

    The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. It also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. These include authorities such as mandatory recall, expanded administrative detention, suspension of facility registration, enhanced product tracing abilities, and additional recordkeeping requirements for high-risk foods. FSMA also gives FDA important new tools to hold imported foods to the same standards as domestic foods.

    FSMA directs FDA to build an integrated national food safety system in partnership with State and local authorities, explicitly recognizing that all food safety agencies need to work together in an integrated way to achieve national public health goals.  FSMA identifies some key priorities in working with partners in areas, such as: reliance on Federal, State, and local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing State and local food safety and defense capacities.

    Full text of the law: http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm247548.htm

    Program Objectives

    The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP), in collaboration with the Office of Regulatory Science (ORS) and the Center for Food Safety and Applied Nutrition (CFSAN), is announcing the availability of up to twenty-eight  (28) awards for ISO/IEC 17025 accreditation maintenance and enhancement for State laboratories, up to fourteen (14) awards for whole genome sequencing activities for State laboratories, and one (1) award for state ISO/IEC 17025 accreditation and whole genome sequencing support by an association to be awarded under Limited Competition.

    The intended outcome of this cooperative agreement is to advance the goal of a national food safety system by supporting and enhancing state food laboratory activities including:

    1.   Ensuring microbiological and chemical food analyses performed on behalf of the State manufactured food regulatory programs are conducted within the scope of an ISO/IEC 17025 accredited laboratory;

    2.   Strengthening the collaboration between the laboratories and State manufactured food regulatory programs;

    3.   Increasing the number of State samples collected and analyzed for surveillance purposes annually;

    4.   Developing a stronger international rapid surveillance system for pathogen traceback through the GenomeTrakr network using a minimum set of metadata fields for all food and environmental isolates; and

    5.   Providing additional support to the State food laboratories through an outside association to offer trainings, workshops, meetings and other educational resources to awardees under this cooperative agreement and to unfunded laboratories seeking ISO/IEC 17025 accreditation. 

    Competition Specific Goals:

    Competition A: ISO/IEC 17025 Accreditation Maintenance and Enhancement

    ISO/IEC 17025 accreditation is one of the most important standards for testing laboratories and attests to the competency and technical capability of a laboratory to perform specific tasks.  ISO/IEC 17025 specifies the general requirements for the competence to carry out testing performed using standard methods, non-standard methods, and laboratory-developed methods.  The results generated are defensible to a recognized standard that is independent of laboratory personnel or other changes. In addition, accreditation supports the traceability of technical results generated by a laboratory. In the event of a large-scale terrorist activity or other large-scale events affecting foods or food products, States and Federal authorities can use laboratory test results from accredited laboratories to respond rapidly with streamlined analytical review and enforce regulatory compliance to protect the safety of the nation's food supply.

    The intended outcome of this competition is for microbiological and chemical food analyses performed on behalf of State manufactured food regulatory programs and under the Collection and Analysis Project of this cooperative agreement to be conducted within the scope of an ISO/IEC 17025 accredited laboratory and the goal of achieving a nationally integrated food safety system to be further advanced. This will be accomplished by assisting the primary food testing laboratories for State manufactured food regulatory programs in maintaining and expanding the scope of their ISO/IEC 17025 laboratory accreditation and enhancing state surveillance sample collection and testing activities.  Increased laboratory analyses from ISO/IEC 17025 accredited laboratories, as would be accomplished through this cooperative agreement, will in effect serve to increase the analytical capacity for FDA, and our state partners, and enhance efforts to protect the food supply.

    The Sample Collection and Analysis Project of this cooperative agreement is intended to help increase the number of State surveillance samples collected and analyzed and to enhance collaboration between the State Manufactured Food Regulatory Program and the laboratories.  Under this project the two programs collaborate to develop a written and signed plan documenting the regulatory program's commitment to collection and the laboratory program's commitment to the analysis of a minimum number of samples annually.  In addition to the increased number of samples collected and analyzed by these programs, this project will continue strengthening the relationship between the laboratories and the State manufactured food regulatory programs.  Funding will be made specifically to eligible laboratories to maintain and expand the scope of their ISO/IEC 17025 accreditation by an impartial and internationally recognized accreditation body and to complete activities under the Sample Collection and Analysis Project. Only proposed projects designed to maintain, and enhance ISO/IEC 17025 laboratory accreditation, and to complete the Sample Collection and Analysis Project will be considered for funding.

    Data generated by recipient laboratories shall be made available for consideration of FDA enforcement actions as well as for surveillance purposes and during response to foodborne outbreaks through eLEXNET.

    This competition is only available to laboratories that were awarded the “Maintenance and Enhancement of ISO/IEC 17025 Accreditation and Whole Genome Sequencing for State Food Testing Laboratories” cooperative agreement in 2017.

    Competition B: Whole Genome Sequencing

    The FDA's Center for Food Safety and Applied Nutrition (CFSAN) has created the first integrated network of State and Federal laboratories to use whole genome sequencing to track foodborne pathogens to improve outbreak response and effective monitoring of preventive controls. Known as GenomeTrakr, the network has created a publicly available, global database containing the genetic makeup of thousands of foodborne disease-causing bacteria.  The data, which are housed in public databases at the National Center for Biotechnology Information (NCBI), can be accessed by researchers and public health officials for real time comparison and analysis that are speeding foodborne illness outbreak investigations and reducing foodborne illnesses and deaths.

    The intended outcome of this track is to develop a stronger international rapid surveillance system for pathogen traceback by further enhancing the GenomeTrakr network and growing the database.  The accurate subtyping and subsequent clustering of isolates of a bacterium associated with a foodborne outbreak event is essential for successful investigation and eventual traceback to a specific food or environmental source.  The genomic information provided by the GenomeTrakr network points investigators to specific food products potentially related to an outbreak and provides insight into the origin of the contaminated food. This capability is particularly important considering the limited number of FDA food inspectors and the global nature of the food supply. Sample collection and sequence cataloging from food production sites can help monitor compliance with FDA’s rules on safe food-handling practices and enhance preventive controls for food safety.  Regulatory offices at FDA are using the whole genome sequencing data and daily phylogenetic trees to identify new contamination events, which are being uncovered on a daily/weekly basis. As the database expands, this high-resolution tool will continue to provide new insights into outbreak causes, risks, and compliance of past contaminators.

    This competition is only available to laboratories that currently have a Research Collaboration Agreement (RCA) with FDA for the GenomeTrakr network, have been provided with a sequencing device by FDA, and are being financially supported by FDA's CFSAN or ORS.

    Competition C: ISO/IEC 17025 Accreditation and Whole Genome Sequencing Support Services

    State and local laboratories play a critical role in the identification, containment, and prevention of foodborne illness. FDA is committed to assisting these laboratories in achieving, maintaining, and expanding the scope of ISO/IEC 17025 accreditation, as well as supporting the groundbreaking work achieved through the GenomeTrakr network.  Effective leveraging of resources and harmonization of efforts will require extensive collaboration with relevant initiatives, including those of federal partners, national initiatives, associations/organizations, and State and local partners.

    The intended outcome of this competition is to assist the non-FDA funded State laboratories with increased readiness for ISO/IEC 17025 accreditation, to assist FDA in the development of trainings, workshops, educational materials, and meetings in support of laboratory accreditation, whole genome sequencing and GenomeTrakr.

    This competition is only available to non-profit, national associations/organizations that represent State and local laboratories that conduct food and/or animal feed testing on behalf of State and local regulatory programs.

    Applicable to All Competitions

    The PD(s)/PI(s) shall retain the primary responsibility and dominant role for planning, directing, and executing the proposed project.  However, the cooperative agreement award mechanism will result in substantial involvement by the FDA. Substantial involvement could include, but is not limited to (as deemed necessary by FDA):

    1.   Monitoring of progress through on-site visits, conference calls, emails, and other correspondence;

    2.   Monitoring and approval of the Sample Collection and Analysis Projects;

    3.   Monitoring and approval of bacterial isolates to be sequenced by Whole Genome Sequencing;

    4.   Review and approval of training and workshop coursework, and meeting materials for the  

          GenomeTrakr network; and

    5.   Technical and financial assistance to maintain and enhance laboratory accreditation, support the

          Sample Collection and Analysis Project, and GenomeTrakr activities.

    Competition Specific Project Objectives (progress assessed semi-annually):

    Competition A: ISO/IEC 17025 Accreditation Maintenance and Enhancement

    1.   Maintain current ISO/IEC 17025 accreditation, which includes conducting a routine internal audit, continuous update and improvement of the quality system;

    2.   Enhance the scope of accreditation in consultation with the State manufactured food regulatory program and the FDA. These accreditation enhancements may include accreditation for additional sections within the lab and expansion of the number and/or type of methods;

    3.   Provide evidence of participation in the Food Emergency Response Network (FERN), including meetings, conference calls, proficiency tests and other activities;

    4.   Complete all activities as outlined in the Sample Collection and Analysis Project.  This includes meeting the minimum sample requirement of the competition selected; and

    5.   Entry of all data generated by the laboratory into eLEXNET, as requested by FDA.  Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET.

    Competition B: Whole Genome Sequencing

    1.   Sequence a mixture of four hundred (400) or more Salmonella, Listeria monocytogenes, shiga toxin-producing Escherichia coli (STEC) and other foodborne related bacterial, viral and parasite pathogen isolates and deposit results, including the metadata, in real-time to NCBI-NIH curated national database for enteric pathogen genomes, in coordination with FDA CFSAN;

    2.   Increase isolates numbers for testing through environmental, food, and water sampling of locally relevant foodborne pathogens through collaboration or other sources;

    3.   Increase collaboration with other researchers via the sharing of live isolate cultures upon request from FDA or the researches themselves; and

    4.   Actively participate in the GenomeTrakr network, including meetings, conference calls, proficiency tests and other activities, such as overflow assignments from neighboring network partners.

    Competition C: ISO/IEC 17025 Accreditation and Whole Genome Sequencing Support Services

    1.   Develop trainings, workshops, and other educational materials and resources for use by GenomeTrakr network and laboratories seeking to achieve, maintain, and enhance ISO/IEC 17025 accreditation;

    2.   Plan and host annual GenomeTrakr face-to-face meeting; and

    3.   Provide direct technical assistance to non-FDA funded state food testing laboratories seeking ISO/IEC 17025 accreditation.

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

    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials)

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications.

    Award(s) will provide one (1) year of support.

    FDA/ORA and FDA/CFSAN intends to fund up to $6.7 million for fiscal year 2019 in support of this grant program.

    It is anticipated that up to 38 awards will be made, not to exceed $310,000 in total costs (direct plus indirect), per award.

    Competition A: ISO/IEC 17025 Accreditation Maintenance and Enhancement

    Awards not to exceed $145,000 total costs (direct and indirect) per year/per award for accredited laboratories seeking to maintain and enhance their scope of ISO/IEC 17025 accreditation and analyze a minimum of 75 samples of FDA regulated products annually will be given.

    Competition B: Whole Genome Sequencing

    Awards not to exceed $165,000 total costs (direct and indirect) per year/per award for laboratories to conduct whole genome sequencing activities.

    Competition C: ISO/IEC 17025 Accreditation and Whole Genome Sequencing Support Services

    Award not to exceed $300,000 total costs (direct and indirect) per year/per award for a non-profit association/organization to provide support services to State food testing laboratories.

    Award Budget

    Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

    Competition A: ISO/IEC 17025 Accreditation Maintenance and Enhancement

    YEAR 01: $145,000

    Competition B: Whole Genome Sequencing

    YEAR 01: $165,000

    Competition C: ISO/IEC 17025 Accreditation and Whole-Genome Sequencing Support Services

    YEAR 01: $300,000

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is one (1) year. 

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

    Section III. Eligibility Information
    1. Eligible Applicants

    Laboratories meeting all of the eligibility requirements of Competition A and B may apply for both.

    Competition A: ISO/IEC 17025 Accreditation Maintenance and Enhancement

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public Institutions of Higher Education:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Governments

    • State Governments

    This opportunity is only available to State-authorized food testing laboratories in Higher Education Institutions and State Governments that meet each of the following criteria:

    1.   Laboratories that are ISO/IEC 17025 accredited.   ISO/IEC 17025 accreditation, including methods of interest to the FDA, shall be maintained throughout the project period of this cooperative agreement;

    2.   Laboratories that are the primary servicing laboratory for conducting microbiological and chemical food analyses on behalf of a State agency enrolled in the Manufactured Food Regulatory Program Standards (MFRPS), or a State that has agreed to enroll in MFRPS at the earliest date.  Enrollment in MFRPS shall be maintained throughout the entire project period of the cooperative agreement;

    3.   Laboratory that is the primary servicing laboratory for their State manufactured food regulatory program.  For purposes of the cooperative agreement, "primary servicing laboratory" is defined as the laboratory that performs greater than or equal to 51% of the microbiological and chemical food analyses.  This percentage shall be maintained throughout the entire project period of the cooperative agreement;

    4.   The State maintains a current human food safety inspection contract with FDA or agrees to apply for a human food safety inspection contract at the earliest possible date.  The human food safety inspection contract shall be maintained with FDA throughout the entire project period of this cooperative agreement;

    5.   Eligible laboratories shall also participate, or enroll within thirty (30) days of the award in FERN;

    6.   Laboratories that agree to and have a written agreement from their State manufactured food regulatory program to participate in the Sample Collection and Analysis Project; and

    7.   Laboratories that agree to enter surveillance and emergency response samples and share the results through eLEXNET.  This will serve to increase the food safety surveillance, detection, and response efforts of the FDA and other regulatory agencies.

    Failure to maintain any of the eligibility requirements at any stage in cooperative agreement project period may result in termination of the award.

    Competition B: Whole Genome Sequencing

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education

    The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public of Higher Education:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Governments

    • State Governments

    This opportunity is only available to laboratories in Higher Education Institutions and State Governments that meet each of the following criteria:

    1.   Laboratories that currently have a Research Collaboration Agreement with FDA for the GenomeTrakr network, have been provided with a sequencing device by FDA, and are being financially supported by FDA's CFSAN or ORS; and

    2.   Laboratories that agree to sequence a mixture of four hundred (400) or more Salmonella, Listeria monocytogenes, shiga toxin-producing Escherichia coli (STEC) and other foodborne related bacterial, viral and parasite pathogen isolates and deposit results, including the metadata, in real-time to NCBI-NIH curated national database for enteric pathogen genomes, in coordination with FDA CFSAN.

    Competition C: ISO/IEC 17025 Accreditation and Whole Genome Sequencing Support Services

    This opportunity is only available to non-profit, national associations/organizations that represent State and local laboratories that conduct food and/or animal feed testing on behalf of State and local regulatory programs.

    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) 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 HHS Grants Policy Statement, are not allowed.

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) 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.

    • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • 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.
    • o   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. 
    • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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.

    Eligible Individuals (Program Director/Principal Investigator)

    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 his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA 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 SF424 (R&R) Application Guide.

    2. Cost Sharing

    This FOA 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.  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.
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

    Page Limitations

    All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

    For this specific FOA, the total Research Strategy section is limited to 30 pages with the following additional requirements:

    • Competition A is limited to 10 pages
    • Competition B is limited to 10 pages
    • Competition C is limited to 10 pages
    Instructions for Application Submission

    The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

    SF424(R&R) Cover

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Project/Performance Site Locations

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Other Project Information

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    SF424(R&R) Senior/Key Person Profile

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    R&R Budget

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

    • If an applicant is applying to more than one competition, the detailed budget form must outline the total sum of all competitions the applicant is applying for, for each year of financial support requested.  The applicant shall submit/upload a single detailed budget narrative justification that clearly distinguishes and demarcates the detailed budget for each competition. 
    • If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission.  This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
    • If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed.  MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract.  MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
    R&R Subaward Budget

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS 398 Cover Page Supplement

    All instructions in the SF424 (R&R) Application Guide must be followed.  

    PHS 398 Research Plan

    All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: 

    Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

    • Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

    Research Strategy:

    Applicants that are applying for more than one Competition must submit/upload a single Research Strategy document that clearly distinguishes the separate activities for each Competition and a clear demarcation for each Competition. Applicants must adhere to the page limits outlined in Section IV. Only one application per organization will be accepted.

    The research strategy submitted should include specific project milestones and metrics for each objective proposed by the applicant. In developing the Research Strategy, the applicant shall specifically address the ability to achieve the following objectives in the cooperative agreement:

    Competition A: ISO/IEC 17025 Accreditation Maintenance and Enhancement

    1.   Demonstrate the ability to maintain a quality management system that is in compliance with the managerial and technical requirements of ISO/IEC 17025 and is accredited by an impartial, independent, and internationally recognized accreditation body;

    2.   Demonstrate the ability to fully participate in initiatives supporting the ISO/IEC 17025 accreditation maintenance and FERN activities, including but not limited to, annual face-to-face meetings, monthly conference calls, sharing of best practices, on-site visits, and program audits;

    3.   Demonstrate the ability to share all laboratory data generated related to food safety through eLEXNET and as requested by the FDA. Ideally, an electronic data exchange shall be established between the laboratory information management system (LIMS) and eLEXNET;

    4.   Demonstrate the availability of adequately trained food program and/or laboratory staff and the criteria and ability to hire and/or train personnel to meet the deliverables of the cooperative agreement;

    5.   Provide a properly detailed budget that is intended to maintain and enhance ISO/IEC 17025 laboratory accreditation and perform activities under the project;

    6.   Demonstrate the ability to satisfy the reporting requirements outlined in section VI.3 of this announcement;

    7.   Provide the previous year and current funding level certification for the laboratory program from State funding appropriations;

    8.   Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs;

    9.   Analyze food samples for chemical and microbiological hazards utilizing analytical methods within the scope of accreditation for emergency response and surveillance efforts - an annual estimate of capability should be provided for chemical and microbiological testing;

    10. Ability to fulfill the mandatory attendance requirement of two (2) key personnel at an annual face-to-face meeting which could include out-of-state travel;

    Laboratories applying for funding for Competition A shall provide a complete description of the facilities, personnel qualifications, management practices, organization, and a commitment to analyze the number of samples as outlined in the selected Competition in their application to include the following:

    1.   Qualifications of all personnel that shall be assigned to the project, including the quality assurance (QA)/quality control (QC) manager, QA/QC personnel, and laboratory technical personnel;

    2.   A detailed summary of the number and type of manufactured food samples analyzed by the applicant for 2 years prior to the application year;

    3.   A description of the current testing program, including a detailed account of the analytical support currently provided to the State manufactured food regulatory program;

    4.   Preliminary description of intended scope of accreditation enhancements, to include the types of products to be tested and analyses performed;

    5.   Include a detailed signed agreement with the State Manufactured regulatory program demonstrating the commitment to meet the minimum sample designation under the Sample Collection and Analysis Project upon the following guidelines:

    o   Acceptable items for inclusion in this project:

    §  Routine Manufactured Foods under the purview of FDA

    §  Non-routine Manufactured Food Samples planned for and collected during alleged illness investigations and complaints

    §  Manufactured Foods under the purview of State Inspection – if also under FDA jurisdiction

    §  Environmental Samples of Manufactured Food (MF) production/storage and transport facilities 

    §  Seafood samples

    §  Processed Shellfish

    §  Bottled Water only (not municipal water)

    §  Produce, if it is washed and processed (cut, sliced, cored or manipulated in any manner from its fresh state) is acceptable. Fresh whole produce may also be included in this initiative, if sampled for pesticides or, in conjunction with an FDA sampling assignment, or in association with a foodborne outbreak.

    o   Unacceptable items for inclusion in this project:

    §  Grade A Dairy products (Milk) - Grade A products are covered under the Grade A Pasteurized Milk Ordinance (PMO) program

    §  Food produced in a retail setting - unless as part of a national sampling assignment, or in conjunction with a foodborne outbreak

    §  Environmental Samples from retail settings - unless associated an illness or complaint, which may include a manufactured food

    §  Municipal Water (that is covered under EPA purview)

    §  USDA regulated products

    §  Foods intended for animals

    §  Raw shellfish (oysters, clams, mussels and scallops covered under the National Shellfish Sanitation Program (NSSP) - processed shellfish products, i.e. breaded oysters, oysters in soup, or heat-treated, (manufactured food products and no longer a National Shellfish Sanitation Program (NSSP) product could be sampled under this initiative)

    o   Acceptable sample analyses:

    §  Chemical

    §  Pesticides

    §  Biological

    §  Physical (foreign matter)-filth

    §  Allergens

    §  Metals

    §  Toxins

    §  Contaminants

    §  Species Substitution/confirmation

    §  Confirmation of product identity - example (Honey)

    o   The State manufactured food regulatory program shall collect the samples.  Effort should be made to collect samples directly from the firm.  Manufactured food samples collected at a retail setting are acceptable in states where the firm inventory of FDA regulated manufactured food firms is low.

    o   While sampling according to FDA's Investigations Operations Manual (IOM) is highly recommended, States may collect the sample size that would allow for State regulatory enforcement action. 

    o    Full Text IOM: http://www.fda.gov/iceci/inspections/iom/default.htm

    Competition B: Whole Genome Sequencing

    1.   Provide laboratory space to conduct the work under this competition;

    2.   Provide scientific staff to oversee and participate in sample preparation, sequencing, analysis, and data transmission;

    3.   Establish partnerships with local universities, government agencies, and other stakeholders to support the collection of relevant samples and isolates (for example, water samples near agricultural areas.)

    4.   Propose critical isolates to FDA for approval and prioritization for draft genomic sequencing.  Proposed critical isolates shall have as many of the critical metadata fields below as possible.  This metadata list to be associated with each isolate conforms to fields agreed to through consultation with NCBI and international partners.  The detailed list is as follows:

    o   Country: State or Country: sub-region/city if international strain

    o   Isolation-source (water, environmental swab, or description of food type)

    o   Collection-date (Date isolated)

    o   Strain/isolate name

    o   Organism (Species ID)

    o   Serotype (Salmonella Montevideo)

    5.   Using the sequencing platform supplied by or acceptable to FDA, sequence a mixture of four hundred (400) or more Salmonella, Listeria monocytogenes, shiga toxin-producing Escherichia coli (STEC) and other foodborne related bacterial, viral and parasite pathogen isolates, as determined in consultation with FDA;

    6.   Ensure the sequences meet the current minimum quality thresholds established by Gen-FS;

    7.   Submit the whole genome sequences, with the metadata, to the NCBI-NIH Pathogen Detection portal in coordination with FDA;

    8.   Provide live isolate culture to other researchers who request the isolates corresponding to the published genome sequences;

    9.   Demonstrate the ability to satisfy the reporting requirements outlined in section VI.3 of this announcement; 

    10. Fulfill the mandatory attendance requirement of two (2) key personnel at the annual face-to-face meeting which may include out-of-state travel;

    11. Provide qualifications of all personnel that shall be assigned to the project; and

    12. Fulfill annual State projected sample workload and the GenomeTrakr requirements, as described in this announcement.

    Competition C: ISO/IEC 17025 Accreditation and Whole-Genome Sequencing Support Services

    1.   Provide educational opportunities, resources, tools, and mentoring for laboratories seeking to achieve, maintain, and enhance the scope of their ISO/IEC 17025 accreditation;

    This shall include efforts to design, develop, document, deliver, manage and implement support programs for ISO/IEC 17025 accreditation in non-FDA funded laboratories.  Monitoring of the selected laboratories to ensure that they are on track and determine solutions to common barriers. 

    2.   Identify, develop and deliver training programs, in coordination with FDA, that will assist State regulatory laboratories in:

    o   Achieving, maintaining, and enhancing ISO/IEC 17025 laboratory accreditation

    o   Whole genome sequencing including, but not limited to, training related to data transfer to GenomeTrakr database at NCBI, and straight forward analytical clustering methods using shareware or other readily available desktop tools.

    Both individual laboratory and broad-based training needs should be considered and met by the grantee.

    Training programs developed shall be pre-reviewed and approved by FDA prior to delivery. FDA will periodically assess the trainer’s performance by reviewing the course assessments and evaluations completed by students (individual and aggregated data).

    Methods of delivery for training could be: Webinars, teleconferences, workshops, on-site technical sessions, face-to-face meetings, or information sharing through web based resources.

    3.   Provide forums, in the form of national and international meetings, to improve communication and collaboration between federal, state and local food and animal feed testing laboratories.

    o   This shall include the organization and execution of an annual GenomeTrakr face-to-face meeting

    o   Meeting agendas and materials shall be pre-reviewed and approved by FDA prior to distribution and execution

    4.   Demonstrate the ability to satisfy the reporting requirements outlined in section VI.3 of this announcement; and

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information

    When involving FDA-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) 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 Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

    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 SF424 (R&R) Application Guide must be followed.

    PHS Assignment Request Form

    All instructions in the SF424 (R&R) Application Guide must be followed. 

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

    See Part 1. 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. Overview Information 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.

    Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). 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. eRA Commons 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. Late applications will not be accepted for this FOA.

    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 the SF424 (R&R) 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.

    These awards may only be used for:

    1. Maintaining and enhancing laboratory ISO/IEC 17025 accreditation
    2. Sample collection and analysis under Competition A
    3. Whole genome sequencing activities
    4. Laboratory support of State laboratory ISO/IEC 17025 accreditation, and Genome Trakr

    Allowable Costs (including but not limited to):

    1. Consultant Services
    2. Employee salaries, wages and fringe benefits
    3. Rental, purchasing, calibration, installation and maintenance of equipment
    4. Indirect costs in accordance with a current federal indirect cost agreement
    5. Recruitment costs for hiring new employees
    6. Registration fees
    7. Purchase or development of IT equipment, software, and support
    8. Shipping and mailing of equipment and supplies
    9. Travel (shall not exceed coach class fare).  Travel expenses for two (2) key personnel to the  face-to-face meetings for Competitions A and B are required.
    10. Speaker fees
    11. ISO/IEC 17025 Accreditation fees
    12. Training courses and materials
    13. Laboratory and office supplies
    14. Subcontracting to State manufactured food program for sample collection costs is limited to 20% of the award amount
    15. Remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount

    Non-allowable costs (including but not limited to):

    1. Facilities and work covered under current FDA food safety inspection contracts and/or any other active FDA cooperative agreement shall not be counted towards fulfillment of this cooperative agreement and shall remain distinct and separate. The State shall be able to account separately for fund expenditures under the food safety inspection contracts and the cooperative agreements.
    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. Activities to support the collection and testing of non-FDA regulated products.
    5. Scope enhancement of methods other than FDA regulated food products.  This includes proficiency tests and training activities.

    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 SF424 (R&R) Application Guide.  Paper applications will not be accepted.

    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) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 FDA. See Section III of this FOA for information on registration requirements.

    The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) 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 Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    Post-submission materials are those submitted after submission of the grant application but prior to initial 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.

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process.

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit.

    Competition A: ISO/IEC 17025 Accreditation Maintenance and Enhancement

    1. Ability to meet the goals of this cooperative agreement (total weight = 25%)
    2. Has adequate program resources (especially staff) and infrastructure to complete project needs, or the ability to obtain adequate program resources (total weight = 25%)
    3. Experience in analyzing FDA regulated products and the number of methods under scope of accreditation to aide in the analysis of those products.  This involves an evaluation of the amount of FDA regulated product analysis versus other types (total weight = 25%)
    4. Current relationship between the laboratory and the State manufactured food regulatory program.  This includes any collaboration for sample collection and analysis for any surveillance or emergency activities (total weight = 25%)

    Competition B: Competition B: Whole Genome Sequencing

    1. Ability to meet the goals of this cooperative agreement (total weight = 25%)
    2. Has adequate program resources (especially staff) and infrastructure to complete project needs, or the ability to obtain adequate program resources (total weight = 25%)
    3. Ability to balance whole genome work, as requested in this announcement, with routine State sample workload (total weight = 25%)
    4. Ability to obtain additional isolates and provide the reporting elements per isolate sequenced (total weight = 25%)

    Competition C: ISO/IEC 17025 Accreditation and Whole-Genome Sequencing Support Services

    1. The rationale and design to meet the goals of the cooperative agreement (total weight = 25%)
    2. Demonstration of competence in implementing effective adult education training programs (total weight = 25%)
    3. Demonstration of advanced experience and competence with the managerial and technical requirements of ISO/IEC 17025 laboratory accreditation to achieve, maintain, and expand the scope of accreditation (total weight = 25%)
    4. Demonstration of advanced experience, competence, and technical knowledge of whole genome sequencing (total weight = 25%)
    Additional Review Considerations

    As applicable for the project proposed, reviewers will evaluate the following additional items but will not give separate scores for these items, and should not consider them in providing an overall score.

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

    For research that involves human subjects and meets the criteria for one or more of the  categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

    When the proposed project involves human subjects and/or FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    Not Applicable

    Renewals

    Not Applicable

    Revisions

    Not Applicable

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

    Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

    Resource Sharing Plans

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

    Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

    2. Review and Selection Process

    Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Committee, using the stated review criteria.

    As part of the objective review, all applications:

    • Will receive a written critique.

    Appeals of objective review will not be accepted for applications submitted in response to this FOA.

    Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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.

    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 grantee’s business official.

    Awardees must comply with any funding restrictions described in Section IV.5. 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 FOA will be subject to terms and conditions found in the HHS Grants Policy Statement

    2. Administrative and National Policy Requirements

    All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that 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.

    HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html.  Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    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 the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, 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 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all FDA grants and cooperative agreements.

    FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.

    Upon acceptance for publication, scientific researchers must submit the author’s final manuscript of the peer-reviewed scientific publication resulting from research supported in whole or in part with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.

    Certificates of Confidentiality – 42 U.S.C. 241(d)

    Awardees are responsible for complying with all requirements to protect the confidentiality of identifiable, sensitive information that is collected or used in biomedical, behavioral, clinical, or other research (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs) funded wholly or in part by the Federal Government.  See 42 U.S.C. 241(d).  All research funded by FDA, in whole or in part, that is within the scope of these requirements is deemed to be issued a “Certificate of Confidentiality” through these Terms and Conditions.   Certificates issued in this manner will not be issued as a separate document. 

    Awardees are expected to ensure that any investigator or institution not funded by FDA who receives a copy of identifiable, sensitive information protected by these requirements, understand they are also subject to the requirements of 42 U.S.C. 241(d).  Awardees are also responsible for ensuring that any subrecipient that receives funds to carry out part of the FDA award involving a copy of identifiable, sensitive information protected by these requirements understand they are also subject to subsection 42 U.S.C. 241(d).

    Additional terms and conditions regarding FDA regulatory, FDA/ORA and FDA/CFSAN programmatic requirements may be part of the Notice of Award.

    Cooperative Agreement Terms and Conditions of Award

    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 awardees is anticipated during the performance of the activities. Under the cooperative agreement, FDA’s objective is to support and stimulate the recipient’s activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role of activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardee for the project as a whole, although specific tasks and activities may be shared between the awardee and the FDA as defined below.

    Cooperative Agreement—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 sufficient clearance and/or background checks 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.

    Cooperative Agreement--FDA Responsibilities:

    An FDA Program Official (PO) and an FDA Project Manager/Technical Advisor will be assigned and named in the NoA. The FDA PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and cooperative agreements. The FDA PO and Project Manager/Technical Advisor will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below.

    The PO and Project Manager/Technical Advisor will have substantial involvement 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 FDA/ORA includes, but is not limited to, the following:

    1.   Provide guidance, direction, and technical assistance in project planning, implementation, and evaluation;

    2.   Provide subject matter expertise, programmatic assistance, and evaluation services to support program studies and activities;

    3.   Actively monitor the supported program via telephone conversations, e-mails, written correspondence, or periodic site visits;

    4.   Evaluate the supported program, including development of program-level performance measures, consistent data collection, and reporting procedures and protocols;

    5.   Convene trainings, meetings, conference calls (hosted by FDA at a frequency chosen by FDA), and site visits with grantee to facilitate collaboration and information sharing;

    6.   Participate in data analysis, interpretation of findings, and where appropriate, co-authorship of publications;

    7.   Development of programs to meet the FDA mission;

    8.   Provision of programmatic technical assistance;

    9.   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;

    10. Considerable participation in the face-to-face meetings with awardees, such as the annual ISO/IEC 17025, and the GenomeTrakr semi-annual meetings;

    11. Conducting on-site technical sessions with the grantee, as deemed necessary by FDA;

    12. Assistance in the sharing of information developed by the grantee to maintain and enhance ISO/IEC 17025 accreditation and GenomeTrakr activities;

    13. Guidance and assistance in coordinating multi-program pilot projects, including the Sample Collection and Analysis; and

    14. Review and approval of training, meeting, workshops, educational materials and resources prior to use.

    Unless another governance structure is mutually agreed upon, the Project Manager shall serve as the primary point of contact for the dissemination of FDA policy and milestones/objectives work planning.

    Monitoring Activities

    The Program Official and Project Manager/Technical Advisor(s) will monitor award recipients periodically. The monitoring may be in the form of face-to-face meetings, telephone conversations, e-mails, or written correspondence between the Program Official/Grants Management Officer/Technical Advisor(s) and the principal investigator. In addition, periodic site visits with officials of the recipient organization may also occur to assess progress. The results of these monitoring activities will be recorded in the official cooperative agreement file and will be available to the grant recipient, upon request, consistent with applicable disclosure statutes and FDA disclosure regulations. Also, the grantee organization shall comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the Program Official and Project Manager/Technical Advisor(s).

    The evaluation of performance includes, but is not limited to: technical meeting and annual face-to face meeting attendance, appropriate PT participation, training (including out of state travel), responsiveness to FDA, conference call participation, successful planning and execution of Sample Collection and Analysis Project, and the general progress of cooperative agreement deliverables as determined by FDA.

    The intended outcome of this cooperative agreement is to advance the goal of a national food safety system by supporting and enhancing state food laboratory activities including:

    1.   Ensuring microbiological and chemical food analyses performed on behalf of the State manufactured food regulatory programs are conducted within the scope of an ISO 17025 accredited laboratory;

    2.   Strengthening the collaboration between the laboratories and State manufactured food regulatory programs;

    3.   Increasing the number of State samples collected and analyzed for surveillance purposed annually;

    4.   Developing a stronger international rapid surveillance system for pathogen traceback through the GenomeTrakr network using a minimum set of metadata fields for all food and environmental isolates; and

    5.   Providing additional support to the State food testing laboratories through an outside association to offer trainings, workshops, and educational resources to both awardees under this cooperative agreement and to non-FDA funded laboratories seeking ISO/IEC 17025 accreditation.

    The following conditions of the award apply to applicants funded under Competition A and shall be maintained throughout the cooperative agreement.  These conditions are considered an eligibility requirement and failure to maintain any of these elements could deem the awardee ineligible for funding in the remaining years of this cooperative agreement.

    1.   The laboratory shall remain the primary servicing laboratory for conducting microbiological and chemical food analyses on behalf of the State manufactured food regulatory program to be eligible to apply and receive funds through this cooperative agreement.  For the purpose of this cooperative agreement, "primary servicing laboratory" is defined as the laboratory conducting greater than or equal to 51% of the microbiological and chemical food analyses.

    2.   The laboratory shall maintain ISO/IEC 17025 accreditation from a nationally recognized accrediting body.

    3.   The laboratory shall maintain active participation in the Food Emergency Response Network (FERN).

    4.   The State manufactured food regulatory program supported by the awarded laboratory shall maintain a food safety inspection contract with FDA.

    5.   The State manufactured food regulatory program shall also maintain enrollment in the MFRPS.

    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award.

    A mid-year progress report will be required.

    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 terms and conditions of award and the HHS Grants Policy Statement.

    The final RPPR shall provide full written documentation of the project, and summaries of accomplishments and goals, as described in the grant application. The documentation shall be in a form and contain sufficient detail such that other State, local, and tribal governments could reproduce the final project.

    The final RPPR shall also detail the strategy, including commitment of personnel, resources, and funding, for maintaining activities after the end of the project period.

    All progress reports shall contain certain elements as applicable to their approved competition and award.  These elements include, but are not limited to, the following:

    Competition A: ISO/IEC 17025 Accreditation Maintenance and Enhancement

    1.   An updated improvement plan for enhancing the scope of accreditation and maintaining accreditation within the established timeframes;

    2.   Hiring of new personnel and training of personnel in order to maintain and enhance ISO/IEC 17025 accreditation. The program shall include initial and ongoing training to ensure consistent quality and continuous improvement, including assisting laboratory personnel in maintaining current knowledge of scientific and technological advances in relevant areas;

    3.   Status report on the installation and operational readiness of any analytical equipment that is utilized in methods under scope of accreditation;

    4.   Summary of laboratory data shared with FDA and other regulatory agencies, including any regulatory actions taken by FDA or another regulatory agency or any significant laboratory findings that advanced the protection of public health;

    5.   Summary of samples collected and analyzed under the Sample Collection and Analysis Project.  This should include the number of samples (including sub sizes), firm from which the sample was collected, matrices, analytes, and determinations;

    6.   Current funding level certification for the laboratory program from State funding appropriations (Final Program Progress report requirement only);

    7.   Budgetary status, to include the amount of funding expended to the date of the report and a detailed description of how this funding was utilized;

    8.   Summary of laboratory participation in FERN activities;

    9.   Evidence of samples submission into eLEXNET;

    10. Current scope of ISO/IEC accreditation, and detailed information on the removal or addition of any methods;

    11. Updated contact information on the key personnel working on the project; and

    12. Summary of any programmatic issues and concerns.

    Competition B: Competition B: Whole Genome Sequencing

    1.   Summary of laboratory data shared with FDA and other regulatory agencies, including any regulatory actions taken by FDA or another regulatory agency or any significant laboratory findings that advanced the protection of public health;

    2.   Summary of foodborne pathogen isolates collected and sequenced under the Cooperative Agreement.  This should include the number and type of isolates sequenced by each participating laboratory, including isolate metadata and NCBI BioProject and BioSample identifiers for isolates submitted to public databases;

    3.   Current funding level certification for the laboratory program from State funding appropriations (Final Program Progress report requirement only);

    4.   GenomeTrakr semi-monthly update call attendance;

    5.   GenomeTrakr annual face-to-face meeting attendance;

    6.   Successful completion in the annual proficiency testing across the GenomeTrakr network;

    7.   Accept and sequence other network members’ isolates as part of overflow assignments, at the request of FDA;

    8.   Budgetary status, to include the amount of funding expended to the date of the report and a detailed description of how this funding was utilized;

    9.   Updated contact information on the key personnel working on the project;

    10. Summary of any programmatic issues and concerns

    Competition C: ISO/IEC 17025 Accreditation and Whole-Genome Sequencing Support Services

    1.   Development status and projected timeline of completion of any trainings, meetings, educational materials or resources for GenomeTrakr and ISO/IEC 17025 accreditation;

    2.   Description of the support being provided to laboratories to obtain, maintain, and enhance ISO/IEC 17025 accreditation.  This includes a summary of the monitoring activities and progress of the laboratories directly being supported through consultant services offered under this award.

    The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 $25,000. 

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 (currently 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 45 CFR Part 75 – Award Term and Conditions 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.

    Application Submission Contacts

    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: http://grants.nih.gov/support/ (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: support@grants.gov

    Scientific/Research Contact(s)

    Marc Allard, PhD
    Center for Food Safety and Applied Nutrition)
    Food and Drug Administration)
    Telephone: 240-402-2941
    Email: Marc.Allard@fda.hhs.gov

    Project Manager/Technical Advisor Contact(s)

    Erin Woodom-Coleman
    Office of Regulatory Affairs (ORA)
    Office of Partnerships
    Telephone: 210-402-4617
    Email: Erin.Woodom-Coleman@fda.hhs.gov

    Objective Review Contact(s)

    Kiara Fowler
    Office of Acquisitions & Grants Services (OAGS)
    Food and Drug Administration
    Telephone: 240-402-3099
    Email: Kiara.Fowler@fda.hhs.gov

    Financial/Grants Management Contact(s)

    Kiara Fowler
    Office of Acquisitions & Grants Services (OAGS)
    Food and Drug Administration
    Telephone: 240-402-3099
    Email: Kiara.Fowler@fda.hhs.gov

    Section VIII. Other Information

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

    Authority and Regulations

    Awards are made under the authorization of section 1009 of the Federal Food, Drug, and Cosmetic Act (21 USC 399), 21 USC 2104, and section 301 of the Public Health Service Act (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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