Required Application Instructions

It is critical that applicants follow the 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.

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

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP), is announcing the availability of cooperative agreements for equipment, supplies, personnel, training, and facility upgrades to Food Emergency Response Network (FERN) microbiological, chemical, and radiological laboratories of State, local, and tribal governments. The cooperative agreements are to enable the analyses of foods and food products in the event that laboratory surge capacity is needed by FERN and the FDA for analyses related to microbiological, chemical, and/or radiological contamination, either through intentional or unintentional means. These grants are also intended to expand participation in networks to enhance Federal, State, local, and tribal food safety and security efforts.

ORA is the primary inspection and analysis component of FDA and has some 1,600 investigators, inspectors, and analysts who cover the country's approximately 175,000 FDA regulated businesses. These investigators inspect more than 14,000 facilities a year and ORA laboratories analyze tens of thousands of samples per year. ORA conducts special investigations, conducts food inspection recall audits, performs consumer complaint inspections, and collects samples of regulated products. Increasingly, ORA has been called upon to expand the testing program addressing the increasing threat to food safety and security through both naturally occurring pathogen outbreaks and intentional terrorism events.

Toward these ends, ORA has developed a suite of screening and analysis methodologies that are used to evaluate foods and food products in such situations. However, in the event of a large-scale outbreak or threat incident, analytical sample capacity in ORA field laboratories has a finite limit. Information from ongoing relationships with State partners through the FERN indicates limited redundancy in State food testing laboratories, both in terms of analytical capabilities and analytical sample capacity. Some State food testing laboratories lack the specialized equipment to perform the analyses and/or the specific methodological expertise in the types of analyses performed for screening foods and food products involving microbiological terrorism events or natural pathogenic organism outbreak.

Recent outbreaks of food borne pathogens serve to highlight the need for the ability to quickly track down and isolate a dangerous pathogen through food testing during a natural outbreak event. These occurrences also make readily apparent the need for surge capabilities of FERN in the event of a large scale outbreak.

The events of September 11, 2001, spotlighted the need to enhance the security of the United States food supply. Congress responded by passing the Bioterrorism Act, which was signed into law on June 12, 2002 (Public Law 107-188).

Subtitle A of the Bioterrorism Act, Protection of Food Supply, section 312 -Surveillance and Information Grants and Authorities created section 317R of the Public Health Service Act to authorize the Secretary of Health and Human Services (the Secretary) to award grants to States and Indian tribes to expand participation in networks to enhance Federal, State, and local food safety efforts (42 USC 247b-20). This may include meeting the costs of establishing and maintaining the food safety surveillance, technical, and laboratory capacity needed for such participation.

The goal of ORA's cooperative agreement program is to enhance the capacity and capabilities of State, Local, and Tribal governments' food testing laboratories in support of an Integrated Food Safety System. With cooperative agreement grant funds this will be accomplished through the provision of supplies, personnel, facility/equipment upgrades, training in current food testing methodologies, participation in proficiency testing for current food testing methodologies, participation in method enhancement activities to extend analytical capability, and analysis of surveillance and emergency outbreak samples. In the event of large-scale contamination events affecting foods or food products, the recipient may be required to perform selected analyses of domestic and imported food samples collected and supplied to the laboratory by FDA or other government agencies through FDA. These samples may consist of, but are not limited to, the following: Vegetables and fruits (fresh and packaged); juices (concentrate and diluted); grains and grain products; seafood and other fish products; milk and other dairy products; infant formula; baby foods; bottled water; condiments; alcoholic products (beer, wine, scotch); feed and vet products. In addition, laboratories will be encouraged to obtain ISO/IEC 17025 accreditation or adopt a quality system comparable to this international standard. To this aim, successful applicants will undergo a quality management system assessment to be conducted by FDA, Office of Regulatory Affairs (ORA), and Office of Regulatory Science (ORS).

Under this funding announcement, laboratories are to submit one application which identifies each track/discipline of which it would like to be considered.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education

Governments

• State Governments
• County Governments
• Indian/Native American Tribal Governments (Federally Recognized)

This cooperative agreement program is only available to FERN laboratories that are currently receiving funding under at least one of the following: (1) FDA FERN Microbiological, (2) FDA FERN Chemical, or (3) FDA FERN Radiological Cooperative Agreement Programs. The FERN cooperative agreement program laboratories have spent several years building capability, capacity and demonstrating competency in FDA regulatory testing methodologies and reporting requirements. These laboratories have developed the quality control measures and standardized procedures that are required by FDA/FERN as a basis for a cohesive national food testing program, and many have demonstrated proficiency in nationally run surveillance programs.

All grant application projects that are developed at State, Local, and Tribal levels must have national implication or application that can enhance Federal food safety and security programs. At the discretion of FDA, successful project formats may be made available to interested Federal, State, Local, and Tribal government FERN laboratories.

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.

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. Late applications will not be accepted for this FOA.

• 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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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.

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

Applicant organizations may submit one application selecting up to 3 tracks for consideration.

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.

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Not Applicable

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 Research Strategy section is limited to 30 pages.

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.

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

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

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

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

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

NOTE: A separate detailed budget is required for each selected track under this cooperative agreement.

Applicants may also apply for only facility upgrades, personnel, training, method extension and surveillance sample analysis if they have the necessary equipment and it will be available for these projects.

Where personnel costs are requested, documentation must be provided to associate these costs with the specific deliverables.

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

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

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

The face page of the application should indicate FDA FERN Cooperative Agreement Program .

NOTE: SECTION I in the Research Plan that must be completed by ALL applicants. SECTION II is to completed based on the track(s) each laboratory wishes to be considered for. A separate detailed budget is required for each selected track.

SECTION I:

(1) The rationale and design to meet the goals of the cooperative agreement.

A full description of the prospective project's intended goals and objectives and how each will guide a full project plan. This section should lay a foundation for the entire program.

(2) Laboratory Facilities.

Purchased Equipment (if applicable): A complete description of the name and address of the facility and the name of the most responsible individual of the facility where the equipment will be installed must be provided.

For the facility, the following information must be provided:

(a) Floor diagrams of the laboratory, including current equipment.

(b) Area where the equipment is to be installed. The installation of equipment in a laboratory will require adequate and appropriate space and physical plant supplies (power, water, etc.);

(c) A description of the envisaged space, to include a floor-plan diagram;

(d) Operational support areas to be used for the project, including details about the availability of ancillary laboratory safety and support equipment and facilities, such as the numbers and types of biosafety cabinet hoods and chemical fume hoods available;

(e) Details describing the sample receiving and sample storage areas and a description of any existing chain-of-custody procedures;

(f) A detailed description of any proposed facilities upgrades including drawings and cost estimates; and

(g) A detailed description of laboratory access procedures, including a description of practices and systems which limit access to laboratory space by unauthorized personnel to include measures in place to ensure that all staff have sufficient clearance and/or background checks to work on this project or program

(3) Laboratory Personnel Qualifications.

(a) Microbiological Qualifications of all personnel that will be assigned to the project must be provided. In particular, information on personnel that have experience in real time PCR, VIDAS, immunomagnetic separation, biochemical analysis and ELISA must be provided.

(b) Chemical Qualifications of all personnel that will be assigned to the project must be provided. In particular, information on personnel that have experience in screening food samples for unknown chemical poisons and toxins using existing FERN GC/MS, LC/MS, ICP/MS, and ELISA methodology must be provided.

(c) Radiological Qualifications of all personnel that will be assigned to the project must be provided. In particular, information on personnel that have experience in Analyzing gamma-, beta-, and alpha-radionuclides using gamma spectrometry, liquid scintillation counting, gas proportional counter, and alpha spectrometry gamma and beta spectroscopy must be provided.

(4) Laboratory Management Practices.

For the laboratory, the following management information must be provided:

(a) A summary description of any security procedures or processes to evaluate the background of laboratory personnel. This should include any procedures for evaluating subcontractors who have access to laboratory space, such as cleaning personnel and for the safeguarding of sensitive information and materials;

(b) A summary description of any quality management system, including a list of methods currently under scope.

(c) A summary description of staffing management, specifically to include abilities and procedures in place to recall personnel, establish extended workweeks, etc.; and

(d) A summary description of procedures in place to monitor sample workflow, including the tracking and monitoring of sample analyses in progress and include a description of the laboratory work product review process. Additionally, the ability to perform and complete the analyses and provide a report of a sample analysis as per directed by the FERN NPO.

(5) Sample Analysis Commitment.

The laboratory will be required to analyze surveillance and emergency response food samples. The FDA estimates that the analysis of up to 480 samples per year may be needed as directed by FERN NPO, contingent on method/matrix combinations, events requiring analysis as well as number of subsamples per sample. For pre-planned surveillance, method development, method validation, and/or matrix extension testing, laboratories will be expected to be capable of analyzing 10 to 20 samples for any given 2 week period in addition to its normal non-FDA FERN directed workload. Additional sample analyses above these numbers could be required during emergency responses. Therefore, an estimate of the number of food samples that will be analyzed in a 1 year period for (1) pathogenic organisms and toxins, (2) toxic chemicals and toxins, or (3) radionuclides by each project area must be submitted. The estimate should also address the number of samples that can be analyzed in a 1 week period. In addition, if a cooperative agreement is awarded, awardees will be informed of any additional documentation, such as worksheets, that should be submitted to FERN.

Ability and commitment to analyze samples generated from large nationwide foodborne disease outbreaks, high volume FDA surveillance assignments and nationwide food defense events. 

The laboratory will be expected to analyze samples and report the results of the analysis into eLEXNET and/or the FERN portal which could include analytical work packages by the agreed upon time span as directed by the FERN NPO.

Ability and willingness to inform the FERN NPO immediately upon detecting a sample that is positive for or cannot be ruled out for the presence of an analyte. As soon as a presumed positive analytical result for an analyte is obtained, the FERN NPO should be notified.

Provide information on the variety and number of samples analyzed in the current food or environmental testing programs.

Ability and commitment to participate in small -scale method development, method validation and matrix extension work as determined by FERN NPO

Ability and willingness to improve the laboratory quality system.

(6)Laboratory Expertise in Analyzing Foods for Unknown Contaminants.

The laboratory should provide a summary of all current and recent laboratory programs for screening food samples for unknown poisons and toxins using existing FERN methods. Because the laboratory is expected to participate in method evaluation and enhancement efforts, submissions should include past accomplishments and/or suggestions for improvement that indicate a familiarity with the advantages and potential weaknesses of the current procedures needed to screen a wide variety of foods for unknown chemical contaminants.

(7) Equipment.

Provide a detailed description and availability of all equipment (analytical instrumentation) that will be used to accomplish the project.

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. With this in mind, it is desirable that methods and procedures developed for FERN applications will enable sample analysis to be completed rapidly so results can be reported to FERN ideally within a few days of sample receipt but at least within two weeks. Timeframes for completing special testing such as for proficiency tests or special assignments will be set accordingly. The format and reporting media will be established by FERN.

Unless approved by FDA, FDA provided equipment may not be transferred by the awardee’s laboratory, and the awardee’s laboratory assumes full responsibility and liability for any claims that may arise as a result of operation of this equipment for the period it is in the possession of the awardee’s laboratory.

NOTE: All equipment loaned by the FDA to selected laboratories must be maintained in working order to support analytical assignments given by the FDA. The FDA requires that all loaned equipment be covered by a service agreement (either a one year renewable or a multi-year service agreement. Grant funds may be utilized for the service agreements.

(8) Document the knowledge in and training for utilization of the Incident Command System.

SECTION II:

Additional requirements by track/discipline:

There are three key project areas identified for this grant that must be addressed:

(1) The use of various standardized cultural and biochemical analytical methods for the detection and identification of pathogens in food. 

(2) The use of various standardized serological analytical methods for the detection and identification of pathogens in food. 

(3) The use of various standardized molecular analytical methods for the detection and identification of pathogens in food.

There are four key project areas identified for this effort that must be addressed:

(1) The use of Gas Chromatography/Mass Spectrometry (GC/MS) analysis for the screening and identification of poisons, toxic substances, and unknown compounds in foods;

(2) The use of Liquid Chromatography/Mass Spectrometry (LC/MS) analysis for the screening and identification of poisons, toxic substances, and unknown compounds in foods;

(3) The use of Inductively Coupled Plasma/Mass Spectrometry (ICP/MS) analysis for the screening and identification of heavy metals and toxic elements in foods; and,

(4) The use of Enzyme-Linked Immunosorbent Assay (ELISA) and other antibody-based analyses for the screening and identification of unknown toxins in foods.

There are three key project areas identified for this effort:

(1) The use of various gamma-ray detection for the identification, screening, and quantitation of gamma-emitting radionuclides in foods, and

(2) The use of various beta counting and alpha detection techniques for the identification, screening, and quantitation of beta-emitting and/or alpha-emitting radionuclides in foods.

(3) Participation in collaborative FERN Radiological method study upon request.

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.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. 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. 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.

This initiative is not subject to intergovernmental review.

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

Only proposed projects designed to address at least one of the three track/discipline areas will be considered for funding. Applicants may also apply for only facility upgrades, personnel, training, method extension and surveillance sample analysis if they have the necessary equipment and it will be available for these projects. Where personnel costs are requested, documentation must be provided to associate these costs with the specific deliverables.

Funds are not to be utilized to conduct food inspections for food safety regulatory agencies, or for new building construction.

A decrease in the amount of the non -competitive segment may occur if there is an unobligated balance from the prior year, in which case prior year funds can be used as an offset for the current year award.

Appropriated funds shall not be used to purchase promotional items when they are not a necessary expense.

Continued funding of a noncompetitive segment is contingent upon satisfactory progress as determined by the FDA program/technical staff, the receipt of a non -competing continuation application, submission of an acceptable annual report and the availability of Federal funds.

Allowable costs (including but not limited to):

1) Employee salaries, wages and fringe benefits

2) Equipment operating and maintenance costs

3) Indirect costs in accordance with a signed current federal indirect cost agreement.

4) Facility Upgrades (except new building construction) - not to exceed 10% of the annual award amount

5) Travel (must not exceed coach class fare)

NOTE: A portion of budgeted travel funds must be set aside for a minimum of 2 key personnel to attend the annual face-to-face FERN meeting.

6) Training courses and materials

7) Laboratory and office supplies

8) Pursuance and Maintenance of laboratory accreditation - not to exceed 20% of the annual award amount

Laboratory accreditation helps contribute to production of accurate and reliable test data. This results in quicker acceptance of analytical results by FDA, and other regulatory agencies, for enforcement actions, surveillance purposes and during response to foodborne outbreaks. Laboratories that do not have other FDA cooperative agreement funds to support laboratory accreditation may use up to 20% of the annual award amount to develop and/or enhance their quality system. Laboratories that are receiving funding under the FDA ISO/IEC 17025:2005 Accreditation for State Food Testing Laboratories Cooperative Agreement shall utilize those funds to support laboratory accreditation.

Non-allowable costs:

1) Facilities and work covered under current FDA food safety inspection contracts cannot be counted towards fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement. The State must be able to account separately for fund expenditures under the food safety inspection contracts and these cooperative agreements.

2) Vehicle purchases are not permitted.

3) Subcontracting to third parties is limited to 25% of each year's award.

4) 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.

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 Applying Electronically.

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 Grants Management Office and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Not Applicable

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

For this particular announcement, note the following:

As part of their evaluation reviewers may consider each of the review criteria below in the determination of scientific merit as appropriate. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Reviewers will consider the applicant responses to the following when scoring the application, and incorporate these responses into their scores within the Significance, Investigator(s), Innovation, Approach and Environment scoring sections below. The issues indicated below should be addressed in your application, as described in Section IV..

• Rationale and design to meet the goals of the cooperative agreement.
• Provide information concerning food safety/ threat agent testing in association with suggested food matrices and documentation that they possess the basic food analytic resources, including laboratory infrastructure and personnel.
• Document expertise in the use of desired techniques/technologies.
• Provide information on the variety and number of samples analyzed in the current food or environmental testing programs.
• Provide information on the adequacy of their facilities, support services, quality control and quality assurance procedures and practices for food and environmental sample analysis.
• Provide and demonstrate enhanced laboratory response capability including the abilities and procedures in place to recall personnel and establish extended work weeks and commitment to analyze emergency response samples utilizing FERN methods.
• Document the ability to quickly provide measurable, documented results and recommendations that may be shared with other FERN laboratories (state, local, and federal).
• Agrees to participate in FERN programs such as methods development, food defense assignments, training, and proficiency testing when available.
• Document the knowledge in and training for utilization of the Incident Command System.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  Does the project outline clear rationale and design to meet the goals of the cooperative agreement?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project.  Does the organization have knowledge in and training for utilization of the Incident Command System?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?  Does the organization agree to participate in FERN programs such as methods development, food defense and food safety assignments, training, and proficiency testing when available?  Is information provided concerning food safety/ threat agent testing in association with suggested food matrices and documentation that they possess the basic food analytic resources, including laboratory infrastructure and personnel?  Does the project document the expertise in the use of desired techniques/technologies?  Is the organization able to provide and demonstrate enhanced laboratory response capability including the abilities and procedures in place to recall personnel and establish extended work weeks and commitment to analyze emergency response samples utilizing FERN methods?  Does the strategy document the ability to quickly provide measurable, documented results and recommendations that may be shared with other FERN laboratories (state, local, and federal).

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, or collaborative arrangements.  Did the project include information on the variety and number of samples analyzed in the current food or environmental testing programs?  Did the project address the adequacy of their facilities, support services, quality control and quality assurance procedures and practices for food and environmental sample analysis?

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the six 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 six 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.

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 children 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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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.

Not Applicable

Not Applicable

Not Applicable

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).

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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. For instance, does the amount requested from FDA appear reasonable as partial support of the total work plan, facilities, staff, etc.? Is the budget organized, reasonable and clearly stated? Does the budget account for the proposed work plan?

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

As part of the scientific 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.

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.

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. 

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

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

Cooperative Agreement Terms and Conditions of Award

Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their work subject to any confidentiality provision under 21 CFR 20.88.

Program monitoring of recipients will be conducted on an ongoing basis and written reports will be reviewed and evaluated at least semi-annually 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 following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an assistance mechanism (rather than an acquisition mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA's purpose is to support and stimulate the recipients activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities.

An FDA 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; and other activities complementary to those of the GMO. The PO and the GMO work as a team in many of these activities.

FDA 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) directions on how tests should be executed, (3) on-site monitoring, (4) supply of equipment, (5) FDA training on processes, (6) enhancement and extension of analytical methodology, and (7) improvement of laboratory quality system.

FDA will provide specific procedures and protocols for the three track/discipline areas to be used for the analysis of pathogens and toxins in food.

FDA will provide guidance on the specific foods to be collected for analysis by the successful applicant.

Awardees are required to participate in all aspects of the FERN Cooperative Agreement Program (CAP), which includes attendance at face-to-face meetings organized by the NPO for the specific purpose of ensuring the adequate oversight and successful completion of this important safety initiative. Accordingly, attendance of at least two laboratory representatives (preferably the supervisor and at least one of the FERN supported FTEs) at the annual FERN CAP Face-to-Face meeting is mandatory for all FERN CAP laboratories. All travel expenses for attendance to this technical meeting must be covered by awarded funding.

The equipment provided by FDA will remain the property of FDA under loan to the awardee’s laboratory for a specified time period described in the agreement with a review every twelve months. FDA may terminate the loan at any time. Unless approved by the FERN NPO, the FDA provided equipment may not be transferred by the awardees' laboratory., and the awardees' laboratory assumes full responsibility and liability for any claims that may arise as a result of operation of this equipment for the period it is in the possession of the awardees' laboratory.

NOTE: All equipment loaned by the FDA to selected laboratories must be maintained in working order to support analytical assignments given by the FDA. The FDA requires that all loaned equipment be covered by a service agreement (either a one year renewable or a multi-year service agreement). Grant funds may be utilized for the service agreements.

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 or toxins. With this in mind, 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 FDA, conference call participation, and the progress of cooperative agreement deliverables as determined by the FERN NPO.

Program Director/Principal Investigator Rights and Responsibilities

The PD(s)/PI(s) will have the primary responsibility for the scientific, technical, or programmatic aspects of the grant and for day- to -day management of the project or program. The PD/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff has sufficient clearance and/or background checks to work on this project or program. This individual will work closely with designated officials within the recipient organization 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 and organizational requirements.

Participation in the Food Emergency Response Network (FERN) program will include access to non-public information from FDA. Therefore, in order to participate, each laboratory must have a long-term confidentiality agreement pursuant to 21 CFR 20.88 with FDA.

The PD(s)/PI(s) will have the primary responsibility for:

Overall management of the study and agree to work cooperatively

Developing and implementing systems necessary for communications among the various study organizational components. All data and samples to be shared freely by methods and within time periods to be specified by the Project Officer.

FDA staffs have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The awardees agree to accept assistance from the designated FDA Project Officer. This person will participate, in the monitoring of issues relating to recruitment, follow-up, and adherence to protocols and will assist in the development and/or adjustment of project activity.

Additionally, an agency program official may be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements.

A mid-year Progress Report is required no later than 30 days after the midyear point of the budget period. The annual Progress Report is required no later than 30 days after the end of the budget period. The mid-year and annual Progress Report should contain a description of project activities covering the applicable reporting period. A report guidance will be provided to grantees by the Grants Management staff A progress report is also due with each continuation application.

All Progress Reports (mid-year, annual, final, and the progress report included in the continuation application) must contain, but are not limited to the following:

(1) A status report on the installation, training, and operational readiness of any equipment that is provided;

(2) A summary report on any proficiency testing performed;

(3) A summary status of samples analyzed at FERN NPO direction and time to complete individual sample testing; and

(4) A summary description of any other testing performed on the equipment (i.e. not directed by FERN NPO). The summary should include but not limited to the name/type of event(s) involved and the type of testing. More detailed testing information may be subject for request by FERN NPO.

(5) Status and results of method extension and enhancement studies submitted as instructed by the FERN NPO.

(6) Status of publications, research projects, or other special projects funded under this cooperative agreement.

(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.

A final progress report, invention statement, the Federal Financial Report, and record of equipment disposition are required for closeout of an award, and due no later than 90 days after the project period, as described in the HHS Grants Policy Statement. The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and FDA grant administration policies.

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

Monitoring Activities

The program project officer will monitor grantees periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project office/grants management office and the principal investigator. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the study will depend on recommendations from the project officer.

The scope of the recommendation will confirm that:

(1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA and FERN NPO requirements; (3) if necessary, there is an indication that adequate corrective actions have taken place to address any identified problems; and (4) assurance that any replacement of personnel will meet the laboratory personnel qualifications as outlined in Section I (3) of the Research Plan.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

Erin Woodom-Coleman
Food and Drug Administration (FDA)
Telephone: 240-205-1606
Email: [email protected]

Jennifer Gabb
Food and Drug Administration (FDA)
Telephone: 301-796-5920
Email: [email protected]

Daniel Lukash
Food and Drug Administration (FDA)
Telephone: 240-402-7596
Email: [email protected]

Daniel Lukash
Food and Drug Administration (FDA)
Telephone: 240-402-7596
Email: [email protected]

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

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.