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.

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

Background:

The National Antimicrobial Resistance Monitoring System (NARMS) is a U.S. public health surveillance system that tracks antibiotic resistance in enteric bacteria from humans, retail meats, and food animals. It was established in 1996 and is a collaboration of the U.S. Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Department of Agriculture (USDA), and State and Local Public Health Departments. The NARMS program helps promote and protect public health by providing information about emerging bacterial resistance, how resistant infections differ from susceptible infections, and the impact of interventions designed to limit the spread of resistance. NARMS is a resource for providing data for animal antibiotics, including post-approval safety monitoring of new animal drugs, and helps assess the risks associated with new animal drugs as well as older agents. The primary bacteria under surveillance are Salmonella, Campylobacter, Escherichia coli, Enterococcus, Vibrio, Aeromonas and other lactose positive bacteria. This FOA is limited to the retail food surveillance portion of the NARMS program.

Problem Statement:

Antimicrobial drugs have been widely used in human and veterinary medicine for more than 70 years, with tremendous benefits to both human and animal health. The development of resistance to these medicines poses a serious public health threat. Antimicrobial drug use creates selective evolutionary pressure that enables antimicrobial resistant bacteria to increase in numbers and thus increases the opportunity for individuals to become infected by resistant bacteria. When antimicrobial drugs are used in food-producing animals, they can enrich for populations of resistant strains that reach humans via the food supply.

Purpose:

FDA announces the availability of fiscal year (FY) 2020 funds to enhance and strengthen antibiotic resistance surveillance in retail food specimens within the National Antimicrobial Resistance Monitoring System (NARMS). This cooperative agreement with the NARMS retail food surveillance program will enable the research and investigations for the collection of critical data to help inform public health stakeholders. Data from investigations conducted by applicants will assist in developing pre-approval safety evaluation of new animal antibiotics, determining parameters for the antimicrobial use in veterinary medicine, and the ability of public health actors to provide information to promote interventions to reduce resistance among foodborne bacteria. This cooperative agreement will address NARMS programmatic needs to implement effective surveillance and response for antibiotic resistance as recommended in the National Strategy for Combating Antibiotic-Resistant Bacteria (CARB). The chief goal of the NARMS food surveillance program is to improve the detection of and surveillance for antimicrobial resistance among enteric bacteria in raw retail meat commodities.

Outcomes:

1. Applicant will be able to research, collect and process samples within the time frame described in the FDA protocol and guidelines

2. Applicant will be able to perform microbiological tests, as described in the project protocol, of the total samples required by the FDA

3. Applicant will be able to use microbiological results from the project to analyze quality assurance practices

4. Applicant will be able to integrate and coordinate surveillance activities with FDA

5. Applicant will be able to exchange relevant and complete surveillance data with FDA and their local public health agencies

6. Applicant will be able to use data to inform program and policy development

7. Applicant will be able to employ data for education on current and emerging hazards

8. Applicant will be able to support awareness of antimicrobial resistance among the public

9. Applicant will be able to identify foodborne illness outbreaks and coordinate outbreak investigations with the local and state public health agencies as well as the FDA

10. Applicant will be able to analyze antimicrobial resistance data for their catchment area over time

11. Applicant will be able to defend their jurisdictions involvement in protecting and promoting the public's health

Project Activities:

Specific activities supported by this cooperative agreement include but are not limited to those listed below:

1. Actively participate in NARMS conference calls and working groups

2. Implement NARMS sampling and laboratory protocols to ensure standardized methodologies

3. Implement standardized data collection and isolate transmission protocols

4. Provide FDA with a list of sampling areas that meet the NARMS sampling requirements

5. Collect fresh retail meat at a minimum of 2 non-consecutive days per month from pre-selected retail locations

6. Perform microbiological tests on fresh retail meat samples for Salmonella

7. Perform microbiological tests on fresh retail poultry samples for Campylobacter

8. Option to perform microbiological tests on fresh retail meat samples for Escherichia coli and Enterococcus

9. Perform microbiological tests on seafood samples for Enterococcus, Aeromonas, Vibrio and other lactose positive bacteria

10. Perform microbiological tests on fresh retail meat samples for other organisms as specified in ad hoc pilot studies

11. Culture other fresh retail food samples for bacteria specified by NARMS

12. Provide serotype and/or species identifications for isolates when available

13. Conduct whole genome sequencing and other molecular testing of isolates cultured from fresh retail foods for the NARMS program

14. Send isolates to the FDA on a monthly basis for further evaluation

15. Submit and adhere to the NARMS data use policy agreement

Specific activities that are NOT supported by this cooperative agreement include but are not limited to those listed below:

1. Collection and testing of meats and/or food products not specified in the sampling assignment

2. Isolation of organisms other than those agreed to or specified in pilot study programs

FDA staff is substantially involved in the NARMS retail food surveillance program activities beyond routine grant monitoring which include but are not limited to the activities listed below:

1. Provide general coordination for all NARMS retail food surveillance sites and the overall NARMS network

2. Develop, facilitate, and participate in collaborative multi-site relationships as needed to support the successful completion of the program activities

3. Provide scientific consultation and technical assistance as necessary in the operation of the NARMS retail food surveillance program

4. Facilitate the development of protocols, procedure manuals, and training of applicants

5. Perform confirmatory bacterial identifications and antimicrobial susceptibility testing

6. Perform whole genome sequencing and other molecular characterization of select NARMS isolates

7. Analyze, interpret, and disseminate surveillance results

8. Coordinating and facilitating communications among NARMS retail food surveillance sites

9. Designing surveillance projects

Evaluation and Performance Measurement Strategy:

Required performance measures for the project period are listed below. Data will be reported on an annual basis, and are used to indicate progress made toward program outcomes. The purpose of evaluation and performance measurement is to help FDA and NARMS Cooperative Agreement awardees: 1) Monitor the extent to which activities planned were successfully completed (e.g., Were activities implemented correctly?); 2) Demonstrate how capacity building activities contribute towards program outcomes (e.g., Were outcomes of interest achieved?); and 3) Inform decisions about future programming that drive continuous program improvement for more efficient and effective program performance (e.g., What and how could things be improved?). Potential data sources will include awardee applications and progress reports (e.g., work plans, performance measures, and success stories).

Below are evaluation questions to be addressed by the FOA during this project period:

1. What are the major activities conducted by awardees that contributed towards achieving NARMS Retail Food Surveillance program outcomes?

2. What were the major outputs (milestones or deliverables) accomplished by awardees that contributed towards achieving NARMS Retail Food Surveillance program outcomes?

3. To what extent were awardees proposed activities implemented as planned?

4. To what extent were awardees able to collect and conduct microbiological tests on the assigned number of retail meat samples per month?

5. To what extent were awardees able to conduct sampling at least twice a month with a minimum of 6 days in between sampling periods?

7. To what extent did awardees attend and participate in NARMS Retail Food Surveillance quarterly calls?

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

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

NOTE: Applicants with current active awards funded under PAR-16-099 NARMS Cooperative Agreement to Enhance and Strengthen Antimicrobial Resistance Surveillance in Retail Food Specimens (U01) are eligible to apply to this FOA. However, if a new award is issued under this FOA to the applicant organization, the applicant agrees to terminate the award that was issued under PAR-16-099 and agrees to forfeit any remaining funds left on their previous award. Applicants cannot have both the award issued under PAR-16-099 and the new award issued under this FOA.

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.

• 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.
• 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.

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 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.

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.

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.

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

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

• Descriptive title of proposed activity
• Name(s), email address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent via electronic mail as a PDF file with the FOA Number and the Institution's Name in the message subject heading to:

Claudine Kabera via [email protected] and Rene Vasquez via [email protected]

A technical session will be held for prospective applicants in May 2020, May 2021, and May 2022. The conference call information will be provided to prospective applicants that submit a letter of intent. The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process. Participation in the technical session is optional, but strongly encouraged.

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. , with the following additional instructions:

• Project Summary/Abstract: A project abstract is a mandatory document within the Research and Related Other Project Information form. This project abstract should be a self-contained, brief summary of the proposed project including the purpose and expected outcomes. It is meant to serve as a succinct and accurate description of the proposed work when separated from the application. This summary must not include any proprietary or confidential information. Applicants must name this file "Project Summary".

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:

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• 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.
• When developing the budget narrative, applicants must consider whether the proposed budget is reasonable and consistent with the purpose, outcomes, and program strategy.
• Applicants should not request travel costs in excess of $5,000 and must be for NARMS specific activities. Only travel that is considered a required activity of this cooperative agreement will be funded by the FDA

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:

Research Strategy (aka Project Plan):

The Research Strategy must be submitted in the following format:

a) Maximum number of pages: 30 (excluding budget, budget narrative, appendices, and required forms). If your Research Strategy exceeds the page limit, the application will have errors

b) Font size: 12 point unreduced

c) Spacing: Single

d) Page Margins: 1 inch

e) Number all narrative pages

• The budget and budget narrative should be included as a separate attachment not to be counted in the Research Strategy page limit.

Applicants must submit a Research Strategy with the application forms. The Research Strategy must be written according to the following outline (see Research Strategy Outline below) using formatting guidelines listed above. The application should contain a A) Background & Overview, B) Approach, C) Capacity of Applicants to Implement the Approach, and D) Evaluation and Performance Strategy. Applicants must name this file "Project Plan".

Research Strategy (Project Plan) Outline:

A. Background & Overview: Applicants must provide a description of relevant background information that includes the context of the problem. Specifically:

i. List of the project component activities being addressed in the application.

ii. Provide information on population size, demographic characteristics, and types of fresh food retailers in your jurisdiction (i.e., traditional, non-traditional, modern retail).

iii. Describe organizational (especially as it relates to the integration of epidemiology and laboratory), fiscal, administrative, and/or programmatic challenges or limitations you expect to face, and measures to overcome them associated with the implementation of the activities you are proposing in this application. Describe plans to assure adequate planning and that activities (e.g., hiring, contracting, procurement, collaborations, etc.) are implemented quickly with rigorous tracking and oversight to avoid delays and reduce the potential for unobligated funds remaining at the end of the budget and project period.

iv. Provide any success stories to capture recent accomplishments that highlight the impact of the NARMS retail food surveillance program in your jurisdiction. These will be used to educate stakeholders, decision makers, and policymakers about the impact of the NARMS program.

B. Approach: Applicants must describe the core information relative to the project and how the applicant's response to the FOA will address the public health priority as described in the Funding Opportunity Description. Specifically:

i. Describe how the application will address the project's needs. Clearly identify the expected outcomes to be achieved by the end of the project period. In addition to the project period outcomes required by the Funding Opportunity Description, applicants should include any additional outcomes they anticipate. Outcomes are the results that the program intends to achieve. All outcomes must indicate the intended direction of change (i.e., increase, decrease, maintain, complete).

ii. Applicants should provide a clear and concise description of the strategies and activities they will use to achieve the project period outcomes. Briefly introduce the activity(ies) being proposed and describe what the expected outputs (e.g., milestones) and outcomes will be over the first 12-month budget period. Applicants may propose additional strategies and activities to achieve the outcomes and describe the rationale for selecting these. Also provide a brief discussion of what will be achieved (i.e., expected outputs and outcomes) over the entire five-year project period.

iii. If applicable, describe collaborations with programs and organizations either internal or external to FDA and describe the extent to which the strategies and activities will target specific population(s) in the collaborators jurisdiction.

C. Capacity of Applicants to Implement the Approach: Address your jurisdiction's current capacity to successfully implement the proposed strategies and activities (including describing staff and other infrastructure already in place that you will build upon).

• Progress Report: If your jurisdiction was funded in the previous funding period you must provide progress on those activities. The time period of progress reports covered should range from the beginning of your last funding period to the time of application. Progress Reports should:
• Describe major activities conducted, the progress of those activities, and significant milestones accomplished as a result of those activities.
• Address progress made for each performance measure written in the FY2020 proposal.
• If applicable, include the reasons that goals (e.g., targets for performance measures) were not met or activities (e.g., milestones) were incomplete, and a discussion of assistance needed to resolve the situation.
• If applicable, describe any barriers encountered, and how the barriers were addressed during implementation of these activities.

D. Evaluation and Performance Measurement Plan: Describe in a brief narrative (5 pages maximum) a plan to monitor activities, demonstrate progress towards program outcomes and inform future program decisions over the five-year project period. The plan should be consistent with the Evaluation and Performance Measurement Strategy listed in the Funding Opportunity Description. Reporting on this plan will occur on an annual basis and at the end of the project period. As needed and on request of the awardee, FDA will work with awardees during the first six months of the project period to finalize an evaluation and performance measurement plan to better monitor the progress of the activities implemented and outcomes achieved.

This plan, at a minimum, should address the following points:

i. Identify key program partners and describe how they will participate in the implementation of the evaluation plan as described within this FOA. These include persons involved in or affected by the program and primary users of the evaluation (e.g., staff from epidemiology, laboratory, and health information systems; program coordinators; partners (if applicable), PI's, etc.)

ii. Consider the evaluation questions outlined in the Evaluation and Performance Strategy. These questions will establish the scope and focus of the evaluation. Applicants may also choose to develop other evaluation questions, in addition to those defined by FDA.

iii. Describe the data (performance measures and associated data) and how you will use the data to answer evaluation questions.

iv. Describe how evaluating findings will be used at the applicant level. Discuss how data collected (i.e., performance measurement data) will be used and shared by the key program partners.

v. Discuss any barriers or challenges expected for implementing the plan, collecting data (i.e., responding to performance measures), and reporting on evaluation results. Describe how these potential barriers would be overcome. In addition, applicants may also describe other measures to be developed or additional data sources and data collection methods that applicants will use.

Specific names provided for Other Attachments must be no more than 50 characters

including spaces.

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:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Appendix:

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

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

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

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.

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.

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

Non-Allowable costs:

1. Manuscripts

2. Travel to meetings not sponsored by the U.S. Food and Drug Administration

3. Travel costs in excess of $5,000. All travel costs must be for NARMS specific activities. Only travel that is considered a required activity of this cooperative agreement will be funded by the FDA.

Additional funding restrictions may be part of the Notice of Award.

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. 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 are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review. Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

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

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

Does the proposal demonstrate proficiency in food microbiology, and familiarity with best practices in laboratory microbiology protocols? Is the proposed work congruent with the public health priorities of the candidate so that testing will not be postponed by competing priorities and reporting of data will not be delayed or compromised?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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 application challenge and seek to shift current research, surveillance, or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Is a refinement or improvement of approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, staffing and analyses 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? Is the budget commensurate with the proposed work?

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, subject populations, or collaborative arrangements? Is the proposed work congruent with the public health priorities of the candidate institute so that testing will not be postponed by competing priorities and reporting of data will not be delayed or compromised?

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.

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.

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.

For Renewals, the committee will consider the progress made in the last funding period.

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 Data Sharing Plan (GDS).

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.

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

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.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

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. For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides 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/fact-sheet-guidance/index.html and https://www.lep.gov. 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.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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.

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 and CVM programmatic requirements may be part of the Notice of Award.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, 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 administrative regulations at 45 CFR 75, and other HHS, PHS, and FDA grant administrative policies.

Support will be in the form of a cooperative agreement. Substantive involvement by the awarding agency is inherent in the cooperative agreement award. Accordingly, FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement.

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 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 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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: 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: [email protected]

Claudine Kabera
NARMS Project Manager
Food and Drug Administration
Center for Veterinary Medicine (CVM)
Telephone: 240-402-5430
Email: [email protected]

Rene Vasquez
Grants Management Specialist
Office of Operations, Office of Finance Budget & Acquisitions
Office of Acquisitions and Grants Services, HFA-500
U.S. Food and Drug Administration
Tel: 301-796-3546
[email protected]

Rene Vasquez
Grants Management Specialist
Office of Operations, Office of Finance Budget & Acquisitions
Office of Acquisitions and Grants Services, HFA-500
U.S. Food and Drug Administration
Tel: 301-796-3546
[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 Section 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.