Participating Organization(s)	U.S. Food and Drug Administration (FDA) NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.
Components of Participating Organizations	FDA Office of Regulatory Affairs
Funding Opportunity Title	Limited Competition: Training for Examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including retail food establishments (U18)
Activity Code	U18 Research Demonstration - Cooperative Agreements
Announcement Type	New
Related Notices	August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
Funding Opportunity Announcement (FOA) Number	RFA-FD-13-011
Companion Funding Opportunity	None
Number of Applications	Only one application per institution is allowed, as defined in Section III.3. Additional Information on Eligibility
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) is issued to announce the availability of cooperative agreements to be awarded under Limited Competition. The goal of the FDA/Office of Regulatory Affairs (ORA) Cooperative Agreement Program is to facilitate long-term improvements to the national food safety system by training food regulatory officials to the standards for examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as related to retail food establishments.

Posted Date	March 21, 2013
Open Date (Earliest Submission Date)	April 2, 2013
Letter of Intent Due Date(s)	April 11, 2013
Application Due Date(s)	May 16, 2013 by 11:59pm Eastern Time
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	June 2013
Advisory Council Review	Not Applicable
Earliest Start Date	August 2013
Expiration Date	May 17, 2013
Due Dates for E.O. 12372	Not Applicable

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

Program Objectives:

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) is announcing the availability of cooperative agreements to be awarded under Limited Competition. FDA is awarding these cooperative agreements under its authority in section 1009 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by section 210 of the FDA Food Safety Modernization Act of 2011 (FSMA). Section 1009(a) sets forth a number of different food safety related activities for which grants may be awarded, and Section 1009(b)(1) provides that entities eligible for grants under section 1009 are States, localities, territories, and Indian tribes, and nonprofit food safety training entities that collaborate with 1 or more institutions of higher education. These cooperative agreements are being awarded under section 1009(a)(2) of the FD&C Act. Section 1009(a)(2) authorizes FDA to make grants to eligible entities to train to the standards of the Secretary for the examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments. As discussed above, as specified in Section 1009(b)(1) the entities that are eligible to apply for these agreements are States, localities, territories, and Indian tribes, and nonprofit food safety training entities that collaborate with 1 or more institutions of higher education.

The term "food" is defined in section 201(f) of the FD&C Act as (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. The definition of food is for both human and animal consumption. In addition, incidents affecting the human food supply will often impact animal feed and vice-versa.

a. Goal

The goal of this cooperative agreement program is to facilitate long-term improvements to the national food safety system by training food regulatory officials to the standards established by the Secretary for examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments.

The outcome of the work provided under this cooperative agreement would be as follows:

1. Advancing an integrated national food safety system, as well as meeting the provisions of FSMA that authorize grants for training;

2. Increasing the number of food regulatory officials trained in the standards established by the Secretary for examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments;

3. Increasing national capacity and capability of State, local, territorial, and tribal food safety officials that conduct examinations, inspections, and investigations that may be used for regulatory consideration by FDA and advance public health protection through adequate training; and

4. Advancing a nationally integrated food safety system by promoting equivalency through uniform training of staff for conducting examinations, inspections, and investigations.

b. Potential Projects

Applicants may pursue a variety of projects to enhance training and skills of personnel in the scientific, technical or practical aspects of examination, inspections, or investigations necessary to increase national uniformity or the acceptability of their work or compliance action. The projects pursued must facilitate long-term improvements to the national food safety system and train to the standards established by the Secretary. The projects should also have utility to other food safety programs, including FDA. Awardees should be aware any project deliverables may be shared with other agencies and within FDA as deemed necessary. Facilitating long-term improvements to the nation’s food supply through the sharing of project deliverables and incorporation into other food safety programs is an expected outcome of this cooperative agreement.

Applicants are strongly encouraged to pursue training opportunities that meet nationally recognized standards and quality standard requirements. Substantial involvement from FDA in the development, selection, and delivery of training and other project deliverables pursued by the applicant should be anticipated.

Potential projects may include, but are not limited to:

1. Projects designed to increase capacity for conformance with training to nationally recognized program standards for the examination, inspection and investigation of food manufacturing, processing, packing, holding, distribution and importation, including as such examination, inspection, and investigation related retailed to retail food establishments. Examples of program standards include the Manufactured Food Regulatory Program Standards (MFRPS) and Voluntary National Retail Food Regulatory Program Standards (VPRFRPS).

2. Projects designed to demonstrate the ability of the program to increase food safety and protection capacity and infrastructure through training to the standards.

3. Projects designed to develop and implement systems for tracking metrics related to training

4. Projects to develop training to the standards for examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation related to retail food establishments;

c. Eligible Entities

As set forth in section 1009(b)(1)(A) of the FD&C Act, eligible entities must be one of the following:

1. States 2. Localities 3. Indian tribes 4. Territories 5. Nonprofit food safety training entities that collaborate with one or more institutions of higher education.

d. Technical Review

A technical review session will be held for prospective grantees in April 2013. The conference call information will be provided to prospective grantees that submit a letter of intent. The technical review session will provide an overview of the submission requirements and allow prospective grantees an opportunity to ask questions regarding the application process. Participation in the technical review session is optional, but strongly encouraged.

e. Funding

Funds received through this cooperative agreement shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this funding opportunity announcement. The funds shall be available only to the extent such entity funds the food safety training programs of such entity independently in each year of the cooperative agreement at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services. Agencies funded under these cooperative agreements will be required to provide the previous and subsequent years of funding to demonstrate that these funds have not replaced allocations for the food protection program.

In addition, work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under these cooperative agreements and the funding provided must remain distinct and separate from other projects and funding sources. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, received through contracts, cooperative agreements, grants, and other funding received by the grantee and these cooperative agreements.

f. Metrics

Projects that are awarded grants are expected to demonstrate measurable increased food safety, public health protection, regulatory compliance, and/or other food safety program enhancements as a result of the project. Therefore, applicants are encouraged to conduct baseline assessments to assess their current capability and capacity to train to the standards established by the Secretary for examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments.

Below are examples of the types of metrics that may be used to measure the success of the grant project. However, applicants may, and indeed are encouraged to, develop food safety outcome measures that apply specifically to their application and project proposal. Applicants must include in the application information regarding how the project’s success will be measured.

Examples of measurable outcomes may include, but are not limited to:

1. Increase in the number or percentage of food regulatory officials that meet the training requirements to support current and projected program work in areas of food and feed safety, defense and response capabilities;

2. Increase in number or percentage of food regulatory officials that are trained on procedures similar to those found in the "Guidelines for Foodborne Disease Outbreak Response and Rapid Response Team (RRT) Best Practices Manual.

3. Increase in number or percentage of food regulatory officials that are trained in a specific technology, technique, or skill related to conducting examinations, inspections, and investigations. Examples may include high risk manufacturing processes (pasteurization, sous vide, retort operations, aseptic processing), high-risk foods (soft cheeses, seafood, ready-to-eat foods), on-farm produce investigations, sterile sampling techniques, in-field rapid test methods, and foodborne illness investigations.

4. Demonstration that training provided has resulted in a reduction in foodborne illness, improved ability to detect and correct food safety risk factors, and/or improved efficiency when conducting inspections, examinations, and/or investigations.

5. Demonstration of the ability to track performance metrics related to training and utilize data to assist in meeting resource requirements specified in standards to meet programmatic goals.

6. Demonstration that training has resulted in increased regulatory compliance or adoption of best practices by industry.

Background

a. FDA Food Protection Plan

Although the United States has one of the safest food supplies in the world, the public health burden of foodborne disease in the nation is substantial. CDC estimates that each year roughly 1 in 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die of foodborne diseases http://www.cdc.gov/foodborneburden/. New challenges continue to arise, including the globalization of the food supply and the emergence of new pathogens in foods. "Food" includes human food and animal feed and is defined in 21 USC 321(f)).

In May 2007, Secretary of Health and Human Services, Michael O. Leavitt and Andrew C. von Eschenbach, M.D., Commissioner of Food and Drugs, charged FDA with developing a comprehensive and integrated FDA Food Protection Plan to keep the nation's food supply safe from both unintentional and deliberate contamination. Driven by science and modern information technology, the Plan aims to identify potential hazards and counter those before they can do harm. A cornerstone of this forward-thinking effort is an increased focus on prevention.

The Plan builds in safety measures to address risks throughout a product’s life cycle, from the time a food is produced to the time it is distributed and consumed. The Plan focuses FDA efforts on preventing problems first, and then uses risk-based interventions to ensure preventive approaches are effective. The Plan also calls for a rapid response as soon as contaminated food or feed is detected or when there is harm to people or animals.

FDA’s integrated approach, within the Food Protection Plan, encompasses three core elements: prevention, intervention and response.

b. President’s Food Safety Working Group

An indication of the significant, national interest in food safety is the President’s Food Safety Working Group (FSWG), initiated in March of 2009 (http://www.foodsafetyworkinggroup.gov/Home.htm). The charge of the FSWG is the following: To have safe food that does not cause us harm and to enhance our food safety systems by fostering coordination throughout the government including enhancing our food safety laws for the 21st century. These laws will be designed to keep the American people safe and will be enforced. Chaired by the Secretary of Health and Human Services and the Secretary of Agriculture, the FSWG recommends a public health-focused approach to food safety that prioritizes prevention, strengthens surveillance and enforcement, and improves response and recovery.

c. National Integrated Food Safety System

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

d. FDA Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. FSMA directs FDA to build an integrated national food safety system in partnership with State, local, territorial, and tribal authorities, explicitly recognizing that all food safety agencies need to work together in an integrated way to achieve national public health goals. FSMA identifies some key priorities in working with partners in areas, such as: reliance on Federal, State, and local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing State and local food safety and defense capacities. In addition, FSMA specifically authorizes grants to certain entities to enhance food safety. Full text of the law: http://www.fda.gov/Food/FoodSafety/FSMA/ucm247548.htm

e. Bioterrorism Act

Alongside the increased national focus on food safety has been the increased focus on emergency preparedness and response since 2001. The events of September 11, 2001, reinforced the need to enhance the safety and defense of the U.S. food supply. Congress responded by passing the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ("Bioterrorism Act"), which President Bush signed into law on June 12, 2002. The Bioterrorism Act is divided into five titles, detailed here: http://www.fda.gov/regulatoryinformation/legislation/ucm148797.htm. .

f. Food and Drug Administration Amendments Act of 2007 (FDAAA)

FDAAA amended the FD&C Act to require FDA to work with the States to undertake activities to assist in improving food safety.

This requirement is contained within Title X (Food Safety) Section 1004 of the FDAAA (Full text: http://www.gpo.gov/fdsys/pkg/PLAW-110publ85/html/PLAW-110publ85.htm).

g. Import Safety Action Plan

The Import Safety Action Plan acknowledges the value of mutual leveraging of State and Federal resources and recommends consideration of cooperative agreements to increase information sharing. Specifically, the ISAP contains Recommendation 12 to maximize federal-state collaboration for federal-state rapid response (http://archive.hhs.gov/importsafety/report/actionplan.pdf; pages 37-38).

Funding Instrument	Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities.
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. FDA intends to fund an estimate of 20 awards, corresponding to a total of $1,400,000, for fiscal year 2013. Future year amounts will depend on annual appropriations.
Award Budget	Application budgets are limited to $70,000 (direct and indirect costs) and need to reflect actual needs of the proposed project.
Award Project Period	The total project period for an application requesting support may not exceed three years.

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

As set forth in section 1009(b)(1)(A) of the FD&C Act, eligible entities must be one of the following:

1. States

2. Localities

3. Indian tribes

4. Territories

5. Nonprofit food safety training entities that collaborate with one or more institutions of higher education.

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. The FDA Policy on Late Submission of Grant Applications states that 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) (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 and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

Only one application per institution (normally identified by having a unique DUNS number) is allowed.

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.

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, 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.

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 IC 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 research
• Name(s), 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 by email to: [email protected] no later than April 11, 2013

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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.

Other Attachments: Provide the following information as a single PDF file with the name NAME.pdf.

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, with the following additional instructions:

Specific Aims: None.

Research Strategy: Page limit is 15.

Letters of Support: None.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) 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.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the deadline 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.

Applicants are responsible for viewing their application before the deadline 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.

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

This award may only be used for activities associated with training food and feed regulatory officials to the standards established by the Secretary for examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments. The funds shall be available only to the extent such entity funds the food safety training programs of such entity independently in each year of the cooperative agreement at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services. If these requirements are not met because such funding was diverted for response to one or more natural disasters or in other extenuating circumstances that the Secretary determines to be appropriate, then a written justification (to be included in the mid-year report or PHS-2590/end of year report) is necessary. The justification should include a description of the natural disaster or other extenuating circumstance, involvement of the grantee, complete and detailed itemization of how grant funds and other appropriations (non-Federal and other Federal sources) were spent, impact on grant progress, and other information as requested by the Secretary.

In addition, work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under these cooperative agreements and the funding provided must remain distinct and separate from other projects and funding sources. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, received through contracts, cooperative agreements, grants, and other funding received by the grantee and these cooperative agreements.

Allowable costs:

1. Salaries

2. Accounting services

3. Laboratory and sample collection supplies, equipment (with prior approval from FDA), and installation

4. Supplies for meetings related to the award

5. Travel and per diem to attend travel for training and attending meetings related to the grant.

6. Printing, shipping, and mailing

7. Web site server, software, hosting, development and integration, computers and other hardware

8. Pass through of funds to eligible local/county/tribal government agencies and non-profit training entities that collaborate with one or more universities directly supporting the grantee is encouraged, but is limited to 40% of each year’s funding. FDA must be provided with a copy of the third party agreement showing involvement and transfer of funds.

9. Subcontracting to a third party is allowed, but is limited to 40% of year’s funds. FDA must be provided with a copy of the third party agreement showing involvement and transfer of funds.

10. Development and publishing of policy and/or procedures manuals, journal articles, and other publications.

11. Indirect costs based on a current Federal indirect cost rate agreement.

Non-allowable costs:

1. Facilities and work covered under current FDA inspection contracts, cooperative agreements/grants, partnership funds, and other sources cannot be counted towards the fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement. The grantee must be able to account separately for fund expenditures other sources of FDA funding and these cooperative agreements.

2. Vehicle purchases are not permitted.

3. Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant ward amount.

Funding Plan: The second and third years of funding for noncompetitive continuation of support will depend on performance, program progress, and the availability of Federal funds.

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.

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 (SAM). 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 by the Office of Acquisition and Grants (OAGS) and responsiveness by the FDA Office of Regulatory Affairs (ORA). Applications that are incomplete and/or nonresponsive will not be reviewed.

The application must specifically describe and demonstrate the ability to meet some or all of the potential outcomes of the cooperative agreement as described above regarding training food regulatory officials to the standards established by the Secretary for examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as such examination, inspection, and investigation relate to retail food establishments. In addition, the strategies developed and implemented must have measurable outcomes and be able to be duplicated by other agencies, including the FDA.

The application must also demonstrate that the funds from this cooperative agreement shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this funding opportunity announcement. The applicant must provide assurance that plans have been developed to engage in the types of activities outlined in the grant application using these grant funds, an itemization of how grant funds will be expended, a description of how grant activities will be monitored, and ability to report information required by the Secretary to conduct evaluations.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115, with the following modifications:

Acceptable post submission materials include:

• Revised budget pages
• Biographical sketches
• Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator.
• News of an article accepted for publication (a copy of the article should not be sent).

Only the review criteria described below will be considered in the review process. All applications submitted to the FDA in support of this announcement are evaluated for scientific and technical merit through the FDA peer review system.

Reviewers will provide an overall impact/ priority 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.

1. The rationale and design to meet the goals of the cooperative agreement (Total Weight = 60%)

a. The Rationale for the proposal advances an integrated national food safety system (Weight 5%);

b. The design appropriately addresses and demonstrates the ability to meet and maintain the goals of the cooperative agreement. The design fits the scope of the potential projects or any other project that meets the goals of this cooperative agreement (Part 2, Section I.(a),(b)) (Weight 20%);

c. The design appropriately addresses and demonstrates the ability to achieve the goals of the FOA. (Part 2, Section I.(a)) (Weight 35%);

2. Demonstration of effectiveness in working with federal, state, and local partners and other appropriate organizations to implement the goals of the cooperative agreement (total weight = 20%)

3. Demonstration of plans to facilitate the incorporation and sustainability of project developed capabilities into the entity's food and/or feed safety system (total weight = 20%)

Note: Only the Scored Review Criteria (criteria 1-3) will be used for scoring during the review of applications for this announcement. Reviewers may consider additional criteria described in the "Overall Impact" and Additional Review Considerations sections, as they relate to the criteria described above. Separate scores will not be given for the additional criteria.

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

Budget and Period of Support

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Panel, in accordance with FDA peer review policy and procedures, using the stated review criteria.

As part of the scientific peer review, all applications:

• Will receive a written critique.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate FDA Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

After the review of the application is completed, the PD/PI will receive his or her Summary Statement (written critique) via email.

Information regarding the disposition of applications is available in the HHS Grants Policy Statement.

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted in the HHS Grants Policy Statement.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NOA. For these terms of award, see the HHS Grants Policy Statement.

Cooperative Agreement Terms and Conditions of Award

The purpose of these cooperative agreements is to facilitate long-term improvements to the national food safety system by training food regulatory officials to the standards for examination, inspection, and investigation of food manufacturing, processing, packing, holding, distribution, and importation, including as related to retail food establishments.

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.

The program project officer, grants management officer and technical advisor will monitor the recipient periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the FDA and the principal investigator. Periodic site visits from representatives of ORA with officials of the recipient organization may also occur. There may be other regular meetings with recipients to assist in fulfilling the requirements of the cooperative agreement.

Funds received through this cooperative agreement shall be used to supplement, and not supplant, non-Federal funds and any other Federal funds available to carry out the activities described in this funding opportunity announcement. The funds shall be available only to the extent such entity funds the food safety programs of such entity independently in each year of the cooperative agreement at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index. Such non-Federal matching funds may be provided directly or through donations from public or private entities and may be in cash or in-kind, fairly evaluated, including plant, equipment, or services. Agencies funded under these cooperative agreements will be required to provide the previous and subsequent years of funding to demonstrate that these funds have not replaced allocations for the food protection program.

In addition, work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under these cooperative agreements and the funding provided must remain distinct and separate from other projects and funding sources. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, received through contracts, cooperative agreements, grants, and other funding received by the grantee and these cooperative agreements.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.

A final progress report and Financial Status Report are required when an award is relinquished, when a recipient changes institutions or when an award is terminated.

An annual Financial Status Report (FSR) (SF-425) must be sent to FDA's grants management specialist within 90 days of the budget period end date of each twelve month cooperative agreement. Failure to file the annual FSR in a timely fashion will be grounds for suspension or termination of the cooperative agreement.

For continuing cooperative agreements, mid-year reports and an annual program progress report are also required. For such cooperative agreements, the Non-Competing Continuation Progress Report (PHS-2590) will be considered the program progress report for the fourth quarter of the budget period.

Mid-year progress reports must contain the elements below as applicable to the grantee proposal and award, but are not limited to, the following:

1. Detailed progress report on the grantee meeting the project milestones detailed in the cooperative agreement and identified in the proposal. Goals and objectives should be broken out and reported against.

2. Status report on the hiring and training of any personnel.

3. Status report on the purchasing and operational readiness of any equipment, computers, or software purchased.

4. Summary of improvements (identify and quantify) in the overall food safety program or system resulting from the cooperative agreement.

5. Identify any pending issues or concerns that may affect accomplishing the objectives and goals of the cooperative agreement. If the objectives and goals of the cooperative agreement are not being met, then a corrective action plan must be submitted. The corrective action plan should detail the tasks, responsible personnel, and updated timeframes to ensure satisfactory performance and meet the deliverables required under the grant.

6. Detailed program budget demonstrating that grant funds are supplementing, not supplanting, existing non-Federal and other Federal sources of funding at a level equal to the level of such funding in the previous year, increased by the Consumer Price Index.

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. See the HHS Grants Policy Statement for additional information on this reporting requirement.

The recipient must file a final program progress report, and FSR, within 90 days after the end date of the project period as noted on the notice of the cooperative agreement award.

The final program progress report must provide full written documentation of the project and summaries of accomplishments and goals, as described in the grant application. The documentation must be in a form and contain sufficient detail such that other entities could reproduce the final project.

Monitoring Activities

The program project officer will monitor the recipient periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the recipient organization may also occur. There may be other regular meetings with recipients to assist in fulfilling the requirements of the cooperative agreement.

The results of these monitoring activities will be recorded in the official cooperative agreement file and will be available to the grant recipient, upon request, consistent with applicable disclosure statutes and FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the 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 regulatory requirements, (3) funds are being used to supplement, not supplant, the building of food safety capacity as described in the application; (4) if necessary, there is an indication that corrective action has taken place.

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)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Phone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

Wendy Campbell
FDA/ORA/Office of Partnerships
12420 Park Lawn Drive; ELEM-3026
Rockville, MD 20857
Telephone: (615) 310-0483
Email: [email protected]

Dan Lukash
Office of Acquisitions and Grants Services (OAGS)
5630 Fishers Lane
Rockville, MD 20857
Telephone: 301-827-6771
Email: [email protected]

Recently issued trans-FDA policy notices may affect your application submission. 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 1009 of the Federal Food, Drug, and Cosmetic Act and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.