Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

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

Building the Capacity of State, Local, Territorial, and Tribal Food Regulatory Agencies to Undertake Examinations, Inspections, and Investigations and other Related Food Safety Activities Under Section 702 of the FD&C Act (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices
  • June 22, 2012 - Notice of Correction to Funds Available and Anticipated Number of Awards for RFA-FD-12-027. See Notice NOT-FD-12-019.
Funding Opportunity Announcement (FOA) Number

RFA-FD-12-027

Companion Funding Opportunity

None

Number of Applications

See 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 building the capacity of state, local, tribal, and territorial food safety agencies to undertake examinations, inspections, and investigations and related food safety activities under section 702 of the FD&C Act.

Key Dates
Posted Date

June 19, 2012

Open Date (Earliest Submission Date)

June 22, 2012

Letter of Intent Due Date

June 29, 2012

Application Due Date(s)

July 30, 2012, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable.

Scientific Merit Review

Standard dates apply.

Advisory Council Review

Not Applicable.

Earliest Start Date(s)

September 1, 2012

Expiration Date

July 31, 2012

Due Dates for E.O. 12372

Not Applicable.

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the HHS 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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

 1.  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) provides for 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)(1) and (a)(4) of the FD&C Act.  Section 1009(a)(1) authorizes FDA to make grants to eligible entities to undertake examinations, inspections, and investigations, and related food safety activities under Section 702 of the FD&C Act.  The entities that conduct these activities under Section 702 of the FD&C Act are States, localities, Indian tribes, and territories.  Section 1009(a)(4) authorizes FDA to make grants to eligible entities to build the infrastructure and capacity of the food safety programs of such eligible entity to meet the standards as outlined in the grant application.  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 goal of this cooperative agreement program is to facilitate long term improvements to the national food safety system by building the capacity of food safety agencies to undertake examinations, inspections, and investigations and related food safety activities under section 702.

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

1. Advancing an integrated national food safety system this as well as meeting provisions of the Food Safety Modernization Act;

2.  Measurable improvement in the capability and capacity for food safety agencies to protect public health by undertaking examinations, inspections, and investigations and other related food safety activities under section 702;

3.  Development of strategies that result in the measurable improvement of the capability and capacity for food safety agencies to protect public health by undertaking examinations, inspections, and investigations and other related food safety activities under section 702 that can be shared and duplicated on a national basis by other food safety agencies; and

4.  Developing the metrics and/or tracking systems to assess the improvement in the capability and capacity for food safety agencies to protect public health by undertaking examinations, inspections, and investigations and other related food safety activities under section 702.

Applicants may pursue a variety of projects to improve the capability and capacity for food safety agencies to protect public health by undertaking examinations, inspections, and investigations, and other related food safety activities under section 702.

Projects to support innovative approaches to a modern public health and prevention focused inspection system including but not limited to:

1.  Development and evaluation of new methodologies or procedures to increase the capacity, efficiency and effectiveness of examinations, inspections, investigations, enforcement efforts, and other food safety activities under section 702. 

2.  Development and evaluation of metrics related to increased efficiency and effectiveness of examinations, inspections, investigations and other food safety activities and the use of these metrics in regards to measuring resource requirements to build capacity in the programs.

3.  Demonstration of innovative, IT solutions that increase the efficiency of conducting

examinations inspections, investigations, and other food safety activities under section 702 or that increase the capability to share, analyze and trend data from examinations, inspections, enforcement actions or other food safety activities under section 702.   

4.  Development and evaluation of algorithms for standardized risk ranking of food processing facilities. 

A technical review session will be held for prospective grantees in July 2012.  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.

Eligible entities must be one of the following:    

1.  State
2.  Locality
3.  Indian tribe
4.  Territory
5.  Nonprofit food safety training entity that collaborates with one or more institutions of higher education. 

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.

Projects that are awarded grants are expected to demonstrate measurable increased food safety or food safety program enhancements as a result of the project.  Therefore, applicants that conduct  examinations, inspections, or investigations, or other related food safety activities under section 702, are encouraged to conduct baseline assessments to assess their current capability and capacity to conduct these activities.

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.  Implementation of a prevention focused, risk-based inspection system for specific commodity areas.

2.  Identification of key, critical elements in rapidly assessing whether a food processing facility, in a specific commodity area, has a well functioning preventive controls system in place. 

3.  Earlier signal detection and identification of uncontrolled critical control points that would likely lead to significant food contamination events. 

4.  Increase in the rate of examinations, inspections, investigations, or other related food safety activity, for high risk firms, under section 702 conducted by a food safety program or an individual.

5.  Decrease in the rate of repeat food safety violations for a given firm, firm type, or industry.

6.  Increase in the compliance rates (i.e. a decrease in the number of violative inspections per total number of inspections conducted) in regulated firms. 

7. Increase in sharing of inspectional or investigational data between FDA and other agencies (and vice-versa) that may be considered for regulatory actions or for surveillance purposes.

2.  Background:

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

a. President’s Food Safety Working Group

An indication of the significant, national interest in food safety is the President’s Food Safety Working Group (FSWG), initiated in March of 2009. 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.  Furthermore, the FSWG has committed to work to “modernize food safety by building collaborative partnerships with consumers, industry and our regulatory partners [and] [t]through a transparent process, build a food safety system that will meet the challenges posed by a global food supply in the 21st century.”

b. National Integrated Food Safety System

FDA is continuing to work with its state partners to create a national, fully integrated food safety system that is characterized by effective communication and efficient processes among federal, state, and local partners in the food safety system. Various initiatives, such as the Food Safety Task Force Program, Innovative Food Defense Program, 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. 

c. Food Safety Modernization Act

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

FSMA directs FDA to build an integrated national food safety system in partnership with State, 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. 

d. 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 the following five titles:

Title I—National Preparedness for Bioterrorism and Other Public Health Emergencies

Title II—Enhancing Controls on Dangerous Biological Agents and Toxins

Title III—Protecting Safety and Security of Food and Drug Supply

Title IV—Drinking Water Security and Safety

Title V—Additional Provisions

Subtitle A of Title III—Protection of Food Supply, Section 311—Grants to States for Inspections, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 909, which authorizes the Secretary of Health and Human Services to award grants to States, territories, and Indian tribes that undertake examinations, inspections, and investigations, and related activities under section 702 of the FD&C Act. The grant funds are only available for the costs of conducting these examinations, inspections, investigations, and related activities.

e. 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. Section 1004 of FDAAA states:

SEC. 1004. STATE AND FEDERAL COOPERATION

(a) IN GENERAL.—The Secretary shall work with the States in undertaking activities and programs that assist in improving the safety of food, including fresh and processed produce, so that State food safety programs and activities conducted by the Secretary function in a coordinated and cost-effective manner. With the assistance provided under subsection (b), the Secretary shall encourage States to—

(1) Establish, continue, or strengthen State food safety programs, especially with respect to the regulation of retail commercial food establishments; and

(2) Establish procedures and requirements for ensuring that processed produce under the jurisdiction of State food safety programs is not unsafe for human consumption.

(b) ASSISTANCE.—The Secretary may provide to a State, for planning, developing, and implementing such a food safety program—

(1) Advisory assistance;

(2) Technical assistance, training, and laboratory assistance (including necessary materials and equipment); and

(3) Financial and other assistance.

(c) SERVICE AGREEMENTS.—The Secretary may, under an agreement entered into with a federal, State, or local agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to carry out the responsibilities of the agency under this section. An agreement entered into with a State agency under this subsection may provide for training of State employees.

f. Action Plan for Import Safety

The Action Plan for Import Safety published in November 2007 acknowledges the value of mutual leveraging of State and Federal resources and recommends consideration of cooperative agreements to increase information sharing. Specifically, the ISAP provides as follows:

Federal-State Rapid Response

Recommendation 12 – Maximize Federal-State Collaboration.

The roles of and the resources used by the federal government and the States in import safety are complementary. States possess legislative authority and resources to respond to unsafe imported products within their jurisdiction. The federal government can take steps to interdict unsafe imported goods at ports-of-entry. Should an unsafe product enter domestic commerce, federal departments and agencies often work with State authorities to track it down, seize it, notify the public if it has already been purchased by consumers, and impose appropriate penalties on domestic entities who violate U.S. law. Also, both the federal government and States may have access to information relevant to protecting consumers that the other does not possess. For example, federal departments and agencies may have relevant information about the foreign source of the imported product and about the importer. This information can help State officials track down an unsafe imported product within their jurisdiction. On the other hand, State officials may identify an unsafe imported product during transport or at the point-of-sale, if the product does get into the country, and can tip-off federal officials to prevent future shipments from entering domestic commerce.

Several federal departments and agencies already collaborate closely with State authorities to protect consumers. For example, FDA has contracts and cooperative agreements with State governments to share information, conduct joint inspections, and collaborate on laboratory analyses. Greater mutual leveraging of State and federal resources can further enhance consumer protection.

12.1 Consider cooperative agreements between the federal inspection agencies and their State counterparts for greater information-sharing. Such cooperative agreements would not infringe on the statutory authorities of federal or State regulators and would encourage a coordinated effort that would result in a more rapid and effective response. Establishing clear procedures and points-of-contact for information sharing and joint enforcement efforts can further enhance the effectiveness of federal-State actions to limit exposure and potential harm to consumers if an unsafe imported product makes it into domestic commerce.

12.2 Review admissibility policies to improve the use of evidence and laboratory results from State investigations of imported products. Currently, there are limitations on the use of State-developed evidence in federal court cases due to the gathering, analysis and retention of such evidence by non-federal government entities. Being able to use this evidence would make it easier for federal departments and agencies to take enforcement actions against bad actors.

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The award is contingent upon FDA appropriations and the submission of a meritorious application.

The total amount of funding available is up to $800,000 total costs for up to 8 awards for fiscal year 2012.  Future year amounts will depend on annual appropriations and performance.

Award Budget

Application budgets are limited to $100,000 (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.  

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

As set forth in section 1009(b)(1) of the FD&C Act, only the following entities are eligible to apply for funding:          

1.  State
2.  Locality
3.  Indian tribe
4.  Territory
5.  Nonprofit food safety training entity that collaborates with one or more institutions of higher education. 

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 SF 424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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.

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

Letter of Intent

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:

The letter of intent should be sent to (Email preferred):

Dan Lukash
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
5630 Fishers Lane
Rockville, MD  20857
Telephone: 301-827-6771
Email: daniel.lukash@fda.hhs.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory 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.

Page Limitations

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

PHS 398 Research Plan Component

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

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 modifications:

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the FDA 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 building the capacity of food safety agencies to undertake examinations, inspections, and investigations and related food safety activities under section 702.  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.  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 directly supporting the grantee is encouraged, but is limited to 25% of each year’s funding. FDA must be provided with a copy of the third party agreement showing involvement and transfer of funds to local/county/tribal governments
9.  Development and publishing of policy and/or procedures manuals, journal articles, and other publications.

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 State 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. Subcontracting to third party (other than local/county/tribal agencies) is limited to 10% of each year's award.

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

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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 SF 424(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 Central Contractor Registration (CCR). 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.  

In order to expedite review, applicants are requested to notify the Project Officer by email at Wendy.Campbell@fda.hhs.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

 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 enhancing the capability and capacity to undertake examinations, inspections, and investigations and other related food safety activities under section 702.  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. 

Post Submission Materials

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).

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the FDA mission, all applications submitted to the FDA in support of biomedical and behavioral research are evaluated for scientific and technical merit through the FDA peer review system.

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

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 criteria and scoring described above will be used for scoring during the review of applications for this announcement.  Reviewers may consider the additional criteria described under "Overall Impact" (below) as they relate to the criteria described above, but separate scores will not be give for the items described below. 

Overall Impact

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 above review criteria and additional review criteria (as applicable for the project proposed).

Additional Review Considerations

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/priority 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 research.

2. Review and Selection Process

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:

The application will compete for available funds. Following initial peer review, recommended applications will receive a second level of review by the ORA project officer for programmatic relevance. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

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, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for DHHS Grants website.

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the DHHS Grants Policy Statement as part of the NoA. For these terms of award, see the DHHS Grants Policy Statement Part II: Terms and Conditions of DHHS Grant Awards, Subpart A: General  and Part II: Terms and Conditions of DHHS Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for DHHS Grants.

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 building the capacity of food safety agencies to undertake examinations, inspections, and investigations and related food safety activities under section 702 of the FD&C Act.

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.

3. Reporting

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.

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 HHS 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. 

An annual Financial Status Report (FSR) (SF-269) must be sent to FDA's grants management officer 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 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 laboratory capacity as described in the application; (4) if necessary, there is an indication that corrective action has taken place.

Section VII. Agency Contacts

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

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding HHS grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Wendy Campbell, Project Officer
FDA Division of Federal-State Relations
Telephone:  615-310-0483
Email:  Wendy.Campbell@fda.hhs.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Dan Lukash
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-6771
Email: daniel.lukash@fda.hhs.gov

Section VIII. Other Information

Recently issued trans-HHS policy notices may affect your application submission. A full list of policy notices published by HHS is provided in the HHS Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Guide for Grants and Contracts.

Authority and Regulations

Awards are made under the authorization of Section 210 of the Food Safety Modernization Act (FSMA) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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