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	Office of Regulatory Affairs/Office of Partnerships
Funding Opportunity Title	Development, Implementation, and Management of a Funding System to Advance Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) (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-13-038
Companion Funding Opportunity	Not Applicable
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
Funding Opportunity Purpose	The intended outcome of this FOA is the development, implementation, and management of a funding system in which State, local, tribal, and territorial retail food regulatory programs can apply and be subawarded funds for completion of projects and training to enhance conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS or Retail Program Standards). Funds will be awarded to a national association/organization to administer and award funds to State, local, territorial, and tribal jurisdictions to facilitate long-term improvements and advancement of the Retail Program Standards.

Posted Date	June 19, 2013
Open Date (Earliest Submission Date)	June 19, 2013
Letter of Intent Due Date(s)	June 26, 2013
Application Due Date(s)	July 19, 2013, 11:59 PM Eastern Time.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	July, 2013
Advisory Council Review	Not Applicable
Earliest Start Date	August 2013
Expiration Date	July 20, 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

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships is announcing the availability of a cooperative agreement to be awarded under Limited Competition to a national association/organization whose membership includes, but may not be limited to, State, local, territorial, and/or tribal retail food safety regulators.

The intended outcome of this FOA is the development, implementation, and management of a funding system in which State, local, tribal, and territorial retail food regulatory programs can apply and be subawarded funds for completion of projects and training to enhance conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS or Retail Program Standards).

The cooperative agreement includes one year of funding with up to two years of additional funding, to be awarded through a funding system developed by the grantee.

The funding system developed by the grantee for issuing the subawards must meet the following criteria:

1. Ensures strong cooperation, coordination, and continuous involvement of the FDA, including Regional Retail Food Specialists, National Retail Food Team Steering Committee, State Cooperative Program Directors, Office of Partnerships, and Office of Foods and Veterinary Medicine.

2. Establishes a joint advisory group including the grantee, FDA, and other stakeholders to ensure the cooperative agreement is achieving the priorities established by FDA.

3. Contains a communications strategy that includes advertising the availability of funds, projects funded, and project outcomes.

4. Describes the process for selecting subawardees that includes active, direct involvement of the FDA Regional Retail Food Specialists and other FDA stakeholders.

5. Describes unbiased methods for solicitation of applications, review of submissions, and selection of awardees to ensure distribution of funds over a wide range of State, local, tribal, and territorial regulatory jurisdictions in keeping with FDA program priorities.

6. Establishes a system for monitoring the progress of subawardees to include the periodic verification of project outcomes and reporting of the project results/outcomes to FDA.

7. Establishes a system for the management, distribution, and verification of the use of funds subawarded to retail food regulatory programs.

8. Establishes a system for development of corrective action plans when subawardees are not completing the projects proposed or using the funds appropriately.

9. Ensures, working with FDA, that the projects proposed by subawardees have not been reimbursed under other cooperative agreements, grants, contracts, and other funding mechanisms.

The FDA anticipates subaward funds will be made available by the grantee in three distinct categories:

Category 1 (Small projects): Awards of $500 - $3,000 for completion of small projects. Examples of small projects include, but may not be limited to, completion of a self-assessment of all nine Standards, completion of a verification audit confirming the results of the jurisdiction’s self-assessment which indicates that it meets one or more of the Standards, completion of smaller cost projects related to achieving a specific Standard's criteria such as developing a written quality assurance program (Standard 4) or a written compliance and enforcement program (Standard 6).

Category 2 (Moderate Projects): Awards of $10,000 - $25,000 for completion of more ambitious projects. Examples include, but may not be limited to, development and implementation of a computer software system that supports elements of the retail food inspection program, completion of foodborne illness risk factor studies, and implementation of comprehensive intervention strategies for reducing foodborne illness risk factors identified as priority areas.

Category 3 (Training Scholarships): Awards of up to $2,000 in individual scholarships for travel to food safety training by FDA, CDC, or other entity that would support furtherance of the retail program. Examples include, but may not be limited to, awards to pay for travel-related expenses to attend Program Standards Self-Assessment and Verification Audit workshops, training courses required in the Standard 2 curriculum, workshops on establishing a Field Training Plan, training courses related to the development and implementation of a foodborne illness risk factor study, and workshops on risk-based inspection methodology.

Projects proposed by the subawardees should target advancement of certain Retail Standards, requirements, or activities. Programs applying for subawards must submit a proposal detailing the use and outcomes of the funds requested and a progress report at the conclusion of the project.

The VNRFRPS were developed by FDA with input from other Federal, State, and local regulatory officials, industry, trade associations, academia, and consumers. The VNRFRPS apply to the operation and management of a retail food regulatory program that is focused on the reduction of risk factors known to contribute to foodborne illness and the promotion of industry action to achieve active managerial control of these risk factors. The Retail Program Standards include nine individual Program Standards. Each Program Standard has one or more corresponding worksheets, forms, and guidance documents.

In developing the Retail Program Standards, FDA recognized that the ultimate goal of all retail food regulatory programs is to reduce the occurrence of foodborne illnesses and deaths and that there are different approaches toward achieving that goal. Federal, state, local, territorial, and tribal agencies continue to employ a variety of mechanisms with differing levels of sophistication in their attempt to ensure food safety at retail. The Retail Program Standards encourage regulatory agencies to improve and build upon existing programs. Further, the Retail Program Standards provide a framework designed to accommodate both traditional and emerging approaches to food safety.

While the Retail Program Standards represent the effective, focused food safety program to which all regulatory programs should ultimately aspire, they begin by providing a foundational system upon which all regulatory programs can build through a continuous improvement process. The Retail Program Standards are intended to reinforce proper sanitation (good retail practices) and operational and environmental prerequisite programs while encouraging regulatory agencies and industry to focus on reducing the factors that contribute to foodborne illness.

The following are the goals of this cooperative agreement:

1. State, local, tribal, and territorial retail food regulatory programs will achieve greater conformance with the VNRFRPS, which promotes uniformity and an integrated national food safety system.

2. Strategies for achieving and sustaining conformance with the Retail Program Standards will be shared and duplicated by other agencies.

3. Retail food regulatory programs will implement innovative intervention strategies to reduce the occurrence of foodborne illness risk factors that can be shared and duplicated by other agencies.

Background

This funding opportunity furthers FDA's efforts to enhance state, local, territorial, and tribal food safety programs. Recent legislative and strategic initiatives have addressed FDA's relationship with state, local, territorial, and tribal authorities in food protection activities.

a. Retail Food Safety Initiative

Announced in October 2010, the Retail Food Safety Initiative is part of the Food and Drug Administration’s overall prevention-based, farm-to-table food safety strategy to reduce foodborne illness. The FDA actions in this initiative are prompted by a 10-year study of more than 800 retail food establishments to determine compliance with five key risk factors in nine types of retail operations.

FDA's partnerships with the retail and foodservice industries; state, local, territorial, and tribal regulatory authorities; and other government agencies are a foundational building block of the initiative and key to its success in four action areas:

• Make the presence of certified food protection managers a common practice.
• Strengthen active managerial controls at the retail level and ensure better compliance.
• Encourage widespread, uniform, and complete adoption of the FDA Food Code.
• Create an enhanced local regulatory environment for retail food operations.

To help create an enhanced local regulatory environment for retail food operations, FDA is committed to:

(1) Promote wider implementation by state, local and tribal regulatory programs of the FDA Voluntary National Retail Food Regulatory Programs Standards.

(2) Ensure universal participation by local regulators in consistent, high quality training through increased access and increased portability and transferability of FDA courses.

(3) Seek increased multi-year funding for the state, local and tribal programs as part of an integrated food safety system.

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

Under FDAAA, FDA is required to work with the states to improve 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.

c. Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. It also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. These include authorities such as mandatory recall, expanded administrative detention, suspension of facility registration, enhanced product tracing abilities, and additional recordkeeping requirements for high-risk foods. FSMA also gives FDA important new tools to hold imported foods to the same standards as domestic foods. FSMA directs FDA to build an integrated national food safety system in partnership with state and local authorities, explicitly recognizing that all food safety agencies need to work together in an integrated way to achieve national public health goals. FSMA identifies some key priorities in working with partners in areas such as: reliance on federal, state, and local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing State and Local food safety and defense capacities.

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	FDA intends to fund one award, corresponding to a total of up to $600,000, for fiscal year 2013. Future year amounts will depend on annual appropriations and performance.
Award Budget	Application budgets are limited to $600,000, but need to reflect the 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.

Nonprofits Other Than Institutions of Higher Education

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

This opportunity is only available to the following nonprofit organizations/associations:

National organization/associations whose membership includes, but is not necessarily limited to, State, local, territorial, and/or tribal retail food safety regulators.

Competition is limited to these national organizations/associations for the following reasons:

1. National organizations/associations with membership that includes, but is not necessarily limited to, State, local, territorial, and/or tribal retail food regulatory jurisdictions will have the relationships and communication systems to effectively promote the funding opportunities being made available under this cooperative agreement. This cooperative agreement is a new method for distributing funds of $25,000 or less to retail food regulatory programs for advancement of the VNRFRPS. Therefore, a strong communications platform to both educate potential applicants and receive feedback will be critical to the success of this project.

2. These national organizations/associations have a vested interest and share FDA’s visions to advance the VNRFRPS and improve public health outcomes. They are also knowledgeable of the VNRFRPS and the requirements to achieve conformance. These national organizations can best collaborate with FDA as the funding management system is developed, such as identifying the criteria for selecting subawardees and monitoring project progress.

3. These national organizations/associations can provide a platform for sharing and national implementation of the projects pursued by the subawardees through national and regional meetings, web site, listervs, and other communications to retail food regulatory programs. Most national associations/organizations also have committees that may further advance the projects pursued by the subawardees.

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 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.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

FDA will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the HHS Grants Policy Statement), except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

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 activity
• 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 no later than June 26, 2013:

Cathy Hosman, Project Officer
FDA Office of Regulatory Affairs/Office of Partnerships
Telephone: 781/587-7443
Email: [email protected]

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

• For this specific FOA, the Research Strategy section is limited to 30 pages.

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, with the following additional instructions: None

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: None

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: None

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, with the following additional instructions: None

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: None

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: None

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: None

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

Specific Aims: None

Research Strategy: None

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 modifications:

• 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 due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, 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 due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

Allowable costs include:

1. Subawards/contracts to third parties: A minimum of 75% of the cooperative agreement funds must be subawarded to State, local, territorial, or tribal regulatory agencies with primary responsibility for retail food establishments in their jurisdictions, or to agencies with substantial control and responsibility over such agencies. Substantial control and responsibility includes conducting standardization and training, promulgating regulations, providing significant funding, and/or directing the activities of agencies with primary responsibility for regulating retail establishments.

2. Audiovisual materials.

3. Employee salaries, wages, and fringe benefits.

4. Rental, purchasing, and maintenance of supplies and equipment.

5. Indirect costs based on a signed, current federal indirect cost rate agreement.

6. Recruit costs for hiring new employees.

7. Registration fees.

8. Purchase or development of IT equipment, software, and support.

9. Shipping and mailing of equipment and supplies.

10. Travel.

11. Speaker fees.

12. Training programs.

Non-allowable costs:

1. Facilities, work, training, and other expenses reimbursed under other cooperative agreements, grants, contracts, and other funding mechanisms must remain distinct and separate from this cooperative agreement.

2. Vehicle purchases are not permitted.

3. Cooperative agreement may not be utilized for new building construction or remodeling of existing facilities.

Please also refer to the HHS Grants Policy Statement for additional information regarding costs.

Funding plan:

Funding for years two through three will be noncompetitive continuation of support and depend on grantee performance, program progress, and 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. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Office of Acquisitions and Grant Services (OAGS) and Office of Regulatory Affairs (ORA). Applications that are incomplete will not be reviewed.

The applicant must specifically address the ability to achieve the following objectives in the cooperative agreement:

1. Demonstrate the ability to develop and implement a comprehensive strategic plan that includes goals and project milestones that will result in the development, implementation, and management of a program to administer and award funds to retail food safety regulatory programs. The funds awarded will result in the advancement and improvement of the Retail Program Standards.

2. Demonstrate the ability to engage and collaborate with retail food safety regulatory programs, FDA, and other stakeholders to meet the goals and objectives of this cooperative agreement and proposed project.

3. Demonstrate the availability of adequately trained staff and the criteria and ability to hire and/or train personnel to meet the deliverables of the cooperative agreement. If needed, provide justification for hiring new staff, including qualifications, training needs, and new equipment needs

4. Provide a properly detailed budget (one for each of the three years) that is intended to promote, award, and administer funds for the advancement of the Retail Program Standards

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

6. Outline a detailed methodology for program assessment, improvement, and collaboration to accomplish the work, as described in this announcement.

7. Demonstrate the ability to provide administrative oversight for funds awarded to retail food safety programs (subawardees) through this cooperative agreement, including distribution of funds, monitoring project deliverables and expenditures, and implementing corrective actions when necessary.

Applicants are required to follow the instructions for post-submission materials, as described in HHS Grants Policy Statement.

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.

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

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 are evaluated for scientific and technical merit through the FDA peer review system.

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

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

1. The proposed system, strategies, and approach to meet the intended outcome of the cooperative agreement are well-reasoned, appropriate, and complete. (Total Weight = 40%)

2. Demonstration of effectiveness in working with federal, state, local, territorial, and/or tribal regulatory jurisdictions on food safety issues that positions the applicant to successfully implement the intended outcome of the cooperative agreement. (Total Weight = 20%)

3. Demonstration that the PI/PD, collaborators, and other key personnel are well-suited to the project with the appropriate experience and training. (Total Weight = 20%)

4. Demonstration of adequate program infrastructure and resources to accomplish the intended outcome of the cooperative agreement, including providing adequate administration and oversight to subawards issued. (Total Weight = 20%)

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

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), in accordance with HHS 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.

The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD/PI will receive a 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 on the Award Conditions and Information for HHS Grants website.

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

Cooperative Agreement Terms and Conditions of Award

The intended outcome of this FOA is the development, implementation, and management of a funding system in which State, local, tribal, and territorial retail food regulatory programs can apply and be subawarded funds for completion of projects and training to enhance conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS or Retail Program Standards). A minimum of 75% of the cooperative agreement funds awarded must be subawarded to State, local, territorial, and tribal regulatory jurisdictions for enhancing conformance with the Retail Program Standards.

Support will be in the form of a cooperative agreement. Substantial 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 and subawards funded by the cooperative agreement.

The program project officer, grants management officer, technical advisor, FDA Regional Retail Food Specialists, FDA National Retail Food Team Steering Committee, FDA State Cooperative Program Directors, FDA/Office of Partnerships Retail Food Program Specialist, and/or representatives from other components within FDA will monitor the recipient and subawardees. 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 or subawardees may also occur. There may be other regular meetings with the recipient and subawardees to assist in fulfilling the requirements of the cooperative agreement.

In addition, work proposed and conducted under this cooperative agreement, including subawards issued, may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed and conducted under this cooperative agreement 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the HHS Grants Policy Statement.

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-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 funding requests received and subawards issued with the following information, at a minimum: name and contact information of agency, summary project proposed, funds requested, funding decision, and progress of the projects/subawardees selected for funded.

5. Identify any pending issues or concerns that may affect accomplishing the objectives and goals of the cooperative agreement, including any subawards made. 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 a minimum of 75% of funds are being subawarded to State, local, territorial, or tribal agencies with primary regulatory responsibility for retail establishments in their jurisdiction, or to agencies with substantial control and responsibility for such agencies.

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.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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 Telephone: 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]

Cathy Hosman, Project Officer
FDA Office of Regulatory Affairs/Office of Partnerships
Telephone: 781/587-7443
Email: [email protected]

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

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

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

Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.