Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.

Components of Participating Organizations

Office of Regulatory Affairs (ORA)
Center for Food Safety and Applied Nutrition (CFSAN)

Funding Opportunity Title

Limited Competition: Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices
  • June 22, 2012 - Notice of Correction to Funds Available, Anticipated Number of Awards and Award Budget for RFA-FD-12-011. See Notice NOT-FD-12-018.
Funding Opportunity Announcement (FOA) Number

RFA-FD-12-011

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

The intended outcome of this FOA is to advance efforts for a nationally integrated food safety system by assisting retail food regulatory programs in achieving conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS or Retail Program Standards).  The Retail Program Standards apply to the operation and management of a retail food regulatory program that is focused on the reduction of risk factors known to cause or contribute to foodborne illness and to the promotion of active managerial control of these risk factors.  These cooperative agreements are intended to assist regulatory food retail programs in developing, implementing, and improving the infrastructure necessary to support conformance with the VNRFRPS. 

Key Dates
Posted Date

June 4, 2012

Open Date (Earliest Submission Date)

June 1, 2012

Letter of Intent Due Date

June 15, 2012

July 16, 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

Standard dates apply

Earliest Start Date(s)

September 1, 2012

Expiration Date

July 17, 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

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR) and the Center for Food Safety and Applied Nutrition (CFSAN), is announcing the availability of cooperative agreements to be awarded under Limited Competition to State, local, territorial, or tribal retail food regulatory programs.  The intended outcome of this FOA is to advance efforts for a nationally integrated food safety system through the conformance with and advancement of the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS or Retail Program Standards).  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 or eliminate the occurrence of illnesses and deaths from food produced at the retail level and that there are different approaches toward achieving that goal.  Federal, state, local, 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 we ultimately aspire, they begin by providing a foundation and 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 the factors that cause and contribute to foodborne illness, with the ultimate goal of reducing the occurrence of those factors.

When first enrolling in the Retail Program Standards, regulatory retail programs are encouraged to conduct a comprehensive self-assessment to identify program needs and then establish priorities to maximize the effectiveness of resources.  Post-assessment, cooperative agreement funds should be used to enhance or establish systems to:

a. Identify program areas where an agency can have the greatest impact on retail food safety.

b. Promote wider application of effective risk-factor intervention strategies.

c. Promote wider application of active managerial control strategies by industry targeted to the risk factors associated with foodborne illness.

c. Assist in identifying program areas most in need of additional attention and strategies to address identified areas.

d. Develop and implement innovations in program implementation and administration.

e. Improve industry and consumer confidence in food protection programs by enhancing uniformity within and between regulatory agencies.

These cooperative agreements are intended to develop, implement, and continuously improve the infrastructure and effectiveness of retail food programs using the FDA VNRFRPS.  Under the cooperative agreement, the state, local, territorial, or tribal jurisdiction would implement a continuous program improvement/enhancement strategy (strategic plan) using the FDA VNRFRPS.  The strategic plan may include implementing  individual standards that have not yet been met, pursuing enhancements to implemented standards, or developing innovative intervention strategies designed to reduce the occurrence of contributing risk factors associated with foodborne illness.  The strategic plan should identify the timeframes, personnel and other resources required for implementation.  Funds may be used to increase personnel to support the FDA VNRFRPS Cooperative Agreement (such as team coordinators, technical experts, and epidemiologists).  Funds may also be used for supplies, training, and equipment, including investigational, GPS interface, communication, and laboratory. 

The goal of developing and sustaining the FDA VNRFRPS is in concert with long-term goals to: enhance the food inspection, food safety and foodborne illness response programs; increase the programs' ability to inspect and obtain compliance in their jurisdiction involved in retail food regulation; and verify compliance with state, local and tribal laws and regulations, food defense, and other food protection requirements in support of the state, local, territorial, and tribal program and the FDA Food Safety Initiative.  Extensive cooperation and coordination with FDA Regional Offices and other FDA program offices is expected.

The outcomes of the work provided under this cooperative agreement are as follows:

1.  Retail food regulatory programs will achieve greater conformance with the Retail Program Standards, which promotes uniformity and an integrated national food safety system.

2.  Retail food regulatory programs will contribute to the continuous improvement and advancement of the Retail Program Standards.   

3.  Develop strategies for achieving and sustaining conformance with the Retail Program Standards that can be shared and duplicated by other agencies. 

4.  Provide the retail food regulatory program the ability to implement innovative intervention strategies designed to reduce the occurrence of contributing risk factors associated with foodborne illness that can be shared and duplicated by other agencies. 

Only state, local, territorial, and tribal agencies with primary regulatory responsibility for retail food establishments, or those government agencies with substantial involvement and control over such agencies, are eligible to apply.   In addition, the retail food regulatory agency must be enrolled in the VNRFRPS and have completed a current self-assessment against the Retail Program Standards as required by Standard 9.

A technical review session will be held for prospective recipients in June 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.

The agreements include one year of funding with up to four years of additional funding, to be awarded non-competitively dependant on performance and availability of funds.  The agreements will require the development and maintenance of Retail Program Standard initiatives through processes to enhance and build the existing infrastructures of retail food protection programs.

Finally, these cooperative agreement funds are intended to supplement, not replace, current funding for program improvement and activities.  Agencies funded under these cooperative agreements will be required to provide the previous and subsequent years of state, local, territorial, or tribal funding to demonstrate that these funds have not replaced previous allocations.

2. 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. 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 food industry; state, local and tribal 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 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.

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 number of awards is contingent upon FDA appropriations, and the submission of a sufficient number of meritorious applications.

FDA intends to fund up to an estimated 25-30 awards, corresponding to a total of up to $1,700,000, for fiscal year 2012. Future year amounts will depend on annual appropriations and performance.

Award Budget

Application budgets are limited to up to $60,000 (direct and indirect costs) but need to reflect actual needs of the proposed project.

Award Project Period

The total project period for an application requesting support may not exceed five years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Governments

This opportunity is only available to the following government agencies:

The agency must have primary regulatory responsibility for retail food establishments within their jurisdiction, or the agency must have substantial control and responsibility for those agencies with primary regulatory responsibility for retail food establishments.  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. 

Competition is limited to these retail food regulatory agencies since the intent of the VNRFRPS is to promote greater uniformity of agencies that regulate the retail food industry using regulations modeled after the FDA Food Code.

Competition is further limited to retail food regulatory agencies that are enrolled in the VNRFRPS and have completed a current self-assessment against the Retail Program Standards as required by Standard 9.  The self-assessment allows the agency to identify program needs and then establish priorities to maximize the effectiveness of resources, including the funds received under this cooperative agreement. 

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

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

Applicant organizations may submit only one application.

 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 emailed to:

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

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 must be followed, with the following exceptions or additional requirement:

PHS 398 Research Plan Component

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

Resource Sharing Plan

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

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, HHS’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 HHS 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.

These awards may only be used for achieving and sustaining conformance with the Retail Program Standards within retail food regulatory programs.   

Allowable costs include:

1) Audiovisual materials such as videotapes, DVDs, public service announcements, etc.

2) Consultant services

3) Employee salaries, wages and fringe benefits

4) Rental, purchasing, calibration, and maintenance of supplies and equipment, including investigational, GPS interface, communication, and laboratory

5) Indirect costs

6) Recruitment 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) Conducting standardizations

13) Training programs, including the development, delivery, and attendance

14) Subcontracting to third parties (other than local/county/tribal agencies) is allowed but limited to 25% of each year's award.  No limit exists for subcontracting to local/county/tribal agencies. 

Non-allowable costs:

1) Facilities, work, and training 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 funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.

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

Funding Plan:

Funding for years 2 through 5 will be noncompetitive continuation of support and 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 HHS.

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 FDA, Office of Acquisition and Grants (OAGS). Applications will also be evaluated for completeness and responsiveness by the FDA, Office of Regulatory Affairs (ORA) and Center for Food Safety and Applied Nutrition (CFSAN).  Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the FDA 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 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 significantly advance conformance with the Retail Program Standards (either within an individual regulatory program or across multiple regulatory programs).  

2.  Demonstrate the ability to fully participate in efforts supporting the Retail Program Standards and the FDA's Retail Food Safety Initiative, such as participating on committees, sharing of best practices, and engaging the retail food industry to promote effective management of foodborne illness risk factors and improve compliance with regulations modeled after the FDA Food Code.    

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. 

4. Provide a properly detailed budget (one for each of the five years) that is intended to advance conformance with the Retail Program Standards (either within an individual regulatory program or across multiple regulatory programs).

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

6. Provide the previous year and current funding level certification for the retail food regulatory program.

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

8. Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs.

Post Submission Materials

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.

Section V. Application Review Information

1. Criteria

All applications submitted to the FDA are evaluated for scientific and technical merit through the FDA peer review system.

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

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

2. Have adequate program resources (especially staff) and infrastructure to complete project needs, or the ability to obtain adequate program resources (weight = 20%);

3. Demonstration that capabilities that can be sustained after the conclusion of the project period.  Expected challenges should be documented and addressed (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 scores will not be given 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 following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria above in the determination of scientific merit, and give a separate score for each.

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 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.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA.  The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be provided a Summary Statement (written critique) via the OAGS Grants Management Specialist.

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 HHS Grants website.

2. Administrative and National Policy Requirements

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

Cooperative Agreement Terms and Conditions of Award

Cooperative Agreement Terms and Conditions of Award.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

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

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.

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, 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 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. 

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

1.  Detailed progress report on the grantee meeting the project milestones identified in the proposal.    

2.  Status report on the hiring and training of food program personnel.

3.  Certification of current appropriation funding levels for the retail food regulatory program.

4.  A strategic plan that accurately reflects when specific objectives and tasks have been, or will be, completed and/or implemented and when new objectives and tasks are identified to advance conformance with the Retail Program Standards.  The strategic plan should include timeframes, responsible personnel, and other required resources. 

5.  Description of program improvements in achieving conformance with the Retail Program Standards and promoting more effective control of foodborne illness risk factors in. 

The final program progress report must provide full written documentation of the entire 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 agencies could reproduce the final project.  The final program progress report should also detail the strategy to continue advancing conformance with the Retail Program Standards (current and future versions). 

Monitoring Activities

The ORA Project Officer and Technical Advisor will monitor award recipients periodically. The monitoring may be in the form of face-to-face meetings, 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 will occur, including program assessments and audits.  The results of these monitoring activities will be recorded in the official cooperative agreement file and will be made 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 and Technical Advisor.

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; and (3) 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.

Wendy Campbell
Project Officer
Food & Drug Administration, Office of Regulatory Affairs
Phone:  615-310-0483
Email:  Wendy.Campbell@fda.hhs.gov

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   

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)

Linda Collins, R.S.
Retail Food Program Specialist
Food and Drug Administration
4040 N. Central Expy, Suite 900
Dallas, TX 75204
(214) 253-4945
Linda.Collins@fda.hhs.gov

Peer Review Contact(s)

Not Applicable.

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 Grants Policy Statement.

Authority and Regulations

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.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


Office of Extramural Research (OER) - Home Page Office of Extramural
Research (OER)
  National Institutes of Health (NIH) - Home Page National Institutes of Health (NIH)
9000 Rockville Pike
Bethesda, Maryland 20892
  Department of Health and Human Services (HHS) - Home Page Department of Health
and Human Services (HHS)
  USA.gov - Government Made Easy
NIH . . . Turning Discovery Into Health

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