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
Funding Opportunity Title	Food Protection Task Force Improvement Project (R18)
Activity Code	R18 Research Demonstration and Disseminations Projects
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. June 19, 2013 - See Notice NOT-FD-13-016. Notice to Terminate this Funding Opportunity Announcement.
Funding Opportunity Announcement (FOA) Number	RFA-FD-13-028
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	This Funding Opportunity Announcement (FOA), issued by the Food and Drug Administration, is intended to improve the national food protection system by facilitating the development and implementation of food protection projects within existing Food Protection Task Forces. It is intended that these projects will have national significance and be able to be adopted and utilized by other federal, state, local and Tribal organizations in their food protection efforts.

Posted Date	March 29, 2013
Open Date (Earliest Submission Date)	May 1, 2013
Letter of Intent Due Date(s)	May 15, 2013. See section IV.2 for additional information.
Application Due Date(s)	(New Date June 18, 2013 per NOT-FD-13-016), Originally July 1, 2013 by 11:59 PM Eastern Time. Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) before 11:59 p.m. Eastern Time on the application due date. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	July 2013
Advisory Council Review	Not Applicable
Earliest Start Date	September 2013
Expiration Date	(Now Expired June 19, 2013 per NOT-FD-13-016), Originally July 2, 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 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.

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

Background

a. Food and Drug Administration (FDA) Food Protection Plan

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

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

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

b. President’s Food Safety Working Group

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

c. National Integrated Food Safety System

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

d. Food Safety Modernization Act

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

e. Bioterrorism Act

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

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. Full text: http://www.fda.gov/RegulatoryInformation/Legislation/ucm155769.htm.

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

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

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

g. Import Safety Action Plan

The Import Safety Action Plan acknowledges the value of mutual leveraging of State and Federal resources and recommends consideration of cooperative agreements to increase information sharing.

Specifically, the ISAP contains Recommendation 12 to maximize federal-state collaboration for federal-state rapid response (http://archive.hhs.gov/importsafety/report/actionplan.pdf; pages 37-38).

Program Objectives
The Food and Drug Administration (FDA) Office of Partnerships plays a significant role in helping to ensure that States are organized, prepared, and communicating with the Agency and one another. The Task Forces, which are uniquely positioned within States as a convener of stakeholders in food safety, can and should be an important element within the greater national food protection framework. This cooperation has resulted in greater awareness of potential vulnerabilities, the creation of more effective prevention programs, new surveillance systems and the ability to respond more quickly to outbreaks of foodborne illness. However, changes in consumer dietary patterns, industry practices, and the U.S. population, combined with an increasingly globalized food supply chain and the emergence of new pathogens and other contaminants pose challenges that require us to continually update our current food protection strategies. As such, groups like the Food Protection Task Forces will continue to be an important component in the national efforts to promote and protect the public health.

This Funding Opportunity Announcement (FOA), issued by the Food and Drug Administration is intended to improve the national food protection system by facilitating the development and implementation of food protection projects within existing Food Safety Task Forces. It is intended that these projects will have national significance and be able to be adopted and utilized by other organizations in their food protection efforts.

The goals of this program are to address and improve the food protection system through State and local activities relating to the following areas:

(1) capacity and resource needs; (2) outbreak coordination and investigations; (3) information sharing and data collection; (4) uniform regulatory standards; (5) communications and education; (6) State/local laboratory operations and coordination; (7) adoption and implementation of the FDA Food Code and other food protection regulations; (8) uniform standards for foodborne illness and outbreak reporting investigation and response; (9) State and local training needs; and (10) food defense activities and coordination.

Applicants may pursue a variety of food protection improvement projects under this grant in order to protect the public health. Collaborations are encouraged with relevant entities such as FDA Rapid Response Teams (RRTs), the CDC Foodborne Diseases Centers for Outbreak Response Enhancement (FoodCORE) Sites, CDC Integrated Food Safety Centers of Excellence, FDA Coordinated Outbreak Response and Evaluation (CORE) Network, FoodNet, Environmental Health Specialists Network (EHS-Net), other Food Protection Task Forces, Partnership for Food Protection (PFP) workgroups, Food Safety Preventive Controls Alliance (FSPCA), Produce Safety Alliance, Sprout Safety Alliance and/or the Council for Improved Foodborne Outbreak Response (CIFOR).

Applicants should focus on no more than two project areas under this grant. Potential projects may include (but are not limited to) the following activities related to the three core elements of food protection (Prevention, Intervention and Response):

• Outreach to stakeholders including industry to promote increased responsibility in protecting the food supply. Examples include developing best business practices relating to food protection and the incorporation of FDA messages related to food defense awareness, ALERT, FIRST, and FSMA educational materials. Activities should be coordinated with existing programs and established Alliances to synergize activities and avoid duplication of efforts.
• Improving the integration of food safety and food defense among public health, food, and agriculture sectors and stakeholders for cohesive food protection integration.
• Establishing best practices for collaboration and alignment of resources among public and private sectors.
• Food Code Adoption/Implementation and Regulatory Measures
• Training/Education to include regulatory partners, internal staff, industry, academia or other stakeholders.
• GAPs/Needs Assessment related to what resources will be needed to assist in recovering from an event based on what is needed at the local, state and regional/national levels.
• Recovery Activities/Reporting best practices recommendations for resumption of operations of a firm following an incident. Reporting structures and needed follow-up activities (as well as roles and responsibilities) after an event has occurred to return to a steady-state as it was prior to an event.
• Communication evaluate communication processes and identify gaps within regulatory agencies and industry, and also coordination of public messages. This may also include utilizing technology (e.g. Task Force websites and social media such as Twitter/Facebook) to improve information sharing among stakeholders.
• Traceability development, piloting/implementation of improved methods for tracing food through the distribution chain efficiently and rapidly to minimize consumer exposure.
• Development/Improvement of electronic data systems related to prevention, intervention and/or response.
• Reporting initiate improved information sharing and reporting mechanisms within States and among/between States and federal agencies.
• Develop processes utilizing existing resources such as the Rapid Response Team (RRT) Manual, which will facilitate the investigation, prevention, and control of foodborne disease outbreaks, e.g., guidelines for responding to multi-jurisdictional outbreaks, and guidelines for sharing results between and among key stakeholders including Federal, State, and local governmental agencies, industry, and consumers.

Projects proposed under this grant may not be duplicated or funded by other grants, cooperative agreements, contracts, or other funding mechanisms. Projects and resources dedicated to the projects must remain distinct and separate from other projects and funding sources.

Projects that are awarded grants are expected to demonstrate measurable increased food safety or food defense program enhancements as a result of the project. These results should be detailed in progress and final reports as described in section VI.3 (reporting).

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 protection 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 should be related to the three core elements of food protection (Prevention, Intervention, and Response) and may include:

1. Prevention. Promoting increased industry responsibility to prevent/mitigate food protection problems. Implementing short or long-term prevention initiatives in high risk commodities or firms. Specific metrics may include an increase in the number of proven prevention initiatives that are published, implemented within the program, by other agencies, and/or by industry; prevention initiatives adopted as regulatory requirements; measurable decline in foodborne illnesses or injury due to implementation of a prevention initiative; and improved efficiency (e.g., cost, time, or resource savings) achieved by regulatory agencies, industry, or consumers through the implementation of a prevention initiative while maintaining an equivalent or greater level of public health protection.

2. Intervention. Improving risk-based inspection, sampling and surveillance at high risk points in the food supply chain. Specific metrics may include an increase in verified compliance with preventative controls being applied to the highest risk areas, or measurable improvements in signals detection which may indicate food contamination.

3. Response. Improving speed and effectiveness in responding to food emergencies using an interagency Food Emergency Response Plan. Improving risk communications to the public, industry and other stakeholders. Specific metrics may include the time required to establish a unified command structure and initiate a response; measuring the median numbers of days and resources required to accomplish the incident objectives; the number of interagency after-action reports written and improvement plans implemented; reducing the time required to issue accurate response-related communications either internally or to the public, industry, or other stakeholders.

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

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
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 commit approximately $125,000 to this grant in FY 2013. Future year amounts will depend on annual appropriations. The number of awards is contingent upon FDA appropriations, and the submission of a sufficient number of meritorious applications. It is anticipated that up to 5 awards will be made, not to exceed $25,000 in total costs per award, per year.
Award Budget	Application budgets are limited to $25,000 per year (Direct + 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 three 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.

Governments

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

This grant program is only available to State, Local, Tribal and Territorial government food protection agencies which have an established multiagency Food Protection Task Force. The Task Force must include representatives from government agencies such as health or agriculture departments with the authority to develop and implement food protection measures within their state. The Food Protection Task Forces foster communication, cooperation, and collaboration within the States among State, local, tribal, and territorial food protection public health, agriculture, and food regulatory agencies. Due to the nature of this program and the fact that it is designed to further develop the activities of the food protection task forces, this FOA is not being extended to other entities. Additionally, only government health, agriculture, and food regulatory agencies have the authority within their respective jurisdictions to implement and enforce food protection requirements.

Individuals selected by State/local/territory/tribal governments may serve as Principal Investigator and may work with their Institution to apply for support under this FOA.

Only one grant under this FOA will be awarded per State. States are urged to collaborate between agencies to submit a single application.

Organizations seeking to organize and hold Food Protection Task Force meetings may apply for the Food Protection Task Force Conference Grant FOA under PAR-FD-13-007.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The HHS 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.
• 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.

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

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

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

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Projects proposed under this grant may not be duplicated or funded by other grants, cooperative agreements, contracts, or other funding mechanisms. Projects and resources dedicated to the projects must remain distinct and separate from other projects and funding sources.

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 Agency staff to estimate the potential review workload and plan the review.

By May 15, 2013, prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity

The letter of intent should be sent by email to: william.foust@fda.hhs.gov with a cc to Jennerfer.Torres-Hernandez@fda.hhs.gov

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

• For this specific FOA, the Research Strategy section is limited to 10 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:

Applications must include the following information in the Research Strategy attachment not to exceed 10 pages in length:

Brief background and summary of current/recent activities of the Food Protection Task Force.

A detailed, sound rationale and appropriate grant design to address the objectives of the FOA.

The project MUST be generic enough in nature to be used by other State, Local, Tribal and Territorial (SLTT) food protection organizations.

A detailed explanation of the desired goals and outcomes of the project.

A full description of the project design, a detailed implementation plan, methods of execution, and a timeline for completion.

A description of the sustainability of the tool or resource that will be developed through this FOA.

A detailed description of measures of effectiveness and a description of the source documents or data collection methods for establishing the baseline for measurement.

The adequacy of facilities, equipment, electronic systems, support services and the expertise of project staff needed for the project.

Applicants should also consider the application scoring criteria (Significance, Investigator(s), Innovation, Approach and Environment) in Section V. when completing the Research Strategy attachment.

Do not complete Sections 2-4 and the Human Subjects Sections (6-10) of the PHS 398 Research Plan.

Funding for routine Food Protection Task Force meetings are provided under a separate announcement, PAR-FD-13-007 and should not be included as part of projects proposed under this funding announcement. If a meeting is included as part of the project proposed under this announcement please include the meeting objectives and logistical arrangements. Describe the proposed date(s) and format and list the agenda and speakers, including the principal topics to be covered, problems to be addressed, and developments or contributions the conference/meeting might stimulate. Provide a detailed justification for the conference/meeting, including the public health need, timeliness, and usefulness of the conference/meeting to the food protection community. Describe the composition and role of the organizing committee, and provide the names and credentials of key participants in the meeting.

Describe plans for the appropriate involvement of women, minorities, and persons with disabilities in the planning of, implementation of, and participation in, the proposed project.

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:

• 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, FDA’s electronic system for grants administration. HHS 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

1. Salaries

2. Accounting services

3. Supplies, rental of equipment and facilities for meetings related to the project described in the application.

4. Training/education related to the project

5. Travel and per diem to attend training and meetings related to the project described in the application. Travel costs for routine Food Protection Task Force meetings/conferences are not allowed.

6. Printing, shipping, and mailing

7. Pass through of funds to eligible State, Local, Tribal and Territorial 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 these organizations.

8. Subcontracting to a third party (other than local/county/tribal agencies as described above) is limited to 25% of each year's award.

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

Non-allowable costs:

Include but are not limited to: organization dues; travel or per diem costs for federal employees; travel costs for routine Food Protection Task Force meetings/conferences; purchase of equipment; transportation costs exceeding U.S. carrier coach class fares; visas; passports; entertainment; tips; bar charges; personal telephone calls; laundry charges; dues; honoraria or other payments for the purpose of conferring distinction or communicating respect, esteem or admiration; patient care; and alterations or renovations. Please also refer to the HHS Grants Policy Statement for additional information regarding costs.

Funds may not be used to offset or to conduct regulatory food inspections for food safety regulatory agencies.

A decrease in the funding amount of the non-competitive segment may occur if there is an unobligated balance from the prior year, in which case prior year funds can be used as an offset for the current year award.

Continued funding of a noncompetitive segment is contingent upon satisfactory progress as determined by FDA procedures, the receipt of a non-competing continuation application, submission of a satisfactory annual report, and the availability of Federal funds.

Prior to submission of an application, the State shall designate one State public health or food safety agency to submit the application, lead and coordinate the project activities.

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 Managment. 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) 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 William.Foust@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 provide assurance that plans have been developed to engage in the types of activities outlined in the grant application using these grant funds, an itemization of how grant funds will be expended, a description of how grant activities will be monitored, and ability to report information required by the Secretary to conduct evaluations.

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

Acceptable post submission materials include:

Revised budget pages

Biographical sketches

Letters of support or collaboration resulting from a change in senior/key personnel due to the hiring, replacement, or loss of an investigator.

News of an article accepted for publication (a copy of the article should not be sent).

Only the review criteria described below will be considered in the review process. All applications submitted to the FDA in support of the Agency’s mission are evaluated for scientific and technical merit through the FDA objective 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.

Significance

Is the purpose of the work plan and its relevance to FDA and food protection clear? Is the work plan timely in terms of currency of the issues to be addressed and the amount of interest that may be generated in response? (Total weight=20%)

Investigator(s)

Is (are) the PD/PI(s) well suited for organizing and fulfilling the goals of this project? Are the qualifications and past performance of the PD/PI(s) appropriate, and are they well suited for their described roles? Are the key personnel appropriate and well suited for their described roles? Does the experience, training, or other indication of competence support the selection of the principal investigator/director as the key person to manage this particular project? Does the proposed team bring complementary and integrated expertise to the project? (Total weight=20%)

Innovation

Does the application present sufficient information to demonstrate that such work develops or employs novel concepts, approaches, methodologies, tools, or technologies for food protection strategies within the respective state? Are the innovative ideas realistic and attainable? (Total weight=20%)

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Are the objectives of the project and methods to evaluate progress/outcomes clearly described? (Total weight=20%)

Environment

Will the environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements? (Total weight=20%)

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

Budget and Period of Support

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

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

As part of the scientific objective review, all applications:

• Will receive a written critique.

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

Applications will compete for available funds. Following initial objective 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:

• 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 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.

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.

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

All project materials (promotional/educational materials, agendas, publications and internet sites) related to this project must include an acknowledgement of FDA grant support and a disclaimer stating the following: Funding for this project was made possible [in part] by [insert grant number] from [insert FDA name]. The views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.

Please see information below under the reporting section regarding publishing your project results to the State’s Food Protection Task Force website.

An agency Program Official or Center Program Director/Project Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA.

Awardees have primary authorities and responsibilities to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of the project.

Program monitoring of recipients will be conducted on an ongoing basis and written mid-year and annual reports will be reviewed and evaluated by the project officer. Project monitoring may also be in the form of email and telephone conversations between the project officer/grants management specialist and the project director/principal investigator.

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

• Detailed progress report on the project activities including the status of achieving the objectives identified in the application. Goals and objectives should be broken out and reported against. Also include project related meeting details such as agendas and minutes.
• Status report on the hiring and training of any personnel.
• Summary of improvements (identify and quantify) in the overall food protection program or system resulting from the grant.
• Identify any pending issues or concerns that may affect accomplishing the objectives and goals of the grant. If the objectives and goals of the grant 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.
• Detailed program budget listing expenditures and remaining funds.

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. Reports must be submitted two months prior to the next budget period start date.

A final Progress Report detailing the project activities/outcomes and a final Federal Financial Report (SF-425) are required within 90 days of the expiration date of the project period as noted on the Notice of Grant Award, or when an award is relinquished, when a recipient changes institutions or when an award is terminated.

Grantees are expected to publish their project results and tools developed under this grant to their Food Protection Task Force website and include a hyperlink in their final report to FDA. Information should be available to other food protection organizations to adopt and utilize for their own use. These websites are available to all Food Protection Task Forces at no charge through FDA’s Office of Partnerships. Please contact Travis.Goodman@fda.hhs.gov for more information regarding websites.

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 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.

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 301-710-0267
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

William J. Foust
FDA/ORA/Office of Partnerships
12420 Parklawn Drive, Room 3017
Rockville, MD 20857
Telephone: 301-796-3470
E-mail: william.foust@fda.hhs.gov

Jennerfer Torres-Hernandez
Office of Acquisitions and Grants Services (OAGS)
5630 Fishers Lane
Rockville, MD 20857
Telephone: 301-827-9607
Email: jennerfer.torres-hernandez@fda.hhs.gov

William J. Foust
FDA/ORA/Office of Partnerships
12420 Parklawn Drive, Room 3017
Rockville, MD 20857
Telephone: 301-796-3470
E-mail: william.foust@fda.hhs.gov

Jennerfer Torres-Hernandez
Office of Acquisitions and Grants Services (OAGS)
5630 Fishers Lane
Rockville, MD 20857
Telephone: 301-827-9607
Email: jennerfer.torres-hernandez@fda.hhs.gov

Recently issued trans-FDA 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.

Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241), Section 1009 of the FD&C Act (21 USC 399), under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92, and section 312 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) (Public Law 107-188) (42 USC 247b-20).

All awards are subject to the terms and conditions, cost principles, and other considerations described in the DHHS Grants Policy Statement. The DHHS Grants Policy Statement can be found at http://www.hhs.gov/grantsnet/adminis/gpd/index.htm.