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 (OP), in collaboration with the Office of Foods and Veterinary Medicine (OFVM), is announcing the availability of up to 3 cooperative agreements to be awarded under a Limited Competition. Only States with current FDA food safety inspection contracts (providing funding to State agency food protection regulatory programs) and are enrolled in the Manufactured Food Regulatory Program Standards (MFRPS) will be eligible to apply. The FDA only guarantees one year of funding with the possibility of up to one year of additional, non-competitive support, contingent on performance and continued availability of federal funds.

The goal of these cooperative agreements is to facilitate long-term improvements to the national integrated food safety system by unifying and coordinating federal/state/local food/feed emergency response efforts including:

1) Strengthening the link among epidemiology, lab and environmental health/regulatory components;

2) Improving States' regulatory and surveillance food/feed protection programs to include using Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to conduct integrated responses to all-hazards food/feed emergencies, rapidly identifying and removing tainted food from commerce, and conducting root cause investigations to inform future prevention efforts; and

3) Addressing supporting components, such as training, data sharing, data analysis, communications, continuous process improvement, and development of best practices and other resources to support national capacity/capability development.

This will be accomplished through the provision of funding to support development of multi-jurisdictional, multi-disciplinary Rapid Response Teams (RRTs) and will require extensive cooperation and coordination with FDA District Offices and other FDA program offices.

Effective leveraging of resources and harmonization of efforts shall require collaboration with relevant initiatives, including those of federal partners (e.g., FDA, the Centers for Disease Control and Prevention (CDC) and the US Department of Agriculture (USDA) Food Safety and Inspection Service), national initiatives (e.g., the FDA Food Safety Modernization Act, the Integrated Food Safety System (IFSS), the National Response Framework, and the Partnership for Food Protection (PFP)), and relevant associations, state, and local partners.

Developing a RRT under these cooperative agreements requires achievement of the following six elements over the course of the project period (see table below). It is expected that RRT development will take 3 years to complete, following the RRT Capacity Building Process and Mentorship Framework (note that this funding opportunity announcement is for a maximum of 2 years' funding). To request a copy of the RRT Capacity Building Process and Mentorship Framework, email [email protected].

Element	Description
RRT Development	Development of an RRT includes identification and development of a collaborative approach (see element 2: Collaboration, below) and RRT structure for training, response, report generation, etc. The approach and structure must support the implementation of RRT best practices over multiple years and demonstrate increasingly effective responses to food emergencies. The specific structures, plans, and their implementation may vary from RRT to RRT, but each should include common core elements as identified in the RRT Best Practices Manual and definable capabilities and measures that can be shared for replication by others. Building a RRT will draw on best practices from the initial RRT development efforts identified by the 18 existing RRTs. New RRTs will also contribute to existing documented RRT best practices (i.e., the RRT Best Practices Manual) to further develop the national framework for rapid response for food or feed emergencies. RRTs will also be encouraged to contribute to training non-RRT states, expected to use existing commodity specific investigation tools and contribute to development of additional commodity-specific investigation tools.
RRT Collaboration	Collaboration for the RRT concept must involve working closely with FDA District Offices and other relevant partners in the RRT project such as federal, state, and local agencies; epidemiology and laboratory counterparts; and other RRTs. These groups would be engaged significantly to accomplish project requirements and develop effective models for responding to food and feed incidents. RRTs must demonstrate improvement on achievement levels in areas such as "Working With Other Agencies," described in the RRT Best Practices Manual. In addition, collaborations should be developed between RRTs and other initiatives, such as the FDA Coordinated Outbreak Response and Evaluation (CORE) Network, FDA Food Protection Task Forces, CDC Foodborne Diseases Centers for Outbreak Response Enhancement (FoodCORE) Sites, CDC FoodNet, and CDC Environmental Health Specialists Network (EHS-Net). RRTs will also be required to participate fully (at least two senior RRT staff) in yearly face to face meetings and in Office of Partnerships (OP) sponsored RRT Program webinars (monthly).
RRT Assessment	Assessment for each RRT will involve continual self-assessment against RRT concepts, elements, and metrics identified in the RRT Prototype and Implementation Projects. OP will inform the Principal Investigators (PIs) of the exact assessment elements for each year. These assessment efforts would result in updates of program improvement plans. In addition, RRTs must contribute to the development of and annually apply metrics for each of the six elements of the RRT project outlined in the program objectives (Section I.A.1-6: RRT development, collaboration, assessment, incorporation, implementation and exercise, and documentation).
RRT Sustainability	Sustainability of the RRT concept requires that each program identify and implement processes to ensure that the core rapid response capabilities developed through these cooperative agreements are fully integrated into the existing system, outside of this funding, and can be sustained beyond the end of these cooperative agreements. All applicants must identify estimated capacities of the rapid response capabilities proposed in the application that can be sustained for 2 years after the conclusion of the project period. This includes general plans for leveraging resources to incorporate the RRT concept (and the staff to maintain it) into existing resources to achieve the level of capacity identified. This Sustainability plan and a timeline must be further developed during the first year; implementation must be on track through any additional years of the project.
RRT Implementation & Exercise	The RRTs funded under these cooperative agreements will conduct responses for both real emergencies and planned exercises to demonstrate and test the RRT capabilities developed. Planned exercises should address the core elements of rapid response as identified in the RRT Best Practices Manual and as indicated by the annual RRT assessment conducted.
Documentation	Documentation for the RRT concept requires that RRTs work with all relevant agencies to capture activities and lessons learned in documents such as the RRT Best Practices Manual throughout the development, assessment, incorporation, and exercise of the RRT concept. This includes providing summary reports and documenting after action reviews conducted following responses to incidents and exercises. This documentation effort also involves working with FDA to identify benchmarks and develop and apply metrics (quantitative measures) for these rapid response capabilities. Such documentation will serve to record and demonstrate accomplishments, provide a tool for other programs to evaluate and adopt similar capabilities, and identify recommendations for incorporation into other national initiatives (e.g., national standards).

The projects funded under these cooperative agreements must be specifically designed by the grantee to help their respective RRT meet the yearly goals as outlined in this FOA.

Additionally, these cooperative agreement funds are intended to supplement, not replace, State funding for food protection program improvement and activities. States funded under these cooperative agreements are required to provide the previous and subsequent years of State funding to demonstrate that these funds have not replaced State allocations for the food protection program.

I.A) Background

The complex challenges in the food safety arena require new, creative responses.  However, no greater challenges exist than in our ability to swiftly investigate and take appropriate measures to control foodborne outbreaks. The scope and complexity of each outbreak varies significantly, and routine good manufacturing practices (GMP) inspection procedures are ineffective in understanding how and why foodborne outbreaks occurred. In some cases, extensive in-plant inspection and environmental investigation including environmental and human or animal sampling from a single facility may be required. In other cases, data/invoices from a web of inter-related firms throughout the State may be needed. Moreover, the inclusion of epidemiologically based environmental investigations is needed. In light of these new, complex challenges in food safety, there is a continued need for an integrated rapid response team concept that facilitates effective, coordinated responses, starting within hours of the verification of a foodborne outbreak or other food protection emergencies.

To address these concerns, this Cooperative Agreement seeks to develop, implement, improve, and integrate rapid response capabilities (both innovative/unique and those considered to be core capabilities) into a resource (the RRT Concept ) that can effectively and rapidly respond to food/feed incidents. This effort integrates with related FDA components and other national programs, such as the FDA Coordinated Outbreak Response and Evaluation Network (CORE), Centers for Disease Control and Prevention (CDC) Integrated Food Safety Centers of Excellence, CDC Foodborne Diseases Centers for Outbreak Response Enhancement (FoodCORE) and Environmental Health Specialists Network (EHS-Net), to collaboratively improve the various, interdependent facets of food incident response. RRTs are also encouraged to use the Guidelines and Toolkit developed by the Council to Improve Foodborne Outbreak Response (CIFOR), which has provided recommendations for program policies in foodborne outbreak response.

I.B) The RRT Concept Framework and Best Practices Manual

The RRT Concept and these cooperative agreements focus on the development and maintenance of rapid response infrastructure and capabilities within the five phases of food/feed incident response: preparedness, surveillance/detection, investigation, control/mitigation, and post-response/prevention. The framework also delineates four core elements (collaboration, communication, written policies and procedures, and resources) that are essential to having an effective capability for each of these phases; and lastly, this framework identifies how continuous improvement and sustainability must be involved throughout the entire system.

The RRT Best Practices Manual is a collection of best practices (e.g., lessons learned, tools) identified by the RRTs that are considered foundational for conducting effective multi-agency responses. Each chapter within the RRT Manual represents a unique rapid response capability that falls within one of the five phases of response, and incorporates each of the four core elements as described above, as well as a series of achievement levels for measuring and assessing continuous improvement of that rapid response capability.

For the purposes of these cooperative agreements, sustainability is considered to be the development of mechanisms to support or maintain a portion of products, outcomes or accomplishments achieved under funding provided by these cooperative agreements. A requirement of these cooperative agreements is that the grantee creates and maintains a sustainability plan (See Section III, Goals). Approaches to sustainability can vary widely, and may include incorporation of RRT processes and procedures into state/local program SOPs or IT systems, transfer of a portion of cooperative agreement supported personnel onto state or local program funds over time to secure a FTE, or cross-training of staff external to those funded by this agreement (to support RRT activities in routine or surge capacity scenarios). Innovative sustainability approaches are encouraged.

The RRT Concept is described in detail within the RRT Manual (available upon request to FDA OP at [email protected]).

I.C) Rapid Response Team Members

1) RRT Members

Although RRT Structure will vary on a case-by-case basis, the following components must be represented on the RRT. It is permissible that projects funded under these cooperative agreements have the aim of furthering incorporation of these components within the RRT.

a) FDA District Office

The nucleus of the RRT is considered the grantee state agency and the corresponding FDA District Office. The FDA District Office will designate one or more persons to be the main point of contact representing the District Office on the RRT, and designate other personnel to participate in RRT activities as appropriate (e.g., joint trainings, joint inspections, joint investigations, etc.).

b) Food Program

This should represent the grantee agency, and is deemed the 'lead' state agency within the RRT. It is a requirement of eligibility for this award for the grantee to be enrolled in the Manufactured Food Regulatory Program Standards. In addition, state regulatory agencies with authority over meat and poultry, shellfish, Grade A milk and retail food establishments should also be included within the RRT.

c) Feed Program

Each Rapid Response Team should include at least one person representing the State’s feed regulatory program. The definition of food in section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) includes human food, animal feed, and ingredients used in each of those classes of products. Many animal feeds contain food processing byproducts, many firms make ingredients for both types of products and, often, salvaged food products are used as animal feed. As a result, it is important that each RRT be able to work with the State feed regulatory program to prevent food emergencies from becoming feed emergencies and vice-versa. Consideration should be given to collaboration with animal health veterinarians and other food animal programs.

d) Epidemiologists

Each Rapid Response Team should ensure inclusion of epidemiological representatives, specifically, an epidemiologist representing the State’s entity with primary responsibility for surveillance and epidemiological investigations of foodborne outbreaks. It is important that there is an intentional and effective partnership between the regulatory/environmental health, surveillance, epidemiology, and laboratory components of the public health system to ensure optimal communication and collaboration during responses to foodborne illness outbreaks.

e) Laboratory

For laboratory support, the RRT shall develop the proper protocols and agreements with both the FDA and/or other federal or State labs for analytical support during foodborne outbreak investigations. The labs would support existing technology for field-based analytical methods like temperature, adenosine triphosphate (ATP) measurements (luminometers), residual chlorine, quaternary ammonium indicators, microscopy, pH, water activity, ORP, and salt content that could be used on-site. Additionally, as approved, real-time technologies could be pilot-tested during actual outbreak investigations.

All lab participants on the response team should be fully trained in team inspections. Lab SMEs (e.g. microbiologists, chemists) shall provide current information on emerging pathogen analytical methodology and servicing lab capability. Lab SMEs shall also keep current information on the best shipping methods to the servicing lab. Purchase of laboratory and investigation sampling equipment (with approval of awarding Agency) and supplies should be considered in the budget for the application. Appropriate development and storage of sampling kits for use in a rapid response should be incorporated.

Uniformity in sample collection is essential to achieve consistent results with multiple serving laboratories. The RRT investigators could use the FDA Investigations Operation Manual (IOM) and compliance program guides or equivalent State procedures to standardize sample size and collection methods. Coordination between the RRT and laboratories is essential to maximize the outcome of foodborne illness response.

f) Local Health Partners

Each RRT should develop a strategy to incorporate key local health department partners in appropriate RRT activities (e.g., situational awareness, coordination for targeted activities, such as recalls, investigations involving the retail point of service, etc.). The move towards a nationally integrated food safety system requires effective integration across all levels of government. As the RRT concept develops, it is important to develop effective models of collaboration in food emergency response to include local partners. It is encouraged that all local health partners involved in the RRT also enroll in the Voluntary National Retail Food Regulatory Program Standards (as well as those state agencies with authority over retail foods).

2) RRT Responsibilities

All members must be familiar with procedures (and any updates to the procedures) associated with the RRT, including but not limited to Joint Investigations/Inspections, Communication Standard Operating Procedures (SOPs), Environmental Assessment Inspections, After Action Reviews, Food Emergency Response Plans, etc.

Other duties/responsibilities of the RRT members could include:

a) Training

Complete detailed training in subjects according to the RRT Training plan (should be aligned with and meet the minimum requirements of the Training Chapter of the RRT Best Practices Manual). Important training areas include: foodborne illness investigations; epi-ready, ICS (100, 200, 300, 305, 400, position specific); sampling techniques; tracebacks; farm investigations; and commodity-specific investigations such as sprouts, eggs, leafy greens, etc. It is important that the RRT delineate in their training plan what training requirements are applicable to which types of RRT members.

RRT members should also provide response-based training for other local, state or federal investigators and industry groups, as appropriate. Additional staff in the food and feed protection programs and in other relevant organizations (e.g., other RRT member agencies, as appropriate) should be trained as a resource to provide surge capacity to the RRT in the event that additional assistance is needed. In particular, a train the trainer approach for response-based activities (such as sampling, recall effectiveness/audit checks, traceback/traceforward, etc.) that reaches the local responder level is highly encouraged.

Unless circumstances mandate otherwise, RRT members (especially state and District investigators) should engage in joint training. This is in accordance with one of the key principles laid out in the Training Chapter of the RRT Best Practices Manual, and helps provide a uniform foundation for rapid response as a team. When true joint training is not possible and separate training courses must be offered in order to reach the full target audience, every effort should be made to coordinate training offerings so as to provide equivalent training content/materials for team members.

All training efforts related to the RRT that promote the training of personnel external to those funded exclusively on this cooperative agreement should be considered to be in support of sustainability of the RRT concept.

Where feasible, RRTs should consider inviting or including other RRTs to participate in training events and/or make available these training materials to other RRTs through FoodSHIELD or other appropriate avenues.

b) Expertise Development:

Each RRT investigator should become an "expert" in at least one core component of rapid response (e.g., commodity-specific agricultural practices, manufacturing processes, water, wildlife, soil amendments, ICS/NIMS, etc). This investigator would then be responsible for training other staff in this area so there is at least one back-up for each area of expertise on the team.

Records related to the RRT expertise development plan and current summary of team member expertise should be included in the RRT Training Plan.

I.D) RRT Functions

This section describes essential or high-interest RRT functions (as per OP), and a base level of accomplishment (as outlined and assessed in the yearly RRT Capability Assessment) is required by all grantees. As such, it is permissible that projects funded under these cooperative agreements have the aim of accomplishing one or more of these RRT functions.

As 'high-interest' RRT functions, the following topics should also be considered as potential areas for special projects under these cooperative agreements by RRTs that wish to further enhance and build their capability to perform these functions.

Although multiple RRT members (including those outside of the grantee agency) might work on and contribute to special projects focused on these topics or other RRT functions, at least one representative from the grantee agency must be routinely involved in the special project or otherwise be part of a regular communication channel. The grantee agency is encouraged to submit budget items in their application that support a state or local RRT member agency outside of their own in accomplishing special projects or carrying out other RRT functions, including prevention efforts.

This listing is not inclusive of all rapid response capabilities.

1) Team Development, Maintenance and Response

This RRT resource within the state should have the appropriate authority, expertise, and training to investigate foodborne illness outbreaks and other food hazards/emergencies (e.g., natural disasters, bioterrorism, intentional contamination, power outages, etc.) from farm to table. Although the RRTs involved in this cooperative agreement all have varied circumstances and needs, each RRT will include relevant partner organizations (including FDA District Offices, other state agencies [i.e. those with epidemiological, laboratory and environmental health/regulatory responsibilities for food and feed]) in the decision-making process and optimize the use of resources while aligning with preparedness plans. When appropriate or necessary, the RRT (representing all component agencies) will use expandable ICS protocols and structures to respond to an outbreak, and mitigate the problem (e.g., remove the contaminated product from commerce). When appropriate, RRTs will work to identify sources of contamination and contributing factors/antecedents for the outbreak, reaching conclusions and identifying possible interventions for the prevention of future incidents whenever possible. The RRT Best Practices Manual will help to support the development and maintenance of rapid response capabilities and is expected to be incorporated into existing state and local programs so that they may remain viable beyond the project period of this cooperative agreement. Additionally, in accordance with the RRT Best Practices Manual CIFOR Chapter, RRTs should incorporate the CIFOR Guidelines and Toolkit into their RRT development/improvement process.

2) Traceback Capabilities

As part of the RRT concept, State and federal partners should continuously improve the effectiveness, standardization, and coordination of their traceback capabilities for investigating foodborne illness outbreaks. Accomplishing improvements in this area could include training of State and local resources in conducting tracebacks; implementing best practices identified by RRTs and other relevant initiatives (e.g., the Council to Improve Foodborne Outbreak Response [CIFOR] Guidelines); and addressing areas of improvement based on after action reviews of responses and exercises. RRTs should continue to identify best practices in tracebacks, including exploration of different approaches and tools (e.g., industry resources, new information technology (IT) options, working with epidemiologists). Routine traceback investigations require skilled, highly trained staff to ensure rapid, accurate collection and analysis of relevant records. Traceback investigations will occasionally be needed to help inform and guide epidemiologic investigations where traditional approaches are unable to pinpoint the specific food responsible for illnesses or outbreaks.

3) Recalls and Market Withdrawals of Food Products/Foodborne Illness Reporting

As part of the RRT concept, State and federal partners continuously improve the effective use of resources to quickly notify consumers and ensure prompt removal of suspect or contaminated products from commerce. This optimizes the ability of the RRT to function within mitigation/control phase of a food/feed incident and plays a critical role in maximizing food protection. Accomplishing improvements in this area (which could be demonstrated by quantifying accomplishments and timeframes for each incident) could include: training of State and local resources; working with industry groups and major retailers/distributors to understand distribution patterns in advance of incidents; and considering use of RRT partners, emergency response resources and other innovative concepts to facilitate the effective removal of product from sale or distribution. The RRT should work with partners at the state, federal and local levels to facilitate better and more rapid communications for national, local, or regional recalls that could be the model for use with other RRTs. Transparency in results and efforts should be a goal in recalls and illness reporting.

4) Environmental Assessment Inspections (EAs)

Important note: the term 'EA inspection' is used consistently throughout this FOA in order to align with FDA's policy that EAs in which FDA is involved be conducted under FDA's inspection authority. FDA fully recognizes and acknowledges that EAs are not necessarily a routine inspection and could require a completely different mindset and process, depending on the context in which they are conducted. The 'inspection' portion of this term refers solely to the need to conduct the EA under the appropriate regulatory authority and should not be interpreted otherwise or used in any other way to qualify, describe or classify an EA.

A purpose of an EA inspection is to identify potential contributing factors and environmental antecedents to foodborne illness outbreaks to provide a regulatory program/agency and industry with information to inform future prevention efforts and compliance/regulatory policies.

In the context of RRT activations or any RRT initiated activities, EA inspections are carried out by Subject Matter Experts (SMEs), which should include representatives from all relevant members (agencies) of the RRT, as appropriate (e.g., the state food regulatory program and the District Office). EA inspections that are conducted under FDA's inspection authority may only include participants who are authorized to conduct inspections under FDA's authority (e.g., FDA employees, commissioned/credentialed individuals, special government employees). Depending on the scenario, representatives from FDA Centers or academic experts may also be included, as appropriate. All agencies and personnel participating in joint EA inspections (particularly joint District-State EA inspections) must coordinate inspection activities in advance. EA inspection activities when any FDA component is involved (including appointing the lead agency for the EA inspection) must be done in accordance with current FDA policy. During a joint EA inspection, SMEs perform EA activities complementary to and in conjunction with each other.

The data and information collected during an EA inspection are more extensive and detailed than what is typically possible to obtain during a routine regulatory inspection and are critical to understand the contributing factors and environmental antecedents that caused a foodborne illness outbreak or food contamination event.

5) Exercises

In the absence of a RRT activation (under ICS/NIMS and Unified Command) involving an after action review and development and subsequent implementation of recommendations during a given grant year, the RRT must complete at least one annual exercise that incorporates the use of ICS and all members of the RRT to promote team building of the RRT and continuous improvement. In either case (activation or exercise), at a minimum, an after action review should be conducted and the following documentation should be maintained and shared with other RRTs as requested by OP:

1.    An incident summary which, at a minimum, defines and describes the size, scope and distribution of the incident.

2.    A list of recommendations and appropriate tracking of subsequent implementation of recommendations

Should a national RRT exercise be held during this funding opportunity's project period, RRTs (at a minimum the funded agency and FDA District Office) shall be required to participate.

6) Communication and Coordination with Industry and Other Stakeholders

The RRT should initiate and maintain contacts with: major food manufacturers, processors, wholesalers, distributors, warehouses, and retail chains; city or county environmental health officers and county public health officers; and academic or private experts in selected areas of interest/need (e.g., surface water, well construction, wildlife, etc), university researchers and extension programs. It is also important to obtain 24-hour emergency phone numbers for contact persons and become familiar with strengths and weaknesses of existing databases for tracebacks and for locating growers, shippers, packers, wholesalers, and retailers. This is in line with concepts outlined in MFRPS Standard #7 - Industry and Community Relations.

These contacts can and should be leveraged for a host of preventive and preparedness activities, as appropriate, to include training and outreach. At a minimum, the maintenance of these contacts will increase the efficiency and effectiveness of the RRT when responding to incidents requiring communication and coordination with these stakeholders.

RRTs are encouraged to leverage State Food Protection Task Forces, where appropriate, to achieve these goals, provided that funding streams are kept separate if the grantee agency is also a recipient of a FDA Food Protection Task Force Grant. Online collaborative and information sharing resources, such as FoodSHIELD or the development of a Task Force Mobile App, can also be a valuable asset in achieving these goals.

For example, the applicant could propose using a State Food Protection Task Force as a mechanism to facilitate new interventions, methods, communication strategies, and other tools to expedite recalls and foodborne illness reporting. See Program Announcement FD 09-005 or PAR-09-123 located at http://www.grants.gov/.

Desired areas of inter-program coordination include with CDC programs such as FoodCORE, EHS Net, FoodNet; the Food Emergency Response Network (FERN), a nationally integrated network of food-testing laboratories that can support emergency responses; and with partners at the US Department of Agriculture (USDA) and the Department of Homeland Security (DHS). In addition, RRTs are encouraged to develop relationships with one or more of the five existing Food Safety Centers of Excellence which were established, per FSMA, to identify new approaches to surveillance and response. These programs have relevant and overlapping goals and activities for food incident response that should be coordinated with RRT activities whenever possible.

Information on some of these initiatives can be located at: http://www.cdc.gov/ncezid/dfwed/orpb/index.html; http://www.cdc.gov/nceh/ehs/default.htm; http://www.cifor.us/; http://www.fernlab.org/

A portion of the infrastructure necessary to develop and sustain rapid response capabilities is established using regulatory program standards, to include the Manufactured Food Regulatory Program Standards (MFRPS), the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) and the Animal Feed Regulatory Program Standards (AFRPS). These Regulatory Program Standards provide the foundation with which to assess and continually improve the infrastructure of a State food regulatory program. Standard 5 within each of the Regulatory Program Standards is focused on response. Although the RRT Concept and the Regulatory Program Standards are separate and distinct, both programs contain elements that complement each other in achieving a common goal (strengthening food/feed regulatory program infrastructure to enhance the ability to respond to food/feed incidents).  The RRT program plays a vital role in establishing innovative best practices that may be incorporated into the regulatory program standards. As such, you will notice references to specific sections of regulatory program standards throughout this FOA.

Each partner state that is awarded funding through the RRT cooperative agreement must be enrolled and actively working towards conformance/implementation of at least the MFRPS. However, it is vital for all grantees to understand that funding streams must be kept separate and non-duplicative if the grantee is a recipient of multiple funding agreements, such as the MFRPS, AFRPS or VNRFRPS Cooperative Agreements.

For more information on the Regulatory Program Standards, please visit the following resources:

1) MFRPS: http://www.fda.gov/ForFederalStateandLocalOfficials/PartnershipsContracts/Overview/default.htm.

2) VNRFRPS: http://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/ProgramStandards/default.htm.

3) AFRPS: http://www.fda.gov/ForFederalStateandLocalOfficials/AnimalFeedRegulatoryProgramStandardsAFRPS/default.htm.

These goals represent yearly requirements for grantees receiving these cooperative agreements. Goals are aligned with the six elements of RRT development (described above in this FOA) and follow the RRT Capacity Building Process and Mentorship Framework. To request a copy of the RRT Capacity Building Process and Mentorship Framework, email [email protected].

Applicants must address how they plan to meet these yearly goals in their application. Grantees shall be required to report out the status of accomplishments for each goal in mid-year and annual reports.

As applicants may request up to two years of funding through this cooperative agreement, one set of goals is provided that shall apply to each grant year. FDA has a strong desire to promote a long-term working relationship in order to provide to each project ample time to fully develop and implement its desired goals and outcomes. The activities proposed by each applicant should demonstrate evolution/growth over the duration of the project period, providing a timeline to fully develop, build, and achieve sustainable outcomes for the applicant's RRT.

Expected Goals:

Year 1

RRT Development/Documentation/Collaboration: 1.A. Hiring and placement of all proposed staff proposed in the application by no later than the end of the year.

RRT Development/Documentation/Collaboration: 1.B. Follow the RRT Capacity Building Process and Mentorship Framework. Specifically:

• Demonstrate that all major elements of Phase 1 of the RRT Capacity Building Process and Mentorship Framework have been completed and begin work on Phase 2. In particular (regarding RRT structure/collaboration), the RRT must demonstrate that there is a representative from the state epidemiologist s office/program participating and rapidly/proactively sharing foodborne illness outbreak data with the RRT in order to facilitate tracebacks.
• Hold at least quarterly meetings (can be face to face or virtual) of the RRT that include identified RRT member agencies (e.g., senior staff from FDA District Offices, other state partners, local).
• Hold at least two joint face-to-face meetings (see Phase 1 of the RRT Capacity Building Process and Mentorship Framework) and one joint training among partners involved including State health and agriculture agency representatives, feed program staff, laboratory staff, and epidemiology and surveillance staff, along with appropriate senior FDA District managers/staff.
• Identify and implement information technology (IT) solutions to identified collaboration challenges, where appropriate.

RRT Development/Documentation/Collaboration: 1.C. Actively participate in a web-based introductory meeting organized by FDA OP in the first quarter.

RRT Development/Documentation/Collaboration: 1.D. Attend the mandatory annual RRT meeting with a minimum of two senior state RRT staff; 1 person to InFORM biennial (November 2017). Conduct at least 2 face to face meetings with RRT mentor assigned by OP (one hosted by the mentee state, one hosted by the mentor state).

RRT Assessment: 2.A. Complete the Capability Assessment Tool and develop an improvement plan based on the results of the assessment.

RRT Implementation/Exercise: 3.A. None for Year 1.

RRT Sustainability: 4.A. Start the sustainability planning process. See Sustainability section in Phase 1 of the RRT Capacity Building Process and Mentorship Framework.

Year 2

RRT Development/Documentation/Collaboration: 1.A. Follow the RRT Capacity Building Process and Mentorship Framework. Specifically:

• Demonstrate that all major elements of Phase 2 of the RRT Capacity Building Process and Mentorship Framework have been started (with an emphasis on establishing a written framework). In particular, demonstrate incorporation of all RRT member agencies (including non-funded agencies) in the RRT Training Plan, as well as progress in two or more of the following areas of focus for the RRT Training Plan (see Phase 2, RRT Capacity Building Process & Mentorship Framework, Establish a Training Plan): proficiency development; use of a train-the-trainer approach; cross-training (cross-disciplinary and cross-agency); and tracking progress/ensuring continuing education. Include a narrative evaluation of the positive and/or negative impact of these approaches on RRT performance.
• Demonstrate improvement of core capabilities in areas of need, as identified in the assessment conducted in year one.

RRT Development/Documentation/Collaboration: 1.B. Attend the mandatory annual RRT meeting with a minimum of two senior state RRT staff; 1 person to InFORM biennial (November 2017). Conduct at least 2 face to face meetings with RRT mentor assigned by OP (one hosted by the mentee state, one hosted by the mentor state).

RRT Development/Documentation/Collaboration: 1.C. Conduct at least one presentation (oral or poster) about the development the RRT or documenting a specific RRT investigation at a regional or national meeting.

RRT Assessment: 2.A. Complete the Capability Assessment Tool and develop an improvement plan based on the results of the assessment.

RRT Implementation/Exercise: 3.A. Complete after action reviews and summary reports in a timely way for exercises and responses to significant real incidents. Documentation shall be made available to other RRTs through the secure RRT Program Workgroup in FoodSHIELD. Key issues/items for improvement related to team performance are incorporated into an improvement plan or into future trainings, as applicable. See RRT CAT, Part III, section 5.4.2. After action reviews/reports should include a calculation and assessment of the time intervals between key response activities to identify opportunities for improvement (most importantly, assessing the interval between FDA and state food/feed regulatory program notification and implementation of effective control measures; but ideally inclusive of lab and epi activities as well, where applicable). Use of the baseline response data in the RRT Manual Metrics Chapter (2013 Edition) and CIFOR Guidelines (2nd Edition) Performance Indicators are recommended.

RRT Implementation/Exercise: 3.B. Complete summary reports of significant RRT investigations, successful prevention efforts, or other RRT actions taken to protect public health to be posted on a Food Protection Task Force webpage, a state agency webpage or other public webpage and notify RRT Program Coordinators to allow cross-linking from the FDA RRT webpage. If the grantee’s attempts to post these reports to a public webpage are fruitless, we will accept posting to the RRT Program Workgroup in FoodSHIELD (please provide a justification in your progress report).

RRT Implementation/Exercise: 3.C. Demonstrate continued improvement in the RRT’s capability to perform tracebacks and successful use of at least one other improved capability (as per milestone 2.A.) during an exercise or incident.

RRT Implementation/Exercise: 3.D.Conduct at least one planned, joint exercise that includes federal and state partners. The exercise must include ICS elements.

RRT Sustainability: 4.A. Submit a sustainability plan for the RRT (use the template in Phase 2 of the RRT Capacity Building Process and Mentorship Framework) and undertake efforts to establish contingency plans for or increase the sustainability of current resources solely funded under this grant (especially data management systems and personnel). High priority efforts include: transitioning solely grant funded personnel to partial state funds; transitioning O&M costs for IT systems and other technologies to state funds. Ideally, by the end of the project period, the RRT budget should demonstrate that support for RRT operations/maintenance is diversified (split across state and grant funds) and reflective/proportional to the typical volume of response work encountered by the RRT, and that RRT grant funds are being used to support collaborative, high-impact, national level efforts for improving or increasing national capacity to respond to all hazards food/feed emergencies. To that end, RRTs shall also provide an estimate of in-kind contributions by the RRT grantee and other RRT member agencies/partners towards accomplishing the aims of this cooperative agreement (inclusive of both RRT operations [actual responses/activations], RRT continuous process improvement/program infrastructure [routine meetings, trainings, exercises, document revision/development], and contributions to national or mentorship activities undertaken as a part of the grant). In-kind contributions include personnel, equipment and supplies used to accomplish RRT activities not obtained through grant funds.

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

These cooperative agreements are intended to follow the constructs and directives of the following items while supporting the infrastructure of grantee State programs to implement integrated rapid response capabilities and sustain them into the future.

IV.A) National Incident Management System (NIMS) and the National Response Framework (NRF)

Issued in 2003 by President Bush, Homeland Security Presidential Directive (HSPD) 5 requires all federal departments and agencies to adopt NIMS and to use it in their individual incident management programs and activities, as well as in support of all actions taken to assist state, tribal and local governments. The directive requires federal departments and agencies to make adoption of NIMS by state, tribal and local organizations a condition for federal preparedness assistance (through grants, contracts and other activities). For more information on this, visit: https://www.fema.gov/national-incident-management-system/implementation-guidance-and-reporting.

The NRF is built on the NIMS and establishes a comprehensive, national, all-hazards approach to domestic incident response. The full NRF is available at: http://www.fema.gov/pdf/emergency/nrf/nrf-core.pdf.

These cooperative agreements require RRTs use Incident Command System (ICS)/National Incident Management System (NIMS) principles and operate under a Unified Command structure.

IV.B) National Integrated Food Safety System

FDA is continuing to work with its state partners to create a national, fully integrated food safety system that is characterized by effective communication and efficient processes among federal, state, and local partners in the food safety system.

The Partnership for Food Protection (http://www.fda.gov/ForFederalStateandLocalOfficials/FoodSafetySystem/PartnershipforFoodProtectionPFP/default.htm) is a major driving force in the establishment of a national integrated food safety system.

In alignment with this concept, these cooperative agreements work to engage partners across multiple sectors of the food safety system to collaborate to identify means of improving and optimizing the nation’s food safety system.

IV.C) FDA Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. 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.

Full text of the law: http://www.fda.gov/food/guidanceregulation/fsma/ucm247548.htm.

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.

State Governments

State manufactured food regulatory programs with current FDA food safety inspection contracts (providing funding to State agency food protection regulatory programs) are eligible to apply for funding under this cooperative agreement. In addition, the State manufactured food regulatory program must also be enrolled in the Manufactured Food Regulatory Program Standards (MFRPS). State programs receiving funds through the current RRT FOAs (RFA-FD-15-020 and RFA-FD-13-006) are not eligible to apply.

Competition is limited to these State manufactured food regulatory programs because the foundational work conducted under the current FDA food safety inspection contracts is necessary for the completion of significant improvements in a nationally integrated food safety system. State manufactured food regulatory programs must also be enrolled in the MFRPS. The MFRPS identifies the elements of a high quality regulatory program, which includes foodborne illness outbreak and response capabilities.

The development, implementation, and sustainability of rapid response capabilities for food and feed emergencies will assist the State program in achieving conformance with the MFRPS. In addition, the MFRPS provides the foundation necessary for building, implementing, and sustaining rapid response capabilities.

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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission. Late applications will not be accepted for this FOA.

• 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.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. 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.

The FDA will not accept duplicate or highly overlapping applications under review at the same time.  This means that the FDA will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

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, including Supplemental Grant Application Instructions 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 FDA 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 via electronic mail as a PDF file with the FOA Number and the Institution's Name in the message subject heading to:

Dan Lukash
Telephone: 240-402-7596
Email: [email protected]

A technical session will be held for prospective applicants in April 2016. The conference call information will be provided to prospective applicants that submit a letter of intent. The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process. Participation in the technical session is optional, but strongly encouraged.

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 20 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

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

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

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

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

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

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed.  MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract.  MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
• Applicants may also apply for personnel, training, and surveillance sample analysis if they have the necessary equipment and it shall be available for these projects.
• Where personnel costs are requested, documentation must be provided to associate these costs with the specific goals.
• A portion of budgeted travel funds must be set aside to attend an annual face-to-face meeting of the RRT States and FDA Headquarters and District Offices, as well as the biennial Integrated Foodborne Outbreak Response Management Conference, which is held in odd number years (a minimum of 2 key personnel for the RRT Annual Meeting and at least 1 person representing the RRT to InFORM), and to conduct at least 2 face to face meetings with RRT mentor assigned by OP (one hosted by the mentee state, one hosted by the mentor state).

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

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

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

Research Strategy:

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

a. Demonstrate the applicant agency's commitment to and support for this project, including the implementation and maintenance of the RRT concept and associated activities. Also demonstrate commitment from other RRT member agencies external to the applicant agency (at a minimum, entities representing feed, epidemiology and laboratory as described above in Section I.C.1) in the form of a letter(s) of support.

b. Demonstrate the availability of adequately trained staff (grant funded and in-kind contributions) and if applicable, the criteria and ability to hire and/or train personnel to meet the goals and aims of cooperative agreement. Provide justification for hiring new staff, including qualifications, training needs, and equipment needs.

c. Demonstrate adequate need within the state for advanced capacity and capabilities to respond to all hazards food/feed emergencies (description of: active state firm inventory [and proportion of high risk firms] for manufactured foods, animal feed, and farms; average number of natural disasters affecting food/feed firm operations; average number of recalls of food/feed commodities resulting from firms in the state; average number of recalls of food/feed commodities with distribution in the state (by class); average number of food/feed outbreaks (especially those involving FDA regulated commodities) where there were illnesses or distribution/processing/production of the contaminated product in the state).

d. Provide the previous year and current funding level certification for the food safety program from State funding appropriations.

e. Outline a detailed methodology to accomplish the goals, as described in this announcement (see Section I, part III, above).

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

g. Demonstrate the ability to fully participate in initiatives supporting the RRT Program, such as sending at least 2 key RRT personnel to an annual face-to-face meeting (as determined by FDA/OP) and at least 1 person representing the RRT to the biennial Integrated Foodborne Outbreak Response Management Conference (held in odd number years), participating in FoodSHIELD workgroups, RRT monthly conference calls, sharing of best practices and other RRT Program activities identified by OP. Demonstrate the ability to conduct at least 2 face to face meetings with RRT mentor assigned by OP (one hosted by the mentee state, one hosted by the mentor state).

Supporting Laboratory Facilities (only for laboratories that are not the main servicing laboratory for the food program as identified in Standard 10 of the MFRPS)

When funds or equipment from the cooperative agreement are provided to a State food/feed laboratory that is not the main servicing laboratory for the food program as identified in Standard 10 of the MFRPS, the following information must be provided as detailed below. It is strongly recommended that any laboratory involved in analyzing samples for the RRT be accredited or pursuing ISO 17025:2005 accreditation for pertinent food/feed analyses/technologies. Cooperative agreement funds may not be used for significant construction (e.g., to construct, renovate, or remodel laboratories or other physical facilities) but instead, for example, for equipment, installation, supplies, or development of policy and/or procedures manuals.

If funds or equipment from the cooperative agreement are provided to a State food/feed laboratory, the applicant must provide a complete description of the laboratory facilities with the mid-year report submission (unless it is the same as was submitted in a previous year under this cooperative agreement, in which case a modified report shall be required). The description must include the following information: The name and address of the State facility conducting the food sample tests; the name of the most responsible individual for the facility conducting the tests; and the location and installation requirements of any equipment purchased with cooperative agreement funds. Other facilities information that may be required includes:

a. Operational support areas to be used for the project, including details about the availability of ancillary laboratory safety and support equipment and facilities;

b. Details describing the sample receiving and sample storage areas and a description of any existing chain-of -custody procedures;

c. A detailed description of the proposed upgrades to existing laboratory facilities to accommodate new equipment, including drawings and cost estimates.

d. A summary description of any quality management system in place or under development as it relates to quality control and quality assurance procedures and practices;

e. A summary description of staffing management, specifically including food sample testing abilities and procedures;

f. A summary description of procedures in place to monitor food sample workflow, including the tracking and monitoring of sample analyses in progress, including a description of the laboratory work product review process and how reports of sample analyses shall be provided within reasonable timeframes;

g. A description of the ability to perform and complete (or an agreement with another laboratory to do so) the food/feed sample analyses and provide reports of sample analyses within reasonable timeframes. A recipient's conformity to the laboratory testing procedures, methodology, and protocols employed and accepted by FDA in the assessment of food/feed samples is a minimum requirement for participation under this cooperative agreement.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans 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.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Foreign (non-U.S.) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions described throughout 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. 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. Late applications will not be accepted for this FOA.

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.

Selected list of allowable costs that have limitations specific to this announcement (including but not limited to):

1) Pass through of funds to RRT member agencies external to the recipient of this award (e.g., other state/local/county/tribal government agencies) to support their contribution to the aims of this grant program is encouraged, but is limited to 50% of each year’s funding (total). FDA must be provided with a copy of the third party agreement showing involvement and transfer of funds to state/local/county/tribal governments.

2) Incident response and surveillance work, including sample collection and laboratory analyses, directly related to RRT activities are allowable.

Non-allowable costs:

1) Pre-award costs are not allowable for this announcement.

2) Facilities and work covered and funded under current FDA food safety inspection contracts shall not be counted towards fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement. The State must be able to account separately for fund expenditures under the food safety inspection contracts and these cooperative agreements.

2) These cooperative agreements are not to fund licensed medicated feed or routine feed safety good manufacturing practice (GMP) inspections, BSE inspections, or retail food or foodservice inspections, which are unrelated to the food manufacturing, processing, wholesaling, transportation, or warehousing of manufactured foods, or any activities which are currently covered by an FDA food or feed inspection contract.

3) Vehicle purchases are not permitted.

4) Subcontracting to third party (other than state/local/tribal government agencies participating in the RRT) is limited to 20% of each year's award.

5) 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.

Additional funding restrictions may be part of the Notice of Award.

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 and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

Reviewers will consider each of the review criteria below in the determination of scientific merit.

1) Effective use of grant funds (10 Points): The relevance/impact of the proposed budget towards achieving the goals/aims of the cooperative agreement.

2) Established relationships (40 points): Develops relationships with partners in other, relevant organizations (e.g., letters of support/commitment from feed program, laboratory and epidemiology programs; steps taken to date to establish a RRT structure/membership) to collaborate as a multi-jurisdictional, multi-disciplinary RRT to respond to all hazards food and feed emergencies

3) Demonstration of impact/benefit/effectiveness (50 points): Demonstration of working with RRT member agencies/partners to develop, share and operationalize capacity/capabilities to rapidly respond to all-hazards food/feed emergencies (with the ultimate goal of shortening the time between agency notification and implementation of effective control measures), as well as supporting surveillance and post-response/prevention activities specifically:

Having adequate need for advanced capacity and capabilities to respond to all hazards food/feed emergencies (description of: active state firm inventory [and proportion of high risk firms] for manufactured foods, animal feed, and farms; average number of natural disasters affecting food/feed firm operations; average number of recalls of food/feed commodities resulting from firms in the state; average number of recalls of food/feed commodities with distribution in the state (by class); average number of food/feed outbreaks (especially those involving FDA regulated commodities) where there were illnesses or distribution/processing/production of the contaminated product in the state);

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 score.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed project involves human subjects and/or FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

Applications will be evaluated for scientific and technical merit by an Objective Review Committee, using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

Appeals of objective 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:

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

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

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 terms and conditions found in the HHS Grants Policy Statement. 

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Additional terms and conditions regarding FDA regulatory and ORA programmatic requirements may be part of the Notice 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 Part 75, and other HHS, PHS, and FDA grant administration policies.

The grantee must maintain a food safety inspection contract with the FDA throughout the cooperative agreement project period. The grantee must also maintain enrollment in the MFRPS throughout the cooperative agreement project period.

State manufactured food programs funded under these cooperative agreements shall be required to provide the previous, current, and subsequent years of State funding to demonstrate that these funds have not replaced State allocations. A minimum of 2 key RRT personnel shall attend an annual face-to -face RRT meeting (as determined by FDA OP) and at least one person representing the RRT shall attend the biennial Integrated Foodborne Outbreak Response Management Conference (held in odd number years) as a condition of the award. The awardee shall plan a minimum of 2 face to face meetings with the RRT mentor assigned by OP (one hosted by the mentee state, one hosted by the mentor state). The awardee should identify funds within the cooperative agreement for travel and plan accordingly.

Facilities, work, and training reimbursed under the FDA food safety inspection contract and other funding mechanisms (including MFRPS, AFRPS, VNRFRPS, FERN, ISO or Food Protection Task Force Conference Grants) must remain distinct and separate from the cooperative agreement. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, under the food safety inspection contracts and other funding mechanisms and these cooperative agreements.

Future funding will be dependent on recommendations from the OP Programmatic Staff. The scope of the recommendation will confirm that acceptable progress has been made, continued compliance with all FDA regulatory requirements, and, if necessary, a corrective action plan has been implemented.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

Mid-year reports are required. The Research Performance Progress Report (RPPR) will be considered the annual program progress report for the budget period.

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

1. General Progress on Cooperative Agreement Project

A) Progress & achievements for each yearly goal.

B) Progress & achievements for other projects, identified by the grantee in the application or subsequent to receiving funding.

2. Summary of significant RRT responses or other activities within the timeframe for the report, including status of AAR & lessons learned/recommendations for improvement

3. Point of Contact and Project Key Personnel

4. Pending Issues/Concerns and Proposed Solutions

5. Funding Expended and Remaining as of date of this report (provide detailed list of funds expended)

The PD(s)/PI(s) will have the primary responsibility for:

The scientific, technical, and programmatic aspects of the grant and for day-to -day management of the project or program. The PD/PI(s) shall maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff has sufficient clearance and/or background checks to work on this project or program. This individual shall work closely with designated officials within the recipient organization to prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements. All applicants will be required to participate in a cooperative manner with FDA.

The awardee is responsible for submitting interim progress reports, when requested, to the FDA Project Scientist (PS)/Project Officer (PO) including summary data on progress to date.

FDA staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

An FDA Project Scientist (PS) will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below. However, the dominant role and prime responsibility for the activity reside with the awardees(s) for the project as a whole, but not necessarily for each task.

The responsibilities of the PS include involvement during conduct of the activity, through technical assistance, advice, coordination, and/or other assistance activities that is above and beyond normal program stewardship for grants.

As appropriate, the PS will participate in the definition of objectives and approaches, and in planning, conducting, analyzing, and publishing results, interpretations, and conclusions of their studies.

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.

In addition to the PS, there may be a separate FDA Program Official (PO) who will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The PO 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. The recipients shall also work with the FDA District Offices in development, training, and exercises for the developing RRT. Periodic site visits with officials of the recipient organization may also occur. The results of these monitoring activities will be recorded in the official cooperative agreement file and will be available to the grant recipient, upon request, consistent with applicable disclosure statutes and FDA disclosure regulations.

Areas of Joint Responsibility include:

During performance of the award, the PS/PO, with assistance from other scientific program staff who are designated based on their relevant expertise, may provide appropriate assistance, advice and guidance. The role of the PS/PO will be to facilitate and not to direct the activities. It is anticipated that decisions in all activities shall be reached by consensus between the PI and the

PS, PO and that the FDA staff shall be given the opportunity to offer input into this process. The PS/PO will facilitate liaison activity for partnerships, and provide assistance with access to FDA supported resources and services as deemed necessary.

The PI(s) shall be responsible for the timely submission of all abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this Cooperative Agreement. Manuscripts shall be submitted to FDA PS/PO within two weeks of acceptance for publication. Publications or oral presentations of work performed under this Cooperative

Agreement shall require appropriate acknowledgement of FDA support. Timely publication of major findings is encouraged.

The PS/PO and relevant FDA field offices will have continuous interaction with the recipient through activities such as the following: collection of progress reports; training; joint inspections; investigational and compliance activities; RRT exercises and coordination; and other activities necessary for the completion of objectives as outlined in this RFA. There may be other regular meetings with recipients to assist in fulfilling the requirements of the cooperative agreement. Specific interactions between relevant FDA field offices and the award recipients include:

a. Coordination, training, and exercises with FDA District and Regional RRT partners (including emergency response coordinators), the FDA Emergency Operations Center, CFSAN and CVM, the FDA CORE, and other federal agencies.

b. Working with other State entities in food protection such as State Departments of Health or Agriculture, emergency operations centers, environmental programs, epidemiologists, local food protection agencies, and others, in the accomplishment of objectives as outlined in this announcement.

c. Engaging other relevant initiatives within the RRT Concept, such as CDC Integrated Food Safety Centers of Excellence, CDC FoodCORE, FoodNet, and EHS-Net sites.

d. All cooperative agreement recipients must have existing food safety inspection and surveillance programs under contract to FDA for food safety inspections and be enrolled in the MFRPS, both of which require extensive District-State coordination (with the caveat that all funding streams must be kept distinct and separate, as described above under Section VI.2 Cooperative Agreement Terms and Conditions of Award).

The equipment purchased by FDA will remain the property of FDA under loan to the awardee’s laboratory for a specified time period with a review every twelve months. FDA may terminate the loan at any time. Unless approved by ORA/OP, the FDA provided equipment may not be transferred by the awardees' laboratory to a third party, and the awardees' laboratory assumes full responsibility and liability for any claims that may arise as a result of operation of this equipment for the period it is in the possession of the awardees' laboratory.

The Government, via the PO, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports. The FDA PO may use information obtained from the data for the preparation of internal reports on the activities of the study. However, awardees shall retain custody of and have primary rights to all data developed under these awards.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award.

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 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.

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)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

Brett Weed
Project Officer
FDA/ORA/Office of Partnerships
Telephone: 404-253-2268
Email: [email protected]

Daniel Lukash
Office of Acquisition & Grants Services (OAGS)
Telephone: 240-402-7596
Email: [email protected]

Daniel Lukash
Office of Acquisition & Grants Services (OAGS)
Telephone: 240-402-7596
Email: [email protected]

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 Sections 301 and 317R of the Public Health Service Act (42 USC 241and 247b-20), section 1009 of the Federal Food, Drug, and Cosmetic Act (21 USC 399), 21 USC 2104, and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.