Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

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

Components of Participating Organizations

Office of Regulatory Affairs (ORA)
Office of Foods and Veterinary Medicine (OFVM)

Funding Opportunity Title

Food Protection Rapid Response Team (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

  • May 3, 2013 - See Notice NOT-FD-13-002. Notice of Change to Approved Pre-Award Cost for Travel.

Funding Opportunity Announcement (FOA) Number

RFA-FD-13-006

Companion Funding Opportunity

Not Applicable

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.103 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is being issued to announce the availability of up to nine (9) cooperative agreements to be awarded under a Limited Competition.

These cooperative agreements are intended to develop, implement, maintain and sustain multi-jurisdictional Rapid Response Teams (RRTs) that operate using Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to support integrated all-hazards preparedness, response, mitigation and recovery/prevention efforts for food/feed within the national integrated food safety system.

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 components;

2) Improving States' regulatory and surveillance food/feed protection programs (with a focus on manufactured foods) to include foodborne illness/outbreak investigations, removing tainted food from commerce, and root cause investigations; and

3) Addressing supporting components, such as training, data sharing, data analysis and communications.

This will be accomplished through the provision of funding for program improvement and will require extensive cooperation and coordination with FDA District Offices and other FDA program offices.

Effective leveraging of resources and harmonization of efforts will require collaboration with relevant initiatives, including those of federal partners (e.g., 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.

Key Dates
Posted Date

March 29, 2013

Open Date (Earliest Submission Date)

May 1, 2013

Letter of Intent Due Date(s)

May 15, 2013

Application Due Date(s)

July 1, 2013 by 11:59 PM Eastern Time.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) before 11:59 p.m. Eastern Time on the application due date. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

July 2013

Advisory Council Review

Not Applicable

Earliest Start Date

September 1, 2013

Expiration Date

July 2, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the HHS Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description

Program Objectives

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 nine cooperative agreements to be awarded under a Limited Competition. 

These cooperative agreements are intended to develop, implement, maintain and sustain multi-jurisdictional Rapid Response Teams (RRTs) that operate using Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to support integrated all-hazards preparedness, response, mitigation and recovery/prevention efforts for food/feed within the national integrated food safety system.

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 components;

2) Improving States' regulatory and surveillance food/feed protection programs (with a focus on manufactured foods) to include foodborne illness/outbreak investigations, removing tainted food from commerce, and root cause investigations; and

3) Addressing supporting components, such as training, data sharing, data analysis and communications, and availability of resources to support the RRT concept.

This will be accomplished through the provision of funding for program improvement and will require extensive cooperation and coordination with FDA District Offices and other FDA program offices.

Effective leveraging of resources and harmonization of efforts will require collaboration with relevant initiatives, including those of federal partners (e.g., 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.

The funding opportunity purpose, program objectives and yearly milestones are in accordance with the RRT Program 5 Year Plan. The RRT Program 5 Year Plan (posted in the FDA RRT Workgroup in FoodSHIELD) consists of 6 Program Objectives, summarized in the below table.

Program Objective

Goals & Outcomes

Mentorship

Propagate Best Practices & Lessons Learned

1) Develop a national RRT mentorship program (incorporating regional elements), including establishment of basic expectations for mentors/mentees and mechanisms to facilitate mentorship match-ups and track and evaluate progress.

2) Develop programmatic infrastructure to support implementation of the RRT Concept and Best Practices Manual by funded and non-funded RRTs.

RRT Capability Data Capture & Assessment

Measure Current Performance and Meaningful Success

1) Measure process improvement, increases in efficiency/effectiveness and success at the individual RRT level and across the RRT Program.

Communication

Transparency & Information Sharing

1) Ensure transparency of objectives and outcomes for the RRT Program.

2) Actively promote and justify sustainment of the RRT Program and individual RRTs through strategic application of capability data capture/assessment and enhanced communications, to include promotional materials.

Post Response & Prevention

Lessons Learned, Corrective Actions & Continuous Improvement

1) Ensure documentation and follow up for lessons learned to support prevention and facilitate continuous process improvement.

2) Operationalize models to analyze outcomes from concluded responses, identify causing factors and develop and effectively communicate recommendations for prevention.

RRT Maturity & Maintenance

Maintenance & Maturity of the RRT Concept: Innovation and Integration

1) Develop multi-jurisdictional RRTs (minimum District/State) that operate under ICS/NIMS to support integrated all-hazards prevention, response and recovery efforts for food/feed.

2) Ensure continual improvement of the RRT Concept through investment in new models, capabilities and methodologies to improve and enhance response.

3) Ensure adequate training opportunities to support development and maintenance of RRT capabilities.

Sustainability

Program Evolution, Viability & Relevance

1) Document and support successful efforts on the part of RRT state components towards sustainability of capabilities developed under the RRT cooperative agreement.

2) Formalize and make operational the RRT Program’s role within a national, cohesive approach to response capacity and capability building (standards, best practices, innovation).

3) Obtain management support and begin to implement a strategy to align the structure, function and capabilities of RRTs within the context of the National Response Framework, including development of infrastructure to support coordination of inter-RRT surge capacity, such as regional support structures.

The projects funded under these cooperative agreements will be in alignment with the RRT Program 5 Year Plan and must be specifically designed by the grantee to help their respective RRT meet the yearly milestones 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 will be 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) All-Hazards Food/Feed Rapid Response Teams (RRT) Concept

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 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 9 pilot RRTs that are considered foundational for conducting effective multiagency 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 with specific objectives and accompanying approaches to achieve sustainability (See Section III, Milestones). 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 OP-ORA@fda.hhs.gov).

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 designated 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, shellfish, Grade A milk and retail 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 will 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) will provide current information on emerging pathogen analytical methodology and servicing lab capability. Lab SMEs will 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 will be 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; ICS (100, 200, 300, 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).This investigator would then be responsible for training other staff in this area so that there is at least one back-up for each area of expertise on the team.

RRTs must include their plan for RRT expertise development and current summary of team member expertise (highlighting expertise developed as a result of grant funds) as part of mid year, annual and final project reports. This may be accomplished by providing the RRT training plan and associated records.

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, and power outages) 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 participates 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 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 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 an 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) will 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 Safety/Defense/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 Conference Grant. Online collaborative and information sharing resources, such as FoodSHIELD or the in development 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/ and http://www.fda.gov/ora/fed_state/food_safety/default.htm.

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/

7) Other Relevant Activities

The following items describe a variety of special projects that could be undertaken by the RRT at their discretion, or may be specifically requested /directed by OP within the project period.

A. On-site evaluation of a “high risk” (as identified under MFRPS Standard #3) food, commodity, or specific type of manufacturer or processor (such as LACF/Acidified Foods), or participation in a special study and assessment to provide additional insights into how food may become contaminated.

The evaluation/exercise/study should be done in collaboration with the FDA District Office and other relevant organizations (e.g. RRT members), and RRTs are encouraged to use a HACCP and/or CARVER + Shock approach. Results should be documented in the form of a final report, programmatic paper, and/or technical document to identify specific hazards and critical control points, strengths of the response team efforts, recommendations and needed improvements.

B. Creation of coordinated District-State surveillance (sampling) assignments for products and contaminants of concern. Assignments should involve coordination of District-State sampling and laboratory testing capacity, and incorporate appropriate measures so as to ensure District and/or State regulatory or compliance action throughout all components of the assignment. Assignments should be targeted (e.g. risk-based; aimed at identifying points of contamination for a product within the farm to fork continuum; or to address other strategic needs).

C. In coordination with OP, develop programmatic infrastructure to support inter-RRT surge capacity efforts (i.e. when the requesting RRT does not have sufficient resources to respond to an emergency).

II) Regulatory Program Standards

A portion of the infrastructure necessary to develop and sustain rapid response capabilities is established using the 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) (not yet released as of the writing of this FOA). These Regulatory Program Standards provide the foundation with which to assess and continually improve the infrastructure and equivalency 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). As such, you will notice references to specific sections of Regulatory Program Standards throughout this FOA.

Each partner state that is awarded funding through these cooperative agreements 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 if the grantee is a recipient of multiple funding agreements, such as the MFRPS or VNRFRPS Cooperative Agreements. See Section VI.2 (Cooperative Agreement Terms and Conditions of Award) of this FOA for more details.

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/FoodSafety/RetailFoodProtection/ProgramStandards/ucm245409.htm.

3) AFRPS: http://www.fda.gov/downloads/ForFederalStateandLocalOfficials/UCM300211.pdf; http://www.fda.gov/AnimalVeterinary/SafetyHealth/AnimalFeedSafetySystemAFSS/ucm286165.htm.

III) Milestones/Expected Accomplishments

These milestones represent yearly requirements for grantees receiving these cooperative agreements. Milestones are aligned with the Program Objectives as outlined in the RRT 5 Year Plan (described above in this FOA).

Applicants must address how they plan to meet these yearly milestones/expected accomplishments in their application, as well as other baseline requirements as outlined in this FOA. Grantees will be required to report out the status of accomplishments for each milestone in mid-year and annual reports.

As applicants may request up to three years of funding through this cooperative agreement, annual milestones are provided. 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. Milestones for the project period should provide a timeline to fully develop, build, and achieve sustainable outcomes for the applicant's RRT.

Year 1 Milestones/Expected Accomplishments:

1. Mentorship:

1. A. RRTs will provide mentorship to at least one 'new' RRT (added to the RRT Program in 2012) and meet minimum mentorship requirements as per the RRT Capacity Building & Mentorship Program.

2. RRT Capability Data Capture & Assessment:

2. A. RRTs will: 1) complete/submit the Capability Assessment Tool; 2) develop an improvement plan based on the results of the assessment; 3) meet yearly benchmarks and other minimum requirements as detailed in the Capability Assessment Tool.

3. Communication

3. A. RRTs will conduct at least one presentation per year (oral or poster) at a regional or national meeting about the development of the RRT or documenting a specific RRT investigation and share a copy of the presentation within the FDA RRT Workgroup in FoodSHIELD.

4. Post Response & Prevention

4. A. RRTs will conduct an after action review and complete subsequent documentation requirements for all exercises and RRT activations as per RRT SOPs (i.e. creation of incident/event summary and documentation of recommendations/tracking of follow up action). Documentation will be made available to other RRTs through the secure FDA RRT Workgroup in FoodSHIELD.

4. B. RRTs will prepare reports of successful prevention efforts and significant investigations to be posted on a Food Protection Task Force webpage or a state agency webpage and will notify RRT Program Coordinators to allow cross-linking from the FDA RRT webpage.

4.C. RRTs will demonstrate progress towards development of infrastructure to support the capacity and capability to participate in coordinated post response and prevention/recovery activities with partners (e.g. RRT members (Dept of Ag, Dept of Health, FDA District Office) and FDA CORE) as directed by the Office of Partnerships (OP). This will include demonstrating incorporation of environmental assessment (EA) training in the RRT training plan for appropriate RRT members and demonstration that conducting environmental assessments or other identification and documentation of contributing factors/antecedents is included in RRT SOPs.

5. RRT Maturity & Maintenance

5. A. RRTs will demonstrate progress within Phase 3 of the RRT Capacity Building & Mentorship Program.

5. B. RRTs may contribute to adapting/developing and evaluating innovations and enhancements to response capabilities to be incorporated into the RRT Concept (e.g. RRT Manual) as per the RRT Manual Expansion, Review and Revision Plan.

6. Sustainability

6. A. RRTs will maintain and submit a sustainability plan for the RRT and demonstrate measurable progress for at least one sustainability objective within the plan.

Year 2 Milestones/Expected Accomplishments:

1. Mentorship:

1. A. RRTs will provide mentorship to at least one 'new' RRT (added to the RRT Program in 2012) and meet minimum mentorship requirements as per the RRT Capacity Building & Mentorship Program.

1.B. RRTs may participate in a pilot offering of the RRT Capacity Building & Mentorship Program to non-funded RRTs (as assigned by FDA Office of Partnerships (OP)), to include an evaluation of the program and contributing to subsequent program revisions or alterations.

1.C. RRTs will work with relevant partners to identify and begin development of programmatic infrastructure to support operational capacity building and implementation of the RRT Concept and Best Practices Manual as appropriate, such as: functional SME centers (accessible remotely and in real-time); seminar series; webinar or functional trainings; updates to the RRT Manual; sharing of AARs/SOPs/other documentation within the FoodSHIELD FDA RRT Workgroup; and development of other supporting tools or documentation.

2. RRT Capability Data Capture & Assessment:

2. A. RRTs will: 1) complete/submit the Capability Assessment Tool; 2) update their improvement plan based on the results of the assessment; 3) meet yearly benchmarks and other minimum requirements as detailed in the Capability Assessment Tool.

3. Communication

3. A. RRTs will conduct at least two presentations per year (oral or poster) at a regional or national meeting about the development of the RRT or documenting a specific RRT investigation and share a copy of the presentation within the FDA RRT Workgroup in FoodSHIELD. RRTs are encouraged to write and submit peer reviewed journal articles (the publication of which would count against the 2 presentation minimum for this milestone).

4. Post Response & Prevention

4. A. RRTs will conduct an after action review and complete subsequent documentation requirements for all exercises and RRT activations as per RRT SOPs (i.e. creation of incident/event summary and documentation of recommendations/tracking of follow up action). Documentation will be made available to other RRTs through the secure FDA RRT Workgroup in FoodSHIELD.

4. B. RRTs will prepare reports of successful prevention efforts and significant investigations to be posted on a Food Protection Task Force webpage or a state agency webpage and will notify RRT Program Coordinators to allow cross-linking from the FDA RRT webpage.

4.C. RRTs will demonstrate increased progress towards development of infrastructure to support the capacity and capability to participate in coordinated post response and prevention/recovery activities with partners (e.g. RRT members (Dept of Ag, Dept of Health, FDA District Office) and FDA CORE) as directed by the Office of Partnerships (OP). This will include implementation of environmental assessment procedures by trained personnel, to include identification, documentation and sharing of contributing factors/antecedents, as well as contributions towards development of subsequent recommendations for industry or other preventive measures.

5. RRT Maturity & Maintenance

5. A. RRTs will demonstrate progress within Phase 3 of the RRT Capacity Building & Mentorship Program.

5. B. RRTs may contribute to adapting/developing and evaluating innovations and enhancements to response capabilities to be incorporated into the RRT Concept (e.g. RRT Manual) as per the RRT Manual Expansion, Review and Revision Plan.

5. C. RRTs may participate in a workgroup to develop a RRT training curriculum customized for non-funded RRTs or non-funded members of a funded RRT (e.g. locals), which addresses the resource constraints and other needs specific to these audiences. Outcomes of this workgroup will be incorporated into future revisions of the RRT Best Practices Manual Training Chapter.

6. Sustainability

6. A. RRTs will maintain and submit a sustainability plan for the RRT and demonstrate measurable progress for at least one sustainability objective within the plan.

Year 3 Milestones/Expected Accomplishments:

1. Mentorship:

1. A. RRTs will provide mentorship to at least one 'new' RRT (added to the RRT Program in 2012) and meet minimum mentorship requirements as per the RRT Capacity Building & Mentorship Program.

1. B. RRTs will actively participate in the RRT Capacity Building & Mentorship Program, to include providing mentorship to at least one 'new' RRT (added to the RRT Program in 2012) as well as non-funded RRTs (as assigned by FDA Office of Partnerships (OP).

1. C. RRTs will work with relevant partners to continue development and begin to operationalize programmatic infrastructure to support operational capacity building and implementation of the RRT Concept and Best Practices Manual by other RRTs.

2. RRT Capability Data Capture & Assessment:

2. A. RRTs will: 1) complete/submit the Capability Assessment Tool; 2) update their improvement plan based on the results of the assessment; 3) meet yearly benchmarks and other minimum requirements as detailed in the Capability Assessment Tool.

3. Communication

3. A. RRTs will conduct at least two presentations per year (oral or poster) at a regional or national meeting about the development of the RRT or documenting a specific RRT investigation and share a copy of the presentation within the FDA RRT Workgroup in FoodSHIELD. RRTs are encouraged to write and submit peer reviewed journal articles (the publication of which would count against the 2 presentation minimum for this milestone).

4. Post Response & Prevention

4. A. RRTs will conduct an after action review and complete subsequent documentation requirements for all exercises and RRT activations as per RRT SOPs (i.e. creation of incident/event summary and documentation of recommendations/tracking of follow up action). Documentation will be made available to other RRTs through the secure FDA RRT Workgroup in FoodSHIELD.

4. B. RRTs will prepare reports of successful prevention efforts and significant investigations to be posted on a Food Protection Task Force webpage or a state agency webpage and will notify RRT Program Coordinators to allow cross-linking from the FDA RRT webpage.

4.C. RRTs will demonstrate the capacity and capability to participate in coordinated post response and prevention/recovery activities with partners (e.g. RRT members (Dept of Ag, Dept of Health, FDA District Office) and FDA CORE) as requested by the Office of Partnerships (OP). This will include implementation of environmental assessment procedures by trained personnel, to include identification, documentation and sharing of contributing factors/antecedents, as well as contributions towards development and implementation of subsequent recommendations for industry or other preventive measures.

5. RRT Maturity & Maintenance

5. A. RRTs will demonstrate progress within Phase 3 of the RRT Capacity Building & Mentorship Program.

5. B. RRTs may contribute to adapting/developing and evaluating innovations and enhancements to response capabilities to be incorporated into the RRT Concept (e.g. RRT Manual) as per the RRT Manual Expansion, Review and Revision Plan.

5. C. RRTs may participate in a workgroup to develop a RRT training curriculum customized for non-funded RRTs or non-funded members of a funded RRT (e.g. locals), which addresses the resource constraints and other needs specific to these audiences. Outcomes of this workgroup will be incorporated into future revisions of the RRT Best Practices Manual Training Chapter.

6. Sustainability

6. A. RRTs will maintain and submit a sustainability plan for the RRT and demonstrate measurable progress for at least one sustainability objective within the plan.

IV Background

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

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: http://www.fema.gov/implementation-and-compliance-guidance-stakeholders.

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/Meetings/ucm249828.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/FoodSafety/FSMA/ucm247548.htm.

IV.D) President’s Food Safety Working Group

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

IV.E) Bioterrorism Act

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

Subtitle A of Title III—Protection of Food Supply, Section 311—Grants to States for Inspections, amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding section 909, which authorizes the Secretary of Health and Human Services to award grants to States, territories, and Indian tribes that undertake examinations, inspections, and investigations, and related activities under section 702 of the FD&C Act. The grant funds are only available for the costs of conducting these examinations, inspections, investigations, and related activities. Full text: http://www.fda.gov/RegulatoryInformation/Legislation/ucm155769.htm.

Subtitle A of Title III—Protection of Food Supply, Section 312, "Surveillance and Information Grants and Authorities," amends part B of Title 111 of the Public Health Service Act to authorize the Secretary of Health and Human Services to award grants to States and Indian tribes to expand participation in networks to enhance Federal, State, and local food safety efforts. This may include meeting the costs of establishing and maintaining the food safety surveillance, technical, and laboratory capacity needed for such participation.

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

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

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

IV.G) Import Safety Action Plan (ISAP)

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

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

Section II. Award Information
Funding Instrument

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

Application Types Allowed

New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

FDA intends to commit approximately $2.7 million to this grant in FY 2013. Future year amounts will depend on annual appropriations.

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

It is anticipated that up to nine (9) awards will be made, not to exceed $300,000 in total costs (direct plus indirect) per award, per year.

Award Budget

Awards are contingent upon the availability of funds. Future year amounts will depend on annual appropriations and performance.  Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs.

Year 01: $300,000.00

Year 02: $300,000.00

Year 03: $300,000.00

Award Project Period

The total project period for an application requesting support may not exceed three (3) years. 

Future year amounts depend on availability of funding and performance.  

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

State Governments: This opportunity is only available to State food safety agencies with current FDA food safety inspection contracts that are also enrolled in the Manufactured Food Regulatory Program Standards (MFRPS) and currently receiving funding under the Food Protection Rapid Response Team cooperative agreements (RFA-FD-11-013 or RFA-FD-12-014).

Competition is limited to these organizations because they have established Rapid Response Teams and have demonstrated significant achievements in accordance with the goal of developing and implementing rapid response concepts. The foundational work conducted under the current FDA food safety inspection contracts and the MFRPS is both necessary and promising for the completion of significant improvements in food emergency response among federal, state, and local partners through the program described in this funding opportunity. Additionally, this cooperative agreement will require a significant mentorship component which necessitates the participation of only established, experienced Food Protection Rapid Response Teams.

Applicants must also maintain MFRPS enrollment and remain under a FDA food safety inspection contract for the duration of the award.

Foreign Institutions

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

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

Required Registrations

Applicant organizations must complete the following registrations as described in the SF424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

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

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

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(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.   

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

Section IV. Application and Submission Information


1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows Agency staff to estimate the potential review workload and plan the review.

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

Descriptive title of proposed research
Name, address, and telephone number of the PD(s)/PI(s)
Names of other key personnel
Participating institutions
Number and title of this funding opportunity
The letter of intent should be sent by email to: William.Foust@fda.hhs.gov and  Jennerfer.Torres-Hernandez@fda.hhs.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be

followed, with the following exception:

PHS 398 Research Plan Component

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

The applicant must specifically address, and will be judged on the following in the cooperative agreement application. Applications must include the following information in the Research Strategy attachment not to exceed 20 pages in length:

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 I.C.1) in the form of a letter(s) of support.

b. Demonstrate the availability of adequately trained food/feed program staff (including field staff, supervisory staff, and support staff) and the criteria to hire and/or train personnel to conduct RRT activities under this cooperative agreement. Solutions must be identified to address areas in which there were inadequate staff resources to fully complete project needs during involvement in the previous, RRT Prototype Project. Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs.

c. Provide a detailed description on any changes/updates to your food regulatory program since the submission of your application for the Food Protection Rapid Response Team and Program Infrastructure Improvement Implementation Project in 2008 or 2009. This should include types of inspections performed and the types and numbers of food establishments in the State inventory.

d. Provide a properly detailed budget that is intended to meet the milestones and accomplish the activities detailed within this FOA, including further development and maintenance of the RRT and associated activities and efforts to enhance the food protection program within the state. Include the previous and current year’s State funding for the program, including program staffing and costs, as well as the final budget under the last year (2012-2013) of your previous RRT cooperative agreement (RRT Prototype Project). Demonstrate the ability to satisfy the reporting requirements outlined in section VI.3 of this announcement.

e. Provide current funding level certification for the food safety program from State funding appropriations.

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

g. Outline a detailed methodology to maintain or enhance RRT membership and functions as described in this announcement (see Section I, parts I.C and I.D, above).

h. Provide the following documentation to allow for baseline characterization of your RRT. For all requested components, please indicate any applicable sustainability measures taken (e.g. is the SOP considered part of the state program's infrastructure and thus applicable to those outside of cooperative agreement funded positions? Are elements of the process/procedure captured within IT systems supported by the state agency?)

Laboratory Facilities

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 will 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 will 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.

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

Resource Sharing Plan

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

Appendix

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

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

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA’s electronic system for grants administration.

Applicants are responsible for viewing their application before the deadline in the eRA Commons to ensure accurate and successful submission.

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

The purpose of these cooperative agreements is to develop, implement, maintain and sustain multi-jurisdictional Rapid Response Teams (RRTs) that operate using Incident Command System (ICS)/National Incident Management System (NIMS) principles and a Unified Command structure to support integrated all-hazards preparedness, response, mitigation and recovery/prevention efforts for food/feed within the national integrated food safety system.  

This will be accomplished through the provision of funding for program improvement to promote the development and enhancement of existing state regulatory programs (RRT members) in providing outbreak response capabilities.

The cooperative agreements will provide funding for additional personnel, equipment, supplies, and training to support activities related to the RRT concept. These awards may only be used for the continued development and implementation of current State RRTs and to enhance and supplement existing State food protection infrastructures. Allowable and unallowable costs are delineated below.

Allowable costs:

1) Supplies

2) Lab equipment (with prior approval from FDA) relevant to the RRT

3) Surveillance work

4) Team development and exercises

5) Sample collection supplies

6) Salaries to include personnel for training development/delivery. RRTs are encouraged to utilize FDA provided training (ICS, etc) when available.

7) Travel and per diem to meetings with RRT members (other state agencies, local agencies, FDA District/Regional Offices), other RRTs, FDA Headquarters, and Annual RRT meetings

8) Pass through of funds to RRT members external to the recipient of this award (e.g. other state/local/county/tribal government agencies) directly involved with the State RRT is encouraged, but is limited to 25% of each year’s funding. FDA must be provided with a copy of the third party agreement showing involvement and transfer of funds to state/local/county/tribal governments.

9) Reimbursement of mileage for travel within a grant recipient’s state is allowable provided that the work directly relates to the RRT.

Facilities and Administrative (F&A) costs requested by consortium participants are included in the direct cost limitation.

Funds may be requested in the budget to travel to FDA for meetings with program staff about the progress of the project and travel for training. 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 (a minimum of 2 key personnel from the grantee agency).

Non-allowable costs:

1) Facilities and work covered and funded under current FDA food safety inspection contracts cannot 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 safety inspection contract.

3) Vehicle purchases are not permitted.

4) Subcontracting to third party (other than local/county/tribal RRT members) is limited to 10% 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.

6. Other Submission Requirements and Information

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.

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 (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the FDA Office of Acquisition and Grants Services (OAGS). Applications that are incomplete will not be forwarded for objective review.

Applications will be evaluated for completeness and responsiveness by the FDA Office of Regulatory Affairs. Applications that are incomplete and/or nonresponsive will not be forwarded for objective review.

Post Submission Materials

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

Acceptable post-submission materials include:

Revised budget page(s) (e.g., change in budget request due to new funding or institutional acquisition of equipment). Biographical sketches (e.g., change in senior/key personnel due to the hiring, replacement, or loss of an investigator).

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

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

Unacceptable post-submission materials include:

Updated Specific Aims or Research Strategy pages.

Late-breaking research findings.

New letters of support or collaboration that do not result from a change in senior /key personnel due to the hiring, replacement, or loss of an investigator.

Section V. Application Review Information


1. Criteria

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

Overall Impact

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

Scored Review Criteria

For this particular announcement, only the following criteria described below (Criteria 1-3) will be considered by reviewers in the review process.

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

a. Rationale for proposed work (the need, the value, etc.) (Weight = 5%);

b. The design appropriately addresses and demonstrates the ability to meet and maintain core RRT membership and functions throughout the duration of the project period (Section I, parts I.C and I.D, above) (weight = 20%);

c. The design appropriately addresses and demonstrates the ability to achieve the expectations of activity as outlined in the Milestones (Section I, part III above) (weight = 35%);

2. Demonstration of effectiveness in working with federal, state, and local partners to develop and share rapid response capabilities (total weight = 20%):

a. Having adequate program resources (especially staff) to complete project needs, including RRT development/maintenance and mentorship (weight = 10%);

b. Past effectiveness and plans to work with partners in other, relevant organizations (e.g., letters of support/commitment) to accomplish RRT tasks and goals (weight = 10%);

3. Demonstration of an existing RRT with functioning core infrastructure necessary for carrying out the objectives of this agreement (as detailed in Section IV.2 PHS 398 Research Plan Component part (h), above). (weight = 20%).

Note: ONLY the criteria and scoring described above (Criteria 1-3) will be used for scoring during the review of applications for this announcement. Reviewers may consider the additional criteria described below as they relate to the criteria described above, but separate scores will not be given for the items described below.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?  

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?   

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?  

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

Not Applicable

Inclusion of Women, Minorities, and Children 

Not Applicable

Vertebrate Animals

Not Applicable

Biohazards

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.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations

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

Select Agent Research

Not Applicable

Resource Sharing Plans

Not Applicable

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. For instance, does the amount requested from FDA appear reasonable as partial support of the total work plan, facilities, staff, etc.? Is the budget organized, reasonable and clearly stated? Does the budget account for the proposed work plan?

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Panel in accordance with FDA's Objective Review Policy and Procedures, using the stated review criteria.

As part of the objective review, all applications will receive a written critique.

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

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

3. Anticipated Announcement and Award Dates

After the review of the application is completed, the PD/PI will receive his or her Summary Statement (written critique) via email.

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

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted in the HHS Grants Policy Statement.

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards include the DHHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and 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 will 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 will attend an annual face-to -face RRT meeting (as determined by FDA OP) as a condition of the award. 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, VNRFRPS or FSMA Recall/Response/Inspections Cooperative Agreements, 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.

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) will 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 will 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 will also be working 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 and may include an audit of the assessment and improvement plan under the MFRPS. 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 will be reached by consensus between the PI and the

PS, PO and that the FDA staff will 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) will 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 will 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 FOA. 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 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 will retain custody of and have primary rights to all data developed under these awards.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non -Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the HHS Grants Policy Statement.

A mid-year Progress Report is required no later than 180 days after the award and beginning of the budget period. The mid-year Progress Report should contain a description of project activities covering a six-month period.

A final report of the outcomes of the grant and a final Financial Status Report (FSR) are required within 90 days of the expiration date of the project period as noted on the Notice of Grant Award, and in the HHS Grants Policy Statement.

Mid-year and Final reports must contain, but are not limited to the following:

1. General Progress on Cooperative Agreement Project

Detailed narrative demonstrating progress and conformance with milestones and expected achievements as outlined in Section I part III (Milestones).

Detailed narrative demonstrating maintenance of requirements for RRT membership and functions as outlined in Section I parts I.C and I.D, as well as progress and achievements with any special projects identified by the grantee in their application or subsequent to receiving funding.

2. Summary of significant RRT responses or other activities within the timeframe for the report, including:

A) Documentation of subsequent recommendations and accompanying implementation status as required under Milestone 4.A in Years 1, 2 and 3 of the award; and

B) The following baseline response data points (from the RRT Best Practices Manual Metrics Chapter):

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 Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the HHS Grants Policy Statement for additional information on this reporting requirement.

The program project officer will monitor award recipients 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 will also be working with the FDA District Offices in development, training, and exercises for the developing Rapid Response Team. 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.

Section VII. Agency Contacts

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

Application Submission Contacts

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

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

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

Scientific/Research Contact(s)

Lauren Yeung
FDA/ORA/Office of Partnerships
12420 Parklawn Drive; ELEM-3025
Rockville, MD 20857
Telephone: (301) 796-6623
Email:  lauren.yeung@fda.hhs.gov

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

Objective Review Contact(s)

Jennerfer Torres-Hernandez
Office of Acquisitions and Grants Services (OAGS)
5630 Fishers Lane
Rockville, MD 20857
Fax: 301-827 -1044
Email: Jennerfer.Torres-Hernandez@fda.hhs.gov

Financial/Grants Management Contact(s)

Jennerfer Torres-Hernandez
Office of Acquisitions and Grants Services (OAGS)
5630 Fishers Lane
Rockville, MD 20857
Fax: 301-827 -1044
Email: Jennerfer.Torres-Hernandez@fda.hhs.gov

Section VIII. Other Information

Recently issued trans-FDA policy notices may affect your application submission.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Section 301 and 317R of the Public Health Service Act as amended (42 USC 241 and 247b-20), Section 311 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

This program is described in the Catalog of Federal Domestic Assistance 93.103 at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372.


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