and Human Services (HHS)
EXPIRED
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. |
Office of Regulatory Affairs (ORA) |
|
Funding Opportunity Title |
Food Protection Rapid Response Teams (U18) |
Activity Code |
U18 Research Demonstration Cooperative Agreements |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-FD-12-013 |
Companion Funding Opportunity |
Not applicable |
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 five cooperative agreements to be awarded under a Limited Competition. These cooperative agreements are intended to develop, implement, and sustain an all-hazards food emergency Rapid Response Team (RRT) concept, encompassing both food and feed protection programs, within the national integrated food safety system. Preparing for and effectively responding to foodborne outbreaks, documenting results in a transparent manner, and identifying potential preventive practices are all significant elements of an effective RRT. Implementing the RRT concept facilitates long-term improvements to the national food safety system by strengthening intra-agency and interagency collaboration, both to improve effectiveness of multiagency responses and to build programs on nationally shared best practices and tools. This will be accomplished through the provision of funding for program improvement and will require extensive cooperation and coordination with critical state agencies, FDA District Offices, and other FDA program offices. Effective leveraging of resources and harmonization of efforts will also require collaboration with relevant initiatives, including those of federal partners (e.g., the Centers for Disease Control and Prevention (CDC)), national initiatives and associations, and State and local partners. |
Posted Date |
May 3, 2012 |
Open Date (Earliest Submission Date) |
May 7, 2012 |
Letter of Intent Due Date |
May 23, 2012 |
Application Due Date(s) |
July 6, 2012 by 5:00 PM local time of applicant organization. |
AIDS Application Due Date(s) |
Not applicable |
Scientific Merit Review |
July or August 2012 |
Advisory Council Review |
Not applicable |
Earliest Start Date(s) |
September 2012 |
Expiration Date |
July 7, 2012 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide, except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR), in collaboration with the Office of Foods, the Center for Food Safety and Applied Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM), is announcing the availability of up to 5 cooperative agreements to be awarded under a Limited Competition. Only States with current FDA food safety inspection contracts (providing funding to State agency food protection regulatory programs) and are enrolled in the Manufactured Food Regulatory Program Standards (MFRPS) will be eligible to apply. The FDA only guarantees one year of funding with the possibility of up to two years of additional, non-competitive support, contingent on performance and continued availability of federal funds.
These cooperative agreements are intended to develop, implement, and sustain an all-hazards food emergency Rapid Response Team (RRT) concept, encompassing both food and feed protection programs, within the national integrated food safety system. Preparing for and effectively responding to foodborne outbreaks, documenting results in a transparent manner, and identifying potential preventive practices are all significant elements of an effective RRT.
Implementing the RRT concept facilitates long-term improvements to the national food safety system by strengthening intra-agency and interagency collaboration, both to improve effectiveness of multiagency responses and to build programs on nationally shared best practices and tools. This will be accomplished through the provision of funding for program improvement and will require extensive cooperation and coordination with critical state agencies, FDA District Offices, and other FDA program offices. Effective leveraging of resources and harmonization of efforts will also require collaboration with relevant initiatives, including those of federal partners (e.g., the Centers for Disease Control and Prevention (CDC)), national initiatives and associations, and State and local partners.
Improving rapid response capabilities under these cooperative agreements requires achievement of the following six elements over the course of the project period:
1. RRT Development
Development of an RRT includes identification and development of a collaborative approach (see element 2: Collaboration, below) and RRT structure for training, response, report generation, etc.. The approach and structure must support the implementation of RRT best practices over multiple years and demonstrate increasingly effective responses to food emergencies. The specific structures, plans, and their implementation may vary from RRT to RRT, but each should include common core elements as identified in the RRT Best Practices Manual (described in Section I.B.2 - The RRT Concept Framework and Best Practices Manual) and definable capabilities and measures that can be shared for replication by others.
The building of the RRT would draw on best practices from the initial RRT development efforts identified by the 9 RRT Pilots (in CA, FL, MA, MI, MN, NC, TX, VA, and WA) under the Food Protection Rapid Response Team and Program Infrastructure Improvement Prototype and Implementation Projects. These RRTs would also contribute to existing documented RRT best practices (i.e., the RRT Best Practices Manual) to further develop the national framework for rapid response for food or feed emergencies. RRTs will also be encouraged to contribute to training non-RRT states, expected to use existing commodity-specific investigation tools and contribute to development of additional commodity-specific investigation tools.
2. Collaboration
Collaboration for the RRT concept must involve working closely with FDA District Offices and other relevant partners in the RRT project such as federal, state, and local agencies; epidemiology and laboratory counterparts; and other RRTs. These groups would be engaged significantly to accomplish project requirements and develop effective models for responding to food and feed incidents. RRTs must demonstrate improvement on achievement levels in areas such as "Working With Other Agencies," described in the RRT Best Practices Manual. In addition, collaborations should be developed between RRTs and other initiatives, such as the FDA Coordinated Outbreak Response and Evaluation (CORE) Network, FDA Food Protection Task Forces, CDC Foodborne Diseases Centers for Outbreak Response Enhancement (FoodCORE) Sites, CDC FoodNet, and CDC Environmental Health Specialists Network (EHS-Net). RRTs will also be required to participate fully (at least two senior RRT staff) in yearly face to face meetings and in DFSR sponsored webinars (approximately quarterly).
3. RRT Assessment
Assessment for each RRT will involve continual self-assessment against RRT concepts, elements, and metrics identified in the RRT Prototype and Implementation Projects. DFSR will inform the Principal Investigators (PIs) of the exact assessment elements for each year. These assessment efforts would result in updates of program improvement plans. In addition, RRTs must contribute to the development of and annually apply metrics for each of the six elements of the RRT project outlined in the program objectives (Section I.A.1-6: RRT development, collaboration, assessment, incorporation, implementation and exercise, and documentation).
4. RRT Incorporation
Incorporation of the RRT concept requires that each program identify and implement processes to ensure that the core rapid response capabilities developed through these cooperative agreements are fully integrated into the existing system, outside of this funding, and can be sustained beyond the end of these cooperative agreements. All applicants must identify estimated capacities of the rapid response capabilities proposed in the application that can be sustained for 2 years after the conclusion of the project period. This includes general plans for leveraging resources to incorporate the RRT concept (and the staff to maintain it) into existing resources to achieve the level of capacity identified. This incorporation plan and a timeline must be further developed during the first year; implementation must be on track through any additional years of the project.
5. RRT Implementation and Exercise
The RRTs funded under these cooperative agreements will conduct responses for both real emergencies and planned exercises to demonstrate and test the RRT capabilities developed. Planned exercises should address the core elements of rapid response as identified by the 9 Pilot RRTs (which began in 2008) and as indicated by the annual RRT assessment conducted.
6. Documentation
Documentation for the RRT concept requires that RRTs work with all relevant agencies to capture activities and lessons learned in documents such as the RRT Best Practices Manual throughout the development, assessment, incorporation, and exercise of the RRT concept. This includes providing summary reports and documenting after action reviews conducted following responses to incidents and exercises. This documentation effort also involves working with FDA to identify benchmarks and develop and apply metrics (quantitative measures) for these rapid response capabilities. Such documentation will serve to record and demonstrate accomplishments, provide a tool for other programs to evaluate and adopt similar capabilities, and identify recommendations for incorporation into other national initiatives (e.g., national standards).
The RRT concept must also incorporate Incident Command System (ICS) concepts for responses to food and feed incidents. This is in accordance with Homeland Security Presidential Directive #5 (Management of Domestic Incidents), which directs federal agencies to adopt the National Incident Management System (NIMS), with ICS concepts, and to work with state and other partners in adopting NIMS. Agencies working in emergency response will increasingly need to ensure appropriate training and utilization of ICS in emergency response work to ensure effective, efficient, and expandable responses in emergencies. Federal, state, and other partners involved in this program must develop capabilities that are in accordance with NIMS/ICS.
The goal of developing and sustaining an RRT is in concert with long-term goals to enhance foodborne illness response programs throughout the nation and to align with national initiatives such as the President’s Food Safety Working Group; the FDA’s efforts to build a national, fully integrated food safety system; the Bioterrorism Act; the FDA Food Safety Modernization Act (FSMA); the Import Safety Action Plan (ISAP); and the Food and Drug Administration Amendments Act of 2007 (FDAAA). (These are described further in Section I.D. - Overall Project Background.)
Finally, these Support Project funds are intended to supplement and not replace state funding for 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.
B. All-Hazards Food/Feed Rapid Response Teams (RRT) Concept
1. RRT Concept Background
The complex challenges in the food safety arena require novel and creative responses. The scope and complexity of each outbreak vary significantly. Examples of complex activities that may be required include extensive in-plant inspections, environmental investigations including environmental and human/animal sampling, and examining data or invoices from a web of inter-related firms throughout a state. Repeatedly, routine Good Manufacturing Practice (GMP) inspection procedures have been ineffective for understanding how foodborne outbreaks occurred, supporting the need to engage multidisciplinary approaches such as epidemiologically-based environmental investigations. In light of new, complex challenges in food safety, there is a continued need to develop multiagency and multidisciplinary approaches to facilitate effective responses that can initiate quickly upon identification of foodborne outbreaks or other food protection emergencies.
To address these concerns, this cooperative agreement seeks to develop, implement, improve, and integrate an RRT Concept that incorporates both innovative ideas and core capabilities to optimize effective and rapid resolution of food and feed incidents. This effort is in line with related, long-term, national initiatives such as the Food Safety Modernization Act (see Section I.D. - Overall Project Background) and works alongside related programs, such as the CDC's FoodCORE, FoodNet, and EHS-Net programs, FDA CORE Network, the CIFOR Guidelines and Toolkit, the National Integrated Food Safety System initiative, programs associated with implementation of the FSMA, etc. to improve the various, interdependent facets of food incident response.
2. The RRT Concept Framework and Best Practices Manual
The RRT project works to develop and implement the foundation of rapid response capabilities, using the framework identified during the RRT Prototype Project that identifies how the five phases (preparedness, surveillance and detection, investigation, control and mitigation, and post-response and prevention) of a response to a food/feed incident must all be addressed. The framework also delineates four core elements (collaboration, communication, policies and procedures, and resources) that are essential to having an effective capability for each of these phases. Lastly, this framework identifies how continuous improvement and sustainability must be involved throughout the entire system.
Documents such as the RRT Best Practices Manual align with this framework and demonstrate how the RRTs are building tools and experience for successful implementation of this concept. The RRT Best Practices Manual is a collection of best practices (e.g., lessons learned, tools) identified by the 9 pilot RRTs. This describes best practices for response capabilities identified by the pilots as foundational for conducting effective multiagency responses.
3. RRT Functions
i. 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 and emergencies (e.g., natural disasters, bioterrorism) from farm to table. Although the states involved in this cooperative agreement all have varied circumstances and needs, each RRT will include relevant partner organizations (including FDA District Offices, other RRTs, partner regulatory and public health agencies, etc.) in the decision-making process and optimize the use of resources while aligning with preparedness plans. When appropriate or necessary, the RRT (representing all relevant agencies) will use expandable ICS protocols and structures to stop an outbreak and mitigate the problem. When possible and appropriate, RRTs will work to identify sources of contamination and contributing factors for the outbreak, reaching conclusions and possible interventions for the prevention of future causes. The capabilities described in the RRT Best Practices Manual that has been developed is expected to be incorporated into state and local programs so that they may remain viable beyond the project period of this cooperative agreement.
ii. Traceback Capabilities
As part of RRT implementation, 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 RRT pilots and other relevant initiatives (e.g., the CIFOR Guidelines); and addressing areas of improvement based on after action reviews of responses and exercises. RRTs should continue to identify best practices in traceback, including exploration of different approaches and tools (e.g., industry resources, 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.
iii. Recalls and Market Withdrawals of Food Products/Foodborne Illness Reporting
As part of RRT implementation, State and federal partners would continuously improve the effective use of its resources to remove suspect or contaminated products from commerce. This work optimizes the program’s work in the 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 for each incident) could include training of State and local resources, working with industry groups, major distributors and others, and considering the use of emergency response resources to facilitate the effective removal of product from the State. The State would work with partners at the 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 States.
iv. Communication 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, county public health officers, county agricultural commissioners, university researchers and extension programs, Food Emergency Response Network (FERN) laboratories, and other information sources such as FoodSHIELD. It is also important to obtain 24-hour emergency phone numbers for contact persons, become familiar with strengths and weaknesses of existing databases for tracebacks and for locating growers, shippers, packers, wholesalers, and retailers.
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 Located at http://www.grants.gov/ and http://www.fda.gov/ora/fed_state/food_safety/default.htm.
Other areas of coordination include with CDC programs (e.g., the Food Safety Office; Division of Foodborne, Waterborne, and Environmental Diseases; Environmental Health Services Branch) and with partners at the US Department of Agriculture (USDA) and the Department of Homeland Security (DHS). These programs have relevant goals and activities for food incident response that should be coordinated with RRT activities whenever possible. Other relevant initiatives include the Council to Improve Foodborne Outbreak Response (CIFOR), which has provided recommendations for program policies in foodborne outbreak response, and the FERN, a nationally integrated network of food-testing laboratories that can support emergency responses.
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/
v. Other Relevant Activities
Other valuable activities for the RRT may include on-site evaluation of a high risk food, as identified under the Manufactured Food Regulatory Program Standards (MFRPS) Standard #3, commodity, or specific type of manufacturer or processor (such as Low-Acid Canned Foods (LACF)/Acidified Foods) per year, or participation in a special study and assessment (e.g., CARVER+Shock) to provide additional insights into how food may become contaminated. The exercise/evaluation should be done in collaboration with the FDA District Office and other relevant organizations. Where appropriate, the exercise should be in accordance with guidance established in the DHS Homeland Security Exercise Evaluation Program (HSEEP). 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, and needed improvements.
4. Rapid Response Team Members
i. 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), Food Emergency Response Plans, etc. 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.
Other duties/responsibilities of the RRT members could include:
a) Training
Complete detailed training in subjects, including those identified by the RRT pilot project (draft set of Best Practices, developed during the Prototype project). General training needs include training in the basics (e.g. ICS 100 and 200, sampling techniques), expected training (e.g. foodborne investigations, traceback, ICS 300 and 400), and advanced training (e.g. commodity-specific products).
Additional staff in the food and feed protection programs and in other relevant organizations should also be trained in the event that additional assistance is needed. RRT members should also provide training for other local, state or federal investigators and industry groups. It is important to note that the team should not be viewed as the group that would complete all aspects of each incident investigation. For example, withdrawals, recalls, and verifications may be completed by other State and/or federal staff.
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 process). 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.
ii. Epidemiologists, Feed, Laboratory and Local Representatives
a) Feed Representative
Each Rapid Response Team should include at least one person representing the State’s feed regulatory program. The definition of food in section 201 of the 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.
b) Epidemiologists
Each Rapid Response Team should ensure inclusion, at some level of direct participation, of representatives from feed, epidemiology, surveillance, and laboratory programs. Specifically, applicants must include participation of an epidemiologist, representing the State’s entity with primary responsibility for surveillance and epidemiological investigations. 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.
c) Laboratory Support
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. 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. Microbiologists will provide current information on emerging pathogen analytical methodology and servicing lab capability. The microbiologists 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.
d) Local Health Partners
As each Rapid Response Team develops, it should begin to incorporate key local health department partners. 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.
C. Milestones
For all of the awarded projects, 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 goals and objectives. FDA anticipates these cooperative agreements to be 3-year projects, with milestones for each year that must be addressed in the application. (Note that funding is only guaranteed for one year; funding for the second and third years is contingent on performance and continued availability of federal funds.) Each year’s milestones for each project should provide a timeline to fully develop, build, and achieve sustained capacity for food safety and response program objectives. It is in the best interests of the FDA to maintain all of these cooperative agreements for the full 3-year funding cycle.
This limited competition will allow for FDA to provide funding to current State manufactured food regulatory programs in order to meet FDA’s goal of enhancing current food protection programs in accordance with various national initiatives and priorities. The funding will provide awardees the opportunity to develop and maintain rapid response teams and other program enhancements in their manufactured food protection programs to positively impact the public health.
In completing the application, the following yearly milestones/expected accomplishments should be taken into account:
Year 1 Milestones
1. RRT Development/Documentation:
a. Complete initial development of the RRT. This includes hiring and placement of all proposed staff and implementation of the collaborative structure proposed in the application by no later than the end of the year.
b. Assess and implement training plans for each RRT member in accordance with RRT best practices.
c. Utilize best practices and tools for specific investigations (e.g., particular commodities, disasters).
d. Complete summary reports of significant RRT investigations.
2. Collaboration:
a. Hold at least two joint face-to-face meetings and one joint training among partners involved including State health and agriculture agency representatives, feed program staff, laboratory staff, and epidemiology and surveillance staff, along with appropriate senior FDA District managers/staff.
b. Actively participate in a web-based introductory meeting involving all RRTs, FDA CORE, Districts, and Regional Offices in the first quarter.
c. Initiate collaborations that functionally include related initiatives (e.g., CDC FoodCORE, FoodNet, EHS-Net), including those identified in the project application.
d. Provide input on information technology (IT) solutions to identified collaboration challenges, where appropriate.
e. Attend the mandatory annual RRT meeting with a minimum of two senior state RRT staff.
3. RRT Concept Assessment:
a. Complete an assessment of RRT capabilities, including against models described in the RRT Best Practices Manual and through the assessment process identified by DFSR.
b. Develop a program improvement plan (strategic plan) based on the outcome of the self-assessment.
4. RRT Concept Incorporation:
Plan sustainability processes for the RRT capabilities in greater detail than the original application (including a timeline) and initiate plan by the end of the first year.
5. RRT Concept Implementation/Exercise:
Demonstrate improvement and standardization in traceback capabilities.
Year 2 Milestones
1. RRT Concept Development/Documentation:
a. Demonstrate improvement of core capabilities in areas of need, as identified in the assessment conducted in year one.
b. Contribute to add to or improve upon at least 3 rapid response capabilities to update the RRT best practices and associated benchmarks/metrics (developed by the 9 Pilot RRTs) and further develop the framework for response to food/feed emergencies (see Section 2.I.B). This should include contributing to developing best practices and tools for specific investigations (e.g., particular commodities, disasters).
c. Complete after action reviews and summary reports in a timely way for exercises and responses to significant real incidents. Reports of significant investigations posted on the state agency’s webpage and copies provided to DFSR for posting on the FDA RRT webpage.
d. Develop metrics for the elements of the RRT project described in program objectives: RRT development, collaboration, assessment, incorporation, implementation/exercise, and documentation (See Section IA).
e. Conduct at least one presentation (oral or poster) about the development the RRT or documenting a specific RRT investigation at a regional or national meeting.
2. Collaboration:
a. Demonstrate effective collaboration with other RRTs (through both national RRT initiatives and unique projects initiated with at least 1 other RRT) to develop the RRT concept and support a national framework for improved rapid response. National RRT initiatives may include developing IT solutions to improve collaboration on epidemiology, laboratory, and environmental health/traceback data.
b. Hold quarterly meetings of the RRT that include previously identified partners (e.g., senior staff from FDA District Offices, other state partners, local).
c. Continue development of collaborations with other initiatives (e.g., FoodCORE).
d. With support from FDA, contribute to the development of training courses in key areas of rapid response (e.g., for non-RRT states, for specialized investigations, to advance the RRT Manual).
e. Attend the mandatory annual RRT meeting with a minimum of two senior state RRT staff.
3. RRT Concept Assessment:
a. Complete an assessment of RRT capabilities through the assessment process identified by DFSR. This should demonstrate progress as proposed in the Year 1 improvement plan.
b. Update improvement plans.
4. RRT Concept Incorporation:
Meet scheduled milestones in the RRT's plan to incorporate RRT capabilities, including ensuring continuation of staff resources for beyond the end of the project.
5. RRT Concept Implementation/Exercise:
Conduct at least one planned, joint exercise that includes federal and state partners.
Year 3 Milestones
1. RRT Development/Documentation:
a. Demonstrate improvement of core capabilities in areas of need, as identified in the assessment conducted in year two.
b. Participate in the development and implementation of individual RRT and project-wide recommendations for national guidelines and standards for rapid response.
c. Complete after action reviews and summary reports in a timely manner for all exercises and responses to real incidents. Reports should demonstrate implementation of corrective actions for problems identified in previous reports. Reports of significant investigations posted on the state agency’s webpage and copies provided to DFSR for posting on the FDA RRT webpage.
d. Document completion of achievements and lessons learned from RRT development, assessment, implementation, and incorporation. This includes further development and application of the metrics for the RRT project elements developed in Year 2 (see Milestone 2.ii.d).
e. Conduct at least one presentation (oral or poster) about the development the RRT or documenting a specific RRT investigation at a regional or national meeting.
2. Collaboration:
a. Document improved information and communication systems collaboration with FDA, health, emergency management, feed, and lab partners for activities related to food/feed emergencies. This may include a baseline evaluation at the beginning of the year and demonstrated improvement by the end of the year (in a documented or quantitative way, such as increased number of joint meetings/reports, inclusion of more local partners, improved training plans and implementation, etc.).
b. Hold quarterly meetings of the RRT that include previously identified partners (e.g., senior staff from FDA District Offices, other state partners, local). With support from FDA, the RRTs will contribute to the development of training courses in key areas of rapid response (e.g., for non-RRT states, for specialized investigations, to advance the RRT manual).
c. Continue development of collaborations with other initiatives (e.g., FoodCORE).
d. Attend the mandatory annual RRT meeting with a minimum of two senior state RRT staff.
3. RRT Concept Assessment:
a. Complete an assessment of RRT capabilities through the assessment process identified by DFSR. This should demonstrate progress as proposed in the Year 2 improvement plan.
b. Update improvement plans.
4. RRT Concept Incorporation:
Meet scheduled milestones in the RRT's plan to incorporate RRT capabilities, including ensuring continuation of staff resources for beyond the end of the project.
5. RRT Concept Implementation/Exercise:
a. Demonstrate successful use of the improved capability during an exercise or incident and of continued improvement in traceback processes. These improvements will be supported with quantitative values (e.g. metrics), where appropriate.
b. Conduct at least one planned, multistate exercise that includes federal and state partners.
D. Overall Project Background
Over the past several years, the food safety system has continually 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. Described below are some key national-level initiatives that demonstrate the interest and need for initiatives like the RRT.
1. 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. 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. While the RRT program funded through these cooperative agreements has greatest emphasis on the third principle (response and recovery), RRTs would also be required to maintain enrollment in the MFRPS to further develop the state food program infrastructure necessary to support the RRT. This is not only because it would support the response, but also to address the key program elements of prevention, surveillance, and enforcement, the first two FSWG principles.
Furthermore, the FSWG has committed to work to modernize food safety by building collaborative partnerships with consumers, industry and our regulatory partners [and] [t]hrough a transparent process, build a food safety system that will meet the challenges posed by a global food supply in the 21st century. These cooperative agreements will help to further achieve these goals, identifying and implementing novel approaches to collaboration in response and strengthening the food safety system in a way that will ultimately extend beyond state borders to have an impact on both national food safety and the associated international food supply.
2. National Integrated Food Safety System
FDA is continuing to work with its state partners to create a national, fully integrated food safety system that is characterized by effective communication and efficient processes among federal, state, and local partners in the food safety system. Various initiatives, such as the Food Safety Task Force Program, Innovative Food Defense Program, and the programs supported by these cooperative agreements, work to engage partners across multiple sectors of the food safety system to collaborate to identify means to improve and optimize the nation’s food safety system.
3. 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.
4. 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 the following five titles:
Title I National Preparedness for Bioterrorism and Other Public Health Emergencies
Title II Enhancing Controls on Dangerous Biological Agents and Toxins
Title III Protecting Safety and Security of Food and Drug Supply
Title IV Drinking Water Security and Safety
Title V Additional Provisions
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.
5. 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. Section 1004 of FDAAA states:
SEC. 1004. STATE AND FEDERAL COOPERATION
(a) IN GENERAL. The Secretary shall work with the States in undertaking activities and programs that assist in improving the safety of food, including fresh and processed produce, so that State food safety programs and activities conducted by the Secretary function in a coordinated and cost-effective manner. With the assistance provided under subsection (b), the Secretary shall encourage States to
(1) Establish, continue, or strengthen State food safety programs, especially with respect to the regulation of retail commercial food establishments; and
(2) Establish procedures and requirements for ensuring that processed produce under the jurisdiction of State food safety programs is not unsafe for human consumption.
(b) ASSISTANCE. The Secretary may provide to a State, for planning, developing, and implementing such a food safety program
(1) Advisory assistance;
(2) Technical assistance, training, and laboratory assistance (including necessary materials and equipment); and
(3) Financial and other assistance.
(c) SERVICE AGREEMENTS. The Secretary may, under an agreement entered into with a federal, State, or local agency, use, on a reimbursable basis or otherwise, the personnel, services, and facilities of the agency to carry out the responsibilities of the agency under this section. An agreement entered into with a State agency under this subsection may provide for training of State employees.
6. 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 provides as follows:
Federal-State Rapid Response
Recommendation 12 Maximize Federal-State Collaboration.
The roles of and the resources used by the federal government and the States in import safety are complementary. States possess legislative authority and resources to respond to unsafe imported products within their jurisdiction. The federal government can take steps to interdict unsafe imported goods at ports-of-entry. Should an unsafe product enter domestic commerce, federal departments and agencies often work with State authorities to track it down, seize it, notify the public if it has already been purchased by consumers, and impose appropriate penalties on domestic entities who violate U.S. law. Also, both the federal government and States may have access to information relevant to protecting consumers that the other does not possess. For example, federal departments and agencies may have relevant information about the foreign source of the imported product and about the importer. This information can help State officials track down an unsafe imported product within their jurisdiction. On the other hand, State officials may identify an unsafe imported product during transport or at the point-of-sale, if the product does get into the country, and can tip-off federal officials to prevent future shipments from entering domestic commerce.
Several federal departments and agencies already collaborate closely with State authorities to protect consumers. For example, FDA has contracts and cooperative agreements with State governments to share information, conduct joint inspections, and collaborate on laboratory analyses. Greater mutual leveraging of State and federal resources can further enhance consumer protection.
12.1 Consider cooperative agreements between the federal inspection agencies and their State counterparts for greater information-sharing. Such cooperative agreements would not infringe on the statutory authorities of federal or State regulators and would encourage a coordinated effort that would result in a more rapid and effective response. Establishing clear procedures and points-of-contact for information sharing and joint enforcement efforts can further enhance the effectiveness of federal-State actions to limit exposure and potential harm to consumers if an unsafe imported product makes it into domestic commerce.
Leads: HHS / FDA, USDA, CPSC, EPA Time Frame: Long Term
12.2 Review admissibility policies to improve the use of evidence and laboratory results from State investigations of imported products. Currently, there are limitations on the use of State-developed evidence in federal court cases due to the gathering, analysis and retention of such evidence by non-federal government entities. Being able to use this evidence would make it easier for federal departments and agencies to take enforcement actions against bad actors.
Leads: DOJ, HHS / FDA, USDA, CPSC Time Frame: Short Term
In combining these actions with the Homeland Security Presidential Directives to develop NIMS and to train Federal, State, and Local Government personnel in ICS, these cooperative agreements are intended to follow the constructs of all the above in supporting the infrastructure of the State programs to implement those activities and sustain them into the future.
FDA is offering these cooperative agreements to state governments to support the continued development of response programs through the enhancement of the capabilities of their existing manufactured food regulatory programs.
Funding Instrument |
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. |
Application Types Allowed |
New The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types. |
Funds Available and Anticipated Number of Awards |
FDA intends to commit approximately $1.5 million to this cooperative agreement program in FY 2012. It is anticipated that up to five (5) awards will be made, not to exceed $300,000 in total costs (direct plus indirect) per award, per year. The number of awards is contingent upon FDA appropriations, and the submission of a sufficient number of meritorious applications. Funding will be provided for one year, with the possibility of up to two years of additional support, contingent on performance and continued availability of federal funds. |
Award Budget |
Application budgets are limited to $300,000 (direct and indirect costs), but need to reflect actual needs of the proposed project. |
Award Project Period |
The total project period for an application requesting support may not exceed three years. |
FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.
Governments
This opportunity is only available to the following State manufactured food regulatory programs:
State manufactured food regulatory programs with current FDA food safety inspection contracts (providing funding to State agency food protection regulatory programs) are eligible to apply for funding under this cooperative agreement. In addition, the State manufactured food regulatory program must also be enrolled in the Manufactured Food Regulatory Program Standards (MFRPS). State programs receiving funds through the Food Protection Rapid Response Team (RRT) Infrastructure Improvement (or Prototype) Project (referred to as the RRT pilots) are not eligible to apply.
Competition is limited to these State manufactured food regulatory programs because the foundational work conducted under the current FDA food safety inspection contracts is necessary for the completion of significant improvements in a nationally integrated food safety system. State manufactured food regulatory programs must also be enrolled in the MFRPS. The MFRPS identifies the elements of a high quality regulatory program, which includes foodborne illness outbreak and response capabilities. The development, implementation, and sustainability of rapid response capabilities for food and feed emergencies will assist the State program in achieving conformance with the MFRPS. In addition, the MFRPS provides the foundation necessary for building, implementing, and sustaining rapid response capabilities.
Both the Food Protection Rapid Response Team (RRT) Infrastructure Improvement and Prototype Project Cooperative Agreements (referred to as the RRT Project) have objectives of building, implementing, and sustaining rapid response capabilities to food or feed emergencies. The work performed by these 9 pilot programs under the RRT Project provides the framework for other State programs to develop and implement RRTs. State programs currently in the RRT Project should have made significant progress towards achieving the objectives stated in this RFA. Therefore, State programs that are receiving funding under these cooperative agreements are not eligible to apply for this cooperative agreement.
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.
All Program Directors/Principal Investigators (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 4-6 weeks prior to the application due date.
Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her eligible organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for FDA support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple
Program Director/Principal Investigator Policy and submission details in the Senior/Key
Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the HHS Grants Policy Statement.
FDA will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.
Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA staff to estimate the potential review workload and plan the review.
A technical review session will be held for prospective grantees in May or June 2012. The conference call information will only be provided to prospective grantees that submit a letter of intent. The technical review session will provide an overview of the submission requirements and allow prospective grantees an opportunity to ask questions regarding the application process. Participation in the technical review session is optional, but strongly encouraged.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent electronically to:
Lisa Ko
Office of Acquisitions and Grants Services
Email: [email protected]
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.
All page limitations described in the SF424 Application Guide and must be followed, with the following exception:
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.
A. Demonstrate the availability of adequately trained food program staff (including field staff, supervisory staff, and support staff) and the criteria to hire and/or train personnel to conduct food program activities, including assessment and implementation.
B. Demonstrate both the availability of adequately trained personnel to support the activities required under this cooperative agreement and the agency's commitment to and support for this project, including the implementation of the RRT.
C. Provide a properly detailed budget (one for each of the three years) that is intended to implement the RRT concept and enhance the food protection program in the State. Include the previous and current year s State funding for the program, including program staffing and costs. Demonstrate the ability to satisfy the reporting requirements outlined in this announcement.
D. Provide previous and current funding level certification for the food safety program from State funding appropriations.
E. Outline a detailed methodology for program assessment, improvement, development, and collaboration to accomplish the work, as described in this announcement.
F. Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs.
G. Clearly describe how the program will develop and implement FDA-state communication procedures to ensure appropriate notification of partners upon the activation of an RRT and the completion of an after-action report (AAR), as warranted by the situation.
H. Outline the estimated capacity of rapid response capabilities of the program that will be sustained beyond the end of the project period. Outline the plan to incorporate the RRT into the existing state program (i.e., sustainability of the RRT) during the course of the 3-year cooperative agreement.
I. Laboratory Facilities
If funds or equipment from the cooperative agreement are provided to the State food laboratory, the applicant must provide at the completion of the first year of funding a complete description of the facilities (unless it is the same as in previous years, 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. 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.
Other facilities information that may be required includes:
1. Operational support areas to be used for the project, including details about the availability of ancillary laboratory safety and support equipment and facilities.
2. Details describing the sample receiving and sample storage areas and a description of any existing chain-of-custody procedures.
3. A detailed description of the proposed upgrades to existing laboratory facilities to accommodate new equipment, including drawings and cost estimates.
4. 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.
5. A summary description of staffing management, specifically including food sample testing abilities and procedures.
6. 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.
7. A description of the ability to perform and complete (or an agreement with another laboratory to do so) the feed sample analyses and provide reports of sample analyses within reasonable timeframes. A recipient's conformity to the laboratory testing procedures, methodology, and protocol employed and accepted by FDA in the assessment of feed samples is a minimum requirement for participation in this program.
Resource Sharing Plan
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.
Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA’s electronic system for grants administration.
Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All FDA awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Pre-award costs are allowable only as described in the HHS Grants Policy Statement.
The purpose of these cooperative agreements is to promote the development and enhancement of existing State food regulatory programs in providing emergency response capabilities. The cooperative agreements will provide funding for additional personnel, equipment, supplies, and training to support activities related to the development and implementation of Rapid Response Team (RRT) capabilities. Allowable and unallowable costs are delineated below.
A. Allowable:
1. Lab equipment (with prior approval from FDA) relevant to the RRT, including rental, purchasing, calibration, and maintenance.
2. Supplies (laboratory, administrative, sampling)
3. Team development, training, and exercises
4. Training and professional development, including registration fees, per diem and travel (not to exceed coach fare)
5. Consultant services
6. Travel and per diem to meetings with FDA District/Regional partners, other state RRTs, FDA Headquarters, and annual face-to-face RRT meetings
7. Employee salaries, wages, and fringe benefits
8. Pass through of funds to 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.
9. Reimbursement of mileage for travel within a grant recipient's state is allowable provided that the work directly related to the RRT and complies with current Federal POV rates (http://www.fsa.gov/portal/content/100715).
10. Indirect costs
11. Recruitment costs for hiring new employees
12. Purchase or development of IT equipment, software, and support
13. Shipping and mailing of equipment and supplies
14. Speaker fees
B. Non-allowable costs
1. Facilities, work, and training reimbursed under the FDA food safety inspection contract and other funding mechanisms must remain distinct and separate from the cooperative agreement. The State 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.
2. These cooperative agreements are not to fund licensed medicated feed or routine feed safety good manufacturing (GMP) inspections, BSE inspections, or retail food or food service inspections, which are unrelated to the food manufacturing, processing, wholesaling, transportation or warehousing of manufactured foods, or any activities which are currently covered by an FDA food or BSE feed safety inspection contract.
3. Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.
4. Subcontracting to third party (other than State/local/county/tribal RRT members) is limited to 10% of each year's award.
5. Vehicle purchases are not permitted.
6. Please also refer to the HHS Grants Policy Statement for additional information regarding costs.
Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.
Important
reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the
Credential field of the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to 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 Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.
See more
tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness by the FDA Office of Acquisition and Grants 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.
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.
Only the review criteria described below will be considered in the review process. As part of the FDA mission, all applications submitted to the FDA are evaluated for scientific and technical merit through the FDA objective review process.
For this particular announcement, only the following criteria described below (Criteria A-C) will be considered in the review process.
A. The rationale and design to meet the goals of the cooperative agreement (total weight = 50%):
1. Rationale for proposed work (the need, the value, etc.) (Weight = 10%);
2. The proposed RRT structure is collaborative (e.g., includes epidemiology partners) can support the implementation of RRT Best Practices over multiple years and an appropriate plan to hire/place staff in a timely way (weight = 10%); and
3. The design appropriately addresses the expectations of activity, including rapid response capability development (including ICS concepts), collaboration, assessment, incorporation, implementation and exercise, and documentation (weight = 30%).
B. Demonstration of effectiveness in working with federal, state, and local partners to develop and share rapid response capabilities (total weight = 35%):
1. Having adequate program resources (including staff) to complete project needs (weight = 5%);
2. Past effectiveness and plans to work with partners in other, relevant organizations to accomplish emergency response tasks and goals (weight = 10%); and
3. Plans to effectively leverage relevant food safety initiatives and resources in the state (e.g., FoodNet, FoodCORE Sites, EHS-Net Sites) to optimize respective results. This should include letters of support from partner programs, including the FDA District Office (weight = 20%).
C. Demonstration of expected rapid response capabilities that can be sustained in the long-term (two years after the conclusion of the project period; expected challenges should be documented and addressed). This includes plans to achieve the incorporation of project-developed capabilities into long-term program work (weight = 15%).
Note: ONLY the criteria and scoring described above (Criteria A-C) 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?
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?
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.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
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?
Applications will be evaluated for scientific and technical merit by (an) appropriate Objective Review Panell in accordance with FDA's Objective Review Policy and Procedures, using the stated review criteria.
As part of the objective review, all applications:
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.
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.
If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA)
will be provided to the applicant organization for successful applications. The
NoA signed by the grants management officer is the authorizing document and
will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to the DUNS,
CCR Registration, and Transparency Act requirements as noted in the HHS Grants Policy
Statement.
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. The grantee must also maintain
enrollment in the MFRPS throughout the cooperative agreement and demonstrate
progress in achieving conformance with the MFRPS.
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. Key RRT personnel will attend an annual face-to-face RRT meeting (as determined by FDA DFSR) as a condition of the award.
Facilities, work, and training reimbursed under the FDA food safety inspection contract and other funding mechanisms 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 DFSR 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.
Awardee will work with the appropriate FDA staff to develop and implement an appropriate rapid data release policy.
Key RRT players will be required to attend the annual face-to-face RRT meeting, as defined by the PS/PO. The awardee should identify funds within the cooperative agreement for travel and plan accordingly.
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. Periodic site visits with officials of the recipient organization may also occur.
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; compliance and program standards audits; RRT exercises and coordination; and other activities necessary for the development of self-assessment and strategic improvement plans and implementation. There may be other regular meetings with recipients to assist in fulfilling the requirements of the cooperative agreement.
a. Coordination, training, and exercises with FDA District and Regional RRT partners (including emergency response coordinators), the FDA Emergency Operations Center, CFSAN and CVM, 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 development of the RRT concept.
c. Engaging other relevant initiatives for the RRT such as CDC FoodCORE, FoodNet, and EHS-Net sites.
d. All cooperative agreement projects that are developed at State agency level must have existing food safety inspection and surveillance programs under contract to FDA for food safety inspections.
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.
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 progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.
Mid-year, Annual and Final reports must contain, but are not limited to the following:
1. Summary of findings/impact (please address each milestone listed in RFA and progress on activities proposed in the original application)
2. Regulatory/Surveillance activities
3. Point of Contact and Key Project 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.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
Grants.gov
Customer Support (Questions regarding Grants.gov registration and
submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding FDA grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
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: [email protected]
Shuen Chai
Food and Drug Administration
Division of Federal-State Relations
12420 Park Lawn Drive; ELEM-3042
Rockville, MD 20857
Telephone: (301) 796-5830
Email: [email protected]
Lisa Ko
Office of Acquisitions and Grants Services (OAGS)
5630 Fishers Lane
Rockville, MD 20857
Telephone: 301-827-5095
Fax: 301-827-1044
Email: [email protected]
William J. Foust
FDA/ORA/Division of Federal-State Relations
12420 Parklawn Drive, Room 3017
Rockville, MD 20857
Telephone: 301-796-3470
E-mail: [email protected]
Lisa Ko
Office of Acquisitions and Grants Services (OAGS)
5630 Fishers Lane
Rockville, MD 20857
Telephone: 301-827-5095
Fax: 301-827-1044
Email: [email protected]
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.
Awards are made under the authorization of Section 301 and of the Public Health Service Act as amended (42 USC 241 and 284), Section 311
of the Public Health Security and Bioterrorism Preparedness and Response Act of
2002 (42 USC 247b-20), 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
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