Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

U. S. Food and Drug Administration

Components of Participating Organizations

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

Funding Opportunity Title

Food Protection Rapid Response Team and Program Infrastructure Improvement Implementation Project (U18)

Activity Code

U18 Research Demonstration – Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-11-013

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility

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

93.103

FOA Purpose

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

These cooperative agreements are intended to develop, implement, and sustain replicable models of an all-hazards food and foodborne illness Rapid Response Team (RRT) concept within the national integrated food safety system.

The goal of these cooperative agreements is to facilitate long-term improvements to the national food safety system by strengthening interagency collaboration and improving States' regulatory and surveillance protection programs for manufactured foods.  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 and associations, state, and local partners.

Key Dates
Posted Date

May 4 , 2011

Open Date (Earliest Submission Date)

May 15, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

June 14, 2011 by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June, 2011

Advisory Council Review

Not Applicable

Earliest Start Date(s)

July, 2011

Expiration Date

June 15, 2011

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.

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

1. Program Objectives

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR), in collaboration with the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM), is announcing the availability of up to six 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 who are currently receiving funding under those contracts are eligible to apply for these competing continuation awards. The FDA only guarantees one year of funding with the possibility of up to one year of additional, non-competitive support, contingent on performance and continued availability of federal funds.

These cooperative agreements are intended to develop, implement, and sustain replicable models of an all-hazards food and foodborne illness Rapid Response Team (RRT) concept within the national integrated food safety system.

The goal of these cooperative agreements is to facilitate long-term improvements to the national food safety system by strengthening interagency collaboration and improving States' regulatory and surveillance protection programs for manufactured foods. 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 and associations, state, and local partners.

The infrastructure necessary to develop and sustain rapid response capabilities is established using the FDA Manufactured Food Regulatory Program Standards (MFRPS) to assess and continually improve the infrastructure and equivalency in effect of a State food regulatory program. Each partner state that is awarded funding through these cooperative agreements must demonstrate progress towards significant compliance with the MFRPS in the first year of the agreement and, given availability of funding for a second year of the agreement, achieve significant compliance with the MFRPS by the end of the second year.

Improving rapid response capabilities under these cooperative agreements requires completing development, assessment, implementation, incorporation, collaboration, and documentation/sharing of an RRT concept, encompassing both food and feed protection programs, over the course of the project period.

Development of a RRT concept includes identification and development of program elements necessary for an improved, effective rapid response to all-hazard food and feed emergencies. Such program elements would serve to build the foundation for a national framework for rapid response for a food or feed incident (described in greater detail in Section VI, 2.A.1 - Principal Investigator Rights and Responsibilities). This includes development of a clear response structure and plan and demonstrated collaboration between relevant federal, state, and local partners. The specific structures and plans may vary from RRT to RRT, but each should include common core elements (as identified in the “RRT Prototype Project,” described below) and definable capabilities (with appropriate measures) that can be shared for replication by others. This work would complete the initial RRT development efforts being undertaken under the Food Protection Rapid Response Team and Program Infrastructure Improvement Prototype Projects (RRT Prototype Project), which were initiated in 6 pilot states in 2008 and in 3 pilot states in 2009. Elements developed must be documented for sharing with other programs and for use in assessment (see “Documentation,” below).

Assessment of the RRT concept requires continual self-assessment of state program implementation of the MFRPS (see MFRPS Standard #9) as well as assessment of the RRT program elements against concepts (including benchmarks and metrics) identified in the RRT Prototype Project. The exact assessment process will be further clarified between DFSR and program principal investigators (PIs) in Year 1 of the program. Both of these assessment efforts would result in updates of program improvement plans.

The projects funded under these cooperative agreements will constitute the RRT Implementation Project.  Implementation of the RRT concept will take place across the project period. Implementation includes not only the development of elements unique and of particular interest to each RRT, but the effective implementation and enhancement of the common core elements of rapid response, as identified by RRTs as a group in during the RRT Prototype Project (which, as discussed earlier, began in 2008) and during the assessment in the first year of the RRT Implementation Project. This includes both implementation of a capability in the RRT concept as well as successful use of the capabilities in exercises and real incidents, as they occur.

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. This process, first initiated during the application process for these cooperative agreements, should be on track to be completed in two years, given availability of funding and continuation of the agreement. All applicants must identify estimated capacities of the rapid response capabilities (proposed in the application) that can be sustained through two years after the conclusion of the project period. This includes general plans for leveraging resources to incorporate the RRT concept into existing resources to achieve the level of capacity identified. This incorporation plan must be further developed (including a timeline) and initiated by the end of the first year. Should funding be available for continuation of the program for a second year, demonstrated progress on the proposed incorporation plans is expected throughout the second year.  RRTs will be expected to report on achievement of identified goals and lessons learned by the fourth quarter of the second year.

Collaboration for the RRT concept must involve working closely with FDA District Offices and other relevant partners in the RRT project (including other state/local agencies and other RRTs) to accomplish project requirements and to develop effective models for responding to food and feed incidents. This also requires that key RRT players attend the annual face-to-face RRT meeting.

Documentation for the RRT concept requires that RRTs work with all relevant agencies to document activities and lessons learned through the development, assessment, implementation, and incorporation of the RRT concept. This includes 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/demonstrate accomplishments, provide a tool for other programs for evaluation and adoption of similar capabilities, and identify recommendations for incorporation into other national initiatives (e.g., MFRPS, CIFOR).

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 achieve the following: approach a fully integrated national food safety system; enhance the food inspection and foodborne illness response programs; and verify compliance with State laws and regulations, good manufacturing practices, food defense, and, as discussed further below, other food protection requirements in support of the State program and the President’s Food Safety Working Group priorities, 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).

Finally, these Support Project funds are intended to supplement, 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.

II) All-Hazards Food/Feed Rapid Response Teams (RRT) Concept

Project Background

The complex challenges in the food safety arena require new, creative responses. The scope and complexity of each outbreak/traceback vary significantly. 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. Repeatedly, routine GMP inspection procedures have been ineffective in understanding how foodborne outbreaks occurred and supports why the inclusion of epidemiologically based environmental investigations is needed. In light of new, complex challenges in food safety, there is a continued need to develop a rapid response team concept that facilitates effective 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 resolve food/feed incidents. This effort works alongside related national programs, such as the Centers for Disease Control and Prevention (CDC) OutbreakNet Sentinel Sites (OSS) and Environmental Health Specialists Network (EHS-Net), to collaboratively improve the various, interdependent facets of food incident 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 states 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, 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 RRT compendium of “best practices” that is 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.

Discussion and Background of the RRT concept to be considered are as follows:

Rapid Response capabilities address the multiple phases involved in a food incident. This project works to develop the foundation of rapid response capabilities, using the framework identified during the RRT Prototype Project that identifies how the five phases (preparedness, surveillance/detection, investigation, control/mitigation, and post-response/prevention) of a response to a food/feed incident must all be addressed. It 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.

Rapid Response Team members

Additional duties/responsibilities of the RRT members could include:

1. Training:

Complete detailed training in subjects, including those identified by the prototype RRT project (draft set of “Best Practices,” developed during the “Prototype” project), and aligned with MFRPS Standard #2.

General Training Needs:

a. This includes 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).

b. 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.

c. RRT members should provide training for other local, State or federal investigators and industry groups.

d. 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.

“Expertise” Development:

a. Each RRT investigator should become an "expert" in at least one core component of rapid response (e.g. commodity-specific, agricultural practices).

b. 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.

2. RRT Functions

All members must be familiar with procedures (and any up dates to the procedures) associated with the RRT, including but not limited to Joint Inspection SOPs, Communication SOPs, Food Emergency Response Plans, etc.

The RRT would 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 valuable activities for the RRT may include on-site evaluation of a “high risk” food, as identified under MFRPS Standard #3, commodity, or specific type of manufacturer or processor (such as LACF/Acidified Foods) per year, or participation in a special study and assessment 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.

Additional RRT Considerations:

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, salvage d 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.

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 traine d 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.

Communication with Industry

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, 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. This is in line with concepts outlined in Standard #7 of the MFRPS.

Collaboration with other groups

The RRT should enhance relationships and partnerships with academia and with other local, State, and federal agencies involved in food protection. This is in line with concepts outlined in Standard #7 of the MFRPS.

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 overlap include the CDC programs (e.g. the Food Safety office, OutbreakNet Sentinel Sites, Environmental Health Services) and USDA FSIS partners. These programs have relevant goals and activities for food incident response that should be coordinated with RRT activities whenever possible. Another resource could be the Council to Improve Foodborne Outbreak Response (CIFOR) project, which has provided recommendations for program policies and procedures in foodborne outbreak response.

Examples can be located at:
http://www.cdc.gov/outbreaknet/index.html
http://www.cdc.gov/nceh/ehs/EHSNet/default.htm
http://www.cifor.us/

III) Manufactured Food Regulatory Program Standards (MFRPS):

The Manufactured Food Regulatory Program Standards (MFRPS) establish a uniform foundation for the design and management of State programs responsible for the regulation of food plants. The elements of the MFRPS describe best practices of a high-quality regulatory program. Implementing these standards requires a comprehensive self-assessment on the part of a State program and continuous reassessment and improvement.

The MFRPS are comprised of ten standards that establish requirements for the critical elements of a regulatory program designed to protect the public from foodborne illness and injury. These elements include the program’s regulatory foundation, staff training, inspection, quality assurance, food defense prepare dness and response, foodborne illness and incident investigation, enforcement, education and outreach, resource management, laboratory resources, and program assessment.

FDA will use the program standards as a tool in this cooperative agreement to assess and improve the program infrastructure within the States in support of this cooperative agreement. States that are awarded the cooperative agreements will be expected to achieve significant compliance with the Standards by the end of the program period.

The goal of fulfilling the MFRPS is to implement a risk-based food safety program by establishing a uniform basis for measuring and improving the performance of manufactured food regulatory programs in the United States. The development and implementation of these program standards will help federal and state programs better direct their regulatory activities at reducing and responding to foodborne illness hazards from farm to table. This includes facilitating and ensuring the effectiveness and sustainability of program elements such as improved responses to food/feed emergencies.

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

Under the RRT implementation and the MFRPS improvement plan, 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.

V) 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 2-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 year is contingent on performance and availability of 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 2-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.

Yearly Milestones:

In completing the application, the following yearly milestones/expected accomplishments should be taken into account:

Year 1:

1. RRT Concept Development/Documentation: Completion of contributions 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 FY08-FY10 RRT prototype project) and further develop the framework for response to food/feed emergencies (see Section VI, 2.A.1 - Principal Investigator Rights and Responsibilities).

2. RRT Concept Assessment: Completion of an assessment of RRT capabilities, including against models described in the RRT set of “best practices” as developed by the RRT “prototype” project (from FY08 through FY10) through the assessment process identified by DFSR. Improvement plans identified/updated.

3. Collaboration: Document improved information and communication systems with FDA, health, emergency management, feed, and lab partners for activities related to food/feed emergencies, including recalls and recall audit checks. 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, etc.).

4. RRT Concept Incorporation: Sustainability processes for the RRT capabilities are planned in greater detail than the original application (including a timeline) and initiated by the end of the first year.

5. RRT Concept Exercise: At least one joint exercise (including federal and state partners) must be conducted. In addition, after action reports should be completed for exercises and responses to real incidents. 

6. MFRPS Implementation: Update of the MFRPS improvement plan as State milestones are achieved/completed; demonstration of near or full compliance with Standard #5.

Year 2:

1. RRT Concept Implementation: Implementation of the core capabilities identified in the RRT set of “best practices” by demonstrated improvement in all areas of need, as identified in the assessment conducted in year one. This includes demonstration of successful use of the improved capability during an exercise or incident and of continued improvement in recall/market withdrawal processes. These improvements will be supported with quantitative values (e.g. metrics), where appropriate.

RRT Concept Incorporation: Implementation of the plan to incorporate RRT capabilities is on schedule by the end of the second quarter. Plan completion and lessons learned sharing is conducted by the fourth quarter.

2. RRT Concept Documentation: Documentation completed of achievements and lessons learned from RRT development, assessment, implementation, and incorporation. Participation in the development of individual RRT and RRT-project-wide recommendations for national guidelines and standards for rapid response.

3. RRT Concept Exercise: At least one multi-state exercise (including federal and state partners) must be conducted. In addition, after action reports should be completed for all exercises and responses to real incidents. Reports should demonstrate corrective actions implemented for problems identified in previous reports.

4. MFRPS Implementation: Achievement of significant compliance with the MFRPS (2010 version).

 VI 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.

a. 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 enforce d.” 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 develop state food program infrastructure through the MFRPS. 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]through 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.

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. 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.

c. Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, provides FDA with tools to better protect public health by strengthening the food safety system. It enables FDA to focus on preventing food safety problems rather than reacting to problems after they occur. It also provides FDA with new enforcement authorities designed to achieve higher rates of compliance with prevention- and risk-based food safety standards and to better respond to and contain problems when they do occur. These include authorities such as mandatory recall, expanded administrative detention, suspension of facility registration, enhanced product tracing abilities, and additional recordkeeping requirements for high-risk foods. FSMA also gives FDA important new tools to hold imported foods to the same standards as domestic foods.

FSMA directs FDA to build an integrated national food safety system in partnership with State and local authorities, explicitly recognizing that all food safety agencies need to work together in an integrated way to achieve national public health goals. FSMA identifies some key priorities in working with partners in areas, such as: reliance on Federal, State, and local agencies for inspections; improving foodborne illness surveillance; and leveraging and enhancing State and local food safety and defense capacities.

d. 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.

e. 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.

f. 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. This will be accomplished through compliance with the MFRPS and implementation of a continuous assessment and improvement system within the State program. This includes work to revise improvement plans to bring programs to significant compliance with the 2010 MFRPS

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, scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The total amount of funding available is $3,000,000 in total costs, for fiscal year 2011. Up to six awards will be made. Funding will be provided for one year, with the possibility of up to one year of additional support, contingent on performance and continued availability of federal funds.

Award Budget

Application budgets are limited to $500,000 (direct and indirect costs).

Award Project Period

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

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

State Governments: This opportunity is only available to State food safety agencies and their manufactured food regulatory programs with current FDA food safety inspection contracts and who are currently receiving funding under the Food Protection Rapid Response Team and Program Infrastructure Improvement Prototype Projects cooperative agreement program (PAR-09-183). Competition is limited to these organizations because they have demonstrated significant achievements in accordance with the goal of developing and piloting rapid response concepts. The foundational work conducted under the current FDA food safety inspection contracts is both necessary and promising for the completion of significant improvements in food emergency response among federal, state, and local partners through the (up to) 2-year program described in this funding opportunity.

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

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) 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 four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

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.

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 application submission. 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 must be followed, with the following exceptions or additional requirements:

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.

PHS 398 Research Plan Component

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

Resource Sharing Plan

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

Appendix

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

3. Submission Dates and Times

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

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All 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 outbreak response capabilities. The cooperative agreements will provide funding for additional personnel, equipment, supplies, and training to support activities related to the FDA MFRPS and 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) Personnel to provide training independently and also with FDA contracts for RRT training

7) Travel and per diem to meetings with FDA District/Regional partners, other state RRTs, FDA Headquarters, and Annual RRT meetings

8) Pass through of funds to 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 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 and complies with current Federal POV rates (http://www.gsa.gov/portal/content/100715)

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

Non-allowable costs:

1) Facilities and work covered 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 ward amount.

Funding Plan:

The second year of funding for noncompetitive continuation of support will depend on performance, program progress, and the availability of Federal funds.

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. It is understood that key members from each State’s RRT must attend these annual meetings.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD/PIs 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 NIH.

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 Office of Regulatory Affairs, FDA. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the ORA Project Officer by email at shuen.chai@fda.hhs.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

The applicant must specifically address, 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. 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.

c. Provide a detailed description on any changes/updates to your foo d regulatory program since the submission of your application for the Food Protection Rapi d Response Team and Program Infrastructure Improvement Implementation Project in 2008. This should include types of inspections performed and the types and numbers of food establishments in the State inventory. Describe how many of these facilities would be covered each year in your state under this agreement.

d. Provide a properly detailed budget (one for each of the two years) that is intended to implement the RRT concept and enhance the foo d 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 section VI.3.A of this announcement.

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

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

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

h. Clearly describe how the program will 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.

i. Outline the estimated capacity of rapid response capabilities of the program that will be sustained beyond the end of the project period (through two years after the end of the funding; expected challenges should be documented and addressed). Outline the plan to incorporate the RRT into the existing state program (i.e. sustainability of the RRT) during the course of the 2-year cooperative agreement.

B. 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: 

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 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.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described below:

Acceptable post-submission materials include:

Unacceptable post-submission materials include:

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 are evaluated for scientific and technical merit through the FDA peer review system.

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

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

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

b. The design appropriately addresses the dual needs of developing/improving certain rapid response capabilities and strengthening infrastructure through achieving compliance with the MFRPS (weight = 20%);

c. The design includes appropriate address of the expectations of activity, including rapid response capability development (including ICS concepts), assessment, implementation, incorporation, collaboration, and documentation (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 (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 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 = 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 under "Overall Impact" (below) as they relate to the criteria described above, but separate scores will not be given for the items described below.

Overall Impact

Reviewers may consider the overall impact of the proposed project to exert a sustained, powerful influence on food emergency response, in consideration of the following review criteria and additional review criteria (farther below).

Scored Review Criteria

Reviewers may consider the areas described, below in consi dering the overall impact of the proposed project. An application does not need to be strong in all categories. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress rapid response? If the aims of the project are achieved, how will food emergency response and food program infrastructure are improved?  

Investigator(s)    

Are the PD/PIs, collaborators, and other partners involved well suited to the project? Does proposed project staff have appropriate experience and training? Does project staff have complementary and integrated expertise for a multidisciplinary response; are their leadership approach, governance and organizational structure appropriate for the project?

Innovation

Does the application challenge and seek to shift current paradigms by utilizing novel solutions or approaches? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy and steps 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 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 proposed project staff adequate for the project proposed? Will the project benefit from unique features of the program, geographic environment, 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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

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

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.

Vertebrate Animals

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

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/priority score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Not Applicable.

Resource Sharing Plans

Not Applicable.

Security Measures.

Reviewers will assess the security procedures, processes and background checks in place to evaluate new and existing laboratory personnel and determine whether they are adequate to safeguard sensitive information and ensure security of the program/project.  This includes policies for hiring foreign nationals and students.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Review Group(s) as convened by the FDA/ORA, in accordance with FDA review policy and procedure, using the stated review criteria.

As part of the Ad Hoc review, all applications:

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial review, recommended applications will be reviewed by the ORA Project Officer for programmatic relevance and responsiveness. The following will be considered in making funding decisions:

3. Anticipated Announcement an d Award Dates

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

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 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 application instructions.

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 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.

FDA staff 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.

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. Interaction with FDA Districts/Regions, State Training Branches, and Office of Regional Operations Divisions.

b. 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.

c. 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.

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 un der 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 final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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 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.

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 FDA grant resources)
Telephone 301-827-7175
TTY 301-480-0434
Email: gladys.bohler@fda.hhs.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/Review Contact(s)

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: shuen.chai@fda.hhs.gov

Financial/Grants Management Contact(s)

Gladys M. Bohler
Food and Drug Administration
Office of Acquisition and Grants
5630 Fishers Lane
Rockville, MD 20857
Telephone: 301-827-7175
Email: gladys.bohler@fda.hhs.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241), Section 312 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


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


Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.