Participating Organization(s)	U.S. Food and Drug Administration (FDA) NOTE: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH. Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA. The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.
Components of Participating Organizations	Office of Regulatory Affairs
Funding Opportunity Title	Building an Integrated Laboratory System to Advance the Safety of Food and Animal Feed (U18)
Activity Code	U18 Research Demonstration Cooperative Agreements
Announcement Type	New
Related Notices	June 8, 2012 - See Notice NOT-FD-12-016. Notice of Correction of Letter of Intent contact and Financial Grants Management Contact(s).
Funding Opportunity Announcement (FOA) Number	RFA-FD-12-025
Companion Funding Opportunity	Not Applicable.
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.103
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) is issued to announce the availability of a cooperative agreement to be awarded under a Limited Competition. The goal of this FDA/ORA Cooperative Agreement Program is to facilitate long-term improvements to the national food and animal feed safety system by strengthening multi-disciplinary laboratory collaboration and equivalency. The advancement of ISO/IEC 17025:2005 laboratory accreditation for food and animal feed regulatory laboratories is a foundational component of building an integrated laboratory system for the advancement of public health. In addition, the provision of funding will establish a formal platform to build an integrated laboratory community consisting of State and local food regulatory laboratories and regulatory program managers. The laboratory community will advance the sharing, equivalency, and acceptability of laboratory results in support of public health goals. Effective leveraging of resources and harmonization of efforts will require collaboration with relevant initiatives, including those of federal partners, national initiatives and associations, State, and local partners.

Posted Date	June 6, 2012
Open Date (Earliest Submission Date)	June 6, 2012
Letter of Intent Due Date	June 15, 2012
Application Due Date(s)	July 16, 2012, by 5:00 PM local time of applicant organization.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	September 1, 2012
Expiration Date	July 17, 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 or in a Notice from the HHS Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Division of Federal-State Relations (DFSR) is announcing the availability of a cooperative agreement to be awarded under a Limited Competition. FDA can guarantee one year of funding with the possibility of up to four years of additional, non-competitive support, dependent on performance and continued availability of federal funds.

The national associations /organizations eligible to apply for funding under this cooperative agreement must be a national association/organization that represents State and local laboratories that conduct food and/or animal feed testing on behalf of State and local regulatory programs.

This cooperative agreement will help prepare food and feed regulatory testing laboratories seeking to achieve, maintain, and enhance ISO/IEC 17025:2005 accreditation by providing adult education and training programs. Laboratory accreditation attests to the competency and technical capability of a laboratory to perform specific tasks. The results generated are defensible to a recognized standard that is independent of lab personnel or other changes. In addition, accreditation supports the traceability of technical results generated by a laboratory. In the event of a large-scale terrorist activity or other large-scale events affecting food or feed products, regulatory authorities can use laboratory test results from accredited laboratories to respond at once and enforce regulatory compliance to protect the safety of the food supply.

State and local laboratories play a critical role in the identification, containment, and prevention of foodborne illness. FDA is committed to assisting these laboratories in achieving, maintaining, and expanding the scope of ISO/IEC 17025:2005 accreditation for State and local regulatory laboratories in order to build an integrated national food safety system. This cooperative agreement will also result in the establishment of an integrated laboratory community consisting of State and local food and animal feed regulatory laboratories. The laboratory community will advance the sharing, equivalency and acceptability of laboratory results in support of public and animal health goals. Effective leveraging of resources and harmonization of efforts will require extensive collaboration with relevant initiatives, including those of federal partners, national initiatives, associations/organizations, and State and local partners. Therefore, eligible organizations must represent food and animal feed regulatory laboratories that conduct testing on behalf of State and local regulatory programs.

The outcome of the work provided under this cooperative agreement would be as follows:

1. Design, development, documentation, delivery, management, and implementation of support programs for ISO/IEC 17025:2005 to advance State laboratory coordination for protecting public health and the safety of the food supply.

2. Identification, pilot testing, and the national implementation of policies and procedures necessary to establish equivalency between Federal, State, and local food and feed testing laboratories. These policies and procedures should cover sample collection, shipment, analysis, storage, retention, and other relevant areas to advance the acceptability of laboratory results for regulatory action and advancing public health.

3. Establishment of nationally accepted models for the rapid sharing and acceptance of laboratory data for FDA and partnering regulatory agencies to pursue regulatory action and advance public and animal health.

4. Facilitate the implementation of a national framework for a unified laboratory response to emerging food or animal feed safety emergencies or other issues of public health significance.

5. Providing forums, including national and international meetings, to improve communication and collaboration between Federal, State, and local food and animal feed testing laboratories and their associated regulatory and public health programs to identify opportunities and strategies for advancing public and animal health through laboratory testing.

6. Provide educational opportunities, resources, tools, and mentoring for laboratories seeking to achieve, maintain, and enhancing the scope of their accreditation.

7. Forming national consensus with Federal and State regulatory officials on models for the acceptance of laboratory data and building a community for the coordination of laboratory resources in response to emerging food and animal feed issues of public and animal health significance.

8. Develop an integrated approach with associations representing State manufactured food and animal feed regulatory programs to assist food and animal testing laboratories to achieve, maintain, and enhance the scope of laboratory accreditation and achieve conformance with applicable program standards as established by the Secretary (such as the Manufactured Food Regulatory Program Standards (MFRPS)).

9. Advance the efforts of FDA to achieve the goals of FSMA related to laboratory analysis and building an integrated food safety system, including the rapid shipment of clinical isolates related to foodborne illness to public health laboratories for submission to PulseNet.

The association/organization will provide through this cooperative agreement the following:

a. Identify, develop and deliver training programs, in coordination with FDA, International Food Protection Training Institute (IFPTI), and other training entities, that will assist State regulatory laboratories to achieve, maintain, and enhance ISO/IEC 17025:2005 laboratory accreditation. Both individual laboratory and broad-based training needs should be considered and met by the grantee.

Training programs developed will be pre-reviewed and approved by FDA prior to delivery. FDA will periodically assess the trainer s performance by reviewing the course assessments and evaluations completed by students (individual and aggregated data).

Methods of delivery for training: Webinars/teleconferences /workshops /on-site technical sessions / face-to-face meetings/information sharing through web based resources

The training program should cover as a minimum the follow topics:

1. Laboratory Management System Requirements: Contracts, Contract Review, Subcontracting, Document Control, Purchasing services and supplies, Control of non-conforming testing work, Improvement, Corrective action, Preventive Action, and Control of Records

2. ISO/IEC 17025 Technical Requirements Training: Personnel, Accommodation and Environmental Conditions ,Test Methods and method Validation, Control of Data, Equipment, Measurement of traceability for testing laboratories, Sampling, Assuring the quality of test results, and Reporting results.

3. Writing a quality manual, procedures, and policies

4. Selecting an accreditation body.

5. Defining the scope of accreditation

6. Selecting and enrolling in Proficiency Test Programs

7. Developing laboratory training programs on ISO/IEC 17025 (Initial and ongoing)

8. Food/feed sample collection methodologies.

9. Types of sample collection procedures.

10. Strategies for writing a sampling collection plan, statistical methods.

11. Sample handling: Procedures to monitor sample work flow from sample receiving to report test results including transportation, receipt, handling, protection, storage retention and/or disposal.

12. Developing steps for an accreditation action plan and timeline plan execution for achieving, enhancing, and/or expanding the scope of accreditation for laboratories

b. Establish a network and community consisting of food and animal feed regulatory laboratory managers, in coordination with their associated regulatory program managers, in the identification and implementation of a framework for a unified response based on the Manufactured Food Regulatory Program Standards (MFRPS), guidelines published by the Council to Improve Foodborne Outbreak Response (CIFOR), and other standards recognized by the Secretary. The community should be actively engaged through a variety of platforms, including web-based resource and information sharing tools, face-to-face meetings, virtual meetings, and other innovative approaches.

c. Identify food, animal feed, and laboratory subject matters experts (SMEs) to identify the criteria to establish laboratory and sample analysis equivalency for FDA and partnering regulatory agencies acceptable for regulatory action and others efforts to protect public and animal health. These SMEs should also advance the role of the laboratory during a foodborne outbreak investigation and establish recommendations for decreasing response times during investigations. A web-based, easily searchable SME registry should be established and maintained with updates/data verification occurring on a quarterly basis.

d. Develop working groups to share accreditation documents, such as Standard Operating Procedures and documents required for accreditation, lessons learned, strategies, best practices, and other resources for laboratories to achieve, maintain, and enhance laboratory accreditation. An on-line searchable document repository will be maintained on a website available to all interested food regulatory and public health laboratories and FDA and shared as broadly as possible.

e. Establish pilot programs for national implementation that enhance the sharing and acceptance of laboratory data for regulatory action by FDA and partnering regulatory agencies. Once adopted nationally, these programs should result in decreased response times during investigations and enhance public health protection.

f. Provide forums, including IT systems, face-to-face meetings, and virtual meetings, for improving communication and collaboration between Federal, State, and local food and feed regulatory laboratories in addition to public health and clinical laboratories.

g. Strengthen the community between FDA, State, and local laboratories that contribute to investigating foodborne illness by building upon existing committee and information sharing infrastructure.

h. Identify primary challenges and recommend solutions for the implementation of pilot projects for the rapid shipment of clinical isolates related to foodborne illness to public health laboratories for submission to PulseNet and strengthening partnerships with clinical laboratories to improve the sharing of samples and information.

i. Provide guidelines on proficiency testing programs, quality laboratory practices, interpretation of recognized accreditation standards (e.g., ISO 17025), and other resources to advance the accreditation of State and local food, feed, public health, and other laboratories that provide analytical support during foodborne illness investigations.

j. Assist FDA in meeting the laboratory related components of FSMA and building an integrated national food safety system.

The research strategy submitted should include specific project milestones and metrics for each objective proposed by the applicant.

2. Background:

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.

Food Protection Plan 2007

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

The Food Protection Plan lays out new goals specific to protecting the food supply and responding to incidents in a rapid and coordinated manner. FDA’s integrated approach, within the Food Protection Plan, encompasses three core elements: prevention, intervention and response.

The prevention element means promoting increased corporate responsibility so that food problems do not occur in the first place. By comprehensively reviewing food supply vulnerabilities and developing and implementing risk reduction measures with industry and other stakeholders, we can best address critical weaknesses.

The intervention element focuses on risk-based inspections, sampling, and surveillance at high risk points in the food supply chain. These interventions must verify that the preventive measures are in fact being implemented, and done so correctly.

The response element bolsters FDA's emergency response efforts by allowing for increased speed and efficiency. They also include the idea of better communication with other federal, state, and local government agencies and industry during and after emergencies. Whether contamination is unintentional or deliberate, there is a need to respond quickly and to communicate clearly with consumers and other stakeholders. The communication should emphasize identifying products of concern as well as assuring the public of what is safe to consume.

Food and Drug Administration Amendments Act of 2007

Under FDAAA, FDA will work with the states to develop food borne illness rapid response teams. Section 1004 of FDAAA states: Secretary shall work to coordinate the function of federal and state food safety programs.

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.

Import Safety Action Plan

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.

The food safety regulatory system in the United States is a tiered system that involves Federal, State, Local and Tribal governments. FDA is responsible for ensuring that all foods moving in interstate commerce, except those under United States Department of Agriculture jurisdiction, are safe, wholesome, and labeled properly.

State agencies conduct inspection and regulatory activities that help ensure that safe food is produced, processed, or sold within their jurisdictions. Many State agencies also conduct food plant inspections under contract with the FDA. These inspections are performed under the States' laws and authorities or the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or both. To maximize the use of resources among the FDA and the State governments, particularly when their jurisdictions overlap, their inspection programs should be equivalent in effect.

In June 2000, the Department of Health and Human Services' Office of the Inspector General (OIG) released a report of FDA's oversight of State contracts. In this report, the OIG recommended that FDA take steps to promote "equivalency among Federal and State food safety standards, inspection programs, and enforcement practices." In response to their findings, FDA developed the Manufactured Food Regulatory Program Standards (MFRPS) that identifies the elements and best practices of a high-quality regulatory program.

The MFRPS are comprised of ten standards that establish requirements for the critical elements of a regulatory program designed to protect the public from food borne illness and injury. These elements include the program's regulatory foundation, staff training, inspection, quality assurance, food defense preparedness and response, food borne illness and incident investigation, enforcement, education and outreach, resource management, laboratory resources, and program assessment. Specifically, Standard 10 of the MFRPS requires the State program to have access to a laboratory that is capable of analyzing a variety of samples, including food, environmental, and clinical. The State program must utilize laboratories that have a current A2LA accreditation or that have quality assurance programs that incorporate the management and technical requirements found in ISO/IEC 17025:2005.

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	The number of awards is contingent upon FDA appropriations, and the submission of a sufficient number of meritorious applications. FDA intends to fund one award, corresponding to a total of $1,500,000, for fiscal year 2012. Future year amounts will depend on annual appropriations and performance.
Award Budget	Application budgets are limited to $1,500,000 per year (including 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 five 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.

The association/organization must be a non-profit national association/organization that represents State and local laboratories that conduct food and/or animal feed testing on behalf of State and local regulatory programs.

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.

• Central Contractor Registration (CCR) must maintain an active registration, to be renewed at least annually
• Grants.gov
• eRA Commons

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 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.

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

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

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

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

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

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

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

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

The letter of intent should be emailed to:

Yemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
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 exceptions or additional requirement:

• For this specific FOA, the Research Strategy section is limited to 30 pages.

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

Resource Sharing Plan

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

• Generally, Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and GWAS Sharing Plan) are expected, but they are not applicable for this FOA.

Appendix

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

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, HHS’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.

This award may only be used for activities associated with achieving the goals and objectives of the cooperative agreement and work proposed by the grantee. Work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under these cooperative agreements and the funding provided must remain distinct and separate from other projects and funding sources. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, received through contracts, cooperative agreements, grants, and other funding received by the grantee and these cooperative agreements.

Strong collaboration between the grantee and associations representing State food and animal feed regulatory officials will be required. Therefore, the grantee is required to subaward a minimum of 25% of the funds received under this award to at least two different associations in order to meet the goals of the cooperative agreement. One association must represent State manufactured food regulatory officials and the other association must represent State animal feed regulatory officials.

Allowable costs:

1. Salaries

2. Accounting services

3. Supplies for meetings related to the award

4. Travel and per diem to attend travel for training and attending meetings related to the grant.

5. Printing, shipping, and mailing

6. Web site server, software, hosting, development and integration, computers and other hardware

7. Pass through of funds to other national associations/organizations representing food and animal feed regulatory programs and laboratories. FDA must be provided with a copy of the third party agreement showing involvement and transfer of funds to other associations.

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

Non-allowable costs:

1. Facilities and work covered under current contracts, cooperative agreements/grants, partnership funds, and other sources cannot be counted towards the fulfillment of the cooperative agreement and must remain distinct and separate from the cooperative agreement. The grantee must be able to account separately for fund expenditures other sources of FDA funding and these cooperative agreements.

2. Vehicle purchases are not permitted.

3. Cooperative agreement funds may not be utilized for new building construction. Remodeling of existing facilities may be allowed, with prior approval, provided that remodeling costs do not exceed 10% of the grant award amount.

Funding Plan: Years 2 - 5 of funding for noncompetitive continuation of support will depend on performance, program progress, and the availability of Federal funds.

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 Office of Acquisition and Grants (OAGS) and responsiveness by the Office of Regulatory Affairs (ORA). Applications that are incomplete and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the Project Officer by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

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

Acceptable post submission materials include:

Revised budget pages

Biographical sketches

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

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

Only the review criteria described below will be considered in the review process. As part of the FDA mission, all applications submitted to the FDA are evaluated for scientific and technical merit through the FDA peer review system.

1. The rationale and design to meet the goals of the cooperative agreement (total weight = 20%)

2. Demonstration of experience in effective communication and collaboration with Federal, State, and local partners and other appropriate organizations to implement the goals of the cooperative agreement (total weight = 20%)

3. Demonstration of capability to facilitate the incorporation and sustainability of project developed capabilities into the national food and feed regulatory and public health systems (total weight = 20%)

4. Demonstration of competence in implementing effective adult education training programs (total weight = 20%)

5. Demonstration of advanced experience and competence with the managerial and technical requirements of ISO/IEC 17025:2005 laboratory accreditation to achieve, maintain, and expand the scope of accreditation (total weight = 20%)

Note: Only the criteria and scoring described above 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 give for the items described below.

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

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.

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.

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

As part of the scientific peer review, all applications:

• Will receive a written critique.

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

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

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

After the peer review of the application is completed, the PD/PI will be provided a copy of 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 on the Award Conditions and Information for HHS Grants website.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA. For these terms of award, see the HHS Grants Policy Statement Part II: Terms and Conditions of HHS Grant Awards, Subpart A: General and Part II: Terms and Conditions of HHS Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for HHS Grants.

Cooperative Agreement Terms and Conditions of Award

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 grantee is required to subaward a minimum of 25% of the funds received under this award to at least two different associations in order to meet the goals of the cooperative agreement. One association must represent State manufactured food regulatory officials and the other association must represent State animal feed regulatory officials. Prior approval of the subawards by FDA is required.

This award may only be used for activities associated with achieving the goals and objectives of this cooperative agreement. Work proposed under this cooperative agreement may not be duplicated or funded by other cooperative agreements, contracts, or other funding mechanisms. Projects proposed under these cooperative agreements and the funding provided must remain distinct and separate from other projects and funding sources. The grantee must be able to account separately for fund expenditures, including employee salaries, wages, and benefits, received through contracts, cooperative agreements, grants, and other funding received by the grantee and these cooperative agreements.

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.

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.

An annual Financial Status Report (FSR) (SF-269) must be sent to FDA's grants management officer within 90 days of the budget period end date of each twelve month cooperative agreement. Failure to file the annual FSR in a timely fashion will be grounds for suspension or termination of the cooperative agreement.

For continuing cooperative agreements, mid year reports and an annual program progress report are also required. For such cooperative agreements, the Non-Competing Continuation Progress Report (PHS-2590) will be considered the program progress report for the fourth quarter of the budget period.

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

a. Development and delivery of training programs that assist State regulatory laboratories to achieve, maintain, and enhance ISO/IEC 17025:2005 laboratory accreditation. A summary of the training programs, including training agenda, materials, and method of delivery, statistics for the participation in the training programs and the results of training assessments and evaluations by attendees should be included.

b. Establishment of a network and community of food and animal feed regulatory program managers and laboratory managers in the identification and implementation of a framework for a unified response based on the Manufactured Food Regulatory Program Standards (MFRPS), guidelines published by the Council to Improve Foodborne Outbreak Response (CIFOR), and other standards recognized by the Secretary. Specific information requested includes the membership, means and frequency of communication, and accomplishments.

c. Identifying food, animal feed, and laboratory subject matters experts (SMEs) to identify the criteria to establish laboratory and sample analysis equivalency for FDA and partnering regulatory agencies acceptable for regulatory action and others efforts to protect public health. The establishment and maintenance of an easily searchable SME web-based registry, including an overview of the functionality of the registry and use by laboratories.

d. Overview of the progress of the working groups, including activities related to sharing lessons learned, strategies, best practices, and other resources for laboratories to achieve, maintain, and enhance laboratory accreditation, membership, and meetings held. Resources should be shared using an on-line searchable document repository. Specific information requested includes an overview of the document repository and frequency of use.

e. Establishment of pilot programs for national implementation that enhance the sharing and acceptance of laboratory data for regulatory action by FDA and partnering regulatory agencies. Specific information should include the pilot programs developed, findings of the pilot program, participants, and recommendations for broader-scale implementation.

f. Progress and achievements of forums, including face-to-face and virtual meetings, for improving communication and collaboration between Federal, State, and local officials at the program level, food and feed regulatory testing laboratories, and public health laboratories. Specific information requested includes the attendees, means and frequency of communication, and accomplishments.

g. Impact of strengthening the community between FDA, State, and local food and feed regulatory laboratories by building upon existing committee and information sharing infrastructure.

h. Identification of primary challenges, solutions, and pilot projects that may be implemented nationally for the rapid shipment of clinical isolates related to foodborne illness to public health laboratories for submission to PulseNet and strengthening partnerships with clinical laboratories to improve the sharing of samples and information.

i. Summary of guidelines on proficiency testing programs, quality laboratory practices, interpretation of recognized accreditation standards (e.g., ISO 17025), and other resources developed to advance the accreditation of State and local food, feed, public health, and other laboratories that provide analytical support during foodborne illness investigations.

j. Assistance provided to FDA in meeting the laboratory related components of FSMA and building an integrated national food safety system.

k. Success in meeting the project milestones and metrics established in the grantee application and identified in conjunction with the FDA.

The recipient must file a final program progress report, and FSR, within 90 days after the end date of the project period as noted on the notice of the cooperative agreement award.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement. The final program progress report must provide full written documentation of the project, and summaries of accomplishments and goals, as described in the cooperative agreement application. The documentation must be in a form and contain sufficient detail.

Monitoring Activities

The program project 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. There may be other regular meetings with recipients to assist in fulfilling the requirements of the cooperative agreement.

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 HHS 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]

Wendy Campbell
Project Officer
Food & Drug Administration, Office of Regulatory Affairs
Phone: 615-310-0483
Email: [email protected]

Yemisi Akinneye
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 301-827-0079
Email: [email protected]

Recently issued trans-HHS policy notices may affect your application submission. A full list of policy notices published by HHS is provided in the HHS Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Guide for Grants and Contracts.

Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.