Required Application Instructions

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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) is announcing the availability of up to $3 million to be awarded under Limited Competition to State food testing laboratories that serve as the primary servicing laboratory for State manufactured food regulatory programs for microbiological and chemical analyses. The intended outcome of this FOA is for microbiological and chemical food analyses performed on behalf of State manufactured food regulatory programs to be conducted within the scope of an ISO/IEC 17025:2005 accredited laboratory and the goal of achieving a nationally integrated food safety system to be further advanced. This will be accomplished by preparing the primary food testing laboratories for State manufactured food regulatory programs to achieve and maintain ISO/IEC 17025:2005 laboratory accreditation by an impartial and internationally recognized accrediting body. Accredited laboratories will also be prepared

for accreditation enhancements, such as accreditation for additional sections within the laboratory and other activities to expand the scope of accreditation. Increased laboratory analyses from ISO/IEC 17025:2005 accredited labs, as would be accomplished through this cooperative agreement, shall in effect serve to increase the analytical capacity for FDA and enhance efforts to protect the food supply. Data generated by recipient laboratories shall be made available for consideration of FDA enforcement actions as well as for surveillance purposes and during response to foodborne outbreaks through eLEXNET. Laboratory accreditation will also assist State manufactured food regulatory programs in achieving conformance with Standard Ten of the Manufactured Food Regulatory Program Standards (MFRPS).

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 foods or food products, States and Federal 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.

Funding will be made specifically to eligible laboratories to achieve and maintain ISO/IEC 17025:2005 accreditation by an impartial and internationally recognized accreditation body. Eligible laboratories currently accredited will also be able to receive funds to maintain accreditation and/or perform enhancements, such as accreditation for additional sections within the laboratory and other activities to expand the scope of accreditation. Only proposed projects designed to obtain, maintain, and/or enhance ISO/IEC 17025:2005 laboratory accreditation will be considered for funding.

The PD(s)/PI(s) shall retain the primary responsibility and dominant role for planning, directing, and executing the proposed project, however, the cooperative agreement award mechanism will result in substantial involvement by the FDA. Substantial involvement includes, but is not limited to:

1) Initial quality management system assessment and gap analysis

2) Timeline plan execution

3) Monitoring of progress through on-site visits, conference calls, emails, and other correspondence

4) Monitoring of sampling agreement

4) Quarterly follow-up of the laboratory's progress

5) FDA training on processes

6) FDA final assessment of laboratory quality management systems

7) FDA technical and financial assistance to apply, maintain, and enhance laboratory accreditation

Successful applicants will undergo a quality management system assessment provided by the FDA, Office of Regulatory Science (ORS). The initial assessment will identify the gaps against the requirements of ISO/IEC 17025:2005 standard followed by the development of a plan to achieve conformance. The plan shall identify the tasks necessary to address non-conformities, responsible personnel, and timeframes to ensure accreditation is achieved, maintained, and/or enhance laboratory accreditation within the established timeframe.

The outcomes of the work provided under this cooperative agreement are as follows:

1. Laboratories supporting state manufactured food regulatory programs conduct chemical and

microbiological analyses of food samples within the scope of ISO/IEC 17025:2005 laboratory accreditation.

2. Strategies for achieving, maintaining, and enhancing a food testing laboratory's ISO/IEC 17025:2005 accreditation shall be developed, shared, and duplicated on a national basis.

3. The laboratory capacity for FDA to protect the safety of the food supply will be increased and public health will be further enhanced.

4. Increased sharing of laboratory results generated under the scope of laboratory accreditation to promote earlier identification and regulatory response to adulterants in the food supply.

5. Advancement of a nationally integrated food safety system.

Only the following laboratories will be eligible to apply:

Laboratories that are the primary servicing laboratory for conducting microbiological and chemical food analyses on behalf of State manufactured food regulatory programs will be eligible to apply. Eligible laboratories shall also participate, or enroll within thirty (30) days of the award, in the Food Emergency Response Network (FERN). These laboratories shall also develop or maintaining a quality management system that is in compliance with the managerial and technical requirements of the ISO/IEC 17025:2005 standard. The laboratories shall also agree to participate in proficiency testing programs and share laboratory results through eLEXNET. In addition, the State manufactured food regulatory program associated with the laboratory shall have a current food safety inspection contract with FDA, or apply for a food safety inspection contract at the earliest possible date. The State manufactured food regulatory program shall maintain a current food contract with FDA throughout the cooperative agreement. The State manufactured food regulatory program shall also be enrolled in the MFRPS, or shall enroll at the earliest possible date. In addition, the State manufactured food regulatory program shall maintain enrollment in the MFRPS and demonstrate progress towards conformance throughout the cooperative agreement. The laboratory and the State manufactured food regulatory program shall agree to and submit in writing a sampling agreement between the two programs which shall be implemented by year two of this cooperative agreement.

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 (http://www.foodsafetyworkinggroup.gov/Home.htm). The charge of the FSWG is the following: To have safe food that does not cause us harm and to enhance our food safety systems by fostering coordination throughout the government including enhancing our food safety laws for the 21st century. These laws will be designed to keep the American people safe and will be enforced. Chaired by the Secretary of Health and Human Services and the Secretary of Agriculture, the FSWG recommends a public health-focused approach to food safety that prioritizes

prevention, strengthens surveillance and enforcement, and improves response and recovery.

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.

The Partnership for Food Protection (http://www.fda.gov/ForFederalStateandLocalOfficials/Meetings/ucm249828.htm) is a

major driving force in the establishment of a national integrated food safety system.

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

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.

Full text of the law: http://www.fda.gov/Food/FoodSafety/FSMA/ucm247548.htm.

FDA is offering these cooperative agreements to laboratories supporting State manufactured food regulatory programs to achieve, maintain, and/or enhance ISO/IEC 17025:2005 laboratory accreditation. Laboratory accreditation also supports state manufactured food regulatory programs in achieving conformance with the Manufactured Food Regulatory Program Standards (MFRPS), Standard 10. Laboratory accreditation will contribute to production of accurate and reliable test data and as a result a quicker acceptance of analytical results by FDA and other regulatory agencies for enforcement actions, surveillance purposes and during response to foodborne outbreaks.

Competition A: Laboratories seeking to obtain ISO/IEC 17025:2005 accreditation:

Year 1:

1. All key laboratory staff are familiar with the requirements for implementation and maintenance of the ISO/IEC 17025:2005 standard. Training records required by ISO/IEC 17025:2005 are developed as well as a training plan for ongoing training to accomplish accreditation.

2. Staffing an independent quality manager position in the laboratory organization that is qualified and trained in QMS and ISO/IEC 17025:2005. The funded laboratory shall submit the contact information of the quality manager that shall be the point of contact for quality management system reports and communication with FDA.

3. Identify methods to be placed under scope of accreditation, as well as additional methods for future scope expansion.

4. Enroll in suitable proficiency testing program(s) and document a four-year proficiency testing plan for meeting the minimum proficiency testing/calibration participation requirements.

5. Laboratory enrolls in the FERN and participates in conference calls, attends conferences, and supports FERN activities.

6. Participation in an on-site lab assessment by the FDA Office of Regulatory Science and establish a timeline/plan of incremental steps to accreditation.

7. All data generated by the laboratory is being entered into eLEXNET and shared with FDA, as requested. Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET.

8. Submit a signed sampling agreement with the State manufactured food regulatory program.

Years 2 - 3:

1. Create and implement a Quality Manual and Management System policies and procedures that meets ISO/IEC 17025:2005 requirements.

2. Conduct at least one internal audit and management review per year to identify non-conformances.

3. Develop an improvement plan to address each non-conformance, including key personnel responsible, timelines, and tasks.

4. Requirements for all suitable proficiency testing are met.

5. Active participation in the FERN continues.

6. Participation in on-site lab assessments by FDA to determine progress to accreditation, and work with FDA to establish a timeline/plan of incremental steps to accreditation.

7. Adequate training for laboratory to meet the requirements of ISO/ISE 17025:2005 accreditation and to keep abreast of scientific and technological advances in relevant areas.

8. All data generated by the laboratory is being entered into eLEXNET and shared with FDA, as requested. Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET.

9. Implement the sampling agreement at the beginning of Year 2.

Year 4:

1. Submit completed application to accrediting body to initiate an assessment of the organization.

2. Assessment, or pre-assessment, is conducted by the accrediting body.

3. Laboratory addresses any areas of non-conformance or deficiencies noted by responding with a written corrective action response.

4. Requirements for all suitable proficiency testing are met.

5. Active participation in the FERN continues.

6. Adequate training for laboratory to keep abreast of scientific and technological advances in relevant areas.

7. All data generated by the laboratory is being entered into eLEXNET and shared with FDA, as requested. Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET.

8. Continue to implement the sampling agreement.

Year 5:

1. Accreditation is granted by the accrediting body.

2. Laboratory submits a plan including the designation of personnel, resources, and funding necessary to maintain accreditation for five years beyond the cooperative agreement program period.

Laboratories are also encouraged to include plans to enhance the scope of accreditation, in consultation with the State manufactured food regulatory program, and the FDA. These accreditation enhancements may include accreditation for additional sections within the lab and expansion of the number and/or type of methods.

3. Active participation in the FERN continues.

4. Adequate training for laboratory to keep abreast of scientific and technological advances in relevant areas.

5. All data generated by the laboratory is being entered into eLEXNET and shared with FDA, as requested. Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET.

6. Continue to implement the sampling agreement.

Competition B: Laboratories currently ISO/IEC 17025:2005 accredited seeking to maintain and enhance the scope of ISO/IEC 17025:2005 accreditation:

Year 1:

1. Actively participate in the FERN, including meetings, conference calls, and other activities.

2. In conjunction with the State manufactured food regulatory program, feed program (if applicable), and the FDA, identify areas to enhance the scope of accreditation.

3. Participate in a mentoring program to assist other laboratories in achieving ISO/IEC 17025: 2005

accreditation.

4. Maintain current ISO/IEC 17025:2005 accreditation.

5. Implement a training program for the laboratory to keep abreast of scientific and technological advances in relevant areas.

6. All data generated by the laboratory is being entered into eLEXNET and shared with FDA, as requested. Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET.

8. Submit a signed sampling agreement with the State manufactured food regulatory program.

Years 2 - 5:

1. Enhance the scope of accreditation in consultation with the State manufactured food regulatory programand the FDA. These accreditation enhancements may include accreditation for additional sections within the lab and expansion of the number and/or type of methods.

2. Continue to actively participate in the FERN.

3. Continue to participate in a mentoring program to assist other laboratories in the cooperative agreement in achieving ISO/IEC 17025:2005 accreditation by the end of Year 5.

4. Continue to maintain ISO/IEC 17025:2005 accreditation, which includes conducting an annual surveillance audit, continuous update and improvement of the Quality Manual and Management System policies and procedures, and a three year full system audit required for renewal.

5. Maintain training for the laboratory to keep abreast of scientific and technological advances in relevant areas.

6. Laboratory submits a plan including the designation of personnel, resources, training, and funding

necessary to maintain accreditation for five years beyond the cooperative agreement program period.

7. All data generated by the laboratory is being entered into eLEXNET and shared with FDA, as requested. Ideally, an automatic, electronic data exchange is established between the laboratory and eLEXNET.

8. Implement the sampling agreement at the beginning of Year 2.

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

Governments

• State Governments

State Governments - This opportunity is only available to State food safety laboratories that meet each of the following criteria:

• State food testing laboratories that serve as the primary servicing laboratory for chemical and microbiology food analyses for State manufactured food regulatory programs to allow for regulatory action to be considered and pursued by a State regulatory agency or FDA. By enhancing the sharing of laboratory results between FDA and State manufactured food regulatory agencies, coordinated and effective approaches to protecting public health can be achieved.
• State food testing laboratories seeking to achieve, maintain, and/or enhance ISO/IEC 17025:2005 laboratory accreditation by an impartial and internationally recognized body. Food testing laboratories that achieve, maintain, and enhance laboratory accreditation will increase the laboratory capacity of FDA. Laboratory accreditation helps to ensure the laboratory results generated are technically valid and may be used by FDA and other regulatory agencies for enforcement actions to protect public health.
• Successful laboratory participation in proficiency testing programs. Successful participation inproficiency testing by a laboratory provides additional evidence the laboratory is generating reliable analytical data that may be used for surveillance, response, and enforcement actions by the FDA.
• Laboratories participating, or that agree to participate within thirty (30) days of the award, in the Food Emergency Response Network (FERN). The FERN allows for Federal and State interagency collaboration and coordination to support the prevention, preparedness, response, and recovery effects for any type of food-related emergency, including accidental, intentional, and natural disaster.
• Laboratory commitment to analyze surveillance and emergency response samples and share the results through eLEXNET. This will serve to increase the food safety surveillance, detection, and response efforts of the FDA and other regulatory agencies.
• The State manufactured food regulatory program shall be under a current food safety inspection contract with the FDA, or apply for a food safety inspection contract with FDA at the earliest possible date. The food safety inspection contract shall be maintained with FDA throughout the cooperative agreement budget and project periods. The foundational work conducted under the FDA food safety inspection contracts is necessary for the completion of significant improvements in a nationally integrated food safety system.
• The State manufactured food regulatory program shall also be enrolled in the MFRPS, or enroll in the MFRPS at the earliest possible date. Enrollment in the MFRPS shall be maintained with FDA throughout the cooperative agreement. The State manufactured food regulatory program shall also demonstrate progress in achieving conformance with the MFRPS. The MFRPS establishes a uniform foundation for the design and management of State manufactured food regulatory programs, which serves to advance a nationally integrated food safety system.
• Laboratory accreditation will assist the State manufactured food regulatory program in achieving conformance with Standard 10 of the MFRPS.
• The laboratory and State manufactured food regulatory program shall enter into a "Sampling Agreement" in which the State manufactured food regulatory program shall collect a specified amount of surveillance samples that the laboratory shall analyze. The amount of samples to be collected shall be an agreed upon amount determined by the laboratory and their State manufactured food regulatory program. This agreement shall be in writing, signed by both programs and submitted to FDA by the end of Year 1 of this project.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the HHS Grants Policy Statement,, are not allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission. Late applications will not be accepted for this FOA.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Applicant organizations may submit only one application.

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

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

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

Applicants must download the application package associated with the Competition they are applying for by referencing the Competition ID field. The Competition ID field will either state:

Competition A

or

Competition B

Applicants may apply for and receive funding for only one competition.

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

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

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

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

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

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity
• Competition ID they are considering (Competition A or Competition B),
• Status of participation in FERN
• Food contract status with FDA
• Status of enrollment in MFRPS for the State manufactured food regulatory program primarily supported by the prospective applicant

The letter of intent should be sent by email no later than May 15, 2015 to:

Dan Lukash
Grants Management Specialist
Food and Drug Administration
Office of Acquisition Support and Grants
Telephone: 240-402-7596
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

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

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

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

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

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

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

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

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed.  MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract.  MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
• Funds should be requested in the budget to travel to meetings with FDA program staff about the progress of the project and for training. A portion of budgeted travel funds should be set aside for at least two key personnel to attend the annual face-to-face ISO meeting and have key personnel to attend on-site visits by FDA.

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

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

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

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

1) Demonstrate the ability to implement and maintain a quality management system that is in compliance with the managerial and technical requirements of ISO/IEC 17025 and is accredited by an impartial, independent, and internationally recognized accreditation body;

2) Demonstrate the ability to fully participate in initiatives supporting the ISO/IEC 17025:2005 accreditation process and FERN activities, including but not limited to, annual face-to-face meeting, monthly conference calls, sharing of best practices, on-site visits, and program audits;

3) Demonstrate the ability to share all laboratory data generated related to food safety through eLEXNET and as requested by the FDA. Ideally, an electronic data exchange shall be established between the laboratory information management system (LIMS) and eLEXNET;

4) Demonstrate the availability of adequately trained food program and/or laboratory staff and the criteria and ability to hire and/or train personnel to meet the deliverables of the cooperative agreement;

5) Provide a properly detailed budget (one for each of year of the project) that is intended achieve, maintain, and/or enhance ISO/IEC 17025:2005 laboratory accreditation;

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

7) Provide the previous year and current funding level certification for the laboratory program from State funding appropriations;

8) Outline a detailed methodology for program assessment, improvement, and collaboration to accomplish the work and program sustainability, as described in this announcement;

9) Provide justification for hiring new staff, including qualifications, training needs, and new equipment needs;

10) Capability to analyze food samples for chemical and microbiological hazards utilizing analytical methods within the scope of accreditation for emergency response and surveillance efforts - an annual estimate of capability should be provided for chemical and microbiological testing;

11) Summary description of procedures or processes in place to evaluate the process for preparing for

accreditation;

12) Summary description of procedures in place to monitor accreditation requirements, including the tracking and monitoring of activities and training in progress to include a description of the laboratory quality manual and technical requirements process and procedures.

Laboratories applying for funding through this FOA shall provide a complete description of the facilities, personnel qualifications, management practices, organization, and a commitment to analyze samples in their application to include the following:

1) Operational support areas to be used for the project, including floor diagrams of the laboratories, details about the availability of ancillary laboratory safety, and support equipment and facilities;

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

3) Detailed description of laboratory access procedures, including a description of practices and system which limit access to laboratory space by unauthorized personnel to include measures in place to ensure that all staff have sufficient clearance and/or background checks to work on this project or program;

4) Qualifications of all personnel that shall be assigned to the project, including the quality assurance

(QA)/quality control (QC) manager, QA/QC personnel, and laboratory technical personnel;

5) Complete description of the laboratory staffing management and structure, food testing capabilities,

policies, procedures, personnel, technical operations, and support services. Provide an organizational chart indicating all reporting relationships and responsibilities;

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

7) 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;

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

9) Previous year and current funding level certification for the laboratory program from State funding

appropriations.

Laboratories shall also provide a summary of the following:

1) Provide a description of the current testing program, including a detailed account of the analytical support currently provided to the State manufactured food regulatory program;

2) Preliminary description of intended scope of accreditation, to include the types of products to be tested and analyses preformed. .

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

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

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

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

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA's electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.

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

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

This initiative is not subject to intergovernmental review.

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

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

These awards may only be used for:

Achieving, maintaining, and/or enhancing laboratory ISO/IEC 17025:2005 accreditation in laboratories that are the primary chemical and microbiological servicing laboratories for State manufactured food regulatory programs, as described in Section III.1 Eligible Applicants.

Allowable costs:
1) Consultant services
2) Employee salaries, wages and fringe benefits
4) Rental, purchasing, calibration, installation and maintenance of equipment
5) Indirect costs in accordance with a current federal indirect cost agreement
6) Recruitment costs for hiring new employees
7) Registration fees
8) Purchase or development of IT equipment, software, and support
9) Shipping and mailing of equipment and supplies
10) Travel (shall not exceed coach class fare)
11) Speaker fees
12) Accreditation fees
13) Training courses and materials
14) Laboratory and office supplies
15) Office supplies
16) Subcontracting to third parties is limited to 25% of each year's award
17) Remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount

Non-allowable costs:
1) Facilities and work covered under current FDA food safety inspection contracts shall not be counted towards fulfillment of the cooperative agreement and shall remain distinct and separate from the cooperative agreement. The State shall be able to account separately for fund expenditures under the food safety inspection contracts and these cooperative agreements
2) Vehicle purchases are not permitted
3) Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount

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

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

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

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

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

Not Applicable

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

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

1. The rationale and design to meet the goals and project milestones of the cooperative agreement (total weight = 40%);

2.  Demonstration of effectiveness in working with federal, state, and local partners and other appropriate organizations to implement the goals of the cooperative agreement (weight = 20%)

3. Have adequate program resources (especially staff) and infrastructure to complete project needs, or the ability to obtain adequate program resources (weight = 20%);

4. Demonstration that capabilities that can be sustained in the long-term (five 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%)

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

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

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

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

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

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

Not Applicable

Not Applicable

Not Applicable

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

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

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 Objective Review Committee, using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

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

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

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

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found in the HHS Grants Policy Statement. 

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

Additional terms and conditions regarding FDA regulatory and ORA programmatic requirements may be part of the Notice of Award.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR 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.

Support will be in the form of a cooperative agreement. Substantive involvement by the awarding agency is inherent in the cooperative agreement award. Accordingly, FDA will have substantial involvement in the program activities of the project funded by the cooperative agreement.

Substantive involvement includes, but is not limited to, the following:

• Hosting of face-to-face meetings with all awardees, such as the annual ISO CAP meeting.
• FDA conducting on-site technical sessions with the grantee.
• FDA hosting monthly (or at a frequency chosen by FDA) conference calls/webinar meetings with individual laboratories and all laboratories within the cooperative agreement.
• FDA assistance in the sharing of information developed by the grantee to achieve, maintain, or enhance ISO/IEC 17025:2005 accreditation.
• FDA assistance in coordinating multi-program pilot projects.

Monitoring Activities

The program project officer and technical advisor will monitor award recipients periodically. The monitoring may be in the form of face-to-face meetings, telephone conversations, e-mails, or written correspondence between the project officer/grants management officer/technical advisor and the principal investigator. In addition, periodic site visits with officials of the recipient organization may also occur to assess progress with achieving, maintaining, or enhancing the scope of ISO/IEC 17025:2005 accreditation for the laboratory. 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. Also, the grantee organization must comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the Project Officer and Technical Advisor.

Recommended support beyond the first year will depend on the availability of funds and approved performance.  The evaluation of performance includes, but is not limited to: technical meeting attendance, appropriate PT participation, training (including out of state travel), responsiveness to FDA, conference call participation, and the progress of cooperative agreement deliverables as determined by FDA.

The scope of the recommendation will confirm that:

1) There has been acceptable progress on the project; 2) there is continued compliance with all FDA

regulatory requirements; 3) if necessary, there is an indication that corrective action has taken place; and (4) assurance that any replacement of personnel must meet the laboratory requirements as well as security background screening.

The purpose of these cooperative agreements is to advance efforts for a nationally integrated food safety system by assisting laboratories that provide laboratory support to State manufactured food regulatory programs to achieve, maintain, and enhance laboratory accreditation.

The following conditions of the award must apply to all funded applicants and must be maintained throughout the cooperative agreement.

1. The laboratory must remain the primary servicing laboratory for conducting microbiological and chemical food analyses on behalf of the State manufactured food regulatory program to be eligible to apply and receive funds through this cooperative agreement.

2. The laboratory must maintain active participation in the Food Emergency Response Network (FERN).

3. The laboratories must successfully participate in proficiency testing programs and share laboratory results with FDA.

4. In addition, the State manufactured food regulatory program supported by the laboratory must maintain a food safety inspection contract with FDA.

5. The State manufactured food regulatory program must also maintain enrollment in the MFRPS and

demonstrate progress towards achieving conformance with the MFRPS.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements.

All progress reports must contain the elements below as applicable to their application and award, but are not limited to, the following:

1) An updated improvement plan demonstrating significant progress towards implementing a quality

management system that will result in the laboratory receiving ISO/ISE 17025:2005 accreditation for

laboratories seeking ISO/IEC 17025:2005 accreditation within the established timeframe. For laboratories currently accredited, an updated improvement plan for enhancing the scope of accreditation and maintaining accreditation within the established timeframes.

2) A proficiency testing plan and results of participation in a recognized proficiency testing program(s) to ensure and demonstrate the quality of the tests performed in the lab.

3) Hiring of new personnel and training of personnel in the implementation and maintenance of a quality system to achieve, maintain, and/or enhance ISO/IEC 17025:2005 accreditation. The program must include initial and ongoing training to ensure consistent quality and continuous improvement, including assisting laboratory personnel in maintaining current knowledge of scientific and technological advances in relevant areas.

4) Summary report on the facility inventory that is maintained by the laboratory.

5) Status report on the installation and operational readiness of any analytical equipment that is purchased.

6) Summary of laboratory data shared with FDA and other regulatory agencies, including any regulatory actions taken by FDA or another regulatory agency or any significant laboratory findings that advanced the protection of public health.

7) Current funding level certification for the laboratory program from State funding appropriations.

All recipients must file a final program progress report, FSR, invention Statement, and disposition of

equipment Statement within 90 days after the end date of the project period as noted on the notice of the cooperative agreement award.

8) Budgetary status, to include the amount of funding expended to the date of the report and a detailed description of how this funding was utilized.

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 grant application. The documentation must be in a form and contain sufficient detail such that other State, local, and tribal governments could reproduce the final project. An audit by an independent accrediting body should confer ISO/ISE 17025:2005 accreditation upon the laboratory. The final program progress report should also detail the strategy, including commitment of personnel, resources, and funding, for maintaining of ISO/ISE 17025:2005 accreditation after the completion of the project.

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

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

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

Erin Woodom-Coleman
Food and Drug Administration (FDA)
Telephone: 240-205-1606
Email: [email protected]

Ruiqing Pamboukian, Ph.D.
Food and Drug Administration (FDA)
Telephone: 301-796-8157
Email: [email protected]

Oluyemisi (Yemisi) Akinneye
Food and Drug Administration (FDA)
Telephone: 240-402-7560
Email: [email protected]

Oluyemisi (Yemisi) Akinneye
Food and Drug Administration (FDA)
Telephone: 240-402-7560
Email: [email protected]

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

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.