Building an Integrated Laboratory System to Advance the Safety of Human and Animal Food (U18) Clinical Trial Not Allowed

Description

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Office of Partnerships (OP) is announcing the availability of a cooperative agreement to be awarded under a Limited Competition for National Associations/Organizations to support both awardees under the Laboratory Flexible Funding Model (LFFM) cooperative agreement program and unfunded laboratories. Non-profit national Associations/Organizations that represent human and/or animal food testing laboratories have the membership, resources, structure, and expertise necessary to build national consensus amongst state and local agencies on key human and animal food safety and laboratory issues. The intended outcome of this FOA is to advance the goal of a national food safety system by supporting and enhancing state human and animal food testing laboratories tasked with surveillance and emergency response testing, including investigations of foodborne disease outbreaks. The resulting cooperative agreement will provide the additional support to these laboratories through the activities of an association that will conduct research on national testing capability and capacity; develop best practices and other guidance manuals; offer trainings, workshops, meetings, and other educational resources; support ISO/IEC 17025 laboratory accreditation for non-accredited laboratories; and other activities to support human and animal food testing laboratories. Program Goals: 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 building laboratory capacity and capability, maintaining and expanding the scope of ISO/IEC 17025 accreditation, and supporting the groundbreaking work achieved through the GenomeTrakr network. 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. The intended outcome of this FOA is to assist laboratories with building laboratory capacity and capability, in addition to assisting FDA in the development of trainings, workshops, educational materials, and meetings in support of LFFM and unfunded laboratories conducting testing of human and animal food samples. This cooperative agreement is only available to non-profit, national associations/organizations that represent state and local laboratories that conduct food and/or animal feed testing on behalf of state and local regulatory programs. Project Objectives (progress assessed semi-annually): 1. Research into the development and implementation of trainings, workshops, and other educational materials and resources for use by laboratories in the LFFM, in addition to unfunded laboratories seeking to achieve, maintain, and enhance ISO/IEC 17025 accreditation. Areas in need include effective workshops and seminars on laboratory procedures, data transfer (to NCBI and FDA data systems), document control, quality management systems, continuous improvement, sample collection, and risk assessment. Methods of delivery for training could include: webinars, teleconferences, workshops, on-site technical sessions, face-to-face meetings, or information sharing through web-based resources. Both individual laboratory and broad-based training needs should be considered and met by the grantee. Training programs developed shall 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). 2. Plan and host annual meetings, including scheduling, agenda planning, invitations, on-site logistics (meeting facilities and AV needs and support), registration, materials, and follow-up evaluations, for: a. The LFFM Face-to-Face Meeting, including breakout sessions for the various LFFM disciplines b. The GenomeTrakr face-to-face meeting. Meeting agendas and materials shall be pre-reviewed and approved by FDA prior to distribution and execution. 3. Provide direct technical assistance to non-FDA funded state human and animal food testing laboratories seeking ISO/IEC 17025 accreditation. 4. Research, develop, and maintain a crosswalk of state and FDA regulations and standards regarding human and animal food-related illness and outbreak response. This crosswalk must include sample collection requirements, analytical methodology, and compliance standards and action levels, among other areas agreed upon with FDA. The association may need to utilize surveys or other means of communication with the state laboratories to develop this crosswalk. This crosswalk also must be made available to FDA in a format agreed upon by FDA. 5. Evaluate data collected from the crosswalk and identify areas of improvement that can be developed into best practices and utilized for training and other resources. 6. Assist states with National Food Safety Data Exchange (NFSDX) implementation, specifically with sample data exchange. 7. Promote Office of Regulatory Affairs Partners Portal (ORAPP), Laboratory Business Services (LBS), and NFSDX at conferences, including providing outreach and recruiting laboratories. This outreach should emphasize how ORAPP, LBS, and NFSDX allows partner organizations to send information to and receive information from the FDA, and other state agencies electronically, and demonstrate how that would be of benefit to such non-federal entities. 8. Integrate FDA-provided NFSDX training modules into existing training programs offered by the association, as appropriate. 9. Collaborate with the Partnership for Food Protection IT Working Group (PFP IT WG) to assist in data system transition activities. 10. Research, develop, and distribute best practices documents, protocols, and standard operating procedures for GenomeTrakr, in collaboration with FDA. 11. Evaluate activities across GenomeTrakr and PulseNet networks and provide a written report identifying the commonalities, differences, and areas of opportunity for collaboration. 12. Provide travel assistanceto laboratorians of non-FDA funded organizations for: GenomeTrakr-contributing laboratorians to trainings, meetings and conference LFFM annual meeting FDA's Office of Training Education and Development (OTED) trainings InFORM meeting Other meetings, training courses, and educational opportunities, as determined by FDA, that are intended for federal, state and local public health and laboratory scientists. 13. Collaborate with Partnership for Food Protection Laboratory Working Group (PFP Lab WG) to support national laboratory initiatives, such as identifying best practices for data sharing and acceptability.

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