Building an Integrated Information Technology Infrastructure for State Regulatory Programs (U2F) [Clinical Trial Not Allowed]

Description

BackgroundThe FDA Food Safety Modernization Act (FSMA), signed into law in January 2011, lays the strategic groundwork for fostering coordination and collaboration of food safety efforts across federal and state, local, tribal, and territorial regulatory and public health partners (SLTT partners) to establish a fully integrated food safety system (IFSS). In coordinated efforts with the Food and Drug Administration's (FDA) strategic partners, the IFSS operations continue to implement risk-based inspections and investigations, ensure consistent and meaningful laboratory data and practices, establish national standards to ensure consistency across all jurisdictions, and improve response capabilities to foodborne illness outbreaks, recalls, and food emergencies. FDA continues to work towards achieving a national IFSS in addition to promoting One Health and supporting domestic mutual reliance (DMR) initiatives to protect the food supply for both humans and animals and advance public health. DMR is a seamless partnership that enables FDA and states with comparable regulatory public health systems, as trusted partners, to rely on, coordinate with, and leverage one another's work, data, and actions to meet the public health goal of a safe national food supply. One of the critical operations to advance these efforts is to have seamless and robust, high-quality data integration and information sharing mechanisms among our SLTT partners. Data management systems are also critical for states to implement and maintain conformance with the regulatory program standards, which is a foundational piece for FDA to rely upon state data.As the work of FDA and SLTT partners requires us across local, regional, national, and global levels to achieve optimal health outcomes, we are also recognizing the interconnection between people, animals, plants, and their shared environment. FDA recognizes and supports a One Health approach to collaborate with stakeholders across disciplines and sectors using science, technology, and innovation to achieve optimal public health outcomes. One Health is a collaborative, multisectoral, and transdisciplinary approach. As FDA and SLTT partners consider how to exchange data to support our work on human and animal food safety, we also need to consider how to share essential information, including epidemiological and laboratory data, across all public health sectors to effectively detect, respond, and prevent outbreaks of foodborne illness and to promote food safety.ObjectivesThe Office of Regulatory Affairs (ORA) is soliciting a new application to support the planning, development, implementation, operation, and maintenance of a data management system to be utilized by our SLTT partners in both human and animal food programs. The grantee would need to have substantial involvement with SLTT partners to establish an integrated information technology infrastructure that enables data management, data exchange, and information sharing between and among SLTT partners and FDA. The grantee will ensure the projects have the maximum benefit to our regulatory and public health partners in advancing technologies to integrate regulatory data into a nation-wide repository as well as addressing the public health administrative functions such as licensing. The application should include a list of collaborators and their roles and responsibilities. The grantee will be expected to work directly with the user community involving a range of stakeholders including, but not limited to federal and SLTT partner agencies for the development and continuous improvement of the data management system.This data management system should include the following capabilities and features:Perform firm search and firm historyStore and share inspection and investigation reports, lab data, complaints, recalls, and enforcement actions.Promote early identification and response to food emergencies by supporting product traceability and identifying trends in the supplier chain.Support implementation and conformance to regulatory program standards with features to assist with risk-based categorization of firms, work-planning, tracking enforcement actions and compliance follow-up in response to violative findings, and tracking consumer complaints.Once the data management system and ORA Data Exchange capabilities are fully developed, FDA will aim to establish data exchange capabilities between SLTT programs and FDA under separate agreements and in line with FDA's information sharing authorities.Utilizing this data management system for the above components will increase efficiency and reliability of regulatory data shared amongst our SLTT partners to advance public health and promote regulatory compliance. The system will assist our SLTT partners to better manage high quality regulatory programs and advance implementation and conformance with the regulatory program standards by enhancing the management of regulatory records including firm inventory, inspection reports (for SLTT conducted inspections and FDA contract inspections), inspection frequencies, laboratory results, consumer complaints, recalls, and enforcement actions. The system will also strengthen collaborations across relevant public health sectors to prepare, detect, respond, and prevent future public health emergencies, such as foodborne illness outbreaks or infectious disease. Supporting a One Health approach includes sharing pertinent information such as complaint investigation and laboratory data.The application should detail how the following will be achieved: User CommunityA. Defining, establishing, and identifying the needs of the stakeholders and user community.B. Develop and maintain contracts, memorandum of understanding (MOUs), or other agreements with participating users. The agreements should encompass such provisions including but not limited to, establishing a non-public information sharing matrix with the user community, projected cost of each user for the development, continuous maintenance and improvement of the project, roles and responsibilities of each party, liability conditions, and obtaining consensus on user requirements. The grantee must collaborate with lead users and FDA during project development and execution. C. Promote widespread usage and adoption of the data management infrastructure by conducting outreach to recruit users across the human and animal food regulatory community. D. Develop a continuous improvement framework to be sustained by the user community, including implementation of a cost sharing model for all system users throughout the development, maintenance, and improvement phases of the project. The cost sharing model should enable the grantee and users to support the maintenance, continuation, and long-term sustainability of the database after the project period. Provide a forum for soliciting user feedback and making system improvements.E. Determine participation criteria of SLTT partners to align with the scope of this project. This data management system may support non-FDA programs based upon user needs and requests using non-FDA funds. The grantee should identify and ensure those costs are incurred by the users or other funding sources as FDA grant funds may only be used to support programs directly related to the mission and regulatory responsibilities of FDA.F. Collaborate with user community to seek innovative approaches to support the One Health concept by leveraging the data management systemTechnology and policiesA. As the data management system is developed, an aim of this project will be to support implementation of data integration, i.e., integrate with ORA Data Exchange (DX), a bidirectional unified platform to securely share information between regulatory partners and FDA. Capabilities of the ORA DX include sharing of FDA data such as firm inventory to state partners and streamlining inspection and lab sample data submissions from state partners to FDA. The ORA DX encompasses component applications for inspection, lab sample, and firm inventory data exchange capabilities including a website portal called the ORA Partners Portal (ORAPP) and a system-to-system web service application programming interface (API) called the National Food Safety Data Exchange (NFSDX). It also includes a downloadable XML-based Enhanced DX Client application for sample data submissions from state labs to FDA. In addition, the ORA DX integrates with other FDA systems including the ORA Field Accomplishments and Compliance Tracking System (FACTS) and the Electronic State Access to FACTS (eSAF), as well as planned future integration with the Automated Laboratory Information System (ALIS). The ORA DX is managed by the ORA Office of Information Systems Management (OISM) and Office of Information Management and Technology (OIMT) in close collaboration with stakeholders across FDA and state regulatory partners. The grantee shall provide development, maintenance, and support for the data management system using processes that facilitate coordination and interoperability with the ORA DX, including but not limited to:Continuously enhance the data management system with new and updated capabilities to ensure ongoing interoperability and feature parity with FDA updates to the ORA DX, as well as interoperability with related FDA systems such as FACTS, eSAF, and ALIS, on a timeframe and release schedule agreed to by the grantee and OISM/OIMT stakeholders.Utilize software development methodologies to ensure long-term sustainability and ease of use and maintenance by state regulatory partners during and after the cooperative agreement period of performance, as well as reduced duplication of effort for development of data exchange systems across the grantee, FDA, and state regulatory partners (including but not limited to open-source development of the data management system for use by FDA and any state regulatory partner, shared application framework

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