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

Background The 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. Objectives The 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 Community A. 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 system Technology and policies A. 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 frameworks, publishing standards and documentation, and API management)Develop and implement contingency plans to ensure data are available and maintained during and after unforeseen events.Coordinating with OISM/OIMT stakeholders on software architecture, design, and management processes to increase adoption of the ORA DX by current and future state regulatory partner users of the data management system, including continuous system enhancements and process improvements to reduce the time and resources required to onboard, upgrade, and troubleshoot and fix integration issues between the ORA DX and the data management system as well as integration issues with related FDA systems such as FACTS, eSAF, and ALIS.Support and provide activities to monitor and maintain availability of state regulatory partner integrations between the ORA DX and the data management system as well as its related FDA systems such as FACTS, eSAF, and ALIS. This includes end-to-end system reliability, testing, quality assurance, and timely resolution of outages and bug fixes.Grantee will need to ensure IT vendor(s) and/or other supportive vendors enter into non-public information disclosure agreements with the participating SLTT partners as necessary to protect state and FDA regulatory information. In order to promote appropriate information sharing, the applicant must have an information sharing agreement with FDA under 21 CFR 20.88(e) or be able to obtain an agreement prior to the start date of the award. Information sharing is limited to pre-decisional information and only for the purpose outlined in this award.B. Leverage and adopt technologies, tools, and approaches in supporting New Era of Smarter Food Safety Blueprints. For example:Ensure the data management system is designed to be interoperable with other systems to monitor and share data between stakeholders on accelerated tracebacks and traceforwardsAdvance New Era Blueprint core element 2.3 (Domestic Mutual Reliance), to further develop and enhance the mechanisms for appropriate data and information sharing to enable FDA and states with comparable regulatory and public health systems to more fully rely on, coordinate with, and leverage one another’s work, data, and actionsC. Leverage and adopt technologies, tools, and approaches in supporting Domestic Mutual Reliance in collaboration with the FDA and user community. For example:Ensure the data management system is designed to be interoperable with other systems to share data and advance an integrated approach to work-planning and risk prioritization/categorization including inspection frequency mandates, comparison/reconciliation of inventories, and sample collectionSupport future advancements of a Food Safety Information Network to enable FDA to work closely with state regulatory human and animal food safety programs to extend efforts to protect public health; collaborate with states to develop and sustain a highly trained workforce and build quality management systems and the infrastructure needed to meet national regulatory program standardsD. Leverage and adopt technologies, tools, and approaches in supporting a One Health approach. For example:Ensure the data management system is designed to be operable with other systems to support cross-jurisdictional coordination and information sharing to address localized environmental contamination in agricultural/farm production, such as produce outbreaks linked to the environmentE. Protect and ensure compliance with applicable regulations on data security, privacy, and usageF. Identify and address barriers to using the data management systemG. Provide documentation on policies for data retention, records management, and security within the repository Resources A. Indicate how the project will be monitored and managed, frequency of oversight, and by whom (e.g., titles, roles). Additionally, determine how the project will support seamless user migration from existing data management systems to the new system. B. Ensure project team have adequate resources and knowledge to ensure project timelines are met.C. Provide, or has a mechanism for others to provide, quality assurance to improve the accuracy and integrity of datasets and metadata.D. Ensure administrative, technical, and physical safeguards are employed to comply with applicable confidentiality, risk management, and continuous monitoring requirements for sensitive data.E. Implement procurement practices and a strategy that accomplishes the objectives of the cooperative agreement and promotes diversity. FDA is committed to promoting Diversity, Equity, Inclusion and Accessibility (DEIA) to achieve FDA's mission to protect public health. The grantee is expected to promote diversity among the vendor(s) for goods and services by developing a diversity procurement strategy. The grantee should use their diversity procurement strategy to take all necessary affirmative steps to assure that disadvantaged and women-owned small business concerns, as defined by the US Small Business Administration and outlined in 13 CFR 124.103(b) and 13 CFR 127.200, are solicited for all procurement opportunities whenever there are possible sources. This provision is in support of 48 CFR 52.219-8 Utilization of Small Business Concerns. The HHS Small Business Office can be solicited for recommendations. The grantee should also consider the diversity efforts of vendors as selection criteria for purchasing goods and services, especially when disadvantaged and women-owned small businesses cannot be directly utilized. The grantee may be asked to participate in outreach efforts such as conferences and/or trade shows for the purpose of this provision.