Building an Integrated Information Technology Infrastructure for State Regulatory Programs (U2F)

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 their 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.

Donor Name: Office of Regulatory Affairs (ORA)

Country: United States

State: All States

Type of Grant: Grant

Deadline (mm/dd/yyyy): 01/20/2022

Size of the Grant: $6,000,000

Grant Duration: 3 Years

Details:

The purpose of this Funding Opportunity Announcement is to build an integrated information technology (IT) data management system and user community to be utilized by state, local, territorial, and tribal (SLTTs) regulatory and public health partners for their human and animal food regulatory and public health programs. This cooperative agreement is intended to establish a robust IT infrastructure to assist SLTT regulatory and public health partners to better manage high quality regulatory programs and advance conformance with the regulatory standards.  The IT infrastructure will be designed with the capability to integrate with FDA data exchange systems, which supports information sharing between states as well as between FDA and state regulatory and public health partners.  The data management system and user community will support continuing efforts in achieving a national integrated food supply system (IFSS), promoting One Health, supporting domestic mutual reliance (DMR) initiatives and implementing the New Era of Smarter Food Safety Blueprint.

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 history
  • Store 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.

Award Information

FDA /ORA intends to commit up to $6,000,000 in FY 2022 to fund one award.

Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

  • YR 01: $6,000,000
  • YR 02: $6,000,000
  • YR 03: $6,000,000

Award Project Period

  • The scope of the proposed project should determine the project period. The maximum project period is three (3) years.

Eligible Applicants

  • Eligible Organizations
    • Nonprofits Other Than Institutions of Higher Education
    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • This opportunity is only available to the following nonprofit food safety training entities that collaborate with 1 or more institutes of higher education:
  • National organization/associations whose membership includes, but is not necessarily limited to, state, local, territorial, and/or tribal food safety regulatory professionals or government agencies and who collaborate with one or more institutions of higher education as defined in 21 USC §399(b).
  • Competition is limited to these national organizations/associations for the following reasons:
  • These national organizations/associations must have the knowledge and understanding of the following but are not limited to state unique regulatory program data management requirements; data sharing initiatives between SLTT and federal partners; state needs and procurement requirements; regulatory program standards and the requirements to achieve conformance. These national organizations/associations have a vested interest and share FDA’s visions to improving food safety and public health outcomes. They strive to lead other initiatives to advance building an integrated food and public health safety system.
  • National organizations/associations can provide a platform for sharing information and national implementation of the projects through national and regional meetings, web sites, listservs, and other communications. They have relationships and communication systems to effectively promote the objectives established under this cooperative agreement.
  • Applicant associations must hold 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.

For more information, visit Grants.gov.