Food Applications Regulatory Management System (FARM)

The Food and Drug Administration (FDA) established this Master IDIQ on June 30, 2014, to provide technical support, operations and maintenance, development, and modernization of the Food Applications Regulatory Management (FARM) System, which FDA's Center for Food Safety and Applied Nutrition (CFSAN) uses to review pre-market submissions for food ingredients and additives. This vehicle is no longer active for new orders; the ordering period closed on June 30, 2019, more than seven years ago.

The 12 task orders awarded under the vehicle total $17.5 million in combined potential value, with $17.3 million (99%) obligated. Orders arrived at a steady rate of two per year from 2015 through 2019. Versatech Inc. held 100% of all awards across the vehicle's lifetime, concentrating all competition risk in a single prime; FDA was the exclusive customer.

Task-order scope split between operations and maintenance support and system development, modernization, and enhancement. Recent orders through mid-2019 include ongoing O&M support for FARM 6.6 while next-generation features were in development, development and modernization efforts supporting CFSAN's regulatory analysis workflows, and invoice processing support. Individual task-order ceilings ranged from approximately $1.17 million to $1.87 million. Pricing models were predominantly labor-hour arrangements; some orders used firm fixed price. Task-order performance periods typically lasted 12 months.

Set-asides reflected a 58% competitive 8(a) to 42% unrestricted split across 12 awards. All work performed at FDA facilities and supporting CFSAN's operations in the Washington, D.C. metropolitan area.

Because the vehicle's ordering window closed in 2019 and no new orders can be placed, the vehicle is closed to new pursuits. Existing primes seeking follow-on support would need to identify a successor vehicle or transition vehicle for continued FARM System work.

To perform its core responsibilities, CFSAN uses the mission critical Food Applications Regulatory Management (FARM) System to review pre market submissions for food ingredients under the Food, Drug, and Cosmetic (FD & C) Act, and the Food Allergen Labeling and Consumer Protection Act (FALCPA). The FARM system is available to CFSAN reviewers to access and review industry submissions and conduct analyses with regards to chemical, toxicological, and environmental analysis and other issues, regarding specific substances. Specifically, this system supports CFSAN's Office of Food Additive Safety (OFAS) and the Office of Nutrition, Labeling and Dietary Supplements (ONLDS) in their review of a wide variety of submissions and petitions submitted by regulated industry. FARM is essential in making regulatory safety regulatory safety decisions.