The FDA is responsible for protecting the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, biological products, medical devices, cosmetics, the nation’s food supply, and certain other products. In total, the FDA regulates more than $1 trillion of consumer goods, or about 25% of consumer expenditures in the United States. The FDA’s optimal performance has significant public health and economic benefits. The Agency can speed innovations to market, leading to more affordable medicines and foods. It protects public health, ensuring that people have access to accurate, science-based information about their medicines and foods. The FDA also coordinates with several international organizations to enable global investigations of potential health risks from products, to respond to emerging new diseases, and to help address the challenges faced by public health officials and individuals around the world. The Human Foods Program (HFP) oversees all FDA activities related to food safety and nutrition, organized in a single group working under the Deputy Commissioner of Human Foods.
The mission of the HFP is to ensure that food is a source of wellness for all U.S. consumers, and our day-to-day activities are focused at protecting and promoting the health and wellness of all people through science-based approaches to prevent foodborne illness, reduce diet related chronic disease, and ensure chemicals in food are safe. The HFP has many interfacing IT systems that support its mission. These include the Food Applications Regulatory Management (FARM), the Chemical Evaluation and Risk Estimation System (CERES), and the Scientific Terminology and Regulatory Information (STARI), and Warp Intelligent Learning Engine (WILEE). The HFP- Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDSI) uses those multiple systems to access and visualize data to support the review and assessment of food ingredients and packaging. The HFP’s Food Applications Regulatory Management (FARM) system and Interfacing IT systems currently support the work of staff across Human Foods Program (HFP) Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDSI) that includes HFP-OFCSDSI Office of PreMarket Additive Safety (OPMAS), HFP-OFCSDSI PostMarket Assessment (OPMA), HFP-OFCSDSI Office of Dietary Supplement Programs (ODSP), , HFP-OFCSDSI-Innovative Foods Staff, HFP-OFCSDSI-Operations Staff. and the HFP-Nutrition Center of Excellence (NCE)- Office of Nutrition and Food Labeling (ONFL).. In addition to HFP, the IT systems support other FDA centers such as FARM supporting the Office of Chief Scientist, Office of Color and Cosmetics (OCS-OCAC), and the Center for Veterinary Medicine (CVM)’s Ingredient Safety Team, Division of Animal Feeds and other scientific reviewers in the Center for Drug Evaluation and Research (CDER). FARM was initiated in 1995 to support premarket and post market safety review of petitions and notifications received from the regulated industry. FARM is the primary system available to HFP reviewers to access and review industry submissions and conduct analysis with regards to chemical, toxicological, and environmental analysis and other issues, regarding specific ingredients. The following submissions/petitions are supported by the FARM system: Food Additive Petitions (FAPs), Color Additive Petitions (CAPs),Generally Recognized as Safe notices (GRNs), Food Contact Notifications (FCNs), Biotechnology Consultations (BNFs), New Protein Consultations (NPCs), Infant Formula Notifications (IFNs), Notifications for Food Allergens (NFAs), Petitions for Food Allergens (PFAs), Citizen Petitions (CZPs), Cell Culture Consultation (CCC), and Cell Culture Ingredients (CCI), New Dietary Ingredient Notifications (NDIs), Structure Function Claims (SFCs) and Health Claims (HC). In addition to providing information technology support to the scientific review of submissions, the FARM System is used to support critical regulatory functions for processing and documenting agency actions pertaining to pre-submission meetings, Prenotification Consultations, Prepetition Consultations, Inquiries/correspondences and Freedom of Information Act (FOIA) requests for information sent to OFCSDFI, OFCSDFI-ODSP, NCE-ONFL and OCS-OCAC.
The purpose of this ID/IQ is to establish a contracting vehicle for operations and maintenance and IT development services to support the mission of the various program areas. The contractor will work with multiple IT systems and interfaces to support the regulatory goals and objectives of each program area.
