Attachment_B_Appendix_I_Amendment_1.pdf
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- Solicitation number
- 75F40126R00042
About this file
This document is an appendix to a solicitation describing the Food Applications Regulatory Management (FARM) System and its current workflow capabilities. Solicitation #75F40126R00042, Amendment #1 outlines the FARM System as an information management tool designed for FDA Agency reviewers to enable electronic document review processes, expedite ingredient safety reviews, and support safety decision-making to maximize productivity.
The FARM System currently contains 265 workflows organized by multiple FDA offices and divisions. The Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDFI) manages 20 workflows including BioTech Notification Files, Cell Culture Consultation, GRAS submissions, Food Contact Notifications, Infant Formula Notifications, and Post-Market Review processes. Additional workflows are maintained by the Office of Dietary Supplement Programs (ODSP) with four dedicated workflows for dietary supplement-related notifications and petitions; the Nutrition Center of Excellence-Office of Nutrition and Food Labeling (NCE-ONFL) with three workflows for health claims and citizen petitions; and the Office of Chief Scientist's Office of Cosmetics and Colors (OCAC) with correspondence workflow capabilities. This appendix serves as reference documentation for the scope and organization of the FARM System's workflow architecture within the federal contract opportunity.
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ATTACHMENT B APPENDIX I
FOOD APPLICATIONS REGULATORY MANAGEMENT (FARM) & IT INTERFACING SYSTEMS
SOLICTATION #75F40126R00042
Amendment #1
Appendix I
The FARM System provides information management tools for Agency reviewers and is the key enabler of the electronic document review process and expedites the ingredient safety review process and subsequent safety decision-making effort to maximize productivity. Currently, FARM has 265 workflows:
Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDFI)
BioTech Notification Files (BNF) Workflow Cell Culture Consultation (CCC) Workflow Cell Culture Consultation for Ingredients (CCI) Workflow Citizen Petition Workflow Correspondence Workflow Electronic Freedom of Information Act (EFOIA) Workflow Food Allergen Labeling and Consumer Protection Act (FALCPA) Workflow Food Contact Notification (FCN) Workflow BPS-Biotechnology Pre-Submission Review, GPS-GRAS Pre-Submission Review, FPS-FALCPA Pre- Submission Review (GBFP) Workflow Generally Recognized as Safe (GRAS) Workflow Infant Formula Notification (IFN) Workflow New Protein Consultation (NPC) Workflow Office of Post-Market Assessment (OPMA)-Division of Chemical Contaminants (DCC) Workflow
Post-Market Review (PMR) Workflow Petition Workflow Pre-Notification Consultation (PNC) Workflow Pre-Petition Consultation (PRP) Workflow Threshold of Regulation (TOR) Workflow
OFCSDFI-Office of Dietary Supplement Programs (ODSP):
OFCSDSI-ODSP Citizen Petition Workflow OFCSDSI-ODSP Correspondence Workflow OFCSDSI-ODSP New Dietary Ingredient Notification (NDI) Workflow OFCSDSI-ODSP Structure Function Notification (SFCN) Workflow
Nutrition Center of Excellence (NCE)- Office of Nutrition and Food Labeling (ONFL):
NCE-ONFL Citizen Petition Workflow NCE-ONFL Health Claims Workflow NCE-ONFL Inquiry and Correspondence Workflow
Office of Chief Scientist (OCS):
OCS-Office of Cosmetics and Colors (OCAC) - Correspondence Workflow
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