Attachment_B_Appendix_I.pdf
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- Solicitation number
- 75F40126R00042
About this file
This is an appendix to a federal solicitation that describes the Food Applications Regulatory Management (FARM) System and its existing IT infrastructure. The document is Attachment B Appendix I to Solicitation #75F40126R00042 and outlines the 25 current workflows within the FARM System that provide information management tools for Agency reviewers to facilitate electronic document review and expedite ingredient safety review processes.
The FARM System currently supports 25 workflows organized across four organizational units: the Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDFI) operates 16 workflows including BioTech Notification Files, Cell Culture Consultation, Citizen Petitions, FALCPA, Food Contact Notification, GRAS, Infant Formula Notification, New Protein Consultation, Post-Market Review, and Threshold of Regulation workflows; the Office of Dietary Supplement Programs (ODSP) operates four workflows covering Citizen Petitions, Correspondence, New Dietary Ingredient Notification, and Structure Function Notification; the Nutrition Center of Excellence and Office of Nutrition and Food Labeling (NCE-ONFL) operates three workflows for Citizen Petitions, Health Claims, and Inquiry and Correspondence; and the Office of Chief Scientist's Office of Cosmetics and Colors (OCS-OCAC) operates one Correspondence Workflow. This appendix serves as reference material describing the existing system landscape rather than specifying new products or services to be delivered.
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ATTACHMENT B APPENDIX I
FOOD APPLICATIONS REGULATORY MANAGEMENT (FARM) & IT INTERFACING SYSTEMS
SOLICTATION #75F40126R00042
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 25 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 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
Appendix I
File details come from the government source that posted it. Updated .