Answer: Details regarding FDA's data requirements can be found in FDA's guidance documents implementing the FCN program, available on FDA's Web page as follows:
"Guidance for Industry, Preparation of Premarket Notifications for Food Contact Substances: Chemistry Recommendations" (made final, April 2002, updated December 2007) is found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm081818.htm
"Guidance for Industry, Preparation of Premarket Notifications for Food Contact Substances: Toxicology Recommendations" (April 2002), is found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm081825.htm
"Guidance for Industry, Preparation of Premarket Notifications for Food Contact Substances: Administrative" (June 2000, updated May 2002), is found at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/ucm081807.htm
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