I® ORIGINAL 1001 G Street, N.W. Suite 500 West Washington, D.C. 20001 tel. 202.434.4100 fax 202.434.4646 Writer's Direct Access Martha E. Marrapese (202) 434-4 123 November 11. 2010
[email protected] Via Federal Express CONTAINS CONFIDENTIAL BUSINESS INFORMATION Food and Drug Administration Division of Animal Feeds (HFV-224) Office of Surveillance and Compliance Center for Veterinary Medicine 7519 Standish Place Rockville, Maryland 20855 Re: GRAS Notification for Chlorine Dioxide and Withdrawal of FAP 2266; Resonant Biosciences, Inc.; Our File No. RE14070 Dear Sir or Madam: The purpose of this letter is to request to participate in the pilot program for a Generally Recognized as safe (GRAS) determination for the safe use of chlorine dioxide generated by the notifier's PureMash* system in the production of food grade and non-food grade ethanol and distillers grains for animal feed use (food producing livestock). 75 Fed. Reg. 31800 (June 4, 2010). In connection with this GRAS notification, Resonant Biosciences, Inc. (RBS or Notifier) is formally withdrawing Food Additive Petition (FAP) 2266. The Notifier previously met with your office to discuss residual testing and a submission plan for this product. The potential eligibility for clearance under the Federal Food, Drug, and Cosmetic Act (FFDCA) as GRAS was raised at that time. We trust that our prior discussions fully satisfy the guidance in the Federal Register that "FDA strongly encourages potential participants in the animal food pilot program to contact the Division of Animal Feeds" prior to submitting notices. 75 Fed. Reg. at 31802. We look forward to confirmation that this submission has been accepted and is complete.