Proposed Rules. Notice of petition
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/register/2016/03/21/2016-06199·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2016-F-0784] Global Nutrition International; Filing of Food Additive Petition (Animal Use) AGENCY: Food and Drug Administration, HHS. ACTION: Notice of petition. SUMMARY: The Food and Drug Administration
(FDA)is announcing we have filed a petition, submitted by Global Nutrition International, proposing that the food additive regulations be amended to provide for the safe use of calcium butyrate as a source of energy in dairy cattle feed. DATES: The food additive petition was filed on February 12, 2016. FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, *chelsea.trull@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice that we have filed a food additive petition (FAP 2294), submitted by Global Nutrition International, Zac de Paron, 5 Rue des Compagnons d'Emmaüs, BP 70166, 35301 Fougères Cedex, France. The petition proposes to amend the food additive regulations in 21 CFR part 573 *Food Additives Permitted in Feed and Drinking Water of Animals* to provide for the safe use of calcium butyrate as a source of energy in dairy cattle feed. The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(r) because it is of a type that does not individually or cumulatively have a significant effect on the human environment. In addition, the petitioner has stated that to their knowledge, no extraordinary circumstances exist. If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection. Dated: March 15, 2016. Tracey H. Forfa, Acting Director, Center for Veterinary Medicine. [FR Doc. 2016-06199 Filed 3-18-16; 8:45 am]
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