Alzchem AG; Filing of Food Additive Petition (Animal Use)

Federal Register, Volume 80 Issue 136 (Thursday, July 16, 2015)

Federal Register Volume 80, Number 136 (Thursday, July 16, 2015)

Proposed Rules

Page 42069

From the Federal Register Online via the Government Publishing Office www.gpo.gov

FR Doc No: 2015-17379

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

Docket No. FDA-2015-F-2337

Alzchem AG; Filing of Food Additive Petition (Animal Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that Alzchem AG has filed a petition proposing that the food additive regulations be amended to provide for the safe use of guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in diets for broiler chickens and turkeys.

DATES: Submit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by August 17, 2015.

ADDRESSES: Submit electronic comments to: http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-

305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a food additive petition (FAP 2292) has been filed by Alzchem AG, Chemiepark Trostberg, Dr.-Albert-Frank-Str. 32, 83308, Trostberg, Germany. The petition proposes to amend Title 21 of the Code of Federal Regulations (CFR) in part 573 Food Additives Permitted in Feed and Drinking Water of Animals (21 CFR part 573) to provide for the safe use of guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in diets for broiler chickens and turkeys. The petitioner has requested a categorical exclusion from preparing an environmental assessment or environmental impact statement under 21 CFR 25.32(r).

Interested persons may submit either electronic or written comments regarding this request for categorical exclusion to the Division of Dockets Management (see DATES and ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

Dated: July 10, 2015.

William T. Flynn,

Acting Director, Center for Veterinary Medicine.

FR Doc. 2015-17379 Filed 7-15-15; 8:45 am

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