[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]
 BILLING CODE 4164-01-P