[Federal Register Volume 78, Number 246 (Monday, December 23, 2013)]
[Proposed Rules]
[Page 77384]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30462]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2013-F-1539]


DSM Nutritional Products; 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 DSM 
Nutritional Products has filed a petition proposing that the food 
additive regulations be amended to provide for the safe use of 
ethoxyquin in vitamin D formulations, including 25-hydroxyvitamin 
D3, used in animal food.

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 January 22, 2014.

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: Isabel W. Pocurull, Center for 
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6853.

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 2276) has been filed by DSM Nutritional 
Products, 45 Waterview Blvd., Parsippany, NJ 07054. 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 ethoxyquin as a 
chemical preservative in vitamin D formulations, including 25-
hydroxyvitamin D3, used in animal food.
    The petitioner has requested a categorical exclusion from preparing 
an environmental assessment or environmental impact statement under 21 
CFR 25.32(k). Interested persons may submit either electronic or a 
single copy of written comments regarding this request for categorical 
exclusion to the Division of Dockets Management (see DATES and 
ADDRESSES). 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: December 17, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-30462 Filed 12-20-13; 8:45 am]
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