Document ID: FDA-2014-F-0469-0001
Agency: fda
Document Type: Proposed Rule
Title: Excentials B.V.; Filing of Food Additive Petition (Animal Use)
Posted Date: 2014-04-23T04:00Z

[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Proposed Rules]
[Page 22602]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09216]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2014-F-0469]

Excentials B.V.; 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 
Excentials B.V. has filed a petition proposing that the food additive 
regulations be amended to provide for the safe use of L-
selenomethionine as a dietary source of selenium in feed for poultry, 
swine, and ruminants.

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 May 23, 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 2278) has been filed by Excentials B.V., 
Vierlinghstraat 51, 4251 LC Werkendam, The Netherlands. 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 L-selenomethionine as 
a dietary source of selenium in feed for poultry, swine, and ruminants.
    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 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: April 18, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-09216 Filed 4-22-14; 8:45 am]
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