Document ID: FDA-2014-F-0149-0001
Agency: fda
Document Type: Proposed Rule
Title: Lohmann Animal Health GMBH; Filing of Food Additive Petition (Animal Use)
Posted Date: 2014-02-10T05:00Z

[Federal Register Volume 79, Number 27 (Monday, February 10, 2014)]
[Proposed Rules]
[Page 7611]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02725]

[[Page 7611]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2014-F-0149]

Lohmann Animal Health GMBH; 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 that 
Lohmann Animal Health GMBH has filed a petition proposing that the food 
additive regulations be amended to provide for the safe use of the 
enzyme phytase from bioengineered Pichia pastoris yeast in animal feed.

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 March 12, 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 (HFV-226), 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 2281) has been filed by Lohmann Animal 
Health GMBH, Heinz-Lohmann-Strasse 4, 27472 Cuxhaven, 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 the enzyme 
phytase from bioengineered Pichia pastoris yeast in animal feed.
    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). 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.

    Dated: February 4, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-02725 Filed 2-7-14; 8:45 am]
BILLING CODE 4160-01-P