[Federal Register Volume 81, Number 216 (Tuesday, November 8, 2016)]
[Proposed Rules]
[Pages 78528-78529]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-26922]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2014-F-0452]


Novus International, Inc.; 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 
Novus International, Inc., has filed a petition proposing that the food 
additive regulations be amended to provide for the safe use of poly (2-
vinylpyridine-co-styrene) as a nutrient protectant for methionine 
hydroxy analog in animal food for beef cattle, dairy cattle, and 
replacement dairy heifers. Additionally, the petition proposes that the 
food additive regulations be amended to provide for the safe use of 
ethyl cellulose as a binder for methionine hydroxy analog to be 
incorporated into animal food.

DATES: Submit either electronic or written comments on the petitioner's 
environmental assessment by December 8, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comment, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2014-F-0452 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; 2-Vinylpyridine-Co-Styrene.'' Received comments will 
be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comment only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Carissa Doody, Center for Veterinary 
Medicine (HFV-228), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-6283, [email protected].

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 2295) has been filed by Novus 
International, Inc., 20 Research Park Dr., Saint Charles, MO 63304. The 
petition proposes to amend part 573 (21 CFR part 573) Food Additives 
Permitted in Feed and Drinking Water of Animals to provide for the safe 
use of poly (2-vinylpyridine-co-styrene) as a nutrient protectant for 
methionine hydroxy analog in animal food for beef cattle, dairy cattle, 
and replacement dairy heifers, and to provide for the safe use of ethyl 
cellulose as a binder for methionine hydroxy analog to be incorporated 
into animal food.
    The potential environmental impact of this action is being 
reviewed. To encourage public participation consistent with regulations 
issued under the National Environmental Policy Act (40 CFR 1501.4(b)), 
the Agency is placing the environmental assessment submitted with the 
petition that is the subject of this notice on public display at the 
Division of Dockets Management (see ADDRESSES) for public review and 
comment. Interested persons may submit to the Division of Dockets 
Management (see DATES and ADDRESSES) either electronic or written 
comments regarding this document. It is only necessary to send one set 
of comments. Identify comments with the docket number found in brackets 
in the

[[Page 78529]]

heading of this document. FDA will also place on public display any 
amendments to, or comments on, the petitioner's environmental 
assessment without further announcement in the Federal Register. If, 
based on its review, the Agency finds that an environmental impact 
statement is not required and this petition results in a regulation, 
the notice of availability of the Agency's finding of no significant 
impact and the evidence supporting that finding will be published with 
the regulation in the Federal Register in accordance with 21 CFR 
25.51(b).

    Dated: November 2, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-26922 Filed 11-7-16; 8:45 am]
 BILLING CODE 4164-01-P