[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Proposed Rules]
[Pages 96405-96406]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31606]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2016-F-3880]


Novus International, Inc.; Filing of Food Additive Petition 
(Animal Use); Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the notice of petition, published in the Federal 
Register of November 8, 2016 (81 FR 78528), 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. FDA is reopening the comment period to 
allow additional time for comments on environmental impacts.

DATES: Submit either electronic or written comments by January 30, 
2017.

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 comments, 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-2016-F-3880 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 comments 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

[[Page 96406]]

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: In the Federal Register of November 8, 2016 
(81 FR 78528), Novus Inc. proposed 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.
    Interested persons were originally given until December 8, 2016, to 
comment on the petitioner's environmental assessment. The November 8, 
2016, notice of petition was published with the incorrect docket 
number. A correction published in the Federal Register of November 29, 
2016 (81 FR 85972). On our own initiative, we are reopening the comment 
period to allow potential respondents to thoroughly evaluate and 
address pertinent environmental issues.

    Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31606 Filed 12-29-16; 8:45 am]
 BILLING CODE 4164-01-P