[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Proposed Rules]
[Pages 44128-44129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20062]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2017-N-5476]
Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition
(Animal Use)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; petition for rulemaking.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing that Akzo Nobel Surface Chemistry AB has filed a petition
proposing that the food additive regulations be amended to provide for
the safe use of glyceryl polyethylene glycol (15) ricinoleate as an
emulsifier in animal food that does not include food for cats, dogs,
vitamin premixes, or aquaculture.
DATES: Submit either electronic or written comments on the petitioner's
[[Page 44129]]
environmental assessment by October 23, 2017.
ADDRESSES: You may submit comments as follows: Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before October 23, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of October 23, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2017-N-5476 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; glyceryl polyethylene glycol (15) ricinoleate.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855, 240-402-6729, [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 2297) has been filed by Akzo Nobel Surface
Chemistry AB, Stenungsunds fabriker, 444 85 Stenungsund, Sweden. 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 glyceryl
polyethylene glycol (15) ricinoleate as an emulsifier in animal food
that does not include food for cats, dogs, vitamin premixes, or
aquaculture.
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 (EA) submitted with
the petition that is the subject of this notice on public display at
the Dockets Management Staff (see DATES and ADDRESSES) for public
review and comment.
FDA will also place on public display, at the Dockets Management
Staff, and at https://www.regulations.gov, any amendments to, or
comments on, the petitioner's EA 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: September 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20062 Filed 9-20-17; 8:45 am]
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