[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Proposed Rules]
[Pages 15089-15090]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07155]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2018-C-1007]


Aker BioMarine; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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[[Page 15090]]

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
announcing that we have filed a petition, submitted by Aker BioMarine, 
proposing that the color additive regulations be amended to provide for 
the safe use of Antarctic krill meal which is composed of the ground 
and dried tissue of Euphausia superba, for use in the feed of salmonid 
fish. The use would enhance the color of the salmonid fish flesh.

DATES: Submit either electronic or written comments on the petitioner's 
environmental assessment by May 9, 2018.

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 May 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of May 9, 2018. 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 comments, 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-2018-C-1007 for ``Aker BioMarine; Filing of Color Additive 
Petition.'' 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 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 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: Stephen DiFranco, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2710.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 721(d)(1) (21 U.S.C. 379e(d)(1))), we are giving notice 
that we have filed a color additive petition (CAP 5C0303), submitted by 
Aker BioMarine, c/o Intertek Scientific & Regulatory Consultancy (Aker 
BioMarine), Rm. 1036, Building A8 Cody Technology Park, Ively Road, 
Farnborough, Hampshire, GU14 0LX, UK. The petition proposes to amend 
the color additive regulations in part 73 (21 CFR part 73) Listing of 
Color Additives Exempt From Certification to provide for the safe use 
of Antarctic krill meal which is composed of the ground and dried 
tissue of Euphausia superba, for use in the feed of salmonid fish. The 
use of such feed would enhance the color of the salmonid fish flesh.
    We are reviewing the potential environmental impact of this 
petition. To encourage public participation consistent with regulations 
issued under the National Environmental Policy Act (40 CFR 1501.4(b)), 
we are placing the environmental assessment submitted with the petition 
that is the subject of this notice on public display at the Dockets 
Management Staff (see ADDRESSES) for public review and comment.
    We will also place on public display, in the Dockets Management 
Staff and at https://www.regulations.gov, any amendments to, or 
comments on, the petitioner's environmental assessment without further 
announcement in the Federal Register. If, based on our review, we find 
that an environmental impact statement is not required, and this 
petition results in a regulation, we will publish the notice of 
availability of our finding of no significant impact and the evidence 
supporting that finding with the regulation in the Federal Register in 
accordance with 21 CFR 25.51(b).

    Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-07155 Filed 4-6-18; 8:45 am]
 BILLING CODE 4164-01-P


