83 FR 15089 - Aker BioMarine; Filing of Color Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 68 (April 9, 2018)

Page Range		15089-15090
FR Document		2018-07155

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.

Federal Register, Volume 83 Issue 68 (Monday, April 9, 2018)

[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Proposed Rules]
[Pages 15089-15090]
From the Federal Register Online  [www.thefederalregister.org]
[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.thefederalregister.org/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

Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Proposed Rules 15089

Authority: 7 U.S.C. 8301–8317; 7 CFR Provisions and Program Standards of significance of the effect(s) can be
2.22, 2.80, and 371.4. the Plan which include, but are not evaluated.
■ 23. In § 147.41, the definition of NPIP limited to, tests and sanitation * * * * *
Technical Committee is amended by procedures, and provide (3) The kit will be provided to the
adding three sentences after the last recommendations to the Delegates of the cooperating laboratories in its final form
sentence to read as follows: National Plan Conference as to whether and include the instructions for use.
they are scientifically or technically The cooperating laboratories must
§ 147.41 Definitions. sound. perform the assay exactly as stated in
* * * * * ■ 27. In § 147.52, paragraph (a) is the supplied instructions. Each
NPIP Technical Committee. * * * revised to read as follows: laboratory must test a panel of at least
The NPIP Technical Committee is 25 known positive samples. In addition,
divided into three subcommittees § 147.52 Authorized laboratories.
each laboratory must test at least 50
(Mycoplasma, Salmonella, and Avian * * * * *
(a) Check-test proficiency. The NPIP known negative samples obtained from
Influenza). NPIP Technical Committee several sources, to provide a
Members may serve on one, two, or all will serve as the lead agency for the
coordination of available check tests representative sampling of the general
three subcommittees. The committee population. The cooperating
will evaluate proposed changes to the from the National Veterinary Services
Laboratories. Further, the NPIP may laboratories must perform a current
Provisions and Program Standards of NPIP procedure or NPIP approved test
the Plan which include, but are not approve and authorize additional
laboratories to produce and distribute a on the samples alongside the test kit for
limited to, tests and sanitation comparison and must provide an
procedures, and provide check test as needed. The authorized
laboratory must use the next available outline of the method on the worksheet
recommendations to the Delegates of the for diagnostic test evaluation.
National Plan Conference as to whether check test for each assay that it
performs. Reproducibility and robustness data
they are scientifically or technically should also be included.
sound. * * * * * (4) Cooperating laboratories will
* * * * * ■ 28. In § 147.54, paragraphs (a)(1), (3),
submit to the kit manufacturer all
■ 24. In § 147.43, paragraph (b) is and (4) are revised to read as follows: compiled output data regarding the
amended by adding a sentence after the § 147.54 Approval of diagnostic test kits assay response. Each sample tested will
second sentence to read as follows: not licensed by the Service. be reported as positive or negative, and
§ 147.43 General Conference Committee. (a) * * * the official NPIP procedure used to
(1) The sensitivity of the kit will be classify the sample must be submitted
* * * * * in addition to the assay response value.
(b) * * * The ballots for electing evaluated in at least three NPIP
authorized laboratories by testing A completed worksheet for diagnostic
regional committee members and their
known positive samples, as determined test evaluation is required to be
alternates will be printed in such a way
by the official NPIP procedures found in submitted with the compiled output
as to allow the specific selection of one
the NPIP Program Standards or through data and may be obtained by contacting
nominee for member, and one nominee
other procedures approved by the the NPIP Senior Coordinator. Data and
for alternate from the remaining
Administrator. Field samples, for which the completed worksheet for diagnostic
nominees. * * *
the presence or absence of the target test evaluation must be submitted to the
* * * * * organism or analyte has been NPIP Senior Coordinator 4 months prior
■ 25. In § 147.46, paragraph (d) is
determined by the current NPIP test, are to the next scheduled General
amended by adding a sentence after the Conference Committee meeting, which
the preferred samples and should be
last sentence to read as follows: is when approval will be sought.
used when possible. Samples from a
§ 147.46 Committee consideration of variety of field cases representing a * * * * *
proposed changes. range of low, medium, and high analyte Done in Washington, DC, this 3rd day of
* * * * * concentrations should be used. In some April 2018.
(d) * * * Once completed, the cases it may be necessary to utilize Kevin Shea,
combined committee report will be samples from experimentally infected
Administrator, Animal and Plant Health
distributed electronically to the Official animals. Spiked samples (clinical Inspection Service.
State Agencies prior to the delegates sample matrix with a known amount of
[FR Doc. 2018–07076 Filed 4–6–18; 8:45 am]
voting on the final day of the biennial pure culture added) should only be used
BILLING CODE 3410–34–P
conference. in the event that no other sample types
* * * * * are available. When the use of spiked
■ 26. In § 147.51, the definition of NPIP samples may be necessary, prior
approval from the NPIP Technical DEPARTMENT OF HEALTH AND
Technical Committee is amended by HUMAN SERVICES
adding three sentences after the last Committee is required. Pure cultures
sentence to read as follows: should never be used. Additionally,
Food and Drug Administration
laboratories should be selected for their
§ 147.51 Definitions. experience with testing for the target
21 CFR Part 73
* * * * * organism or analyte with the current
sradovich on DSK3GMQ082PROD with PROPOSALS

NPIP Technical Committee. * * * NPIP approved test. (e.g., a Salmonella [Docket No. FDA–2018–C–1007]
The NPIP Technical Committee is test should be evaluated by NPIP
divided into three subcommittees authorized laboratories that test for Aker BioMarine; Filing of Color
(Mycoplasma, Salmonella, and Avian Salmonella routinely). If certain Additive Petition
Influenza). NPIP Technical Committee conditions or interfering substances are AGENCY: Food and Drug Administration,
Members may serve on one, two, or all known to affect the performance of the HHS.
three subcommittees. The committee kit, appropriate samples will be
ACTION: Notification of petition.
will evaluate proposed changes to the included so that the magnitude and

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Document Created: 2018-04-07 02:39:26
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Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notification of petition.
Dates		Submit either electronic or written comments on the petitioner's environmental assessment by May 9, 2018.
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.
FR Citation		83 FR 15089

83 FR 15089 - Aker BioMarine; Filing of Color Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 68 (April 9, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration