Aker BioMarine; Filing of Color Additive Petition, 15089-15090 [2018-07155]

Download as PDF Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Proposed Rules Authority: 7 U.S.C. 8301–8317; 7 CFR 2.22, 2.80, and 371.4. 23. In § 147.41, the definition of NPIP Technical Committee is amended by adding three sentences after the last sentence to read as follows: ■ § 147.41 Definitions. * * * * * NPIP Technical Committee. * * * The NPIP Technical Committee is divided into three subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP Technical Committee Members may serve on one, two, or all three subcommittees. The committee will evaluate proposed changes to the Provisions and Program Standards of the Plan which include, but are not limited to, tests and sanitation procedures, and provide recommendations to the Delegates of the National Plan Conference as to whether they are scientifically or technically sound. * * * * * ■ 24. In § 147.43, paragraph (b) is amended by adding a sentence after the second sentence to read as follows: § 147.43 General Conference Committee. * * * * * (b) * * * The ballots for electing regional committee members and their alternates will be printed in such a way as to allow the specific selection of one nominee for member, and one nominee for alternate from the remaining nominees. * * * * * * * * ■ 25. In § 147.46, paragraph (d) is amended by adding a sentence after the last sentence to read as follows: § 147.46 Committee consideration of proposed changes. * * * * * (d) * * * Once completed, the combined committee report will be distributed electronically to the Official State Agencies prior to the delegates voting on the final day of the biennial conference. * * * * * ■ 26. In § 147.51, the definition of NPIP Technical Committee is amended by adding three sentences after the last sentence to read as follows: sradovich on DSK3GMQ082PROD with PROPOSALS § 147.51 Definitions. * * * * * NPIP Technical Committee. * * * The NPIP Technical Committee is divided into three subcommittees (Mycoplasma, Salmonella, and Avian Influenza). NPIP Technical Committee Members may serve on one, two, or all three subcommittees. The committee will evaluate proposed changes to the VerDate Sep<11>2014 16:17 Apr 06, 2018 Jkt 244001 Provisions and Program Standards of the Plan which include, but are not limited to, tests and sanitation procedures, and provide recommendations to the Delegates of the National Plan Conference as to whether they are scientifically or technically sound. ■ 27. In § 147.52, paragraph (a) is revised to read as follows: § 147.52 Authorized laboratories. * * * * * (a) Check-test proficiency. The NPIP will serve as the lead agency for the coordination of available check tests from the National Veterinary Services Laboratories. Further, the NPIP may approve and authorize additional laboratories to produce and distribute a check test as needed. The authorized laboratory must use the next available check test for each assay that it performs. * * * * * ■ 28. In § 147.54, paragraphs (a)(1), (3), and (4) are revised to read as follows: § 147.54 Approval of diagnostic test kits not licensed by the Service. (a) * * * (1) The sensitivity of the kit will be evaluated in at least three NPIP authorized laboratories by testing known positive samples, as determined by the official NPIP procedures found in the NPIP Program Standards or through other procedures approved by the Administrator. Field samples, for which the presence or absence of the target organism or analyte has been determined by the current NPIP test, are the preferred samples and should be used when possible. Samples from a variety of field cases representing a range of low, medium, and high analyte concentrations should be used. In some cases it may be necessary to utilize samples from experimentally infected animals. Spiked samples (clinical sample matrix with a known amount of pure culture added) should only be used in the event that no other sample types are available. When the use of spiked samples may be necessary, prior approval from the NPIP Technical Committee is required. Pure cultures should never be used. Additionally, laboratories should be selected for their experience with testing for the target organism or analyte with the current NPIP approved test. (e.g., a Salmonella test should be evaluated by NPIP authorized laboratories that test for Salmonella routinely). If certain conditions or interfering substances are known to affect the performance of the kit, appropriate samples will be included so that the magnitude and PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 15089 significance of the effect(s) can be evaluated. * * * * * (3) The kit will be provided to the cooperating laboratories in its final form and include the instructions for use. The cooperating laboratories must perform the assay exactly as stated in the supplied instructions. Each laboratory must test a panel of at least 25 known positive samples. In addition, each laboratory must test at least 50 known negative samples obtained from several sources, to provide a representative sampling of the general population. The cooperating laboratories must perform a current NPIP procedure or NPIP approved test on the samples alongside the test kit for comparison and must provide an outline of the method on the worksheet for diagnostic test evaluation. Reproducibility and robustness data should also be included. (4) Cooperating laboratories will submit to the kit manufacturer all compiled output data regarding the assay response. Each sample tested will be reported as positive or negative, and the official NPIP procedure used to classify the sample must be submitted in addition to the assay response value. A completed worksheet for diagnostic test evaluation is required to be submitted with the compiled output data and may be obtained by contacting the NPIP Senior Coordinator. Data and the completed worksheet for diagnostic test evaluation must be submitted to the NPIP Senior Coordinator 4 months prior to the next scheduled General Conference Committee meeting, which is when approval will be sought. * * * * * Done in Washington, DC, this 3rd day of April 2018. Kevin Shea, Administrator, Animal and Plant Health Inspection Service. [FR Doc. 2018–07076 Filed 4–6–18; 8:45 am] BILLING CODE 3410–34–P 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: E:\FR\FM\09APP1.SGM Notification of petition. 09APP1 15090 Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Proposed Rules 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. SUMMARY: 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. ADDRESSES: sradovich on DSK3GMQ082PROD with PROPOSALS 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: VerDate Sep<11>2014 16:17 Apr 06, 2018 Jkt 244001 • 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/201523389.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 PO 00000 Frm 00009 Fmt 4702 Sfmt 9990 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. 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). SUPPLEMENTARY INFORMATION: 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 E:\FR\FM\09APP1.SGM 09APP1

Agencies

[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
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