83_FR_10693 83 FR 10645 - Excentials B.V.; Withdrawal of Food Additive Petition (Animal Use)

83 FR 10645 - Excentials B.V.; Withdrawal of Food Additive Petition (Animal Use)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 48 (March 12, 2018)

Page Range10645-10645
FR Document2018-04775

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (animal use) proposing that the food additive regulations be amended to provide for the safe use of L-selenomethionine as a dietary source of selenium in feed for poultry, swine, and ruminants.

Federal Register, Volume 83 Issue 48 (Monday, March 12, 2018)
[Federal Register Volume 83, Number 48 (Monday, March 12, 2018)]
[Proposed Rules]
[Page 10645]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-04775]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2014-F-0469]


Excentials B.V.; Withdrawal of Food Additive Petition (Animal 
Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; withdrawal of petition for rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
withdrawal, without prejudice to a future filing, of a food additive 
petition (animal use) proposing that the food additive regulations be 
amended to provide for the safe use of L-selenomethionine as a dietary 
source of selenium in feed for poultry, swine, and ruminants.

DATES: The food additive petition was withdrawn on November 10, 2017.

ADDRESSES: For access to the docket, 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, HFV-224, Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-402-6729, [email protected].

SUPPLEMENTARY INFORMATION: In a document published in the Federal 
Register on April 23, 2014 (79 FR 22602), FDA announced that a food 
additive petition (FAP 2278) had been filed by Excentials B.V., 
Vierlinghstraat 51, 4251 LC Werkendam, The Netherlands. The petition 
proposed to amend part 573 of title 21 of the Code of Federal 
Regulations (CFR), Food Additives Permitted in Feed and Drinking Water 
of Animals, to provide for the safe use of L-selenomethionine as a 
dietary source of selenium in feed for poultry, swine, and ruminants. 
Excentials B.V. has now withdrawn the petition without prejudice to a 
future filing in accordance with 21 CFR 571.7.

    Dated: March 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-04775 Filed 3-9-18; 8:45 am]
 BILLING CODE 4164-01-P



                                                                         Federal Register / Vol. 83, No. 48 / Monday, March 12, 2018 / Proposed Rules                                                    10645

                                                 7400.11B is publicly available as listed                under the criteria of the Regulatory                    DEPARTMENT OF HEALTH AND
                                                 in the ADDRESSES section of this                        Flexibility Act.                                        HUMAN SERVICES
                                                 document. FAA Order 7400.11B lists
                                                 Class A, B, C, D, and E airspace areas,                 Environmental Review                                    Food and Drug Administration
                                                 air traffic service routes, and reporting                  This proposal will be subject to an
                                                 points.                                                                                                         21 CFR Part 573
                                                                                                         environmental analysis in accordance
                                                 The Proposal                                            with FAA Order 1050.1F,
                                                                                                         ‘‘Environmental Impacts: Policies and                   [Docket No. FDA–2014–F–0469]
                                                    The FAA is proposing an amendment
                                                 to Title 14, Code of Federal Regulations                Procedures’’ prior to any FAA final                     Excentials B.V.; Withdrawal of Food
                                                 (14 CFR) part 71 by amending the Class                  regulatory action.                                      Additive Petition (Animal Use)
                                                 E airspace extending upward from 700                    List of Subjects in 14 CFR Part 71
                                                 feet above the surface to within a 6.6-                                                                         AGENCY:    Food and Drug Administration,
                                                 mile radius (decreased from a 6.7-mile                   Airspace, Incorporation by reference,                  HHS.
                                                 radius) at Halliburton Field, Duncan,                   Navigation (air).                                       ACTION: Notification; withdrawal of
                                                 OK, and removing the extension to the                                                                           petition for rulemaking.
                                                 north of the airport associated with the                The Proposed Amendment
                                                 Halliburton Field Localizer. This                                                                               SUMMARY:    The Food and Drug
                                                                                                           Accordingly, pursuant to the
                                                 proposal would add an extension within                                                                          Administration (FDA) is announcing the
                                                 4 miles each side of the 359° bearing                   authority delegated to me, the Federal
                                                                                                         Aviation Administration proposes to                     withdrawal, without prejudice to a
                                                 from the airport from the 6.6-mile radius                                                                       future filing, of a food additive petition
                                                 to 11.6 miles north of the airport. The                 amend 14 CFR part 71 as follows:
                                                                                                                                                                 (animal use) proposing that the food
                                                 geographic coordinates of the airport                                                                           additive regulations be amended to
                                                 would also be updated to coincide with                  PART 71—DESIGNATION OF CLASS A,
                                                                                                         B, C, D, AND E AIRSPACE AREAS; AIR                      provide for the safe use of L-
                                                 the FAA’s aeronautical database, and                                                                            selenomethionine as a dietary source of
                                                 the name of the city associated with the                TRAFFIC SERVICE ROUTES; AND
                                                                                                         REPORTING POINTS                                        selenium in feed for poultry, swine, and
                                                 airport in the airspace description                                                                             ruminants.
                                                 would be removed to comply with a
                                                 change to FAA Order 7400.2L,                            ■ 1. The authority citation for 14 CFR                  DATES:The food additive petition was
                                                 Procedures for Handling Airspace                        part 71 continues to read as follows:                   withdrawn on November 10, 2017.
                                                 Matters.                                                  Authority: 49 U.S.C. 106(f), 106(g); 40103,           ADDRESSES:   For access to the docket, go
                                                    This action is necessary due to an                   40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,            to https://www.regulations.gov and
                                                 airspace review caused by the                           1959–1963 Comp., p. 389.                                insert the docket number, found in
                                                 decommissioning of the Duncan VOR as                                                                            brackets in the heading of this
                                                 part of the VOR MON Program and                         § 71.1       [Amended]                                  document, into the ‘‘Search’’ box and
                                                 cancellation of the associated                                                                                  follow the prompts; and/or go to the
                                                                                                         ■ 2. The incorporation by reference in
                                                 instrument procedures.                                                                                          Dockets Management Staff, 5630 Fishers
                                                    Class E airspace designations are                    14 CFR 71.1 of FAA Order 7400.11B,
                                                                                                         Airspace Designations and Reporting                     Lane, Rm. 1061, Rockville, MD 20852.
                                                 published in paragraph 6005 of FAA
                                                 Order 7400.11B, dated August 3, 2017,                   Points, dated August 3, 2017, and                       FOR FURTHER INFORMATION CONTACT:
                                                 and effective September 15, 2017, which                 effective September 15, 2017, is                        Chelsea Trull, Center for Veterinary
                                                 is incorporated by reference in 14 CFR                  amended as follows:                                     Medicine, HFV–224, Food and Drug
                                                 71.1. The Class E airspace designation                                                                          Administration, 7519 Standish Pl.,
                                                                                                         Paragraph 6005 Class E Airspace Areas
                                                 listed in this document will be                                                                                 Rockville, MD 20855, 240–402–6729,
                                                                                                         Extending Upward From 700 Feet Or More
                                                 published subsequently in the Order.                    Above The Surface of The Earth.
                                                                                                                                                                 chelsea.trull@fda.hhs.gov.
                                                 Regulatory Notices and Analyses                         *        *      *      *       *                        SUPPLEMENTARY INFORMATION:     In a
                                                                                                                                                                 document published in the Federal
                                                    The FAA has determined that this                     ASW OK E5           Duncan, OK [Amended]                Register on April 23, 2014 (79 FR
                                                 regulation only involves an established                 Halliburton Field, OK                                   22602), FDA announced that a food
                                                 body of technical regulations for which                   (Lat. 34°28′17″ N, long. 97°57′36″ W)                 additive petition (FAP 2278) had been
                                                 frequent and routine amendments are                                                                             filed by Excentials B.V., Vierlinghstraat
                                                                                                           That airspace extending upward from 700
                                                 necessary to keep them operationally                                                                            51, 4251 LC Werkendam, The
                                                                                                         feet above the surface within a 6.6-mile
                                                 current, is non-controversial and                                                                               Netherlands. The petition proposed to
                                                                                                         radius of Halliburton Field, and within 4.0
                                                 unlikely to result in adverse or negative                                                                       amend part 573 of title 21 of the Code
                                                                                                         miles each side of the 359° bearing from the
                                                 comments. It, therefore: (1) Is not a                                                                           of Federal Regulations (CFR), Food
                                                                                                         airport extending from the 6.6-mile radius to
                                                 ‘‘significant regulatory action’’ under                                                                         Additives Permitted in Feed and
                                                                                                         11.6 miles north of the airport.
                                                 Executive Order 12866; (2) is not a                                                                             Drinking Water of Animals, to provide
                                                 ‘‘significant rule’’ under DOT                            Issued in Fort Worth, Texas, on March 5,
                                                                                                                                                                 for the safe use of L-selenomethionine
                                                 Regulatory Policies and Procedures (44                  2018.
                                                                                                                                                                 as a dietary source of selenium in feed
                                                 FR 11034; February 26, 1979); and (3)                   Christopher L. Southerland,                             for poultry, swine, and ruminants.
                                                 does not warrant preparation of a                       Acting Manager, Operations Support Group,               Excentials B.V. has now withdrawn the
daltland on DSKBBV9HB2PROD with PROPOSALS




                                                 regulatory evaluation as the anticipated                ATO Central Service Center.                             petition without prejudice to a future
                                                 impact is so minimal. Since this is a                   [FR Doc. 2018–04925 Filed 3–9–18; 8:45 am]              filing in accordance with 21 CFR 571.7.
                                                 routine matter that will only affect air                BILLING CODE 4910–13–P
                                                 traffic procedures and air navigation, it                                                                         Dated: March 6, 2018.
                                                 is certified that this rule, when                                                                               Leslie Kux,
                                                 promulgated, would not have a                                                                                   Associate Commissioner for Policy.
                                                 significant economic impact on a                                                                                [FR Doc. 2018–04775 Filed 3–9–18; 8:45 am]
                                                 substantial number of small entities                                                                            BILLING CODE 4164–01–P




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Document Created: 2018-11-01 08:51:54
Document Modified: 2018-11-01 08:51:54
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotification; withdrawal of petition for rulemaking.
DatesThe food additive petition was withdrawn on November 10, 2017.
ContactChelsea Trull, Center for Veterinary Medicine, HFV-224, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected]
FR Citation83 FR 10645 

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