80_FR_48627 80 FR 48471 - Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use)

80 FR 48471 - Adisseo France S.A.S.; Filing of Food Additive Petition (Animal Use)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 156 (August 13, 2015)

Page Range48471-48472
FR Document2015-19884

The Food and Drug Administration (FDA) is announcing that Adisseo France S.A.S. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of selenomethionine hydroxy analogue as a source of selenium in feed for chickens, turkeys, swine, dairy cattle, and beef cattle.

Federal Register, Volume 80 Issue 156 (Thursday, August 13, 2015) 
[Federal Register Volume 80, Number 156 (Thursday, August 13, 2015)]
[Proposed Rules]
[Pages 48471-48472]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-19884]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2015-F-2712]


Adisseo France S.A.S.; Filing of Food Additive Petition (Animal 
Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of petition.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Adisseo France S.A.S. has filed a petition proposing that the food 
additive regulations be amended to provide for the safe use of 
selenomethionine hydroxy analogue as a source of selenium in feed for 
chickens, turkeys, swine, dairy cattle, and beef cattle.

DATES: Submit either electronic or written comments on the petitioner's 
request for categorical exclusion from preparing an environmental 
assessment or environmental impact statement by September 14, 2015.

ADDRESSES: Submit electronic comments to: http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Isabel Pocurull, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl.,

[[Page 48472]]

Rockville, MD 20855, 240-402-5877, isabel.pocurull@fda.hhs.gov.

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 2291) has been filed by Adisseo France 
S.A.S., Immeuble Antony Parc II, 10 Place du G[eacute]n[eacute]ral de 
Gaulle, 92160 Antony, France. 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 selenomethionine hydroxy analogue as a 
source of selenium in feed for chickens, turkeys, swine, dairy cattle, 
and beef cattle. The petitioner has requested a categorical exclusion 
from preparing an environmental assessment or environmental impact 
statement under 21 CFR 25.32(r).
    Interested persons may submit either electronic or written comments 
regarding this request for categorical exclusion to the Division of 
Dockets Management (see DATES and ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: August 7, 2015.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2015-19884 Filed 8-12-15; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 156 / Thursday, August 13, 2015 / Proposed Rules 48471 decisions on the proposal. Comments feet above the surface within an 11.2- § 71.1 [Amended] are specifically invited on the overall mile radius of Searcy County Airport, ■ 2. The incorporation by reference in regulatory, aeronautical, economic, Marshall, AR, to accommodate new 14 CFR 71.1 of FAA Order 7400.9Y, environmental, and energy-related standard instrument approach Airspace Designations and Reporting aspects of the proposal. procedures. Controlled airspace is Points, dated August 6, 2014, and Communications should identify both needed for the safety and management effective September 15, 2014, is docket numbers and be submitted in of IFR operations at the airport. amended as follows: triplicate to the address listed above. Class E airspace areas are published Paragraph 6005 Class E Airspace Areas Commenters wishing the FAA to in Paragraph 6005 of FAA Order Extending Upward From 700 Feet or More acknowledge receipt of their comments 7400.9Y, dated August 6, 2014, and Above the Surface of the Earth on this notice must submit with those effective September 15, 2014, which is * * * * * comments a self-addressed, stamped incorporated by reference in 14 CFR postcard on which the following 71.1. The Class E airspace designation ASW AR E5 Marshall, AR [New] statement is made: ‘‘Comments to listed in this document will be Searcy County Airport, AR Docket No. FAA–2015–1833/Airspace published subsequently in the Order. (Lat. 35°53′55″ N., long. 92°39′23″ W.) Docket No. 15–ASW–7.’’ The postcard That airspace extending upward from 700 will be date/time stamped and returned Regulatory Notices and Analyses feet above the surface within an 11.2-mile to the commenter. The FAA has determined that this radius of Searcy County Airport. Availability of NPRMs proposed regulation only involves an Issued in Fort Worth, TX, on July 28, 2015. established body of technical Walter Tweedy, An electronic copy of this document regulations for which frequent and may be downloaded through the Acting Manager, Operations Support Group, routine amendments are necessary to ATO Central Service Center. Internet at http://www.regulations.gov. keep them operationally current. It, [FR Doc. 2015–19151 Filed 8–12–15; 8:45 am] Recently published rulemaking therefore, (1) is not a ‘‘significant documents can also be accessed through BILLING CODE 4910–13–P regulatory action’’ under Executive the FAA’s Web page at http:// Order 12866; (2) is not a ‘‘significant www.faa.gov/airports_airtraffic/air_ rule’’ under DOT Regulatory Policies traffic/publications/airspace_ and Procedures (44 FR 11034; February DEPARTMENT OF HEALTH AND amendments/. 26, 1979); and (3) does not warrant HUMAN SERVICES You may review the public docket preparation of a Regulatory Evaluation containing the proposal, any comments Food and Drug Administration as the anticipated impact is so minimal. received and any final disposition in person in the Dockets Office (see Since this is a routine matter that will 21 CFR Part 573 ADDRESSES section for address and only affect air traffic procedures and air phone number) between 9:00 a.m. and navigation, it is certified that this rule, [Docket No. FDA–2015–F–2712] 5:00 p.m., Monday through Friday, when promulgated, will not have a significant economic impact on a Adisseo France S.A.S.; Filing of Food except Federal holidays. An informal Additive Petition (Animal Use) docket may also be examined during substantial number of small entities normal business hours at the office of under the criteria of the Regulatory AGENCY: Food and Drug Administration, the Central Service Center, 2601 Flexibility Act. HHS. Meacham Blvd., Fort Worth, TX 76137. Environmental Review ACTION: Notice of petition. Persons interested in being placed on a mailing list for future NPRMs should This proposal will be subject to an SUMMARY: The Food and Drug contact the FAA’s Office of Rulemaking environmental analysis in accordance Administration (FDA) is announcing (202) 267–9677, to request a copy of with FAA Order 1050.1E, that Adisseo France S.A.S. has filed a Advisory Circular No. 11–2A, Notice of ‘‘Environmental Impacts: Policies and petition proposing that the food additive Proposed Rulemaking Distribution Procedures’’ prior to any FAA final regulations be amended to provide for System, which describes the application regulatory action. the safe use of selenomethionine procedure. List of Subjects in 14 CFR Part 71 hydroxy analogue as a source of selenium in feed for chickens, turkeys, Availability and Summary of Airspace, Incorporation by reference, swine, dairy cattle, and beef cattle. Documents Proposed for Incorporation Navigation (air). by Reference DATES: Submit either electronic or The Proposed Amendment written comments on the petitioner’s This document proposes to amend request for categorical exclusion from FAA Order 7400.9Y, Airspace In consideration of the foregoing, the preparing an environmental assessment Designations and Reporting Points, Federal Aviation Administration or environmental impact statement by dated August 6, 2014, and effective proposes to amend 14 CFR part 71 as September 14, 2015. September 15, 2014. FAA Order follows: ADDRESSES: Submit electronic 7400.9Y is publicly available as listed in the ADDRESSES section of this proposed PART 71—DESIGNATION OF CLASS A, comments to: http:// rule. FAA Order 7400.9Y lists Class A, B, C, D, AND E AIRSPACE AREAS; AIR www.regulations.gov. Submit written comments to the Division of Dockets tkelley on DSK3SPTVN1PROD with PROPOSALS B, C, D, and E airspace areas, air traffic TRAFFIC SERVICE ROUTES; AND service routes, and reporting points. REPORTING POINTS Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. The Proposal ■ 1. The authority citation for Part 71 1061, Rockville, MD 20852. This action proposes to amend Title continues to read as follows: FOR FURTHER INFORMATION CONTACT: 14, Code of Federal Regulations (14 Authority: 49 U.S.C. 106(f), 106(g); 40103, Isabel Pocurull, Center for Veterinary CFR), Part 71 by establishing Class E 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, Medicine, Food and Drug airspace extending upward from 700 1959–1963 Comp., p. 389. Administration, 7519 Standish Pl., VerDate Sep<11>2014 16:12 Aug 12, 2015 Jkt 235001 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 E:\FR\FM\13AUP1.SGM 13AUP1

48472 Federal Register / Vol. 80, No. 156 / Thursday, August 13, 2015 / Proposed Rules Rockville, MD 20855, 240–402–5877, temporary regulations will allow only a 1095–A, are covered by the rules in isabel.pocurull@fda.hhs.gov. single 30-day non-automatic extension § 1.6081–8T(a). SUPPLEMENTARY INFORMATION: Under the of time to file these information returns. These proposed regulations would Federal Food, Drug, and Cosmetic Act In addition, the temporary regulations remove the automatic 30-day extension (section 409(b)(5) (21 U.S.C. 348(b)(5)), will update the list of information of time to file the information returns notice is given that a food additive returns subject to the rules regarding listed in § 1.6081–8T(a) and allow only petition (FAP 2291) has been filed by extensions of time to file. These a single non-automatic extension of time Adisseo France S.A.S., Immeuble proposed regulations incorporate the to file all information returns listed in Antony Parc II, 10 Place du Général de temporary regulations with respect to § 1.6081–8T. Gaulle, 92160 Antony, France. The extensions of time to file information The IRS anticipates that, as described petition proposes to amend Title 21 of returns on forms in the W–2 series in the temporary regulations with (except Form W–2G). In addition, these respect to forms in the W–2 series (other the Code of Federal Regulations (CFR) proposed regulations would remove the than Forms W–2G), under the proposed in part 573 Food Additives Permitted in automatic 30-day extension of time to regulations, the IRS will grant the non- Feed and Drinking Water of Animals (21 file all information returns listed in the automatic 30-day extension of time to CFR part 573) to provide for the safe use temporary regulation. file information returns listed in of selenomethionine hydroxy analogue DATES: Written or electronic comments § 1.6081–8(a) only in limited cases as a source of selenium in feed for and requests for a public hearing must where the filer’s or transmitter’s chickens, turkeys, swine, dairy cattle, be received by November 12, 2015. explanation demonstrates that an and beef cattle. The petitioner has ADDRESSES: Send submissions to: extension of time to file is needed as a requested a categorical exclusion from CC:PA:LPD:PR (REG–132075–14), Room result of extraordinary circumstances or preparing an environmental assessment catastrophe, such as a natural disaster or or environmental impact statement 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, fire destroying the books and records a under 21 CFR 25.32(r). filer needs for filing the information Interested persons may submit either Washington, DC 20044. Submissions may be hand-delivered between the returns. electronic or written comments Treasury and the IRS request regarding this request for categorical hours of 8 a.m. and 4 p.m. to comments on the appropriate timing of exclusion to the Division of Dockets CC:PA:LPD:PR (REG–132075–14), the removal of the automatic 30-day Management (see DATES and Courier’s Desk, Internal Revenue extension of time to file information ADDRESSES). It is only necessary to send Service, 1111 Constitution Avenue NW., returns covered by these proposed one set of comments. Identify comments Washington, DC, or sent via the Federal regulations, such as Form 1042–S, with the docket number found in eRulemaking Portal at including whether special transitional brackets in the heading of this www.regulations.gov (IRS REG–132075– considerations should be given for any document. Received comments may be 14). category or categories of forms or filers seen in the Division of Dockets FOR FURTHER INFORMATION CONTACT: relative to other forms or filers. Management between 9 a.m. and 4 p.m., Concerning these proposed regulations, Although these regulations are proposed Monday through Friday, and will be Jonathan R. Black, (202) 317–6845; to be effective for requests for posted to the docket at http:// concerning submissions of comments extensions of time to file information www.regulations.gov. and/or requests for a hearing, Regina returns due on or after January 1 of the Dated: August 7, 2015. Johnson (202) 317–6901 (not toll-free calendar year immediately following the numbers). date of publication of a Treasury Bernadette Dunham, Director, Center for Veterinary Medicine. SUPPLEMENTARY INFORMATION: decision adopting these rules as final regulations in the Federal Register, [FR Doc. 2015–19884 Filed 8–12–15; 8:45 am] Background and Explanation of removal of the automatic 30-day BILLING CODE 4164–01–P Provisions extension of time to file will not apply Temporary regulations § 1.6081–8T in to information returns (other than forms the Rules and Regulations section of this in the W–2 series except Forms W–2G) DEPARTMENT OF THE TREASURY issue of the Federal Register will amend due any earlier than January 1, 2018. 26 CFR part 1 by removing the Please follow the instructions in the Internal Revenue Service automatic extension of time to file ‘‘Comments and Requests for Public information returns on forms in the W– Hearing’’ portion of this preamble. 26 CFR Part 1 2 series (except Form W–2G), effective The temporary regulations affect [REG–132075–14] for filing season 2017. The temporary taxpayers who are required to file regulations will allow only a single 30- information returns on forms in the W– RIN 1545–BM49 day non-automatic extension of time to 2 series (except Forms W–2G) and need file these information returns that the an extension of time to file. These Extension of Time to File Certain IRS may, in its discretion, grant if the proposed regulations also affect Information Returns IRS determines that an extension of time taxpayers who need an extension of AGENCY: Internal Revenue Service (IRS), to file is warranted based on the filer’s time to file any of the information Treasury. or transmitter’s explanation attached to returns listed in § 1.6081–8T(a). ACTION: Notice of proposed rulemaking. a Form 8809, ‘‘Application for The substance of the temporary tkelley on DSK3SPTVN1PROD with PROPOSALS Extension of Time to File Information regulations is incorporated in these SUMMARY: In the Rules and Regulations Returns,’’ signed under penalties of proposed regulations. The preamble to section of this issue of the Federal perjury. The temporary regulations will the temporary regulations explains these Register, the IRS is issuing temporary also add Forms 3921, 3922, 1094–C, and amendments. These proposed regulations that will remove the forms in the 1097 series to the list of regulations would also expand the rules automatic extension of time to file information returns covered by in § 1.6081–8T(b) to the other information returns on forms in the W– § 1.6081–8T(a) and clarify that Forms information returns, which are listed in 2 series (except Form W–2G). The 1095–B and 1095–C, but not Form § 1.6081–8T(a). VerDate Sep<11>2014 16:12 Aug 12, 2015 Jkt 235001 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 E:\FR\FM\13AUP1.SGM 13AUP1


Document Created: 2018-02-23 10:57:15
Document Modified: 2018-02-23 10:57:15
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
ActionNotice of petition.
DatesSubmit either electronic or written comments on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement by September 14, 2015.
ContactIsabel Pocurull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5877, [email protected]
FR Citation80 FR 48471 
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR