Food Additives Permitted in Feed and Drinking Water of Animals; Spent Bleaching Clay, 28898-28899 [2020-10035]

Download as PDF 28898 Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Proposed Rules frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) Is not a ‘‘significant regulatory action’’ under Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. 1. The authority citation for 14 CFR part 71 continues to read as follows: Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., p. 389. [Amended] 2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11D, Airspace Designations and Reporting Points, dated August 8, 2019, and effective September 15, 2019, is amended as follows: ■ jbell on DSKJLSW7X2PROD with PROPOSALS Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. * AGL OH E5 Coshocton, OH [Amended] Richard Downing Airport, OH (Lat. 40°18′37″ N, long. 81°51′09″ W) That airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Richard Downing Airport, and within 2 miles each side of the 037° bearing VerDate Sep<11>2014 16:27 May 13, 2020 Jkt 250001 Food and Drug Administration 21 CFR Part 573 Food and Drug Administration, Notification; petition for rulemaking; amendment. ACTION: ■ * DEPARTMENT OF HEALTH AND HUMAN SERVICES HHS. PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS * BILLING CODE 4910–13–P AGENCY: The Proposed Amendment Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows: * [FR Doc. 2020–10356 Filed 5–13–20; 8:45 am] Food Additives Permitted in Feed and Drinking Water of Animals; Spent Bleaching Clay List of Subjects in 14 CFR Part 71 Airspace, Incorporation by reference, Navigation (air). * Issued in Fort Worth, Texas, on April 11, 2020. Steven T. Phillips, Acting Manager, Operations Support Group, ATO Central Service Center. [Docket No. FDA–2017–F–0969] Environmental Review This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1F, ‘‘Environmental Impacts: Policies and Procedures’’ prior to any FAA final regulatory action. § 71.1 from the airport extending from the 6.5-mile radius to 8.6 miles northeast of the airport, and within 2 miles each side of the 217° bearing from the airport extending from the 6.5-mile radius to 9.3 miles southwest of the airport. The Food and Drug Administration (FDA, the Agency, or we) is amending a notice of petition announcing that the Canadian Oilseed Processors Association has filed a petition proposing that the food additive regulations be amended to provide for the safe use of spent bleaching clay as a flow agent in canola meal for all livestock and poultry species. Additionally, the petition proposes that the regulations be amended to provide for the safe use of silicon dioxide and diatomaceous earth as components of spent bleaching clay. At our request, a revised environmental assessment (EA) has been placed in the docket for public review and comment. DATES: Submit either electronic or written comments on the petitioner’s environmental assessment by June 15, 2020. 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 June 15, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of June 15, 2020. 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. SUMMARY: PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 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– 2017–F–0969 for ‘‘Food Additives Permitted in Feed and Drinking Water of Animals; Spent Bleaching Clay.’’ 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 E:\FR\FM\14MYP1.SGM 14MYP1 jbell on DSKJLSW7X2PROD with PROPOSALS Federal Register / Vol. 85, No. 94 / Thursday, May 14, 2020 / Proposed Rules 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.govinfo.gov/content/pkg/FR02015-09-18/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: Chelsea Cerrito, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV–224), Rockville, MD 20855, 240– 402–6729, Chelsea.Cerrito@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), notice was given in the Federal Register of April 18, 2017 (82 FR 18268), that a food additive petition (FAP 2299) has been filed by the Canadian Oilseed Processors Association, 404–167 Lombard Ave., Winnipeg MB R3B 0T6, Canada. 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 spent bleaching clay as a flow agent in canola meal for all livestock and poultry species. Additionally, the submission proposes that the existing regulations be amended to provide for the safe use of silicon dioxide (21 CFR 573.940) and diatomaceous earth (21 VerDate Sep<11>2014 17:16 May 13, 2020 Jkt 250001 CFR 573.340) for use as components of spent bleaching clay. In a Federal Register notice published on March 19, 2019 (84 FR 9989), an amendment was made to the petition to include an environmental assessment. Based on a review of that assessment, we have asked the petitioner to make revisions. To encourage public participation consistent with regulations issued under the National Environmental Policy Act (40 CFR 1501.4(b)), we are placing the revised EA submitted with FAP 2299 on public display at the Dockets Management Staff (see DATES and ADDRESSES) for public review and comment. We will also place on public display, at the Dockets Management Staff and at https://www.regulations.gov, any amendments to, or comments on, the petitioner’s EA 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: May 6, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–10035 Filed 5–13–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF JUSTICE Drug Enforcement Administration 21 CFR Part 1308 [Docket No. DEA–477] Schedules of Controlled Substances: Placement of Zipeprol in Schedule I Drug Enforcement Administration, Department of Justice. ACTION: Notice of proposed rulemaking. AGENCY: The Drug Enforcement Administration (DEA) proposes placing the substance zipeprol (Chemical name: 1-methoxy-3-[4-(2-methoxy-2phenylethyl)piperazin-1-yl]-1phenylpropan-2-ol), including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers, whenever the existence of such isomers, esters, ethers and salts is possible, in schedule I of the Controlled Substances Act. This action is being taken to enable the United States to meet its obligations under the 1971 Convention on SUMMARY: PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 28899 Psychotropic Substances. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or propose to handle zipeprol. DATES: Comments must be submitted electronically or postmarked on or before July 13, 2020. Interested persons may file a request for hearing or waiver of hearing pursuant to 21 Code of Federal Regulations (CFR) 1308.44 and in accordance with 21 CFR 1316.45 and/or 1316.47, as applicable. Requests for hearing and waivers of an opportunity for a hearing or to participate in a hearing must be received on or before June 15, 2020. ADDRESSES: Interested persons may file written comments on this proposal in accordance with 21 CFR 1308.43(g). Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period. To ensure proper handling of comments, please reference ‘‘Docket No. DEA–477’’ on all electronic and written correspondence, including any attachments. • Electronic comments: DEA encourages that all comments be submitted electronically through the Federal eRulemaking Portal, which provides the ability to type short comments directly into the comment field on the web page or attach a file for lengthier comments. Please go to https:// www.regulations.gov and follow the online instructions at that site for submitting comments. Upon completion of your submission you will receive a Comment Tracking Number for your comment. Please be aware that submitted comments are not instantaneously available for public view on regulations.gov. If you have received a Comment Tracking Number, your comment has been successfully submitted and there is no need to resubmit the same comment. • Paper comments: Paper comments that duplicate electronic submissions are not necessary and are discouraged. Should you wish to mail a paper comment in lieu of an electronic comment, it should be sent via regular or express mail to: Drug Enforcement Administration, Attn: DEA Federal Register Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia 22152. E:\FR\FM\14MYP1.SGM 14MYP1

Agencies

[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Proposed Rules]
[Pages 28898-28899]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10035]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2017-F-0969]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Spent Bleaching Clay

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; petition for rulemaking; amendment.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
amending a notice of petition announcing that the Canadian Oilseed 
Processors Association has filed a petition proposing that the food 
additive regulations be amended to provide for the safe use of spent 
bleaching clay as a flow agent in canola meal for all livestock and 
poultry species. Additionally, the petition proposes that the 
regulations be amended to provide for the safe use of silicon dioxide 
and diatomaceous earth as components of spent bleaching clay. At our 
request, a revised environmental assessment (EA) has been placed in the 
docket for public review and comment.

DATES: Submit either electronic or written comments on the petitioner's 
environmental assessment by June 15, 2020.

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 June 15, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 15, 2020. 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-2017-F-0969 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Spent Bleaching Clay.'' 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

[[Page 28899]]

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.govinfo.gov/content/pkg/FR-02015-09-18/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: Chelsea Cerrito, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-224), 
Rockville, MD 20855, 240-402-6729, [email protected].

SUPPLEMENTARY INFORMATION: Under section 409(b)(5) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), notice was given in the 
Federal Register of April 18, 2017 (82 FR 18268), that a food additive 
petition (FAP 2299) has been filed by the Canadian Oilseed Processors 
Association, 404-167 Lombard Ave., Winnipeg MB R3B 0T6, Canada. 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 spent 
bleaching clay as a flow agent in canola meal for all livestock and 
poultry species. Additionally, the submission proposes that the 
existing regulations be amended to provide for the safe use of silicon 
dioxide (21 CFR 573.940) and diatomaceous earth (21 CFR 573.340) for 
use as components of spent bleaching clay.
    In a Federal Register notice published on March 19, 2019 (84 FR 
9989), an amendment was made to the petition to include an 
environmental assessment. Based on a review of that assessment, we have 
asked the petitioner to make revisions.
    To encourage public participation consistent with regulations 
issued under the National Environmental Policy Act (40 CFR 1501.4(b)), 
we are placing the revised EA submitted with FAP 2299 on public display 
at the Dockets Management Staff (see DATES and ADDRESSES) for public 
review and comment.
    We will also place on public display, at the Dockets Management 
Staff and at https://www.regulations.gov, any amendments to, or 
comments on, the petitioner's EA 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: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10035 Filed 5-13-20; 8:45 am]
 BILLING CODE 4164-01-P
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