Supplemental Questions and Answers Regarding Food Facility Registration; Draft Guidance for Industry; Availability, 42062-42063 [2018-17852]

Download as PDF 42062 Proposed Rules Federal Register Vol. 83, No. 161 Monday, August 20, 2018 This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection DEPARTMENT OF THE TREASURY 19 CFR Part 190 [USCBP–2018–0029] RIN 1515–AE23 Modernized Drawback; Correction U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury. ACTION: Notice of proposed rulemaking; correction. AGENCY: This document corrects a proposed regulation in a notice of proposed rulemaking published in the Federal Register of August 2, 2018, regarding Modernized Drawback. Specifically, CBP inadvertently proposed in 19 CFR 190.32(d)(2) an exemption for drawback claims for wine which included an imprecise reference to the entirety of paragraph (b). The reference should have been only to paragraphs (b)(1) and (b)(2), the specific paragraphs regarding the ‘‘lesser of’’ rule. As is evident from the entirety of the proposed rule, paragraph (b)(3), which implements the statutory prohibition on double drawback, applies to all drawback claims for wine. This technical correction remedies a clerical error that occurred when the language of paragraph (b)(3) was moved from a different part of the proposed regulations. 1. On page 37936 in the first column, correct § 190.32 by revising paragraph (d)(2) to read as follows: § 190.32 Substitution unused merchandise drawback. * * * * * (d) * * * (2) Allowable refund. For any drawback claim for wine (as defined in § 190.2) based on subsection (j)(2), the total amount of drawback allowable will be equal to 99 percent of the duties, taxes, and fees paid with respect to the imported merchandise, without regard to the limitations in paragraph (b)(1) or (b)(2). Dated: August 14, 2018. Robert E. Perez, Acting Deputy Commissioner, U.S. Customs and Border Protection. Approved: Timothy E. Skud, Deputy Assistant Secretary of the Treasury. [FR Doc. 2018–17847 Filed 8–17–18; 8:45 am] BILLING CODE 9111–14–P SUMMARY: DATES: August 20, 2018. daltland on DSKBBV9HB2PROD with PROPOSALS FOR FURTHER INFORMATION CONTACT: Randy Mitchell, U.S. Customs and Border Protection, Office of Trade, Trade Policy and Programs, 202–863– 6532, randy.mitchell@cbp.dhs.gov. SUPPLEMENTARY INFORMATION: In proposed rule FR Doc. 2018–16279 appearing on page 37886 in the Federal Register issue of August 2, 2018, the following corrections are made: VerDate Sep<11>2014 18:07 Aug 17, 2018 Jkt 244001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 You may submit comments on any guidance at any time as follows: ADDRESSES: 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 [Docket No. FDA–2012–D–1002] Supplemental Questions and Answers Regarding Food Facility Registration; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notification of availability. The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ‘‘Supplemental Questions and Answers Regarding Food Facility Registration.’’ This draft guidance is intended to supplement the guidance document entitled ‘‘Questions and Answers Regarding Food Facility Registration.’’ DATES: Submit either electronic or written comments on the draft guidance by October 19, 2018 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance. SUMMARY: PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 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– 2012–D–1002 for ‘‘Supplemental Questions and Answers Regarding Food Facility Registration.’’ Received comments 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. E:\FR\FM\20AUP1.SGM 20AUP1 daltland on DSKBBV9HB2PROD with PROPOSALS Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Proposed Rules • 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 and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Office of Compliance, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two selfaddressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Courtney Buchanan, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2487. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 18:07 Aug 17, 2018 Jkt 244001 I. Background II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. Dated: August 14, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–17852 Filed 8–17–18; 8:45 am] BILLING CODE 4164–01–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R09–OAR–2018–0587; FRL–9982– 58—Region 9] Revisions to California State Implementation Plan; South Coast Air Quality Management District, San Joaquin Valley Air Pollution Control District and Yolo-Solano Air Quality Management; Nonattainment New Source Review Requirements for the 2008 8-Hour Ozone Standard AGENCY: Environmental Protection Agency. Proposed rule. ACTION: PO 00000 Frm 00002 Fmt 4702 The Environmental Protection Agency (EPA) is proposing to approve three state implementation plan (SIP) revisions submitted by the State of California addressing the nonattainment new source review (NNSR) requirements for the 2008 8-hour ozone National Ambient Air Quality Standards (NAAQS). These SIP revisions address the South Coast Air Quality Management District (SCAQMD or District), San Joaquin Valley Air Pollution Control District (SJVAPCD or District) and Yolo-Solano Air Quality Management District (YSAQMD or District) portions of the California SIP. This action is being taken pursuant to the Clean Air Act (CAA or ‘‘Act’’) and its implementing regulations. DATES: Any comments must arrive by September 19, 2018. ADDRESSES: Submit your comments, identified by Docket ID No. EPA–R09– OAR–2018–0587 at https:// www.regulations.gov, or via email to R9AirPermits@epa.gov. For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be removed or edited from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/ commenting-epa-dockets. FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region 9, (415) 972–3534, yannayon.laura@epa.gov. SUPPLEMENTARY INFORMATION: Throughout this document, the terms ‘‘we,’’ ‘‘us,’’ and ‘‘our’’ refer to EPA. SUMMARY: We are announcing the availability of a draft guidance for industry entitled ‘‘Supplemental Questions and Answers Regarding Food Facility Registration.’’ We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. This draft guidance does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. Elsewhere in this issue of the Federal Register, FDA is announcing the guidance document entitled ‘‘Questions and Answers Regarding Food Facility Registration (Seventh Edition),’’ to which this draft guidance is a supplement. We intend to finalize this draft guidance document by incorporating the questions and answers into a future edition of the guidance document entitled ‘‘Questions and Answers Regarding Food Facility Registration (Seventh Edition).’’ Sfmt 4702 42063 Table of Contents I. Background and Purpose II. The State’s Submittal A. What did the State submit? E:\FR\FM\20AUP1.SGM 20AUP1

Agencies

[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Proposed Rules]
[Pages 42062-42063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17852]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2012-D-1002]


Supplemental Questions and Answers Regarding Food Facility 
Registration; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a draft guidance for industry entitled ``Supplemental 
Questions and Answers Regarding Food Facility Registration.'' This 
draft guidance is intended to supplement the guidance document entitled 
``Questions and Answers Regarding Food Facility Registration.''

DATES: Submit either electronic or written comments on the draft 
guidance by October 19, 2018 to ensure that the Agency considers your 
comment on the draft guidance before it begins work on the final 
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows:

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-2012-D-1002 for ``Supplemental Questions and Answers Regarding Food 
Facility Registration.'' Received comments 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.

[[Page 42063]]

     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.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Office of Compliance, Center for Food Safety and Applied Nutrition, 
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. 
Send two self-addressed adhesive labels to assist that office in 
processing your request. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Courtney Buchanan, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2487.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a draft guidance for industry 
entitled ``Supplemental Questions and Answers Regarding Food Facility 
Registration.'' We are issuing the draft guidance consistent with our 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the current thinking of FDA on this 
topic. This draft guidance does not establish any rights for any person 
and is not binding on FDA or the public. You can use an alternate 
approach if it satisfies the requirements of the applicable statutes 
and regulations. This guidance is not subject to Executive Order 12866.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the guidance document entitled ``Questions and Answers Regarding Food 
Facility Registration (Seventh Edition),'' to which this draft guidance 
is a supplement. We intend to finalize this draft guidance document by 
incorporating the questions and answers into a future edition of the 
guidance document entitled ``Questions and Answers Regarding Food 
Facility Registration (Seventh Edition).''

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

    Dated: August 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17852 Filed 8-17-18; 8:45 am]
 BILLING CODE 4164-01-P

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