83 FR 42062 - Supplemental Questions and Answers Regarding Food Facility Registration; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 161 (August 20, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 161 (August 20, 2018)
| Page Range | 42062-42063 | |
| FR Document | 2018-17852 |
[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)] [Proposed Rules] [Pages 42062-42063] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17852] ======================================================================= ----------------------------------------------------------------------- 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21 CFR Part 1 [Docket No. FDA-2012-D-1002] Supplemental Questions and Answers Regarding Food Facility Registration; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``Supplemental Questions and Answers Regarding Food Facility Registration.'' This draft guidance is intended to supplement the guidance document entitled ``Questions and Answers Regarding Food Facility Registration.'' DATES: Submit either electronic or written comments on the draft guidance by October 19, 2018 to ensure that the Agency considers your comment on the draft guidance before it begins work on the final version of the guidance.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.thefederalregister.org/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
![42062
Proposed Rules Federal Register
Vol. 83, No. 161
Monday, August 20, 2018
This section of the FEDERAL REGISTER 1. On page 37936 in the first column, ADDRESSES: You may submit comments
contains notices to the public of the proposed correct § 190.32 by revising paragraph on any guidance at any time as follows:
issuance of rules and regulations. The (d)(2) to read as follows: § 190.32
purpose of these notices is to give interested Electronic Submissions
Substitution unused merchandise
persons an opportunity to participate in the drawback. Submit electronic comments in the
rule making prior to the adoption of the final
* * * * * following way:
rules.
(d) * * * • Federal eRulemaking Portal:
(2) Allowable refund. For any https://www.regulations.gov. Follow the
DEPARTMENT OF HOMELAND drawback claim for wine (as defined in instructions for submitting comments.
SECURITY § 190.2) based on subsection (j)(2), the Comments submitted electronically,
total amount of drawback allowable will including attachments, to https://
U.S. Customs and Border Protection be equal to 99 percent of the duties, www.regulations.gov will be posted to
taxes, and fees paid with respect to the the docket unchanged. Because your
DEPARTMENT OF THE TREASURY imported merchandise, without regard comment will be made public, you are
to the limitations in paragraph (b)(1) or solely responsible for ensuring that your
19 CFR Part 190 (b)(2). comment does not include any
confidential information that you or a
[USCBP–2018–0029] Dated: August 14, 2018.
third party may not wish to be posted,
RIN 1515–AE23 Robert E. Perez, such as medical information, your or
Acting Deputy Commissioner, U.S. Customs anyone else’s Social Security number, or
Modernized Drawback; Correction and Border Protection. confidential business information, such
Approved: as a manufacturing process. Please note
AGENCY: U.S. Customs and Border
Timothy E. Skud, that if you include your name, contact
Protection, Department of Homeland
Security; Department of the Treasury. Deputy Assistant Secretary of the Treasury. information, or other information that
[FR Doc. 2018–17847 Filed 8–17–18; 8:45 am] identifies you in the body of your
ACTION: Notice of proposed rulemaking;
BILLING CODE 9111–14–P comments, that information will be
correction.
posted on https://www.regulations.gov.
SUMMARY: This document corrects a • If you want to submit a comment
proposed regulation in a notice of with confidential information that you
DEPARTMENT OF HEALTH AND do not wish to be made available to the
proposed rulemaking published in the
HUMAN SERVICES public, submit the comment as a
Federal Register of August 2, 2018,
regarding Modernized Drawback. written/paper submission and in the
Food and Drug Administration
Specifically, CBP inadvertently manner detailed (see ‘‘Written/Paper
proposed in 19 CFR 190.32(d)(2) an Submissions’’ and ‘‘Instructions’’).
21 CFR Part 1
exemption for drawback claims for wine Written/Paper Submissions
which included an imprecise reference [Docket No. FDA–2012–D–1002]
to the entirety of paragraph (b). The Submit written/paper submissions as
reference should have been only to Supplemental Questions and Answers follows:
paragraphs (b)(1) and (b)(2), the specific Regarding Food Facility Registration; • Mail/Hand delivery/Courier (for
paragraphs regarding the ‘‘lesser of’’ Draft Guidance for Industry; written/paper submissions): Dockets
rule. As is evident from the entirety of Availability Management Staff (HFA–305), Food and
the proposed rule, paragraph (b)(3), Drug Administration, 5630 Fishers
which implements the statutory AGENCY: Food and Drug Administration, Lane, Rm. 1061, Rockville, MD 20852.
prohibition on double drawback, HHS. • For written/paper comments
applies to all drawback claims for wine. ACTION: Notification of availability. submitted to the Dockets Management
This technical correction remedies a Staff, FDA will post your comment, as
clerical error that occurred when the SUMMARY: The Food and Drug well as any attachments, except for
language of paragraph (b)(3) was moved Administration (FDA or we) is information submitted, marked and
from a different part of the proposed announcing the availability of a draft identified, as confidential, if submitted
regulations. guidance for industry entitled as detailed in ‘‘Instructions.’’
‘‘Supplemental Questions and Answers Instructions: All submissions received
DATES: August 20, 2018. Regarding Food Facility Registration.’’ must include the Docket No. FDA–
FOR FURTHER INFORMATION CONTACT: This draft guidance is intended to 2012–D–1002 for ‘‘Supplemental
Randy Mitchell, U.S. Customs and supplement the guidance document Questions and Answers Regarding Food
daltland on DSKBBV9HB2PROD with PROPOSALS
Border Protection, Office of Trade, entitled ‘‘Questions and Answers Facility Registration.’’ Received
Trade Policy and Programs, 202–863– Regarding Food Facility Registration.’’ comments will be placed in the docket
6532, randy.mitchell@cbp.dhs.gov. DATES: Submit either electronic or and, except for those submitted as
SUPPLEMENTARY INFORMATION: In written comments on the draft guidance ‘‘Confidential Submissions,’’ publicly
proposed rule FR Doc. 2018–16279 by October 19, 2018 to ensure that the viewable at https://www.regulations.gov
appearing on page 37886 in the Federal Agency considers your comment on the or at the Dockets Management Staff
Register issue of August 2, 2018, the draft guidance before it begins work on between 9 a.m. and 4 p.m., Monday
following corrections are made: the final version of the guidance. through Friday.
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![Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Proposed Rules 42063
• Confidential Submissions—To I. Background SUMMARY: The Environmental Protection
submit a comment with confidential We are announcing the availability of Agency (EPA) is proposing to approve
information that you do not wish to be a draft guidance for industry entitled three state implementation plan (SIP)
made publicly available, submit your ‘‘Supplemental Questions and Answers revisions submitted by the State of
comments only as a written/paper Regarding Food Facility Registration.’’ California addressing the nonattainment
submission. You should submit two We are issuing the draft guidance new source review (NNSR)
copies total. One copy will include the consistent with our good guidance requirements for the 2008 8-hour ozone
information you claim to be confidential practices regulation (21 CFR 10.115). National Ambient Air Quality Standards
with a heading or cover note that states The draft guidance, when finalized, will (NAAQS). These SIP revisions address
‘‘THIS DOCUMENT CONTAINS represent the current thinking of FDA the South Coast Air Quality
CONFIDENTIAL INFORMATION.’’ The on this topic. This draft guidance does Management District (SCAQMD or
Agency will review this copy, including not establish any rights for any person District), San Joaquin Valley Air
the claimed confidential information, in and is not binding on FDA or the public. Pollution Control District (SJVAPCD or
its consideration of comments. The You can use an alternate approach if it District) and Yolo-Solano Air Quality
second copy, which will have the satisfies the requirements of the Management District (YSAQMD or
claimed confidential information applicable statutes and regulations. This District) portions of the California SIP.
redacted/blacked out, will be available guidance is not subject to Executive This action is being taken pursuant to
for public viewing and posted on Order 12866. the Clean Air Act (CAA or ‘‘Act’’) and
https://www.regulations.gov. Submit Elsewhere in this issue of the Federal its implementing regulations.
both copies to the Dockets Management Register, FDA is announcing the DATES: Any comments must arrive by
Staff. If you do not wish your name and guidance document entitled ‘‘Questions September 19, 2018.
contact information to be made publicly and Answers Regarding Food Facility ADDRESSES: Submit your comments,
available, you can provide this Registration (Seventh Edition),’’ to identified by Docket ID No. EPA–R09–
information on the cover sheet and not which this draft guidance is a OAR–2018–0587 at http://
in the body of your comments and you supplement. We intend to finalize this www.regulations.gov, or via email to
must identify this information as draft guidance document by R9AirPermits@epa.gov. For comments
‘‘confidential.’’ Any information marked incorporating the questions and answers submitted at Regulations.gov, follow the
as ‘‘confidential’’ will not be disclosed into a future edition of the guidance online instructions for submitting
except in accordance with 21 CFR 10.20 document entitled ‘‘Questions and comments. Once submitted, comments
and other applicable disclosure law. For Answers Regarding Food Facility cannot be removed or edited from
more information about FDA’s posting Registration (Seventh Edition).’’ Regulations.gov. For either manner of
of comments to public dockets, see 80 submission, the EPA may publish any
FR 56469, September 18, 2015, or access II. Electronic Access comment received to its public docket.
the information at: https://www.gpo.gov/ Persons with access to the internet Do not submit electronically any
fdsys/pkg/FR-2015-09-18/pdf/2015- may obtain the draft guidance at either information you consider to be
23389.pdf. https://www.fda.gov/FoodGuidances or Confidential Business Information (CBI)
Docket: For access to the docket to https://www.regulations.gov. Use the or other information whose disclosure is
read background documents or the FDA website listed in the previous restricted by statute. Multimedia
electronic and written/paper comments sentence to find the most current submissions (audio, video, etc.) must be
received, go to https:// version of the guidance. accompanied by a written comment.
www.regulations.gov and insert the The written comment is considered the
Dated: August 14, 2018.
docket number, found in brackets in the official comment and should include
Leslie Kux,
heading of this document, into the discussion of all points you wish to
‘‘Search’’ box and follow the prompts Associate Commissioner for Policy.
make. The EPA will generally not
and/or go to the Dockets Management [FR Doc. 2018–17852 Filed 8–17–18; 8:45 am] consider comments or comment
Staff, 5630 Fishers Lane, Rm. 1061, BILLING CODE 4164–01–P contents located outside of the primary
Rockville, MD 20852. submission (i.e. on the web, cloud, or
You may submit comments on any other file sharing system). For
guidance at any time (see 21 CFR ENVIRONMENTAL PROTECTION additional submission methods, please
10.115(g)(5)). AGENCY contact the person identified in the FOR
Submit written requests for single FURTHER INFORMATION CONTACT section.
copies of the draft guidance to the Office 40 CFR Part 52 For the full EPA public comment policy,
of Compliance, Center for Food Safety information about CBI or multimedia
and Applied Nutrition, Food and Drug [EPA–R09–OAR–2018–0587; FRL–9982– submissions, and general guidance on
Administration, 5001 Campus Dr., 58—Region 9] making effective comments, please visit
College Park, MD 20740. Send two self- http://www2.epa.gov/dockets/
Revisions to California State commenting-epa-dockets.
addressed adhesive labels to assist that
Implementation Plan; South Coast Air
office in processing your request. See FOR FURTHER INFORMATION CONTACT:
Quality Management District, San
the SUPPLEMENTARY INFORMATION section Laura Yannayon, EPA Region 9, (415)
Joaquin Valley Air Pollution Control
for electronic access to the draft 972–3534, yannayon.laura@epa.gov.
daltland on DSKBBV9HB2PROD with PROPOSALS
District and Yolo-Solano Air Quality
guidance. SUPPLEMENTARY INFORMATION:
Management; Nonattainment New
FOR FURTHER INFORMATION CONTACT: Source Review Requirements for the Throughout this document, the terms
Courtney Buchanan, Center for Food 2008 8-Hour Ozone Standard ‘‘we,’’ ‘‘us,’’ and ‘‘our’’ refer to EPA.
Safety and Applied Nutrition, Food and Table of Contents
Drug Administration, 5001 Campus Dr., AGENCY: Environmental Protection
College Park, MD 20740, 240–402–2487. Agency. I. Background and Purpose
ACTION:Proposed rule. II. The State’s Submittal
SUPPLEMENTARY INFORMATION: A. What did the State submit?
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Document Created: 2018-08-18 01:29:25
Document Modified: 2018-08-18 01:29:25
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification of availability. | |
| 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. | |
| Contact | Courtney Buchanan, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2487. | |
| FR Citation | 83 FR 42062 |
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