83 FR 42024 - Questions and Answers Regarding Food Facility Registration (Seventh Edition); 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 | 42024-42025 | |
| FR Document | 2018-17853 |
[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)] [Rules and Regulations] [Pages 42024-42025] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-17853] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1 [Docket No. FDA-2012-D-1002] Questions and Answers Regarding Food Facility Registration (Seventh Edition); 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 final guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition).'' The guidance provides updated information relating to the food facility registration requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act). DATES: The announcement of the guidance is published in the Federal Register on August 20, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances 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. [[Page 42025]] 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 ``Questions and Answers Regarding Food Facility Registration (Seventh Edition).'' 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. 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 guidance to the Office of Compliance, Division of Field Programs and Guidance, 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 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 guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition).'' This guidance provides updated information relating to the food facility registration requirements in the FD&C Act. We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866. In the Federal Register of December 27, 2016 (81 FR 95068), we made available a draft guidance for industry entitled ``Questions and Answers Regarding Food Facility Registration (Seventh Edition)'' and gave interested parties an opportunity to submit comments by March 27, 2017, for us to consider before beginning work on the final version of the guidance. We received numerous comments on the draft guidance and have modified the final guidance where appropriate. In addition, we made editorial changes to improve clarity. The guidance announced in this notice finalizes the draft guidance dated December 2016. FDA is also publishing elsewhere in this issue of the Federal Register notification of availability of a supplemental draft guidance document entitled ``Supplemental Questions and Answers Regarding Food Facility Registration'' that includes additional questions and answers to clarify our thinking about who should register in certain situations involving more than one possible registrant, such as a lessor and one or more lessees for an establishment. When the draft guidance is finalized, we intend to incorporate it into a future edition of the guidance document that is the subject of this notification. II. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 1.230 through 1.235 and 21 CFR 1.245 have been approved under OMB control number 0910-0502. III. Electronic Access Persons with access to the internet may obtain the 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. 2018-17853 Filed 8-17-18; 8:45 am] BILLING CODE 4164-01-P
![42024 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations
parties were invited to participate in routine matter that only affects air traffic Issued in Seattle, Washington, on August
this rulemaking effort by submitting procedures and air navigation, it is 13, 2018.
written comments on the proposal to the certified that this rule, when Shawn M. Kozica,
FAA. Five comments were received in promulgated, will not have a significant Manager, Operations Support Group, Western
support of the action. One commenter economic impact on a substantial Service Center.
had concerns that were not substantive number of small entities under the [FR Doc. 2018–17821 Filed 8–17–18; 8:45 am]
to the establishment of Class E airspace. criteria of the Regulatory Flexibility Act. BILLING CODE 4910–13–P
The concerns addressed the quality of
the altimeter values reported by the Environmental Review
Creswell Automated Weather Observing DEPARTMENT OF HEALTH AND
System (AWOS) and the potential for The FAA has determined that this
HUMAN SERVICES
conflict with the visual flight rules action qualifies for categorical exclusion
(VFR) traffic pattern. The concerns under the National Environmental Food and Drug Administration
regarding AWOS have been forwarded Policy Act in accordance with FAA
to the servicing System Support Center. Order 1050.1F, ‘‘Environmental 21 CFR Part 1
The RNAV procedure at Hobby Field Impacts: Policies and Procedures,’’
[Docket No. FDA–2012–D–1002]
should only be used when the wind is paragraph 5–6.5a. This airspace action
favoring runway 16, so the VFR traffic is not expected to cause any potentially Questions and Answers Regarding
pattern should shift to match. significant environmental impacts, and Food Facility Registration (Seventh
Class E airspace designations are no extraordinary circumstances exist Edition); Guidance for Industry;
published in paragraph 6005 of FAA that warrant preparation of an Availability
Order 7400.11B, dated August 3, 2017, environmental assessment.
and effective September 15, 2017, which AGENCY: Food and Drug Administration,
is incorporated by reference in 14 CFR Lists of Subjects in 14 CFR Part 71 HHS.
71.1. The Class E airspace designation ACTION: Notification of availability.
Airspace, Incorporation by reference,
listed in this document will be
Navigation (air). SUMMARY: The Food and Drug
published subsequently in the Order.
Administration (FDA or we) is
Availability and Summary of Adoption of the Amendment announcing the availability of a final
Documents for Incorporation by In consideration of the foregoing, the guidance for industry entitled
Reference Federal Aviation Administration ‘‘Questions and Answers Regarding
This document amends FAA Order Food Facility Registration (Seventh
amends 14 CFR part 71 as follows:
7400.11B, Airspace Designations and Edition).’’ The guidance provides
Reporting Points, dated August 3, 2017, PART 71—DESIGNATION OF CLASS A, updated information relating to the food
and effective September 15, 2017. FAA B, C, D, AND E AIRSPACE AREAS; AIR facility registration requirements in the
Order 7400.11B is publicly available as TRAFFIC SERVICE ROUTES; AND Federal Food, Drug, and Cosmetic Act
listed in the ADDRESSES section of this (FD&C Act).
REPORTING POINTS
document. FAA Order 7400.11B lists DATES: The announcement of the
Class A, B, C, D, and E airspace areas, guidance is published in the Federal
■ 1. The authority citation for part 71
air traffic service routes, and reporting Register on August 20, 2018.
continues to read as follows:
points. ADDRESSES: You may submit either
Authority: 49 U.S.C. 106(f), 106(g); 40103, electronic or written comments on
The Rule 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, Agency guidances at any time as
This amendment to Title 14, Code of 1959–1963 Comp., p. 389. follows:
Federal Regulations (14 CFR) part 71
establishes Class E airspace extending
§ 71.1 [Amended] Electronic Submissions
upward from 700 feet above the surface ■ 2. The incorporation by reference in Submit electronic comments in the
at Hobby Field, Creswell, OR, to 14 CFR 71.1 of FAA Order 7400.11B, following way:
accommodate new RNAV procedures at • Federal eRulemaking Portal:
Airspace Designations and Reporting
this airport for the safety and https://www.regulations.gov. Follow the
Points, dated August 3, 2017, and
management of IFR operations. instructions for submitting comments.
effective September 15, 2017, is Comments submitted electronically,
Regulatory Notices and Analyses amended as follows: including attachments, to https://
The FAA has determined that this www.regulations.gov will be posted to
Paragraph 6005 Class E Airspace Areas
regulation only involves an established Extending Upward From 700 Feet or More
the docket unchanged. Because your
body of technical regulations for which Above the Surface of the Earth. comment will be made public, you are
frequent and routine amendments are solely responsible for ensuring that your
necessary to keep them operationally * * * * * comment does not include any
current, non-controversial and unlikely ANM OR E5 Creswell, OR [New] confidential information that you or a
to result in adverse or negative Hobby Field, OR
third party may not wish to be posted,
comments. It, therefore: (1) Is not a (Lat. 43°55′51″ N, long. 123°00′24″ W) such as medical information, your or
‘‘significant regulatory action’’ under anyone else’s Social Security number, or
That airspace extending upward from 700
Executive Order 12866; (2) is not a confidential business information, such
daltland on DSKBBV9HB2PROD with RULES
feet above the surface within a 2.1-mile
‘‘significant rule’’ under DOT as a manufacturing process. Please note
radius of Hobby Field, and within 1.8 miles
Regulatory Policies and Procedures (44 that if you include your name, contact
each side of the 354° bearing from the airport
FR 11034; February 26, 1979); and (3) information, or other information that
extending from the 2.1-mile radius to 7.1
does not warrant preparation of a identifies you in the body of your
miles north of the airport.
Regulatory Evaluation as the anticipated comments, that information will be
impact is so minimal. Since this is a posted on https://www.regulations.gov.
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![Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations 42025
• If you want to submit a comment the information at: https://www.gpo.gov/ addition, we made editorial changes to
with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- improve clarity. The guidance
do not wish to be made available to the 23389.pdf. announced in this notice finalizes the
public, submit the comment as a Docket: For access to the docket to draft guidance dated December 2016.
written/paper submission and in the read background documents or the FDA is also publishing elsewhere in
manner detailed (see ‘‘Written/Paper electronic and written/paper comments this issue of the Federal Register
Submissions’’ and ‘‘Instructions’’). received, go to https:// notification of availability of a
www.regulations.gov and insert the supplemental draft guidance document
Written/Paper Submissions
docket number, found in brackets in the entitled ‘‘Supplemental Questions and
Submit written/paper submissions as heading of this document, into the Answers Regarding Food Facility
follows: ‘‘Search’’ box and follow the prompts Registration’’ that includes additional
• Mail/Hand delivery/Courier (for and/or go to the Dockets Management questions and answers to clarify our
written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, thinking about who should register in
Management Staff (HFA–305), Food and Rockville, MD 20852. certain situations involving more than
Drug Administration, 5630 Fishers You may submit comments on any one possible registrant, such as a lessor
Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR and one or more lessees for an
• For written/paper comments 10.115(g)(5)). establishment. When the draft guidance
submitted to the Dockets Management Submit written requests for single is finalized, we intend to incorporate it
Staff, FDA will post your comment, as copies of the guidance to the Office of into a future edition of the guidance
well as any attachments, except for Compliance, Division of Field Programs document that is the subject of this
information submitted, marked and and Guidance, Center for Food Safety notification.
identified, as confidential, if submitted
and Applied Nutrition, Food and Drug
as detailed in ‘‘Instructions.’’ II. Paperwork Reduction Act of 1995
Administration, 5001 Campus Dr.,
Instructions: All submissions received This guidance refers to previously
must include the Docket No. FDA– College Park, MD 20740. Send two self-
addressed adhesive labels to assist that approved collections of information
2012–D–1002 for ‘‘Questions and found in FDA regulations. These
Answers Regarding Food Facility office in processing your request. See
the SUPPLEMENTARY INFORMATION section collections of information are subject to
Registration (Seventh Edition).’’ review by the Office of Management and
Received comments will be placed in for electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT:
Budget (OMB) under the Paperwork
the docket and, except for those Reduction Act of 1995 (44 U.S.C. 3501–
submitted as ‘‘Confidential Courtney Buchanan, Center for Food
Safety and Applied Nutrition, Food and 3520). The collections of information in
Submissions,’’ publicly viewable at 21 CFR 1.230 through 1.235 and 21 CFR
https://www.regulations.gov or at the Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2487. 1.245 have been approved under OMB
Dockets Management Staff between 9
control number 0910–0502.
a.m. and 4 p.m., Monday through SUPPLEMENTARY INFORMATION:
Friday. III. Electronic Access
• Confidential Submissions—To I. Background
Persons with access to the internet
submit a comment with confidential We are announcing the availability of may obtain the guidance at either
information that you do not wish to be a guidance for industry entitled https://www.fda.gov/FoodGuidances or
made publicly available, submit your ‘‘Questions and Answers Regarding https://www.regulations.gov. Use the
comments only as a written/paper Food Facility Registration (Seventh FDA website listed in the previous
submission. You should submit two Edition).’’ This guidance provides sentence to find the most current
copies total. One copy will include the updated information relating to the food version of the guidance.
information you claim to be confidential facility registration requirements in the
with a heading or cover note that states FD&C Act. We are issuing this guidance Dated: August 14, 2018.
‘‘THIS DOCUMENT CONTAINS consistent with our good guidance Leslie Kux,
CONFIDENTIAL INFORMATION.’’ The practices regulation (21 CFR 10.115). Associate Commissioner for Policy.
Agency will review this copy, including The guidance represents the current [FR Doc. 2018–17853 Filed 8–17–18; 8:45 am]
the claimed confidential information, in thinking of FDA on this topic. It does BILLING CODE 4164–01–P
its consideration of comments. The not establish any rights for any person
second copy, which will have the and is not binding on FDA or the public.
claimed confidential information You can use an alternative approach if DEPARTMENT OF DEFENSE
redacted/blacked out, will be available it satisfies the requirements of the
for public viewing and posted on applicable statutes and regulations. This Office of the Secretary
https://www.regulations.gov. Submit guidance is not subject to Executive
both copies to the Dockets Management Order 12866. 32 CFR Part 295
Staff. If you do not wish your name and In the Federal Register of December [Docket ID: DOD–2017–OS–0024]
contact information to be made publicly 27, 2016 (81 FR 95068), we made
available, you can provide this available a draft guidance for industry RIN 0790–AJ65
information on the cover sheet and not entitled ‘‘Questions and Answers
in the body of your comments and you Regarding Food Facility Registration Office of the Inspector General,
must identify this information as (Seventh Edition)’’ and gave interested Freedom of Information Act Program
‘‘confidential.’’ Any information marked parties an opportunity to submit
daltland on DSKBBV9HB2PROD with RULES
AGENCY: Office of Inspector General,
as ‘‘confidential’’ will not be disclosed comments by March 27, 2017, for us to DoD.
except in accordance with 21 CFR 10.20 consider before beginning work on the ACTION: Final rule.
and other applicable disclosure law. For final version of the guidance. We
more information about FDA’s posting received numerous comments on the SUMMARY: This final rule removes DoD’s
of comments to public dockets, see 80 draft guidance and have modified the regulation concerning the Office of the
FR 56469, September 18, 2015, or access final guidance where appropriate. In Inspector General (OIG), Freedom of
VerDate Sep<11>2014 17:41 Aug 17, 2018 Jkt 244001 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 E:\FR\FM\20AUR1.SGM 20AUR1](https://thefederalregister.org/doc/83_FR_42185/page/2.svg)
Document Created: 2018-08-18 01:29:14
Document Modified: 2018-08-18 01:29:14
| 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 | Rules and Regulations | |
| Action | Notification of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on August 20, 2018. | |
| 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 42024 |
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