Questions and Answers Regarding Food Facility Registration (Seventh Edition); Guidance for Industry; Availability, 42024-42025 [2018-17853]

Download as PDF 42024 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. Five comments were received in support of the action. One commenter had concerns that were not substantive to the establishment of Class E airspace. The concerns addressed the quality of the altimeter values reported by the Creswell Automated Weather Observing System (AWOS) and the potential for conflict with the visual flight rules (VFR) traffic pattern. The concerns regarding AWOS have been forwarded to the servicing System Support Center. The RNAV procedure at Hobby Field should only be used when the wind is favoring runway 16, so the VFR traffic pattern should shift to match. Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order. routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. Availability and Summary of Documents for Incorporation by Reference This document amends FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11B lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points. Adoption of the Amendment daltland on DSKBBV9HB2PROD with RULES The Rule This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface at Hobby Field, Creswell, OR, to accommodate new RNAV procedures at this airport for the safety and management of IFR operations. Regulatory Notices and Analyses The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, 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 VerDate Sep<11>2014 17:41 Aug 17, 2018 Jkt 244001 Issued in Seattle, Washington, on August 13, 2018. Shawn M. Kozica, Manager, Operations Support Group, Western Service Center. [FR Doc. 2018–17821 Filed 8–17–18; 8:45 am] BILLING CODE 4910–13–P Environmental Review The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, ‘‘Environmental Impacts: Policies and Procedures,’’ paragraph 5–6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment. DEPARTMENT OF HEALTH AND HUMAN SERVICES Lists of Subjects in 14 CFR Part 71 HHS. Airspace, Incorporation by reference, Navigation (air). In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows: PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for 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. § 71.1 [Amended] 2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017, is amended as follows: ■ Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. * * * ANM OR E5 * * Creswell, OR [New] Hobby Field, OR (Lat. 43°55′51″ N, long. 123°00′24″ W) That airspace extending upward from 700 feet above the surface within a 2.1-mile radius of Hobby Field, and within 1.8 miles each side of the 354° bearing from the airport extending from the 2.1-mile radius to 7.1 miles north of the airport. PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 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: ACTION: Food and Drug Administration, Notification of availability. 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: SUMMARY: 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. E:\FR\FM\20AUR1.SGM 20AUR1 Federal Register / Vol. 83, No. 161 / Monday, August 20, 2018 / Rules and Regulations daltland on DSKBBV9HB2PROD with RULES • 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 VerDate Sep<11>2014 17:41 Aug 17, 2018 Jkt 244001 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 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 selfaddressed 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 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 42025 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 DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 295 [Docket ID: DOD–2017–OS–0024] RIN 0790–AJ65 Office of the Inspector General, Freedom of Information Act Program AGENCY: Office of Inspector General, DoD. ACTION: Final rule. This final rule removes DoD’s regulation concerning the Office of the Inspector General (OIG), Freedom of SUMMARY: E:\FR\FM\20AUR1.SGM 20AUR1

Agencies

[Federal Register Volume 83, Number 161 (Monday, August 20, 2018)]
[Rules and Regulations]
[Pages 42024-42025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17853]


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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.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 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
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