Menu Labeling: Supplemental Guidance for Industry; Availability, 20731-20733 [2018-09725]

Download as PDF Federal Register / Vol. 83, No. 89 / Tuesday, May 8, 2018 / Rules and Regulations AIRAC Date State City Airport Mexia-Limestone Co .. Mexia-Limestone Co .. Perry County .............. 8/7712 8/7713 8/7718 4/6/18 4/6/18 4/6/18 NDB–A, Amdt 4 RNAV (GPS) RWY 36, Orig-A VOR/DME RWY 26, Amdt 2 Perry County .............. 8/7719 4/6/18 RNAV (GPS) RWY 26, Orig-A Teterboro .................... Teterboro .................... Teterboro .................... Teterboro .................... Teterboro .................... Teterboro .................... Teterboro .................... Ruston Rgnl ............... Ruston Rgnl ............... Ruston Rgnl ............... Barnstable MuniBoardman/Polando Field. Barnstable MuniBoardman/Polando Field. Lawrence J Timmerman. Lawrence J Timmerman. Lawrence J Timmerman. Teterboro .................... Lawrence J Timmerman. Lawrence J Timmerman. Mora Muni .................. Mora Muni .................. Mora Muni .................. Decorah Muni ............. 8/8099 8/8101 8/8102 8/8105 8/8106 8/8121 8/8122 8/8418 8/8420 8/8424 8/8563 4/11/18 4/11/18 4/11/18 4/11/18 4/11/18 4/11/18 4/11/18 4/6/18 4/6/18 4/6/18 4/11/18 ILS OR LOC RWY 6, Amdt 29G COPTER ILS OR LOC RWY 6, Amdt 1F ILS OR LOC RWY 19, Orig-A RNAV (GPS) X RWY 6, Amdt 2 RNAV (GPS) Y RWY 6, Amdt 2B VOR/DME RWY 6, Orig-D VOR RWY 24, Orig-D NDB RWY 18, Orig-D RNAV (GPS) RWY 18, Orig-A RNAV (GPS) RWY 36, Orig-A ILS OR LOC RWY 15, Amdt 5 8/8564 4/11/18 RNAV (GPS) RWY 15, Orig-A 8/9042 4/9/18 RNAV (GPS) RWY 4L, Orig-B 8/9044 4/9/18 RNAV (GPS) RWY 15L, Orig-B 8/9051 4/9/18 RNAV (GPS) RWY 22R, Orig-C 8/9174 8/9495 4/13/18 4/9/18 VOR/DME–B, Amdt 2D VOR RWY 4L, Amdt 9B 8/9497 4/9/18 LOC RWY 15L, Amdt 6B 8/9655 8/9656 8/9657 8/9849 4/6/18 4/6/18 4/6/18 4/6/18 NDB RWY 35, Orig RNAV (GPS) RWY 35, Orig-A Takeoff Minimums and Obstacle DP, Orig RNAV (GPS) RWY 11, Orig-C 24-May-18 24-May-18 24-May-18 TX TX OH 24-May-18 OH 24-May-18 24-May-18 24-May-18 24-May-18 24-May-18 24-May-18 24-May-18 24-May-18 24-May-18 24-May-18 24-May-18 NJ NJ NJ NJ NJ NJ NJ LA LA LA MA Mexia ....... Mexia ....... New Lexington. New Lexington. Teterboro Teterboro Teterboro Teterboro Teterboro Teterboro Teterboro Ruston ...... Ruston ...... Ruston ...... Hyannis .... 24-May-18 MA Hyannis .... 24-May-18 WI Milwaukee 24-May-18 WI Milwaukee 24-May-18 WI Milwaukee 24-May-18 24-May-18 NJ WI Teterboro Milwaukee 24-May-18 WI Milwaukee 24-May-18 24-May-18 24-May-18 24-May-18 MN MN MN IA Mora ......... Mora ......... Mora ......... Decorah ... [FR Doc. 2018–09565 Filed 5–7–18; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 11 and 101 [Docket No. FDA–2011–F–0172] Menu Labeling: Supplemental 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 guidance for industry entitled ‘‘Menu Labeling: Supplemental Guidance for Industry.’’ The guidance addresses stakeholder concerns regarding the implementation of nutrition labeling required for foods sold in covered establishments, includes expanded and new examples of alternatives to aid in sradovich on DSK3GMQ082PROD with RULES SUMMARY: VerDate Sep<11>2014 16:05 May 07, 2018 Jkt 244001 FDC No. FDC Date 20731 compliance, identifies places where we intend to be more flexible in our approach, and advises of our intent to exercise enforcement discretion regarding nutrient declaration for ‘‘calories from fat’’ as part of the additional written nutrition information. The guidance also includes many graphical depictions to convey our thinking on various topics and to provide examples of options for implementation, and addresses calorie disclosure signage for self-service foods, including buffets and grab-and-go foods; reasonable basis, and the criteria for considering the natural variation of foods, when determining nutrition labeling for such foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer. The announcement of the guidance is published in the Federal Register on May 8, 2018. DATES: PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 Subject You may submit either electronic or written comments on FDA guidances 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 E:\FR\FM\08MYR1.SGM 08MYR1 20732 Federal Register / Vol. 83, No. 89 / Tuesday, May 8, 2018 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES 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– 2011–F–0172 for ‘‘Menu Labeling: Supplemental Guidance for Industry.’’ 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.’’ We will review this copy, including the claimed confidential information, in our 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. VerDate Sep<11>2014 16:05 May 07, 2018 Jkt 244001 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 Nutrition and Food Labeling (HFS–800), 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: Loretta A. Carey, Center for Food Safety and Applied Nutrition (HFS–820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2371. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for industry entitled ‘‘Menu Labeling: Supplemental Guidance for Industry.’’ 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 1, 2014 (79 FR 71156), we published a final rule on nutrition labeling of standard menu items in restaurants and similar retail food establishments to implement the menu labeling provisions of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(H)). The menu labeling requirements are codified at Title 21 of the Code of Federal Regulations, § 101.11 (21 CFR 101.11). In the Federal Register of May 4, 2017 (82 FR 20825), we published an interim final rule extending the compliance date to May 7, 2018. Our goals are to ensure that consumers are provided with consistent nutrition information they can use to make informed choices for PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 themselves and their families, and to guide industry in clearly understanding the flexible ways in which the requirements can be implemented. In the Federal Register of November 9, 2017 (82 FR 52036), we made available a draft guidance for industry entitled ‘‘Menu Labeling: Supplemental Guidance for Industry’’ and gave interested parties an opportunity to submit comments by January 8, 2018, for us to consider before beginning work on the final version of the guidance. The draft guidance addressed concerns raised by stakeholders regarding the implementation of nutrition labeling required for foods sold in covered establishments. It included expanded and new examples of alternatives to aid in compliance and identified places where we intend to be more flexible in our approach. The draft guidance also included many graphical depictions to convey our thinking on various topics and to provide examples of options for implementation. It addressed calorie disclosure signage for self-service foods, including buffets and grab-and-go foods; reasonable basis, and the criteria for considering the natural variation of foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer. We received numerous comments on the draft guidance and have modified the final guidance where appropriate. Changes to the guidance include adding new questions and answers 3.4, 3.5, and 8.3 and Figures 12, 13, 16, 17, and 18. In addition, we made editorial changes to improve clarity in questions and answers 4.1, 5.4, 6.2, 7.1, 8.1, 10.1, and 10.2 and clarified the headings for the graphics in Figures 3 and 14. In addition, the final guidance announces our intent to exercise enforcement discretion regarding the ‘‘calories from fat’’ nutrient declaration requirement as part of the additional written nutrition information required in § 101.11(b)(2)(ii)(A). As discussed in the final guidance, we are taking this position because the current science supports a view that the type of fat is more relevant with respect to the risk of chronic disease than the overall caloric fat intake, and to align with the final rule, ‘‘Food Labeling: Revision of the Nutrition and Supplement Facts Labels’’ (81 FR 33742, May 27, 2016). (Our current thinking on this issue is discussed in the preamble to the final rule titled, ‘‘Food Labeling: Revision of the Nutrition and Supplement Facts Labels’’ (81 FR 33742 at 33780 through E:\FR\FM\08MYR1.SGM 08MYR1 Federal Register / Vol. 83, No. 89 / Tuesday, May 8, 2018 / Rules and Regulations 33781) now codified primarily at 21 CFR 101.9 and 101.36). With respect to our enforcement discretion policy pertaining to ‘‘calories from fat’’ declarations, this part of the guidance is immediately effective because we have determined that prior public participation is not feasible or appropriate (21 CFR 10.115(g)(2)). The guidance announced in this notice finalizes the draft guidance dated November 2017. 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 § 101.11(b)(2), (c)(3), and (d) have been approved under OMB control number 0910–0783. 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: May 3, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–09725 Filed 5–7–18; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 147 [Docket Number USCG–2017–0446] RIN 1625–AA00 Safety Zone; Appomattox FPS, Mississippi Canyon 437, Outer Continental Shelf on the Gulf of Mexico Coast Guard, DHS. Final rule. AGENCY: ACTION: The Coast Guard is establishing a permanent safety zone extending 500 meters around the Appomattox Floating Production System (FPS) facility located in Mississippi Canyon Block 437 on the Outer Continental Shelf (OCS) in the Gulf of Mexico. This action is necessary to protect the facility from all vessels operating outside the normal shipping channels and fairways that are not sradovich on DSK3GMQ082PROD with RULES SUMMARY: VerDate Sep<11>2014 16:05 May 07, 2018 Jkt 244001 providing services to or working with the facility. Only vessels measuring less than 100 feet in length overall and not engaged in towing, attending vessels as defined in 33 CFR 147.20, or those vessels specifically authorized by the Eighth Coast Guard District Commander or a designated representative are permitted to enter or remain in the safety zone. DATES: This rule is effective on May 8, 2018. ADDRESSES: To view documents mentioned in this preamble as being available in the docket, go to https:// www.regulations.gov, type USCG–2017– 0446 in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open Docket Folder on the line associated with this rule. FOR FURTHER INFORMATION CONTACT: If you have questions on this rule, call or email Ms. Laura Knoll, U.S. Coast Guard, District Eight Waterways Management Branch; telephone 504– 671–2139, Laura.B.Knoll@uscg.mil. SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FPS Floating production system FR Federal Register NPRM Notice of proposed rulemaking OCS Outer Continental Shelf § Section U.S.C. United States Code II. Background Information and Regulatory History Shell Exploration and Production Co. requested that the Coast Guard establish an Outer Continental Shelf (OCS) safety zone extending 500 meters from each point on the Appomattox Floating Production System (FPS) facility structure’s outermost edge. In response to Shell Exploration and Production Co.’s request and on the basis of the District Commander’s safety analysis, on March 20, 2018, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Appomattox FPS, Mississippi Canyon 437, Outer Continental Shelf on the Gulf of Mexico (83 FR 12144). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to establishing the 500-meter safety zone. During the comment period that ended on April 19, 2018, we received no comments. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be contrary to the public interest because immediate action is PO 00000 Frm 00015 Fmt 4700 Sfmt 4700 20733 needed to respond to the potential safety concerns and hazards that could occur within 500 meters of the facility. III. Legal Authority and Need for Rule The Coast Guard is issuing this rule under the authority provided in 14 U.S.C. 85, 43 U.S.C. 1333, and Department of Homeland Security Delegation No. 0170.1(90), and Title 33, CFR 147.1, 147.5, and 147.10. The District Commander determined that placing a safety zone around the facility will significantly reduce the threat of allisions, oil spills, and releases of natural gas, and thereby protect the safety of life, property, and living marine resources. The purpose of this rule is to protect the facility from all vessels operating outside the normal shipping channels and fairways that are not providing services to or working with the facility. IV. Discussion of Comments, Changes, and the Rule As noted above, we received no comments on our NPRM published on March 20, 2018. This regulatory text of this final rule contains one technical amendment. In the NPRM, we indicated that permission to enter the safety zone may be obtained from the District Commander or a designated representative in the discussion of the proposed rule but not the regulatory text. This final rule corrects the regulatory text to indicate that permission to enter the safety zone may be obtained from the District Commander or a designated representative. This rule establishes a safety zone on the OCS in the deepwater area of the Gulf of Mexico at Mississippi Canyon Block 437. The area for the safety zone is 500 meters (1640.4 feet) from each point on the facility, which is located at 28°34′25.47″ N 87°56′03.11″ W. Only vessels measuring less than 100 feet in length overall and not engaged in towing, attending vessels as defined in 33 CFR 147.20, or those vessels specifically authorized by the Eighth Coast Guard District Commander or a designated representative are permitted to enter or remain in the safety zone. V. Regulatory Analyses We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors. E:\FR\FM\08MYR1.SGM 08MYR1

Agencies

[Federal Register Volume 83, Number 89 (Tuesday, May 8, 2018)]
[Rules and Regulations]
[Pages 20731-20733]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09725]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0172]


Menu Labeling: Supplemental 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 guidance for industry entitled ``Menu Labeling: 
Supplemental Guidance for Industry.'' The guidance addresses 
stakeholder concerns regarding the implementation of nutrition labeling 
required for foods sold in covered establishments, includes expanded 
and new examples of alternatives to aid in compliance, identifies 
places where we intend to be more flexible in our approach, and advises 
of our intent to exercise enforcement discretion regarding nutrient 
declaration for ``calories from fat'' as part of the additional written 
nutrition information. The guidance also includes many graphical 
depictions to convey our thinking on various topics and to provide 
examples of options for implementation, and addresses calorie 
disclosure signage for self-service foods, including buffets and grab-
and-go foods; reasonable basis, and the criteria for considering the 
natural variation of foods, when determining nutrition labeling for 
such foods; various methods for providing calorie disclosure 
information, including those for pizza; compliance and enforcement; and 
criteria for distinguishing between menus and other information 
presented to the consumer.

DATES: The announcement of the guidance is published in the Federal 
Register on May 8, 2018.

ADDRESSES: You may submit either electronic or written comments on FDA 
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.
     If you want to submit a comment with confidential 
information that you

[[Page 20732]]

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-2011-F-0172 for ``Menu Labeling: Supplemental Guidance for 
Industry.'' 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.'' We will review 
this copy, including the claimed confidential information, in our 
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 Nutrition and Food Labeling (HFS-800), 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: Loretta A. Carey, Center for Food 
Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Menu Labeling: Supplemental Guidance for Industry.'' 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 1, 2014 (79 FR 71156), we 
published a final rule on nutrition labeling of standard menu items in 
restaurants and similar retail food establishments to implement the 
menu labeling provisions of section 403(q)(5)(H) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(H)). The menu labeling 
requirements are codified at Title 21 of the Code of Federal 
Regulations, Sec.  101.11 (21 CFR 101.11).
    In the Federal Register of May 4, 2017 (82 FR 20825), we published 
an interim final rule extending the compliance date to May 7, 2018. Our 
goals are to ensure that consumers are provided with consistent 
nutrition information they can use to make informed choices for 
themselves and their families, and to guide industry in clearly 
understanding the flexible ways in which the requirements can be 
implemented.
    In the Federal Register of November 9, 2017 (82 FR 52036), we made 
available a draft guidance for industry entitled ``Menu Labeling: 
Supplemental Guidance for Industry'' and gave interested parties an 
opportunity to submit comments by January 8, 2018, for us to consider 
before beginning work on the final version of the guidance. The draft 
guidance addressed concerns raised by stakeholders regarding the 
implementation of nutrition labeling required for foods sold in covered 
establishments. It included expanded and new examples of alternatives 
to aid in compliance and identified places where we intend to be more 
flexible in our approach. The draft guidance also included many 
graphical depictions to convey our thinking on various topics and to 
provide examples of options for implementation. It addressed calorie 
disclosure signage for self-service foods, including buffets and grab-
and-go foods; reasonable basis, and the criteria for considering the 
natural variation of foods; various methods for providing calorie 
disclosure information, including those for pizza; compliance and 
enforcement; and criteria for distinguishing between menus and other 
information presented to the consumer.
    We received numerous comments on the draft guidance and have 
modified the final guidance where appropriate. Changes to the guidance 
include adding new questions and answers 3.4, 3.5, and 8.3 and Figures 
12, 13, 16, 17, and 18. In addition, we made editorial changes to 
improve clarity in questions and answers 4.1, 5.4, 6.2, 7.1, 8.1, 10.1, 
and 10.2 and clarified the headings for the graphics in Figures 3 and 
14.
    In addition, the final guidance announces our intent to exercise 
enforcement discretion regarding the ``calories from fat'' nutrient 
declaration requirement as part of the additional written nutrition 
information required in Sec.  101.11(b)(2)(ii)(A). As discussed in the 
final guidance, we are taking this position because the current science 
supports a view that the type of fat is more relevant with respect to 
the risk of chronic disease than the overall caloric fat intake, and to 
align with the final rule, ``Food Labeling: Revision of the Nutrition 
and Supplement Facts Labels'' (81 FR 33742, May 27, 2016). (Our current 
thinking on this issue is discussed in the preamble to the final rule 
titled, ``Food Labeling: Revision of the Nutrition and Supplement Facts 
Labels'' (81 FR 33742 at 33780 through

[[Page 20733]]

33781) now codified primarily at 21 CFR 101.9 and 101.36). With respect 
to our enforcement discretion policy pertaining to ``calories from 
fat'' declarations, this part of the guidance is immediately effective 
because we have determined that prior public participation is not 
feasible or appropriate (21 CFR 10.115(g)(2)). The guidance announced 
in this notice finalizes the draft guidance dated November 2017.

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 Sec.  101.11(b)(2), (c)(3), and (d) have 
been approved under OMB control number 0910-0783.

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: May 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09725 Filed 5-7-18; 8:45 am]
 BILLING CODE 4164-01-P
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