80_FR_39807 80 FR 39675 - Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date

80 FR 39675 - Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 132 (July 10, 2015)

Page Range39675-39676
FR Document2015-16865

The Food and Drug Administration (FDA or we) is extending the compliance date for the final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments. The final rule appeared in the Federal Register of December 1, 2014. We are taking this action in response to requests for an extension and for further clarification of the rule's requirements.

Federal Register, Volume 80 Issue 132 (Friday, July 10, 2015)
[Federal Register Volume 80, Number 132 (Friday, July 10, 2015)]
[Rules and Regulations]
[Pages 39675-39676]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16865]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 11 and 101

[Docket No. FDA-2011-F-0172]
RIN 0910-AG57


Food Labeling; Nutrition Labeling of Standard Menu Items in 
Restaurants and Similar Retail Food Establishments; Extension of 
Compliance Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; extension of compliance date.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
compliance date for the final rule requiring disclosure of certain 
nutrition information for standard menu items in certain restaurants 
and retail food establishments. The final rule appeared in the Federal 
Register of December 1, 2014. We are taking this action in response to 
requests for an extension and for further clarification of the rule's 
requirements.

DATES: 
    Effective date: This final rule is effective December 1, 2015.
    Compliance date: Covered establishments must comply with the rule 
published December 1, 2014 (79 FR 71156) by December 1, 2016.

FOR FURTHER INFORMATION CONTACT: Ashley Rulffes, Center for Food Safety 
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371, email: 
ashley.rulffes@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 1, 2014 (79 FR 71156), we 
published a final rule requiring disclosure of certain nutrition 
information for standard menu items in certain restaurants and retail 
food establishments. The final rule implements provisions of section 
403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
343(q)(5)(H)) and:
     Defines terms, including terms that describe criteria for 
determining whether an establishment is subject to the rule;
     establishes which foods are subject to the nutrition 
labeling requirements and which foods are not subject to these 
requirements;
     requires that calories for standard menu items be declared 
on menus and menu boards that list such foods for sale;
     requires that calories for standard menu items that are 
self-service or on display be declared on signs adjacent to such foods;
     requires that written nutrition information for standard 
menu items be available to consumers who ask to see it;
     requires, on menus and menu boards, a succinct statement 
concerning suggested daily caloric intake (succinct statement), 
designed to help the public understand the significance of the calorie 
declarations;
     requires, on menus and menu boards, a statement regarding 
the availability of the written nutrition information (statement of 
availability);
     establishes requirements for determination of nutrient 
content of standard menu items;
     establishes requirements for substantiation of nutrient 
content determined for standard menu items, including requirements for 
records that a covered establishment must make available to FDA within 
a reasonable period of time upon request; and
     establishes terms and conditions under which restaurants 
and similar retail food establishments not otherwise subject to the 
rule could elect to be subject to the requirements by registering with 
FDA.
    In the preamble to the final rule (79 FR 71156 at 71239 through 
71241), we stated that the rule would be effective on December 1, 2015, 
and also provided a compliance date of December 1, 2015, for covered 
establishments. The final rule (at 21 CFR 101.11(a)) defines ``covered 
establishment'' as a restaurant or similar retail food establishment 
that is a part of a chain with 20 or more locations doing business 
under the same name (regardless of the type of ownership, e.g., 
individual franchises) and offering for sale substantially the same 
menu items, as well as a restaurant or similar retail food 
establishment that is voluntarily registered to be covered under 21 CFR 
101.11(d).

II. Extending the Compliance Date

    Since we published the final rule in the Federal Register, we have 
received numerous requests asking us to further

[[Page 39676]]

interpret portions of the final rule or to respond to questions asking 
whether specific practices would be acceptable for purposes of 
complying with the rule. We issued a document in the Federal Register 
(80 FR 13225, March 13, 2015) announcing the availability of a ``Small 
Entity Compliance Guide'' for the rule, and are considering what 
additional guidance might be helpful.
    Since February 2015, we have received four requests asking us to 
extend the compliance date of the final rule based on concerns that 
covered establishments do not have adequate time to fully implement the 
requirements of the rule by the compliance date. These requests were 
submitted by a large retailer and trade and other associations, and 
they provide information regarding steps involved in implementation of 
the requirements. More specifically, the requests describe steps 
involved in developing software, information systems, and other 
technologies for providing nutrition information in ways that better 
correspond to how foods are offered for sale in covered establishments 
and allow for more efficient and product-specific nutrition labeling. 
In addition, the requests describe steps involved in training staff, 
implementing standard operating procedures, and developing and 
installing updated and consistent menu boards across all locations 
within a chain. Most requests sought to extend the compliance date by 1 
year.
    In light of these requests, we have decided to extend the 
compliance date for the final rule to December 1, 2016. The final rule 
requirements are intended to ensure that consumers are provided 
accurate, clear, and consistent nutrition information for foods sold in 
covered establishments in a direct and accessible manner to enable 
consumers to make informed and healthful dietary choices. Therefore, 
allowing adequate time for covered establishments to fully implement 
the final rule's requirements, as described in the requests, helps 
accomplish the primary objective of the final rule and is in the public 
interest.

III. Economic Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). FDA has developed a regulatory impact analysis that presents 
the benefits and costs of this final rule (Ref. 1). The Agency believes 
that this final rule is not a significant regulatory action under 
Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the final rule changes the compliance date 
from December 1, 2015, to December 1, 2016, the Agency certifies that 
the final rule will not have a significant economic impact on a 
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Paperwork Reduction Act

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

V. Environmental Impact

    We have determined under 21 CFR 25.30(k) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and is 
available electronically at http://www.regulations.gov. (FDA has 
verified the Web site address in this reference section, but we are not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)

    1. FDA, ``Food Labeling; Nutrition Labeling of Standard Menu 
Items in Restaurants and Similar Retail Food Establishments; 
Extension of Compliance Date,'' 2015. Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.

    Dated: July 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16865 Filed 7-9-15; 8:45 am]
 BILLING CODE 4164-01-P



                                                                     Federal Register / Vol. 80, No. 132 / Friday, July 10, 2015 / Rules and Regulations                                        39675

                                                safety data, go to                                         Done in Washington, DC, this 6th day of                 • Defines terms, including terms that
                                                productdata.aphis.usda.gov.                              July 2015.                                            describe criteria for determining
                                                *     *     *     *  *                                   Kevin Shea,                                           whether an establishment is subject to
                                                                                                         Administrator, Animal and Plant Health                the rule;
                                                ■  3. Section 112.5 is amended as                        Inspection Service.                                       • establishes which foods are subject
                                                follows:                                                 [FR Doc. 2015–16898 Filed 7–9–15; 8:45 am]            to the nutrition labeling requirements
                                                ■ a. In the introductory text, by                        BILLING CODE 3410–34–P                                and which foods are not subject to these
                                                removing the words ‘‘paragraph (c) of                                                                          requirements;
                                                this section and under the master label                                                                            • requires that calories for standard
                                                system provided in paragraph (d)’’ and                   DEPARTMENT OF HEALTH AND                              menu items be declared on menus and
                                                adding the words ‘‘paragraph (d) of this                 HUMAN SERVICES                                        menu boards that list such foods for
                                                section and under the master label                                                                             sale;
                                                system provided in paragraph (e)’’ in                    Food and Drug Administration                              • requires that calories for standard
                                                their place.                                                                                                   menu items that are self-service or on
                                                                                                         21 CFR Parts 11 and 101                               display be declared on signs adjacent to
                                                ■ b. In paragraph (a), by removing the
                                                                                                                                                               such foods;
                                                words ‘‘(http://www.aphis.usda.gov/                      [Docket No. FDA–2011–F–0172]                              • requires that written nutrition
                                                animal_health/vet_biologics/vb_                                                                                information for standard menu items be
                                                                                                         RIN 0910–AG57
                                                forms.shtml)’’ and adding the words                                                                            available to consumers who ask to see
                                                ‘‘(productdata.aphis.usda.gov)’’ in their                Food Labeling; Nutrition Labeling of                  it;
                                                place.                                                   Standard Menu Items in Restaurants                        • requires, on menus and menu
                                                ■ c. By redesignating paragraphs (b)                     and Similar Retail Food                               boards, a succinct statement concerning
                                                through (g) as paragraphs (c) through                    Establishments; Extension of                          suggested daily caloric intake (succinct
                                                (h).                                                     Compliance Date                                       statement), designed to help the public
                                                ■ d. By adding a new paragraph (b).                                                                            understand the significance of the
                                                                                                         AGENCY:    Food and Drug Administration,
                                                                                                                                                               calorie declarations;
                                                ■ e. In newly redesignated paragraph                     HHS.                                                      • requires, on menus and menu
                                                (d)(1), by removing the citation                         ACTION:Final rule; extension of                       boards, a statement regarding the
                                                ‘‘§ 112.5(d)’’ and adding the words                      compliance date.                                      availability of the written nutrition
                                                ‘‘paragraph (e) of this section’’ in its                                                                       information (statement of availability);
                                                                                                         SUMMARY:    The Food and Drug
                                                place.
                                                                                                         Administration (FDA or we) is                             • establishes requirements for
                                                ■ f. In newly redesignated paragraph                     extending the compliance date for the                 determination of nutrient content of
                                                (e)(1)(ii), by removing the citation                     final rule requiring disclosure of certain            standard menu items;
                                                ‘‘§ 112.5(d)(1)(iii)’’ and adding the                                                                              • establishes requirements for
                                                                                                         nutrition information for standard menu
                                                words ‘‘paragraph (e)(1)(iii) of this                                                                          substantiation of nutrient content
                                                                                                         items in certain restaurants and retail
                                                section’’ in its place.                                                                                        determined for standard menu items,
                                                                                                         food establishments. The final rule
                                                                                                                                                               including requirements for records that
                                                ■ g. In newly redesignated paragraph                     appeared in the Federal Register of
                                                                                                                                                               a covered establishment must make
                                                (e)(1)(iii), by removing the citation                    December 1, 2014. We are taking this
                                                                                                                                                               available to FDA within a reasonable
                                                ‘‘§ 112.5(d)(1)(i)’’ and adding the words                action in response to requests for an
                                                                                                                                                               period of time upon request; and
                                                ‘‘paragraph (e)(1)(i) of this section’’ in               extension and for further clarification of
                                                                                                                                                                   • establishes terms and conditions
                                                its place.                                               the rule’s requirements.
                                                                                                                                                               under which restaurants and similar
                                                ■ h. In newly redesignated paragraph                     DATES:                                                retail food establishments not otherwise
                                                (e)(1)(iv), by removing the citation                        Effective date: This final rule is                 subject to the rule could elect to be
                                                ‘‘§ 112.5(d)(1)(ii)’’ and adding the words               effective December 1, 2015.                           subject to the requirements by
                                                ‘‘paragraph (e)(1)(ii) of this section’’ in                 Compliance date: Covered
                                                                                                                                                               registering with FDA.
                                                its place.                                               establishments must comply with the                       In the preamble to the final rule (79
                                                                                                         rule published December 1, 2014 (79 FR                FR 71156 at 71239 through 71241), we
                                                ■ i. In newly redesignated paragraph (h),                71156) by December 1, 2016.
                                                by removing the citation ‘‘§ 112.5(c)’’                                                                        stated that the rule would be effective
                                                                                                         FOR FURTHER INFORMATION CONTACT:                      on December 1, 2015, and also provided
                                                and adding the words ‘‘paragraph (d) of
                                                                                                         Ashley Rulffes, Center for Food Safety                a compliance date of December 1, 2015,
                                                this section’’ in its place.
                                                                                                         and Applied Nutrition (HFS–820), Food                 for covered establishments. The final
                                                   The addition reads as follows:                        and Drug Administration, 5100 Paint                   rule (at 21 CFR 101.11(a)) defines
                                                                                                         Branch Pkwy., College Park, MD 20740,                 ‘‘covered establishment’’ as a restaurant
                                                § 112.5   Review and approval of labeling.
                                                                                                         240–402–2371, email: ashley.rulffes@                  or similar retail food establishment that
                                                *      *    *     *    *                                 fda.hhs.gov.                                          is a part of a chain with 20 or more
                                                   (b) A data summary, available on the                  SUPPLEMENTARY INFORMATION:                            locations doing business under the same
                                                Internet at productdata.aphis.usda.gov,                                                                        name (regardless of the type of
                                                shall be used with each submission of                    I. Background
                                                                                                                                                               ownership, e.g., individual franchises)
                                                efficacy and safety data in support of a                    In the Federal Register of December 1,             and offering for sale substantially the
                                                label claim. Manufacturers will submit                   2014 (79 FR 71156), we published a                    same menu items, as well as a restaurant
                                                the efficacy and safety data information                 final rule requiring disclosure of certain            or similar retail food establishment that
mstockstill on DSK4VPTVN1PROD with RULES




                                                with either the efficacy and safety                      nutrition information for standard menu               is voluntarily registered to be covered
                                                studies or at the time of label                          items in certain restaurants and retail               under 21 CFR 101.11(d).
                                                submission. This information will be                     food establishments. The final rule
                                                posted at productdata.aphis.usda.gov to                  implements provisions of section                      II. Extending the Compliance Date
                                                allow public disclosure of product                       403(q)(5)(H) of the Federal Food, Drug,                  Since we published the final rule in
                                                performance.                                             and Cosmetic Act (21 U.S.C.                           the Federal Register, we have received
                                                *      *    *     *    *                                 343(q)(5)(H)) and:                                    numerous requests asking us to further


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                                                39676                Federal Register / Vol. 80, No. 132 / Friday, July 10, 2015 / Rules and Regulations

                                                interpret portions of the final rule or to               and safety, and other advantages;                       1. FDA, ‘‘Food Labeling; Nutrition Labeling
                                                respond to questions asking whether                      distributive impacts; and equity). FDA                of Standard Menu Items in Restaurants and
                                                specific practices would be acceptable                   has developed a regulatory impact                     Similar Retail Food Establishments;
                                                for purposes of complying with the rule.                 analysis that presents the benefits and               Extension of Compliance Date,’’ 2015.
                                                                                                                                                               Available at: http://www.fda.gov/AboutFDA/
                                                We issued a document in the Federal                      costs of this final rule (Ref. 1). The                ReportsManualsForms/Reports/
                                                Register (80 FR 13225, March 13, 2015)                   Agency believes that this final rule is               EconomicAnalyses/.
                                                announcing the availability of a ‘‘Small                 not a significant regulatory action under
                                                Entity Compliance Guide’’ for the rule,                  Executive Order 12866.                                  Dated: July 6, 2015.
                                                and are considering what additional                         The Regulatory Flexibility Act                     Leslie Kux,
                                                guidance might be helpful.                               requires Agencies to analyze regulatory               Associate Commissioner for Policy.
                                                   Since February 2015, we have                          options that would minimize any                       [FR Doc. 2015–16865 Filed 7–9–15; 8:45 am]
                                                received four requests asking us to                      significant impact of a rule on small                 BILLING CODE 4164–01–P
                                                extend the compliance date of the final                  entities. Because the final rule changes
                                                rule based on concerns that covered                      the compliance date from December 1,
                                                establishments do not have adequate                      2015, to December 1, 2016, the Agency
                                                time to fully implement the                              certifies that the final rule will not have           DEPARTMENT OF THE TREASURY
                                                requirements of the rule by the                          a significant economic impact on a
                                                compliance date. These requests were                     substantial number of small entities.                 Office of Foreign Assets Control
                                                submitted by a large retailer and trade                     Section 202(a) of the Unfunded
                                                and other associations, and they provide                 Mandates Reform Act of 1995 requires                  31 CFR Part 591
                                                information regarding steps involved in                  that Agencies prepare a written
                                                implementation of the requirements.                      statement, which includes an                          Venezuela Sanctions Regulations
                                                More specifically, the requests describe                 assessment of anticipated costs and                   AGENCY:  Office of Foreign Assets
                                                steps involved in developing software,                   benefits, before proposing ‘‘any rule that            Control, Treasury.
                                                information systems, and other                           includes any Federal mandate that may
                                                technologies for providing nutrition                     result in the expenditure by State, local,            ACTION: Final rule.
                                                information in ways that better                          and tribal governments, in the aggregate,
                                                correspond to how foods are offered for                                                                        SUMMARY:   The Department of the
                                                                                                         or by the private sector, of $100,000,000             Treasury’s Office of Foreign Assets
                                                sale in covered establishments and                       or more (adjusted annually for inflation)
                                                allow for more efficient and product-                                                                          Control (OFAC) is issuing regulations to
                                                                                                         in any one year.’’ The current threshold              implement the Venezuela Defense of
                                                specific nutrition labeling. In addition,                after adjustment for inflation is $144
                                                the requests describe steps involved in                                                                        Human Rights and Civil Society Act of
                                                                                                         million, using the most current (2014)                2014 (Pub. L. 113–278) and Executive
                                                training staff, implementing standard                    Implicit Price Deflator for the Gross
                                                operating procedures, and developing                                                                           Order 13692 of March 8, 2015
                                                                                                         Domestic Product. FDA does not expect                 (‘‘Blocking Property and Suspending
                                                and installing updated and consistent                    this final rule to result in any 1-year
                                                menu boards across all locations within                                                                        Entry of Certain Persons Contributing to
                                                                                                         expenditure that would meet or exceed                 the Situation in Venezuela’’). OFAC
                                                a chain. Most requests sought to extend                  this amount.
                                                the compliance date by 1 year.                                                                                 intends to supplement this part 591
                                                   In light of these requests, we have                   IV. Paperwork Reduction Act                           with a more comprehensive set of
                                                decided to extend the compliance date                      This final rule contains no collection              regulations, which may include
                                                for the final rule to December 1, 2016.                  of information. Therefore, clearance by               additional interpretive and definitional
                                                The final rule requirements are intended                 the Office of Management and Budget                   guidance and additional general
                                                to ensure that consumers are provided                    under the Paperwork Reduction Act of                  licenses and statements of licensing
                                                accurate, clear, and consistent nutrition                1995 is not required.                                 policy.
                                                information for foods sold in covered                                                                          DATES:   Effective: July 10, 2015.
                                                establishments in a direct and accessible                V. Environmental Impact
                                                                                                                                                               FOR FURTHER INFORMATION CONTACT:
                                                manner to enable consumers to make                         We have determined under 21 CFR
                                                informed and healthful dietary choices.                  25.30(k) that this action is of a type that           Assistant Director for Licensing, tel.:
                                                Therefore, allowing adequate time for                    does not individually or cumulatively                 202/622–2480, Assistant Director for
                                                covered establishments to fully                          have a significant effect on the human                Policy, tel.: 202/622–6746, Assistant
                                                implement the final rule’s requirements,                 environment. Therefore, neither an                    Director for Regulatory Affairs, tel.: 202/
                                                as described in the requests, helps                      environmental assessment nor an                       622–4855, Assistant Director for
                                                accomplish the primary objective of the                  environmental impact statement is                     Sanctions Compliance & Evaluation,
                                                final rule and is in the public interest.                required.                                             tel.: 202/622–2490, OFAC, or Chief
                                                                                                                                                               Counsel (Foreign Assets Control), tel.:
                                                III. Economic Analysis of Impacts                        VI. Reference                                         202/622–2410, Office of the General
                                                   FDA has examined the impacts of the                      The following reference has been                   Counsel, Department of the Treasury
                                                final rule under Executive Order 12866,                  placed on display in the Division of                  (not toll free numbers).
                                                Executive Order 13563, the Regulatory                    Dockets Management (see ADDRESSES)                    SUPPLEMENTARY INFORMATION:
                                                Flexibility Act (5 U.S.C. 601–612), and                  and may be seen by interested persons
                                                                                                                                                               Electronic and Facsimile Availability
                                                the Unfunded Mandates Reform Act of                      between 9 a.m. and 4 p.m., Monday
                                                1995 (Pub. L. 104–4). Executive Orders                   through Friday, and is available                        This document and additional
mstockstill on DSK4VPTVN1PROD with RULES




                                                12866 and 13563 direct Agencies to                       electronically at http://                             information concerning OFAC are
                                                assess all costs and benefits of available               www.regulations.gov. (FDA has verified                available from OFAC’s Web site
                                                regulatory alternatives and, when                        the Web site address in this reference                (www.treasury.gov/ofac). Certain general
                                                regulation is necessary, to select                       section, but we are not responsible for               information pertaining to OFAC’s
                                                regulatory approaches that maximize                      any subsequent changes to the Web site                sanctions programs also is available via
                                                net benefits (including potential                        after this document publishes in the                  facsimile through a 24-hour fax-on-
                                                economic, environmental, public health                   Federal Register.)                                    demand service, tel.: 202/622–0077.


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Document Created: 2018-02-23 09:15:23
Document Modified: 2018-02-23 09:15:23
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule; extension of compliance date.
DatesEffective date: This final rule is effective December 1, 2015.
ContactAshley Rulffes, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371, email: [email protected]
FR Citation80 FR 39675 
RIN Number0910-AG57
CFR Citation21 CFR 101
21 CFR 11

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