82_FR_20910 82 FR 20825 - Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date; Request for Comments

82 FR 20825 - Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date; Request for Comments

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 85 (May 4, 2017)

Page Range20825-20829
FR Document2017-09029

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. In the Federal Register of December 30, 2016, we stated that the compliance date for the final rule would be May 5, 2017. We are extending the compliance date to May 7, 2018. We are taking this action to enable us to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration's policies.

Federal Register, Volume 82 Issue 85 (Thursday, May 4, 2017)
[Federal Register Volume 82, Number 85 (Thursday, May 4, 2017)]
[Rules and Regulations]
[Pages 20825-20829]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-09029]


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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-ZA48


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; extension of compliance date; request for 
comments.

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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. In the Federal Register of December 30, 
2016, we stated that the compliance date for the final rule would be 
May 5, 2017. We are extending the compliance date to May 7, 2018. We 
are taking this action to enable us to consider how we might further 
reduce the regulatory burden or increase

[[Page 20826]]

flexibility while continuing to achieve our regulatory objectives, in 
keeping with the Administration's policies.

DATES: Compliance date: As of May 4, 2017, the compliance date for 
covered establishments set out in the final rule published December 1, 
2014 (79 FR 71156), and extended in final rules published on July 10, 
2015 (80 FR 39675) and December 30, 2016 (81 FR 96364), is further 
extended. Covered establishments must comply with the rule published 
December 1, 2014 (79 FR 71156), by May 7, 2018.
    Comment date: Submit either electronic or written comments 
regarding this compliance date extension, implementation of the 
December 2014 final rule, and the various topics flagged in the 
SUPPLEMENTARY INFORMATION section of this document, by July 3, 2017.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of July 3, 2017. Comments received by 
mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``Food Labeling; Nutrition Labeling of Standard 
Menu Items in Restaurants and Similar Retail Food Establishments; 
Extension of Compliance Date; Request for Comments.'' Received 
comments, those filed in a timely manner (see DATES), will be placed in 
the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Division of Dockets Management 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 Division of Dockets Management. If you do not wish your 
name and contact information to be made publicly available, you can 
provide this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Felicia B. Billingslea, 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

    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, which is now codified at Sec.  
101.11 (21 CFR 101.11), 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

[[Page 20827]]

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 Sec.  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 Sec.  
101.11(d).

II. Extension of the Compliance Date and Request for Comments

    In the Federal Register of July 10, 2015 (80 FR 39675), in response 
to requests from affected entities, we announced our decision to extend 
the compliance date for the final rule to December 1, 2016.
    On December 18, 2015, the President signed the Consolidated 
Appropriations Act, 2016 (Pub. L. 114-113). Section 747 of that law 
states that none of the funds made available under the Consolidated 
Appropriations Act may be used to implement, administer, or enforce the 
final rule entitled ``Food Labeling; Nutrition Labeling of Standard 
Menu Items in Restaurants and Similar Retail Food Establishments'' 
until the later of December 1, 2016 or 1 year after the date we publish 
a Level 1 guidance with respect to nutrition labeling of standard menu 
items in restaurants and similar retail food establishments.
    In the Federal Register of May 5, 2016 (81 FR 27067), we announced 
the availability of the Level 1 guidance document and stated that 
enforcement of the final rule published December 1, 2014, would 
commence on May 5, 2017 (81 FR 27067 at 27068). In the Federal Register 
of December 30, 2016 (81 FR 96364), we confirmed that the compliance 
date would be May 5, 2017.
    This interim final rule extends the compliance date to May 7, 2018. 
We are taking this action consistent with Executive Orders 13777, 
13771, and 13563, as well as in response to the diverse and complex set 
of stakeholders affected by the rule and continued, numerous, and 
fundamental questions they raise regarding the final rule and its 
implementation. The continued, fundamental questions and concerns with 
the final rule suggest that critical implementation issues, including 
some related to scope, may not have been fully understood and the 
agency does not want to proceed if we do not have all of the relevant 
facts on these matters. Retailers with many different and diverse 
business models have raised concerns about how the rule lacks 
flexibility to permit them to provide meaningful nutrition information 
to consumers given their type of business and different operations. 
Moreover, we continue to receive many questions about calorie 
disclosure signage for self-service foods, including buffets and grab-
and-go foods. We do not want to proceed with a rule that might turn out 
to be too inflexible to support innovation in delivering information to 
consumers. In addition, we have received questions regarding how to 
distinguish a menu, which requires the posting of calorie information, 
from advertisements and other marketing pieces, which do not require 
calorie information. Many of these menu questions are complex and have 
highlighted for the agency the need for further consideration and 
clarification. How to address the natural calorie variations for foods 
has also been raised by stakeholders as an issue that needs additional 
guidance and clarity. Finally, some entities with certain business 
models have stated that they continue to have questions about what 
provisions of the final rule are applicable to them. We believe 
questions like this still need to be addressed.
    The previous extensions, as well as Congressional concern regarding 
implementation expressed through letters and appropriations law, are a 
reflection of the challenge in implementing this rule for a diverse 
industry of approximately 298,600 covered establishments, organized 
under 2,130 chains, that we estimated to be covered by the 2014 final 
rule. Executive Order 13777, ``Enforcing the Regulatory Reform Agenda'' 
(82 FR 12285, March 1, 2017), sets forth a policy to alleviate 
unnecessary regulatory burdens. Given the principles and policies set 
forth in these executive orders, particularly with respect to reducing 
burdens, reducing costs, maintaining flexibility, and improving 
effectiveness, we have decided to extend the compliance date to May 7, 
2018. The additional time will allow us to consider what opportunities 
there may be to address these fundamental and complex questions and 
reduce the cost and enhance the flexibility of these requirements 
beyond those reflected in the final rule. Given our decision to 
reconsider the rule consistent with these Executive Orders, it would 
not make sense to require establishments covered by our final rule to 
come into compliance with the rule (for which compliance is not yet 
required), as well as incur additional ongoing costs to maintain or 
update compliance, when these requirements may change as a result of 
our reconsideration of the rule. We solicit comment on the extension of 
the compliance date.
    To assist us in our review, we invite interested parties to submit 
comments on how we might further reduce the regulatory burden or 
increase flexibility while continuing to achieve our regulatory 
objectives to provide consumers with nutrition information so that they 
can make informed choices for themselves and their families. In 
particular, and in light of the issues we have noted above, we are 
interested in hearing about approaches to reduce the regulatory burden 
or increase flexibility with respect to:
    (1) Calorie disclosure signage for self-service foods, including 
buffets and grab-and-go foods;
    (2) methods for providing calorie disclosure information other than 
on the menu itself, including how different kinds of retailers might 
use different methods; and
    (3) criteria for distinguishing between menus and other information 
presented to the consumer. (See ADDRESSES for instructions on 
submitting comments.) These questions have been identified by 
stakeholders as among the fundamental issues that continue to pose 
significant implementation challenges. As of April 7, 2017, we have 
received five requests for an extension of the compliance period, which 
we will add to the docket. In addition, on April 5, 2017, a request to 
stay the effective date was submitted to FDA (see Docket No. FDA-2017-
P-2164); this request is currently under consideration.
    To the extent that 5 U.S.C. 553 applies to this extension of the 
compliance date, the action is exempt from notice and comment because 
it constitutes a rule of procedure under 5 U.S.C. 553(b)(A). 
Alternatively, to the extent that the notice-and-comment and delayed 
effective date requirements set forth in 5 U.S.C. 553 applies to this 
action, the implementation of this action without opportunity for 
public comment, effective immediately upon publication today in the 
Federal Register, is based

[[Page 20828]]

on the good cause exceptions in 5 U.S.C. 553(b)(B) and (d)(3). Given 
the imminence of the compliance date (May 5, 2017), and the fact that, 
as discussed above, a number of regulated establishments continue to 
raise numerous, complex questions about applicability of the menu 
labeling requirements and about how to implement them, we have decided 
that providing an opportunity for public comment would be impracticable 
and contrary to the public interest. This is because providing 
immediate notice to covered establishments of the additional time to 
come into compliance allows for more efficient planning and accounting 
for implementation of requirements, thus reducing regulatory burden and 
costs on affected entities. In addition, providing immediate notice 
that there will be additional time to comply is necessary so that 
affected entities can avoid incurring immediate costs and efficiently 
plan and account for implementation of the requirements by the imminent 
compliance date. Good cause exists to delay the compliance date without 
comment and effective immediately. In accordance with 21 CFR 
10.40(e)(1), however, we note that interested parties may provide 
comment on the compliance date extension, including whether it should 
be modified or revoked. In addition, interested parties may submit 
comments on how we might further reduce the regulatory burden or 
increase flexibility while continuing to achieve our regulatory 
objectives with respect to providing consumers with nutrition 
information so that they can make informed choices for themselves and 
their families. In addition, as we have done throughout this complex 
rulemaking process, we will continue to work with stakeholders as we go 
forward.

III. Economic Analysis of Impacts

    We have examined the impacts of the interim final rule under 
Executive Order 12866, Executive Order 13563, Executive Order 13771, 
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 us 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). Executive Order 13771 
requires that the costs associated with new regulations shall ``be 
offset by the elimination of existing costs associated with at least 
two prior regulations.'' We have developed an Economic Analysis of 
Impacts that assesses the impacts of the interim final rule, including 
cost savings to industry and foregone benefits to consumers. We 
estimate at least one type of impact in at least one year to be greater 
than $100 million. Thus, we believe that this interim final rule is an 
economically significant regulatory action as defined by 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 this rule reduces the burden on covered 
establishments by further extending the compliance date for the ``Food 
Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and 
Similar Retail Food Establishments'' final rule (79 FR 71156, December 
1, 2014 (final rule); 80 FR 39675, July 10, 2015 (extending the 
compliance date to December 1, 2016); 81 FR 96364, December 30, 2016 
(clarifying extension of the compliance date to May 5, 2017)), we 
certify the interim final rule will not have a significant economic 
impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``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 $148 
million, using the most current (2016) Implicit Price Deflator for the 
Gross Domestic Product. This interim final rule would not result in an 
expenditure by industry in any year that meets or exceeds this amount.
    This interim final rule extends the compliance date to May 7, 2018, 
for the final rule requiring disclosure of certain nutrition 
information for standard menu items in certain restaurants and similar 
retail food establishments. The principal benefit of this interim final 
rule will be the reduction in costs to covered establishments 
associated with extending the compliance date by one year. The total 
annualized benefit (i.e., cost savings) of this interim final rule, 
using a 3-percent discount rate over 20 years, would be from $2 to $6 
million; with a 7-percent discount rate, the annualized benefit would 
be $3 to $8 million. The principal cost of this interim final rule will 
be the reduction in benefits to consumers associated with extending the 
compliance date by one year. The total annualized cost (i.e., foregone 
benefits) of this interim final rule, using a 3-percent discount rate 
over 20 years, would be from $5 to $15 million; with a 7-percent 
discount rate, the annualized cost would be $6 to $19 million. 
Extending the compliance date of the ``Food Labeling: Nutrition 
Labeling of Standard Menu Items in Restaurants and Similar Retail Food 
Establishments'' final rule by one year reduces the annualized net 
benefits (discounted at 3 percent) approximately 1 percent, from $506 
million to $501 million. While average annualized net benefits decrease 
by $5 million, they are still positive. We recognize that there may be 
additional costs and benefits to both consumers and covered 
establishments that we do not have the data to quantify here. We are 
presenting the estimated benefits and costs of the menu labeling final 
rule, which takes effect according to the dates in this interim final 
rule. These quantitative estimates reflect an assumed baseline in which 
the menu labeling regulation eventually goes fully into effect. If 
statutory or other changes that are separate from FDA rulemaking were 
to impact full implementation, the quantitative benefits estimates 
would be lower and the quantitative cost estimates higher than shown 
here. We invite comment on both this Regulatory Impact Analysis and the 
Regulatory Impact Analysis for the December 2014 final rule.
    The full analysis of economic impacts is available in the docket 
for this interim final rule (Ref. 1) and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

IV. Paperwork Reduction Act

    This interim 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. Analysis of 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 is on display in the Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically

[[Page 20829]]

at https://www.regulations.gov. FDA has verified the Web site 
addresses, as of the date this document publishes in the Federal 
Register, but Web sites are subject to change over time.

1. FDA, interim economic impact analysis for ``Food Labeling; 
Nutrition Labeling of Standard Menu Items in Restaurants and Similar 
Retail Food Establishments; Extension of Compliance Date; Request 
for Comment,'' April 2017. Available at: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses.

    Dated: May 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-09029 Filed 5-1-17; 4:15 pm]
 BILLING CODE 4164-01-P



                                                                 Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Rules and Regulations                                                20825

                                             (d) Subject                                             but if any crack is found as identified in               (2) You must use this service information
                                               Air Transport Association (ATA) of                    Boeing 707 Alert Service Bulletin A3543,              as applicable to do the actions required by
                                             America Code 53, Fuselage.                              dated September 15, 2016, concurrence by              this AD, unless the AD specifies otherwise.
                                                                                                     the Manager, Los Angeles Aircraft                        (i) Boeing 707 Alert Service Bulletin
                                             (e) Unsafe Condition                                    Certification Office (ACO), FAA, is required          A3543, dated September 15, 2016.
                                                This AD was prompted by a determination              before issuance of the special flight permit.            (ii) Reserved.
                                             that undetected web fatigue cracking caused                                                                      (3) For service information identified in
                                                                                                     (j) Alternative Methods of Compliance                 this AD, contact Boeing Commercial
                                             by oil canning may exist in the station 1440            (AMOCs)
                                             aft pressure bulkhead web. We are issuing                                                                     Airplanes, Attention: Contractual & Data
                                             this AD to detect and correct fatigue cracking             (1) The Manager, Los Angeles ACO, FAA,             Services (C&DS), 2600 Westminster Blvd.,
                                             of the aft pressure bulkhead web, which                 has the authority to approve AMOCs for this           MC 110–SK57, Seal Beach, CA 90740–5600;
                                             could grow in length and ultimately reduce              AD, if requested using the procedures found           telephone 562–797–1717; Internet https://
                                             the structural integrity of the web and lead            in 14 CFR 39.19. In accordance with 14 CFR            www.myboeingfleet.com.
                                             to rapid decompression of the airplane.                 39.19, send your request to your principal               (4) You may view this service information
                                                                                                     inspector or local Flight Standards District          at the FAA, Transport Airplane Directorate,
                                             (f) Compliance                                          Office, as appropriate. If sending information        1601 Lind Avenue SW., Renton, WA. For
                                                Comply with this AD within the                       directly to the manager of the ACO, send it           information on the availability of this
                                             compliance times specified, unless already              to the attention of the person identified in          material at the FAA, call 425–227–1221.
                                             done.                                                   paragraph (k) of this AD. Information may be             (5) You may view this service information
                                                                                                     emailed to: 9-ANM-LAACO-AMOC-                         that is incorporated by reference at the
                                             (g) Repetitive Inspections and Related                  Requests@faa.gov.                                     National Archives and Records
                                             Investigative and Corrective Actions                       (2) Before using any approved AMOC,                Administration (NARA). For information on
                                                At the applicable time specified in                  notify your appropriate principal inspector,          the availability of this material at NARA, call
                                             paragraph 1.E., ‘‘Compliance,’’ of Boeing 707           or lacking a principal inspector, the manager         202–741–6030, or go to: http://
                                             Alert Service Bulletin A3543, dated                     of the local flight standards district office/        www.archives.gov/federal-register/cfr/ibr-
                                             September 15, 2016, except as required by               certificate holding district office.                  locations.html.
                                             paragraph (h)(1) of this AD: Do all applicable             (3) An AMOC that provides an acceptable
                                                                                                                                                             Issued in Renton, Washington, on April 24,
                                             actions specified in paragraphs (g)(1), (g)(2),         level of safety may be used for any repair,
                                                                                                                                                           2017.
                                             and (g)(3) of this AD, in accordance with the           modification, or alteration required by this
                                             Accomplishment Instructions of Boeing 707               AD if it is approved by the Boeing                    Paul Bernado,
                                             Alert Service Bulletin A3543, dated                     Commercial Airplanes Organization                     Acting Manager, Transport Airplane
                                             September 15, 2016, except as required by               Designation Authorization (ODA) that has              Directorate, Aircraft Certification Service.
                                             paragraph (h)(2) of this AD.                            been authorized by the Manager, Los Angeles           [FR Doc. 2017–08828 Filed 5–3–17; 8:45 am]
                                                (1) Do a detailed inspection of the station          ACO, to make those findings. To be                    BILLING CODE 4910–13–P
                                             1440 aft pressure bulkhead web for any oil              approved, the repair method, modification
                                             canning. Repeat the inspection at the                   deviation, or alteration deviation must meet
                                             applicable time specified in paragraph 1.E.,            the certification basis of the airplane, and the
                                             ‘‘Compliance,’’ of Boeing 707 Alert Service             approval must specifically refer to this AD.          DEPARTMENT OF HEALTH AND
                                             Bulletin A3543, dated September 15, 2016.                  (4) Except as required by paragraph (h) of         HUMAN SERVICES
                                                (2) Do all applicable related investigative          this AD: For service information that
                                             actions, including detailed, eddy current, and          contains steps that are labeled as RC, the            Food and Drug Administration
                                             high frequency eddy current (HFEC)                      provisions of paragraphs (j)(4)(i) and (j)(4)(ii)
                                             inspections. Repeat the applicable                      of this AD apply.                                     21 CFR Parts 11 and 101
                                             inspections thereafter at the applicable time              (i) The steps labeled as RC, including
                                             specified in paragraph 1.E., ‘‘Compliance,’’ of         substeps under an RC step and any figures             [Docket No. FDA–2011–F–0172]
                                             Boeing 707 Alert Service Bulletin A3543,                identified in an RC step, must be done to
                                                                                                                                                           RIN 0910–ZA48
                                             dated September 15, 2016.                               comply with the AD. If a step or substep is
                                                (3) Do all applicable corrective actions at          labeled ‘‘RC Exempt,’’ then the RC
                                             the applicable time specified in paragraph              requirement is removed from that step or
                                                                                                                                                           Food Labeling; Nutrition Labeling of
                                             1.E., ‘‘Compliance,’’ of Boeing 707 Alert               substep. An AMOC is required for any                  Standard Menu Items in Restaurants
                                             Service Bulletin A3543, dated September 15,             deviations to RC steps, including substeps            and Similar Retail Food
                                             2016.                                                   and identified figures.                               Establishments; Extension of
                                                                                                        (ii) Steps not labeled as RC may be                Compliance Date; Request for
                                             (h) Service Information Exceptions                      deviated from using accepted methods in               Comments
                                               (1) Where Boeing 707 Alert Service                    accordance with the operator’s maintenance
                                             Bulletin A3543, dated September 15, 2016,               or inspection program without obtaining               AGENCY:   Food and Drug Administration,
                                             specifies a compliance time ‘‘after the                 approval of an AMOC, provided the RC steps,           HHS.
                                             original issue date of this service bulletin,’’         including substeps and identified figures, can        ACTION:Interim final rule; extension of
                                             this AD requires compliance within the                  still be done as specified, and the airplane
                                             specified compliance time after the effective
                                                                                                                                                           compliance date; request for comments.
                                                                                                     can be put back in an airworthy condition.
                                             date of this AD.                                                                                              SUMMARY:    The Food and Drug
                                               (2) Where Boeing 707 Alert Service                    (k) Related Information
                                             Bulletin A3543, dated September 15, 2016,                 For more information about this AD,                 Administration (FDA or we) is
                                             specifies to contact Boeing for repair                  contact George Garrido, Aerospace Engineer,           extending the compliance date for the
                                             instructions, and specifies that action as              Airframe Branch, ANM–120L, FAA, Los                   final rule requiring disclosure of certain
                                             Required for Compliance (RC), this AD                   Angeles Aircraft Certification Office (ACO),          nutrition information for standard menu
                                             requires repair using a method approved in              3960 Paramount Boulevard, Lakewood, CA                items in certain restaurants and retail
                                             accordance with the procedures specified in             90712–4137; phone: 562–627–5232; fax: 562–            food establishments. In the Federal
pmangrum on DSK3GDR082PROD with RULES




                                             paragraph (j) of this AD.                               627–5210; email: george.garrido@faa.gov.              Register of December 30, 2016, we
                                             (i) Special Flight Permit                               (l) Material Incorporated by Reference                stated that the compliance date for the
                                                Special flight permits may be issued in                 (1) The Director of the Federal Register           final rule would be May 5, 2017. We are
                                             accordance with sections 21.197 and 21.199              approved the incorporation by reference               extending the compliance date to May 7,
                                             of the Federal Aviation Regulations (14 CFR             (IBR) of the service information listed in this       2018. We are taking this action to enable
                                             21.197 and 21.199) to operate the airplane to           paragraph under 5 U.S.C. 552(a) and 1 CFR             us to consider how we might further
                                             a location where the airplane can be repaired,          part 51.                                              reduce the regulatory burden or increase


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                                             20826               Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Rules and Regulations

                                             flexibility while continuing to achieve                 Written/Paper Submissions                             fdsys/pkg/FR-2015-09-18/pdf/2015-
                                             our regulatory objectives, in keeping                                                                         23389.pdf.
                                             with the Administration’s policies.                        Submit written/paper submissions as                   Docket: For access to the docket to
                                                                                                     follows:                                              read background documents or the
                                             DATES:  Compliance date: As of May 4,                      • Mail/Hand delivery/Courier (for
                                             2017, the compliance date for covered                                                                         electronic and written/paper comments
                                                                                                     written/paper submissions): Division of               received, go to https://
                                             establishments set out in the final rule                Dockets Management (HFA–305), Food
                                             published December 1, 2014 (79 FR                                                                             www.regulations.gov and insert the
                                                                                                     and Drug Administration, 5630 Fishers                 docket number, found in brackets in the
                                             71156), and extended in final rules                     Lane, Rm. 1061, Rockville, MD 20852.
                                             published on July 10, 2015 (80 FR                                                                             heading of this document, into the
                                                                                                        • For written/paper comments                       ‘‘Search’’ box and follow the prompts
                                             39675) and December 30, 2016 (81 FR
                                                                                                     submitted to the Division of Dockets                  and/or go to the Division of Dockets
                                             96364), is further extended. Covered
                                                                                                     Management, FDA will post your                        Management, 5630 Fishers Lane, Rm.
                                             establishments must comply with the
                                                                                                     comment, as well as any attachments,                  1061, Rockville, MD 20852.
                                             rule published December 1, 2014 (79 FR
                                                                                                     except for information submitted,                     FOR FURTHER INFORMATION CONTACT:
                                             71156), by May 7, 2018.
                                                                                                     marked and identified, as confidential,               Felicia B. Billingslea, Center for Food
                                               Comment date: Submit either                           if submitted as detailed in
                                             electronic or written comments                                                                                Safety and Applied Nutrition (HFS–
                                                                                                     ‘‘Instructions.’’                                     820), Food and Drug Administration,
                                             regarding this compliance date
                                                                                                        Instructions: All submissions received             5001 Campus Dr., College Park, MD
                                             extension, implementation of the
                                                                                                     must include the Docket No. FDA–                      20740, 240–402–2371.
                                             December 2014 final rule, and the
                                                                                                     2011–F–0172 for ‘‘Food Labeling;                      SUPPLEMENTARY INFORMATION:
                                             various topics flagged in the
                                                                                                     Nutrition Labeling of Standard Menu
                                             SUPPLEMENTARY INFORMATION section of                                                                          I. Background
                                                                                                     Items in Restaurants and Similar Retail
                                             this document, by July 3, 2017.
                                                                                                     Food Establishments; Extension of                         In the Federal Register of December 1,
                                             ADDRESSES:   You may submit comments                    Compliance Date; Request for                          2014 (79 FR 71156), we published a
                                             as follows. Please note that late,                      Comments.’’ Received comments, those                  final rule requiring disclosure of certain
                                             untimely filed comments will not be                     filed in a timely manner (see DATES),                 nutrition information for standard menu
                                             considered. The https://                                will be placed in the docket and, except              items in certain restaurants and retail
                                             www.regulations.gov electronic filing                   for those submitted as ‘‘Confidential                 food establishments. The final rule,
                                             system will accept comments until                       Submissions,’’ publicly viewable at                   which is now codified at § 101.11 (21
                                             midnight Eastern Time at the end of July                https://www.regulations.gov or at the                 CFR 101.11), implements provisions of
                                             3, 2017. Comments received by mail/                     Division of Dockets Management                        section 403(q)(5)(H) of the Federal Food,
                                             hand delivery/courier (for written/paper                between 9 a.m. and 4 p.m., Monday                     Drug, and Cosmetic Act (21 U.S.C.
                                             submissions) will be considered timely                  through Friday.                                       343(q)(5)(H)) and:
                                             if they are postmarked or the delivery                     • Confidential Submissions—To                          • Defines terms, including terms that
                                             service acceptance receipt is on or                     submit a comment with confidential                    describe criteria for determining
                                             before that date.                                       information that you do not wish to be                whether an establishment is subject to
                                             Electronic Submissions                                  made publicly available, submit your                  the rule;
                                                                                                     comments only as a written/paper                          • establishes which foods are subject
                                               Submit electronic comments in the                     submission. You should submit two                     to the nutrition labeling requirements
                                             following way:                                          copies total. One copy will include the               and which foods are not subject to these
                                               • Federal eRulemaking Portal:                         information you claim to be confidential              requirements;
                                             https://www.regulations.gov. Follow the                 with a heading or cover note that states                  • requires that calories for standard
                                             instructions for submitting comments.                   ‘‘THIS DOCUMENT CONTAINS                              menu items be declared on menus and
                                             Comments submitted electronically,                      CONFIDENTIAL INFORMATION.’’ We                        menu boards that list such foods for
                                             including attachments, to https://                      will review this copy, including the                  sale;
                                             www.regulations.gov will be posted to                   claimed confidential information, in our                  • requires that calories for standard
                                             the docket unchanged. Because your                      consideration of comments. The second                 menu items that are self-service or on
                                             comment will be made public, you are                    copy, which will have the claimed                     display be declared on signs adjacent to
                                             solely responsible for ensuring that your               confidential information redacted/                    such foods;
                                             comment does not include any                            blacked out, will be available for public                 • requires that written nutrition
                                             confidential information that you or a                  viewing and posted on https://                        information for standard menu items be
                                             third party may not wish to be posted,                  www.regulations.gov. Submit both                      available to consumers who ask to see
                                             such as medical information, your or                    copies to the Division of Dockets                     it;
                                             anyone else’s Social Security number, or                Management. If you do not wish your                       • requires, on menus and menu
                                             confidential business information, such                 name and contact information to be                    boards, a succinct statement concerning
                                             as a manufacturing process. Please note                 made publicly available, you can                      suggested daily caloric intake (succinct
                                             that if you include your name, contact                  provide this information on the cover                 statement), designed to help the public
                                             information, or other information that                  sheet and not in the body of your                     understand the significance of the
                                             identifies you in the body of your                      comments and you must identify this                   calorie declarations;
                                             comments, that information will be                      information as ‘‘confidential.’’ Any                      • requires, on menus and menu
                                             posted on https://www.regulations.gov.                  information marked as ‘‘confidential’’                boards, a statement regarding the
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                                               • If you want to submit a comment                     will not be disclosed except in                       availability of the written nutrition
                                             with confidential information that you                  accordance with 21 CFR 10.20 and other                information (statement of availability);
                                             do not wish to be made available to the                 applicable disclosure law. For more                       • establishes requirements for
                                             public, submit the comment as a                         information about FDA’s posting of                    determination of nutrient content of
                                             written/paper submission and in the                     comments to public dockets, see 80 FR                 standard menu items;
                                             manner detailed (see ‘‘Written/Paper                    56469, September 18, 2015, or access                      • establishes requirements for
                                             Submissions’’ and ‘‘Instructions’’).                    the information at: https://www.gpo.gov/              substantiation of nutrient content


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                                                                 Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Rules and Regulations                                           20827

                                             determined for standard menu items,                     diverse and complex set of stakeholders               to consider what opportunities there
                                             including requirements for records that                 affected by the rule and continued,                   may be to address these fundamental
                                             a covered establishment must make                       numerous, and fundamental questions                   and complex questions and reduce the
                                             available to FDA within a reasonable                    they raise regarding the final rule and its           cost and enhance the flexibility of these
                                             period of time upon request; and                        implementation. The continued,                        requirements beyond those reflected in
                                                • establishes terms and conditions                   fundamental questions and concerns                    the final rule. Given our decision to
                                             under which restaurants and similar                     with the final rule suggest that critical             reconsider the rule consistent with these
                                             retail food establishments not otherwise                implementation issues, including some                 Executive Orders, it would not make
                                             subject to the rule could elect to be                   related to scope, may not have been                   sense to require establishments covered
                                             subject to the requirements by                          fully understood and the agency does                  by our final rule to come into
                                             registering with FDA.                                   not want to proceed if we do not have                 compliance with the rule (for which
                                                In the preamble to the final rule (79                all of the relevant facts on these matters.           compliance is not yet required), as well
                                             FR 71156 at 71239 through 71241), we                    Retailers with many different and                     as incur additional ongoing costs to
                                             stated that the rule would be effective                 diverse business models have raised                   maintain or update compliance, when
                                             on December 1, 2015, and also provided                  concerns about how the rule lacks                     these requirements may change as a
                                             a compliance date of December 1, 2015,                  flexibility to permit them to provide                 result of our reconsideration of the rule.
                                             for covered establishments. The final                   meaningful nutrition information to                   We solicit comment on the extension of
                                             rule (at § 101.11(a)) defines ‘‘covered                 consumers given their type of business                the compliance date.
                                             establishment’’ as a restaurant or similar              and different operations. Moreover, we                   To assist us in our review, we invite
                                             retail food establishment that is a part                continue to receive many questions                    interested parties to submit comments
                                             of a chain with 20 or more locations                    about calorie disclosure signage for self-            on how we might further reduce the
                                             doing business under the same name                      service foods, including buffets and                  regulatory burden or increase flexibility
                                             (regardless of the type of ownership,                   grab-and-go foods. We do not want to                  while continuing to achieve our
                                             e.g., individual franchises) and offering               proceed with a rule that might turn out               regulatory objectives to provide
                                             for sale substantially the same menu                    to be too inflexible to support                       consumers with nutrition information
                                             items, as well as a restaurant or similar               innovation in delivering information to               so that they can make informed choices
                                             retail food establishment that is                       consumers. In addition, we have                       for themselves and their families. In
                                             voluntarily registered to be covered                    received questions regarding how to                   particular, and in light of the issues we
                                             under § 101.11(d).                                      distinguish a menu, which requires the                have noted above, we are interested in
                                                                                                     posting of calorie information, from                  hearing about approaches to reduce the
                                             II. Extension of the Compliance Date
                                                                                                     advertisements and other marketing                    regulatory burden or increase flexibility
                                             and Request for Comments
                                                                                                     pieces, which do not require calorie                  with respect to:
                                                In the Federal Register of July 10,                                                                           (1) Calorie disclosure signage for self-
                                             2015 (80 FR 39675), in response to                      information. Many of these menu
                                                                                                                                                           service foods, including buffets and
                                             requests from affected entities, we                     questions are complex and have
                                                                                                                                                           grab-and-go foods;
                                             announced our decision to extend the                    highlighted for the agency the need for                  (2) methods for providing calorie
                                             compliance date for the final rule to                   further consideration and clarification.              disclosure information other than on the
                                             December 1, 2016.                                       How to address the natural calorie                    menu itself, including how different
                                                On December 18, 2015, the President                  variations for foods has also been raised             kinds of retailers might use different
                                             signed the Consolidated Appropriations                  by stakeholders as an issue that needs                methods; and
                                             Act, 2016 (Pub. L. 114–113). Section 747                additional guidance and clarity. Finally,                (3) criteria for distinguishing between
                                             of that law states that none of the funds               some entities with certain business                   menus and other information presented
                                             made available under the Consolidated                   models have stated that they continue to              to the consumer. (See ADDRESSES for
                                             Appropriations Act may be used to                       have questions about what provisions of               instructions on submitting comments.)
                                             implement, administer, or enforce the                   the final rule are applicable to them. We             These questions have been identified by
                                             final rule entitled ‘‘Food Labeling;                    believe questions like this still need to             stakeholders as among the fundamental
                                             Nutrition Labeling of Standard Menu                     be addressed.                                         issues that continue to pose significant
                                             Items in Restaurants and Similar Retail                    The previous extensions, as well as                implementation challenges. As of April
                                             Food Establishments’’ until the later of                Congressional concern regarding                       7, 2017, we have received five requests
                                             December 1, 2016 or 1 year after the                    implementation expressed through                      for an extension of the compliance
                                             date we publish a Level 1 guidance with                 letters and appropriations law, are a                 period, which we will add to the docket.
                                             respect to nutrition labeling of standard               reflection of the challenge in                        In addition, on April 5, 2017, a request
                                             menu items in restaurants and similar                   implementing this rule for a diverse                  to stay the effective date was submitted
                                             retail food establishments.                             industry of approximately 298,600                     to FDA (see Docket No. FDA–2017–P–
                                                In the Federal Register of May 5, 2016               covered establishments, organized                     2164); this request is currently under
                                             (81 FR 27067), we announced the                         under 2,130 chains, that we estimated to              consideration.
                                             availability of the Level 1 guidance                    be covered by the 2014 final rule.                       To the extent that 5 U.S.C. 553 applies
                                             document and stated that enforcement                    Executive Order 13777, ‘‘Enforcing the                to this extension of the compliance date,
                                             of the final rule published December 1,                 Regulatory Reform Agenda’’ (82 FR                     the action is exempt from notice and
                                             2014, would commence on May 5, 2017                     12285, March 1, 2017), sets forth a                   comment because it constitutes a rule of
                                             (81 FR 27067 at 27068). In the Federal                  policy to alleviate unnecessary                       procedure under 5 U.S.C. 553(b)(A).
                                             Register of December 30, 2016 (81 FR                    regulatory burdens. Given the principles              Alternatively, to the extent that the
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                                             96364), we confirmed that the                           and policies set forth in these executive             notice-and-comment and delayed
                                             compliance date would be May 5, 2017.                   orders, particularly with respect to                  effective date requirements set forth in
                                                This interim final rule extends the                  reducing burdens, reducing costs,                     5 U.S.C. 553 applies to this action, the
                                             compliance date to May 7, 2018. We are                  maintaining flexibility, and improving                implementation of this action without
                                             taking this action consistent with                      effectiveness, we have decided to                     opportunity for public comment,
                                             Executive Orders 13777, 13771, and                      extend the compliance date to May 7,                  effective immediately upon publication
                                             13563, as well as in response to the                    2018. The additional time will allow us               today in the Federal Register, is based


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                                             20828               Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Rules and Regulations

                                             on the good cause exceptions in 5 U.S.C.                regulations.’’ We have developed an                   year. The total annualized cost (i.e.,
                                             553(b)(B) and (d)(3). Given the                         Economic Analysis of Impacts that                     foregone benefits) of this interim final
                                             imminence of the compliance date (May                   assesses the impacts of the interim final             rule, using a 3-percent discount rate
                                             5, 2017), and the fact that, as discussed               rule, including cost savings to industry              over 20 years, would be from $5 to $15
                                             above, a number of regulated                            and foregone benefits to consumers. We                million; with a 7-percent discount rate,
                                             establishments continue to raise                        estimate at least one type of impact in               the annualized cost would be $6 to $19
                                             numerous, complex questions about                       at least one year to be greater than $100             million. Extending the compliance date
                                             applicability of the menu labeling                      million. Thus, we believe that this                   of the ‘‘Food Labeling: Nutrition
                                             requirements and about how to                           interim final rule is an economically                 Labeling of Standard Menu Items in
                                             implement them, we have decided that                    significant regulatory action as defined              Restaurants and Similar Retail Food
                                             providing an opportunity for public                     by Executive Order 12866.                             Establishments’’ final rule by one year
                                             comment would be impracticable and                         The Regulatory Flexibility Act                     reduces the annualized net benefits
                                             contrary to the public interest. This is                requires Agencies to analyze regulatory               (discounted at 3 percent) approximately
                                             because providing immediate notice to                   options that would minimize any                       1 percent, from $506 million to $501
                                             covered establishments of the additional                significant impact of a rule on small                 million. While average annualized net
                                             time to come into compliance allows for                 entities. Because this rule reduces the               benefits decrease by $5 million, they are
                                             more efficient planning and accounting                  burden on covered establishments by                   still positive. We recognize that there
                                             for implementation of requirements,                     further extending the compliance date                 may be additional costs and benefits to
                                             thus reducing regulatory burden and                     for the ‘‘Food Labeling: Nutrition                    both consumers and covered
                                             costs on affected entities. In addition,                Labeling of Standard Menu Items in                    establishments that we do not have the
                                             providing immediate notice that there                   Restaurants and Similar Retail Food                   data to quantify here. We are presenting
                                             will be additional time to comply is                    Establishments’’ final rule (79 FR 71156,             the estimated benefits and costs of the
                                             necessary so that affected entities can                 December 1, 2014 (final rule); 80 FR                  menu labeling final rule, which takes
                                             avoid incurring immediate costs and                     39675, July 10, 2015 (extending the                   effect according to the dates in this
                                             efficiently plan and account for                        compliance date to December 1, 2016);                 interim final rule. These quantitative
                                             implementation of the requirements by                   81 FR 96364, December 30, 2016                        estimates reflect an assumed baseline in
                                             the imminent compliance date. Good                      (clarifying extension of the compliance               which the menu labeling regulation
                                             cause exists to delay the compliance                    date to May 5, 2017)), we certify the                 eventually goes fully into effect. If
                                             date without comment and effective                      interim final rule will not have a                    statutory or other changes that are
                                             immediately. In accordance with 21                      significant economic impact on a                      separate from FDA rulemaking were to
                                             CFR 10.40(e)(1), however, we note that                  substantial number of small entities.                 impact full implementation, the
                                             interested parties may provide comment                     The Unfunded Mandates Reform Act                   quantitative benefits estimates would be
                                             on the compliance date extension,                       of 1995 (section 202(a)) requires us to               lower and the quantitative cost
                                             including whether it should be modified                 prepare a written statement, which                    estimates higher than shown here. We
                                             or revoked. In addition, interested                     includes an assessment of anticipated                 invite comment on both this Regulatory
                                             parties may submit comments on how                      costs and benefits, before issuing ‘‘any              Impact Analysis and the Regulatory
                                             we might further reduce the regulatory                  rule that includes any Federal mandate                Impact Analysis for the December 2014
                                             burden or increase flexibility while                    that may result in the expenditure by                 final rule.
                                             continuing to achieve our regulatory                    State, local, and tribal governments, in                 The full analysis of economic impacts
                                             objectives with respect to providing                    the aggregate, or by the private sector, of           is available in the docket for this interim
                                             consumers with nutrition information                    $100,000,000 or more (adjusted                        final rule (Ref. 1) and at http://
                                             so that they can make informed choices                  annually for inflation) in any one year.’’            www.fda.gov/AboutFDA/
                                             for themselves and their families. In                   The current threshold after adjustment                ReportsManualsForms/Reports/
                                             addition, as we have done throughout                    for inflation is $148 million, using the              EconomicAnalyses/default.htm.
                                             this complex rulemaking process, we                     most current (2016) Implicit Price
                                             will continue to work with stakeholders                 Deflator for the Gross Domestic Product.              IV. Paperwork Reduction Act
                                             as we go forward.                                       This interim final rule would not result                This interim final rule contains no
                                                                                                     in an expenditure by industry in any                  collection of information. Therefore,
                                             III. Economic Analysis of Impacts                       year that meets or exceeds this amount.               clearance by the Office of Management
                                                We have examined the impacts of the                     This interim final rule extends the                and Budget under the Paperwork
                                             interim final rule under Executive Order                compliance date to May 7, 2018, for the               Reduction Act of 1995 is not required.
                                             12866, Executive Order 13563,                           final rule requiring disclosure of certain
                                             Executive Order 13771, the Regulatory                   nutrition information for standard menu               V. Analysis of Environmental Impact
                                             Flexibility Act (5 U.S.C. 601–612), and                 items in certain restaurants and similar                We have determined under 21 CFR
                                             the Unfunded Mandates Reform Act of                     retail food establishments. The principal             25.30(k) that this action is of a type that
                                             1995 (Pub. L. 104–4). Executive Orders                  benefit of this interim final rule will be            does not individually or cumulatively
                                             12866 and 13563 direct us to assess all                 the reduction in costs to covered                     have a significant effect on the human
                                             costs and benefits of available regulatory              establishments associated with                        environment. Therefore, neither an
                                             alternatives and, when regulation is                    extending the compliance date by one                  environmental assessment nor an
                                             necessary, to select regulatory                         year. The total annualized benefit (i.e.,             environmental impact statement is
                                             approaches that maximize net benefits                   cost savings) of this interim final rule,             required.
                                             (including potential economic,                          using a 3-percent discount rate over 20
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                                             environmental, public health and safety,                years, would be from $2 to $6 million;                VI. Reference
                                             and other advantages; distributive                      with a 7-percent discount rate, the                     The following reference is on display
                                             impacts; and equity). Executive Order                   annualized benefit would be $3 to $8                  in the Division of Dockets Management
                                             13771 requires that the costs associated                million. The principal cost of this                   (see ADDRESSES) and is available for
                                             with new regulations shall ‘‘be offset by               interim final rule will be the reduction              viewing by interested persons between
                                             the elimination of existing costs                       in benefits to consumers associated with              9 a.m. and 4 p.m., Monday through
                                             associated with at least two prior                      extending the compliance date by one                  Friday; it is also available electronically


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                                                                 Federal Register / Vol. 82, No. 85 / Thursday, May 4, 2017 / Rules and Regulations                                         20829

                                             at https://www.regulations.gov. FDA has                 delivery service acceptance receipt is on             submission. You should submit two
                                             verified the Web site addresses, as of the              or before that date.                                  copies total. One copy will include the
                                             date this document publishes in the                                                                           information you claim to be confidential
                                                                                                     Electronic Submissions
                                             Federal Register, but Web sites are                                                                           with a heading or cover note that states
                                             subject to change over time.                              Submit electronic objections in the                 ‘‘THIS DOCUMENT CONTAINS
                                                                                                     following way:                                        CONFIDENTIAL INFORMATION.’’ We
                                             1. FDA, interim economic impact analysis for
                                                                                                       • Federal eRulemaking Portal:                       will review this copy, including the
                                                 ‘‘Food Labeling; Nutrition Labeling of
                                                 Standard Menu Items in Restaurants and              https://www.regulations.gov. Follow the               claimed confidential information, in our
                                                 Similar Retail Food Establishments;                 instructions for submitting comments.                 consideration of comments. The second
                                                 Extension of Compliance Date; Request               Objections submitted electronically,                  copy, which will have the claimed
                                                 for Comment,’’ April 2017. Available at:            including attachments, to https://                    confidential information redacted/
                                                 http://www.fda.gov/AboutFDA/                        www.regulations.gov will be posted to                 blacked out, will be available for public
                                                 ReportsManualsForms/Reports/                        the docket unchanged. Because your                    viewing and posted on https://
                                                 EconomicAnalyses.                                   objection will be made public, you are                www.regulations.gov. Submit both
                                               Dated: May 1, 2017.                                   solely responsible for ensuring that your             copies to the Division of Dockets
                                             Anna K. Abram,                                          objection does not include any                        Management. If you do not wish your
                                             Deputy Commissioner for Policy, Planning,               confidential information that you or a                name and contact information to be
                                             Legislation, and Analysis.                              third party may not wish to be posted,                made publicly available, you can
                                             [FR Doc. 2017–09029 Filed 5–1–17; 4:15 pm]              such as medical information, your or                  provide this information on the cover
                                             BILLING CODE 4164–01–P
                                                                                                     anyone else’s Social Security number, or              sheet and not in the body of your
                                                                                                     confidential business information, such               comments and you must identify this
                                                                                                     as a manufacturing process. Please note               information as ‘‘confidential.’’ Any
                                             DEPARTMENT OF HEALTH AND                                that if you include your name, contact                information marked as ‘‘confidential’’
                                             HUMAN SERVICES                                          information, or other information that                will not be disclosed except in
                                                                                                     identifies you in the body of your                    accordance with 21 CFR 10.20 and other
                                             Food and Drug Administration                            objection, that information will be                   applicable disclosure law. For more
                                                                                                     posted on https://www.regulations.gov.                information about FDA’s posting of
                                             21 CFR Part 177                                           • If you want to submit an objection                comments to public dockets, see 80 FR
                                                                                                     with confidential information that you                56469, September 18, 2015, or access
                                             [Docket No. FDA–2016–F–1805]                            do not wish to be made available to the               the information at: https://www.gpo.gov/
                                                                                                     public, submit the objection as a                     fdsys/pkg/FR-2015-09-18/pdf/2015-
                                             Indirect Food Additives: Polymers                       written/paper submission and in the                   23389.pdf.
                                             AGENCY:    Food and Drug Administration,                manner detailed (see ‘‘Written/Paper
                                                                                                     Submissions’’ and ‘‘Instructions’’).                     Docket: For access to the docket to
                                             HHS.                                                                                                          read background documents or the
                                             ACTION:   Final rule.                                   Written/Paper Submissions                             electronic and written/paper comments
                                                                                                        Submit written/paper submissions as                received, go to https://
                                             SUMMARY:   The Food and Drug                                                                                  www.regulations.gov and insert the
                                             Administration (FDA or we) is                           follows:
                                             amending the food additive regulations                     • Mail/Hand delivery/Courier (for                  docket number, found in brackets in the
                                                                                                     written/paper submissions): Division of               heading of this document, into the
                                             to no longer provide for the use of                                                                           ‘‘Search’’ box and follow the prompts
                                             potassium perchlorate as an additive in                 Dockets Management (HFA–305), Food
                                                                                                     and Drug Administration, 5630 Fishers                 and/or go to the Division of Dockets
                                             closure-sealing gaskets for food                                                                              Management, 5630 Fishers Lane, Rm.
                                             containers because this use has been                    Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                        • For written/paper objections                     1061, Rockville, MD 20852.
                                             abandoned. This action is in response to
                                                                                                     submitted to the Division of Dockets                  FOR FURTHER INFORMATION CONTACT:
                                             a petition filed by Keller and Heckman
                                                                                                     Management, FDA will post your                        Vivian Gilliam, Center for Food Safety
                                             LLP on behalf of the Society of the
                                                                                                     objection, as well as any attachments,                and Applied Nutrition (HFS–275), Food
                                             Plastics Industry, Inc.
                                                                                                     except for information submitted,                     and Drug Administration, 5001 Campus
                                             DATES: This rule is effective May 4,                    marked and identified, as confidential,
                                             2017. Submit either electronic or                                                                             Dr., College Park, MD 20740–3835, 240–
                                                                                                     if submitted as detailed in                           402–1193.
                                             written objections and requests for a                   ‘‘Instructions.’’
                                             hearing on the final rule by June 5,                       Instructions: All submissions received             SUPPLEMENTARY INFORMATION:
                                             2017. See the ADDRESSES section, and                    must include the Docket No. FDA–
                                             SUPPLEMENTARY INFORMATION section VIII
                                                                                                                                                           I. Background
                                                                                                     2016–F–1805 for ‘‘Indirect Food
                                             of this document, for further                           Additives: Polymers.’’ Received                         In a document published in the
                                             information on the filing of objections.                objections, those filed in a timely                   Federal Register of June 30, 2016 (81 FR
                                             ADDRESSES: You may submit objections                    manner (see DATES), will be placed in                 42585), we announced that we filed a
                                             and requests for a hearing as follows.                  the docket and, except for those                      food additive petition (FAP 6B4816)
                                             Please note that late, untimely filed                   submitted as ‘‘Confidential                           submitted on behalf of Society of the
                                             objections will not be considered.                      Submissions,’’ publicly viewable at                   Plastics Industry, Inc. (SPI) by Keller
                                             Electronic objections must be submitted                 https://www.regulations.gov or at the                 and Heckman LLP, 1001 G Street NW.,
                                             on or before June 5, 2017. The https://                 Division of Dockets Management                        Suite 500 West, Washington, DC 20001.
pmangrum on DSK3GDR082PROD with RULES




                                             www.regulations.gov electronic filing                   between 9 a.m. and 4 p.m., Monday                     The petition proposed to amend
                                             system will accept comments until                       through Friday.                                       § 177.1210 (21 CFR 177.1210) to no
                                             midnight Eastern Time at the end of                        • Confidential Submissions—To                      longer provide for the use of potassium
                                             June 5, 2017. Objections received by                    submit an objection with confidential                 perchlorate as an additive in closure-
                                             mail/hand delivery/courier (for written/                information that you do not wish to be                sealing gaskets for food containers
                                             paper submissions) will be considered                   made publicly available, submit your                  because the use has been intentionally
                                             timely if they are postmarked or the                    objections only as a written/paper                    and permanently abandoned.


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Document Created: 2017-05-04 01:48:57
Document Modified: 2017-05-04 01:48:57
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
ActionInterim final rule; extension of compliance date; request for comments.
DatesCompliance date: As of May 4, 2017, the compliance date for covered establishments set out in the final rule published December 1, 2014 (79 FR 71156), and extended in final rules published on July 10, 2015 (80 FR 39675) and December 30, 2016 (81 FR 96364), is further extended. Covered establishments must comply with the rule published December 1, 2014 (79 FR 71156), by May 7, 2018.
ContactFelicia B. Billingslea, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371.
FR Citation82 FR 20825 
RIN Number0910-ZA48
CFR Citation21 CFR 101
21 CFR 11

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