Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date, 96364-96366 [2016-31597]
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96364
Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Rules and Regulations
(c) Applicability
This AD applies to Safran Helicopter
Engines, S.A. Arriel 2B, 2B1, 2C, 2C1, 2C2,
2D, 2E, 2S1, and 2S2 turboshaft engines with
an engine accessory gearbox (AGB), part
number 0292120650, with a machined front
casing.
srobinson on DSK5SPTVN1PROD with RULES
(d) Unsafe Condition
This AD was prompted by a report of an
uncommanded in-flight shutdown (IFSD) of
an Arriel 2S2 engine caused by rupture of the
41-tooth gear, which forms part of the bevel
gear in the engine AGB. We are issuing this
AD to prevent failure of the engine AGB,
uncommanded IFSD, damage to the engine,
and damage to the helicopter.
(e) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(1) Initial Wear Inspection
(i) For all affected engines, perform a wear
inspection of the engine AGB cover before
the engine AGB, module M01, exceeds 850
engine hours (EH) since new or since last
overhaul (SLO), or within 50 EHs after April
14, 2016, or before the next flight after the
effective date of this AD, whichever occurs
latest.
(ii) Reserved.
(2) Repetitive Wear Inspection Intervals
(i) For Arriel 2E engines, repeat the engine
AGB cover wear inspection within every 800
EH since last inspection (SLI).
(ii) For all affected engines, except for
Arriel 2E engines, repeat the engine AGB
cover wear inspection within every 600 EH
SLI.
(3) Inspection Criteria
(i) Use paragraph 2.4.2 of Safran Helicopter
Engines, S.A. Mandatory Service Bulletin
(MSB) No. 292 72 2861, Version D, dated
September 23, 2016, to do the inspections
required by paragraphs (e)(1) and (e)(2) of
this AD.
(ii) Reserved.
(4) Corrective Actions Based on the Results
of the Most Recent Wear Inspection
(i) If the wear measured from the most
recent wear inspection is 0.15 mm or less, no
further action is required. However, you must
still comply with the repetitive inspection
requirements of paragraph (e)(2) of this AD.
(ii) If the most recent wear inspection was
performed while the engine was in service,
and the wear is greater than 0.15 mm, do the
following:
(A) If the wear measured from the most
recent wear inspection is greater than 0.15
mm, but 0.30 mm or less, remove the engine
AGB from service within 200 EH SLI and
replace with a part eligible for installation.
(B) If the wear measured from the most
recent wear inspection is greater than 0.30
mm, but 0.40 mm or less, remove the engine
AGB from service within 25 EH SLI and
replace with a part eligible for installation.
(C) If the wear measured from the most
recent wear inspection is greater than 0.40
mm, remove the engine AGB from service
before further flight and replace with a part
eligible for installation.
(iii) If the most recent wear inspection was
performed on the engine during an engine
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18:11 Dec 29, 2016
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shop visit, and the wear is greater than 0.15
mm, remove the engine AGB before further
flight and replace with a part eligible for
installation.
(f) Credit for Previous Action
If you have previously performed a wear
inspection of the engine AGB cover prior to
the effective date of this AD in accordance
with the instructions given in Turbomeca
MSB No. 292 72 2861, Version C, dated
March 9, 2016, or Turbomeca MSB No. 292
72 2861, Version B, dated February 2, 2016,
then you may take credit for that wear
inspection as the ‘‘most recent’’ wear
inspection for the purposes of paragraph
(e)(4) of this AD.
(g) Definition
For the purpose of this AD, an engine shop
visit is defined as the induction of an engine
into the shop for maintenance involving the
separation of any major mating engine
flanges, except that the separation of engine
flanges solely for the purposes of
transportation without subsequent engine
maintenance does not constitute an engine
shop visit.
(h) Alternative Methods of Compliance
(AMOCs)
The Manager, Engine Certification Office,
FAA, may approve AMOCs for this AD. Use
the procedures found in 14 CFR 39.19 to
make your request. You may email your
request to: ANE-AD-AMOC@faa.gov.
(i) Related Information
(1) For more information about this AD,
contact Philip Haberlen, Aerospace Engineer,
Engine Certification Office, FAA, Engine &
Propeller Directorate, 1200 District Avenue,
Burlington, MA 01803; phone: 781–238–
7770; fax: 781–238–7199; email:
philip.haberlen@faa.gov.
(2) Refer to MCAI European Aviation
Safety Agency AD 2016–0055R1, dated
October 11, 2016, for more information. You
may examine the MCAI in the AD docket on
the Internet at https://www.regulations.gov/
document?D=FAA-2015-3753-0006.
(j) Material Incorporated by Reference
(1) The Director of the Federal Register
approved the incorporation by reference
(IBR) of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR
part 51.
(2) You must use this service information
as applicable to do the actions required by
this AD, unless the AD specifies otherwise.
(i) Safran Helicopter Engines, S.A.
Mandatory Service Bulletin No. 292 72 2861,
Version D, dated September 23, 2016.
(ii) Reserved.
(3) For Safran Helicopter Engines, S.A.
service information identified in this AD,
contact Safran Helicopter Engines, S.A.
40220 Tarnos, France; phone: 33 0 5 59 74
40 00; fax: 33 0 5 59 74 45 15.
(4) You may view this service information
at FAA, Engine & Propeller Directorate, 1200
District Avenue, Burlington, MA. For
information on the availability of this
material at the FAA, call 781–238–7125.
(5) You may view this service information
at the National Archives and Records
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Administration (NARA). For information on
the availability of this material at NARA, call
202–741–6030, or go to: https://
www.archives.gov/federal-register/cfr/ibrlocations.html.
Issued in Burlington, Massachusetts, on
November 29, 2016.
Colleen M. D’Alessandro,
Manager, Engine & Propeller Directorate,
Aircraft Certification Service.
[FR Doc. 2016–31695 Filed 12–29–16; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 11 and 101
[Docket No. FDA–2011–F–0172]
RIN 0910–AG57
Food Labeling; Nutrition Labeling of
Standard Menu Items in Restaurants
and Similar Retail Food
Establishments; Extension of
Compliance Date
AGENCY:
Food and Drug Administration,
HHS.
Final rule; extension of
compliance date.
ACTION:
The Food and Drug
Administration (FDA or we) is
extending the compliance date for the
final rule requiring disclosure of certain
nutrition information for standard menu
items in certain restaurants and retail
food establishments. The final rule
appeared in the Federal Register of
December 1, 2014, and on May 5, 2016,
we stated in the Federal Register that
the enforcement of the final rule would
begin on May 5, 2017. We are taking this
action to clarify and confirm that the
compliance date for the final rule is May
5, 2017.
DATES: Effective date: This final rule is
effective December 30, 2016.
Compliance date: Covered
establishments must comply with the
rule published December 1, 2014 (79 FR
71156) by May 5, 2017.
FOR FURTHER INFORMATION CONTACT:
Ashley Rulffes, Center for Food Safety
and Applied Nutrition (HFS–820), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240–402–
2371, email: ashley.rulffes@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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
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Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Rules and Regulations
items in certain restaurants and retail
food establishments. The final rule,
which is now codified at § 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
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 § 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
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18:11 Dec 29, 2016
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voluntarily registered to be covered
under § 101.11(d).
II. Extending the Compliance Date
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. The final rule
requirements are intended to ensure that
consumers are provided accurate, clear,
and consistent nutrition information for
foods sold in covered establishments in
a direct and accessible manner to enable
consumers to make informed and
healthful dietary choices. We stated in
that extension that allowing adequate
time for covered establishments to fully
implement the final rule’s requirements,
as described in the requests, would help
accomplish the primary objective of the
final rule and is in the public interest.
On December 18, 2015, the President
signed the Consolidated Appropriations
Act, 2016 (Pub. L. 114–113). Section 747
of the Consolidated Appropriations Act
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 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). While FDA
made clear that we would not begin
enforcing menu labeling requirements
prior to May 5, 2017, we did not at that
time formally make a change to the
compliance date through rulemaking.
Therefore, through this final rule, we
are clarifying and confirming that the
compliance date for the final rule
entitled ‘‘Food Labeling; Nutrition
Labeling of Standard Menu Items in
Restaurants and Similar Retail Food
Establishments,’’ codified at § 101.11, is
May 5, 2017.
III. Economic Analysis of Impacts
We have examined the impacts of the
final rule under Executive Order 12866,
Executive Order 13563, the Regulatory
Flexibility Act (5 U.S.C. 601–612), and
the Unfunded Mandates Reform Act of
1995 (Pub. L. 104–4). Executive Orders
12866 and 13563 direct us to assess all
costs and benefits of available regulatory
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96365
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). We have
developed a comprehensive Economic
Analysis of Impacts that assesses the
impacts of the final rule. We believe that
this final rule is not a 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 provides more
flexibility 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) (menu labeling final rule), we
certify that the 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 $146 million, using the
most current (2015) Implicit Price
Deflator for the Gross Domestic Product.
This final rule would not result in an
expenditure in any year that meets or
exceeds this amount.
This rule extends the compliance date
of the menu labeling final rule by
approximately 5 months: From
December 1, 2016, to May 5, 2017. The
estimated costs and benefits accrued in
any given year that the menu labeling
rule is in effect, relative to the first year
of compliance, does not change;
however, because the compliance date
is being extended by 5 months, the
discounted value of both total costs and
total benefits decreases. The principal
benefit of this final rule will be the
reduction in costs associated with
extending the compliance date by 5
months. The principal cost of this final
rule will be the reduction in benefits
associated with extending the
compliance date by 5 months.
Extending the compliance date of the
menu labeling final rule by 5 months
reduces the annualized net benefits
(discounted at 3 percent) approximately
3 percent, from $457 million to $442
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Federal Register / Vol. 81, No. 251 / Friday, December 30, 2016 / Rules and Regulations
million. While average annualized net
benefits decrease by $15 million, they
are still positive. We note that this
extension of the compliance date will
not have an actual effect on the cost or
benefits of the menu labeling rule,
because, under section 747 of the
Consolidated Appropriations Act, 2016,
FDA was not authorized to spend funds
to ‘‘implement, administer, or enforce’’
the rule until May 5, 2017, a year after
the date on which published a Level 1
guidance with respect to nutrition
labeling of standard menu items in
restaurants and similar retail food
establishments. We are presenting the
benefits and costs of the menu labeling
final rule, which takes effect according
to the dates in this rule.
The full analysis of economic impacts
is available in the docket for this final
rule (Ref. 1) and at https://www.fda.gov/
AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/default.htm.
IV. Paperwork Reduction Act
This final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
V. 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.
srobinson on DSK5SPTVN1PROD with RULES
VI. Reference
The following reference is on display
in the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and is
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; it is also
available electronically 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, ‘‘Food Labeling; Nutrition Labeling
of Standard Menu Items in Restaurants
and Similar Retail Food Establishments;
Extension of Compliance Date,’’ 2015.
Available at: https://www.fda.gov/
AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/.
Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–31597 Filed 12–29–16; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA–2014–N–1205]
Orthopedic Devices; Reclassification
of Pedicle Screw Systems, Henceforth
To Be Known as Thoracolumbosacral
Pedicle Screw Systems, Including
Semi-Rigid Systems
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA) is issuing a final
order to reclassify pedicle screw
systems, a preamendments class III
device (regulated under product code
NKB), into class II (special controls),
renaming the device
‘‘thoracolumbosacral pedicle screw
systems’’; reclassify dynamic
stabilization systems, a subtype of
pedicle screw systems regulated under
product code NQP when used as an
adjunct to fusion, into class II (special
controls), renaming this device subtype
‘‘semi-rigid systems’’; and clarify the
device identification of pedicle screw
systems to more clearly delineate
between rigid pedicle screw systems
and semi-rigid systems. FDA is
finalizing this action based on a
reevaluation of information pertaining
to the device type.
DATES: This order is effective on
December 30, 2016. See further
discussion in section V,
‘‘Implementation Strategy.’’
FOR FURTHER INFORMATION CONTACT:
Constance P. Soves, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1437, Silver Spring,
MD 20993, 301–796–6951,
Constance.Soves@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background—Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Medical Device Amendments of 1976
(the 1976 amendments) (Pub. L. 94–
295), the Safe Medical Devices Act of
1990 (Pub. L. 101–629), the Food and
Drug Administration Modernization Act
of 1997 (Pub. L. 105–115), the Medical
Device User Fee and Modernization Act
of 2002 (Pub. L. 107–250), the Medical
Devices Technical Corrections Act (Pub.
L. 108–214), the Food and Drug
Administration Amendments Act of
2007 (Pub. L. 110–85), and the Food and
PO 00000
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Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112–
144), among other amendments,
established a comprehensive system for
the regulation of medical devices
intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c)
established three categories (classes) of
devices, reflecting the regulatory
controls needed to provide reasonable
assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Under section 513(d) of the FD&C Act,
devices that were in commercial
distribution before the enactment of the
1976 amendments, May 28, 1976
(generally referred to as preamendments
devices), are classified after FDA has: (1)
Received a recommendation from a
device classification panel (an FDA
advisory committee); (2) published the
panel’s recommendation for comment,
along with a proposed regulation
classifying the device; and (3) published
a final regulation classifying the device.
FDA has classified most
preamendments devices under these
procedures.
Devices that were not in commercial
distribution prior to May 28, 1976
(generally referred to as
‘‘postamendments devices’’) are
automatically classified by section
513(f) of the FD&C Act into class III
without any FDA rulemaking process.
Those devices remain in class III and
require premarket approval unless, and
until, the device is reclassified into class
I or II or FDA issues an order finding the
device to be substantially equivalent, in
accordance with section 513(i) of the
FD&C Act, to a predicate device that
does not require premarket approval.
The Agency determines whether new
devices are substantially equivalent to
predicate devices by means of
premarket notification procedures in
section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and part 807 (21 Code of
Federal Regulations (CFR) part 807).
A preamendments device that has
been classified into class III and devices
found substantially equivalent by means
of premarket notification (510(k))
procedures to such a preamendments
device or to a device within that type
(both the preamendments and
substantially equivalent devices are
referred to as preamendments class III
devices) may be marketed without
submission of a premarket approval
application (PMA) until FDA issues a
final order under section 515(b) of the
FD&C Act (21 U.S.C. 360e(b)) requiring
premarket approval.
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]]>Agencies
[Federal Register Volume 81, Number 251 (Friday, December 30, 2016)]
[Rules and Regulations]
[Pages 96364-96366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31597]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 11 and 101
[Docket No. FDA-2011-F-0172]
RIN 0910-AG57
Food Labeling; Nutrition Labeling of Standard Menu Items in
Restaurants and Similar Retail Food Establishments; Extension of
Compliance Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; extension of compliance date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is extending the
compliance date for the final rule requiring disclosure of certain
nutrition information for standard menu items in certain restaurants
and retail food establishments. The final rule appeared in the Federal
Register of December 1, 2014, and on May 5, 2016, we stated in the
Federal Register that the enforcement of the final rule would begin on
May 5, 2017. We are taking this action to clarify and confirm that the
compliance date for the final rule is May 5, 2017.
DATES: Effective date: This final rule is effective December 30, 2016.
Compliance date: Covered establishments must comply with the rule
published December 1, 2014 (79 FR 71156) by May 5, 2017.
FOR FURTHER INFORMATION CONTACT: Ashley Rulffes, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740, 240-402-2371, email:
ashley.rulffes@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of December 1, 2014 (79 FR 71156), we
published a final rule requiring disclosure of certain nutrition
information for standard menu
[[Page 96365]]
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 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. Extending the Compliance Date
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. The final
rule requirements are intended to ensure that consumers are provided
accurate, clear, and consistent nutrition information for foods sold in
covered establishments in a direct and accessible manner to enable
consumers to make informed and healthful dietary choices. We stated in
that extension that allowing adequate time for covered establishments
to fully implement the final rule's requirements, as described in the
requests, would help accomplish the primary objective of the final rule
and is in the public interest.
On December 18, 2015, the President signed the Consolidated
Appropriations Act, 2016 (Pub. L. 114-113). Section 747 of the
Consolidated Appropriations Act 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 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). While FDA made clear
that we would not begin enforcing menu labeling requirements prior to
May 5, 2017, we did not at that time formally make a change to the
compliance date through rulemaking.
Therefore, through this final rule, we are clarifying and
confirming that the compliance date for the final rule entitled ``Food
Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and
Similar Retail Food Establishments,'' codified at Sec. 101.11, is May
5, 2017.
III. Economic Analysis of Impacts
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct 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). We
have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. We believe that this final rule
is not a 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 provides more flexibility 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) (menu labeling
final rule), we certify that the 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 $146
million, using the most current (2015) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
This rule extends the compliance date of the menu labeling final
rule by approximately 5 months: From December 1, 2016, to May 5, 2017.
The estimated costs and benefits accrued in any given year that the
menu labeling rule is in effect, relative to the first year of
compliance, does not change; however, because the compliance date is
being extended by 5 months, the discounted value of both total costs
and total benefits decreases. The principal benefit of this final rule
will be the reduction in costs associated with extending the compliance
date by 5 months. The principal cost of this final rule will be the
reduction in benefits associated with extending the compliance date by
5 months. Extending the compliance date of the menu labeling final rule
by 5 months reduces the annualized net benefits (discounted at 3
percent) approximately 3 percent, from $457 million to $442
[[Page 96366]]
million. While average annualized net benefits decrease by $15 million,
they are still positive. We note that this extension of the compliance
date will not have an actual effect on the cost or benefits of the menu
labeling rule, because, under section 747 of the Consolidated
Appropriations Act, 2016, FDA was not authorized to spend funds to
``implement, administer, or enforce'' the rule until May 5, 2017, a
year after the date on which published a Level 1 guidance with respect
to nutrition labeling of standard menu items in restaurants and similar
retail food establishments. We are presenting the benefits and costs of
the menu labeling final rule, which takes effect according to the dates
in this rule.
The full analysis of economic impacts is available in the docket
for this final rule (Ref. 1) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
IV. Paperwork Reduction Act
This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.
V. 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 (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and is available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday; it
is also available electronically 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, ``Food Labeling; Nutrition Labeling of Standard Menu Items
in Restaurants and Similar Retail Food Establishments; Extension of
Compliance Date,'' 2015. Available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/.
Dated: December 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31597 Filed 12-29-16; 8:45 am]
BILLING CODE 4164-01-P
