A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods-Part II (Menu Labeling Requirements in Accordance With the Patient Protection Affordable Care Act of 2010); Guidance for Industry; Availability, 27067-27068 [2016-10462]
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Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Proposed Rules
§ 421.152 Time limits to provide evidence
supporting a request for relief.
(a) An applicant has 30 days after the
date on which he or she submits a
request for relief under § 421.150 to
provide us with the evidence required
under § 421.151(b)(1) through (3).
(b) An applicant may ask us for more
time to submit evidence under
paragraph (a) of this section. The
request for an extension of time must be
in writing and must give the reasons
why the applicant cannot give us the
required evidence within the 30-day
period. If the applicant shows us that he
or she had good cause for missing the
deadline, we will extend the 30-day
period. To determine whether good
cause exists, we use the standards
explained in § 404.911 of this chapter.
(c) If the applicant does not submit
the evidence required under § 421.151
within the 30-day period provided
under paragraph (a) of this section, or
within the extended period provided
under paragraph (b) of this section, we
will dismiss the request for relief.
§ 421.155
relief.
Burden of proof in requests for
An applicant who requests relief
under § 421.150 must prove that he or
she is not likely to act in a manner
dangerous to public safety and that
granting relief from the prohibitions
imposed by 18 U.S.C. 922(d)(4) and
(g)(4) will not be contrary to the public
interest.
§ 421.160
Granting a request for relief.
(a) We may grant an applicant’s
request for relief if the applicant
establishes, to our satisfaction, that the
circumstances regarding the disability,
and the applicant’s record and
reputation, are such that the applicant
will not be likely to act in a manner
dangerous to public safety, and that the
granting of the relief would not be
contrary to the public interest.
(b) We will not grant an applicant’s
request for relief if the applicant is
prohibited from possessing firearms by
the law of the State in which the
applicant resides.
ehiers on DSK5VPTVN1PROD with PROPOSALS
§ 421.165
Actions on a request for relief.
(a) After the applicant submits the
evidence required under § 421.151 and
any other evidence he or she wants us
to consider, we will review the
evidence, which will include any
evidence from our records that we
determine is appropriate. A decision
maker who was not involved in making
the finding that the applicant’s benefit
payments be made through a
representative payee will review the
evidence and act on the request for
VerDate Sep<11>2014
14:43 May 04, 2016
Jkt 238001
relief. We will notify the applicant in
writing of our action regarding the
request for relief.
(b) If we deny an applicant’s request
for relief, we will send the applicant a
written notice that explains the reasons
for our action. We will also inform the
applicant that if he or she is dissatisfied
with our action, he or she has 60 days
from the date he or she receives the
notice of our action to file a petition
seeking judicial review in Federal
district court.
(c) If we grant an applicant’s request
for relief, we will send the applicant a
written notice that explains the reasons
for our action. We will inform the
applicant that we will notify the
Attorney General, or his or her delegate,
that the individual’s record should be
removed from the NICS database. We
will also notify the applicant that he or
she is no longer prohibited under 18
U.S.C. 922(g)(4) from purchasing,
possessing, receiving, shipping, or
transporting firearms or ammunition
based on the prohibition that we granted
the applicant relief from. We will notify
the Attorney General, or his or her
delegate, that the applicant’s record
should be removed from the NICS
database after we grant the applicant’s
request for relief.
(d) The NIAA requires us to process
each application for relief not later than
365 days after the date we receive it. If
we fail to resolve an application for
relief within that period for any reason,
including a lack of appropriated funds,
we will be deemed to have denied the
relief request without cause. In
accordance with the NIAA, judicial
review of any petition brought under
this paragraph shall be de novo.
§ 421.170 Judicial review following a
denial of a request for relief.
(a) Judicial review of our action
denying an applicant’s request for
review is available according to the
standards contained in 18 U.S.C. 925(c).
An individual for whom we have
denied an application for relief may file
a petition for judicial review with the
United States district court for the
district in which he or she resides.
(b) If, on judicial review, a Federal
court grants an applicant’s request for
relief, we will notify the Attorney
General that the individual’s record
should be removed from the NICS
database.
[FR Doc. 2016–10424 Filed 5–4–16; 8:45 am]
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27067
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 11 and 101
[Docket No. FDA–2011–F–0172]
A Labeling Guide for Restaurants and
Retail Establishments Selling AwayFrom-Home Foods—Part II (Menu
Labeling Requirements in Accordance
With the Patient Protection Affordable
Care Act of 2010); Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a
guidance for industry entitled ‘‘A
Labeling Guide for Restaurants and
Retail Establishments Selling AwayFrom-Home Foods—Part II (Menu
Labeling Requirements in Accordance
With FDA’s Food Labeling
Regulations).’’ The guidance will help
certain restaurants and similar retail
food establishments comply with the
menu labeling requirements, including
the requirements to provide calorie and
other nutrition information for standard
menu items, including food on display
and self-service food. In addition, we
note that enforcement of the Nutrition
Labeling of Standard Menu Items in
Restaurants and Similar Retail Food
Establishments final rule will
commence 1 year after the date on
which this document publishes in the
Federal Register.
DATES: Submit either electronic or
written comments on FDA guidances at
any time.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
E:\FR\FM\05MYP1.SGM
05MYP1
27068
Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Proposed Rules
ehiers on DSK5VPTVN1PROD with PROPOSALS
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 ‘‘A Labeling Guide for
Restaurants and Retail Establishments
Selling Away-From-Home Foods—Part
II (Menu Labeling Requirements in
Accordance with 21 CFR 101.11).’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
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.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the 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
VerDate Sep<11>2014
14:43 May 04, 2016
Jkt 238001
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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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.
Submit written requests for single
copies of the guidance to Office of
Nutrition and Food Labeling, Center for
Food Safety and Applied Nutrition
(HFS–820), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send
two self-addressed adhesive labels to
assist that office in processing your
request. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance.
FOR FURTHER INFORMATION CONTACT:
Ashley Rulffes, Center for Food Safety
and Applied Nutrition (HFS–820), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–2371.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a guidance for industry, entitled ‘‘A
Labeling Guide for Restaurants and
Retail Establishments Selling AwayFrom-Home Foods—Part II (Menu
Labeling Requirements in Accordance
with 21 CFR 101.11).’’ We are issuing
this guidance consistent with our good
guidance practices regulation (21 CFR
10.115). The guidance represents the
current thinking of FDA on this topic.
It does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
In the Federal Register of September
16, 2015 (80 FR 55564), we announced
the availability of a draft guidance for
industry entitled ‘‘A Labeling Guide for
Restaurants and Retail Establishments
Selling Away-From-Home Foods—Part
II (Menu Labeling Requirements in
PO 00000
Frm 00020
Fmt 4702
Sfmt 9990
Accordance with 21 CFR 101.11).’’ We
invited comment on the draft guidance
by November 2, 2015.
We received many comments on the
draft guidance and have modified the
guidance as appropriate by revising
several questions and answers and
adding new questions and answers.
(The new questions and answers are at
5.5, 5.7, 5.11, 5.17, 5.35, 7.11, and 7.12.)
Changes to the guidance include
additional examples and explanations to
clarify how the provisions of the rule
would apply to various situations. The
guidance announced in this document
finalizes the draft guidance dated
September 2015.
II. Enforcement
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. As a
result, enforcement of the final rule
published December 1, 2014 (79 FR
71156), will commence May 5, 2017.
III. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
§ 101.11(d), (c)(3), and (b)(2) have been
approved under OMB control no. 0910–
0783.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/FoodGuidances* or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
Dated: April 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–10462 Filed 5–4–16; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\05MYP1.SGM
05MYP1
Agencies
[Federal Register Volume 81, Number 87 (Thursday, May 5, 2016)]
[Proposed Rules]
[Pages 27067-27068]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10462]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 11 and 101
[Docket No. FDA-2011-F-0172]
A Labeling Guide for Restaurants and Retail Establishments
Selling Away-From-Home Foods--Part II (Menu Labeling Requirements in
Accordance With the Patient Protection Affordable Care Act of 2010);
Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a guidance for industry entitled ``A Labeling Guide for
Restaurants and Retail Establishments Selling Away-From-Home Foods--
Part II (Menu Labeling Requirements in Accordance With FDA's Food
Labeling Regulations).'' The guidance will help certain restaurants and
similar retail food establishments comply with the menu labeling
requirements, including the requirements to provide calorie and other
nutrition information for standard menu items, including food on
display and self-service food. In addition, we note that enforcement of
the Nutrition Labeling of Standard Menu Items in Restaurants and
Similar Retail Food Establishments final rule will commence 1 year
after the date on which this document publishes in the Federal
Register.
DATES: Submit either electronic or written comments on FDA guidances at
any time.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note
[[Page 27068]]
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 ``A Labeling Guide for Restaurants and Retail
Establishments Selling Away-From-Home Foods--Part II (Menu Labeling
Requirements in Accordance with 21 CFR 101.11).'' Received comments
will be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the 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.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the 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.fda.gov/regulatoryinformation/dockets/default.htm.
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.
Submit written requests for single copies of the guidance to Office
of Nutrition and Food Labeling, Center for Food Safety and Applied
Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels
to assist that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance.
FOR FURTHER INFORMATION CONTACT: Ashley Rulffes, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of a guidance for industry,
entitled ``A Labeling Guide for Restaurants and Retail Establishments
Selling Away-From-Home Foods--Part II (Menu Labeling Requirements in
Accordance with 21 CFR 101.11).'' We are issuing this guidance
consistent with our good guidance practices regulation (21 CFR 10.115).
The guidance represents the current thinking of FDA on this topic. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.
In the Federal Register of September 16, 2015 (80 FR 55564), we
announced the availability of a draft guidance for industry entitled
``A Labeling Guide for Restaurants and Retail Establishments Selling
Away-From-Home Foods--Part II (Menu Labeling Requirements in Accordance
with 21 CFR 101.11).'' We invited comment on the draft guidance by
November 2, 2015.
We received many comments on the draft guidance and have modified
the guidance as appropriate by revising several questions and answers
and adding new questions and answers. (The new questions and answers
are at 5.5, 5.7, 5.11, 5.17, 5.35, 7.11, and 7.12.) Changes to the
guidance include additional examples and explanations to clarify how
the provisions of the rule would apply to various situations. The
guidance announced in this document finalizes the draft guidance dated
September 2015.
II. Enforcement
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. As a result, enforcement of the final rule published
December 1, 2014 (79 FR 71156), will commence May 5, 2017.
III. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in Sec. 101.11(d), (c)(3), and (b)(2) have
been approved under OMB control no. 0910-0783.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/FoodGuidances* or https://www.regulations.gov.
Use the FDA Web site listed in the previous sentence to find the most
current version of the guidance.
Dated: April 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-10462 Filed 5-4-16; 8:45 am]
BILLING CODE 4164-01-P