81 FR 27067 - 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 87 (May 5, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 87 (May 5, 2016)
| Page Range | 27067-27068 | |
| FR Document | 2016-10462 |
[Federal Register Volume 81, Number 87 (Thursday, May 5, 2016)] [Proposed Rules] [Pages 27067-27068] From the Federal Register Online [www.thefederalregister.org] [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: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://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 http://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 http://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 http://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: http://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 http://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 http://www.fda.gov/FoodGuidances* or http://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
![Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Proposed Rules 27067
§ 421.152 Time limits to provide evidence relief. We will notify the applicant in DEPARTMENT OF HEALTH AND
supporting a request for relief. writing of our action regarding the HUMAN SERVICES
(a) An applicant has 30 days after the request for relief.
date on which he or she submits a Food and Drug Administration
(b) If we deny an applicant’s request
request for relief under § 421.150 to
for relief, we will send the applicant a 21 CFR Parts 11 and 101
provide us with the evidence required
written notice that explains the reasons
under § 421.151(b)(1) through (3). [Docket No. FDA–2011–F–0172]
(b) An applicant may ask us for more for our action. We will also inform the
time to submit evidence under applicant that if he or she is dissatisfied
A Labeling Guide for Restaurants and
paragraph (a) of this section. The with our action, he or she has 60 days
Retail Establishments Selling Away-
request for an extension of time must be from the date he or she receives the From-Home Foods—Part II (Menu
in writing and must give the reasons notice of our action to file a petition Labeling Requirements in Accordance
why the applicant cannot give us the seeking judicial review in Federal With the Patient Protection Affordable
required evidence within the 30-day district court. Care Act of 2010); Guidance for
period. If the applicant shows us that he (c) If we grant an applicant’s request Industry; Availability
or she had good cause for missing the for relief, we will send the applicant a
deadline, we will extend the 30-day AGENCY: Food and Drug Administration,
written notice that explains the reasons HHS.
period. To determine whether good for our action. We will inform the
cause exists, we use the standards ACTION: Notification of availability.
applicant that we will notify the
explained in § 404.911 of this chapter. Attorney General, or his or her delegate, SUMMARY: The Food and Drug
(c) If the applicant does not submit that the individual’s record should be Administration (FDA or we) is
the evidence required under § 421.151 removed from the NICS database. We announcing the availability of a
within the 30-day period provided guidance for industry entitled ‘‘A
will also notify the applicant that he or
under paragraph (a) of this section, or Labeling Guide for Restaurants and
she is no longer prohibited under 18
within the extended period provided Retail Establishments Selling Away-
U.S.C. 922(g)(4) from purchasing,
under paragraph (b) of this section, we From-Home Foods—Part II (Menu
will dismiss the request for relief. possessing, receiving, shipping, or
transporting firearms or ammunition Labeling Requirements in Accordance
§ 421.155 Burden of proof in requests for based on the prohibition that we granted With FDA’s Food Labeling
relief. the applicant relief from. We will notify Regulations).’’ The guidance will help
An applicant who requests relief certain restaurants and similar retail
the Attorney General, or his or her
under § 421.150 must prove that he or food establishments comply with the
delegate, that the applicant’s record
she is not likely to act in a manner menu labeling requirements, including
should be removed from the NICS
dangerous to public safety and that the requirements to provide calorie and
database after we grant the applicant’s other nutrition information for standard
granting relief from the prohibitions request for relief.
imposed by 18 U.S.C. 922(d)(4) and menu items, including food on display
(d) The NIAA requires us to process and self-service food. In addition, we
(g)(4) will not be contrary to the public
interest. each application for relief not later than note that enforcement of the Nutrition
365 days after the date we receive it. If Labeling of Standard Menu Items in
§ 421.160 Granting a request for relief. we fail to resolve an application for Restaurants and Similar Retail Food
(a) We may grant an applicant’s relief within that period for any reason, Establishments final rule will
request for relief if the applicant including a lack of appropriated funds, commence 1 year after the date on
establishes, to our satisfaction, that the we will be deemed to have denied the which this document publishes in the
circumstances regarding the disability, relief request without cause. In Federal Register.
and the applicant’s record and accordance with the NIAA, judicial DATES: Submit either electronic or
reputation, are such that the applicant review of any petition brought under written comments on FDA guidances at
will not be likely to act in a manner this paragraph shall be de novo. any time.
dangerous to public safety, and that the ADDRESSES: You may submit comments
granting of the relief would not be § 421.170 Judicial review following a as follows:
contrary to the public interest. denial of a request for relief.
(b) We will not grant an applicant’s Electronic Submissions
(a) Judicial review of our action
request for relief if the applicant is Submit electronic comments in the
denying an applicant’s request for
prohibited from possessing firearms by following way:
review is available according to the • Federal eRulemaking Portal: http://
the law of the State in which the standards contained in 18 U.S.C. 925(c).
applicant resides. www.regulations.gov. Follow the
An individual for whom we have instructions for submitting comments.
§ 421.165 Actions on a request for relief. denied an application for relief may file Comments submitted electronically,
(a) After the applicant submits the a petition for judicial review with the including attachments, to http://
evidence required under § 421.151 and United States district court for the www.regulations.gov will be posted to
any other evidence he or she wants us district in which he or she resides. the docket unchanged. Because your
to consider, we will review the (b) If, on judicial review, a Federal comment will be made public, you are
evidence, which will include any solely responsible for ensuring that your
ehiers on DSK5VPTVN1PROD with PROPOSALS
court grants an applicant’s request for
evidence from our records that we relief, we will notify the Attorney comment does not include any
determine is appropriate. A decision General that the individual’s record confidential information that you or a
maker who was not involved in making should be removed from the NICS third party may not wish to be posted,
the finding that the applicant’s benefit database. such as medical information, your or
payments be made through a anyone else’s Social Security number, or
[FR Doc. 2016–10424 Filed 5–4–16; 8:45 am]
representative payee will review the confidential business information, such
evidence and act on the request for BILLING CODE 4191–02–P as a manufacturing process. Please note
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![27068 Federal Register / Vol. 81, No. 87 / Thursday, May 5, 2016 / Proposed Rules
that if you include your name, contact comments and you must identify this Accordance with 21 CFR 101.11).’’ We
information, or other information that information as ‘‘confidential.’’ Any invited comment on the draft guidance
identifies you in the body of your information marked as ‘‘confidential’’ by November 2, 2015.
comments, that information will be will not be disclosed except in We received many comments on the
posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other draft guidance and have modified the
• If you want to submit a comment applicable disclosure law. For more guidance as appropriate by revising
with confidential information that you information about FDA’s posting of
do not wish to be made available to the several questions and answers and
comments to public dockets, see 80 FR adding new questions and answers.
public, submit the comment as a 56469, September 18, 2015, or access
written/paper submission and in the (The new questions and answers are at
the information at: http://www.fda.gov/
manner detailed (see ‘‘Written/Paper 5.5, 5.7, 5.11, 5.17, 5.35, 7.11, and 7.12.)
regulatoryinformation/dockets/
Submissions’’ and ‘‘Instructions’’). Changes to the guidance include
default.htm.
additional examples and explanations to
Written/Paper Submissions Docket: For access to the docket to
read background documents or the clarify how the provisions of the rule
Submit written/paper submissions as electronic and written/paper comments would apply to various situations. The
follows: received, go to http:// guidance announced in this document
• Mail/Hand delivery/Courier (for www.regulations.gov and insert the finalizes the draft guidance dated
written/paper submissions): Division of September 2015.
docket number, found in brackets in the
Dockets Management (HFA–305), Food
heading of this document, into the II. Enforcement
and Drug Administration, 5630 Fishers
‘‘Search’’ box and follow the prompts
Lane, Rm. 1061, Rockville, MD 20852. On December 18, 2015, the President
• For written/paper comments and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm. signed the Consolidated Appropriations
submitted to the Division of Dockets
Management, FDA will post your 1061, Rockville, MD 20852. Act, 2016 (Pub. L. 114–113). Section 747
comment, as well as any attachments, Submit written requests for single of the Consolidated Appropriations Act
except for information submitted, copies of the guidance to Office of states that none of the funds made
marked and identified, as confidential, Nutrition and Food Labeling, Center for available under the Consolidated
if submitted as detailed in Food Safety and Applied Nutrition Appropriations Act may be used to
‘‘Instructions.’’ (HFS–820), Food and Drug implement, administer, or enforce the
Instructions: All submissions received Administration, 5100 Paint Branch final rule entitled ‘‘Food Labeling;
must include the Docket No. FDA– Pkwy., College Park, MD 20740. Send Nutrition Labeling of Standard Menu
2011–F–0172 for ‘‘A Labeling Guide for two self-addressed adhesive labels to Items in Restaurants and Similar Retail
Restaurants and Retail Establishments assist that office in processing your Food Establishments’’ until 1 year after
Selling Away-From-Home Foods—Part request. See the SUPPLEMENTARY the date we publish a Level 1 guidance
II (Menu Labeling Requirements in INFORMATION section for electronic with respect to nutrition labeling of
Accordance with 21 CFR 101.11).’’ access to the guidance. standard menu items in restaurants and
Received comments will be placed in FOR FURTHER INFORMATION CONTACT: similar retail food establishments. As a
the docket and, except for those Ashley Rulffes, Center for Food Safety result, enforcement of the final rule
submitted as ‘‘Confidential and Applied Nutrition (HFS–820), Food published December 1, 2014 (79 FR
Submissions,’’ publicly viewable at and Drug Administration, 5100 Paint 71156), will commence May 5, 2017.
http://www.regulations.gov or at the Branch Pkwy., College Park, MD 20740,
Division of Dockets Management 240–402–2371. III. Paperwork Reduction Act of 1995
between 9 a.m. and 4 p.m., Monday SUPPLEMENTARY INFORMATION: This guidance refers to previously
through Friday. approved collections of information
• Confidential Submissions—To I. Background
found in FDA regulations. These
submit a comment with confidential We are announcing the availability of collections of information are subject to
information that you do not wish to be a guidance for industry, entitled ‘‘A review by the Office of Management and
made publicly available, submit your Labeling Guide for Restaurants and
Budget (OMB) under the Paperwork
comments only as a written/paper Retail Establishments Selling Away-
Reduction Act of 1995 (44 U.S.C. 3501–
submission. You should submit two From-Home Foods—Part II (Menu
3520). The collections of information in
copies total. One copy will include the Labeling Requirements in Accordance
§ 101.11(d), (c)(3), and (b)(2) have been
information you claim to be confidential with 21 CFR 101.11).’’ We are issuing
approved under OMB control no. 0910–
with a heading or cover note that states this guidance consistent with our good
‘‘THIS DOCUMENT CONTAINS guidance practices regulation (21 CFR 0783.
CONFIDENTIAL INFORMATION.’’ The 10.115). The guidance represents the IV. Electronic Access
Agency will review this copy, including current thinking of FDA on this topic.
the claimed confidential information, in It does not establish any rights for any Persons with access to the Internet
its consideration of comments. The person and is not binding on FDA or the may obtain the guidance at either http://
second copy, which will have the public. You can use an alternative www.fda.gov/FoodGuidances* or http://
claimed confidential information approach if it satisfies the requirements www.regulations.gov. Use the FDA Web
redacted/blacked out, will be available of the applicable statutes and site listed in the previous sentence to
for public viewing and posted on regulations. find the most current version of the
ehiers on DSK5VPTVN1PROD with PROPOSALS
http://www.regulations.gov. Submit In the Federal Register of September guidance.
both copies to the Division of Dockets 16, 2015 (80 FR 55564), we announced Dated: April 29, 2016.
Management. If you do not wish your the availability of a draft guidance for
Leslie Kux,
name and contact information to be industry entitled ‘‘A Labeling Guide for
made publicly available, you can Restaurants and Retail Establishments Associate Commissioner for Policy.
provide this information on the cover Selling Away-From-Home Foods—Part [FR Doc. 2016–10462 Filed 5–4–16; 8:45 am]
sheet and not in the body of your II (Menu Labeling Requirements in BILLING CODE 4164–01–P
VerDate Sep<11>2014 14:43 May 04, 2016 Jkt 238001 PO 00000 Frm 00020 Fmt 4702 Sfmt 9990 E:\FR\FM\05MYP1.SGM 05MYP1](https://thefederalregister.org/doc/81_FR_27154/page/2.svg)
Document Created: 2016-05-05 01:15:37
Document Modified: 2016-05-05 01:15:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification of availability. | |
| Dates | Submit either electronic or written comments on FDA guidances at any time. | |
| 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. | |
| FR Citation | 81 FR 27067 | |
| CFR Citation | 21
CFR
101 21 CFR 11 |
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