80 FR 55564 - 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Foods-Part II (Menu Labeling Requirements in Accordance with the Patient Protection Affordable Care Act of 2010); Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 179 (September 16, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 179 (September 16, 2015)
| Page Range | 55564-55564 | |
| FR Document | 2015-23232 |
[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)] [Proposed Rules] [Page 55564] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-23232] ======================================================================== Proposed Rules Federal Register ________________________________________________________________________ This section of the FEDERAL REGISTER contains notices to the public of the proposed issuance of rules and regulations. The purpose of these notices is to give interested persons an opportunity to participate in the rule making prior to the adoption of the final rules. ======================================================================== Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / Proposed Rules [[Page 55564]] 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Foods--Part II (Menu Labeling Requirements in Accordance with the Patient Protection Affordable Care Act of 2010); Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled ``A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods--Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11); Draft Guidance for Industry.'' The draft guidance, when finalized, will help certain restaurants and similar retail food establishments comply with the menu labeling requirements, including the requirements to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. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 2, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Office of Nutrition, Labeling, and Dietary Supplements (HFS-820), Center for Food Safety and Applied Nutrition, 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 draft guidance. Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Lynn Szybist, 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 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); Draft Guidance for Industry.'' We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent our current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. In the Federal Register of December 1, 2014 (79 FR 71156), we published a final rule on nutrition labeling of standard menu items in restaurants and similar retail food establishments; the rule is codified at Title 21 of the Code of Federal Regulations at Sec. 101.11 (21 CFR 101.11). The final rule implements requirements of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 343(q)(5)(H)), which in general, requires that restaurants and similar retail food establishments that are part of a chain with 20 or more locations, doing business under the same name, and offering for sale substantially the same menu items, provide calorie information for standard menu items (including food on display and self-service food), provide, upon request, additional written nutrition information for standard menu items, and comply with other requirements described in section 403(q)(5)(H) of the FD&C Act. The draft guidance uses a question and answer format and is intended to help restaurants and similar retail food establishments covered by the final rule comply with the nutrition labeling requirements of the final rule. II. Paperwork Reduction Act of 1995 This draft 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. III. Comments Interested persons may submit either electronic comments regarding the draft guidance to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the draft guidance document at 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: September 11, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-23232 Filed 9-15-15; 8:45 am] BILLING CODE 4164-01-P
![55564
Proposed Rules Federal Register
Vol. 80, No. 179
Wednesday, September 16, 2015
This section of the FEDERAL REGISTER Food and Drug Administration, 5100 offering for sale substantially the same
contains notices to the public of the proposed Paint Branch Pkwy., College Park, MD menu items, provide calorie information
issuance of rules and regulations. The 20740. Send two self-addressed for standard menu items (including food
purpose of these notices is to give interested adhesive labels to assist that office in on display and self-service food),
persons an opportunity to participate in the
rule making prior to the adoption of the final
processing your request. See the provide, upon request, additional
rules. SUPPLEMENTARY INFORMATION section for written nutrition information for
electronic access to the draft guidance. standard menu items, and comply with
Submit electronic comments on the other requirements described in section
DEPARTMENT OF HEALTH AND draft guidance to http:// 403(q)(5)(H) of the FD&C Act. The draft
HUMAN SERVICES www.regulations.gov. Submit written guidance uses a question and answer
comments on the draft guidance to the format and is intended to help
Food and Drug Administration Division of Dockets Management (HFA– restaurants and similar retail food
305), Food and Drug Administration, establishments covered by the final rule
21 CFR Parts 11 and 101 5630 Fishers Lane, Rm. 1061, Rockville, comply with the nutrition labeling
[Docket No. FDA–2011–F–0172]
MD 20852. requirements of the final rule.
FOR FURTHER INFORMATION CONTACT: II. Paperwork Reduction Act of 1995
A Labeling Guide for Restaurants and Lynn Szybist, Center for Food Safety
Retail Establishments Selling Away- and Applied Nutrition (HFS–820), Food This draft guidance refers to
From-Home Foods—Part II (Menu and Drug Administration, 5100 Paint previously approved collections of
Labeling Requirements in Accordance Branch Pkwy., College Park, MD 20740, information found in FDA regulations.
with the Patient Protection Affordable 240–402–2371. These collections of information are
Care Act of 2010); Draft Guidance for SUPPLEMENTARY INFORMATION: subject to review by the Office of
Industry; Availability Management and Budget (OMB) under
I. Background the Paperwork Reduction Act of 1995
AGENCY: Food and Drug Administration, (44 U.S.C. 3501–3520). The collections
We are announcing the availability of
HHS. of information in § 101.11(d), (c)(3), and
a draft guidance for industry entitled ‘‘A
ACTION: Notification of availability. Labeling Guide for Restaurants and (b)(2) have been approved under OMB
Retail Establishments Selling Away- Control No. 0910–0783.
SUMMARY: The Food and Drug
From-Home Foods—Part II (Menu III. Comments
Administration (FDA or we) is
Labeling Requirements in Accordance
announcing the availability of a draft
with 21 CFR 101.11); Draft Guidance for Interested persons may submit either
guidance for industry entitled ‘‘A
Industry.’’ We are issuing the draft electronic comments regarding the draft
Labeling Guide for Restaurants and
guidance consistent with our good guidance to http://www.regulations.gov
Retail Establishments Selling Away-
guidance practices regulation (21 CFR or written comments to the Division of
From-Home Foods—Part II (Menu
10.115). The draft guidance, when Dockets Management (see ADDRESSES). It
Labeling Requirements in Accordance
finalized, will represent our current is only necessary to send one set of
with 21 CFR 101.11); Draft Guidance for
thinking on this topic. It does not create comments. Identify comments with the
Industry.’’ The draft guidance, when
or confer any rights for or on any person docket number found in brackets in the
finalized, will help certain restaurants
and does not operate to bind FDA or the heading of this document. Received
and similar retail food establishments
public. You can use an alternate comments may be seen in the Division
comply with the menu labeling
approach if it satisfies the requirements of Dockets Management between 9 a.m.
requirements, including the
of the applicable statutes and and 4 p.m., Monday through Friday, and
requirements to provide calorie and
regulations. will be posted to the docket at http://
other nutrition information for standard
In the Federal Register of December 1, www.regulations.gov.
menu items, including food on display
2014 (79 FR 71156), we published a
and self-service food. IV. Electronic Access
final rule on nutrition labeling of
DATES: Although you can comment on standard menu items in restaurants and Persons with access to the Internet
any guidance at any time (see 21 CFR similar retail food establishments; the may obtain the draft guidance document
10.115(g)(5)), to ensure that we consider rule is codified at Title 21 of the Code at http://www.fda.gov/FoodGuidances
your comment on the draft guidance of Federal Regulations at § 101.11 (21 or http://www.regulations.gov. Use the
before we begin work on the final CFR 101.11). The final rule implements FDA Web site listed in the previous
version of the guidance, submit either
asabaliauskas on DSK7TPTVN1PROD with PROPOSALS
requirements of section 403(q)(5)(H) of sentence to find the most current
electronic or written comments on the the Federal Food, Drug, and Cosmetic version of the guidance.
draft guidance by November 2, 2015. Act (the FD&C Act) (21 U.S.C.
Dated: September 11, 2015.
ADDRESSES: Submit written requests for 343(q)(5)(H)), which in general, requires
single copies of the draft guidance to the that restaurants and similar retail food Leslie Kux,
Office of Nutrition, Labeling, and establishments that are part of a chain Associate Commissioner for Policy.
Dietary Supplements (HFS–820), Center with 20 or more locations, doing [FR Doc. 2015–23232 Filed 9–15–15; 8:45 am]
for Food Safety and Applied Nutrition, business under the same name, and BILLING CODE 4164–01–P
VerDate Sep<11>2014 21:44 Sep 15, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4702 Sfmt 4702 E:\FR\FM\16SEP1.SGM 16SEP1](https://thefederalregister.org/doc/80_FR_55743/page/1.svg)
Document Created: 2018-02-26 10:16:24
Document Modified: 2018-02-26 10:16:24
| 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 | Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance, submit either electronic or written comments on the draft guidance by November 2, 2015. | |
| Contact | Lynn Szybist, 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 | 80 FR 55564 | |
| CFR Citation | 21
CFR
101 21 CFR 11 |
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