Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Proposed Rules 52037 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

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 to 

implement the menu labeling provisions 

of section 403(q)(5)(H) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

343(q)(5)(H)). The menu labeling 

requirements are codified at Title 21 of 

the Code of Federal Regulations, 

§ 101.11 (21 CFR 101.11). 

In the Federal Register of May 4, 2017 

(82 FR 20825), we published an interim 

final rule (IFR) extending the 

compliance date to May 7, 2018. Our 

goals are to ensure that consumers are 

provided with consistent nutrition 

information they can use to make 

informed choices for themselves and 

their families, and to guide industry in 

clearly understanding the flexible ways 

in which the requirements can be 

implemented. 

This draft guidance addresses 

concerns raised by stakeholders 

regarding the implementation of 

nutrition labeling required for foods 

sold in covered establishments. The 

draft guidance reflects extensive further 

analysis by FDA in light of the 

comments we received to the IFR. In 

addition, given extensive further 

analysis by the Agency, we are 

withdrawing Questions and Answers 

5.17 and 5.18 in our previous guidance 

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)’’ announced in the Federal 

Register of May 5, 2016 (81 FR 27067). 

We address the issue of distinguishing 

between menus and other information 

presented to the consumer in this draft 

guidance, and once finalized, this will 

represent our current thinking on this 

topic. The draft guidance also includes 

many graphical depictions to further 

illustrate our thinking on various topics. 

As previously stated, although you can 

comment on any guidance at any time 

(see 21 CFR 10.115(g)(5)), we do not 

intend to extend the comment period for 

the guidance, as we intend to finalize 

this guidance and provide clarity to the 

industry on these remaining questions 

ahead of the new compliance date of 

May 7, 2018. 

II. 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(b)(2), (c)(3), and (d) have been 

approved under OMB control number 

0910–0783. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft 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: November 2, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24246 Filed 11–7–17; 11:15 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 73 

[Docket No. FDA–2017–C–6238] 

Colorcon, Inc.; Filing of Color Additive 

Petition 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of petition. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that we have filed a 

petition, submitted by Colorcon, Inc., 

proposing that the color additive 

regulations be amended by expanding 

the permitted uses of synthetic iron 

oxide as a color additive to include use 

in dietary supplement tablets and 

capsules. 

DATES: The color additive petition was 

filed on October 3, 2017. 

ADDRESSES: For access to the docket to 

read background documents or 

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Molly A. Harry, Center for Food Safety 

and Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–1075. 

SUPPLEMENTARY INFORMATION: Under 

section 721(d)(1) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

379e(d)(1)), we are giving notice that we 

have filed a color additive petition (CAP 

7C0308), submitted by Colorcon, Inc., 

275 Ruth Rd., Harleysville, PA 19438. 

The petition proposes to amend the 

color additive regulations in § 73.200 

(21 CFR 73.200) Synthetic iron oxide by 

expanding the permitted uses of 

synthetic iron oxide as a color additive 

to include use in dietary supplement 

tablets and capsules with a proposed 

limit of 5 milligrams, calculated as 

elemental iron, per day for labeled 

dosages. 

We have determined under 21 CFR 

25.32(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. 

Dated: November 6, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–24421 Filed 11–8–17; 8:45 am] 

BILLING CODE 4164–01–P 


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