Colorcon, Inc.; Filing of Color Additive Petition, 52037 [2017-24421]

Download as PDF Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Proposed Rules sradovich on DSK3GMQ082PROD with PROPOSALS 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 This draft guidance addresses concerns raised by stakeholders regarding the implementation of nutrition labeling required for foods sold in covered establishments. The draft guidance reflects extensive further analysis by FDA in light of the comments we received to the IFR.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 We address the issue of distinguishing between menus and other information presented to the consumer in this draft guidance, and once finalized, this will represent our current thinking on this topic. The draft guidance also includes many graphical depictions to further illustrate our thinking on various topics.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 VerDate Sep<11>2014 17:09 Nov 08, 2017 Jkt 244001 (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. The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Colorcon, Inc., SUMMARY: PO 00000 Frm 00023 Fmt 4702 Sfmt 9990 52037 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. 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. DATES: 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 E:\FR\FM\09NOP1.SGM 09NOP1

Agencies

[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Proposed Rules]
[Page 52037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24421]


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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.

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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 Sec.  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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