Colorcon, Inc.; Filing of Color Additive Petition, 52037 [2017-24421]
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Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Proposed Rules
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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This draft guidance addresses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draft guidance reflects extensive further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presented to the consumer in this draft
guidance, and once finalized, this will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 The draft guidance also includes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
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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–
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§ 101.11(b)(2), (c)(3), and (d) have been
approved under OMB control number
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III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
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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
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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.
-----------------------------------------------------------------------
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