83 FR 55323 - Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 214 (November 5, 2018)

Page Range		55323-55324
FR Document		2018-24124

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size- Related Issues, Dual-Column Labeling, and Miscellaneous Topics.'' The draft guidance, when finalized, will provide questions and answers on topics related primarily to implementing two final rules, one entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments,'' and the other entitled ``Food Labeling: Revision of the Nutrition and Supplement Facts Labels.'' This draft guidance also discusses formatting issues for dual-column labeling, products that have limited space for nutrition labeling, and additional issues dealing with compliance.

Federal Register, Volume 83 Issue 214 (Monday, November 5, 2018)

[Federal Register Volume 83, Number 214 (Monday, November 5, 2018)]
[Proposed Rules]
[Pages 55323-55324]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-24124]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2018-D-1459]

Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed at One Eating Occasion, Reference Amounts Customarily
Consumed, Serving Size-Related Issues, Dual-Column Labeling, and
Miscellaneous Topics; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Food
Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One
Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-
Related Issues, Dual-Column Labeling, and Miscellaneous Topics.'' The
draft guidance, when finalized, will provide questions and answers on
topics related primarily to implementing two final rules, one entitled
``Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed
At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and
Establishing Certain Reference Amounts Customarily Consumed; Serving
Size for Breath Mints; and Technical Amendments,'' and the other
entitled ``Food Labeling: Revision of the Nutrition and Supplement
Facts Labels.'' This draft guidance also discusses formatting issues
for dual-column labeling, products that have limited space for
nutrition labeling, and additional issues dealing with compliance.

DATES: Submit either electronic or written comments on the draft
guidance by January 4, 2019 to ensure that we consider your comment on
the draft guidance before we begin work on the final version of the
guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2018-D-1459 for ``Food Labeling: Serving Sizes of Foods That Can
Reasonably Be Consumed At One Eating Occasion, Reference Amounts
Customarily Consumed, Serving Size-Related Issues, Dual-Column
Labeling, and Miscellaneous Topics; Draft Guidance for Industry.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff 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.'' We will review
this copy, including the claimed confidential information, in our
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 https://www.regulations.gov. Submit both
copies to the Dockets Management Staff. 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:
https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Office of Nutrition and Food Labeling, Center for Food Safety and
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
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.

FOR FURTHER INFORMATION CONTACT: Jillonne Kevala, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-1450.

SUPPLEMENTARY INFORMATION:

I. Background

We are announcing the availability of a draft guidance for industry
entitled ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed At One Eating Occasion, Reference Amounts Customarily
Consumed, Serving Size-Related Issues, Dual-

[[Page 55324]]

Column Labeling, and Miscellaneous Topics.'' We are issuing the draft
guidance consistent with our good guidance practices regulation (21 CFR
10.115). The draft guidance, when finalized, will represent 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
alternate approach if it satisfies the requirements of the applicable
statutes and regulations. This guidance is not subject to Executive
Order 12866.
The draft guidance, when finalized, will provide questions and
answers on topics related primarily to implementing two final rules:
(1) ``Food Labeling: Serving Sizes of Foods That Can Reasonably Be
Consumed At One Eating Occasion; Dual-Column Labeling; Updating,
Modifying, and Establishing Certain Reference Amounts Customarily
Consumed; Serving Size for Breath Mints; and Technical Amendments'' (81
FR 34000 (May 27, 2016)) and (2) ``Food Labeling: Revision of the
Nutrition and Supplement Facts Labels'' (81 FR 33742 (May 27, 2016)).
This draft guidance also discusses formatting issues for dual-column
labeling, products that have limited space for nutrition labeling, and
additional issues dealing with compliance.

II. The Paperwork Reduction Act

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 21 CFR part 101 have been approved under
OMB control number 0910-0381.

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 website listed in the previous
sentence to find the most current version of the guidance.

Dated: October 30, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24124 Filed 11-2-18; 8:45 am]
BILLING CODE 4164-01-P

55324 Federal Register / Vol. 83, No. 214 / Monday, November 5, 2018 / Proposed Rules

Column Labeling, and Miscellaneous DEPARTMENT OF THE TREASURY (1962). Congress enacted subpart F in
Topics.’’ We are issuing the draft part to address taxpayers who had
guidance consistent with our good Internal Revenue Service ‘‘taken advantage of the multiplicity of
guidance practices regulation (21 CFR foreign tax systems to avoid taxation by
10.115). The draft guidance, when 26 CFR Part 1 the United States on what could
finalized, will represent the current [REG–114540–18] ordinarily be expected to be U.S. source
thinking of FDA on this topic. It does income.’’ Id. at 58.
not establish any rights for any person
RIN 1545–BO88 Before the 1962 Act, United States
shareholders (as defined in section
and is not binding on FDA or the public. Amount Determined Under Section 956 951(b)) (‘‘U.S. shareholders’’) of
You can use an alternate approach if it for Corporate United States controlled foreign corporations (as
satisfies the requirements of the Shareholders defined in section 957) (‘‘CFCs’’) were
applicable statutes and regulations. This not subject to U.S. tax on earnings of the
guidance is not subject to Executive AGENCY: Internal Revenue Service (IRS),
Treasury. foreign corporations unless and until
Order 12866. earnings of the foreign corporations
ACTION: Notice of proposed rulemaking.
The draft guidance, when finalized, were distributed to the shareholders as
will provide questions and answers on SUMMARY: This document contains a dividend. S. Rep. No. 1881 at 78
topics related primarily to proposed regulations that reduce the (1962). The subpart F regime eliminated
implementing two final rules: (1) ‘‘Food amount determined under section 956 deferral for certain—generally passive or
Labeling: Serving Sizes of Foods That of the Internal Revenue Code with highly mobile—earnings of CFCs by
Can Reasonably Be Consumed At One respect to certain domestic corporations. subjecting those earnings to immediate
Eating Occasion; Dual-Column Labeling; The proposed regulations affect certain U.S. taxation regardless of whether there
Updating, Modifying, and Establishing domestic corporations that own (or are was an actual distribution. Id. at 80.
treated as owning) stock in foreign Earnings that were not subject to
Certain Reference Amounts Customarily
corporations. immediate U.S. taxation under the
Consumed; Serving Size for Breath
subpart F regime were generally taxable
Mints; and Technical Amendments’’ (81 DATES: Written or electronic comments
only upon repatriation, as those
FR 34000 (May 27, 2016)) and (2) ‘‘Food and requests for a public hearing must earnings did not present the same
Labeling: Revision of the Nutrition and be received by December 5, 2018. concerns regarding indefinite tax
Supplement Facts Labels’’ (81 FR 33742 ADDRESSES: Send submissions to: deferral compared to earnings subject to
(May 27, 2016)). This draft guidance CC:PA:LPD:PR (REG–114540–18), subpart F.
also discusses formatting issues for Internal Revenue Service, Room 5203, Section 956 was enacted alongside the
dual-column labeling, products that P.O. Box 7604, Ben Franklin Station, subpart F regime in the 1962 Act to
have limited space for nutrition Washington, DC 20044. Submissions ensure that a CFC’s earnings not subject
labeling, and additional issues dealing may be hand-delivered Monday through to immediate tax when earned (under
with compliance. Friday between the hours of 8 a.m. and the subpart F regime) would be taxed
4 p.m. to CC:PA:LPD:PR (REG–114540– when repatriated, either through a
II. The Paperwork Reduction Act 18), Courier’s Desk, Internal Revenue dividend or an effective repatriation.
Service, 1111 Constitution Avenue NW, Recognizing that repatriation of foreign
This draft guidance refers to
Washington, DC 20224, or sent earnings was possible through means
previously approved collections of electronically via the Federal other than a taxable distribution,
information found in FDA regulations. eRulemaking Portal at http:// Congress enacted section 956 ‘‘to
These collections of information are www.regulations.gov (IRS REG–114540– prevent the repatriation of income to the
subject to review by the Office of 18). United States in a manner which does
Management and Budget (OMB) under FOR FURTHER INFORMATION CONTACT: not subject it to U.S. taxation.’’ H.R.
the Paperwork Reduction Act of 1995 Concerning the proposed regulations, Rep. No. 1447 at 58. Congress
(44 U.S.C. 3501–3520). The collections Rose E. Jenkins, (202) 317–6934; determined that the investment by a
of information in 21 CFR part 101 have concerning submissions of comments or CFC of its earnings in United States
been approved under OMB control requests for a public hearing, Regina property, including obligations of a U.S.
number 0910–0381. Johnson, (202) 317–6901 (not toll-free person, ‘‘is substantially the equivalent
numbers). of a dividend.’’ See S. Rep. No. 1881 at
III. Electronic Access
88 (1962). See also S. Rep. No. 94–938
SUPPLEMENTARY INFORMATION:
Persons with access to the internet at 226 (1976) (‘‘[S]ince the investment
may obtain the draft guidance at either Background . . . in the stock or debt obligations of
https://www.fda.gov/FoodGuidances or a related U.S. person or its domestic
I. Section 956 affiliates makes funds available for use
https://www.regulations.gov. Use the
The Revenue Act of 1962 (the ‘‘1962 by the U.S. shareholders, it constitutes
FDA website listed in the previous Act’’), Pub. L. 87–834, sec. 12, 76 Stat. an effective repatriation of earnings
sentence to find the most current at 1006, enacted sections 951 and 956 as which should be taxed.’’). Accordingly,
version of the guidance. part of subpart F of part III, subchapter Congress enacted section 956 as an anti-
Dated: October 30, 2018. N, chapter 1 of the 1954 Internal abuse measure to tax a CFC’s investment
Leslie Kux, Revenue Code (‘‘subpart F’’), as of earnings in United States property in
Associate Commissioner for Policy. amended. Subpart F was enacted in the same manner as if it had distributed
order to limit the use of low-tax those earnings to the United States. See
[FR Doc. 2018–24124 Filed 11–2–18; 8:45 am]
jurisdictions for the purposes of JCS–10–87 at 1081–82 (1987) (‘‘In
BILLING CODE 4164–01–P
obtaining indefinite deferral of U.S. tax general, two kinds of transactions are
on certain earnings that would repatriations that end deferral and
otherwise be subject to U.S. federal trigger tax. First, an actual dividend
income tax. H.R. Rep. No. 1447 at 57 payment ends deferral. . . . Second, in

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Document Created: 2018-11-03 00:29:16
Document Modified: 2018-11-03 00:29:16

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 the draft guidance by January 4, 2019 to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance.
Contact		Jillonne Kevala, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1450.
FR Citation		83 FR 55323

83 FR 55323 - Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed at One Eating Occasion, Reference Amounts Customarily Consumed, Serving Size-Related Issues, Dual-Column Labeling, and Miscellaneous Topics; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 214 (November 5, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration