81 FR 8869 - Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Reopening of the Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 35 (February 23, 2016)

Page Range		8869-8870
FR Document		2016-03716

In the Federal Register of November 18, 2015, the Food and Drug Administration (FDA) published a proposed rule entitled ``Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods.'' The proposed rule would establish requirements concerning ``gluten-free'' labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients. We are taking this action to reopen the comment period in response to requests to allow interested persons additional time to submit comments.

Federal Register, Volume 81 Issue 35 (Tuesday, February 23, 2016)

[Federal Register Volume 81, Number 35 (Tuesday, February 23, 2016)]
[Proposed Rules]
[Pages 8869-8870]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-03716]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. FDA-2014-N-1021]

Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed
Foods; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of the comment period.

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SUMMARY: In the Federal Register of November 18, 2015, the Food and
Drug Administration (FDA) published a proposed rule entitled ``Food
Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods.'' The
proposed rule would establish requirements concerning ``gluten-free''
labeling for foods that are fermented or hydrolyzed or that contain
fermented or hydrolyzed ingredients. We are taking this action to
reopen the comment period in response to requests to allow interested
persons additional time to submit comments.

DATES: FDA is reopening the comment period on the proposed rule
published November 18, 2015 (80 FR 71990). Submit either electronic or
written comments by April 25, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2014-N-1021 for ``Food Labeling; Gluten-Free Labeling of Fermented
or Hydrolyzed Foods.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management 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.'' The Agency will
review this copy, including the claimed confidential information, in
its 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Carol D'Lima, Center for Food Safety
and Applied Nutrition (HFS-820), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-2371, FAX: 301-436-
2636.

SUPPLEMENTARY INFORMATION: The proposed rule would establish
requirements concerning ``gluten-free'' labeling for foods that are
fermented or hydrolyzed or that contain fermented or hydrolyzed
ingredients. These additional requirements for the ``gluten-free''
labeling rule are needed to help ensure that individuals with celiac
disease are not misled and receive truthful and accurate information
with respect to fermented or hydrolyzed foods labeled as ``gluten-
free.'' We provided a 90-day comment period for the proposed rule.
We received multiple requests for a 60-day extension of the comment
period and one request for a 90-day extension of the comment period for
the proposed rule. Each request conveyed concern that the original 90-
day comment period does not allow sufficient time to develop a
meaningful or thoughtful response to the proposed rule. We have
considered the requests and are reopening the comment period for the

[[Page 8870]]

proposed rule until April 25, 2016. We believe that an additional 60-
day period allows adequate time for interested persons to submit
comments without significantly delaying rulemaking on these important
issues. The period for comments regarding information collection issues
under the Paperwork Reduction Act of 1995 remains unchanged, where
comments were to be submitted until February 22, 2016 (see 81 FR 3751,
January 22, 2016).

Dated: February 18, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-03716 Filed 2-22-16; 8:45 am]
BILLING CODE 4164-01-P

8870 Federal Register / Vol. 81, No. 35 / Tuesday, February 23, 2016 / Proposed Rules

proposed rule until April 25, 2016. We a.m. and 4 p.m. to CC:PA:LPD:PR (REG– The Treasury Department and IRS
believe that an additional 60-day period 129067–15), Courier’s Desk, Internal recognize the need to clarify the
allows adequate time for interested Revenue Service, 1111 Constitution definition of political subdivision to
persons to submit comments without Avenue NW., Washington, DC, or sent provide greater certainty to prospective
significantly delaying rulemaking on electronically via the Federal issuers and to promote greater
these important issues. The period for eRulemaking Portal at consistency in how the definition is
comments regarding information www.regulations.gov (REG–129067–15). applied across a wide range of factual
collection issues under the Paperwork The public hearing will be held at the situations. These proposed regulations
Reduction Act of 1995 remains Internal Revenue Building, 1111 (the Proposed Regulations) would
unchanged, where comments were to be Constitution Avenue NW., Washington, provide a new definition of political
submitted until February 22, 2016 (see DC. subdivision for purposes of tax-exempt
81 FR 3751, January 22, 2016). FOR FURTHER INFORMATION CONTACT: bonds and would update and streamline
Dated: February 18, 2016. Concerning the proposed regulations, other portions of the Existing
Leslie Kux, Spence Hanemann at (202) 317–6980; Regulations. The definition of political
concerning submissions of comments subdivision in the Proposed Regulations
Associate Commissioner for Policy.
and the hearing, Oluwafunmilayo does not apply in determining whether
[FR Doc. 2016–03716 Filed 2–22–16; 8:45 am]
(Funmi) Taylor at (202) 317–6901 (not an entity is treated as a political
BILLING CODE 4164–01–P subdivision of a State for purposes of
toll-free numbers).
SUPPLEMENTARY INFORMATION: section 414(d) of the Code.
DEPARTMENT OF THE TREASURY Background Explanation of Provisions
This document contains proposed 1. Definition of Political Subdivision
Internal Revenue Service
amendments to 26 CFR part 1 under The Proposed Regulations clarify and
26 CFR Part 1 section 103 of the Internal Revenue further develop the eligibility
Code (Code). Section 103 generally requirements for a political subdivision.
[REG–129067–15] provides that, with certain exceptions, To qualify as a political subdivision
RIN 1545–BM99 gross income does not include interest under the Proposed Regulations, an
on any obligation of a State or political entity must meet three requirements,
Definition of Political Subdivision subdivision thereof. Section 1.103–1 of taking into account all of the facts and
the Income Tax Regulations (the circumstances: sovereign powers,
AGENCY: Internal Revenue Service (IRS), Existing Regulations) defines political governmental purpose, and
Treasury. subdivision as ‘‘any division of any governmental control. The Proposed
ACTION: Notice of proposed rulemaking State or local governmental unit which Regulations also authorize the
and notice of public hearing. is a municipal corporation or which has Commissioner to set forth in future
been delegated the right to exercise part guidance to be published in the Internal
SUMMARY: This document contains of the sovereign power of the unit.’’
proposed regulations that provide Revenue Bulletin additional
On a few occasions, Federal courts circumstances in which an entity
guidance regarding the definition of have ruled on whether an entity
political subdivision for purposes of tax- qualifies as a political subdivision.
qualifies as a political subdivision. E.g.,
exempt bonds. The proposed Philadelphia Nat’l Bank v. United A. Sovereign Powers
regulations are necessary to specify the States, 666 F.2d 834 (3d Cir. 1981); The Proposed Regulations continue,
elements of a political subdivision. The Comm’r of Internal Revenue v. White’s without substantive change, the
proposed regulations will affect State Estate, 144 F.2d 1019 (2d Cir. 1944). longstanding requirement that a
and local governments that issue tax- The IRS has also addressed this issue in political subdivision be empowered to
exempt bonds and users of property revenue rulings, most recently in 1983. exercise at least one of the generally
financed with tax-exempt bonds. Under E.g., Rev. Rul. 83–131 (1983–2 CB 184); recognized sovereign powers. The three
certain transition rules, however, the Rev. Rul. 78–138 (1978–1 CB 314). sovereign powers recognized for this
proposed definition of political Because the results in these revenue purpose are eminent domain, police
subdivision will not apply for rulings generally turn on the unique power, and taxing power. See Comm’r
determining whether outstanding bonds facts and circumstances of the of Internal Revenue v. Shamberg’s
are obligations of a political subdivision individual cases, numerous entities Estate, 144 F.2d 998 (2d Cir. 1944). The
and will not apply to existing entities have sought and received letter rulings entity must be able to exercise a
for a transition period. This document on whether they are political substantial amount of at least one of
also provides a notice of a public subdivisions. Letter rulings, however, these powers. See, e.g., Rev. Rul. 77–164
hearing for these proposed regulations. are limited to their particular facts, may (1977–1 CB 20); Rev. Rul. 77–165
DATES: Written or electronic comments not be relied upon by taxpayers other (1977–1 CB 21).
must be received by May 23, 2016. than the taxpayer that received the
Request to speak and outlines of topics ruling, and are not a substitute for B. Governmental Purpose
to be discussed at the public hearing published guidance. See 26 U.S.C. In determining whether an entity is a
asabaliauskas on DSK5VPTVN1PROD with PROPOSALS

scheduled for June 6, 2016, at 10:00 6110(k)(3) (2015) (providing generally political subdivision, the case law and
a.m., must be received by May 23, 2016. that a ruling, determination letter, or administrative guidance interpreting the
ADDRESSES: Send submissions to: technical advice memorandum may not definition of political subdivision in the
CC:PA:LPD:PR (REG–129067–15), be used or cited as precedent). Existing Regulations commonly
Internal Revenue Service, P.O. Box Commenters have requested consider whether the entity serves a
7604, Ben Franklin Station, Washington, additional published guidance, to be public purpose. Historically, the
DC 20044. Submissions may be hand applied prospectively, on which facts determination of whether an entity
delivered to: CC:PA:LPD:PR Monday and circumstances are germane to an serves a public purpose has focused on
through Friday between the hours of 8 entity’s status as a political subdivision. the purpose for which the entity was

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Document Created: 2018-02-02 14:33:19
Document Modified: 2018-02-02 14:33:19

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		Proposed rule; reopening of the comment period.
Dates		FDA is reopening the comment period on the proposed rule published November 18, 2015 (80 FR 71990). Submit either electronic or written comments by April 25, 2016.
Contact		Carol D'Lima, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2371, FAX: 301-436- 2636.
FR Citation		81 FR 8869

81 FR 8869 - Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Reopening of the Comment Period

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 35 (February 23, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration