Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed Foods; Reopening of the Comment Period, 3751 [2016-01177]
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Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Proposed Rules
comment period.4 In addition, NAESB
considers requests for waivers of the
charges on a case-by-case basis
depending on need.
Dated: January 15, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016–01237 Filed 1–21–16; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA–2014–N–1021]
RIN 0910–AH00
Food Labeling; Gluten-Free Labeling of
Fermented or Hydrolyzed Foods;
Reopening of the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Proposed rule; reopening of the
comment period.
ACTION:
In the Federal Register of
November 18, 2015 (80 FR 71990), the
Food and Drug Administration (FDA)
published a proposed rule entitled,
‘‘Food Labeling; Gluten-Free Labeling of
Fermented or Hydrolyzed Foods.’’ Due
to an inadvertent error, the publication
contained conflicting dates for
submission of comments under the
Paperwork Reduction Act of 1995. This
notice corrects that error.
DATES: Submit either electronic or
written comments on information
collection issues under the PRA by
February 22, 2016.
ADDRESSES: Submit comments on
information collection issues to the
Office of Management and Budget in the
following ways:
• Fax to the Office of Information and
Regulatory Affairs, OMB, Attn: FDA
Desk Officer, FAX: 202–395–7285, or
email to oira_submission@omb.eop.gov.
All comments should be identified with
the title ‘‘Recordkeeping Requirements
for Gluten-Free Labeling of Fermented
or Hydrolyzed Foods.’’
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On
November 18, 2015 (80 FR 71990), the
Food and Drug Administration (FDA)
published a proposed rule entitled,
‘‘Food Labeling; Gluten-Free Labeling of
Fermented or Hydrolyzed Foods.’’ In the
DATES section of the proposed rule, we
provided a 30-day period for submitting
comments with respect to the
information collection issues under the
Paperwork Reduction Act of 1995
(PRA). However, in the PRA discussion
for the proposed rule, an error was made
that provided 60 days for PRA
comments. To address this error, we
have reopened the comment period for
the information collection provisions of
the proposed rule. Accordingly,
comments regarding information
collection issues may be received until
February 22, 2016. The comment period
for all other aspects of the proposed rule
remains unchanged where comments
may be submitted until February 16,
2016.
Dated: January 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–01177 Filed 1–21–16; 8:45 am]
BILLING CODE 4164–01–P
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SUMMARY:
4 Procedures for non-members to evaluate work
products before purchasing, https://www.naesb.org/
misc/NAESB_Nonmember_Evaluation.pdf.
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14:28 Jan 21, 2016
Jkt 238001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. FDA–2014–N–1209]
Neurological Devices; Reclassification
of Cranial Electrotherapy Stimulator
Intended To Treat Insomnia and/or
Anxiety; Effective Date of Requirement
for Premarket Approval for Cranial
Electrotherapy Stimulator Intended To
Treat Depression
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed order.
The Food and Drug
Administration (FDA) is issuing a
proposed administrative order to
reclassify the cranial electrotherapy
stimulator (CES) devices intended to
treat insomnia and/or anxiety, a
preamendments class III device, into
class II (special controls) and subject to
premarket notification, and to require
the filing of a premarket approval
application (PMA) for CES devices
intended to treat depression. FDA is
proposing the reclassification of CES
devices intended to treat insomnia and/
or anxiety under the Federal Food,
Drug, and Cosmetic Act (the FD&C Act)
based on new information pertaining to
the device. This proposed action would
SUMMARY:
PO 00000
Frm 00004
Fmt 4702
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3751
implement certain statutory
requirements. FDA is also clarifying the
identification for CES devices in this
proposed order by identifying CES as a
prescription device that applies
electrical current that is not intended to
induce a seizure to a patient’s head to
treat psychiatric conditions. This
clarification distinguishes CES from
electroconvulsive therapy (ECT).
DATES: Submit either electronic or
written comments on this proposed
order by April 21, 2016. See sections IX
and XVII of this document for,
respectively, the proposed dates when
the new requirements apply and the
proposed effective date of a final order
based on this proposed order.
ADDRESSES: You may submit comments
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): 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.’’
E:\FR\FM\22JAP1.SGM
22JAP1
]]>Agencies
[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)]
[Proposed Rules]
[Page 3751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01177]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. FDA-2014-N-1021]
RIN 0910-AH00
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.
-----------------------------------------------------------------------
SUMMARY: In the Federal Register of November 18, 2015 (80 FR 71990),
the Food and Drug Administration (FDA) published a proposed rule
entitled, ``Food Labeling; Gluten-Free Labeling of Fermented or
Hydrolyzed Foods.'' Due to an inadvertent error, the publication
contained conflicting dates for submission of comments under the
Paperwork Reduction Act of 1995. This notice corrects that error.
DATES: Submit either electronic or written comments on information
collection issues under the PRA by February 22, 2016.
ADDRESSES: Submit comments on information collection issues to the
Office of Management and Budget in the following ways:
Fax to the Office of Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to
oira_submission@omb.eop.gov. All comments should be identified with the
title ``Recordkeeping Requirements for Gluten-Free Labeling of
Fermented or Hydrolyzed Foods.''
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On November 18, 2015 (80 FR 71990), the Food
and Drug Administration (FDA) published a proposed rule entitled,
``Food Labeling; Gluten-Free Labeling of Fermented or Hydrolyzed
Foods.'' In the DATES section of the proposed rule, we provided a 30-
day period for submitting comments with respect to the information
collection issues under the Paperwork Reduction Act of 1995 (PRA).
However, in the PRA discussion for the proposed rule, an error was made
that provided 60 days for PRA comments. To address this error, we have
reopened the comment period for the information collection provisions
of the proposed rule. Accordingly, comments regarding information
collection issues may be received until February 22, 2016. The comment
period for all other aspects of the proposed rule remains unchanged
where comments may be submitted until February 16, 2016.
Dated: January 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-01177 Filed 1-21-16; 8:45 am]
BILLING CODE 4164-01-P
