81 FR 3751 - 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 14 (January 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 14 (January 22, 2016)
| Page Range | 3751-3751 | |
| FR Document | 2016-01177 |
[Federal Register Volume 81, Number 14 (Friday, January 22, 2016)] [Proposed Rules] [Page 3751] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01177] ======================================================================= ----------------------------------------------------------------------- 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 [email protected]. 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, [email protected]. 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
![Federal Register / Vol. 81, No. 14 / Friday, January 22, 2016 / Proposed Rules 3751
comment period.4 In addition, NAESB Food and Drug Administration (FDA) implement certain statutory
considers requests for waivers of the published a proposed rule entitled, requirements. FDA is also clarifying the
charges on a case-by-case basis ‘‘Food Labeling; Gluten-Free Labeling of identification for CES devices in this
depending on need. Fermented or Hydrolyzed Foods.’’ In the proposed order by identifying CES as a
Dated: January 15, 2016. DATES section of the proposed rule, we prescription device that applies
Nathaniel J. Davis, Sr., provided a 30-day period for submitting electrical current that is not intended to
comments with respect to the induce a seizure to a patient’s head to
Deputy Secretary.
information collection issues under the treat psychiatric conditions. This
[FR Doc. 2016–01237 Filed 1–21–16; 8:45 am]
Paperwork Reduction Act of 1995 clarification distinguishes CES from
BILLING CODE 6717–01–P
(PRA). However, in the PRA discussion electroconvulsive therapy (ECT).
for the proposed rule, an error was made DATES: Submit either electronic or
that provided 60 days for PRA written comments on this proposed
DEPARTMENT OF HEALTH AND comments. To address this error, we order by April 21, 2016. See sections IX
HUMAN SERVICES have reopened the comment period for and XVII of this document for,
Food and Drug Administration the information collection provisions of respectively, the proposed dates when
the proposed rule. Accordingly, the new requirements apply and the
21 CFR Part 101 comments regarding information proposed effective date of a final order
collection issues may be received until based on this proposed order.
[Docket No. FDA–2014–N–1021] February 22, 2016. The comment period ADDRESSES: You may submit comments
RIN 0910–AH00 for all other aspects of the proposed rule as follows:
remains unchanged where comments
may be submitted until February 16, Electronic Submissions
Food Labeling; Gluten-Free Labeling of
Fermented or Hydrolyzed Foods; 2016. Submit electronic comments in the
Reopening of the Comment Period Dated: January 15, 2016.
following way:
• Federal eRulemaking Portal: http://
AGENCY: Food and Drug Administration, Leslie Kux, www.regulations.gov. Follow the
HHS. Associate Commissioner for Policy. instructions for submitting comments.
Proposed rule; reopening of the
ACTION: [FR Doc. 2016–01177 Filed 1–21–16; 8:45 am] Comments submitted electronically,
comment period. BILLING CODE 4164–01–P including attachments, to http://
www.regulations.gov will be posted to
SUMMARY: In the Federal Register of the docket unchanged. Because your
November 18, 2015 (80 FR 71990), the DEPARTMENT OF HEALTH AND comment will be made public, you are
Food and Drug Administration (FDA) HUMAN SERVICES solely responsible for ensuring that your
published a proposed rule entitled, comment does not include any
‘‘Food Labeling; Gluten-Free Labeling of Food and Drug Administration confidential information that you or a
Fermented or Hydrolyzed Foods.’’ Due third party may not wish to be posted,
to an inadvertent error, the publication 21 CFR Part 882 such as medical information, your or
contained conflicting dates for anyone else’s Social Security number, or
submission of comments under the [Docket No. FDA–2014–N–1209]
confidential business information, such
Paperwork Reduction Act of 1995. This as a manufacturing process. Please note
Neurological Devices; Reclassification
notice corrects that error. that if you include your name, contact
of Cranial Electrotherapy Stimulator
DATES: Submit either electronic or Intended To Treat Insomnia and/or information, or other information that
written comments on information Anxiety; Effective Date of Requirement identifies you in the body of your
collection issues under the PRA by for Premarket Approval for Cranial comments, that information will be
February 22, 2016. Electrotherapy Stimulator Intended To posted on http://www.regulations.gov.
ADDRESSES: Submit comments on Treat Depression • If you want to submit a comment
information collection issues to the with confidential information that you
Office of Management and Budget in the AGENCY: Food and Drug Administration, do not wish to be made available to the
following ways: HHS. public, submit the comment as a
• Fax to the Office of Information and ACTION: Proposed order. written/paper submission and in the
Regulatory Affairs, OMB, Attn: FDA manner detailed (see ‘‘Written/Paper
Desk Officer, FAX: 202–395–7285, or SUMMARY: The Food and Drug Submissions’’ and ‘‘Instructions’’).
email to oira_submission@omb.eop.gov. Administration (FDA) is issuing a
All comments should be identified with proposed administrative order to Written/Paper Submissions
the title ‘‘Recordkeeping Requirements reclassify the cranial electrotherapy Submit written/paper submissions as
for Gluten-Free Labeling of Fermented stimulator (CES) devices intended to follows:
or Hydrolyzed Foods.’’ treat insomnia and/or anxiety, a • Mail/Hand delivery/Courier (for
FOR FURTHER INFORMATION CONTACT: FDA preamendments class III device, into written/paper submissions): Division of
PRA Staff, Office of Operations, Food class II (special controls) and subject to Dockets Management (HFA–305), Food
and Drug Administration, 8455 premarket notification, and to require and Drug Administration, 5630 Fishers
Colesville Rd., COLE–14526, Silver the filing of a premarket approval Lane, rm. 1061, Rockville, MD 20852.
wgreen on DSK2VPTVN1PROD with PROPOSALS
Spring, MD 20993–0002, PRAStaff@ application (PMA) for CES devices • For written/paper comments
fda.hhs.gov. intended to treat depression. FDA is submitted to the Division of Dockets
proposing the reclassification of CES Management, FDA will post your
SUPPLEMENTARY INFORMATION: On
devices intended to treat insomnia and/ comment, as well as any attachments,
November 18, 2015 (80 FR 71990), the
or anxiety under the Federal Food, except for information submitted,
4 Procedures for non-members to evaluate work Drug, and Cosmetic Act (the FD&C Act) marked and identified, as confidential,
products before purchasing, https://www.naesb.org/ based on new information pertaining to if submitted as detailed in
misc/NAESB_Nonmember_Evaluation.pdf. the device. This proposed action would ‘‘Instructions.’’
VerDate Sep<11>2014 14:28 Jan 21, 2016 Jkt 238001 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 E:\FR\FM\22JAP1.SGM 22JAP1](https://thefederalregister.org/doc/81_FR_3765/page/1.svg)
Document Created: 2016-01-22 01:16:33
Document Modified: 2016-01-22 01:16:33
| 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 | Submit either electronic or written comments on information collection issues under the PRA by February 22, 2016. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected] | |
| FR Citation | 81 FR 3751 | |
| RIN Number | 0910-AH00 |
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