[Federal Register Volume 84, Number 132 (Wednesday, July 10, 2019)]
[Proposed Rules]
[Pages 32848-32849]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14666]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 84, No. 132 / Wednesday, July 10, 2019 /
Proposed Rules
[[Page 32848]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 101 and 102
[Docket No. FDA-2019-D-0892]
The Use of an Alternate Name for Potassium Chloride in Food
Labeling; Draft Guidance for Industry; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of availability; extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the draft guidance for industry entitled ``The Use
of an Alternate Name for Potassium Chloride in Food Labeling,'' which
was announced in the Federal Register of May 20, 2019. In the
notification, FDA requested comments on the use of ``potassium chloride
salt'' as an alternate common or usual name for potassium chloride. We
are taking this action in response to requests for an extension to
allow interested persons additional time to submit comments.
DATES: FDA is extending the comment period on the draft guidance
published May 20, 2019 (84 FR 22749). Submit either electronic or
written comments by September 17, 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comment on the draft guidance before we begin work on the final version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-2019-D-0892 for ``The Use of an Alternate Name for Potassium
Chloride in Food Labeling.'' 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.'' 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 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.gpo.gov/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.
FOR FURTHER INFORMATION CONTACT: Andrea Krause, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240-402-2371.
SUPPLEMENTARY INFORMATION: In the Federal Register of May 20, 2019, FDA
published a notification announcing the availability of a draft
guidance entitled ``The Use of an Alternate Name for Potassium Chloride
in Food Labeling: Draft Guidance for Industry'' with a 60-day comment
period to request comments on the use of ``potassium chloride salt'' as
an alternate common or usual name for potassium chloride. The draft
guidance is intended to explain to food manufacturers our intent to
exercise enforcement discretion for the declaration of the name
``potassium chloride salt'' in the ingredient statement on food labels
as an alternative to the common or usual name ``potassium chloride.''
We have received requests for a 60-day extension of the comment
period for the draft guidance. The requests conveyed concern that the
current 60-day comment period does not allow
[[Page 32849]]
sufficient time to develop a meaningful or thoughtful response to the
draft guidance.
We have considered the requests and are extending the comment
period for the draft guidance for 60 additional days, until September
17, 2019. We believe that a 60-day extension allows adequate time for
interested persons to submit comments.
Dated: July 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14666 Filed 7-9-19; 8:45 am]
BILLING CODE 4164-01-P