[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Labeling; Draft Guidance for Industry; Extension of Comment Period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.

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

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comment period for the draft guidance for industry entitled ``The Use 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DATES: FDA is extending the comment period on the draft guidance 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comment on the draft guidance before we begin work on the final version 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


