[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55444-55446]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19501]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0528]


Quantitative Labeling of Sodium, Potassium, and Phosphorus for 
Human Over-the-Counter and Prescription Drug Products; Draft Guidance 
for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a draft guidance for industry entitled 
``Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human 
Over-the-Counter and Prescription Drug Products.'' This draft guidance 
is intended to assist industry in providing information in labeling 
about the quantities at which sodium, potassium, and phosphorus as 
constituents of active or inactive drug ingredients are present in 
human over-the-counter (OTC) and prescription drug products.

DATES: Submit either electronic or written comments on the draft 
guidance by November 8, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2021-D-0528 for ``Quantitative Labeling of Sodium, Potassium, and 
Phosphorus for Human Over-the-Counter and Prescription Drugs.'' 
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, 240-402-7500.
     Confidential Submissions--To submit a comment with 
confidential

[[Page 55445]]

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, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 3334, Silver Spring, MD 20993, 240-402-8926, or Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Quantitative Labeling of Sodium, Potassium, and Phosphorus 
for Human Over-the-Counter and Prescription Drugs Products.'' This 
draft guidance focuses on sodium, potassium, and phosphorus when 
present as constituents of active or inactive drug product ingredients 
(e.g., sodium as a constituent of the inactive ingredient anhydrous 
trisodium citrate, phosphorus as a constituent of the inactive 
ingredient dibasic calcium phosphate, or sodium as a constituent of the 
active ingredient naproxen sodium).
    Sodium, potassium, and phosphorus are often present in drug 
products as constituents of active or inactive ingredients. The amounts 
of these constituents can vary among drug products, including drugs 
with the same active ingredient, depending on factors such as the 
manufacturer, formulation, and dosage form. For example, the amount of 
sodium, potassium, or phosphorus may differ between a reference listed 
drug and a generic version of the drug, or the amount may vary among 
different generic versions of the same drug.
    This draft guidance restates the legal requirements set forth in 
current regulations for the quantitative labeling of sodium and 
potassium for OTC products intended for oral ingestion. There is no 
current regulation requiring quantitative information specifically for 
sodium or potassium in prescription drugs. However, this draft guidance 
recommends that manufacturers of OTC and prescription drug products 
include quantitative information for sodium, potassium, and phosphorus 
(when present above threshold levels described in the draft guidance) 
in the product's labeling to assist healthcare providers and patients.
    Healthcare providers generally recommend that patients with certain 
clinical conditions such as heart failure, hypertension, or chronic 
kidney disease, restrict dietary intake of sodium, potassium, or 
phosphorus. Including information about the quantities of these 
constituents in drug product labeling would allow healthcare providers 
and patients to account for the amounts of these constituents present 
in a patient's daily drug regimen when determining an individual's 
total daily intake. Quantifying these constituents in drug product 
labeling as recommended in this draft guidance may allow healthcare 
providers and patients to select drug products with lower amounts of 
these constituents when necessary if such alternatives are available.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Quantitative 
Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-
Counter and Prescription Drug Products.'' It does not establish any 
rights for any person and is not binding on FDA or the public. You can 
use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to proposed collections of information 
described in FDA's 60-day notice requesting public comment on the 
proposed collection of information entitled, ``Agency Information 
Collection Activities; Proposed Collection; Comment Request; General 
Drug Labeling Provisions and Over-the-Counter Monograph Drug User Fee 
Submissions.'' The proposed collections of information are subject to 
review by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). As required by the 
PRA, FDA has published an analysis of these information collection 
provisions elsewhere in this edition of the Federal Register and will 
submit them for OMB approval following the period for public comment.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in certain sections of 21 CFR part 201 have been approved under OMB 
control number 0910-0572; the collections of information in 21 CFR part 
314 have been approved under OMB control number 0910-0001; and the 
collections of information in 21 CFR part 601 have been approved under 
OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/

[[Page 55446]]

vaccines-blood-biologics/guidance-compliance-regulatory-information-
biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.regulations.gov.

    Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19501 Filed 9-8-22; 8:45 am]
BILLING CODE 4164-01-P