[Federal Register Volume 87, Number 174 (Friday, September 9, 2022)]
[Notices]
[Pages 55438-55440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19500]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1837]


Statement of Identity and Strength--Content and Format of 
Labeling for Human Nonprescription Drug Products; Draft Guidance for 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the availability of a draft guidance for industry entitled ``Statement 
of Identity and Strength--Content and Format of Labeling for Human 
Nonprescription Drug Products.'' This draft guidance provides 
recommendations for the content and format of the required statement of 
identity on the labeling of human nonprescription drug products. This 
draft guidance also provides recommendations on the inclusion of the 
drug product's strength on the labeling. The recommendations in this 
draft guidance are intended to help manufacturers, packers, 
distributors, applicants, relabelers, and sponsors ensure consistent 
content and format of the statement of identity and strength for all 
human nonprescription drug products. Consistent content and format

[[Page 55439]]

of the statement of identity and strength may aid consumers in 
comparing nonprescription drug products and assist consumers in 
appropriate self-selection.

DATES: Submit either electronic or written comments on the draft 
guidance by November 8, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2022-D-1837 for ``Statement of Identity and Strength--Content and 
Format of Labeling for Human Nonprescription Drug Products.'' 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 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.govinfo.gov/content/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. 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: Helen Lee, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 5493, Silver Spring, MD 20993, 301-796-6848.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Statement of Identity and Strength--Content and Format of 
Labeling for Human Nonprescription Drug Products.'' This draft guidance 
provides recommendations for the content and format of the required 
statement of identity on the labeling of human nonprescription drug 
products. This draft guidance also provides recommendations on the 
inclusion of the drug product's strength on the labeling.
    Labeling for nonprescription drug products is intended to enable 
consumers to self-select appropriately and use the nonprescription drug 
product safely and effectively without the supervision of a healthcare 
practitioner. Nonprescription drug products must comply with applicable 
labeling requirements for over-the-counter (OTC) products under 21 CFR 
part 201, including, but not limited to, the statement of identity 
under Sec.  201.61 (21 CFR 201.61). The statement of identity is one of 
the principal features on nonprescription drug product labeling and 
consists of the established name for the nonprescription drug product, 
if one exists, followed by an accurate statement of the general 
pharmacological category(ies) or the principal intended action(s) of 
the drug. The labeling of all nonprescription drug products must 
display the statement of identity on the product's principal display 
panel (Sec.  201.61(a)).
    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 ``Statement of 
Identity and Strength--Content and Format of Labeling for Human 
Nonprescription 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

[[Page 55440]]

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. 
3501-3521). 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 21 CFR part 314 have 
been approved under OMB control number 0910-0001.

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/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19500 Filed 9-8-22; 8:45 am]
BILLING CODE 4164-01-P


