[Federal Register Volume 89, Number 50 (Wednesday, March 13, 2024)]
[Notices]
[Pages 18418-18420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05293]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-5616]


Annual Reportable Labeling Changes for New Drug Applications and 
Abbreviated New Drug Applications for Nonprescription Drug Products; 
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
announcing the availability of a draft guidance for industry entitled 
``Annual Reportable Labeling Changes for NDAs and ANDAs for 
Nonprescription Drug Products.'' This draft guidance provides 
recommendations to applicants of approved new drug applications (NDAs) 
and abbreviated new drug applications (ANDAs) for nonprescription drug 
products on documenting minor labeling changes in the next annual 
report and provides examples of minor labeling changes that may be 
submitted in an annual report. The recommendations in this draft 
guidance address the types of minor labeling changes that may be 
appropriate to submit in an annual report to ensure that consumers have 
timely access to the most current labeling for a nonprescription drug 
product to ensure the product's safe and effective use. We anticipate 
that these recommendations may assist industry in understanding the 
circumstances in which it would be appropriate to document minor 
changes in the applicant's next annual report rather than submitting a 
prior approval supplement or ``changes being effected'' supplement, 
thereby reducing burden on industry and FDA.

DATES: Submit either electronic or written comments on the draft 
guidance by May 13, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-2023-D-5616 for ``Annual Reportable Labeling Changes for NDAs and 
ANDAs for 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

[[Page 18419]]

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: Trang Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 4139, Silver Spring, MD 20993-0002, 240-402-7945.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Annual Reportable Labeling Changes for NDAs and ANDAs for 
Nonprescription Drug Products.'' This draft guidance provides 
recommendations to applicants of approved NDAs and ANDAs for 
nonprescription drug products on documenting minor labeling changes in 
the next annual report. The draft guidance also provides examples of 
minor labeling changes that may be submitted in an annual report.
    FDA evaluates whether the data and information submitted as part of 
an NDA or ANDA for a nonprescription drug product demonstrate that the 
drug product is safe and effective for nonprescription use under the 
conditions prescribed, recommended, or suggested in its proposed 
labeling.\1\ A nonprescription drug must be labeled with adequate 
directions for use.\2\ Adequate directions for use are the directions 
under which the consumer can use the drug safely and for the purposes 
for which it is intended.\3\ Therefore, labeling for a nonprescription 
drug product enables consumers to appropriately self-select and use the 
nonprescription drug product safely and effectively without the 
supervision of a healthcare practitioner.
---------------------------------------------------------------------------

    \1\ See sections 505(d) and 503(b)(1) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(d) and 353(b)(1)).
    \2\ See section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)).
    \3\ See 21 CFR 201.5.
---------------------------------------------------------------------------

    After FDA approves an NDA or ANDA, an applicant may make, or in 
certain cases propose to FDA, changes to the approved application. 
Section 506A of the FD&C Act (21 U.S.C. 356a) and FDA regulations under 
Sec. Sec.  314.70, 314.71, and 314.97 (21 CFR 314.70, 314.71, and 
314.97) provide certain requirements for making and reporting to FDA 
changes to an approved NDA or ANDA, including an NDA or ANDA for a 
nonprescription drug product. Changes to an approved NDA or ANDA, 
including labeling changes, are categorized into one of three reporting 
categories: major, moderate, or minor.\4\
---------------------------------------------------------------------------

    \4\ See Sec. Sec.  314.70 and 314.97; see also the guidance for 
industry entitled ``Changes to an Approved NDA or ANDA,'' available 
at https://www.fda.gov/media/71846/download.
---------------------------------------------------------------------------

    ``Minor changes'' include certain changes that have a minimal 
potential to have an adverse effect on the identity, strength, quality, 
purity, or potency of a drug product as these factors may relate to the 
safety or effectiveness of the drug product.\5\ Minor changes with an 
approved NDA or ANDA may be implemented immediately by the applicant 
without the applicant submitting a supplement to FDA. The applicant 
must document minor changes, including minor labeling changes, in its 
next annual report in accordance with Sec.  314.81(b)(2) (21 CFR 
314.81(b)(2)) (i.e., the annual report covering the period when the 
change or changes occurred) submitted to FDA.\6\ The annual report must 
include a summary of any changes in labeling, including minor changes, 
that have been made since the last report listed by date in the order 
in which they were implemented, or if no changes have been made, a 
statement of that fact.\7\
---------------------------------------------------------------------------

    \5\ See Sec.  314.70(d).
    \6\ See Sec. Sec.  314.70(d) and 314.81(b)(2). Additionally, a 
representative sample of, among other things, the package labels 
must be submitted in the annual report (Sec.  314.81(b)(2)(iii)(a)).
    \7\ See Sec.  314.81(b)(2)(iii)(c).
---------------------------------------------------------------------------

    Determining the reporting category for a change to nonprescription 
drug labeling may present certain considerations that differ from 
changes to prescription drug labeling. Changes to the approved labeling 
for a nonprescription drug product may affect consumers' ability to 
appropriately self-select and use the nonprescription drug product 
safely and effectively without the supervision of a healthcare 
practitioner. Thus, changes to nonprescription labeling may not be 
considered minor even though similar changes may be considered minor 
when applied to the labeling of a prescription drug product. For 
example, certain changes in the layout of the package or container 
label for a prescription drug product that are consistent with FDA 
regulations (e.g., 21 CFR part 201), without a change in the content of 
the labeling, might not affect the safe and effective use of the 
prescription drug product because it is used under the supervision of a 
healthcare practitioner. In contrast, changes in the layout of the 
package or container label and other changes to nonprescription drug 
labeling could affect consumers' ability to comprehend the 
nonprescription drug labeling and to appropriately self-select and use 
the nonprescription drug product such that the change would not be a 
minor change under Sec.  314.70(d).
    FDA generally does not expect that editorial and similar minor 
labeling changes to nonprescription drug labeling would affect 
consumers' ability to appropriately self-select and use the 
nonprescription drug product without the supervision of a healthcare 
practitioner. Based on FDA's experience approving nonprescription drug 
labeling, FDA is providing specific examples of such editorial or 
similar minor labeling changes for nonprescription drug products that 
may be appropriate to include in an annual report.
    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

[[Page 18420]]

on ``Annual Reportable Labeling Changes for NDAs and ANDAs for 
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

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved 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). The collections of information 
in 21 CFR part 314 relating to the submissions of NDAs and ANDAs, 
supplemental applications, and annual reports have been approved under 
OMB control number 0910-0001. The collections of information in 21 CFR 
part 201 for the format and content requirements for nonprescription 
drug product labeling have been approved under OMB control number 0910-
0340. The collections of information in 21 CFR part 211 have been 
approved under OMB control number 0910-0139.

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: March 8, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05293 Filed 3-12-24; 8:45 am]
BILLING CODE 4164-01-P