Guidance: Annual Reportable Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products

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Labeling Changes for New Drug Applications and Abbreviated New Drug Applications for Nonprescription Drug Products; Draft Guidance for Industry; Availability

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Submit either electronic or written comments on the draft guidance by May 13, 2024 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

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 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.

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.

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 §§ 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⁾

"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 § 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⁾

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 § 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 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 .

[FR Doc. 2024-05293 Filed 3-12-24; 8:45 am]

BILLING CODE 4164-01-P

⁽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.

⁽⁴⁾  See §§ 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.

⁽⁵⁾  See § 314.70(d).

⁽⁶⁾  See §§ 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 (§ 314.81(b)(2)(iii)( a )).

⁽⁷⁾  See § 314.81(b)(2)(iii)( c ).