Hearings, Meetings, Proceedings, etc.: Increasing Access to Nonprescription Drugs

Increasing Access to Nonprescription Drugs; Public Meeting; Request for Comments

DATES:

The public meeting will be held virtually and in person on April 23, 2026, from 12:30 p.m. to 5 p.m. Eastern Time. Either electronic or written comments on this public meeting must be submitted by May 8, 2026. See the SUPPLEMENTARY INFORMATION section for registration date and information.

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-2025-N-4731 for "Increasing Availability of Nonprescription Drugs; Public Meeting; Request for Comments." Received comments, those filed in a timely manner (see ADDRESSES ), 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.

SUPPLEMENTARY INFORMATION:

I. Background

In connection with the Federal Register notice entitled "Increasing Access to Nonprescription Drugs; Request for Information," published December 2, 2025 (90 FR 55316) (the December 2025 notice), we are announcing a public meeting to discuss topics related to increasing access to nonprescription drugs. This public meeting will be convened and supported by a cooperative agreement between FDA and the Duke-Margolis Institute for Health Policy. We also welcome any comments on specific topics covered at the public meeting or about increasing access to nonprescription drugs generally. If you submitted a comment to the December 2025 notice, you do not need to resubmit it here.

II. Participating in the Public Meeting

Registration: To register for the public meeting, please visit the event website: https://duke.is/p/4g3b.

Registration is free and based on space availability, with priority given to early registrants. Persons interested in attending this public meeting in person must register by April 22, 2026, at 5 p.m. Eastern Time and receive registration confirmation. Early registration is recommended because seating is limited. Persons attending virtually must register by April 23, 2026, at 5 p.m. Eastern Time. Registrants will receive confirmation when they have been accepted. If you need special accommodations due to a disability, please contact [email protected] no later than April 22, 2026, at 5 p.m. Eastern Time.

Streaming Webcast of the Public Meeting: This public meeting will also be webcast via Zoom. The archived footage will be available at the event website: https://duke.is/p/4g3b.

Transcripts: A link to the transcript will be available on the internet at https://duke.is/p/4g3b.

Notice of this meeting is given pursuant to 21 CFR 10.65.