SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a final guidance for industry titled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” This guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of nonprescription drugs without approved new drug applications that are governed by section 505G of the FD&C Act (21 U.S.C. 355h) (hereafter referred to as OTC monograph drugs) or organizations nominated by sponsors or requestors to represent their interests in a proceeding. For the purposes of this guidance, a formal meeting includes any meeting that is requested by a sponsor or requestor of OTC monograph drugs (hereafter referred to collectively as meeting requester(s)) to obtain advice on the studies and other information necessary to support OTC monograph order submissions, to obtain advice on other matters relevant to OTC monograph drug regulation, or to obtain advice on OTC monograph drug development and includes meetings conducted in any format ( i.e., hybrid in person face-to-face, virtual face-to-face video conference, teleconference, and written response only).

Section 505G of the FD&C Act was added by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Public Law 116-136, 134 Stat. 281, 457, which was enacted on March 27, 2020. As required by section 505G(l) of the FD&C Act (21 U.S.C. 355l), this guidance discusses the procedures and principles for formal meetings between FDA and meeting requesters. In doing so, and as required by section 505G(h) of the FD&C Act, this guidance describes procedures under which meeting requesters can meet with appropriate FDA officials to obtain advice on the studies and other information necessary to support submissions under section 505G of the FD&C Act, to obtain advice on other matters relevant to the regulation of nonprescription drugs, and to obtain advice on the development of new OTC monograph drugs. This guidance also applies to meetings with FDA to obtain advice on clinical investigations that may be conducted under an investigational new drug application (IND) where the purpose of the IND is to conduct a clinical investigation to support a determination of whether an OTC monograph condition is generally recognized as safe and effective under section 505G(b) of the FD&C Act. As required by section 505G(i) of the FD&C Act, this guidance also describes procedures to facilitate efficient participation in joint meetings by multiple meeting requesters and/or organizations nominated by them to represent their interests.

This guidance does not apply to formal meetings for the development of nonprescription drug products intended for submission in new drug applications or abbreviated new drug applications under section 505 of the FD&C Act.

In support of the CARES Act, FDA agreed to specific performance goals and procedures described in the document “Over-the-Counter Monograph User Fee Program Performance Goals and Procedures—Fiscal Years 2018-2022,” commonly referred to as the OMUFA Commitment Letter (the document can be accessed at https://www.fda.gov/​media/​106407/​download and the document with updated goal dates for fiscal years 2021-2025 can be accessed at https://www.fda.gov/​media/​146283/​download). In the OMUFA Commitment Letter, FDA committed to issuing this guidance under specific timelines. Under the reauthorization of the Over-the-Counter Monograph User Fee Amendments (OMUFA) (Pub. L. 119-37, 139 Stat. 637), which was enacted on November 12, 2025, FDA continued to agree to specific performance goals and procedures as described in the document “Over-the-Counter Monograph Drug User Fee Program Performance Goals and Procedures—Fiscal Years 2026-2030 document (OMUFA II commitment letter) and to apply them to formal meetings between FDA staff and meeting requesters (the document can be accessed at https://www.fda.gov/​media/​182750/​download). The OMUFA II commitment letter includes updated meeting management goals for formal meetings that occur between FDA and meeting requesters, which are incorporated into this guidance.

This guidance finalizes the draft guidance titled “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs” issued on February 7, 2022 (87 FR 6877). FDA considered comments received on the draft guidance as the guidance was finalized. Changes from the draft guidance to the final guidance are primarily intended to improve clarity and to address comments. On our own initiative, we revised the guidance to apply to meetings with FDA to obtain advice on clinical investigations that may be conducted under an IND, where the purpose of the IND is to conduct a clinical investigation to support a determination of whether there are conditions under which a nonprescription drug is generally recognized as safe and effective. To conform to the OMUFA II commitment letter, FDA also made clarifying revisions to specify the requirements in order to qualify for specific meeting performance goals. For consistency and clarity, FDA clarified the meeting formats. To address commenters' concerns that FDA was limiting the number of Type Y meetings, which could affect OTC monograph order development, we explain that there are three different categories of Type Y meetings and that generally FDA will grant one Type Y meeting per category during the course of the meeting requester's OTC monograph order development program. On our own initiative, we revised the meetings formats ( i.e., in person face-to-face, virtual face-to-face, teleconference, and written response only (WRO)) to better accommodate virtual and hybrid meetings. To address apparent commenter confusion, we removed the use of the term “OTC monograph industry working group” and replaced it with the term “joint meeting requester” to avoid confusion. To address commenter concerns about confidentiality, we clarified when information submitted to FDA in connection with formal meetings is considered confidential and when FDA would post information in connection with a formal meeting. To address commenter questions, we explained the process for meeting requesters to submit clarifying questions on information in the meeting minutes or WRO to FDA following their receipt.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs.” 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

Under section 505G(o) of the FD&C Act, the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) does not apply to collections of information made under section 505G of the FD&C Act. The information collections made in this guidance implement the provisions of three subsections of ( printed page 43100) section 505G: (1) Section 505G(l)(1), which requires FDA to issue guidance that specifies the procedures and principles for formal meetings between FDA and sponsors or requestors for drugs subject to section 505G; (2) section 505G(h), which requires FDA to establish procedures under which meeting requestors can meet with appropriate FDA officials to obtain advice on the studies and other information necessary to support submissions under section 505G, other matters relevant to the regulation of nonprescription drugs, and the development of new nonprescription drugs under section 505G; and (3) section 505G(i), which requires FDA to, among other things, establish procedures to facilitate efficient participation in joint meetings by multiple meeting requesters and/or organizations nominated by them to represent their interests. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required for these collections of information.

While this guidance contains no collection of information, it does refer to previously approved FDA collections of information subject to review by the Office of Management and Budget (OMB) under the PRA. The collections of information in 21 CFR 312 for investigational new drug applications have been approved under OMB control number 0910-0014. The collections of information in 21 CFR 201 subpart C for Labeling requirements for Over-the-Counter drugs and submission of OTC monograph fees have been approved under OMB control number 0910-0340. The information collections for OTC meetings and OTC information not exempted from PRA under section 505G of the FD&C Act have been approved under OMB control number 0910-0340.

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.