H.R. 9774 — To amend the Federal Food, Drug, and Cosmetic Act to provide for expedited approval of priority nonprescription drugs, and for other purposes.

This section establishes a priority nonprescription drug designation process under new section 506M of the Federal Food, Drug, and Cosmetic Act. The Secretary may designate a nonprescription drug subject to a section 505(b) application if it targets a novel indication offering a meaningful public health benefit, is a new molecular entity, or contains an active ingredient never previously available over the counter, excluding drugs subject to a risk evaluation and mitigation strategy or controlled substances. Designation decisions must occur within 60 days of a sponsor request. The Secretary must facilitate development and expedite review through meetings, interactive advice, senior staff involvement, a cross-disciplinary project lead, and efficient trial design, including real-world evidence. The Secretary must publish a list of qualifying conditions in the Federal Register within 18 months, with 30 days for public comment, and submit a report to Congress within 4 years on designations, approvals, resources, and recommendations. The authority sunsets on September 30, 2032.