Federal Register #FDA-2026-D-2698

FDA Draft Guidance Release: Forms FDA 3542a and FDA 3542 for Patent Information Submission

This notice announces the release of a draft guidance by the Food and Drug Administration (FDA) for industry regarding Forms FDA 3542a and FDA 3542. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Purpose: - Provides draft guidance to assist New Drug Application (NDA) applicants and holders in preparing and submitting patent information using Forms FDA 3542a and FDA 3542 - Answers common questions about the forms and submission process - Offers instructions for obtaining, completing, and submitting the forms as required under the Federal Food, Drug, and Cosmetic Act - No procurement activity: - No products, services, OEMs, or vendors are being requested or procured - No quantities, part numbers, or unique technical requirements are listed - Notable details: - This is an informational release, not a solicitation or contract opportunity

Description

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance aims to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542 and assist applicants in preparing and submitting these forms to FDA. It provides detailed instructions on obtaining, filling out, and submitting patent information related to New Drug Applications (NDAs). The guidance is intended to help NDA applicants and holders comply with patent submission requirements under the Federal Food, Drug, and Cosmetic Act.

View original listing