FDA Releases Draft Answers for Two Routine Forms
Published Date: 6/15/2026
Notice
Summary
The FDA just dropped a draft guide to help businesses fill out Forms FDA 3542a and FDA 3542 without confusion. If you submit these forms, this guide answers your top questions and makes the process smoother. You’ve got until August 14, 2026, to send in your feedback before the FDA finalizes the guide—no extra costs, just clearer steps!
Analyzed Economic Effects
6 provisions identified: 5 benefits, 1 costs, 0 mixed.
Draft Q&A for FDA Forms 3542a/3542
The FDA published a draft guidance titled "Forms FDA 3542a and FDA 3542: Questions and Answers" to help New Drug Application (NDA) applicants and NDA holders prepare and submit patent information using Forms FDA 3542a and FDA 3542. The document organizes answers into three topics: obtaining/filling the forms, Section 6 (Declaration Certification), and submitting patent information.
Public Comment Deadline: August 14, 2026
Stakeholders may submit electronic or written comments on the draft guidance to the docket, and FDA must receive comments by August 14, 2026 for consideration before the final guidance is developed. Comments submitted to regulations.gov will be posted publicly unless submitted as confidential written/paper submissions per the instructions.
No New Information Collection Under PRA
The draft guidance states it "contains no collection of information" under the Paperwork Reduction Act, but it refers to previously approved FDA collections related to NDA submissions under OMB control number 0910-0001. The guidance therefore does not establish new PRA reporting requirements.
When to Use Form 3542a vs Form 3542
The guidance explains that Form FDA 3542a must be used when an NDA applicant submits patent information for an unapproved original NDA, an NDA amendment, or an NDA supplement, while Form FDA 3542 must be used when an NDA holder submits patent information for an approved NDA or an approved supplement to an NDA (see 21 CFR 314.53(c)).
Guidance Is Non‑Binding; Alternatives Allowed
FDA states the draft guidance, when finalized, will represent the Agency's current thinking but does not establish any rights and is not binding on FDA or the public; you may use an alternative approach if it satisfies applicable statutes and regulations. This preserves flexibility for applicants who can demonstrate compliance by other means.
30‑Day Post‑Approval Patent Submission Requirement
The notice restates that under 21 U.S.C. 355(c)(2) an NDA holder must submit certain patent information no later than 30 days after the date of approval for patents that could reasonably be asserted against manufacture, use, or sale of the drug. The guidance is intended to assist holders in meeting that statutory submission requirement.
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