# 2026-11966: FDA Releases Draft Answers for Two Routine Forms

2026-11966, Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2026-06-15, effective Submit either electronic or written comments on the draft guidance by August 14, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.; PRIA reads it as touching household money (as of 2026-06-22).

- Canonical: https://policyrisk.com/federal-register/2026-11966
- As of: 2026-06-22
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-11966
- Title: Forms FDA 3542a and FDA 3542: Questions and Answers; Draft Guidance for Industry; Availability
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 35985
- Published: 2026-06-15
- Effective: Submit either electronic or written comments on the draft guidance by August 14, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Comments close: 2026-08-14
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-06-22

## In one line

FDA Releases Draft Answers for Two Routine Forms

## 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!

## Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Forms FDA 3542a and FDA 3542: Questions and Answers." This draft guidance is intended to answer commonly asked questions regarding Forms FDA 3542a and FDA 3542, and to assist applicants in preparing and submitting these forms to FDA.

## Effects PRIA read

- Draft Q&A for FDA Forms 3542a/3542: benefit, low. The FDA published a draft guidance titled "Forms FDA 3542a and FDA 3542: Questions and Answers" to help New Drug Application (NDA) applicants and NDA holders prepare and submit patent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…
- Public Comment Deadline: August 14, 2026: benefit, low. 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 writt…
- No New Information Collection Under PRA: benefit, low. 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: benefit, low. 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 supplemen…
- Guidance Is Non‑Binding; Alternatives Allowed: benefit, low. 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 w…
- 30‑Day Post‑Approval Patent Submission Requirement: cost, low. 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…

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## Sources
- [2026-11966 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/15/2026-11966/forms-fda-3542a-and-fda-3542-questions-and-answers-draft-guidance-for-industry-availability)
- [2026-11966 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-15/pdf/2026-11966.pdf)

## Related
- [Previous: 2026-11964, Combined Notice of Filings #1](https://policyrisk.com/federal-register/2026-11964)
- [Next: 2026-11967, Actions Taken at the June 4, 2026 Meeting](https://policyrisk.com/federal-register/2026-11967)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-11966 (as of 2026-06-22).