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The FDA published a draft guidance titled "Forms FDA 3542a and FDA 3542: Questions and Answers" to help New Drug Application (NDA) applicants and NDA holders prepare and submit patent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Stakeholders may submit electronic or written comments on the draft guidance to the docket, and FDA must receive comments by August 14, 2026 for consideration before the final guidance is developed.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The draft guidance states it "contains no collection of information" under the Paperwork Reduction Act, but it refers to previously approved FDA collections related to NDA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FDA states the draft guidance, when finalized, will represent the Agency's current thinking but does not establish any rights and is not binding on FDA or the public; you may use an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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-15343, Generic Drug User Fee Rates for Fiscal Year 2027
The Federal Food, Drug, and Cosmetic Act (FD&C Act or statute), as amended by the Generic Drug User Fee Amendments of 2022 (GDUFA III), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs); drug master files (DMFs); generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, and contract manufacturing organization (CMO) facilities; and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2027 rates for GDUFA III fees.
2026-15346, Biosimilar User Fee Rates for Fiscal Year 2027
Starting October 1, 2026, companies making biosimilar drugs will pay updated fees to the FDA for developing and getting approval for their products. These fees cover new drug development, application reviews, and yearly program costs. This helps the FDA keep biosimilar drug reviews speedy and fair while supporting innovation.
2026-15335, Medical Device User Fee Rates for Fiscal Year 2027
Starting October 1, 2026, medical device companies will see updated user fees for submitting their products to the FDA and for annual registrations. These fees help the FDA review and monitor medical devices, with special discounts available for small businesses. If you’re in the medical device world, get ready to budget for these new costs through September 30, 2027!
2026-15337, Food Safety Modernization Act Third-Party Certification Program User Fee Rate for Fiscal Year 2027
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies applying for direct FDA accreditation.
Previous / Next Documents
Previous: 2026-11964, Combined Notice of Filings #1
The Federal Energy Regulatory Commission got several new filings from energy companies about power projects, rate changes, and rule updates. These filings affect companies like 64NB 8me LLC, Piedra Solar, and PJM Interconnection, with some changes set to take effect as soon as June or August 2026. If you want to weigh in, comments are due by late June or early July, so don’t miss your chance to speak up!
Next: 2026-11967, Actions Taken at the June 4, 2026 Meeting
On June 4, 2026, the Susquehanna River Basin Commission gave the green light to several water projects in Pennsylvania, including new and renewed water withdrawals. They also updated their budget and water program, extended an emergency certificate, and secured important grants. These moves affect local communities and businesses by managing water use carefully, with some projects allowing up to 5 million gallons per day, starting immediately.