Federal Register #Docket No. FDA-2026-N-0497

FDA Request for Public Comment on Information Collection for Patent Term Restoration and Due Diligence Petitions

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, is requesting public comment on its proposed information collection for patent term restoration and due diligence petitions under 21 CFR part 60. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Office location: Three White Flint North, North Bethesda, MD - Products/Services Requested: - Information collection supporting patent term restoration, due diligence petitions, and related filings - Includes requests for revision of regulatory review period determinations, due diligence petitions, and hearings - OEMs and Vendors: - No OEMs or vendors are mentioned; this is an information collection activity - Unique/Notable Requirements: - Submission of factual and legal information necessary for requests and petitions - May require integration of legal analysis, scientific and technical documentation, and detailed factual timelines - Supports federal rulemaking and regulatory review processes - Place of Performance: - FDA, Three White Flint North, North Bethesda, MD

Description

The Food and Drug Administration (FDA) is announcing a proposed collection of information submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. This collection supports FDA regulations related to patent term restoration, due diligence petitions, and the filing, format, and content of petitions under 21 CFR part 60. The information collection involves requests for revision of regulatory review period determinations, due diligence petitions, and hearings related to patent term extensions. The FDA is seeking public comments on this collection by June 22, 2026.

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