Federal Register #FDA-2026-N-3400

FDA Requests Public Comment on Orphan Drug Information Collection

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is requesting public comment on its information collection activities related to orphan drugs. - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - Scope: - Proposed collection of information for orphan drug development, designation, exclusivity, and investigational use - Implementation of sections 525, 526, 527, and 528 of the Federal Food, Drug, and Cosmetic Act - Key Elements: - Includes guidance documents and forms (e.g., Form FDA 4035 for orphan drug designation requests) - Procedures for requesting meetings with the Office of Orphan Products Development - Notable Requirements: - No products or services are being procured - No OEMs or vendors are mentioned - FDA is seeking feedback from the public, not soliciting bids or proposals

Description

The Food and Drug Administration (FDA) is announcing that a proposed collection of information related to orphan drugs has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. This collection supports the implementation of sections 525, 526, 527, and 528 of the Federal Food, Drug, and Cosmetic Act concerning the development, designation, exclusivity, and investigational use of orphan drugs for rare diseases or conditions. The information collection includes guidance documents, forms, and procedures for requesting orphan drug designation, meetings with the Office of Orphan Products Development, and related submissions. Public comments on this collection are requested by October 21, 2026.

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