Federal Register #Docket No. FDA-2026-N-3400

FDA Seeks Public Comment on Orphan Drug Information Collection Requirements

This notice from the Food and Drug Administration (FDA) seeks public comment on proposed information collection related to orphan drug requirements: - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Purpose: - Collects information to support orphan drug development, designation, exclusivity, and open protocols under the Federal Food, Drug, and Cosmetic Act - Information Collected: - Orphan drug designation requests - Annual reports and amendments - Meeting requests with the Office of Orphan Products Development - Related submissions and forms (e.g., Form FDA 4035) - Notable Requirements: - Applies to orphan drugs, including biological products and antibiotics - Seeks feedback on necessity, accuracy, and burden of information collection - Guidance documents and forms provided to assist sponsors - No OEMs or vendors are specified, as this is a regulatory information collection notice, not a procurement for products or services - No products or services are being purchased or contracted

Description

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to orphan drug requirements under the Paperwork Reduction Act of 1995. This collection supports the implementation of sections 525-528 of the Federal Food, Drug, and Cosmetic Act concerning the development, designation, exclusivity, and open protocols for orphan drugs. The FDA invites comments on the necessity, accuracy, and ways to minimize the burden of this information collection, which includes submissions such as orphan drug designation requests, annual reports, and meeting requests with the Office of Orphan Products Development. Comments must be submitted by June 15, 2026.

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