Federal Register #2026-21714

FDA Information Collection for Export Certificates for Regulated Products

The U.S. Food and Drug Administration is seeking public comments on information collection for export certificates covering FDA-regulated products; this is not a procurement or contract award. - Government agency: Department of Health and Human Services (HHS), Food and Drug Administration (FDA). - Opportunity type: Regulatory information-collection notice, not a request to purchase products or services. - Scope: Export certification information for human and animal drugs, biologics, medical devices, food, and other FDA-regulated products. - Forms discussed: Proposed revisions to Forms 3613, 3613a, and 3613b, plus new Forms 3613h (Supplementary Information; Certificate of Free Sale) and 3613i (Supplementary Information; Current Good Manufacturing Practice Certificate). - Estimated activity: 50,944 responses annually across FDA centers. - OEMs, vendors, and purchased items: None identified; no products or services are being procured.

Description

The Food and Drug Administration (FDA) is seeking public comments on its proposed information collection concerning export certificates for FDA-regulated products. The collection includes FDA forms used to request export certifications and supplementary information for products including drugs, biologics, medical devices, food, and veterinary products. The notice describes proposed revisions to certain forms and the addition of two new forms, along with electronic submission processes. Comments are due by December 22, 2026.

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