Federal Register #2026-21713

FDA public comment request on product jurisdiction and combination-product information collection

The FDA is seeking public input on an information collection about product jurisdiction and combination products, not purchasing goods or services. - Government buyer: U.S. Department of Health and Human Services, Food and Drug Administration (FDA). - Scope: Information collection supporting FDA product-classification and jurisdiction determinations under 21 CFR Parts 3 and 4. - Covers Requests for Designation (RFDs), Pre-RFD submissions, and Combination Product Agreement Meeting (CPAM) requests. - Respondents and estimated burden: 149 respondents annually—52 RFD requests, 94 Pre-RFD submissions, and 3 CPAM requests—with an estimated 3,579 total annual burden hours. - Estimated response time: 24 hours per RFD or Pre-RFD submission and 25 hours per CPAM request. - No OEMs, vendors, products, or quantities for purchase are identified. This is a regulatory comment request, not a procurement opportunity.

Description

The FDA is soliciting public comments on an information collection concerning product jurisdiction and combination product regulations under 21 CFR Parts 3 and 4. The collection supports FDA product classification and jurisdiction determinations, including Requests for Designation (RFDs), Pre-RFD submissions, and Combination Product Agreement Meeting requests. Respondents are sponsors of medical products, including combination products; FDA estimates 149 respondents annually. Comments are due December 22, 2026.

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