Federal Register #FDA-2026-N-9638

FDA Requests Public Comment on Information Collection for HCT/Ps Regulatory Compliance

This opportunity involves the Food and Drug Administration (FDA), under the Department of Health and Human Services, seeking public comment on information collection requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps). - Government Buyer: - Food and Drug Administration (FDA) - Department of Health and Human Services - OEMs and Vendors: - No OEMs or vendors are specified; this is not a procurement opportunity. - Products/Services Requested: - No products or services are being procured. - The notice pertains to information collection related to regulatory compliance for HCT/Ps. - Notable Requirements: - Covers statutory and regulatory requirements under 21 CFR part 1271. - Includes registration, listing, donor eligibility, manufacturing methods, and recordkeeping for establishments handling HCT/Ps. - FDA is seeking input on the necessity, accuracy, and burden of these information collection activities. - Suggestions for minimizing respondent burden are encouraged. - No part numbers, quantities, or unique product/service requirements are specified.

Description

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to statutory and regulatory requirements governing certain human cells, tissues, and cellular and tissue-based products (HCT/Ps). This includes registration, listing, donor eligibility, manufacturing methods, and recordkeeping requirements under 21 CFR part 1271. The notice invites comments on the necessity, accuracy, and burden of the information collection, as well as ways to minimize respondent burden. Comments must be submitted by November 9, 2026.

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