FDA Seeks Comment on HCT/P Information Collection

September 09, 2026

The Food and Drug Administration is seeking public comment on the information collection associated with requirements for human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulated under 21 CFR part 1271. The agency estimates an annual burden of approximately 2.2 million hours for recordkeeping and 2.4 million hours for third-party disclosures, which remains unchanged from the current approval. Comments are due Nov. 9.