FDA Seeks Comments on Tissue Product Paperwork Burden
Published Date: 9/9/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about human cells and tissues used in medicine. This affects anyone who handles or regulates these products, and they’re asking for comments by November 9, 2026. No big money changes yet, just making sure the paperwork is clear and easy for everyone.
Analyzed Economic Effects
5 provisions identified: 0 benefits, 5 costs, 0 mixed.
Mandatory HCT/P Registration and Listing
If your establishment recovers, processes, stores, labels, packages, or distributes human cells, tissues, or cellular and tissue-based products (HCT/Ps) regulated solely under section 361 of the Public Health Service Act, you must register and submit a list of each HCT/P using Form FDA 3356. FDA estimates 2,531 total annual respondents (2,374 existing registrants and 157 new registrants) and requires registration whether or not the HCT/P enters interstate commerce.
Extensive Recordkeeping and SOP Obligations
Establishments must establish and maintain standard operating procedures (SOPs) and records documenting methods, facilities, and controls used for manufacture of HCT/Ps, including recovery, donor screening/testing, processing, storage, labeling, packaging, and distribution. FDA estimates recordkeeping burden includes 157 recordkeepers establishing SOPs at 48 hours each (7,536 hours), 2,374 recordkeepers updating SOPs at 24 hours each (56,976 hours), and a total recordkeeping burden of 2,235,005 hours annually for part 1271.
Large Third-Party Disclosure Burden
Certain provisions require disclosure of information to third parties as part of good tissue practice/CGTP; FDA estimates 1,611 respondents will make a combined total of 8,030,435 disclosures annually, with an estimated 2,389,226 hours of burden each year for those disclosures. These disclosures relate to distribution and other CGTP requirements.
Specific Reporting Duties and Hours
Part 1271 requires establishments to submit specific reports such as initial registrations (2,374 responses), new establishment registrations (157 responses), updates to listings (566 responses), location/ownership amendments (346 responses), adverse action reports (214 responses), import notifications (560 responses), and other filings. FDA estimates the total annual reporting burden across these activities is 2,102 hours.
Required Electronic Submission via eHCTERs
FDA requires electronic submission of establishment registration and product listing information through the Electronic Human Cell and Tissue Establishment Registration System (eHCTERs) using Form FDA 3356 under Sec. 1271.22. A request for waiver of the electronic format may be submitted under Sec. 1271.23, and if granted, establishments may submit a paper Form FDA 3356 by mail.
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