2016-09372: Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Rescheduling of Public Hearing; Request for Comments
Public comment closed .
Get alerted when the next rule lands
New rules open for comment on their own schedule. Pick how you want to hear about them — we email you when one appears.
Publishing to members? Embed a live rule tracker on your own site — the proposed rules in your area and the comment deadlines closing on them, updating themselves. Free, one line of HTML.
Create a free account & build one →Summary
The Food and Drug Administration (FDA or Agency) is announcing a 2-day public hearing to obtain input on four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). FDA had announced a 1-day public hearing for April 13, 2016, to obtain input on the guidances, but on February 29, 2016, announced that due to considerable interest in the public hearing and to give stakeholders additional time to provide comments to the Agency, the hearing was postponed. FDA also stated its intent to extend the comment period for the four draft guidance documents and to schedule a scientific workshop to identify and discuss the scientific considerations and challenges to help inform the development of HCT/Ps subject to premarket approval, including stem cell-based products. FDA will consider information it obtains from the public hearing in the finalization of the four draft guidance documents.
The agency’s own summary, as published.
What this changes
Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.
Don't miss the comment window
One Click Politics alerts you on every deadline, hearing, and rule change.
See all rules with comments due soon →