FDA Requests Public Comment on Proposed Collection of Information for Reporting of Biological Product and Human Cell Deviations

Summary

The Food and Drug Administration (FDA) is seeking public input on a proposed rule requiring the reporting of deviations in biological products and human cells, tissues, and cellular and tissue-based products, as outlined in Form FDA 3486 and Addendum 3486A, in accordance with the Paperwork Reduction Act of 1995.