The Food and Drug Administration (FDA) is inviting public comments on a proposal to collect certain information related to infectious disease issues in xenotransplantation, which involves transplanting animal organs into humans. This proposed data collection aims to help regulate and ensure the safety of these procedures by maintaining records and specimens for 50 years to prevent disease transmission. Interested parties can submit their comments electronically or in writing by June 30, 2025. The FDA also outlines the estimated burden placed on organizations participating in xenotransplantation studies, including reporting, recordkeeping, and third-party disclosures.
Simple Explanation
Imagine the FDA wants to learn more about how safe it is to put animal organs in people to help them get better. They are asking people what they think about keeping track of important safety information for a very long time, like 50 years, to make sure nobody gets sick.