29 Jul 2025
🧬FDA Information Collection on Infectious Disease in Xenotransplantation
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
Summary
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The document outlines FDA requirements for information collection related to xenotransplantation, which impacts compliance and regulatory responsibilities for businesses involved in this field. Specifically, it mandates recordkeeping and reporting of health-related data, creating obligations for clinical study sponsors and source animal facilities.