PHS Guideline on Infectious Disease Issues in Xenotransplantation

OMB 0910-0456

OMB 0910-0456

This information collection supports implementation of sections 351 and 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 262 and 264) and certain drug provisions of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), regarding xenotransplantation. As set forth in the “PHS Guideline on Infectious Disease Issues in Xenotransplantation,” guidelines have been developed by the Public Health Service (PHS) to identify general principles for the prevention and control of infectious diseases associated with xenotransplantation that may pose a risk to public health. The PHS guideline recommends procedures to diminish the risk of transmission of infectious agents to the xenotransplantation product recipient and to the general public.

The latest form for PHS Guideline on Infectious Disease Issues in Xenotransplantation expires 2022-06-30 and can be found here.

OMB Details

Notification to FDA when source facility or sponsor ceases operations

Federal Enterprise Architecture: Health - Health Care Services


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