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Guidance Issuing OfficeCenter for Biologics Evaluation and Research
On behalf of the U.S. Public Health Service (PHS), the Food and Drug Administration (FDA) is announcing the availability of a guideline entitled ‘‘PHS Guideline on Infectious Disease Issues in Xenotransplantation’’ dated January 19, 2001. This guideline was developed by the PHS to identify general principles for the prevention and control of infectious diseases associated with xenotransplantation that may pose a hazard to public health. The guideline is intended to provide general guidance to local review bodies evaluating proposed xenotransplantation protocols and to sponsors in developing xenotransplantation protocols, in preparing submissions to FDA and the Secretary’s Advisory Committee on Xenotransplantation, and in conducting xenotransplantation clinical trials.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: 96M-0311.