February 2, 2001
PHS Guideline on Infectious Disease Issues in Xenotransplantation Moves Forward
The U.S. Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation received final approval from the Office of Management and Budget on Jan. 19. The guideline has not changed from the Oct. 18, 2000 version made accessible to the public for the purpose of comments on its associated paperwork burden, except that it is no longer marked as "draft." Formal publication in the Federal Register of the Notice of Availability may be delayed pending further administrative review [see Washington Highlights, Jan. 26]; however, the guideline itself is already public. As a reminder, the guideline is not a rule or regulation, and therefore does not have the force of law. However, FDA can implement the guideline in its assessment of safety as part of the IND process (21 CFR 312).
In related news, the Secretary's Advisory Committee on Xenotransplantation (SACX) will hold its first meeting Feb. 20-21, as announced in the Jan. 31 Federal Register [66 FR 8421-2]. The meeting will be open to the public and will be primarily for orientation and organizational purposes. At the time of the news release, the names of the 18 SACX members had not been announced.
Information: Andrew Quon, AAMC Division of Biomedical and Health Sciences Research, 202-828-0485.
