🩺FDA Notice on Xenotransplantation and Infectious Disease Guidelines
Agency Information Collection Activities; Proposed Collection; Comment Request; Public Health Service Guideline on Infectious Disease Issues in Xenotransplantation
Summary
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to this notice. This notice solicits comments on the collection of information contained in the Public Health Service (PHS) guideline entitled "PHS Guideline on Infectious Disease Issues in Xenotransplantation" dated January 19, 2001.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The content discusses the FDA’s information collection regarding xenotransplantation, involving regulatory requirements for businesses in this niche area. Compliance with guidelines for data collection and record retention (including 50-year documentation) impacts businesses involved in xenotransplantation and related clinical studies, necessitating regulatory adherence that could influence operational costs and processes.