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Important Information for HCT/P Establishments

Regarding Zika Virus

Bulletin 17-3

March 13, 2017

We would like to bring to your attention important information for human cell, tissue and cellular and tissue-based product establishments regarding Zika virus. This information is posted on the FDA's web site.

Based on the movement of the population between Miami-Dade, Broward, and Palm Beach counties, CDC has also identified a potential increased risk to blood and tissue safety for Broward and Palm Beach counties that also dates back to June 15, 2016. Palm Beach County was previously identified as an area of active ZIKV transmission from August 24, 2016 to November 2, 2016 for the purposes of blood and tissue safety intervention. Although the threshold for designation as an area of active transmission has not been reached for Broward County, individuals in both Broward and Palm Beach counties have been identified as having potential increased risk due to local movement of the population within the contiguous tri-county area that includes Miami-Dade County.

More information is available on the Center for Disease Control website:

Areas at risk for locally-acquired Vector-borne Zika cases

If you have any questions, please feel free to contact industry.biologics@fda.hhs.gov.