(a) Subject to its cooperation agreement with FDA, TOPS will work in coordination with the FDA's Coordinated Outbreak Response and Evaluation ("CORE") Network to respond to an outbreak which has been identified by CORE.
(b) FDA will be the lead agency conducting on-site visits and inspections related to an outbreak.

Source Note: The provisions of this §11.4 adopted to be effective September 11, 2019, 44 TexReg 4855