date:Apr 15, 2014
developing FSMA rules. But both Romero and Hipp noted that these meetings do not constitute formal consultation.
FDA is a subsidiary of HHS. So is its sister agency, the Indian Health Service (IHS), which has a very good template for formal Tribal Consultation. But, for some unknown reason, FDA is choosing not to follow a well-established Tribal Consultation Policy of HHS, Romero said.
In addition to the lack of face-to-face consultation, Hipp pointed out that FDA did not attempt to consult wi