FDA has provided Article 3 notice to NTEU that the Office of Food Safety (OFS) plans to implement a new standard operating procedure (SOP) entitled “Engagement in Regulatory Activities and Outbreak Response Efforts.” According to the notice, the purpose of the SOP is to clarify roles and responsibilities and to have the current process written down. The agency contends that establishing a written SOP will allow the OFS to point to the SOP when external groups wish to engage. The SOP explains how the branch will conduct their work in response to the external groups asking OFS for SME input.
NTEU has requested a briefing and to bargain this change. If you have any comments or questions, please share them with your chapter president.