FDA has provided Article 3 notice to NTEU that the Office of Regulatory Affairs plans to implement a Standard Operating Procedure (SOP) for “Disclosure of Information to State and Local Partners.” According to the notice, the SOP sets forth the procedures related to the sharing of non-public information with state and local (including tribal) government officials pursuant to requests for information the FDA receives per 21 C.F.R. § 20.88 (20.88 requests). The SOP pertains to all requests for non-public information submitted to the FDA from state government officials and agencies that OSPOP’s Division of Information Disclosure Policy staff receives and handles. A copy of the proposed SOP and list of impacted bargaining unit employees (BUEs) is available upon request from an impacted BUE.
NTEU has requested a briefing and to bargain this change. If you have any comments or questions, please contact your chapter president.