ORA “Authorizing Testimony” SOP

FDA has provided Article 3 notice to NTEU that ORA will revise the “Authorizing Testimony” SOP.

Testimony in courtThe FDA has provided Article 3 notice to NTEU that the Office of Regulatory Affairs (ORA) will revise its Standard Operating Procedure (SOP) for “Authorizing Testimony.” According to the notice, the SOP sets forth the procedures for handling requests for FDA employee testimony where the agency is not a party. FDA regulations do not permit employees to provide testimony, whether written or oral, pertaining to any function of the FDA, or with respect to any information acquired in performing their official duties, unless authorized by the FDA Commissioner or another FDA official to whom this authority has been delegated.

NTEU has requested a briefing and to bargain this change.

If you have any comments or questions, please contact your chapter president.