FDA Office of Regulatory Affairs Program Alignment Implementation

Office of Regulatory Affairs (ORA) logoIt has come to NTEU’s attention that the ORA Denver Laboratory announced that it will be moving forward with Program Alignment as early as April 1, 2016. FDA Labor Relations Staff (LR) has repeatedly told NTEU that the agency would not be moving forward with this initiative until the statutory and contractual bargaining obligations were met. The agency also indicated that it had issued a cease-and-desist order to the labs and would soon issue a formal notice. NTEU has not received formal notice and the parties have not started formal bargaining as of yet.

Associate Commissioner for Regulatory Affairs (ACRA) Melinda Plaisier, head of ORA, assured NTEU that the agency will not move forward with Program Alignment by April 1 since Congress has not approved the agency’s proposal and the required bargaining with NTEU has not concluded.

I emailed this information to Denver Laboratory Director Mark Madson asking him to cease and desist misinforming employees about laboratory realignment.

Please let me know if management officials inform employees or actually move forward with Program Alignment implementation.

NTEU is prepared to take any necessary legal action to protect the Union’s right to bargain over impact and implementation of changes in working conditions.