Article 3 Notice of ORA Laboratory Optimization

On March 15, 2016, FDA provided formal notice to NTEU regarding a plan to implement a laboratory optimization initiative in the Office of Regulatory Affairs (ORA). According to the notice, the purpose of the initiative is to reorganize laboratory functions in order to create distinct “specialized” laboratories and programs across ORA. This reorganization will align the Office of Regulatory Science (ORS) to the Office of the Associate Commissioner of Regulatory Affairs (OACRA), and further aligns all ORA laboratories to ORS in order to provide a centralized managerial structure. Although laboratory employees will remain in the same scientific discipline (e.g., Microbiologist, Biologist, Chemist, and Engineer), they will be required to specialize their work, going from “generalists” to “specialists” within a designated program area.

The agency contends that this laboratory optimization initiative will have minimal impact on employees; however, based on the fact that employees will be required to specialize in a program area, NTEU believes that the initiative will impact the work that laboratory employees perform on a daily basis.

The proposed ORA Laboratory Optimization is part of the proposed FDA/ORA Program Realignment that I wrote to you about earlier this month. NTEU has been briefed on the Program Realignment and has requested a briefing and to bargain over the proposed laboratory optimization initiative as well.

NTEU will use the same bargaining team already appointed for the FDA/ORA Program Realignment and will bargain the two initiatives together. The bargaining team includes Chapter Presidents Cheryl Monroe (Chapter 230), David Arvelo (Chapter 254), Mike Theodorakis (Chapter 282), Russell Glapion (Chapter 290), and Joe Teixeira (Chapter 288) as alternate.

I welcome and encourage your comments and questions on this issue.