FDA has provided Article 3 notice to NTEU of proposed changes to the Office of the Commissioner (OC). According to the notice, there are four primary aspects to the proposed change:
- Elevating the role of the Centers and the field force in support of FDA’s science driven culture. Specifically, the agency proposes to “flatten” the OC organizational structure by having all Center Directors and the Associate Commissioner for Regulatory Affairs engage directly with the Commissioner helps facilitate strong, direct communications, and ensures that FDA’s policies are Center-led efforts.
- Realigning several entities across OC to promote the agency’s strategic priorities. The agency’s proposed OC reorganization would include realignments to the Office of Policy, Planning, Legislation and Analysis, which will become known as the Office of Policy, Legislation and International Affairs (OPLIA). OPLIA’s primary focus would be to advise OC on agency policy and legislative issues and working closely with the Centers and ORA to strategically advance the FDA’s priorities. This office would also represent FDA to Congress, state and international governments, and manages these key relationships; as well as serving as a primary point of coordination with HHS and other federal partners. Additionally, according to the agency’s proposal, the Office of Minority Health (OMH), Office of Women’s Health (OWH), and the Office of Laboratory Safety (OLS) will be supervised by the Office of the Chief Scientist (OCS).
- Consolidating operational work in the Office of Operations (OO) to more effectively support the agency’s mission and elevating the staffing and recruiting function to hire and retain top talent. The agency proposes to consolidate some operational work into OO that currently occurs in different areas across OC. OO will also be restructured to ensure the attention and support of all critical Human Resources (HR) and OO functions. According to the notice, the key changes would include:
- Creating an Office of Enterprise Management Services: this will provide support to FDA OC offices and staff similar to the Office of Management structure that currently exists in the Centers and ORA;
- Splitting and elevating the HR function into two offices: The Office of Talent Solutions will focus on staffing and hiring; and the Office of Human Capital Management will be responsible for Human Resources IT, labor and employee relations; and,
- Moving the Office of Planning to OO: This will help better align planning, evaluation, and reporting activities with other operational work that supports the Centers.
- Strengthening and modernizing certain key functions to enhance communication to stakeholders and further elevate the role of patients and consumers. The agency claims to be taking important steps to strengthen the Office of External Affairs, enabling the organization to provide better strategic advice, products and services to the OC, the Centers and ORA, while also improving external communications and relationships. The agency contends that the changes will allow it to maximize staff and capital resources, including aligning media and social media staff, creating an editorial and creative services team to focus on non-media content, and focusing stakeholder engagement efforts on key and sensitive agency priorities and policies.
The agency has stated that the proposed changes are subject to approval by HHS and notification to Congress in the coming months. NTEU has requested a briefing and to bargain this change. If you have any comments or questions, please share them with your chapter president.