Office of Regulatory Affairs (ORA)

The Food and Drug Administration’s (FDA), Office of Regulatory Affairs (ORA) hosted the following:

2017 ORA Senior Management Team (SMT) Meeting
08/01/2017-08/03/2017 at the
Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Blvd.
Gaithersburg, MD 20878

How did the 2017 ORA Senior Management Team (SMT) Meeting advance the mission of the agency?

The Senior Management Team (SMT) Meeting brings together approximately 215 ORA senior managers. In May 2017, ORA's reorganization went into effect and ORA is at a critical juncture of implementing the new management model for ORA. Program Alignment transitioned ORA from a geographic management model to a program management model, moving investigations and compliance to exclusive specialization in pharmaceutical quality, human and animal food, medical devices and radiological health, biologics, BIMO, tobacco and imports.

We are in a year of implementing the transition of a 4,900 plus person organization to realign by program, enhance technical specialization for investigative workforce, tracking to appropriation lines, among other organizational and operational changes. Program Alignment transitions directly impact the managers in attendance at this meeting, as well as those they supervise. It is a key time for the Associate Commissioner of Regulatory Affairs to meet with the managers. Additionally, on the last day of the meeting, FDA Commissioner Gottlieb, the Center Directors, the Acting Deputy Commissioner for Global Regulatory Operations and Policy, the Associate Commissioner for International Programs, and the Assistant Commissioner for Food Safety Integration joined and participated in panel sessions throughout the day. This was a unique opportunity for ORA's field and headquarters managers to engage with FDA Senior Leadership.

Cost and Attendance
Total Cost: $245,688
Total Attendees: 215
Total Feds on Travel: 136
Total Non-Feds on Travel Funded by FDA: 0

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6th Manufactured Food Regulatory Program Alliance (MFRPA) Meeting
01/23/2017-01/26/2017 at the
Trade Winds Island Grand Hotel and Conference Center
5500 Gulf Boulevard
St Petersburg, FL 33706

How did the 6th Manufactured Food Regulatory Program Alliance (MFRPA) Meeting advance the mission of the agency?

The Manufactured Food Regulatory Program Standards (MFRPS) establish a uniform foundation for the design and management of State programs responsible for the regulation of food plants. The MFRPS are comprised of ten standards that establish requirements for the critical elements of a regulatory program designed to protect the public from foodborne illness and injury. Lab ISO Accreditation is a component of the MFRPS (Standard 10). Conformance with these program standards will assist and provide FDA the foundation for pursuing regulatory action based upon the findings of State regulatory agencies to protect public health and advance building an integrated food safety system.

Achieving conformance with the MFRPS by State manufactured food regulatory programs is critical for advancing an integrated national food safety system, as mandated by the Food Safety Modernization Act (FSMA), and improving public health outcomes. Participation in this meeting is mandatory for grantees in the Achieving Conformance with the MFRPS and ISO Accreditation. It is a requirement of the State programs’ cooperative agreements to send a minimum of two people in each program to the MFRPA Meeting.

Cost and Attendance
Total Cost: $ 141,029.13
Total Attendees: 369
Total Feds on Travel: 84
Total Non-Feds on Travel Funded by FDA: 0