FDA s Office of Regulatory Affairs Aligns for the Future Jennifer Thomas Acting, ORA Office of Enforcement and Import Operations December 2017
Modernize and strengthen the FDA workforce to improve public health response. 2013 FDA Program Alignment Charge 2
OLD Geographically Aligned Organizational Model 3
New Program Aligned Organizational Model Office of the Associate Commissioner for Regulatory Affairs Office Of Management Office of Communications and Project Management Office of Criminal Investigations Office of Partnerships and Operational Policy Office of Medical Products and Tobacco Operations Office of Regulatory Science Office of Human and Animal Food Operations Office of Enforcement and Import Operations Office of Training, Education and Development 4
Program Alignment: Key Changes From Geographic management of operations Regional Food & Drug s Degrees of program specialization for investigations, compliance and operational managers 20 District s who manage the geographic district and all programs operations within the district One import district and a range of import operations embedded within the 16 other districts To Program management of operations, management teams based on staff: Bioresearch Monitoring 2 management teams Biologics 2 management teams Human and Animal Food 12 management teams Medical Device and Radiological Health 3 management teams Pharmaceutical Quality 4 management teams Tobacco Plus Imports as a program 5 management teams Program s Exclusive specialization in one program for investigations, compliance and operational managers 20 District s who manage the geographic district and only one program for operations. Plus eight new program division directors who manage program operations only total 28 management teams Five import divisions (four of them new) covering all borders, managing import operations nationally as a program 5
Program Alignment: Key Changes From 13 labs reporting into the regions National Lab Management 13 labs reporting into ORA s Office of Regulatory Science with three additional directors managing separate lab program operations and specialization Division of Human Resource Development within the Office of Resource Management State Cooperative Programs decentralized across five regions shellfish, milk, retail To Office of Training, Education and Development Office of State Cooperative Programs under the Human and Animal Food Operations, as a single national program(s) Functions based in geography: consumer complaint coordinators, state liaisons, emergency response coordinators Functions decentralized local reporting: Freedom of Information (FOI) staff, industrial hygienists (IH), and administrative staff Retain certain functions based in geography: consumer complaint coordinators, state liaisons, emergency response coordinators Staff remain embedded locally, but report into a single office: FOI staff report into Division of Information Disclosure; IHs report into the Office of Regulatory Science; administrative staff report into the Office of Management 6
Office of Regulatory Science Dr. Paul Norris Office of Regulatory Science Office of Business and Safety Operations Immediate Office (Lab Planning, Safety, and Training Staff) Office of Medical Products, Tobacco and Specialty Laboratory Operations Medical Products and Tobacco Scientific Staff Office of Food and Feed Laboratory Operations Food and Feed Scientific Staff Forensic Chemistry Center Winchester Engineering Analytical Center Arkansas Laboratory Denver Laboratory Detroit Laboratory Northeast Medical Products Laboratory Kansas City Laboratory Northeast Food and Feed Laboratory Pacific Southwest Medical Products Laboratory Philadelphia Laboratory Pacific Northwest Laboratory San Francisco Laboratory San Juan Laboratory Southeast Tobacco Laboratory Office of Research Coordination and Evaluation Southeast Food and Feed Laboratory Pacific Southwest Food and Feed Laboratory 7
Office of Regulatory Science 8
Office of Enforcement and Import Operations Doug Stearn, JD Office of Enforcement and Import Operations Division of Enforcement Division of Food Defense Targeting Division of Import Operations Division of Southwest Imports Division of Southeast Imports Division of Northeast Imports Division of Northern Border Imports Division of West Coast Imports 9
Office of Enforcement and Import Operations 10
Office of Enforcement and Import Operations Office/Division Title Name OEIO Doug Stearn Deputy Armando Zamora Division of Enforcement Scott MacIntire Division of Food Defense Targeting Angel Suarez Division of Import Operations John Verbeten Division of Southwest Imports Todd Cato Division of Southeast Imports Ruth Dixon Division of Northeast Imports Matthew Palo (acting) Division of Northern Border Imports Keith Jasukaitis (acting) Division of West Coast Imports Dan Solis (acting) 11
Office of Human and Animal Food Operations Michael Rogers Assistant Commissioner Office of Human and Animal Food (HAF) Operations (acting) Ellen Buchanan Audit Staff Vinetta Howard-King Office of HAF Operations-East (acting) Joann Givens Office of HAF Operations-West Laurie Farmer Office of State Cooperative Programs (acting) 12
Office of Human and Animal Food Operations 13
Office of State Cooperative Programs Laurie Farmer Office of State Cooperative Programs (acting) Division of Retail Food Protection Division of Milk Safety Division of Shellfish Sanitation 14
Office Of Human and Animal Food Operations-East Vinetta Howard-King Office of Human and Animal Food Operations-East (acting) Divisions I-VI of Human and Animal Food Operations-East Division of Foreign Human and Animal Food Operations 15
Office of Human and Animal Food Operations - EAST Office/Division Title Name OHAFO East Immediate Office Vinetta Howard-King (acting) OHAFO East Immediate Office Deputy W. Charles Becoat OHAFO East Division 1 OHAFO East Division 2 OHAFO East Division 3 OHAFO East Division 4 OHAFO East Division 5 OHAFO East Division 6 Program /District Program /District Program /District Program /District Program /District Program /District Ron Pace Evelyn Bonnin Ingrid Zambrana Maridalia Torres Steven Barber William Weissinger 16
Office Of Human and Animal Food Operations-West Joann Givens Office of Human and Animal Food Operations-West Divisions I-VI of Human and Animal Food Operations-West Division of Domestic Human and Animal Food Operations 17
Office of Human and Animal Food Operations - WEST Office/Division Title Name OHAFO West Immediate Office Joann Givens OHAFO West Immediate Office Deputy Glenn Bass OHAFO West Division 1 OHAFO West Division 2 OHAFO West Division 3 OHAFO West Division 4 OHAFO West Division 5 OHAFO West Division 6 Program /District Program /District Program /District Program /District Program /District Program /District Michael Dutcher, DVM Cheryl Bigham Edmundo Garcia, Jr. LaTonya Mitchell-Holmes Darla Bracy Miriam Burbach 18
What s Next? Complete the first phase - realignment Continue to invest in ORA s culture and values Advance the next phase operational change 19