FDA ’ S OFFICE OF REGULATORY AFFAIRS ALIGNS FOR THE FUTURE PRESENTED TO ROCKY MOUNTAIN REGULATORY AFFAIRS SOCIETY (RMRAS) E. Mark Harris Director Investigations Branch FDA Office of Regulatory Affairs Denver District Office/Office of Human and Animal Foods, Division 4 West January 17, 2018 1 www.fda.gov
“ …Modernize and strengthen the FDA workforce to improve public ” health response. 2013 FDA Program Alignment Charge 2 www.fda.gov
OLD Geographically Aligned Organizational Model 3 www.fda.gov
New Program Aligned Organizational Model 4 www.fda.gov
Civil & Criminal Compliance Investigators Import Officers Operations State 13 Laboratories Cooperative Programs – Milk, Retail, Shellfish Emergency Response Coordinators State Contracts, Grants & Agreements Recall Coordinators ORA at a State Liaisons Glance Consumer Complaint Coordinators Quality Systems Managers Official Establishment Inventory Planning & Coordinators Evaluation Analysts Disclosure & Operational FOIA Policy Analysts Training, Education & Administrative Development Communication & Mission Staff s Staff Support 5 www.fda.gov
Program Alignment: Key Changes From To Geographic management of operations 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 SES Regional Food & Drug Directors SES Program Directors Degrees of program specialization for Exclusive specialization in one program for investigations, compliance investigations, compliance and and operational managers operational managers 20 District Directors who manage the 20 District Directors who manage the geographic district and only one geographic district and all programs program for operations. Plus eight new program division directors who manage program operations only – total 28 management teams operations within the district One import district and a range of Five import divisions (four new import divisions) covering all borders, import operations embedded within the managing import operations nationally as a program 16 other districts 6 www.fda.gov
Program Alignment: Key Changes From To 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 program operations Division of Human Resource Development within Office of Training, Education and Development the Office of Resource Management State Cooperative Programs decentralized across Office of State Cooperative Programs under the five regions – shellfish, milk, retail Human and Animal Food Operations, as a single national program(s) Functions based in geography: consumer complaint Retain certain functions based in geography: coordinators, state liaisons, emergency response consumer complaint coordinators, state liaisons, coordinators emergency response coordinators Functions decentralized local reporting: Freedom of Staff remain embedded locally, but report into a Information (FOI) staff, industrial hygienists (IH), single office: FOI staff report into Division of and administrative staff Information Disclosure; IHs report into the Office of Regulatory Science; administrative staff report into the Office of Management 7 www.fda.gov
Offices of… Melinda Plaisier, MSW Associate Commissioner for Regulatory Affairs Doug Stearn, JD Paul Norris, DVM, MPA Director, Office of Enforcement Director, Office of and Import Operations Regulatory Science 8 www.fda.gov
Office of Enforcement and Import Operations Doug Stearn, JD Director, Office of Enforcement and Import Operations 9 www.fda.gov
Office of Enforcement and Import Operations 10 www.fda.gov
Office of Regulatory Science Paul Norris, DVM, MPA Director, Office of Regulatory Science 11 www.fda.gov
Office of Regulatory Science 12 www.fda.gov
Office of Partnerships Barbara Cassens, Barbara Cassens Director Office of Director , Office of Partnerships Partnerships 13 www.fda.gov
Office of Training, Education and Development Patricia Alcock, Director Office of Training, Education, and Development 14 www.fda.gov
Office of Medical Products and Tobacco Operations Ellen Morrison Assistant Commissioner Office of Medical Products and Tobacco Operations Director Tobacco Staff [vacant] Jan Welch Ginette Chrissy Alonza Cruse Director, Office Michaud, MD Cochran, PhD Director, of Medical Director, Office Director, Office Office of Device and of Biological of Bioresearch Pharmaceutical Radiological Products Monitoring Quality Health Operations Operations Operations Operations 15 www.fda.gov
Office of Biological Products Operations Ginette Michaud, MD Director, Office of Biological Products Operations 16 www.fda.gov
Office of Biological Products Operations 17 www.fda.gov
Office of Bioresearch Monitoring Operations Chrissy Cochran, PhD Director, Office of Bioresearch Monitoring Operations 18 www.fda.gov
Office of Bioresearch Monitoring Operations 19 www.fda.gov
Office of Medical Device and Radiological Health Operations Jan Welch Director, Office of Medical Device and Radiological Health 20 www.fda.gov
Office of Medical Device and Radiological Health Operations 21 www.fda.gov
Office of Pharmaceutical Quality Operations Alonza Cruse Director, Office of Pharmaceutical Quality Operations 22 www.fda.gov
Office of Pharmaceutical Quality Operations 23 www.fda.gov
Office of Human and Animal Food Operations Michael Rogers, MS Assistant Commissioner for Human and Animal Foods [acting] Laurie Farmer Ellen Buchanan Director, Director, Office of State Audit Staff Cooperative Programs [acting] Vinetta Howard -King Joann Givens Director, Office of Director, Office of Human and Animal Human and Animal Foods East [acting] Foods West 24 www.fda.gov
Office of Human and Animal Food Operations 25 www.fda.gov
ORA Ombudsman • Informally and impartially addresses concerns, complaints, and disputes between ORA and external parties: – Industry – Federal, state, territory, and tribal government entities – Public • Contact: – 513-679-2777 or 240-535-6021 Jessica Zeller, JD, MA – ORAOmbudsman@fda.hhs.gov Ombudsman Enhancing ORA operations by serving as an objective, neutral PUBLIC HEALTH resource to improve communication channels, resolve disputes, and PARTNERSHIPS: foster positive relationships with internal and external stakeholders. 26 www.fda.gov
OFFICE OF HUMAN AND ANIMAL FOODS DIVISION 4 WEST
OFFICE OF HUMAN AND ANIMAL FOODS DIVISION 4 WEST (HAF4W) LaTonya M. Mitchell District Director/Program Division Director District Director Director Director Secretary Compliance Branch Investigations Branch Supervisory Consumer State Liaisons Compliance Officers Safety Officers Elisa Beard, Nathan Moon Emergency Response Consumer Safety Coordinator, Officers (Investigators) Quality Systems Manager
HAF4W COMPLIANCE BRANCH Kimetha F. King Director of Compliance Branch (01/21/2018) Nancy Schmidt, CO Florence House, CST Recall Coordinator Caroline Le Mariah Jackson, CST Hanna Potter, CO Carolyn Pinney, CO Detailee Compliance Officer 29
HAF4W INVESTIGATIONS BRANCH E. Mark Harris Director of Investigations Branch Consumer Complaint Coordinator Roger Adams, SCSO Stephanie Chastagner Jennifer Hicks, SCSO Ginger Sykes, SCSO (SLC-RP) OEI Coordinator Holly Miller 16 CSOs Denver 4 CSOs Salt Lake City 3 CSOs Tempe 1 CSO Albuquerque 3 CSTs (2 Denver, 1 SLC) 30
Resources and Contacts www.FDA.gov/ORA ORA Contacts • • ORA Organization Charts and State and local inquiries Boundary Maps – District Director/Program • Division Directors Fact Sheets – State Liaison – ORA’s New Structure • General Inquiries – Operational Offices – engageORA@fda.hhs.gov • Investigations Operations Manual • Partnerships – Headquarters, District/Division – OP-ORA@fda.hhs.gov Contact Information 31 www.fda.gov
Thank You Questions and Discussion 32 www.fda.gov
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