FDA ’ S OFFICE OF REGULATORY AFFAIRS ALIGNS FOR THE FUTURE (U PDATE ) PRESENTED TO CASA Ronald Pace NY District Director/HAF-E1 Division Director FDA Office of Regulatory Affairs Office of Human and Animal Foods April 24, 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
Program Alignment • Consistency within the same program across ORA • Better coordinated efforts • ORA strong participant in policy-making with Centers 3
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 operations within the district manage program operations only – total 28 management teams 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 4 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 5 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 6 www.fda.gov
Office of Enforcement and Import Operations Doug Stearn, JD Director, Office of Enforcement and Import Operations 7 www.fda.gov
Office of Enforcement and Import Operations 8 www.fda.gov
Import Operations • Division of Southeast Imports • Division of Northeast Imports PDD- Ruth P. Dixon PDD- Dawne Hines DIB- Vacant DIB1- Facundo Bernal DCB- Anna Alexander DIB2- Chris Boulmay • Division of West Coast Imports DCB- Tammara P. Threats PDD- Dan Solis DIB- VACANT • Division of Northern Border Imports DCB- Lawton Lum PDD- Keith Jasukaitis • Division of Southwest Imports DIB1- Sandi Sylvester PDD- Todd Cato DIB2- Eric Joneson DIB- Stacy Below DCB- Sherea Dillon DCB- Alex Lopez 9
Office of Regulatory Science Paul Norris, DVM, MPA Director, Office of Regulatory Science 10 www.fda.gov
Office of Regulatory Science 11 www.fda.gov
Office of Partnerships Barbara Cassens, Barbara Cassens Director Office of Director , Office of Partnerships Partnerships 12 www.fda.gov
Office of Training, Education and Development Patricia Alcock, Director Office of Training, Education, and Development 13 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 14 www.fda.gov
Office of Biological Products Operations 15 www.fda.gov
Office of Biological Products Operations • Division 1 PDD- Elizabeth Waltrip DIB- Lisa Harlan DCB- Julie Bringger • Division 2 PDD- Kartlon Watson DIB- Tricia Marinez DCB- Catherine Quinlan 16
Office of Bioresearch Monitoring Operations 17 www.fda.gov
Office of Bioresearch Monitoring Operations • Division 1 PDD- Anne Johnson DIB- Christine Smith • Division 2 PDD- Eric Pittman DIB- Vacant 18
Office of Pharmaceutical Quality Operations 19 www.fda.gov
Office of Pharmaceutical Quality Operations • Division 1 • Division 3 PDD- Diana Amador Toro PDD- Art Czabaniuk DIB 1- Karyn Campbell DIB- Jeffrey Meng (Acting) DIB 2- Nerizza Guerin DCB- Nicholas Lyons (Acting) • Division 4 DCB- Ernest Bizjak (Acting) PDD- Steven Porter • Division 2 DIB- Katherine Jacobits (acting) PDD- Monica Maxwell DCB- Thomas Berry DIB- Vincent Williams DCB- John Diehl 20
Office of Medical Device and Radiological Health Operations 21 www.fda.gov
Office of Medical Device and Radiological Health Operations • Division 1 • Division 3 PDD- Joseph Matrisciano PDD- Shari Shambaugh DIB- Arduino Frankovic DIB- Eric Anderson DCB- Gina Brackett DCB- Kelly Sheppard • Division 2 PDD- Blake Bevill DIB- Kathleen Sinninger DCB- VACANT 22
Office of Human and Animal Food Operations Michael Rogers, MS Assistant Commissioner for Human and Animal Foods Laurie Farmer Ellen Buchanan Director, Director, Office of State Audit Staff Cooperative Programs Vinetta Howard -King Joann Givens Director, Office of Director, Office of Human and Animal Human and Animal Foods East [acting] Foods West 23 www.fda.gov
Office of Human and Animal Food Operations 24 www.fda.gov
OHAFO-West • Division 1 • Division 4 PDD- Michael Dutcher PDD- Latonya Mitchell DIB- Gregory Smith DIB- Edward Harris DCB- Christopher VanTwuyver DCB- Kimetha King • Division 2 • Division 5 PDD- Cheryl Bigham PDD- Darla Bracy DIB- Vacant DIB- Darlene Almogela DCB- Miguel Hernandez DCB- Sergio Chavez Sanchez • Division 6 • Division 3 PDD- Miriam Burbach PDD-Edmundo Garcia DIB- Katie Alford DIB- Karen Daugherty DCB- Lisa Althar DCB- Jessica Hensley (Acting) 25
OHAFO-East • Division 1 • Division 4 PDD- Ronald Pace PDD- Elizabeth Ormond (a) DIB- Lori Holmquist DIB- Ramon Hernandez DCB- CDR Catherine Beer DCB- Edwin Ramos • Division 2 • Division 5 PDD- Evelyn Bonnin PDD- Steven Barber DIB- Vacant DIB1- Thomas Clarida DCB- Randy Pack DIB2- Vacant • Division 3 DCB- Toniette Williams PDD-Ingrid Zambrana • Division 6 DIB- Ivy Sweeney PDD- William Wiessinger DCB- Derek Price DIB- Tamar Qtami 26 DCB- Kelli Wilkinson
OHAF- Division of Domestic HAF Operations • Division Director- Gerald Bromley Jr – Operations Branch – Produce Safety Branch • LCDR Brittany Laymon • Brandi McGrady 27
Geographical Coverage (NY/NWE) ERC- Kimberly Langello (ME, MA, CT, VT, NH, RI) ERC- Nicole Vaught (NY) State Liaison- CDR Jay Lewis (VT, MA, ME, NH) State Liaison- Jeanette McGinnis (CT, RI, NY) 28
Geographical Coverage (NWJ, PA, DE, MD, VA, WV, DC) ERC (MD, VA, WV, DC)- CDR Martin Guardia ERC (NWJ)- Bill Muszynski ERC (PA, DE)- Judith Paterson State Liaison (VA, DC) – Natasha DeZinna State Liaison- (WV, MD, DC)- William Murray State Liaison (NWJ) – JoAnn Declement State Liaison (PA, DE)- LCDR Margaret Digennaro 29
ORA Field Leadership Contacts • https://go.usa.gov/xQWx3 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 Contact Information – OP-ORA@fda.hhs.gov 31 www.fda.gov
Protecting Public Health ORA Infographic FY 2017
To download the FY 2017 ORA infographic, please visit: https://go.usa.gov/xntmK 33 www.fda.gov
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100 year anniversary- 14 FDA Districts
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