ALIGNS FOR THE FUTURE (U PDATE ) PRESENTED TO CASA Ronald Pace NY - - PowerPoint PPT Presentation
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
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Ronald Pace NY District Director/HAF-E1 Division Director FDA Office of Regulatory Affairs Office of Human and Animal Foods April 24, 2018
FDA’S OFFICE OF REGULATORY AFFAIRS ALIGNS FOR THE FUTURE (UPDATE)
PRESENTED TO
CASA
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…Modernize and strengthen the FDA workforce to improve public health response.
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2013 FDA Program Alignment Charge
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Program Alignment
same program across ORA
efforts
in policy-making with Centers
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Program Alignment: Key Changes
From To
Geographic management of operations Program management of operations, management teams based on staff:
SES Regional Food & Drug Directors SES Program Directors Degrees of program specialization for investigations, compliance and
Exclusive specialization in one program for investigations, compliance and operational managers 20 District Directors who manage the geographic district and all programs
20 District Directors 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 One import district and a range of import operations embedded within the 16 other districts Five import divisions (four new import divisions) covering all borders, managing import operations nationally as a program
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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
Division of Human Resource Development within the Office of Resource Management Office of Training, Education and Development State Cooperative Programs decentralized across five regions – shellfish, milk, retail 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 Retain certain 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 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
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Offices of…
www.fda.gov Melinda Plaisier, MSW Associate Commissioner for Regulatory Affairs Paul Norris, DVM, MPA Director, Office of Regulatory Science Doug Stearn, JD Director, Office of Enforcement and Import Operations
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Office of Enforcement and Import Operations
www.fda.gov Doug Stearn, JD Director, Office of Enforcement and Import Operations
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Office of Enforcement and Import Operations
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Import Operations
PDD- Ruth P. Dixon DIB1- Facundo Bernal DIB2- Chris Boulmay DCB- Tammara P. Threats
PDD- Keith Jasukaitis DIB1- Sandi Sylvester DIB2- Eric Joneson DCB- Sherea Dillon
PDD- Dawne Hines DIB- Vacant DCB- Anna Alexander
PDD- Dan Solis DIB- VACANT DCB- Lawton Lum
PDD- Todd Cato DIB- Stacy Below DCB- Alex Lopez
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Office of Regulatory Science
www.fda.gov Paul Norris, DVM, MPA Director, Office of Regulatory Science
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Office of Regulatory Science
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Office of Partnerships
Barbara Cassens, Director Office of Partnerships Barbara Cassens Director , Office of Partnerships
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Office of Training, Education and Development
www.fda.gov Patricia Alcock, Director Office of Training, Education, and Development
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Office of Medical Products and Tobacco Operations
Ellen Morrison Assistant Commissioner Office of Medical Products and Tobacco Operations Alonza Cruse Director, Office of Pharmaceutical Quality Operations Jan Welch Director, Office
Device and Radiological Health Operations Chrissy Cochran, PhD Director, Office
Monitoring Operations Ginette Michaud, MD Director, Office
Products Operations Director Tobacco Staff [vacant] www.fda.gov
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Office of Biological Products Operations
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Office of Biological Products Operations
PDD- Elizabeth Waltrip DIB- Lisa Harlan DCB- Julie Bringger
PDD- Kartlon Watson DIB- Tricia Marinez DCB- Catherine Quinlan
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Office of Bioresearch Monitoring Operations
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Office of Bioresearch Monitoring Operations
PDD- Anne Johnson DIB- Christine Smith
PDD- Eric Pittman DIB- Vacant
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Office of Pharmaceutical Quality Operations
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Office of Pharmaceutical Quality Operations
PDD- Diana Amador Toro DIB 1- Karyn Campbell DIB 2- Nerizza Guerin (Acting) DCB- Ernest Bizjak (Acting)
PDD- Monica Maxwell DIB- Vincent Williams DCB- John Diehl
PDD- Art Czabaniuk DIB- Jeffrey Meng (Acting) DCB- Nicholas Lyons
PDD- Steven Porter DIB- Katherine Jacobits (acting) DCB- Thomas Berry
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Office of Medical Device and Radiological Health Operations
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Office of Medical Device and Radiological Health Operations
PDD- Joseph Matrisciano DIB- Arduino Frankovic DCB- Gina Brackett
PDD- Blake Bevill DIB- Kathleen Sinninger DCB- VACANT
PDD- Shari Shambaugh DIB- Eric Anderson DCB- Kelly Sheppard
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Office of Human and Animal Food Operations
www.fda.gov Michael Rogers, MS Assistant Commissioner for Human and Animal Foods Joann Givens Director, Office of Human and Animal Foods West Vinetta Howard -King Director, Office of Human and Animal Foods East [acting] Laurie Farmer Director, Office of State Cooperative Programs Ellen Buchanan Director, Audit Staff
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Office of Human and Animal Food Operations
www.fda.gov
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OHAFO-West
PDD- Michael Dutcher DIB- Gregory Smith DCB- Christopher VanTwuyver
PDD- Cheryl Bigham DIB- Vacant DCB- Miguel Hernandez Sanchez
PDD-Edmundo Garcia DIB- Karen Daugherty DCB- Jessica Hensley (Acting)
PDD- Latonya Mitchell DIB- Edward Harris DCB- Kimetha King
PDD- Darla Bracy DIB- Darlene Almogela DCB- Sergio Chavez
PDD- Miriam Burbach DIB- Katie Alford DCB- Lisa Althar
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OHAFO-East
PDD- Ronald Pace DIB- Lori Holmquist DCB- CDR Catherine Beer
PDD- Evelyn Bonnin DIB- Vacant DCB- Randy Pack
PDD-Ingrid Zambrana DIB- Ivy Sweeney DCB- Derek Price
PDD- Elizabeth Ormond (a) DIB- Ramon Hernandez DCB- Edwin Ramos
PDD- Steven Barber DIB1- Thomas Clarida DIB2- Vacant DCB- Toniette Williams
PDD- William Wiessinger DIB- Tamar Qtami DCB- Kelli Wilkinson
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OHAF- Division of Domestic HAF Operations
– Operations Branch – Produce Safety Branch
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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)
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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
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ORA Field Leadership Contacts
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Resources and Contacts
www.FDA.gov/ORA
Boundary Maps
– ORA’s New Structure – Operational Offices
– Headquarters, District/Division Contact Information
ORA Contacts
– District Director/Program Division Directors – State Liaison
– engageORA@fda.hhs.gov
– OP-ORA@fda.hhs.gov
www.fda.gov
Protecting Public Health ORA Infographic FY 2017
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To download the FY 2017 ORA infographic, please visit: https://go.usa.gov/xntmK
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100 year anniversary- 14 FDA Districts
Imogene Gollinger, FDA's first female field inspector, was sworn into office by the FDA Commissioner.
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District Directors-1969
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District Directors- 2017