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Ronald PaceNY District Director/HAF-E1 Division DirectorFDA Office of Regulatory AffairsOffice of Human and Animal FoodsApril 24, 2018
FDA’S OFFICE OF REGULATORY AFFAIRSALIGNS FOR THE FUTURE (UPDATE)
PRESENTED TOCASA
www.fda.gov
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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• Consistency within the
same program across ORA
• Better coordinated efforts
• ORA strong participant in policy-making with Centers
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Program Alignment: Key ChangesFrom ToGeographic 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 investigations, compliance and operational managers
Exclusive specialization in one program for investigations, compliance and operational managers
20 District Directors who manage the geographic district and all programs operations within the district
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 ChangesFrom 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 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, JDDirector, Office of
Enforcement and Import Operations
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Office of Enforcement and Import Operations
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Import Operations• Division of Southeast Imports
PDD- Ruth P. DixonDIB1- Facundo BernalDIB2- Chris BoulmayDCB- Tammara P. Threats
• Division of Northern Border ImportsPDD- Keith JasukaitisDIB1- Sandi SylvesterDIB2- Eric JonesonDCB- Sherea Dillon
• Division of Northeast ImportsPDD- Dawne HinesDIB- VacantDCB- Anna Alexander
• Division of West Coast ImportsPDD- Dan SolisDIB- VACANTDCB- Lawton Lum
• Division of Southwest ImportsPDD- Todd Cato DIB- Stacy Below DCB- Alex Lopez
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Office of Regulatory Science
www.fda.gov
Paul Norris, DVM, MPADirector, Office of
Regulatory Science
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Office of Regulatory Science
www.fda.gov
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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
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Patricia Alcock, Director Office of
Training, Education, and Development
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Office of Medical Products andTobacco Operations
Ellen Morrison Assistant Commissioner
Office of Medical Products and Tobacco Operations
Alonza Cruse Director, Office of
Pharmaceutical Quality
Operations
Jan Welch Director, Office
of Medical Device and
Radiological Health
Operations
Chrissy Cochran, PhD
Director, Office of Bioresearch
Monitoring Operations
Ginette Michaud, MD
Director, Office of Biological
Products Operations
Director Tobacco Staff
[vacant]
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Office of Biological Products Operations
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Office of Biological Products Operations
• Division 1PDD- Elizabeth WaltripDIB- Lisa HarlanDCB- Julie Bringger
• Division 2PDD- Kartlon WatsonDIB- Tricia MarinezDCB- Catherine Quinlan
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Office of Bioresearch Monitoring Operations
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Office of Bioresearch Monitoring Operations
• Division 1PDD- Anne JohnsonDIB- Christine Smith
• Division 2PDD- Eric PittmanDIB- Vacant
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Office of Pharmaceutical Quality Operations
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Office of Pharmaceutical Quality Operations
• Division 1PDD- Diana Amador ToroDIB 1- Karyn CampbellDIB 2- Nerizza Guerin (Acting)DCB- Ernest Bizjak (Acting)
• Division 2PDD- Monica MaxwellDIB- Vincent WilliamsDCB- John Diehl
• Division 3PDD- Art CzabaniukDIB- Jeffrey Meng (Acting)DCB- Nicholas Lyons
• Division 4PDD- Steven PorterDIB- 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
• Division 1PDD- Joseph MatriscianoDIB- Arduino FrankovicDCB- Gina Brackett
• Division 2PDD- Blake BevillDIB- Kathleen SinningerDCB- VACANT
• Division 3PDD- Shari ShambaughDIB- 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• Division 1
PDD- Michael DutcherDIB- Gregory SmithDCB- Christopher VanTwuyver
• Division 2PDD- Cheryl BighamDIB- VacantDCB- Miguel Hernandez Sanchez
• Division 3PDD-Edmundo GarciaDIB- Karen DaughertyDCB- Jessica Hensley (Acting)
• Division 4PDD- Latonya MitchellDIB- Edward HarrisDCB- Kimetha King
• Division 5PDD- Darla BracyDIB- Darlene AlmogelaDCB- Sergio Chavez
• Division 6PDD- Miriam BurbachDIB- Katie AlfordDCB- Lisa Althar
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OHAFO-East• Division 1
PDD- Ronald PaceDIB- Lori HolmquistDCB- CDR Catherine Beer
• Division 2PDD- Evelyn BonninDIB- VacantDCB- Randy Pack
• Division 3PDD-Ingrid ZambranaDIB- Ivy SweeneyDCB- Derek Price
• Division 4PDD- Elizabeth Ormond (a)DIB- Ramon HernandezDCB- Edwin Ramos
• Division 5PDD- Steven BarberDIB1- Thomas ClaridaDIB2- VacantDCB- Toniette Williams
• Division 6PDD- William WiessingerDIB- Tamar QtamiDCB- Kelli Wilkinson
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OHAF- Division of Domestic HAF Operations
• Division Director- Gerald Bromley Jr– Operations Branch– Produce Safety Branch
• LCDR Brittany Laymon• Brandi McGrady
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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 GuardiaERC (NWJ)- Bill MuszynskiERC (PA, DE)- Judith Paterson
State Liaison (VA, DC) – Natasha DeZinnaState Liaison- (WV, MD, DC)- William MurrayState Liaison (NWJ) – JoAnn DeclementState Liaison (PA, DE)- LCDR Margaret Digennaro
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Resources and Contacts
www.FDA.gov/ORA
• ORA Organization Charts and Boundary Maps
• Fact Sheets – ORA’s New Structure– Operational Offices
• Investigations Operations Manual– Headquarters, District/Division
Contact Information
ORA Contacts
• State and local inquiries – District Director/Program
Division Directors– State Liaison
• General Inquiries– [email protected]
• Partnerships– [email protected]
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Protecting Public HealthORA 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
