FDA S OFFICE OF REGULATORY AFFAIRS ALIGNS FOR THE …...FDA Office of Regulatory Affairs Office of...

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

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…Modernize and strengthen the FDA workforce to improve public health response.

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“”

2013 FDA Program Alignment Charge

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

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

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

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

Office of Regulatory Science

www.fda.gov

Paul Norris, DVM, MPADirector, Office of

Regulatory Science

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

Office of Training, Education and Development

www.fda.gov

Patricia Alcock, Director Office of

Training, Education, and Development

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

• 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

• Division 1PDD- Anne JohnsonDIB- Christine Smith

• Division 2PDD- Eric PittmanDIB- Vacant

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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

• Division 1PDD- Joseph MatriscianoDIB- Arduino FrankovicDCB- Gina Brackett

• Division 2PDD- Blake BevillDIB- Kathleen SinningerDCB- VACANT

• Division 3PDD- Shari ShambaughDIB- Eric Anderson DCB- Kelly Sheppard

Office of Human and Animal Food Operations

www.fda.gov

Michael Rogers, MS Assistant

Commissioner for Human and Animal

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

Office of Human and Animal Food Operations

www.fda.gov

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

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

OHAF- Division of Domestic HAF Operations

• Division Director- Gerald Bromley Jr– Operations Branch– Produce Safety Branch

• LCDR Brittany Laymon• Brandi McGrady

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)

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

ORA Field Leadership Contacts• https://go.usa.gov/xQWx3

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– engageORA@fda.hhs.gov

• Partnerships– OP-ORA@fda.hhs.gov

www.fda.gov

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.

District Directors-1969

District Directors- 2017

FDA S OFFICE OF REGULATORY AFFAIRS ALIGNS FOR THE …...FDA Office of Regulatory Affairs Office of...

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