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FDA Detroit District Import Operations Importation of Biologicals Workshop November 30, 2016 University of Michigan Art O. Czabaniuk FDA Detroit District Director

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Page 1: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

FDA Detroit District Import Operations

Importation of Biologicals Workshop

November 30, 2016

University of Michigan

Art O. Czabaniuk

FDA Detroit District Director

Page 2: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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Presentation Summary

• Overview of FDA Organization

• Overview of Detroit District Import Operations

• Video – Importing FDA Regulated Biologics

Page 3: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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FDA Organization

Office of Commissioner

Specialized Program “Centers” (HQ)

• Center for Food Safety and Applied Nutrition (CFSAN)

• Center for Drug Evaluation and Research (CDER)

• Center for Biologics Evaluation and Research (CBER)

• Center for Devices and Radiological Health (CDRH)

• Center for Veterinary Medicine (CVM)

• Center for Tobacco Products (CTP)

“The Field” (District Offices)

• Office of Regulatory Affairs (ORA)

Page 4: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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Role of Specialized Program Centers• Approve/clear new drugs, medical devices, and biologics.

• Work with ORA to construct inspectional work plan

• Set policies, regulations and guidance documents.

• Collaborate with Districts on Regulatory Actions.

• Provide Subject Matter Experts (SME).

• Provide Policy and Guidance to ORA Field Import Staff.

Role of ORA District Offices (“the field”)

• Implement Policy and Work Directed by Center

• Import examinations, entry review, and sample collections per Workplan

• Conduct inspections – Domestic and Foreign.

• Office of Enforcement Import Operations. Agency focal point for

Headquarters/field relationships on all import programs operations.

FDA Organization

Page 5: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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Office of Enforcement Import Operations

• Provides direction, assistance, management, and oversight of

field import operations.

• Establishes field uniformity for import activities through

adherence to procedural policies and operations automated

systems

• Establishes and oversees a field import quality control program.

• Develops and/or reviews Agency import policies, laws &

regulations, procedures, programs, and assignments, including

the responsibility for issuing import informational directives

(Import Alerts, Bulletins, etc.);

Page 6: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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ORA Field Organization

Page 7: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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FDA Detroit District Import Organization

• Art O. Czabaniuk, District Director

• Keith J. Jasukaitis Director, Investigations Branch (Imports & Domestic)

• Vacant - Director, Compliance Branch

• Phenicia Petty, Supervisor - Ambassador Bridge (Detroit, MI)

• Melissa M. Tyrrell, Supervisor - Port Huron, MI

IMPORT STAFF

• 19 Consumer Safety Officers, 1 Consumer Safety Inspector

• 2 Imports Compliance Officers

OEIO- DIVISION OF IMPORT OPERATIONS

(IMPORT OPERATIONS & MAINTENANCE BRANCH)

• Jeff Hilgendorf – Regional Area Manager - District Office

Page 8: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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Detroit District Office Locations

– Detroit, Michigan (District Office)

– Ambassador Bridge (Detroit, MI)

– Grand Rapids, MI

– Port Huron, MI

– Kalamazoo, MI

– Indianapolis, IN

– South Bend, IN

– Fort Wayne, IN

– Evansville, IN

Page 9: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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Detroit Ambassador Bridge

• Lines – 1,487,825 = 65%

Port Huron Blue Water Bridge

• Lines – 544,896 = 24%

FDA Detroit District Major Port Locations

http://www.flickr.com/photos/larrythebiker/145084414/
http://www.flickr.com/photos/larrythebiker/145084414/
Page 10: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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FDA Detroit District Other Port Locations

(Michigan and Indiana)

Michigan

– Detroit Metro Airport (16,438 Entries)

– Sault Ste. Marie – International Bridge (3,198)

– Grand Rapids (1827)

– Battle Creek (261)

– Saginaw/BayCity/Flint (15)

Indiana

– FEDEX Hub – Indianapolis (95,740)

– Indianapolis Airport (10,718)

– Fort Wayne (35)

Page 11: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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FDA Detroit District Import Operations

Page 12: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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FDA Detroit District Import Operations

Page 13: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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FDA Detroit District Import Operations

Border Locations & Contacts

www.fda.gov

DETROIT AMBASSADOR BRIDGE PORT HURON BLUEWATER BRIDGE SAULT STE MARIE

2810 W. Fort Street 2321 Pine Grove Avenue, Suite 2114 900 International Bridge Plaza

Detroit, MI 48207 Port Huron, MI 48060 Sault Ste Marie, MI 49783

(313) 226-5249 (P) (810) 985-8514 (P) Presently Not Staffed

(313) 226-2250 (P) (810) 985-8513 (P)

(313) 226-5698 (F) (810) 985-8528 (F)

DAYS & HOURS OF OPERATION

DETROIT AMBASSADOR BRIDGE PORT HURON BLUEWATER BRIDGE SAULT STE MARIE

Monday – Friday 6:00 am – 6:00 pm Monday – Friday 8:00 am – 4:30 pm Presently Not Staffed

Saturday/Sunday 8:00 am – Noon

DETROIT CROSSING OPERATIONAL ALL HOLIDAYS 8:00 AM – NOON

EXCEPT THE FOLLOWING:

January 1st (New Years Day) July 4th (Independence Day)

• November (Thanksgiving Day ) December 25th (Christmas Day)

AFTER HOURS IMPORT CONTACT ALL CROSSINGS

Melissa Tyrrell, SCSO (313) 434-8477

Phenicia Petty, SCSO (313) 212-9533

Keith Jasukaitis, DIB (313) 617-4464

Art O. Czabaniuk DD (313) 779-5973

Page 14: FDA Detroit District Import Operations · 3 FDA Organization Office of Commissioner Specialized Program “Centers” (HQ) •Center for Food Safety and Applied Nutrition (CFSAN)•Center

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