Importation of Biologicals Workshop November 30, 2016 University of Michigan Art O. Czabaniuk FDA Detroit District Director
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1 FDA Detroit District Import Operations Importation of Biologicals Workshop November 30, 2016 University of Michigan Art O. Czabaniuk FDA Detroit District Director
2 Presentation Summary Overview of FDA Organization Overview of Detroit District Import Operations Video Importing FDA Regulated Biologics 2
3 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) 3
4 FDA Organization 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. 4
5 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.); 5
6 ORA Field Organization 6
7 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 7
8 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 8
9 FDA Detroit District Major Port Locations Detroit Ambassador Bridge Lines 1,487,825 = 65% Port Huron Blue Water Bridge Lines 544,896 = 24% 9
10 FDA Detroit District Other Port Locations (Michigan and Indiana) Michigan Detroit Metro Airport (16,438 Entries) Indiana Sault Ste. Marie International Bridge (3,198) Grand Rapids (1827) Battle Creek (261) Saginaw/BayCity/Flint (15) FEDEX Hub Indianapolis (95,740) Indianapolis Airport (10,718) Fort Wayne (35) 10
11 FDA Detroit District Import Operations 11
12 FDA Detroit District Import Operations 12
13 FDA Detroit District Import Operations Border Locations & Contacts DETROIT AMBASSADOR BRIDGE PORT HURON BLUEWATER BRIDGE SAULT STE MARIE 2810 W. Fort Street 2321 Pine Grove Avenue, Suite International Bridge Plaza Detroit, MI Port Huron, MI Sault Ste Marie, MI (313) (P) (810) (P) Presently Not Staffed (313) (P) (810) (P) (313) (F) (810) (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) Phenicia Petty, SCSO (313) Keith Jasukaitis, DIB (313) Art O. Czabaniuk DD (313)
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