FDA Import Operations Importation of Biologicals Workshop October 10, 2017 University of Michigan

1. FDA Import OperationsImportation of Biologicals Workshop October 10, 2017 University of Michigan Keith J. Jasukaitis Acting Northern Border Division Director, Office of Regulatory Affairs, FDA

2. Presentation Summary • Overview of FDA Organization • Program Alignment of FDA / ORA • Overview of Detroit District Import Operations • Video – Importing FDA Regulated Biologics

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)

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 (now Program Divisions) on Regulatory Actions. • Provide Subject Matter Experts (SME). • Provide Policy and Guidance to ORA Field Import Staff. Role of ORA District Offices/Divisions (“the field”) • Implement Policy and Perform Work Directed by Center • Import examinations, entry review, and sample collections per Workplan • Conduct inspections – Domestic and Foreign. • Office of Enforcement Import Operations (OEIO). Agency focal point for Headquarters/field relationships on all import programs operations.

5. www.fda.gov

6. 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 utilizing 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.);

7. Previous ORA Field Organization

8. Office of Enforcement and Import Operations www.fda.gov

9. FDA Division of Northern Border Imports Organization • Keith J. Jasukaitis NB Program Division Director, Acting • Sandra Sylvester & Eric Joneson, NB Import Investigations Branch Directors (East and West). Detroit is in the west. • 9 Supervisory Investigative groups across NB • Sherea Dillon – Import Compliance Branch Director, Acting (Chicago) • Phenicia Petty, Supervisor - Ambassador Bridge (Detroit, MI) • Melissa M. Tyrrell, Supervisor – Blue Water Bridge (Port Huron, MI) IMPORT STAFF • 102 Consumer Safety Officers, Inspectors, Technicians • 11 Imports Compliance Officers OEIO- DIVISION OF IMPORT OPERATIONS (IMPORT OPERATIONS & MAINTENANCE BRANCH) • Jeff Hilgendorf – Regional Area Manager - Detroit Office

10. Office of Enforcement and Import Operations Doug Stearn, JD Director, Office of Enforcement and Import Operations www.fda.gov

11. Offices of… www.fda.gov

12. Office of Regulatory Science www.fda.gov

13. Office of Medical Products andTobacco Operations www.fda.gov

14. Office of Biological Products Operations www.fda.gov

15. Office of Bioresearch Monitoring Operations www.fda.gov

16. Office of Pharmaceutical Quality Operations www.fda.gov

17. Detroit District/Area 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

18. FDA Detroit Area Major Port Locations Detroit Ambassador Bridge • Lines – 1,487,825 = 65% Port Huron Blue Water Bridge • Lines – 544,896 = 24%

19. FDA 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)

21. FDA Detroit District Import Operations

22. FDA Detroit District Import Operations

23. Importing CBER-Regulated Products: Clinical Laboratories and Basic Scientific Research • Q1?: I want to import biological specimens (e.g., blood, tissue, DNA) for testing in a clinical laboratory or for basic scientific research. Does FDA regulate biological specimens intended only for testing in a clinical laboratory or use for basic scientific research? https://www.fda.gov:80/FDAgov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/BiologicsImportingExporting/ucm390716.htm

24. Answer Q1: No. If the biological specimens you are offering for import are intended for use only for testing in a clinical laboratory or for basic scientific research and are not articles intended for the prevention, treatment, diagnosis, or cure of diseases, injuries, or conditions in human beings, the specimens are not considered to be biological products subject to licensure by FDA in accordance with Section 351(a) [42 USC 262(a)] of the Public Health Service Act (PHS Act), nor would they appear to be a drug or device as defined in sections 201(g) and (h), respectively, of the Federal Food, Drug, and Cosmetic Act [21 USC 321(g) and (h)], nor an HCT/P as defined in 21 CFR 1271.3, which was promulgated under Section 361 of the PHS Act [42 USC 264].

25. Importing CBER-Regulated Products: Clinical Laboratories and Basic Scientific Research Q2? How do I tell FDA that a biological specimen is being imported for testing in a clinical laboratory or for basic scientific research? https://www.fda.gov:80/FDAgov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/BiologicsImportingExporting/ucm390716.htm Answer Q2: When submitting an entry notification, a filer will determine the appropriate tariff code for the product being offered for importation. CBP uses the tariff code, in part, to determine if other government agencies also need to make an admissibility determination. However, a tariff code may cover a wide range of products and may include products that are not subject to FDA jurisdiction. When this is the case, filers are usually given the option of "disclaiming" FDA jurisdiction. This is accomplished by disclaiming the "line" in the entry that applies to those products.

26. Tariff codes that cover both FDA and non-FDA regulated products have an "Other Government Agency (OGA)" flag which would allow the filer to disclaim FDA jurisdiction. If the tariff code you or your filer are using for your specimens does not have an OGA flag that will allow the filer to "disclaim" the line(s) in the entry, the filer should contact: FDA's Division of Import Operations & Policy at: 301-796-0356 to determine if the OGA flag for the tariff code can be modified to allow use of the disclaim process.

27. Importing CBER-Regulated Products: Clinical Laboratories and Basic Scientific Research Q3? What are my responsibilities as an importer of such biological specimens? https://www.fda.gov:80/FDAgov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/BiologicsImportingExporting/ucm390716.htm Answer Q3: If your biological specimens are intended for testing in a clinical laboratory or for basic scientific research, the product is not regulated by FDA. Thus, when submitting the entry notification for the specimens, the filer should disclaim that line. Note that if the person to whom the product is shipped (the consignee) is not using the samples for testing, but instead is processing or manufacturing HCT/Ps or biological products, drugs, or devices with these biological specimens, then the products are subject to FDA jurisdiction and must meet FDA's requirements for HCT/Ps, biological products, drugs, and/or devices.

28. In addition, to avoid possible delays with importation of specimens for testing or research, it is recommended that the labeling of each specimen container include the following information to make clear that the specimens do not fall under FDA regulation: • An accurate description of the biological specimens. For example: human blood specimen, human tissue specimen, human DNA specimen. • A statement regarding the intended use of the specimen. For example: "Human Blood For Testing in a Clinical Laboratory," or "Human DNA Specimen for Basic Scientific Research." • If the biological specimen has been tested for infectious agents such as the hepatitis B surface antigen (HBsAg) and/or the antibody to human immunodeficiency virus (anti-HIV), a statement relative to the test results should be included.

29. Importing CBER-Regulated Products: Clinical Laboratories and Basic Scientific Research Q4? I want to import human tissues for educational use or for basic scientific research. Does FDA regulate human tissue intended only for educational use or for basic scientific research? https://www.fda.gov:80/FDAgov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/ComplianceActivities/BiologicsImportingExporting/ucm390716.htm Answer to Q4.: No. If the human tissues you are offering for import are intended for use only for educational use or for basic scientific research and are not intended for implantation, transplantation, infusion, or transfer into a human recipient, the tissues are not subject to FDA’s human tissue regulations or FDA import review. If your broker needs to “disclaim” FDA jurisdiction, please see (link to “How do I tell FDA that a biological specimen is being imported for testing in a clinical laboratory or for basic scientific research?”

30. Are there any other federal agencies that may have requirements that apply to biological specimens? Yes. The Centers for Disease Control and Prevention (CDC); the US Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS); and the US Customs and Border Protection have regulations that may also apply to biological specimens. If the material is suspected or known to contain etiologic agents or has not been tested for etiologic agents, a CDC Etiologic Agent Import Permit may be required.

31. DETROIT AMBASSADOR BRIDGEPORT HURON BLUEWATER BRIDGESAULT 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) 226-5698 (F) (810) 985-8528 (F) DAYS & HOURS OF OPERATION DETROIT AMBASSADOR BRIDGEPORT HURON BLUEWATER BRIDGESAULT 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 EMERGENCY IMPORT CONTACT (Detroit Area) Melissa Tyrrell, SCSO (313) 434-8477 Phenicia Petty, SCSO (313) 212-9533 Eric Joneson, Acting DIB (313) 363-9733 Keith Jasukaitis, Acting PDD (313) 617-4464 Art O. Czabaniuk, DD (313) 779-5973 FDA Import Operations Border Locations & Contacts General Inquiry: FDAImportsInquiry@fda.hhs.gov; Import Offices/Contacts: www.fda.gov/ForIndustry/ImportProgram/ucm319216.htm www.fda.gov

32. Resources and Contacts www.FDA.gov/ORA 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 • ORA Organization Charts and Boundary Maps • Fact Sheets • ORA’s New Structure • Operational Offices • Investigations Operations Manual • Headquarters, District/Division Contact Information www.fda.gov

33. ORA Ombudsman • Informally and impartially addresses concerns, complaints, and disputes between ORA and external parties: • Industry • Federal, state, territory, and tribal government entities • Public • Contact: • 513-679-2777 or 240-535-6021 • ORAOmbudsman@fda.hhs.gov Jessica Zeller, JD, MA Ombudsman Enhancing ORA operations by serving as an objective, neutral resource to improve communication channels, resolve disputes, and foster positive relationships with internal and external stakeholders. PUBLIC HEALTH PARTNERSHIPS: www.fda.gov

34. Importing and Exporting CBER regulated products On August 3-4, 2016, the CDC Import Permit Program hosted a two-day Federal Partners Import/Export Regulations webcast to provide information addressing import and export regulations for infectious biological agents, infectious substances, and vectors, as well as import and export exemptions. Video start: Day 2, Part 1, 1:24:16 (end approx. 1:56). https://www.cdc.gov/phpr/ipp/webcast-2016/index.htm Questions: CBERImportInquiry@hhs.fda.gov (240)402-9155

35. Thank You Questions ? www.fda.gov