Importation of Biologicals Workshop

Tuesday, October 10, 2017 9:00 am to 5:00 pm
Pre-registration is required, U-M employees can register directly through My LINC, external guests must email SafetyTraining@umich.edu with participant first and last names, and email addresses.

Location

Great Lakes rooms on the fourth floor of the University of Michigan Palmer Commons

Details

The presentations will differ from last year's talks and will offer additional information relating to the international importation of biological shipments for testing and research.

Our guest presenters include the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), US Customs and Border Protection (CBP), and the United States Department of Agriculture (USDA). Additionally, there will be an Import Specialist who will provide information related to the role of a customs broker for biological importations.

AGENDA

A light breakfast and lunch will be provided courtesy of the University

9:00 - 9:10     

Welcome and Introductions            

Kimberly Nott

a)      Purpose of Training                      

b)      Goal of Training

Each Government Agency’s Responsibilities relating to the international importation of biological shipments for testing and/or research will be addressee                     

9:10 - 9:55          

Robyn Cotting

Customs and Border Protection Field Office:  Requirements for the importation of biologicals into the United States and what to expect if your biological does not meet these requirements

9:55 – 10:40         

Customs and Border Protection Import Specialist:  The role of the broker in the importation of biological substances; specific topics to be covered: Why do you need a broker, why do you give a broker power of attorney, what questions should you ask when hiring a broker, a review some of the major regulations outlining the requirements of importing goods, including biologicals, into the United States.

10:40 – 10:50            

Break

10:50 – 11:35            

Craig Kellogg

U.S. Department of Agriculture: Role in the Importation of Biologicals, USDA permits

11:35 – 12:20            

Keith Jasukaitis

Food and Drug Administration: Importing FDA regulated biologics, Overview of FDA Organization including local offices and specialized program centers.

12:20 – 1:15              

Lunch Break

1:15 – 2:00                        

Elizabeth Harton

Centers for Disease Control: CDC Import regulations of biological substances, CDC import permit inspection program, CDC regulated products, Certification statement of non-infectiousness, specific examples of biological importations that did not meet CDC guidelines.

2:00 – 2:45                

Federal Aviation Administration        (Pending)

2:45 – 2:55                 

Break

2:55 – 3:40                          

Adam Pitt

Customs and Border Protection Detroit Metro Airport: Common biological interceptions in the passenger air environment, cases of biologicals being imported improperly and the final disposition. A specific case study will be presented involving the improper importation and exportation of biologicals for other than legitimate research purposes which is being investigated by CBP and other participating federal agencies. 

3:40 – 4:25                

Homeland Security Investigations      (Pending)

4:25 – 5:00                

Questions / Comments

Please feel free to contact Janet Follo for additional information, follo@umich.edu.