Importing CBER-Regulated Products: FDA Interactions with other Agencies
How does the U.S. Customs and Border Protection (CBP) notify FDA of entries of FDA-regulated products?
FDA receives electronic information about most FDA related entries from the US Customs and Border Protection (CBP). FDA currently receives this information through its Operational and Administrative System for Import Support (OASIS).
When submitting an entry notification, a filer will determine the appropriate Harmonized Tariff Schedule (tariff) code for each 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 both products that are subject to FDA jurisdiction and 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. (Each distinct category of product in an entry will have its own “line” in the entry. For example, if a shipment of a vaccine consisted of both multi-dose vials and pre-filled, single dose syringes, the vials would be one line and the syringes another line.)
The CBP has primary responsibility for regulating and facilitating international trade, collecting import duties, and enforcing United States trade laws. All goods imported or offered for importation into the United States must first pass through CBP control. CBP can be contacted at:
US Customs and Border Protection
1300 Pennsylvania Avenue, N.W.
Washington, D.C. 20229
What information is submitted to CBP and FDA about an FDA-regulated product?
The entry information submitted to CBP and then to FDA includes:
- the identification of the product by the tariff code;
- the entry type;
- the entry number;
- the arrival date;
- the port of entry;
- the port of unlading;
- the carrier code;
- the vessel name and voyage, flight or trip number;
- the importer and ultimate consignee;
- the quantity;
- the value;
- the country of origin;
- the bill of lading or airway bill number;
- the manufacturer;
- the importer of record; and
- the ultimate consignee.
The tariff codes are flagged to indicate which products will require FDA review. The additional information that is currently transmitted to FDA includes:
- the FDA manufacturer;
- the FDA shipper;
- the FDA Country of Production (country of origin);
- the complete FDA product code;
- a description of the article in common business terms;
- the quantity for each FDA line; and
- Affirmations of Compliance.
Affirmations of Compliance (AOC) are voluntary data elements that a customs broker or self-filer currently may use when transmitting certain information to FDA through the CBP’s electronic interface with OASIS. Each AOC provides a mechanism to indicate (or affirm) compliance with a specific FDA regulatory requirement. For example, for a licensed biological product, the AOC would be the BLN (Biologics License Number) or STN (Submission Tracking Number), while for an investigational biological drug product, it would be the IND (Investigational New Drug Application) number.
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. CDC can be contacted at:
Centers for Disease Control and Prevention
Office of Health and Safety FO5
Atlanta, Georgia 30333
Phone: (404) 639-3311 or (404) 498-2260
The U. S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), Veterinary Services (VS), regulates the import of all animal-origin materials that could represent a disease risk to United States livestock and the import and transport of infectious organisms and vectors of disease agents. This includes not only animal products and by products, but biological materials that contain or have been in contact with certain organisms and animal materials (including cell cultures). USDA/APHIS/VS can be contacted at:
USDA, APHIS, VS
National Center for Import and Export
4700 River Rd. Unit 39
Riverdale, MD 20737
Phone: (301) 734-3277