The United States Customs Service is the lead Federal agency for controlling the import of foreign-products. Importers are required to comply with any number of federal regulations, both Customs and other agency regulations. For products regulated by FDA, certain data elements are required to be submitted for an electronic admissibility decision to be made. This lesson will focus on those data elements.

First, a brief overview of the U.S. Customs automated import system is presented below.

The Automated Commercial System (ACS) is the system used by the U.S. Customs Service to track, control, and process all commercial goods imported into the United States. ACS facilitates merchandise processing, significantly cuts costs, and reduces paperwork requirements for both Customs and the trade community.

The Automated Broker Interface is an integral part of ACS that permits qualified participants to file import data electronically with Customs. ABI is a voluntary program available to brokers, importers, carriers, port authorities, and independent service centers. Currently, over 96% of all entries are filed through ABI.

ABI expedites the release of merchandise for the trade community. Entry summaries are electronically transmitted, validated, confirmed, corrected, and paid. Administrative messages keep participants informed of all current information and issues.

Participants can query quota status, visa requirements, manufacturer information, and entry/entry summary processing status. ABI allows filers to pay multiple entries with one payment transaction through statement processing. ABI filers can also pay Customs duties, fees, and taxes electronically through the Automated Clearinghouse (ACH)

ACS interfaces with other government agencies (OGA) to electronically transfer data on import transactions. The interface eliminates the need for paper copies of other agencies' forms which are otherwise required by Customs with the entry or entry summary. The OGA interface allows filers to comply with Department of Transportation, Bureau of Census, Federal Communications Commission, U.S. Fish and Wildlife Service and the Food and Drug Administration requirements.

With the OGA interface you can:

• File entry and entry summary data electronically and receive ACS, Census, DOT, FCC, FDA, and FWS edit results.
• Identify transactions subject to other agency review.
• File other agency data electronically, get faster cargo release, and reduce the number of paper documents.
• Receive other agency cargo status and authorizations for cargo disposition.

The filer submits the information through their ABI software application. If the product is regulated by the FDA, information is electronically sent to the agency for review. The information is processed through FDA's Operational and Administrative System for Import Support. (OASIS).

The Operational and Administrative System for Import Support, known as OASIS, is an automated FDA system for processing and making admissibility determinations for shipments of foreign-origin FDA-regulated products seeking to enter domestic commerce.

OASIS enables FDA to handle more efficiently and effectively the burgeoning volume of shipments (now over 8 million/year -- up by 50% in the last four years) of imported products, despite decreasing agency resources.

OASIS has improved the turnaround time in which FDA makes its admissibility determinations for imported products. Under the legacy manual system, FDA's review processes took days; OASIS routes electronic admissibility decisions to 2200 importers agents' PCs within minutes after their shipment data is transmitted electronically to FDA through the Automated Broker Interface. With OASIS, 85% of the shipments are cleared without any submission of paper by the importers, versus the previous requirement for submission of paper documentation for all shipments.

OASIS assists in targeting probable problem areas and, ultimately, in the identification and stoppage of violative goods. Automated screening functions enhance FDA's ability to detect problems, thereby keeping violative products from entering the country and safeguarding the public. OASIS brings consistency to FDA enforcement decisions at the 350 U.S. ports of entry nationwide, where FDA-regulated products arrive, to an extent that was not possible with the manual system.

OASIS improves the effectiveness and productivity of the 350 FDA employees responsible for processing shipments that are candidates for importation, enabling them to handle an ever-increasing workload that could not be efficiently managed under the legacy manual system. FDA employees doing this work are dispersed nationwide -- a modern automated processing system is essential for consistency in FDA's enforcement decision-making.

If a foreign product requires FDA approval, five specific data elements, in addition to the information required by U.S. Customs, must be submitted for FDA review. Those data elements are discussed below.

The commercial description is an actual description of the product. This is usually obtained from the invoice.

The FDA Manufacturer is the site-specific location where the product is manufactured, produced or grown. FDA needs to know the actual manufacturer of the product. U.S. Customs Service only requires the "invoicing firm," which may or may not be the manufacturer. For example:

• ABC Co, in Hong Kong manufacturers and labels canned mushrooms under contract for XYZ Corp. in Peoples Republic of China.

• XYZ Corp. invoices and ships the product to the U.S.

• RESULT: FDA considers ABC Co. to be the manufacturer; U.S. Customs Service considers it to be XYZ Corp.

Many FDA regulated products, food items (for example, Low Acid Canned Foods), medical devices, human and veterinary drugs, and biologics always require evidence they were produced in a facility that has registered, licensed and/or listed its products with FDA. For these products, the site-specific location must be submitted as the FDA Manufacturer. The name and address of a corporate headquarters, "trading company," or other intermediate supplier is not acceptable. The only exception to this data requirement is where a valid Memorandum of Understanding (MOU) or other binding agreement between FDA and a foreign governmental agency directs otherwise.

If a product (such as a raw agricultural commodity) does not require registration, listing, or licensing, and the actual site-specific FDA Manufacturer information is not available, after making a good faith effort to determine same, the filer may instead transmit the FDA Shipper in lieu of the FDA Manufacturer. Note: In this case the FDA Country of Origin remains the country where the actual site-specific FDA Manufacturer is located; the filer may be able to determine this from the invoice "Product of - - " statement. If after diligence the filer cannot determine the FDA Country of Origin, the Customs Country of Origin may be substituted in its place.

While it is technically permissible to transmit the shipper or consolidator under the situations described in example three above, every effort must be taken to provide the actual FDA Manufacturer. Failure to do so may result in the wrong firm being added to an FDA Import Alert and future shipments could be subject to Detention Without Physical Exam when another firm is actually responsible for the violation.

The FDA Shipper is the actual shipper of the product. This can be determined from the freight bill or bill of lading, etc. The FDA Shipper is usually the same as the U.S. Customs Service invoicing party.

FDA considers the country of origin to be that of the actual manufacturer. U.S. Customs Service considers it to be the country where the product last underwent a "substantial transformation" (resulting in an increase in value). For example:

• ABC Co. in Japan manufactures stereo systems, which contain a CD player manufactured by XYZ Corp. in Korea.

• USCS considers Japan to be the country of origin – based on ABC Co. manufacturing the stereo system.

• FDA only regulates the CD player and considers the country of origin to be Korea, where the CD player was manufactured.

The FDA Product Code is a 7 character alphanumeric code. The Code identifies the specific product and must agree with the invoice description of the product. Each FDA line of the entry papers must have a FDA Product Code. This training tutorial covers the FDA Product Code in detail.

Optional data is not applicable to all products. But, in some cases where it is applicable, providing optional FDA data often speeds the FDA review process. Below are descriptions of the five optional data elements

One of the functions of the FDA – ACS Interface is the automated screening of FDA regulated import entries to determine which entries to " MAY PROCEED" without FDA examination and which entries require further "FDA REVIEW." Affirmation of Compliance (AofC) codes, transmitted at the FDA line level, is one data element used in this screening process.

By using a three letter AofC Code, the filer affirms the product identified in a FDA line meets requirements specific to each code. While submission of this information is voluntary, transmission of the data can greatly expedite initial screening and further review of an entry. The manufacturer or shipper should be able to indicate when these affirmations should be used and supply the qualifier information when required.

The three letter code identifies the type of affirmation. Qualifier information depends on the affirmation but is usually a number, such as a model number, application number or a date. For example the AofC ANA stands for Abbreviated New Animal Drug Number. The qualifier would be the actual number issued by FDA's Center for Veterinary Medicine for the animal drug product identified in the FDA line.

Use of these codes does not guarantee a May Proceed, as the FDA line, or other FDA lines in the entry, may be subject to a random exam or may fall under other screening criteria resulting in a directed exam or a detention without physical examination.

Click here to review and/or print FDA's list and description of the AofC Codes and Qualifier Information. You need Adobe Acrobat Reader to open this document.

Quantity Data provides additional information to FDA about the product and how it is packaged. The basic format for Quantity Data is in multiple pairs of data – quantity and unit of measure, i.e., 500 cases, 12 ounces, fluid, 1000 cartons, etc. Up to 6 data pairs may be submitted. The first pairs describe the containers. The last pair must describe the amount of product in the smallest container. Here are some examples:

Product: 1000 cases of mineral water, 24/12 ounce bottles in each case

Data pairs: 1000 CS (Case)

24 BO (Bottle, Non-protected, Cyl)

12 FOZ (Ounces, fluid)

Product: 200 cartons of 100 rolls surgical gauze, 75 square yards per roll

Data pairs: 200 CT (Carton)

100 RO (Roll)

75 (SYD (Square Yards)

Product: 100 cartons of 24 aspirin bottles, 100 tablets, 325 mg.

Data pairs: 100 CT (Carton)

24 BO (Bottles, Non-protected, Cyl)

100 TAB (Tablets)

Click here to review and/or print FDA's Quantity Data Instructions document. The document explains the rules and use of quantity data, provides several examples and lists the quantity unit codes and container codes. You need Adobe Acrobat Reader to open this document.

Value must be submitted in U.S. dollars. The value of the FDA line cannot exceed the value of the U.S. Customs Service entry. To insure the Customs line/entry value is not exceeded, it is permissible to decrease the FDA line value to make required adjustment. Such line value adjustments should be recorded on the invoice. These annotations will expedite review and comparison of the entry documents to the electronic data.

The FDA consignee data field only needs to be transmitted when the consignee transmitted for U.S. Customs Service data is not a U.S. firm. The reason is that FDA must know where the product is going.