1. One of the most common errors is the submission of duplicate units of measure when describing the quantity of product on a single FDA line. FDA’s quantity reporting requirements have not changed with ACE and filers should continue to describe the product from largest container down to the smallest base unit. An example would be a product that ships in 100 cartons (CT), each containing 24 boxes (BX), each containing 10 packages (PK) of 12 oz. (OZ) each. It is not appropriate to send cartons, boxes, packages or ounces twice on this example line. Different packaging sizes should be transmitted as separate lines in order to accurately reflect the product’s state when making entry into the country. Instructions on transmitting quantity to FDA are attached to this CSMS message.
Further quantity 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) (Base Unit)
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) (Base Unit)
2. FDA requires Manufacturer (MF) as a mandatory entity in PG19 for lines on entries with Product Codes that are identified as “Non-Food” (not requiring Prior Notice) and for lines on entries with Product Codes that are identified as “Food” and already having a Prior Notice Confirmation. Filers need to provide the Manufacturer entity in PG19 for these scenarios.
3. FDA limits “Affirmation of Compliance Qualifier field” in PG23 (Affirmation of Compliance) to a size of 30 characters. Filers should provide no more than 30 characters for this field in PG23. In addition, the qualifier must follow the syntax indicated in the FDA Supplemental Guide.
4. Intended Use Code: FDA requires trade to provide a valid intended use code which is listed in the FDA Supplemental Guide 2.4.1 and CBP ACE CATAIR
5. Missing/Invalid Affirmations of Compliance- AofC Codes are required based on product type (and FDA Product Code), intended use, mode of transport. There have been additions and changes to many AofCs in ACE
6. Missing/Invalid Entities • 4-5 Entities are required for Non-PN Lines • 7 Entities are required for PN Lines Incorrect entity role codes for a given commodity can cause processing errors and delays. Refer to the FDA Supplemental Guide to determine which entities should be provided for a given product. Please direct any questions to ACE_SUPPORT@FDA.HHS.GOV
THE FOOD & DRUG ADMINISTRATION
To download an Adobe copy FDA-ACE Quantity Data Instructions please follow this link: ACE FDA Quantity Instructions
Source Document CSMS #16-000557