FDA has published a summary of compliance with the prior notice requirement. The timing of the summary is important because FDA is scheduled to begin full enforcement of the provisions tomorrow. While the summary is not as detailed as AFI and others requested, it does contain some useful information.
The entire summary can be seen at http://www.cfsan.fda.gov/~pn/pnsum.html
Points of interest include:
· Approximately 75 percent of prior notice submissions using Customs’ Automated Commercial System (The system brokers use) are complete. Less than 1 percent fail to submit any prior notice information.
· Most prior notice data is being submitted. Importer, Consignee, Product Description, Quantity, Product Code and County of Shipping are all at or near 100 percent completion as is Carrier information for air, sea, and rail. Submitter, Arrival, and Owner are complete in more than 90 percent of prior notice submissions.
· Completion of registration number and bill of lading is lower. Failure to submit a registration number for products that require one is a continuing concern. Of the prior notices submitted through ACS, 13 percent contain no registration information and 3 percent contain a registration number not on file at the FDA.
· Another area under review is the timeliness of submissions. In the last week of June almost 7 percent of submissions through ACS were untimely as defined by the regulation. Although this had decreased from nearly 8 percent at the beginning of the month, FDA says the decrease was too small to be confident of a positive trend. It adds that as with other types of violations, shipments with untimely prior notice submissions could be held at the border.
· FDA is also looking more closely at the validity and consistency of the data being entered. For example, although a consignee is entered on 100 percent of the submissions through ACS, its examination of the information entered indicates that almost 2 percent of consignee data indicates unknown/consolidated consignee, and not the ultimate consignee as required by the PN interim final rule.
· FDA and Customs are identifying specific submitters and transmitters (broker/filers) whose submissions tend to be error prone and are providing information to industry to encourage better compliance.
