FDA Issues Revised Summary Information on Prior Notice Submissions for Imported Food
The Food and Drug Administration (FDA) has issued an April 2005 version of a document entitled, "Prior Notice Summary Information" which had previously been titled "Compliance Summary Information: Prior Notice."
Sign up for a free preview to unlock the rest of this article
Communications Daily is required reading for senior executives at top telecom corporations, law firms, lobbying organizations, associations and government agencies (including the FCC). Join them today!
The FDA states that this is the fourth posting of summary information describing Prior Notice (PN) submissions, and contains updates for some of the information previously reported. This updated document also includes information on specific information requirements such as registration number and carrier information.
(See ITT's Online Archives or 04/08/04, 05/20/04, and 08/20/04 news, 04040815, 04052010, and 04082015, for BP summaries of the April, May, and August 2004 versions of this guide.)
FDA's Statistics Indicate Most PNs Are Submitted as Additional Info for ABI Transactions
The FDA's summary information indicates that 170,000 PNs are submitted to FDA each week and 9,000,000 PN submissions are expected to be received in fiscal year (FY) 2005. From December 2003 through December 2004 about 77% of PN submissions were submitted as additional information on transactions submitted to U.S. Customs and Border Protection (CBP) through its Automated Broker Interface of the Automated Commercial System (ABI/ACS).
About 22% of PN submissions were submitted through FDA's Prior Notice System Interface (PNSI). The FDA notes that about half of those PNs received through PNSI could have been submitted through ABI/ACS and the remainder were submitted for transactions that could not be accommodated by ABI/ACS.
According to the FDA, the percentage of PNSI submissions has risen steadily, with PNSI submissions representing around 18% of PN submissions in FY 2004 and 22% of PN submissions thus far in FY 2005.
Compliance is Improving for Both ABI/ACS & PNSI Submissions
With respect to ABI/ACS, the FDA states that compliance has steadily increased since August 2004. The FDA notes that submission of most of the information through ABI/ACs is at, or very near, 100% compliance.
However, several elements of planned shipment information do not reflect submission rates near or nearing 100%. For example, the container number is often not submitted for food arriving by rail and the carrier is often not provided for food arriving by road.
For PNSI, the FDA states that compliance is also improving and notes that since November 2004, 100% of PNSI submissions now include a manufacturer registration number or a reason code indicating why the registration number is not submitted.
Again, the FDA notes that several elements of planned shipment information do not reflect submission rates near or nearing 100%. For example, according to graphs contained this FDA document, the voyage/flight/trip number for sea, air, road and rail shipments is well short of 100% compliance for the months of August, September, and December 2004. With regard to the bill of lading for all four modes of transport, compliance also falls short for these three months.
See FDA's updated summary for additional graphs comparing ABI/ACS and PNSI compliance figures, etc.
FDA updated summary (dated April 2005) available athttp://www.cfsan.fda.gov/pn/pnsum.html