Effective April 14th ABI, FDA Software to be Modified to Improve the FDA Prior Notice Filing Process
U.S. Customs and Border Protection (CBP) has issued an administrative message announcing that several changes will be made to ABI and FDA software, effective April 14, 2004, to improve the process for filing FDA Prior Notices of imported food (PNs), as follows:
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PNs for FD1, FD2, and "Blank" to be Allowed. CBP states that edits on tariff records marked with an FD1, FD2 or "no FD marker" (i.e., blank) will be relaxed effective April 14, 2004, in order to allow ABI filers to file PNs, when in the judgment of the filer, a PN is required.
PNs will continue to be allowed or required to be filed on FD3 and FD4 items, as applicable. PNs will still not be able to be filed for items marked FD0, for which no FDA data, prior notice or otherwise, is permitted.
(FD0 - FDA has no interest in the product
FD1 - product may be regulated by FDA, and if so, FDA 801(a) data is required
FD2 - product is regulated by FDA and always requires FDA 801(a) data
FD3 - both FDA 801(A) and/or PN data may be required
FD4 - both FDA 801(A) and PN data is required)
New FDA transmission 'P' for 'PN data required.' CBP states that FDA validates the need for PN data based on the FDA product code. Effective April 14, 2004, if the FDA looks for PN data based on the FDA product code and finds none, FDA will transmit the letter 'P' (PN data required) in the BN02 record of the BN application, and the entry will be placed in Prior Notice rejected status in ACS. The filer then must provide the PN data to FDA using the CP application. This 'P' status message applies only to entries (HN,HI, EI).
New FDA transmission 'W' for 'PN not required.' According to CBP, if the ABI filer provides PN data for a transaction that does not require a PN based on the FDA product code, effective April 14, 2004, FDA will issue a warning message of 'W' (PN is not required) in the BN02 record of the BN application. This 'W' status message applies only to entries (HN,HI, EI).
New Affirmation of Compliance Code (PN Disclaimer). Certain tariff numbers, especially those that cover American Goods Returned, are marked as FD3 and may cover goods regulated by the FDA's 801(a) regulations but are not subject to the PN requirement for imported food.
In situations where the PN must be disclaimed, the FDA has made a new Affirmation of Compliance Code, 'PND' for Prior Notice disclaimed, that will take effect on April 14, 2004.
In cases where the product requires FDA 801(a) data, but PN data is not required, CBP states that the filer should transmit the PND disclaimer and the information required for 801(a).
CBP adds thatthe PND affirmation must be the first Affirmation of Compliance reported in the FD01 record, and does not require a qualifier.
Merchandise entered from a FTZ into a warehouse. CBP states that merchandise entered from a Foreign Trade Zone (FTZ) into a warehouse (entry type 21) does not require a PN. To report this transaction, effective April 14, 2004, filers are to transmit the code FTZNNNX in the vessel name/foreign trade zone number field of the H2 record, with the value of the NNN from 001 through 300. If this isn't done, ACS will issue error message MSG VDP: 'FTZ Number Invalid.'
(CBP adds that filers should also note that affirmation of compliance codes PK1-PK0 apply to all FDA regulated transactions, not only to PN transactions.)
(See ITT's Online Archives or 10/28/03 news, 03102810 for BP summary regarding FD0 - FD4 markers. See ITT's Online Archives or 11/25/03 news, 03112505 for BP summary on the new FD3 or FD4 markers.)
CBP Adm: 04-0586 (dated 03/24/04), available by email or fax, by emailing documents@brokerpower.com