CSMS Message: 95-000106

THIS ADMIN. MESSAGE REGARDING THE FOOD AND DRUG ADMINISTRATION (FDA)
DISCLAIM POLICY IS BEING SENT ON FDA 'S BEHALF. PLEASE NOTE THE
FOLLOWING:

****PARTICIPANTS IN THE FDA/CUSTOMS ELECTRONIC INTERFACE****

DURING THE DUAL (PAPER AND ELECTRONIC) TRANSMISSION PHASE,
PARTICIPANTS MUST SUBMIT DOCUMENTATION TO FDA FOR ALL ENTRIES
OF PRODUCTS WHOSE HTS OGA FIELDS ARE FLAGGED FD1, WHETHER OR NOT
THEY ARE BEING DISCLAIMED. AT THE DISCRETION OF THE FDA DISTRICT,
FOR ENTRIES FLAGGED FD1 THAT CONSIST SOLELY OF AMERICAN GOODS
RETURNED PRODUCTS WHICH THE FILER BELIEVES ARE NOT REGULATED BY
FDA, THE ENTRY DOCUMENTATION MAY BE CONSOLIDATED BY THE FILER AND
SUBMITTED TO FDA WITH ONE COVER DOCUMENT FOR ALL SUCH ENTRIES FOR
A GIVEN IMPORTER OF RECORD FOR A SINGLE DAY.

FILERS WHO ARE IN "PAPERLESS" STATUS DO NOT NEED TO SUBMIT
DOCUMENTATION TO FDA FOR DISCLAIMED ENTRIES.

FILERS' PERFORMANCE IN CORRECTLY DISCLAIMING NON-FDA-REGULATED
PRODUCTS WILL BE REVIEWED AS PART OF THE FILER EVALUATION PROCESS.

****NON-PARTICIPANTS IN THE FDA/CUSTOMS ELECTRONIC INTERFACE****

NON-PARTICIPATING FILERS ARE RESPONSIBLE FOR SUBMITTING PAPER
ENTRY DOCUMENTATION TO FDA FOR ALL ENTRIES OF PRODUCTS WHOSE
HTS OGA FIELDS ARE FLAGGED FD1. AT THE DISCRETION OF THE FDA
DISTRICT, FOR ENTRIES FLAGGED FD1 THAT CONSIST SOLELY OF AMERICAN
GOODS RETURNED WHICH THE FILER BELIEVES ARE NOT REGULATED BY FDA,
THE ENTRY DOCUMENTATION MAY BE CONSOLIDATED BY THE FILER AND
SUBMITTED TO FDA WITH ONE COVER DOCUMENT FOR ALL SUCH ENTRIES FOR
A GIVEN IMPORTER OF RECORD FOR A SINGLE DAY.