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FDA Program / CargoPoint UI Guidance11/10/2020
This document is offered as a guideline for the proper completion of ACE/PGA transactions that include tariff numbers requiring the submission of data to FDA via ACE/ITDS and its proprietary EDI messaging.
FDA has supplied the trade community with a document that included message-set requirements for the 8 commodity area that it oversees: biologics, cosmetics, medical devices, foods, radiation emitting products, tobacco and animal drugs & devices.
This guidance document will supply the following for each of FDA’s 8 commodity and additional commodity sub-type areas:
A high-level profile of the commodities associated with each of the “Government Agency Program Codes”, as well as the commodity sub-types associated with “Government Agency Processing Codes”
A 4-page example of each Program/Processing combination, including:o A brief description of the “business case” example depicted.o A “bullet-point” text providing the distinguishing data requirements
involved in complying with the needs of each commodity / commodity sub-type scenario and the specifics for the particular variant represented.
o Screen-shots of the FDA screens from the CargoPoint applications User Interface (UI) which demonstrate completeness and compliance for each scenario.
o A sample message set provided for each of the scenarios, with essential data highlighted.
We believe that the Customs Broker’s familiarity with historic FDA forms and their contents will go a long way toward making this document and the UI functions that it depicts very accessible and clear. Wherever possible, we designed the UI to guide the user by enabling required fields and disabling superfluous fields – for the specific scenario at hand. Field-level, sectional and screen validations also provide insurance that data is appropriate, properly formatted and complete in order to insure the highest level of success in submissions to both CBP and FDA.
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Commodity and Commodity Sub-Types
Program Code Processing Code Page
BIO – Biologics ALG Allergens 3BBA Blood Bag w/ Anticoagulant 7BDP Blood Derivatives 11BLD Licensed Devices 15BLO Blood and Blood Products 19BRD Regulated Devices (wo/ licensing) 23CGT Cell & Gene Therapy 27HCT Human Cells & Tissue 31PVE Plasma Volume Expander 35VAC Vaccines 39XEN Xenotransplant 43
COS – Cosmetics (no processing code required) 47
DRU – Drugs PRE Prescription 51OTC Over the Counter 55INV Investigational 59PHN Pharm’ Necessities & Containers 63RND Research and Development 67804 Importation Program 71
FOO – Food ADD Additives and Colors 76CCW Ceramics / Food Contact Substances 80DSU Dietary Supplements 83FEE Animal / Pet Food 88NSF Natural State Food 92PRO Processed Food 96
DEV – Medical Devices NED Non-Radiation Emitting 100RED Radiation Emitting 104
TOB – Tobacco CSU Consumer Use 108FFM For Further Manufacturing 115INV Investigational 116
RAD – Radiation Emitting Products REP Non-Medical Products 120
VME – Veterinary Drugs and Devices ADE Animal Devices 124ADR Animal Drugs 128
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BIO / ALG – Biologics / AllergensFlobivax brand allergens imported from Italy
Distinguishing Data-entry Requirements:
Program Code: BIO Processing Code: ALG No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes Ingredients Detail
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BIO / ALG – Screen Shots
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ACE / PGA Message set for BIO / ALG
OI········ALLERGENSPG01001FDABIOALG·························080.000PG02PFDP·57G--19PG0639·ITPG07FLOBIVAXPG10···················FLOBIVAX·ALLERGENSPG04YFLOBIVAX·ALLERGEN··································000000000600FOZ··0850000PG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23BLN··7777PG23IND··55555PG23REG··999999999PG23STN··666666PG25···000000···········································000000025000000000016667PG261000000001000CTPG262000000000500BXPG263000000000300FOZPG27MAEU-173704630292PG30A0306201613002···0901
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BIO / BBA – Biologics / Blood Bag with AnticoagulantBlood bag with anticoagulant from Salice brand of Italy
Distinguishing Data-entry Requirements:
Program Code: BIO Processing Code: BBA No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
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BIO / BBA – Screen Shots
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ACE / PGA Message set for BIO / BBA
OI········BLOOD·BAG·W/·ANTICOAGULANTPG01001FDABIOBBA·························100.000PG02PFDP·57V--01PG0639·ITPG07SALICEPG10···················BLOOD·BAG·W/·ANTICOAGULANTPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23AND··BA55555PG23BLN··4444PG23DA···BA666666PG23IND··55555PG23REG··999999999PG23STN··666666PG25···000000···········································000000250000000000041667PG261000000000200CTPG262000000005000BXPG263000000000600FOZPG27MAEU-349019230292PG30A0220201613002···0901
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BIO / BDP – Biologics / Blood DerivativesHuman blood granulocytes from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: BIO Processing Code: BDP No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
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BIO / BDP – Screen Shots
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ACE / PGA Message set for BIO / BDP
OI········HUMAN·BLOOD·GRANULOCYTESPG01001FDABIOBDP·························082.000PG02PFDP·57D--32PG0639·ITPG07SALICEPG10···················HUMAN·BLOOD·GRANULOCYTESPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23BLN··4444PG23IND··55555PG23REG··999999999PG23STN··666666PG25···000000···········································000000025000000000001221PG261000000000100CTPG262000000025600BXPG263000000000800FOZPG27MAEU-179708730292PG30A0307201609002···0901
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BIO / BLD – Biologics / Licensed DevicesDevice / kit from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: BIO Processing Code: BLD No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
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BIO / BLD – Screen Shots
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ACE / PGA Message set for BIO / BLD
OI········BIO-DEVICEPG01001FDABIOBLD·························180.010PG02PFDP·57V--11PG0639·ITPG07SALICEPG10···················BIOLOGICS-DEVICEPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23BLN··4444PG23IND··55555PG23REG··999999999PG23STN··666666PG25···000000···········································000000250000000000041667PG261000000000200CTPG262000000005000BXPG263000000000600FOZPG27MAEU-389019230292PG30A0220201613002···0901
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BIO / BLO – Biologics / Blood and Blood ProductsHuman blood plasma from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: BIO Processing Code: BLO No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
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BIO / BLO – Screen Shots
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ACE / PGA Message set for BIO / BLO
OI········HUMAN·BLOOD·PLASMAPG01001FDABIOBLO·························082.000PG02PFDP·57D--32PG0639·ITPG07SALICEPG10···················HUMAN·BLOOD·PLASMAPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23BLN··4444PG23IND··55555PG23REG··999999999PG23STN··666666PG25···000000···········································000000025000000000001221PG261000000000100CTPG262000000025600BXPG263000000000800FOZPG27MAEU-179704730292PG30A0307201609002···0901
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BIO / BRD – Biologics / Regulated Devices (not requiring license)Devices from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: BIO Processing Code: BRD No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
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BIO / BRD – Screen Shots
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ACE / PGA Message set for BIO / BRD
OI········BIO-DEVICEPG01001FDABIOBRD·························180.010PG02PFDP·57V--11PG0639·ITPG07SALICEPG10···················BIOLOGICS-DEVICEPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23CPT··55555PG23DEV··1234567890PG23IDE··55555PG23LST··Q123456PG23PM#··BP55555PG23PMA··BP4444PG25···000000···········································000000250000000000041667PG261000000000200CTPG262000000005000BXPG263000000000600FOZPG27MAEU-389719230292PG30A0220201613002···0901
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BIO / CGT – Biologics / Cell & Gene TherapyCartilage cells from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: BIO Processing Code: CGT No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
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BIO / CGT – Screen Shots
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ACE / PGA Message set for BIO / CGT
OI········CGT·-·CARTILAGE·CELLSPG01001FDABIOCGT·························080.000PG02PFDP·57C--26PG0639·ITPG07SALICEPG10···················CGT·-·CARTILAGE·CELLSPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23BLN··4444PG23IND··55555PG23REG··999999999PG23STN··666666PG25···000000···········································000000025000000000016667PG261000000001000CTPG262000000000500BXPG263000000000300FOZPG27MAEU-179504630292PG30A0306201613002···0901
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BIO / HCT – Biologics / Human cells & tissueHCT from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: BIO Processing Code: HCT No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes Ingredients Detail
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BIO / HCT – Screen Shots
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ACE / PGA Message set for BIO / HCT
OI········HCTPG01001FDABIOHCT·························080.000PG02PFDP·57J--07PG0639·ITPG07FLOBIVAXPG10···················HCTPG04YHCT················································000000000600FOZ··0850000PG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23HRN··0000055555PG25···000000···········································000000025000000000016667PG261000000001000CTPG262000000000500BXPG263000000000300FOZPG27MAEU-173709630292PG30A0306201613002···0901
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BIO / PVE – Biologics / Plasma Volume ExpanderPVE from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: BIO Processing Code: PVE No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
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BIO / PVE – Screen Shots
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ACE / PGA Message set for BIO / PVE
OI········PLASMA·EXPANDERPG01001FDABIOPVE·························100.000PG02PFDP·57V--01PG0639·ITPG07SALICEPG10···················PLASMA·STERTCHERPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23AND··BA45454PG23BLN··4444PG23DA···BN55555PG23IND··666666PG23REG··999999999PG23STN··555555PG25···000000···········································000000250000000000041667PG261000000000200CTPG262000000005000BXPG263000000000600FOZPG27MAEU-349719230292PG30A0220201613002···0901
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BIO / VAC – Biologics / Human cells & tissueHepatitis B vaccine from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: BIO Processing Code: VAC No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes Ingredients Detail
39
BIO / VAC – Screen Shots
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41
ACE / PGA Message set for BIO / VAC
OI········HEPATITIS·B·VACCINEPG01001FDABIOVAC·························080.000PG02PFDP·57C--26PG0639·ITPG07RECOMBIVAXPG10···················RECOMBIVAX·HEPITITIS·B·VACCINEPG04YHEP·B·VACCINE······································000000000600FOZ··0850000PG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23BLN··1234PG23IND··55555PG23REG··999999999PG23STN··666666PG25···000000···········································000000025000000000016667PG261000000001000CTPG262000000000500BXPG263000000000300FOZPG27MAEU-179704630292PG30A0306201613002···0901
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BIO / XEN – Biologics / XenotransplantPorcine cartilage from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: BIO Processing Code: XEN No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
43
BIO / XEN – Screen Shots
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45
ACE / PGA Message set for BIO / XEN
OI········PORCINE·CARTILAGEPG01001FDABIOXEN·························080.000PG02PFDP·57J--07PG0639·ITPG07SALICEPG10···················PORCINE·CARTILAGEPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23REG··999999999PG25···000000···········································000000025000000000016667PG261000000001000CTPG262000000000500BXPG263000000000300FOZPG27MAEU-173709330292PG30A0306201613002···0901
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COS – CosmeticsHair lacquer from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: COS Processing Code: none available / required No Prior Notice FDA Product Code Intended Use Code disabled / not required Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Affirmation of Compliance not required Container #s Required Country Type Codes and Country Codes
47
COS – Screen Shots
48
49
ACE / PGA Message set for COS
OI········HAIR·LACQUERPG01001FDACOSPG02PFDP·53E--02PG0639·ITPG07SALICEPG10···················HAIR·LACQUERPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG25···000000···········································000000025000000000000007PG261000000010000CTPG262000000043200BXPG263000000000100AEPG264000000000800FOZPG27MAEU-381717830292PG30A0228201613002···0901
50
DRU / PRE – Drugs / PrescriptionPrescription antibiotics from Clavamox of Italy
Distinguishing Data-entry Requirements:
Program Code: DRU Processing Code: PRE No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance
o DRU with IUC 100.000 needs no AofC o DRU with IUC 970.000 needs no AofC
Container #s Required Country Type Codes and Country Codes Ingredients Detail
51
DRU / PRE – Screen Shots
52
53
ACE / PGA Message set for DRU / PRE
OI········CLAVAMOX·ANTIBIOTICPG01001FDADRUPRE·························100.000PG02PFDP·56J--99PG0639·ITPG07CLAVAMOXPG10···················CLAVAMOX·ANTIBIOTICPG04YFLOUROQUINOLONE····································000000005000G····0250000PG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG25···000000···········································000000025000000000000100PG261000000001000CTPG262000000025000BXPG263000000001000PCSPG27MAEU-179734830292PG30A0228201613002···0901
54
DRU / OTC – Drugs / Over the CounterOver the counter antibiotics from Clavamox of Italy
Distinguishing Data-entry Requirements:
Program Code: DRU Processing Code: OTC No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance
o DRU with IUC 100.000 needs no AofC o DRU with IUC 970.000 needs no AofC
Container #s Required Country Type Codes and Country Codes Ingredients Detail
55
DRU / OTC – Screen Shots
56
57
ACE / PGA Message set for DRU / OTC
OI········CLAVAMOX·OTC·ANTIBIOTICPG01001FDADRUOTC·························130.000PG02PFDP·56J--99PG0639·ITPG07CLAVAMOXPG10···················CLAVAMOX·OTC·ANTIBIOTICPG04YFLOUROQUINOLONE····································000000005000G····0250000PG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21GD·GUGLIELMO·PAZZO········31-4567-3445···[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23DLS··1234567890PG23IND··666666PG23PLRPG23DA···888888PG23REG··999999999PG25···000000···········································000000025000000000000100PG261000000001000CTPG262000000025000BXPG263000000001000PCSPG27MAEU-379734130292PG30A0228201613002···0901
58
DRU / INV – Drugs / InvestigationalAntibiotic from Clavamox of Italy for investigative purposes
Distinguishing Data-entry Requirements:
Program Code: DRU Processing Code: INV No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance
o DRU with IUC 100.000 needs no AofC o DRU with IUC 970.000 needs no AofC
Container #s Required Country Type Codes and Country Codes Ingredients Detail
59
DRU / INV – Screen Shots
60
61
ACE / PGA Message set for DRU / INV
OI········CLAVAMOX·ANTIBIOTICPG01001FDADRUINV·························180.009PG02PFDP·56J--99PG0639·ITPG07CLAVAMOXPG10···················CLAVAMOX·ANTIBIOTICPG04YFLOUROQUINOLONE····································000000005000G····0250000PG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23DFE··1234567PG25···000000···········································000000025000000000000100PG261000000001000CTPG262000000025000BXPG263000000001000PCSPG30A0228201613002···0901
62
DRU / PHN – Drugs / Pharmaceutical Necessities & ContainersGlass cannulae from Wagner of Italy
Distinguishing Data-entry Requirements:
Program Code: DRU Processing Code: PHN No Prior Notice FDA Product Code No Intended Use Code Required Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities No Affirmation of Compliance Required Container #s Required Country Type Codes and Country Codes Ingredients Detail
63
DRU / PHN – Screen Shots
64
65
ACE / PGA Message set for DRU / PHN
OI········CANNULAEPG01001FDADRUPHNPG02PFDP·55C--99PG0639·ITPG07WAGNERPG10···················CANNULAEPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG25···000000···········································000000025000000000000010PG261000000001000CTPG262000000025000BXPG263000000010000PCSPG30A0228201613002···0901
66
DRU / RND – Drugs / Research & DevelopmentAntibiotic from Clavamox of Italy for R&D purposes
Distinguishing Data-entry Requirements:
Program Code: DRU Processing Code: RND No Prior Notice FDA Product Code Only Intended Use Code allowed is 180.017 Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities No Affirmation of Compliance Required Container #s Required Country Type Codes and Country Codes Ingredients Detail
67
DRU / RND – Screen Shots
68
69
ACE / PGA Message set for DRU / RND
OI········CLAVAMOX·ANTIBIOTICPG01001FDADRURND·························180.017PG02PFDP·56J--99PG0639·ITPG07CLAVAMOXPG10···················CLAVAMOX·ANTIBIOTICPG04YFLOUROQUINOLONE····································000000005000G····0250000PG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG25···000000···········································000000025000000000000100PG261000000001000CTPG262000000025000BXPG263000000001000PCSPG27MAEU-179434830292PG30A0228201613002···0901
70
DRU / 804 – Drugs / Importation ProgramPrescription drugs for human use, excluding those under a Biologics Licensing Application
Example: Antibiotic from Clavamox of Canada
Distinguishing Data-entry Requirements:
CBP / Entry Unloading, Entry and Filing: 3801 only Program Code: DRU Processing Code: 804 FDA Product Code
o Limited to Industry Codes: 54, 56, 60, 61, 62, 63, 64, 65, or 66 Only Intended Use Codes allowed: 080.012 & UNK Line Value Anticipated Arrival Date & Time / District Port = 3801 Packaging Details Required & Optional Entities
o Required MF DEQ … Country = “CA” DP FD1
Affirmation of Complianceo Required
DA DLS FSR PRN
Container #s Lot Number(s) and Qualifier (“1” = Manufacturer) Required Country Type Codes (30 or 39) and Country Code = “CA” Ingredients Detail: either Quantity or % API is required
71
DRU / 804 – Screen Shots
District Port of 3801 / Detroit is the only valid port for the 804 Importation Program. When required, utilize Remote Entry Filing.
72
73
74
ACE / PGA Message set for DRU / 804
OI········CLAVAMOX·OTC·ANTIBIOTICPG01001FDADRU804·························080.012·········PRESCRIPTION·HEALTH·PPG02PFDP·56BKG09PG0639·CAPG07CLAVAMOXPG10···················CLAVAMOX·SULFONOMIDPG04YFLOUROQUINOLONE····································000000005000G····0250000PG19DEQ··················ORTO·PUGLIA·OF·ONTARIO··········1234·HAMILONIAN·EXPRESSPG60AD1WAYPG20·····································HAMILTON·············ON·CAH9L·5H4PG21DEQBERNARD·FITZHUGH·······845-978-6655···[email protected]·16·123456789······COULTER·INDUSTRIES··············1·EXECUTIVE·DRIVE,·SUITPG60AD1E·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············1·EXECUTIVE·DRIVE,·SUITPG60AD1E·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················LEVESQUE·PHARMA·················123·RUE·CARTIERPG20·····································MONTREAL·············QC·CAH2X1M4PG19PK···················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG60AD1IRST·FLOORPG20ADDRESS·LINE·3·······················NASHUA···············NH·US03064PG21PK·EIN123456789··CONTACT·N603-555-1212···[email protected]···666666PG23DLS··0987654321PG23FSR··123456789PG23PRN··12345678PG25···000000·14561222··································000000025000000000000100PG261000000001000CTPG262000000025000BXPG263000000001000PCSPG27MAEU379774130292PG30A1109202013002···3801
75
FOO / ADD – Food / Additives and ColorsFood coloring with Cochineal from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: FOO Processing Code: ADD FOO / ADD - Prior Notice Required FDA Product Code FOO - No Intended Use Code Required Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities
o PNS and PNT Entities required w/ PN Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
o FOO – Code “CSH” required
76
FOO / ADD – Screen Shots
77
78
ACE / PGA Message set for FOO / ADD
OI········FOOD·COLORING·W/·COCHINEALPG01001FDAFOOADDPG02PFDP·45D--99PG06CSHITPG0639·ITPG07SALICEPG10···················FOOD·COLORING·W/·COCHINEALPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]··················COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DFPERICA·COULTER··········9784822707·····[email protected]···················COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]··················COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21MF·GUGLIELMO·PAZZO········31-4567-3445···[email protected]··················COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21PNSERICA·COULTER··········9784822707·····[email protected]··················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG20FAX·440-826-4333·····················NASHUA···············NH·US03064PG21PNTTOM·BROKER·············603-555-1212···[email protected]···················COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21UC·ERICA·COULTER··········9784822707·····[email protected]··12345677778PG23VES··MOODY·MAERSKPG23VFT··555PG25···000000···········································000000006000000000002400PG261000000001000CTPG262000000002500BGPG263000000000200KGPG27MAEU-339117830222PG30A0214201613002···0901
79
FOO / CCW – Food / Ceramics & Food Contact SubstancesCeramic dinner plates from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: FOO Processing Code: CCW FOO / CCW – No Prior Notice Required FDA Product Code Intended Use Code FOO - No Intended Use Code Required Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities
o PNS and PNT Entities required w/ PN Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
o FOO – Code “CSH” required
80
FOO / CCW – Screen Shots
81
82
ACE / PGA Message set for FOO / CCWOI········CERAMIC·DINNER·PLATESPG01001FDAFOOCCWPG02PFDP·52A--28PG0639·ITPG06CSHITPG07SALICEPG10···················CERAMIC·DINNER·PLATESPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DFPERICA·COULTER··········9784822707·····[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG19PNS··················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG20·····································NASHUA···············NH·US03064PG21PNSTOM·BROKER·············603-555-1212···[email protected]··················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG20·····································NASHUA···············NH·US03064PG21PNTTOM·BROKER·············603-555-1212···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21UC·ERICA·COULTER··········9784822707·····[email protected]··45678912345PG25···000000···········································000000006000000000012000PG261000000001000CTPG262000000000500BXPG263000000000100DOZPG27MAEU-339717430922PG30A0228201613002···0901
83
FOO / DSU – Food / Dietary SupplementsWild ginseng powder from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: FOO Processing Code: DSU FOO - Prior Notice Required FDA Product Code FOO - No Intended Use Code Required Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities
o PNS and PNT Entities required w/ PN Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
o FOO – Code “CSH” required
84
FOO / DSU – Screen Shots
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86
ACE / PGA Message set for FOO / DSU
OI········WILD·GINSENG·POWDERPG01001FDAFOODSUPG02PFDP·25L--31PG0639·ITPG06CSHITPG07SALICEPG10···················WILD·GINSENG·POWDERPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DFPERICA·COULTER··········9784822707·····[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG19PNS··················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG20·····································NASHUA···············NH·US03064PG21PNSTOM·BROKER·············603-555-1212···[email protected]··················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG20·····································NASHUA···············NH·US03064PG21PNTTOM·BROKER·············603-555-1212···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21UC·ERICA·COULTER··········9784822707·····[email protected]··555PG23VES··MOODY·MAERSKPG23PFR··12345678901PG25···000000···········································000000006000000000001200PG261000000001000CTPG262000000002500BGPG263000000000200KGPG27MAEU-889717838222PG30A0315201613002···0901
87
FOO / FEE – Food / Animal & Pet FoodYellow dent corn as livestock feed from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: FOO Processing Code: FEE No Prior Notice FOO - Prior Notice Required FDA Product Code Intended Use Code FOO - No Intended Use Code Required Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities
o PNS and PNT Entities required w/ PN Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
o FOO – Code “CSH” required
88
FOO / FEE – Screen Shots
89
90
ACE / PGA Message set for FOO / FEE
OI········YELLOW·DENT·CORNPG01001FDAFOOFEEPG02PFDP·70D--02PG06CSHITPG07SALICEPG10···················CORN·-·YELLOW·DENTPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DFPERICA·COULTER··········9784822707·····[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21MF·GUGLIELMO·PAZZO········31-4567-3445···[email protected]··················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG20·····································NASHUA···············NH·US03064PG21PNSTOM·BROKER·············603-555-1212···[email protected]··················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG20·····································NASHUA···············NH·US03064PG21PNTTOM·BROKER·············603-555-1212···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21UC·ERICA·COULTER··········9784822707·····[email protected]··34567890123PG23VES··MOODY·MAERSKPG23VFT··555PG25···000000···········································000000025000000000000100PG261000000000200BIPG262000002500000KGPG27MAEU-379717830292PG30A0228201613002···0901
91
FOO / NSF – Food / In Natural StateRabbits from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: FOO Processing Code: NSF FOO - Prior Notice Required FDA Product Code FOO - No Intended Use Code Required Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities
o PNS and PNT Entities required w/ PN Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
o FOO – Code “CSH” requiredo NSF – Code “262” required
92
FOO / NSF – Screen Shots
93
94
ACE / PGA Message set for FOO / NSF
OI········RABBITPG01001FDAFOONSFPG02PFDP·17AVD06PG06262ITPG06CHSITPG07SALICEPG10···················RABBITPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DFIGUGLIELMO·PAZZO········31-4567-3445···[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DFPERICA·COULTER··········9784822707·····[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]··················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG20·····································NASHUA···············NH·US03064PG21PNSTOM·BROKER·············603-555-1212···[email protected]··················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG20·····································NASHUA···············NH·US03064PG21PNTTOM·BROKER·············603-555-1212···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21UC·ERICA·COULTER··········9784822707·····[email protected]··12345678901PG23VES··MOODY·MAERSKPG23VFT··555PG25···000000···········································000000006000000000001200PG261000000001000CTPG262000000002500BGPG263000000000200KGPG27MAEU-339717838222PG30A0228201612002···0901
95
FOO / PRO – Food / Processed FoodTomato paste from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: FOO Processing Code: PRO FOO - Prior Notice Required FDA Product Code FOO - No Intended Use Code Required Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities
o PNS and PNT Entities required w/ PN Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
o FOO – Code “CSH” required
96
FOO / PRO – Screen Shots
97
98
ACE / PGA Message set for FOO / PRO
OI········WHEY·BASED·LIQUID·CONCENTRATE·INFANT·FORMULAPG01001FDAFOOPROPG02PFDP·40O--03PG0639·ITPG06CSHITPG07SALICEPG10···················BABY·FORMULA·-·LIQ.·CONC.·WHEYPG19DEQ··················ABC·COMPANY·ABC·COMPANY2·ABC·COM1·MAIN·ST·ON·THE·OCEANPG60ENAPANY3·ABC·COMPANY4PG60AD1BY·THE·SEA·INSIDE·THE·WALLXPG201·MAIN·ST·ON·THE·OCEAN·BY·THE·SE·····PORTSMOUTH···········NH·US038031234PG60AD2A·INSIDE·THE·WALL2PG21DEQABCCO·CONTACT··········603-889-3200···[email protected]·123456789······COULTER·INDUSTRIES··············1·EXECUTIVE·DRIVE,·SUITPG60AD1E·201PG20·····································CHELMSFORD···········MA·US01824PG21DFPERICA·COULTER··········9784822707·····[email protected]·16·123456789······COULTER·INDUSTRIES··············1·EXECUTIVE·DRIVE,·SUITPG60AD1E·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············1·EXECUTIVE·DRIVE,·SUITPG60AD1E·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG19PNS··················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG60AD1IRST·FLOORPG20·····································NASHUA···············NH·US03064PG21PK·TOM·BROKER·············603-555-1212···[email protected]··················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG60AD1IRST·FLOORPG20·····································NASHUA···············NH·US03064PG21PK·TOM·BROKER·············603-555-1212···[email protected]·16·123456789······COULTER·INDUSTRIES··············1·EXECUTIVE·DRIVE,·SUITPG60AD1E·201PG20·····································CHELMSFORD···········MA·US01824PG21UC·ERICA·COULTER··········9784822707·····[email protected]··54687792201PG23VFT··555PG23VES··MOODY·MAERSKPG25···000000·14758846733···············0312201603252016000000006000000000001200PG261000000001000CTPG262000000005000JRPG263000000000100KGPG27MAEU-339717840722PG30A0705201601002···0901
99
DEV / NED – Medical Devices / Non-Radiation EmittingPacemakers from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: DEV Processing Code: NED No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
100
DEV / NED – Screen Shots
101
102
ACE / PGA Message set for DEV / NED
OI········PACEMAKERSPG01001FDADEVNED·························100.000PG02PFDP·84M--RUPG0639·ITPG07SALICEPG10···················PACEMAKERSPG19CR···················ABC·COMPANY·····················1·MAIN·STPG20·····································PORTSMOUTH···········NH·US038031234PG21CR·ABCCO·CONTACT··········603-889-3200···[email protected]··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG19PE···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21PE·GUGLIELMO·PAZZO········31-4567-3445···[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21SE·GUGLIELMO·PAZZO········31-4567-3445···[email protected]··1234567PG23DI···666666ABCDEPG25···000000···········································000000250000000000250000PG261000000000200CTPG262000000005000BXPG263000000000100PCSPG30A0220201613002···0901
103
DEV / RED – Medical Devices / Radiation EmittingUltrasound scanners from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: DEV Processing Code: RED No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
104
DEV / RED – Screen Shots
105
106
ACE / PGA Message set for DEV / RED
OI········ULTRASOUND·SCANNERSPG01001FDADEVRED·························081.001PG02PFDP·90L--XEPG0639·ITPG07SALICEPG10···················ULTRASOUND·SCANNERSPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DIIERICA·COULTER··········9784822707·····[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23DEV··1234567890PG23DFE··55555PG23LST··E666666PG25···000000···········································000000250000000000250000PG261000000000200CTPG262000000005000BXPG263000000000100PCSPG27MAEU-389314830292PG30A0318201615002···0901
107
TOB / CSU – Tobacco / Consumer UseCigarettes from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: TOB Processing Code: CSU No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
108
TOB / CSU – Screen Shots
109
110
ACE / PGA Message set for TOB / CSU
OI········CIGARETTESPG01001FDATOBCSU·························130.000PG02PFDP·98B--01PG0639·ITPG07SALICEPG10···················CIGARETTESPG19DEQ··················ABC·COMPANY·····················1·MAIN·STPG20·····································PORTSMOUTH···········NH·US038031234PG21DEQABCCO·CONTACT··········603-889-3200···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ABC·COMPANY·····················1·MAIN·STPG20·····································PORTSMOUTH···········NH·US038031234PG21MF·ABCCO·CONTACT··········603-889-3200···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21TB·ERICA·COULTER··········9784822707·····[email protected]···000000···········································000000002500000000000016PG261000000010000CTPG262000000000800PKPG263000000002000PCSPG27MAEU-384717430292PG30A0220201615002···0901
111
TOB / FFM – Tobacco / For Further ManufacturingGround tobacco from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: TOB Processing Code: FFM No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
112
TOB / FFM – Screen Shots
113
114
ACE / PGA Message set for TOB / FFM
OI········GROUND TOBACCOPG01001FDATOBFFM·························155.000PG02PFDP·98B--01PG0639·ITPG07SALICEPG10···················GROUND·TOBACCOPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG19TB···················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG20·····································NASHUA···············NH·US03064PG21TB·TOM·BROKER·············603-555-1212···[email protected]···000000···········································000000002500000000000500PG261000000010000CTPG262000000000500KGPG27MAEU-419717430292PG30A0318201615002···0901
115
TOB / INV – Tobacco / InvestigationalCigarettes for testing from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: TOB Processing Code: INV No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
116
TOB / INV – Screen Shots
117
118
ACE / PGA Message set for TOB / INV
OI········CIGARETTES·FOR·TESTINGPG01001FDATOBINV·························180.000PG02PFDP·98B--01PG0639·ITPG07SALICEPG10···················CIGARETTES·FOR·TESTINGPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]··················ABC·COMPANY·····················1·MAIN·STPG20·····································PORTSMOUTH···········NH·US038031234PG21LABABCCO·CONTACT··········603-889-3200···[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG19TB···················TRANSPORT·SERVICES··············44·FRANKLIN·STREET·::·FPG20·····································NASHUA···············NH·US03064PG21TB·TOM·BROKER·············603-555-1212···[email protected]···000000···········································000000002500000000000016PG261000000010000CTPG262000000000800PKPG263000000002000PCSPG27MAEU-419717430292PG30A0220201615002···0901
119
RAD / REP – Radiation Emitting Products / Non-MedicalMicrowave ovens from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: RAD Processing Code: REP No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
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RAD / REP – Screen Shots
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ACE / PGA Message set for RAD / REP
OI········MICROWAVE·OVENSPG01001FDARADREP·························100.000PG02PFDP·96R--CRPG0639·ITPG07SALICEPG10···················MICROWAVE·OVENSPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]···················COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]··················COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21MF·GUGLIELMO·PAZZO········31-4567-3445···[email protected]···000000···········································000000025000000000004167PG261000000010000CTPG262000000000600BXPG263000000000100PCSPG27MAEU-389317830292PG30A0219201613002···0901
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VME / ADE – Veterinary / DevicesVeterinary implant devices from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: VME Processing Code: ADE No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes
124
VME / ADE – Screen Shots
125
126
ACE / PGA Message set for VME / ADE
OI········PACEMAKERSPG01001FDAVMEADEPG02PFDP·84M--RUPG0639·ITPG07SALICEPG10···················PACEMAKERSPG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23NDC··1234567890PG23REG··123456789PG23VAN··123456PG23VIN··258369PG23VNA··1245PG25···000000···········································000000250000000000250000PG261000000000200CTPG262000000005000BXPG263000000000100PCSPG27MAEU-389319830292PG30A0220201613002···0901
127
VME / ADE – Veterinary / DrugsVeterinary antibiotic from Salice of Italy
Distinguishing Data-entry Requirements:
Program Code: VME Processing Code: ADR No Prior Notice FDA Product Code Intended Use Code Line Value Anticipated Arrival Date & Time Packaging Details Unit Value Required & Optional Entities Required & Optional Affirmation of Compliance Container #s Required Country Type Codes and Country Codes Ingredients Detail
128
VME / ADR – Screen Shots
129
130
ACE / PGA Message set for VME / ADR
OI········CLAVAMOX·ANTIBIOTICPG01001FDAVMEADR·························100.000PG02PFDP·56J--99PG0639·ITPG07CLAVAMOXPG10···················CLAVAMOX·ANTIBIOTICPG04YFLOUROQUINOLONE····································000000005000G····0250000PG19DEQ··················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG21DEQGUGLIELMO·PAZZO········31-4567-3445···[email protected]·16·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21DP·ERICA·COULTER··········9784822707·····[email protected]·123456789······COULTER·INDUSTRIES··············SUITE·201PG20·····································CHELMSFORD···········MA·US01824PG21FD1ERICA·COULTER··········9784822707·····[email protected]···················ORTO·PUGLIA·····················VIA·GARIBALDI·1335PG20·····································VALENZANO···············ITPG23NDC··1234567890PG23REG··123456789PG23VIN··666666PG23VNA··4444PG23VES··MOODY·MAERSKPG25···000000···········································000000025000000000000100PG261000000001000CTPG262000000025000BXPG263000000001000PCSPG27MAEU-379714830292PG30A0228201613002···0901
131
