FDA Supplemental Guidance CBP and Trade Automated ...

FDA Supplemental Guidance

CBP and Trade Automated Interface Requirements

FDA Supplemental Guidance for the Automated Commercial Environment/International Trade Data System (ACE/ITDS) Version 2.5.1 April 10, 2018

FDA Supplemental Guidance - Release 2.5.1

FDA Supplemental Guidance

Contents

Change Log ................................................................................................................................................................6 General Introduction ................................................................................................................................................ 20

FDA Overview ..................................................................................................................................................... 20 Points of Contact ................................................................................................................................................. 21 Legends ................................................................................................................................................................... 22 Field Requirements ............................................................................................................................................. 22 Field Data Types ................................................................................................................................................. 22 Required (Mandatory and/or Conditional)Data Elements for all FDA Commodities ............................................... 23 FDA Commodities, Commodity Sub-Types & Corresponding Industry Codes ....................................................... 24 Biologics Commodity Data Elements and Values ................................................................................................... 25 Biologics Example ............................................................................................................................................... 27 Record Identifier PG01 (PGA Identifier) .............................................................................................................. 28 Record Identifier PG02 (Product Identifier) ......................................................................................................... 31 Record Identifier PG04 (Product Constituent Element) ...................................................................................... 32 Record Identifier PG06 (Product Origin) ............................................................................................................. 33 Record Identifier PG07 (Product Trade Names) ................................................................................................. 34 Record Identifier PG10 (Product Characteristics) ............................................................................................... 35 Record Identifier PG19 (Entity Data)................................................................................................................... 36 Record Identifier PG20 (Entity Address) ............................................................................................................. 38 Record Identifier PG21 (Point of Contact)........................................................................................................... 39 Record Identifier PG23 (Affirmation of Compliance) ........................................................................................... 40 Record Identifier PG24 (Remarks) ...................................................................................................................... 45 Record Identifier PG25 (Product Condition)........................................................................................................ 46 Record Identifier PG26 (Product Packaging) ...................................................................................................... 47 Record Identifier PG27 (Shipping Container Information) .................................................................................. 51 Record Identifier PG30 (Anticipated Arrival Information) .................................................................................... 52 Record Identifier PG55 (Additional Entity Roles) ................................................................................................ 54 Record Identifier PG60 (Additional Information) ................................................................................................. 55 Record Identifier PG00 (Data Substitution) ......................................................................................................... 56 Cosmetics Commodity Data Elements and Values ................................................................................................. 57 Cosmetics Example............................................................................................................................................. 58 Record Identifier PG01 (PGA Identifier) .............................................................................................................. 59 Record Identifier PG02 (Product Identifier) ......................................................................................................... 60 Record Identifier PG06 (Product Origin) ............................................................................................................. 61 Record Identifier PG07 (Product Trade Names) ................................................................................................. 62 Record Identifier PG10 (Product Characteristics) ............................................................................................... 63 Record Identifier PG19 (Entity Data)................................................................................................................... 64 Record Identifier PG20 (Entity Address) ............................................................................................................. 66 Record Identifier PG21 (Point of Contact)........................................................................................................... 67 Record Identifier PG23 (Affirmation of Compliance) ........................................................................................... 68 Record Identifier PG24 (Remarks) ...................................................................................................................... 69 Record Identifier PG25 (Product Condition)........................................................................................................ 70 Record Identifier PG26 (Product Packaging) ...................................................................................................... 71 Record Identifier PG27 (Shipping Container Information) .................................................................................. 73 Record Identifier PG30 (Anticipated Arrival Information) .................................................................................... 74 Record Identifier PG55 (Additional Entity Roles) ................................................................................................ 76 Record Identifier PG60 (Additional Information) ................................................................................................. 77 Record Identifier PG00 (Data Substitution) ......................................................................................................... 78 Drug Commodity Data Elements and Values .......................................................................................................... 79 Drug Example...................................................................................................................................................... 81 Record Identifier PG01 (PGA Identifier) .............................................................................................................. 82 Record Identifier PG02 (Product Identifier) ......................................................................................................... 85 Record Identifier PG04 (Product Constituent Element) ...................................................................................... 87

FDA Supplemental Guidance - Release 2.5.1

FDA Supplemental Guidance

Record Identifier PG06 (Product Origin) ............................................................................................................. 90 Record Identifier PG07 (Product Trade Names) ................................................................................................. 91 Record Identifier PG10 (Product Characteristics) ............................................................................................... 92 Record Identifier PG19 (Entity Data)................................................................................................................... 93 Record Identifier PG20 (Entity Address) ............................................................................................................. 95 Record Identifier PG21 (Point of Contact)........................................................................................................... 96 Record Identifier PG23 (Affirmation of Compliance) ........................................................................................... 97 Record Identifier PG24 (Remarks) .................................................................................................................... 102 Record Identifier PG25 (Product Condition)...................................................................................................... 103 Record Identifier PG26 (Product Packaging) .................................................................................................... 105 Record Identifier PG30 (Anticipated Arrival Information) .................................................................................. 108 Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 110 Record Identifier PG60 (Additional Information) ............................................................................................... 111 Record Identifier PG00 (Data Substitution) ....................................................................................................... 112 Stand Alone Prior Notice Submission Data Elements and Values........................................................................ 113 Prior Notice Non-PGA Data Elements by Mode of Transportation (See Note)................................................. 113 Food Commodity Data Elements and Values ................................................................................................... 116 Prior Notice Example......................................................................................................................................... 118 Record Identifier PG01 (PGA Identifier) ............................................................................................................ 119 Record Identifier PG02 (Product Identifier) ....................................................................................................... 120 Record Identifier PG06 (Product Origin) ........................................................................................................... 121 Record Identifier PG10 (Product Characteristics) ............................................................................................. 123 Record Identifier PG13 (License Plate Issuer).................................................................................................. 124 Record Identifier PG14 (License Plate Number)............................................................................................... 125 Record Identifier PG19 (Entity Data)................................................................................................................. 126 Record Identifier PG20 (Entity Address) ........................................................................................................... 130 Record Identifier PG21 (Point of Contact)......................................................................................................... 131 Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 132 Record Identifier PG24 (Remarks) .................................................................................................................... 135 Record Identifier PG25 (Product Condition)...................................................................................................... 136 Record Identifier PG26 (Product Packaging) .................................................................................................... 137 Record Identifier PG27 (Shipping Container Information) ................................................................................ 142 Record Identifier PG28 (Express Courier Tracking Number)............................................................................ 143 Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival) .................................................... 144 Record Identifier PG55 (Additional Roles) ........................................................................................................ 145 Record Identifier PG60 (Additional Information) ............................................................................................... 146 Record Identifier PG00 (Data Substitution) ....................................................................................................... 147 Food Commodity Combined Entry Submission - Data Elements and Values....................................................... 148 Prior Notice Non-PGA Data Elements by Mode of Transportation (See Note)................................................. 150 Prior Notice Combined Entry Example.............................................................................................................. 152 Record Identifier PG01 (PGA Identifier) ............................................................................................................ 153 Record Identifier PG02 (Product Identifier) ....................................................................................................... 154 Record Identifier PG06 (Product Origin) ........................................................................................................... 155 Record Identifier PG07 (Product Trade Names) ............................................................................................... 156 Record Identifier PG10 (Product Characteristics) ............................................................................................. 157 Record Identifier PG13 (License Plate Issuer).................................................................................................. 158 Record Identifier PG14 (License Plate Number)............................................................................................... 159 Record Identifier PG19 (Entity Data)................................................................................................................. 160 Record Identifier PG20 (Entity Address) ........................................................................................................... 164 Record Identifier PG21 (Point of Contact)......................................................................................................... 165 Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 167 Record Identifier PG24 (Remarks) .................................................................................................................... 171 Record Identifier PG25 (Product Condition)...................................................................................................... 172 Record Identifier PG26 (Product Packaging) .................................................................................................... 174 Record Identifier PG27 (Shipping Container Information) ................................................................................ 179

FDA Supplemental Guidance - Release 2.5.1

FDA Supplemental Guidance

Record Identifier PG28 (Express Courier Tracking Number and Container Dimensions for AF and LACF).... 180 Record Identifier PG30 (Anticipated Arrival Information and Port of Arrival / Entry) ........................................ 182 Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 183 Record Identifier PG60 (Additional Information) ............................................................................................... 184 Record Identifier PG00 (Data Substitution) ....................................................................................................... 185 Non-PN Food Commodity OR PN Requirements Previously Met - Data Elements and Values........................... 186 Food Example ................................................................................................................................................... 188 Record Identifier PG01 (PGA Identifier) ............................................................................................................ 189 Record Identifier PG02 (Product Identifier) ....................................................................................................... 190 Record Identifier PG06 (Product Origin) ........................................................................................................... 191 Record Identifier PG07 (Product Trade Names) ............................................................................................... 192 Record Identifier PG10 (Product Characteristics) ............................................................................................. 193 Record Identifier PG14 (PN Confirmation Number) .......................................................................................... 194 Record Identifier PG19 (Entity Data)................................................................................................................. 195 Record Identifier PG20 (Entity Address) ........................................................................................................... 197 Record Identifier PG21 (Point of Contact)......................................................................................................... 198 Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 200 Record Identifier PG24 (Remarks) .................................................................................................................... 203 Record Identifier PG25 (Product Condition)...................................................................................................... 204 Record Identifier PG26 (Product Packaging) .................................................................................................... 205 Record Identifier PG27 (Shipping Container Information) ................................................................................ 210 Record Identifier PG28 (Container Dimensions for AF and LACF) .................................................................. 211 Record Identifier PG30 (Anticipated Arrival Information) .................................................................................. 212 Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 214 Record Identifier PG60 (Additional Information) ............................................................................................... 215 Record Identifier PG00 (Data Substitution) ....................................................................................................... 216 Medical Devices Commodity Data Elements and Values ..................................................................................... 217 Medical Devices Example ................................................................................................................................. 219 Record Identifier PG01 (PGA Identifier) ............................................................................................................ 220 Record Identifier PG02 (Product Identifier) ....................................................................................................... 222 Record Identifier PG06 (Product Origin) ........................................................................................................... 223 Record Identifier PG07 (Product Trade Names) ............................................................................................... 224 Record Identifier PG10 (Product Characteristics) ............................................................................................. 225 Record Identifier PG19 (Entity Data)................................................................................................................. 226 Record Identifier PG20 (Entity Address) ........................................................................................................... 228 Record Identifier PG21 (Point of Contact)......................................................................................................... 229 Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 230 Record Identifier PG24 (Remarks) .................................................................................................................... 236 Record Identifier PG25 (Product Condition)...................................................................................................... 237 Record Identifier PG26 (Product Packaging) .................................................................................................... 238 Record Identifier PG27 (Shipping Container Information) ................................................................................ 240 Record Identifier PG30 (Anticipated Arrival Information) .................................................................................. 241 Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 243 Record Identifier PG60 (Additional Information) ............................................................................................... 244 Record Identifier PG00 (Data Substitution) ....................................................................................................... 245 Tobacco Commodity Data Elements and Values .................................................................................................. 246 Tobacco Example.............................................................................................................................................. 248 Record Identifier PG01 (PGA Identifier) ............................................................................................................ 249 Record Identifier PG02 (Product Identifier) ....................................................................................................... 251 Record Identifier PG06 (Product Origin) ........................................................................................................... 252 Record Identifier PG07 (Product Trade Names) ............................................................................................... 253 Record Identifier PG10 (Product Characteristics) ............................................................................................. 254 Record Identifier PG19 (Entity Data)................................................................................................................. 255 Record Identifier PG20 (Entity Address) ........................................................................................................... 257 Record Identifier PG21 (Point of Contact)......................................................................................................... 258

FDA Supplemental Guidance - Release 2.5.1

FDA Supplemental Guidance

Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 259 Record Identifier PG24 (Remarks) .................................................................................................................... 261 Record Identifier PG25 (Product Condition)...................................................................................................... 262 Record Identifier PG26 (Product Packaging) .................................................................................................... 263 Record Identifier PG30 (Anticipated Arrival Information) .................................................................................. 266 Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 268 Record Identifier PG60 (Additional Information) ............................................................................................... 269 Record Identifier PG00 (Data Substitution) ....................................................................................................... 270 Radiation Emitting Products Commodity Data Elements and Values ................................................................... 271 Radiation Emitting Products Example............................................................................................................... 275 Record Identifier PG01 (PGA Identifier) ............................................................................................................ 276 Record Identifier PG02 (Product Identifier) ....................................................................................................... 278 Record Identifier PG06 (Product Origin) ........................................................................................................... 279 Record Identifier PG07 (Product Trade Names) ............................................................................................... 280 Record Identifier PG10 (Product Characteristics) ............................................................................................. 281 Record Identifier PG19 (Entity Data)................................................................................................................. 282 Record Identifier PG20 (Entity Address) ........................................................................................................... 284 Record Identifier PG21 (Point of Contact)......................................................................................................... 285 Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 286 Record Identifier PG24 (Remarks) .................................................................................................................... 290 Record Identifier PG25 (Product Condition)...................................................................................................... 291 Record Identifier PG26 (Product Packaging) .................................................................................................... 292 Record Identifier PG27 (Shipping Container Information) ................................................................................ 294 Record Identifier PG30 (Anticipated Arrival Information) .................................................................................. 295 Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 297 Record Identifier PG60 (Additional Information) ............................................................................................... 298 Record Identifier PG00 (Data Substitution) ....................................................................................................... 299 Animal Drugs and Devices Commodity Data Elements and Values ..................................................................... 300 Animal Drugs and Devices Example ................................................................................................................. 302 Record Identifier PG01 (PGA Identifier) ............................................................................................................ 303 Record Identifier PG02 (Product Identifier) ....................................................................................................... 305 Record Identifier PG04 (Product Constituent Element) .................................................................................... 306 Record Identifier PG06 (Product Origin) ........................................................................................................... 308 Record Identifier PG07 (Product Trade Names) ............................................................................................... 309 Record Identifier PG10 (Product Characteristics) ............................................................................................. 310 Record Identifier PG19 (Entity Data)................................................................................................................. 311 Record Identifier PG20 (Entity Address) ........................................................................................................... 313 Record Identifier PG21 (Point of Contact)......................................................................................................... 314 Record Identifier PG23 (Affirmation of Compliance) ......................................................................................... 315 Record Identifier PG24 (Remarks) .................................................................................................................... 318 Record Identifier PG25 (Product Condition)...................................................................................................... 319 Record Identifier PG26 (Product Packaging) .................................................................................................... 320 Record Identifier PG30 (Anticipated Arrival Information) .................................................................................. 322 Record Identifier PG55 (Additional Entity Roles) .............................................................................................. 324 Record Identifier PG60 (Additional Information) ............................................................................................... 325 Record Identifier PG00 (Data Substitution) ....................................................................................................... 326 Appendix A: Use of PG10 Record ......................................................................................................................... 327 Appendix B: Food Facility Registration Exemption (FME) .................................................................................... 328 Appendix C: Sample use of PG04 ? Product Constituent Element....................................................................... 329 Appendix D: FDA Unit of Measurement Codes ..................................................................................................... 329

FDA Supplemental Guidance - Release 2.5.1

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