FDA - Food and Drug Administration

This section of the manual contains the instructions for entering FDA into the appropriate PGA screens. It is divided by product type.

We hosted a webinar on entering FDA, please see this link for the recording: https://www.youtube.com/watch?v=YBaio17nLr8

FDA – Disclaim

If your product is flagged for FDA but it does not apply to your product, you can send a disclaimer for FDA.

Field/Button	Status	Description
Agency	Mandatory	Must be FDA.
Program	Mandatory	FDA
Processing Code	Not used	Not used
Disclaimer	Mandatory	1 Select the appropriate Disclaim Option A = Product is NOT regulated by this Agency B = Data is NOT required per Agency Guidance
OK/Cancel	Buttons	Click OK to save the PGA Information and move on to the next screen. Cancel will cancel and go back to the PGA screen without saving.

Click "Ok" to return to the Line Items screen.

FDA – Biologics

Field/Button	Status	Description
Agency	Mandatory	Must be FDA.
Program	Mandatory	BIO
Processing Code	Not used	Enter the appropriate Processing Code (ALG, BBA, BDP, BLD, etc)
OK/Cancel	Buttons	Click OK to save the PGA Information and move on to the next screen. Cancel will cancel and go back to the PGA screen without saving.

Field/Button	Status	Description
Item Type	Mandatory	Defaulted to P for Product.
Intended Use Code	Conditional	Enter Intended Use Code *** If the Intended Use is unknown, you have the option to choose UNKN-Unknown but if not required, leave blank.
Intended Use Description	Optional	Intended Use Description is optional
Product Code Qualifier	Mandatory	“FDP” (FDA Product)
Product Code Number	Mandatory	FDA Product Code Must be equal to 7 characters
Constituent Elements	Optional	This is an optional PGA input record that provides data pertaining to Constituent Active Ingredient Qualifier, Name of the Constituent Element, Quantity of Constituent Element, Unit of Measure, and Percent of Constituent Element for the product identified by Product Code Number
Genus Name	Optional	Scientific Genus Name of the merchandise being entered.
Species Name	Optional	Scientific Species Name of the merchandise being entered.
Sub Species Name	Optional	Scientific Sub Species Name of the merchandise being entered.
Source Type	Mandatory	Mandatory valid value is 39 (Country of Production) or 30 (Country of Source). 294 (Country of Refusal) is MANDATORY if previously refused.
Country	Mandatory	Country of production or source is required for Biologics.
Trade Name / Brand Name	Conditional	The make of the product (or component) by manufacturer or distributor from the label or invoice.
Characteristic Description	Mandatory	Include proper name (if applicable) OR invoice description here - NOT product code description. · *** If the Brand Name is unknown, you have the option to enter Unknown

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product entities screen. Click Del to delete a line.
Entity Role Codes	Mandatory	Select your Entity Role Codes, one at a time. Under Product Entities, enter all mandatory Entities for BIOLOGICS. (Mandatory entites are marked *MANDATORY* in the picklist.) HINT: Mandatory entities for BIOLOGICS MF Manufacturer of goods DEQ Shipper FD1 FDA Importer (Importer of Record) DP Delivered To Party
Entity ID Type	Conditional	Select an Entity ID Type if you have an Entity ID.
Entity Number	Conditional	MANDATORY Only when indicating EPN (EPA Producer Establishment Number) NOTE, EPN format = NNNNNNAAANNN (N = Number, A = Letter, no dashes).
Name	Conditional	Name of the entity.
Address 1	Conditional	Address 1 of the entity, mandatory if name is entered.
City	Conditional	City of the entity, mandatory if name is entered.
State	Conditional	State of the entity, mandatory if name is entered.
Country	Conditional	Country of the entity, mandatory if name is entered.
Address 2	Conditional	Address 2 of the entity.
Apartment/Suite Number	Conditional	Apartment/Suite Number of the entity.
Postal Code	Conditional	Postal code of the entity, mandatory if name is entered.
Add/Edit/Del	Button	Click Add or Edit to open the Individual Entities screen. Each Entity added must have an Individual Entity added. (This is a point of contact) This CAN be the filer’s contact info. Click Del to delete a line.

Field/Button	Status	Description
Name	Conditional	Name of the individual at the company. MANDATORY for all Roles
Individual Qualifier	Conditional	Individual Qualifier MUST match the Entity Role Code.
Phone Number	Conditional	Phone number of the individual at the company.
Email	Conditional	Email of the individual at the company.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the affirmations of compliance screen. Click Del to delete a line.
Affirmation of Compliance Code	Conditional	A code used to affirm compliance with FDA requirements.
Affirmation of Compliance Allowable Description Formats	Conditional	Text describing the information required by the FDA. This could include a number or a country code, etc.
Affirmation of Compliance Description	Conditional	Enter the Affirmation of Compliance Description

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the value lot numbers screen. Click Del to delete a line.
Lot Number Qualifier	Conditional	Code of the entity that assigned the Lot number. For Biologics the only valid value is: 1 = Manufacturer
Lot Number	Conditional	The lot number that the manufacturer/ producer/grower assigned to the product
Lot Production Start Date	Optional	The date when the production for the Lot started.
Lot Production End Date	Optional	The date when the production for the Lot started.
Temperature Qualifier	Optional	Temperature Category being reported for quality control or preservation purposes.
Degree Type	Optional	F = Fahrenheit, C = Celsius , K = Kelvin
Actual Temperature	Optional	Reported temperature.
Location of Temperature Recording	Optional	Identifies recorded temperature is for A = product B = container C = conveyance
PGA Line Value	Mandatory	The value associated with the PGA line number in whole dollars. I
PGA Unit Value	Optional	The value of the lowest unit of measure

Field/Button

Status

Description

Package Quantity

Mandatory

Outermost (largest=1) packages to the innermost (smallest=6) packages. The total quantity for the packaging level.

Packaging UOM

Mandatory

Type of packaging / packaging level.

Field/Button

Status

Description

Add/Edit/Del

Button

Click Add or Edit to open the containers screen. Click Del to delete a line.

Container Number (Equipment ID)

Optional

The number of the shipping container as entered in the Bill of Lading.

Field/Button	Status	Description
Arrival Status	Mandatory	A is the ONLY valid code for FDA: A = Anticipated arrival information.
Anticipated Arrival date	Mandatory	Date of the anticipated arrival.
Port No.	Optional	Enter a valid port code.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the remarks screen. Click Del to delete a line.
Remarks Type Code	Optional	A code indicating the type of remarks. FDA uses either NAM or GEN as its valid values.
Remarks Text	Optional	Free form text relevant to the shipment or the commodity.

Once you are at the bottom of the PGA screen, click "Ok" to return to the Line Items screen.

FDA – Cosmetics

Field/Button	Status	Description
Agency	Mandatory	Must be FDA.
Program	Mandatory	COS
Processing Code	Not used	Cosmetics does not require a processing code.
OK/Cancel	Buttons	Click OK to save the PGA Information and move on to the next screen. Cancel will cancel and go back to the PGA screen without saving.

Field/Button	Status	Description
Item Type	Mandatory	Defaulted to P for Product.
Intended Use Code	Conditional	Enter Intended Use Code *** If the Intended Use is unknown, you have the option to choose UNKN-Unknown but if not required, leave blank.
Intended Use Description	Optional	Intended Use Description is optional
Product Code Qualifier	Mandatory	“FDP” (FDA Product)
Product Code Number	Mandatory	FDA Product Code Must be equal to 7 characters
Source Type	Mandatory	Mandatory valid value is 39 (Country of Production) or 30 (Country of Source). 294 (Country of Refusal) is MANDATORY if previously refused.
Country	Mandatory	Country of production or source is required for Biologics.
Trade Name / Brand Name	Conditional	The make of the product (or component) by manufacturer or distributor from the label or invoice.
Characteristic Description	Mandatory	Include proper name (if applicable) OR invoice description here - NOT product code description. · *** If the Brand Name is unknown, you have the option to enter Unknown

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product entities screen. Click Del to delete a line.
Entity Role Codes	Mandatory	Select your Entity Role Codes, one at a time. Under Product Entities, enter all mandatory Entities for COSMETICS. (Mandatory entites are marked *MANDATORY* in the picklist.) HINT: Mandatory entities for COSMETICS MF Manufacturer of goods DEQ Shipper FD1 FDA Importer (Importer of Record) DP Delivered To Party
Entity ID Type	Conditional	Select an Entity ID Type if you have an Entity ID.
Entity Number	Conditional	Enter the entity number
Name	Conditional	Name of the entity.
Address 1	Conditional	Address 1 of the entity, mandatory if name is entered.
City	Conditional	City of the entity, mandatory if name is entered.
State	Conditional	State of the entity, mandatory if name is entered.
Country	Conditional	Country of the entity, mandatory if name is entered.
Address 2	Conditional	Address 2 of the entity.
Apartment/Suite Number	Conditional	Apartment/Suite Number of the entity.
Postal Code	Conditional	Postal code of the entity, mandatory if name is entered.
Add/Edit/Del	Button	Click Add or Edit to open the Individual Entities screen. Each Entity added must have an Individual Entity added. (This is a point of contact) This CAN be the filer’s contact info. Click Del to delete a line.

Field/Button	Status	Description
Name	Conditional	Name of the individual at the company. MANDATORY for all Roles
Individual Qualifier	Conditional	Individual Qualifier MUST match the Entity Role Code.
Phone Number	Conditional	Phone number of the individual at the company.
Email	Conditional	Email of the individual at the company.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the affirmations of compliance screen. Click Del to delete a line.
Affirmation of Compliance Code	Conditional	A code used to affirm compliance with FDA requirements.
Affirmation of Compliance Allowable Description Formats	Conditional	Text describing the information required by the FDA. This could include a number or a country code, etc.
Affirmation of Compliance Description	Conditional	Enter the Affirmation of Compliance Description

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the value lot numbers screen. Click Del to delete a line.
Lot Number Qualifier	Conditional	Code of the entity that assigned the Lot number. For Biologics the only valid value is: 1 = Manufacturer
Lot Number	Conditional	The lot number that the manufacturer/ producer/grower assigned to the product
Lot Production Start Date	Optional	The date when the production for the Lot started.
Lot Production End Date	Optional	The date when the production for the Lot started.
Temperature Qualifier	Optional	Temperature Category being reported for quality control or preservation purposes.
Degree Type	Optional	F = Fahrenheit, C = Celsius , K = Kelvin
Actual Temperature	Optional	Reported temperature.
Location of Temperature Recording	Optional	Identifies recorded temperature is for A = product B = container C = conveyance
PGA Line Value	Mandatory	The value associated with the PGA line number in whole dollars.
PGA Unit Value	Optional	The value of the lowest unit of measure

Field/Button

Status

Description

Package Quantity

Mandatory

Outermost (largest=1) packages to the innermost (smallest=6) packages. The total quantity for the packaging level.

Packaging UOM

Mandatory

Type of packaging / packaging level.

Field/Button

Status

Description

Add/Edit/Del

Button

Click Add or Edit to open the containers screen. Click Del to delete a line.

Container Number (Equipment ID)

Optional

The number of the shipping container as entered in the Bill of Lading.

Field/Button	Status	Description
Arrival Status	Mandatory	A is the ONLY valid code for FDA: A = Anticipated arrival information.
Anticipated Arrival date	Mandatory	Date of the anticipated arrival.
Port No.	Optional	Enter a valid port code.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the remarks screen. Click Del to delete a line.
Remarks Type Code	Optional	A code indicating the type of remarks. FDA uses either NAM or GEN as its valid values.
Remarks Text	Optional	Free form text relevant to the shipment or the commodity.

Once you are at the bottom of the PGA screen, click "Ok" to return to the Line Items screen.

FDA – Drugs

Field/Button	Status	Description
Agency	Mandatory	Must be FDA.
Program	Mandatory	DRU
Processing Code	Mandatory	Choose appropriate Processing code (INV, OTC, PHN, PRE, RND)
OK/Cancel	Buttons	Click OK to save the PGA Information and move on to the next screen. Cancel will cancel and go back to the PGA screen without saving.

Field/Button	Status	Description
Item Type	Mandatory	Defaulted to P for Product.
Intended Use Code	Conditional	Enter Intended Use Code * If the Intended Use is unknown, you have the option to choose UNKN-Unknown but if not required, leave blank. Prescription (PRE) Finished Form: 080 For Human Medical Use as a Non-Food Product under Controlled Distribution – Prescription (PRE) 970.000 Import for Export 100.000 Importation for Personal Use 155.012 Drug to be used as a constituent part in a Medical Device (Finished Dosage Form Drug) Not Finished Form Active Pharmaceutical Ingredient / Bulk Drug Substance: 150.007 Active Pharmaceutical Ingredient / Bulk Drug Substance for processing into a pharmaceutical product 970.000 Import for Export 150.017 Drug to be used as a component in a Medical Device (Active Pharmaceutical Ingredient / Bulk Drug Substance) Over the Counter (OTC) Finished Form: 130 For Consumer Use as a Non-Food Product – Over the Counter (OTC) 970.000 Import for Export 100.000 Importation for Personal Use 155.012 Drug to be used as a constituent part in a Medical Device (Finished Dosage Form Drug) Not finished form: Active Pharmaceutical Ingredient / Bulk Drug Substance: 150.007 Active Pharmaceutical Ingredient / Bulk Drug Substance for processing into a pharmaceutical product 970.000 Import for Export 150.017 Drug to be used as a component in a Medical Device (Active Pharmaceutical Ingredient / Bulk Drug Substance) Pharmaceutical Necessities & Containers (PHN) No intended use codes for this Commodity Sub-Type Research and Development (INV) 180.009 Chemical for research and development in a pharmaceutical product – clinical trial or other human/animal use Research and Development (RND) 180.017 Chemical for research and development in a pharmaceutical product – laboratory testing only, no human/animal use**
Intended Use Description	Optional	Intended Use Description is optional
Product Code Qualifier	Mandatory	“FDP” (FDA Product)
Product Code Number	Mandatory	FDA Product Code Must be equal to 7 characters

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the constituent elements screen. Click Del to delete a line.
Active Ingredient	Conditional	If commodity sub-type = PRE, OTC, INV or RND then YES = “Y” if yes, blank (= NO)
Name of Active Ingredient	Conditional	IF FINISHED: Name of Active Ingredient contained in the dosage form IF ACTIVE PHARMACEUTICAL INGREDIENT/BULK DRUG SUBSTANCE: name of the Active Pharmaceutical Ingredient (API)
Percent of Active Ingredient	Conditional	Only needed for Active Pharmaceutical Ingredients otherwise left blank.
Quantity of Active Ingredient	Conditional	IF FINISHED – amount of active ingredient per dose IF API/BULK DRUG SUBSTANCE: total volume of API
Unit of Measure	Conditional	IF FINISHED: Unit of measure for Quantity of Constituent Element IF API/BULK DRUG SUBSTANCE: Unit of measure for Quantity of Constituent Element

Field/Button	Status	Description
Source Type Code	Mandatory	Mandatory valid values are 30 (Country of Source) or 39 (Country of Production). 294 (Country of Refusal) if previously refused.
Source Country	Mandatory	Country of production or source is required
Trade Name/Brand Name	Conditional	If Government Agency Program Code = ‘DRU’ and [ if PG01 Intended use code = 150.007 (indicates API/Bulk) or Agency Processing Code = ‘PHN’ OR ‘RND’ ] then Trade/Brand Name of the Drug is optional; otherwise, the Trade/Brand Name of the Drug is MANDATORY.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product characteristics screen. Click Del to delete a line.
Characteristic Description	Mandatory	This should be Invoice Description NOT product code description.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product entities screen. Click Del to delete a line.
Entity Role Codes	Mandatory	Select your Entity Role Codes, one at a time. Under Product Entities, enter all mandatory Entities for DRUGS. (Mandatory entites are marked *MANDATORY* in the picklist.) For DRU, the mandatory entities are: MF Manufacturer of goods (Final producer for the final drug product). If the product is a bulk API, use “MF” as the Entity Role Code (rather than “GD – Producer of API); If the product is in finished form, provide MF of final product and GD for each API. DEQ Shipper FD1 FDA Importer (Importer of Record) DP Delivered To Party NOTE: other parties, in addition to those that are Mandatory may be entered API – Active Pharmaceutical Ingredient Rules for Finished Dosage Form Drugs * IF Intended Use Code = 080 For Human Medical Use as a Non-Food Product under Controlled Distribution – Prescription (PRE) OR 130 For Consumer Use as a Non- Food Product – Over the Counter (OTC) THEN: must include MF and at least one GD
Entity ID Type	Conditional	Select an Entity ID Type if you have an Entity ID. FDA requires Entity Name and Entity Address. Additionally, FDA prefers to use DUNS numbers for identifying the Entity; IF DUNS is not available THEN FEI
Entity Number	Conditional	Enter the entity number
Name	Conditional	Name of the entity.
Address 1	Conditional	Address 1 of the entity, mandatory if name is entered.
City	Conditional	City of the entity, mandatory if name is entered.
State	Conditional	State of the entity, mandatory if name is entered.
Country	Conditional	Country of the entity, mandatory if name is entered.
Address 2	Conditional	Address 2 of the entity.
Apartment/Suite Number	Conditional	Apartment/Suite Number of the entity.
Postal Code	Conditional	Postal code of the entity, mandatory if name is entered.
Add/Edit/Del	Button	Click Add or Edit to open the Individual Entities screen. Each Entity added must have an Individual Entity added. (This is a point of contact) This CAN be the filer’s contact info. Click Del to delete a line.

Field/Button	Status	Description
Name	Conditional	Name of the individual at the company. MANDATORY for all Roles
Individual Qualifier	Conditional	Individual Qualifier MUST match the Entity Role Code.
Phone Number	Conditional	Phone number of the individual at the company.
Email	Conditional	Email of the individual at the company.

Field/Button

Status

Description

Add/Edit/Del

Button

Click Add or Edit to open the affirmations of compliance screen. Click Del to delete a line.

Affirmation of Compliance Code

Conditional

A code used to affirm compliance with FDA requirements. *** If LST, Device Listing Number is unknown, you have the option to choose UNKN-Unknown

For Government Program Code = DRU AND Government Processing Code =

PHN: Pharmaceutical Necessities & Containers; or
RND: Research and Development

THEN Affirmation of Compliance is not required

*** R&D products, Import For Export entries, and Personal Importations do not require AofCs ***

For Government Program Code = DRU AND Intended Use code =

180.100: Chemical for research and development in a pharmaceutical product – laboratory testing only, no human/animal ingestion; OR
210.000: Importation for Personal Use; OR
970.001: Import For Export

THEN AOC is not required

The list of AoC codes mandatory to FDA Drugs Message Sets is below:

Data Element

Code

Description

Business Rules

Affirmation of Compliance Code

REG

Drug Registration Number

IF Government Agency Program Code = DRU and IF Government Agency Processing Code is PRE or OTC AND Intended Use Code NOT = 180.009 THEN REG IS MANDATORY

The list of AoC codes conditional to FDA Drugs Message Sets is below:

*Data Element*	*Code*	*Description*	*Syntax*	*Business Rules*
Affirmation of Compliance Code	DA	New Drug Application Number or Abbreviated New Drug Application Number or Therapeutic Biologic Application Number	6N	IF Government Agency Program Code = DRU AND Government Agency Processing Code = ‘PRE’ AND Intended Use Code NOT = 180.009 THEN DA IS MANDATORY IF Government Agency Program Code = DRU AND Government Agency Processing Code = ‘ ‘OTC’ THEN DA IS OPTIONAL The DA AofC includes all the previous AoC codes, NDA, ANDA and BLA.
	DLS	Drug Listing Number	10N	IF Government Agency Program Code = DRU and IF Government Agency Processing Code is PRE or OTC,AND Intended Use Code NOT = 180.009 THEN DLS IS MANDATORY unless affirmation “PLR” is declared
	IND	Investigational New Drug Number	6N	IF Government Agency Program Code = DRU and IF Government Agency Processing Code is PRE or OTC or INV AND Intended Use Code = 180.009 THEN IND is MANDATORY

The list of AoC codes optional to FDA Drugs Message Sets is below:

*Data Element*	*Code*	*Description*	*Syntax*	*Business Rules*
Affirmation of Compliance Code	ERR	Entry Review Requested	Indicator only	ERR is just used as an indicator, no data will follow
	HDE	Humanitarian Device Exemption	H followed by 6 digits	IF Government Agency Program Code = DRU THEN HDE IS ALLOWED
	UFC	Unacceptable to Foreign Country (Products other than food)	2A	ISO Country code
	PLR	Used to identify the shipment as a PLAIR import shipment	Indicator only	Used as an indicator, no data will follow.
	LST	Device Listing Number		IF Government Agency Program Code = DRU AND Intended Use Code = 150.100 [Component/Constituent Part of a Medical Device] THEN Device Listing is Optional
	PM#	Device Premarket Number	Any of the following: P+6N; N+4N, 5N, or 6N; D+6N; H+6N; K+6N; DEN+6N;	IF Government Agency Program Code = DRU AND Intended Use Code = 150.100 [Component/Constituent Part of a Medical Device] THEN Device Premarket Application is Optional
	IDE	Investigational Device Exemption Number	G+6N OR "NSR"

Affirmation of Compliance Allowable Description Formats

Conditional

Text describing the information required by the FDA. This could include a number or a country code, etc.

Affirmation of Compliance Description

Conditional

Enter the Affirmation of Compliance Description

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the value lot numbers screen. Click Del to delete a line.
Lot Number Qualifier	Conditional	Code of the entity that assigned the Lot number.
Lot Number	Conditional	The lot number that the manufacturer/ producer/grower assigned to the product
Lot Production Start Date	Optional	The date when the production for the Lot started.
Lot Production End Date	Optional	The date when the production for the Lot started.
Temperature Qualifier	Optional	Temperature Category being reported for quality control or preservation purposes.
Degree Type	Optional	F = Fahrenheit, C = Celsius , K = Kelvin
Actual Temperature	Optional	Reported temperature.
Location of Temperature Recording	Optional	Identifies recorded temperature is for A = product B = container C = conveyance
PGA Line Value	Mandatory	The value associated with the PGA line number in whole dollars.
PGA Unit Value	Optional	The value of the lowest unit of measure

Field/Button

Status

Description

Package Quantity

Mandatory

Outermost (largest=1) packages to the innermost (smallest=6) packages. The total quantity for the packaging level.

Packaging UOM

Mandatory

Type of packaging / packaging level.

Field/Button	Status	Description
Arrival Status	Mandatory	A is the ONLY valid code for FDA: A = Anticipated arrival information.
Anticipated Arrival date	Mandatory	Date of the anticipated arrival.
Port No.	Optional	Enter a valid port code.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the remarks screen. Click Del to delete a line.
Remarks Type Code	Optional	A code indicating the type of remarks. FDA uses either NAM or GEN as its valid values.
Remarks Text	Optional	Free form text relevant to the shipment or the commodity.

Once you are at the bottom of the PGA screen, click "Ok" to return to the Line Items screen.

FDA – Food

Field/Button	Status	Description
Agency	Mandatory	Must be FDA.
Program	Mandatory	FOO
Processing Code	Mandatory	Choose appropriate Processing code (ADD, CCW, DSU, FEE, NSF, PRO)
OK/Cancel	Buttons	Click OK to save the PGA Information and move on to the next screen. Cancel will cancel and go back to the PGA screen without saving.

Field/Button	Status	Description
Item Type	Mandatory	Defaulted to P for Product.
Intended Use Code	Optional	Enter Intended Use Code *** If the Intended Use is unknown, you have the option to choose UNKN-Unknown but if not required, leave blank.
Intended Use Description	Optional	Intended Use Description is optional
Prior Notice Number	Conditional	Enter Prior Notice Number if Prior Notice was previously submitted.
Product Code Qualifier	Mandatory	“FDP” (FDA Product)
Product Code Number	Mandatory	FDA Product Code Must be equal to 7 characters
Genus Name	Optional	Scientific Genus Name of the merchandise being entered.
Species Name	Optional	Scientific Species Name of the merchandise being entered.
Sub Species Name	Optional	Scientific Sub Species Name of the merchandise being entered.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the source processing screen. Click Del to delete a line.
Source Type Code	Mandatory	Source Type Code must be selected using the following logic. 1) IF Government Agency Program Code = FOO and Government Agency Processing Code = NSF then use 262 (Place of growth) ELSE Source Type Code can be 39 (Country of Production). IF Government Agency Program Code = FOO, THEN Country of Shipment CSH is required. IF Government Agency Program Code = FOO then Country of Entry Refusal 294 is required, if previously refused from other country(s)
Source Country	Mandatory	Foods require the harvesting or production location of the product.
Trade Name/Brand Name	Conditional	If Government Agency Program Code = ‘DRU’ and [ if PG01 Intended use code = 150.007 (indicates API/Bulk) or Agency Processing Code = ‘PHN’ OR ‘RND’ ] then Trade/Brand Name of the Drug is optional; otherwise, the Trade/Brand Name of the Drug is MANDATORY.

Field/Button	Status	Description
Trade Name/Brand Name	Optional	Market, Trade, or Brand Name that describes the food or feed product at each line level

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product characteristics screen. Click Del to delete a line.
Characteristic Description	Mandatory	Common, market or usual name or description, NOT product code description of the product. Free form description of the item.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product entities screen. Click Del to delete a line.
Entity Role Codes	Mandatory	Select your Entity Role Codes, one at a time. Under Product Entities, enter all mandatory Entities for FOOD. (Mandatory entites are marked *MANDATORY* in the picklist.) NOTE: Entities for entries with previously reported Prior Notice (PNSI), the mandatory entities are: MF Manufacturer of goods DEQ Shipper FD1 FDA Importer (Importer of Record) DP Delivered To Party NOTE: to submit PRIOR NOTICE, be sure to provide the additional Entities required to satisfy BTA. NOTE: Entities for entries with Prior Notice and without the PNSI, the mandatory entities are: DEQ Shipper DFP Owner FD1 FDA Importer 1 PNS PN Submitter PNT PN Transmitter UC Ultimate Consignee NOTE: Entities for entries with Prior Notice and without the PNSI, which may be required entities are: MF Manufacturer of goods FDC Consolidator DFI Crop Grower
Entity ID Type	Conditional	Select an Entity ID Type if you have an Entity ID. FDA requires Entity Name and Entity Address. Additionally, FDA prefers to use DUNS numbers for identifying the Entity; IF DUNS is not available THEN FEI
Entity Number	Conditional	Enter the entity number
Name	Conditional	Name of the entity.
Address 1	Conditional	Address 1 of the entity, mandatory if name is entered.
City	Conditional	City of the entity, mandatory if name is entered.
State	Conditional	State of the entity, mandatory if name is entered.
Country	Conditional	Country of the entity, mandatory if name is entered.
Address 2	Conditional	Address 2 of the entity.
Apartment/Suite Number	Conditional	Apartment/Suite Number of the entity.
Postal Code	Conditional	Postal code of the entity, mandatory if name is entered.
Add/Edit/Del	Button	Click Add or Edit to open the Individual Entities screen. Each Entity added must have an Individual Entity added. (This is a point of contact) This CAN be the filer’s contact info. Click Del to delete a line.

Field/Button	Status	Description
Name	Conditional	Name of the individual at the company. MANDATORY for all Roles
Individual Qualifier	Conditional	Individual Qualifier MUST match the Entity Role Code.
Phone Number	Conditional	Phone number of the individual at the company.
Email	Conditional	Email of the individual at the company.

Field/Button

Status

Description

Add/Edit/Del

Button

Click Add or Edit to open the affirmations of compliance screen. Click Del to delete a line.

Affirmation of Compliance Code

Conditional

A code used to affirm compliance with FDA requirements.

The below information may be helpful in regards to optional and conditional Affirmation of Compliance codes:

*Data Element*	*Code*	*Description*	*Business Rules*
Affirmation of Compliance Code	FME	Food Processing Facility Registration Exemption	To be used when Food or Feed is no longer in its natural state or when PFR number is not provided. Either FME or PFR is required in the case of Manufacturer or when consolidator/grower is entered in lieu of manufacturer for food in natural state. If both are submitted, FME is not used by the FDA.
	RNO	Rail Car Number	Required If MOT = Rail
	VFT	Voyage, Trip, Flight Number	If the article of food is arriving by express consignment operator or carrier and neither the PN submitter nor PN transmitter is the express consignment operator or carrier, the express consignment operator or carrier tracking number may be submitted in lieu of the flight number. Otherwise, VFT is required if MOT = Air VFT is also required if MOT = Rail or Truck
	VES	Vessel Name	Required If MOT = Ocean
	PFR	Manufacturers food facility registration number	Manufacturer registration number is required unless FME and Reason code is submitted or consolidator / grower role code is submitted in lieu of manufacturer for food in its natural state. If both FME and PFR are submitted, FME is not used by the FDA.

The list of optional AoC codes for the FDA food Prior Notice Message Set is below:

*Data Element*	*Code*	*Description*	*Business Rules*
	SFR	Shippers food facility registration number	Optional
	UFR	Ultimate consignee food facility registration number	Optional
	IFR	Importers food facility registration number	Optional
	TFR	Transmitter food facility registration number	Optional
	ORN	Owners food facility registration number-	Optional
	SRN	Submitters food facility registration number	Optional
	CFR	FDA Consolidator food facility registration number	optional
	GFR	Growers food facility registration number	optional

The list of conditional AoC codes for the FDA Food (Non-PN) Message Set is below:

*Data Element*	*Code*	*Description*	*Business Rules*
Affirmation of Compliance Code

	FCE	Food Canning Establishment Number	IF Government Agency Program Code = FOO AND the product is either LACF or AF THEN FCE may be entered. See Note 1.
	SID	Schedule Identifier Number	IF Government Agency Program Code = FOO AND the product is LACF or AF THEN AoC Code ‘SID’ may be entered. See Note 1.
	VOL	LACF/AF Volume	IF Government Agency Program Code = FOO AND the product is either LACF or AF THEN VOL IS ALLOWED. See Note 1.

The list of optional AoC codes for the FDA Food (Non-PN) Message Set is below:

*Data Element*	*Code*	*Description*	*Business Rules*
Affirmation of Compliance Code	CCC	Chinese Ceramic Ware Factory Code	IF Government Agency Program Code = FOO AND Government Agency Processing Code = CCW THEN CCC IS ALLOWED
	CCN	Carrier ISO Country Code	ISO Country code
	CIN	Color Identification Number	IF Government Agency Program Code = FOO AND Government Agency Processing Code = ADD THEN CIN IS ALLOWED
	ERR	Entry Review Requested	ERR is just used as an indicator, no data will follow
	FAP	Food Additive Petition Approval Number	IF Government Agency Program Code = FOO AND Government Agency Processing Code = ADD THEN FAP IS ALLOWED
	FCC	French Cheese Facility Certification Number	IF Government Agency Program Code = FOO AND Government Agency Processing Code = PRO THEN FCC IS ALLOWED

	IBP	Indian Black Pepper Certificate	IF Government Agency Program Code = FOO AND Government Agency Processing Code = NSF THEN IBP IS ALLOWED
	IFE	Import For Export
	PKC	Package/Can Code	IF Government Agency Program Code = FOO THEN PKC IS ALLOWED
	AIN	Food Additive Identification Number	IF Government Agency Program Code = FOO AND Government Agency Processing Code = ADD THEN AIN IS ALLOWED
	JIF	Juice HACCP Importer Firm	IF Government Agency Program Code = FOO AND the product is HACCP THEN JIF IS ALLOWED
	SIF	Seafood HACCP Importer Firm	IF Government Agency Program Code = FOO AND the product is HACCP THEN SIF IS ALLOWED

Affirmation of Compliance Allowable Description Formats

Conditional

Text describing the information required by the FDA. This could include a number or a country code, etc.

Affirmation of Compliance Description

Conditional

Enter the Affirmation of Compliance Description

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the value lot numbers screen. Click Del to delete a line.
Lot Number Qualifier	Conditional	Note – for Lot Number Qualifier, if processing code is NSF, Lot Number Qualifier must be 3. Otherwise Lot Number Qualifier is = 1. (per PGA Supplemental Guide 2.4)
Lot Number	Conditional	The lot number that the manufacturer/ producer/grower assigned to the product
Lot Production Start Date	Optional	The date when the production for the Lot started.
Lot Production End Date	Optional	The date when the production for the Lot started.
Temperature Qualifier	Optional	Temperature Category being reported for quality control or preservation purposes.
Degree Type	Optional	F = Fahrenheit, C = Celsius , K = Kelvin
Actual Temperature	Optional	Reported temperature.
Location of Temperature Recording	Optional	Identifies recorded temperature is for A = product B = container C = conveyance
PGA Line Value	Mandatory	The value associated with the PGA line number in whole dollars.
PGA Unit Value	Optional	The value of the lowest unit of measure

Field/Button

Status

Description

Package Quantity

Mandatory

Outermost (largest=1) packages to the innermost (smallest=6) packages. The total quantity for the packaging level.

Packaging UOM

Mandatory

Type of packaging / packaging level.

Field/Button	Status	Description
Arrival Status	Mandatory	A is the ONLY valid code for FDA: A = Anticipated arrival information.
Anticipated Arrival date	Mandatory	Date of the anticipated arrival.
Port No.	Optional	Enter a valid port code.

Field/Button

Status

Description

Add/Edit/Del

Button

Click Add or Edit to open the containers screen. Click Del to delete a line.

Container Number (Equipment ID)

Optional

The number of the shipping container as entered in the Bill of Lading.

Field/Button

Status

Description

Can Dimensions #1/ #2/ #3

Conditional

*NOTE-If container is a rectangle the dimension should be entered in WIDTH, HEIGHT, LENGTH order. If Cylindrical, the dimensions are in DIAMETER and HEIGHT order.

LACF and Acidified:

Industry Codes: 02-39, 41, 71, & 72

With Process Indicator Code (PIC): Acidified-I, Aseptic-F, Commercially Sterile-E

If the product is LACF, the can measurements (height and diameter) must be provided in CAN DIMENSIONS section unless both the Affirmation of Compliance codes FCE (Food Canning Establishment number) and SID (Schedule Identifier Number) are provided.

If Acidified Food (AF), one of the following must be provided unless FCE and SID are provided:

Can Measurements in PG28 (either height and diameter or height/length, width and thickness
Container Volume (VOL)

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the remarks screen. Click Del to delete a line.
Remarks Type Code	Optional	A code indicating the type of remarks. FDA uses either NAM or GEN as its valid values.
Remarks Text	Optional	Free form text relevant to the shipment or the commodity.

Once you are at the bottom of the PGA screen, click "Ok" to return to the Line Items screen.

FDA – Medical Devices

Field/Button	Status	Description
Agency	Mandatory	Must be FDA.
Program	Mandatory	DEV
Processing Code	Mandatory	Enter the Applicable Processing code (NED, or RED)
OK/Cancel	Buttons	Click OK to save the PGA Information and move on to the next screen. Cancel will cancel and go back to the PGA screen without saving.

Field/Button	Status	Description
Item Type	Mandatory	Defaulted to P for Product.
Intended Use Code	Conditional	Enter Intended Use Code *** If the Intended Use is unknown, you have the option to choose UNKN-Unknown but if not required, leave blank.
Intended Use Description	Optional	Intended Use Description is optional
Product Code Qualifier	Mandatory	“FDP” (FDA Product)
Product Code Number	Mandatory	FDA Product Code Must be equal to 7 characters
Source Type	Mandatory	Mandatory valid value is 39 (Country of Production) or 30 (Country of Source). 294 (Country of Refusal) is MANDATORY if previously refused.
Country	Mandatory	Country of production or source is required for Medical Devices.
Trade Name / Brand Name	Mandatory	Trade/Brand Name of the Medical Device. For example, Zimmer Reusable Tourniquet Cuff.
Characteristic Description	Mandatory	Free form description, NOT product code description, of the item, either to supplement the above data elements or in place of the above.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product entities screen. Click Del to delete a line.
Entity Role Codes	Mandatory	Select your Entity Role Codes, one at a time. Under Product Entities, enter all mandatory Entities for MEDICAL DEVICES (Mandatory entites are marked *MANDATORY* in the picklist.) HINT: Mandatory entities for MEDICAL DEVICES MF Manufacturer of goods DEQ Shipper FD1 FDA Importer (Importer of Record) DDI Device Initial Importer DP Delivered To Party
Entity ID Type	Conditional	Select an Entity ID Type if you have an Entity ID. For MEDICAL DEVICES the vast majority of registration numbers are FEIs
Entity Number	Conditional	Enter the entity number
Name	Conditional	Name of the entity.
Address 1	Conditional	Address 1 of the entity, mandatory if name is entered.
City	Conditional	City of the entity, mandatory if name is entered.
State	Conditional	State of the entity, mandatory if name is entered.
Country	Conditional	Country of the entity, mandatory if name is entered.
Address 2	Conditional	Address 2 of the entity.
Apartment/Suite Number	Conditional	Apartment/Suite Number of the entity.
Postal Code	Conditional	Postal code of the entity, mandatory if name is entered.
Add/Edit/Del	Button	Click Add or Edit to open the Individual Entities screen. Each Entity added must have an Individual Entity added. (This is a point of contact) This CAN be the filer’s contact info. Click Del to delete a line.

Field/Button	Status	Description
Name	Conditional	Name of the individual at the company. MANDATORY for all Roles
Individual Qualifier	Conditional	Individual Qualifier MUST match the Entity Role Code.
Phone Number	Conditional	Phone number of the individual at the company.
Email	Conditional	Email of the individual at the company.

Field/Button

Status

Description

Add/Edit/Del

Button

Click Add or Edit to open the affirmations of compliance screen. Click Del to delete a line.

Affirmation of Compliance Code

Conditional

A code used to affirm compliance with FDA requirements.

Intended Use (see PG01 for definitions)	Import Scenarios	Mandatory Affirmations	Conditional¹ Affirmations	Optional Affirmations
081.001	· Standard import of device, accessories, or components regulated as a finished device · Import of refurbished device · Import of a reprocessed device	DEV, DFE, LST	DI, IRC, LWC, PM#
081.002*	Import of a device for domestic refurbishing	DEV, DFE, LST	DI, IRC, LWC, PM#
081.003	domestically manufactured device that is part of a medical device convenience kit	DDM, DFE, KIT, LST	DI, IRC, LWC, PM#
081.004	foreign manufactured device that is Part of a medical device convenience kit	KIT, DEV, DFE, LST	PM#, DI, LWC;IRC
081.005	Device constituent part for drug-device combination product	DEV, DFE, LST	DA, IND
140.000	Import of a device for charity	DEV, DFE, LST	DI, IRC, LWC, PM#
155.010	Component for further manufacturing into a finished medical device	CPT		LST, PM#
155.011	Device component for use in a drug-device combination product	CPT	DA, IND
170.000	Repair of medical device and re-exportation	DDM, IFE	DFE, DI, LST, IRC, LWC, PM#
180.010	Import of research or investigational use in vitro diagnostic device
180.014*	· Import of a device for non-clinical use/bench testing · Import of device sample for customer evaluation
180.0015	Import of a medical device for clinical investigational use	IDE
920.001	Import of a device that is US goods returned for refund/overstock (to manufacturer)	DDM, LST	DFE, DI, IRC, LWC, PM#
920.002*	Import of device that is US goods returned for sale to a third party	DFE, DDM, LST	DI, IRC, LWC, PM#
950.001*	Import of a single-use device for domestic reprocessing	DDM, LST	DFE, DI, IRC, LWC, PM#
950.002*	Import of a multi-use device for domestic reprocessing		DDM, DFE, DI, IRC, LST, LWC, PM#
970.000	Import for Export: · Import of a medical device for further processing and re-exportation · Importation of a medical device or accessory for further manufacturing into an export-only medical device	DEV, DFE, IFE, LST
970.002	Import for Export: · Importation of a medical device component for further manufacturing into an export-only medical device	IFE, CPT, DDM, LST
110.000* 100.000* 940.000* 081.006	· Public Exhibition/Trade Show · Device For Personal Use · Compassionate Use/Emergency device · Import of a medical device under enforcement discretion

Affirmation of Compliance Allowable Description Formats

Conditional

Text describing the information required by the FDA. This could include a number or a country code, etc.

Affirmation of Compliance Description

Conditional

Enter the Affirmation of Compliance Description

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the value lot numbers screen. Click Del to delete a line.
Lot Number Qualifier	Conditional	Code of the entity that assigned the Lot number. For Biologics the only valid value is: 1 = Manufacturer
Lot Number	Conditional	The lot number that the manufacturer/ producer/grower assigned to the product
Lot Production Start Date	Optional	The date when the production for the Lot started.
Lot Production End Date	Optional	The date when the production for the Lot started.
Temperature Qualifier	Optional	Temperature Category being reported for quality control or preservation purposes.
Degree Type	Optional	F = Fahrenheit, C = Celsius , K = Kelvin
Actual Temperature	Optional	Reported temperature.
Location of Temperature Recording	Optional	Identifies recorded temperature is for A = product B = container C = conveyance
PGA Line Value	Mandatory	The value associated with the PGA line number in whole dollars.
PGA Unit Value	Optional	The value of the lowest unit of measure

Field/Button

Status

Description

Package Quantity

Mandatory

Outermost (largest=1) packages to the innermost (smallest=6) packages. The total quantity for the packaging level.

Packaging UOM

Mandatory

Type of packaging / packaging level.

Field/Button

Status

Description

Add/Edit/Del

Button

Click Add or Edit to open the containers screen. Click Del to delete a line.

Container Number (Equipment ID)

Optional

The number of the shipping container as entered in the Bill of Lading.

Field/Button	Status	Description
Arrival Status	Mandatory	A is the ONLY valid code for FDA: A = Anticipated arrival information.
Anticipated Arrival date	Mandatory	Date of the anticipated arrival.
Port No.	Optional	Enter a valid port code.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the remarks screen. Click Del to delete a line.
Remarks Type Code	Optional	A code indicating the type of remarks. FDA uses either NAM or GEN as its valid values.
Remarks Text	Optional	Free form text relevant to the shipment or the commodity.

Once you are at the bottom of the PGA screen, click "Ok" to return to the Line Items screen.

FDA – Radiation

Field/Button	Status	Description
Agency	Mandatory	Must be FDA.
Program	Mandatory	RAD
Processing Code	Mandatory	REP
OK/Cancel	Buttons	Click OK to save the PGA Information and move on to the next screen. Cancel will cancel and go back to the PGA screen without saving.

Field/Button	Status	Description
Item Type	Mandatory	Defaulted to P for Product.
Intended Use Code	Optional	Enter Intended Use Code *** If the Intended Use is unknown, you have the option to choose UNKN-Unknown but if not required, leave blank.
Intended Use Description	Optional	Intended Use Description is optional
Prior Notice Number	Conditional	Enter Prior Notice Number if Prior Notice was previously submitted.
Product Code Qualifier	Mandatory	“FDP” (FDA Product)
Product Code Number	Mandatory	FDA Product Code Must be equal to 7 characters

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the source processing screen. Click Del to delete a line.
Source Type Code	Mandatory	Source Type Code must be selected using the following logic. 1) IF Government Agency Program Code = FOO and Government Agency Processing Code = NSF then use 262 (Place of growth) ELSE Source Type Code can be 39 (Country of Production). IF Government Agency Program Code = FOO, THEN Country of Shipment CSH is required. IF Government Agency Program Code = FOO then Country of Entry Refusal 294 is required, if previously refused from other country(s)
Source Country	Mandatory	A two-letter code that identifies the country from where the product was produced, packed or shipped.

Field/Button	Status	Description
Trade Name/Brand Name	Mandatory	Trade/Brand Name of the Radiation-Emitting Device. For example, Sony Laser scanner RM2.
Model	Optional	The Item Identity Number. This is the Model Number or the Serial Number based on the qualifier entered below
ID Number Qualifier	Optional	Code identifying the type of Item Identity Number being provided

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product characteristics screen. Click Del to delete a line.
Characteristic Description	Mandatory	Common, market or usual name or description, NOT product code description of the product. Free form description of the item.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product entities screen. Click Del to delete a line.
Entity Role Codes	Mandatory	Select your Entity Role Codes, one at a time. Under Product Entities, enter all mandatory Entities for RADIATION. (Mandatory entites are marked *MANDATORY* in the picklist.) HINT: Mandatory entities for RADIATION MF Manufacturer of goods DEQ Shipper FD1 FDA Importer (Importer of Record) DP Delivered To Party
Entity ID Type	Conditional	Select an Entity ID Type if you have an Entity ID. FDA requires Entity Name and Entity Address. Additionally, FDA prefers to use DUNS numbers for identifying the Entity; IF DUNS is not available THEN FEI
Entity Number	Conditional	Enter the entity number
Name	Conditional	Name of the entity.
Address 1	Conditional	Address 1 of the entity, mandatory if name is entered.
City	Conditional	City of the entity, mandatory if name is entered.
State	Conditional	State of the entity, mandatory if name is entered.
Country	Conditional	Country of the entity, mandatory if name is entered.
Address 2	Conditional	Address 2 of the entity.
Apartment/Suite Number	Conditional	Apartment/Suite Number of the entity.
Postal Code	Conditional	Postal code of the entity, mandatory if name is entered.
Add/Edit/Del	Button	Click Add or Edit to open the Individual Entities screen. Each Entity added must have an Individual Entity added. (This is a point of contact) This CAN be the filer’s contact info. Click Del to delete a line.

Field/Button	Status	Description
Name	Conditional	Name of the individual at the company. MANDATORY for all Roles
Individual Qualifier	Conditional	Individual Qualifier MUST match the Entity Role Code.
Phone Number	Conditional	Phone number of the individual at the company.
Email	Conditional	Email of the individual at the company.

Field/Button

Status

Description

Add/Edit/Del

Button

Click Add or Edit to open the affirmations of compliance screen. Click Del to delete a line.

Affirmation of Compliance Code

Conditional

A code used to affirm compliance with FDA requirements.

List of Affirmation of Compliance codes CONDITIONAL to FDA Radiation Emitting Product Message Sets

If 2877 is required:

Affirmation	Qualifier	Examples and additional information	Additional Affirmations Required	Text on 2877
RA1	date	format MM/YYYY		1.Were manufactured prior to the effective date of any applicable standard. Date of Manufacture:____________________________
RA2	text	text is reason for exclusion. Example: DOD exemption		2. Are excluded by the applicability clause or definition in the standard or by FDA written guidance. Specify reason for exclusion:______________
RA3	none			3. Are personal household goods of an individual entering the U.S. or being returned to a U.S. resident (Limit: 3 of each product type)
RA4*	none			4. Are property of a party residing outside the U.S. and will be returned to the owner after repair or servicing.
RA5*	text	text is description of the end product. Example: Laser Diode		5. Are components or subassemblies to be used in manufacturing or as replacement parts
RA6	none			6. Are prototypes intended for ongoing product development by the importing firms, are labeled "FOR TEST/EVALUATION ONLY" and will be exported, destroyed, or held for future testing.- there is a quantity limit for this option-stated on the back of the 2877 (page 2)
RA7*	text	text is description of the end product		7.Are being reprocessed in accordance with P.L. 104-134 or other FDA guidance, are labeled "FOR EXPORT ONLY" and will not be sold, distributed or transferred without FDA approval.
RB1*	none		If RB1 then ACC (product report accession number) OR ANC (annual report accession number) must be provided. (ACC+7N or ANC+7N)	B1.Comply with the performance standards- 1.Last annual report or Product/Initial Report
RB2*	text	text is reason the product complies		B2.Comply with the performance standards-2. Unknown manufacturer/report number. State reason:
RC1*	none			C1.Do not comply with performance standards; are being held under a temporary import bond; will not be introduced into commerce, will be used under a radiation protection plan, and will be destroyed or exported under U.S. Customs Supervision when the mission is complete - 1. Research , Investigations/Studies, or Training (Attach Form FDA 766)
RC2	text	text is dates and use restriction		C2.Do not comply with performance standards; are being held under a temporary import bond; will not be introduced into commerce, will be used under a radiation protection plan, and will be destroyed or exported under U.S. Customs Supervision when the mission is complete - 1. Trade Show/Demonstration; List dates and use restrictions
RD1*	none			D1. Do not comply with performance standards; are held and will remain under bond; and will not be introduced into commerce until notification is received from FDA that products have been brought into compliance in accordance with an FDA approved petition.(See Form FDA 766) -1. Approved Petition is attached.
RD2*	none			D2. Do not comply with performance standards; are held and will remain under bond; and will not be introduced into commerce until notification is received from FDA that products have been brought into compliance in accordance with an FDA approved petition.(See Form FDA 766) -2.Petition request is attached.
RD3	date	date is the date form 766 will be provided, due within 60 days of submission.		D3. Do not comply with performance standards; are held and will remain under bond; and will not be introduced into commerce until notification is received from FDA that products have been brought into compliance in accordance with an FDA approved petition.(See Form FDA 766) - 3.Request will be submitted within 60 days.

*Annotates that additional information may be needed at time of entry in order for FDA to make a final admissibility decision.

Affirmation of Compliance Allowable Description Formats

Conditional

Text describing the information required by the FDA. This could include a number or a country code, etc.

Affirmation of Compliance Description

Conditional

Enter the Affirmation of Compliance Description

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the value lot numbers screen. Click Del to delete a line.
Lot Number Qualifier	Conditional	Note – for Lot Number Qualifier, if processing code is NSF, Lot Number Qualifier must be 3. Otherwise Lot Number Qualifier is = 1. (per PGA Supplemental Guide 2.4)
Lot Number	Conditional	The lot number that the manufacturer/ producer/grower assigned to the product
Lot Production Start Date	Optional	The date when the production for the Lot started.
Lot Production End Date	Optional	The date when the production for the Lot started.
Temperature Qualifier	Optional	Temperature Category being reported for quality control or preservation purposes.
Degree Type	Optional	F = Fahrenheit, C = Celsius , K = Kelvin
Actual Temperature	Optional	Reported temperature.
Location of Temperature Recording	Optional	Identifies recorded temperature is for A = product B = container C = conveyance
PGA Line Value	Mandatory	The value associated with the PGA line number in whole dollars.
PGA Unit Value	Optional	The value of the lowest unit of measure

Field/Button

Status

Description

Package Quantity

Mandatory

Outermost (largest=1) packages to the innermost (smallest=6) packages. The total quantity for the packaging level.

Packaging UOM

Mandatory

Type of packaging / packaging level.

Field/Button

Status

Description

Add/Edit/Del

Button

Click Add or Edit to open the containers screen. Click Del to delete a line.

Container Number (Equipment ID)

Optional

The number of the shipping container as entered in the Bill of Lading.

Field/Button	Status	Description
Arrival Status	Mandatory	A is the ONLY valid code for FDA: A = Anticipated arrival information.
Anticipated Arrival date	Mandatory	Date of the anticipated arrival.
Port No.	Optional	Enter a valid port code.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the remarks screen. Click Del to delete a line.
Remarks Type Code	Optional	A code indicating the type of remarks. FDA uses either NAM or GEN as its valid values.
Remarks Text	Optional	Free form text relevant to the shipment or the commodity.

Once you are at the bottom of the PGA screen, click "Ok" to return to the Line Items screen.

FDA – Radiation

Field/Button	Status	Description
Agency	Mandatory	Must be FDA.
Program	Mandatory	RAD
Processing Code	Mandatory	REP
OK/Cancel	Buttons	Click OK to save the PGA Information and move on to the next screen. Cancel will cancel and go back to the PGA screen without saving.

Field/Button	Status	Description
Item Type	Mandatory	Defaulted to P for Product.
Intended Use Code	Optional	Enter Intended Use Code *** If the Intended Use is unknown, you have the option to choose UNKN-Unknown but if not required, leave blank.
Intended Use Description	Optional	Intended Use Description is optional
Prior Notice Number	Conditional	Enter Prior Notice Number if Prior Notice was previously submitted.
Product Code Qualifier	Mandatory	“FDP” (FDA Product)
Product Code Number	Mandatory	FDA Product Code Must be equal to 7 characters

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the source processing screen. Click Del to delete a line.
Source Type Code	Mandatory	Source Type Code must be selected using the following logic. 1) IF Government Agency Program Code = FOO and Government Agency Processing Code = NSF then use 262 (Place of growth) ELSE Source Type Code can be 39 (Country of Production). IF Government Agency Program Code = FOO, THEN Country of Shipment CSH is required. IF Government Agency Program Code = FOO then Country of Entry Refusal 294 is required, if previously refused from other country(s)
Source Country	Mandatory	A two-letter code that identifies the country from where the product was produced, packed or shipped.

Field/Button	Status	Description
Trade Name/Brand Name	Mandatory	Trade/Brand Name of the Radiation-Emitting Device. For example, Sony Laser scanner RM2.
Model	Optional	The Item Identity Number. This is the Model Number or the Serial Number based on the qualifier entered below
ID Number Qualifier	Optional	Code identifying the type of Item Identity Number being provided

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product characteristics screen. Click Del to delete a line.
Characteristic Description	Mandatory	Common, market or usual name or description, NOT product code description of the product. Free form description of the item.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product entities screen. Click Del to delete a line.
Entity Role Codes	Mandatory	Select your Entity Role Codes, one at a time. Under Product Entities, enter all mandatory Entities for RADIATION. (Mandatory entites are marked *MANDATORY* in the picklist.) HINT: Mandatory entities for RADIATION MF Manufacturer of goods DEQ Shipper FD1 FDA Importer (Importer of Record) DP Delivered To Party
Entity ID Type	Conditional	Select an Entity ID Type if you have an Entity ID. FDA requires Entity Name and Entity Address. Additionally, FDA prefers to use DUNS numbers for identifying the Entity; IF DUNS is not available THEN FEI
Entity Number	Conditional	Enter the entity number
Name	Conditional	Name of the entity.
Address 1	Conditional	Address 1 of the entity, mandatory if name is entered.
City	Conditional	City of the entity, mandatory if name is entered.
State	Conditional	State of the entity, mandatory if name is entered.
Country	Conditional	Country of the entity, mandatory if name is entered.
Address 2	Conditional	Address 2 of the entity.
Apartment/Suite Number	Conditional	Apartment/Suite Number of the entity.
Postal Code	Conditional	Postal code of the entity, mandatory if name is entered.
Add/Edit/Del	Button	Click Add or Edit to open the Individual Entities screen. Each Entity added must have an Individual Entity added. (This is a point of contact) This CAN be the filer’s contact info. Click Del to delete a line.

Field/Button	Status	Description
Name	Conditional	Name of the individual at the company. MANDATORY for all Roles
Individual Qualifier	Conditional	Individual Qualifier MUST match the Entity Role Code.
Phone Number	Conditional	Phone number of the individual at the company.
Email	Conditional	Email of the individual at the company.

Field/Button

Status

Description

Add/Edit/Del

Button

Click Add or Edit to open the affirmations of compliance screen. Click Del to delete a line.

Affirmation of Compliance Code

Conditional

A code used to affirm compliance with FDA requirements.

List of Affirmation of Compliance codes CONDITIONAL to FDA Radiation Emitting Product Message Sets

If 2877 is required:

Affirmation	Qualifier	Examples and additional information	Additional Affirmations Required	Text on 2877
RA1	date	format MM/YYYY		1.Were manufactured prior to the effective date of any applicable standard. Date of Manufacture:____________________________
RA2	text	text is reason for exclusion. Example: DOD exemption		2. Are excluded by the applicability clause or definition in the standard or by FDA written guidance. Specify reason for exclusion:______________
RA3	none			3. Are personal household goods of an individual entering the U.S. or being returned to a U.S. resident (Limit: 3 of each product type)
RA4*	none			4. Are property of a party residing outside the U.S. and will be returned to the owner after repair or servicing.
RA5*	text	text is description of the end product. Example: Laser Diode		5. Are components or subassemblies to be used in manufacturing or as replacement parts
RA6	none			6. Are prototypes intended for ongoing product development by the importing firms, are labeled "FOR TEST/EVALUATION ONLY" and will be exported, destroyed, or held for future testing.- there is a quantity limit for this option-stated on the back of the 2877 (page 2)
RA7*	text	text is description of the end product		7.Are being reprocessed in accordance with P.L. 104-134 or other FDA guidance, are labeled "FOR EXPORT ONLY" and will not be sold, distributed or transferred without FDA approval.
RB1*	none		If RB1 then ACC (product report accession number) OR ANC (annual report accession number) must be provided. (ACC+7N or ANC+7N)	B1.Comply with the performance standards- 1.Last annual report or Product/Initial Report
RB2*	text	text is reason the product complies		B2.Comply with the performance standards-2. Unknown manufacturer/report number. State reason:
RC1*	none			C1.Do not comply with performance standards; are being held under a temporary import bond; will not be introduced into commerce, will be used under a radiation protection plan, and will be destroyed or exported under U.S. Customs Supervision when the mission is complete - 1. Research , Investigations/Studies, or Training (Attach Form FDA 766)
RC2	text	text is dates and use restriction		C2.Do not comply with performance standards; are being held under a temporary import bond; will not be introduced into commerce, will be used under a radiation protection plan, and will be destroyed or exported under U.S. Customs Supervision when the mission is complete - 1. Trade Show/Demonstration; List dates and use restrictions
RD1*	none			D1. Do not comply with performance standards; are held and will remain under bond; and will not be introduced into commerce until notification is received from FDA that products have been brought into compliance in accordance with an FDA approved petition.(See Form FDA 766) -1. Approved Petition is attached.
RD2*	none			D2. Do not comply with performance standards; are held and will remain under bond; and will not be introduced into commerce until notification is received from FDA that products have been brought into compliance in accordance with an FDA approved petition.(See Form FDA 766) -2.Petition request is attached.
RD3	date	date is the date form 766 will be provided, due within 60 days of submission.		D3. Do not comply with performance standards; are held and will remain under bond; and will not be introduced into commerce until notification is received from FDA that products have been brought into compliance in accordance with an FDA approved petition.(See Form FDA 766) - 3.Request will be submitted within 60 days.

*Annotates that additional information may be needed at time of entry in order for FDA to make a final admissibility decision.

Affirmation of Compliance Allowable Description Formats

Conditional

Text describing the information required by the FDA. This could include a number or a country code, etc.

Affirmation of Compliance Description

Conditional

Enter the Affirmation of Compliance Description

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the value lot numbers screen. Click Del to delete a line.
Lot Number Qualifier	Conditional	Note – for Lot Number Qualifier, if processing code is NSF, Lot Number Qualifier must be 3. Otherwise Lot Number Qualifier is = 1. (per PGA Supplemental Guide 2.4)
Lot Number	Conditional	The lot number that the manufacturer/ producer/grower assigned to the product
Lot Production Start Date	Optional	The date when the production for the Lot started.
Lot Production End Date	Optional	The date when the production for the Lot started.
Temperature Qualifier	Optional	Temperature Category being reported for quality control or preservation purposes.
Degree Type	Optional	F = Fahrenheit, C = Celsius , K = Kelvin
Actual Temperature	Optional	Reported temperature.
Location of Temperature Recording	Optional	Identifies recorded temperature is for A = product B = container C = conveyance
PGA Line Value	Mandatory	The value associated with the PGA line number in whole dollars.
PGA Unit Value	Optional	The value of the lowest unit of measure

Field/Button

Status

Description

Package Quantity

Mandatory

Outermost (largest=1) packages to the innermost (smallest=6) packages. The total quantity for the packaging level.

Packaging UOM

Mandatory

Type of packaging / packaging level.

Field/Button

Status

Description

Add/Edit/Del

Button

Click Add or Edit to open the containers screen. Click Del to delete a line.

Container Number (Equipment ID)

Optional

The number of the shipping container as entered in the Bill of Lading.

Field/Button	Status	Description
Arrival Status	Mandatory	A is the ONLY valid code for FDA: A = Anticipated arrival information.
Anticipated Arrival date	Mandatory	Date of the anticipated arrival.
Port No.	Optional	Enter a valid port code.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the remarks screen. Click Del to delete a line.
Remarks Type Code	Optional	A code indicating the type of remarks. FDA uses either NAM or GEN as its valid values.
Remarks Text	Optional	Free form text relevant to the shipment or the commodity.

Once you are at the bottom of the PGA screen, click "Ok" to return to the Line Items screen.

FDA – Tobacco

Field/Button	Status	Description
Agency	Mandatory	Must be FDA.
Program	Mandatory	TOB
Processing Code	Mandatory	· Enter the appropriate Processing Code (CSU, FFM, INV)
OK/Cancel	Buttons	Click OK to save the PGA Information and move on to the next screen. Cancel will cancel and go back to the PGA screen without saving.

Field/Button	Status	Description
Item Type	Mandatory	Defaulted to P for Product.
Intended Use Code	Conditional	Enter Intended Use Code *** If the Intended Use is unknown, you have the option to choose UNKN-Unknown but if not required, leave blank.
Intended Use Description	Optional	Intended Use Description is optional
Product Code Qualifier	Mandatory	“FDP” (FDA Product)
Product Code Number	Mandatory	FDA Product Code Must be equal to 7 characters

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the source processing screen. Click Del to delete a line.
Source Type Code	Mandatory	For Tobacco, Source Type Code 39 (Country of Production) is required. Other Source Type Codes, 262 (Place of Growth) or HRV (Harvested) or 30 (Country of Source) may be entered, if available. There would be at least one PG06 with source type code of 39. More PG06 records may be repeated for the optional Source Type Codes, 262, HRV or 30.. Additionally, if previously refused, then trade would also provide another PG06 with source type code 294 (Country of Refusal).
Source Country	Mandatory	Country of production or source is required for Tobacco.

Field/Button	Status	Description
Trade Name/Brand Name	Conditional	If Government Agency Processing Code is INV (Investigational) or CSU (Consumer Use) then trade or brand name is mandatory. If Government Agency Processing Code is FFM (For Further Manufacturing), then trade name/brand name is optional.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product characteristics screen. Click Del to delete a line.
Characteristic Description	Mandatory	Free form invoice description, NOT product code description. This field will capture such information as length, color, and pack count. Under 21 1140.16(b), cigarette packages are required to contain a minimum of 20 cigarettes.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product entities screen. Click Del to delete a line.
Entity Role Codes	Mandatory	Select your Entity Role Codes, one at a time.Under Product Entities, enter all mandatory Entities for TOBACCO. (Mandatory entites are marked *MANDATORY* in the picklist.) HINT: Mandatory entities for TOBACCO MF Manufacturer of goods DEQ Shipper FD1 FDA Importer (Importer of Record) TB Submitter DP Delivered To Party
Entity ID Type	Conditional	Select an Entity ID Type if you have an Entity ID. FDA requires Entity Name and Entity Address. Additionally, FDA prefers to use DUNS numbers for identifying the Entity; IF DUNS is not available THEN FEI
Entity Number	Conditional	Enter the entity number
Name	Conditional	Name of the entity.
Address 1	Conditional	Address 1 of the entity, mandatory if name is entered.
City	Conditional	City of the entity, mandatory if name is entered.
State	Conditional	State of the entity, mandatory if name is entered.
Country	Conditional	Country of the entity, mandatory if name is entered.
Address 2	Conditional	Address 2 of the entity.
Apartment/Suite Number	Conditional	Apartment/Suite Number of the entity.
Postal Code	Conditional	Postal code of the entity, mandatory if name is entered.
Add/Edit/Del	Button	Click Add or Edit to open the Individual Entities screen. Each Entity added must have an Individual Entity added. (This is a point of contact) This CAN be the filer’s contact info. Click Del to delete a line.

Field/Button	Status	Description
Name	Conditional	Name of the individual at the company. MANDATORY for all Roles
Individual Qualifier	Conditional	Individual Qualifier MUST match the Entity Role Code.
Phone Number	Conditional	Phone number of the individual at the company.
Email	Conditional	Email of the individual at the company.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the affirmations of compliance screen. Click Del to delete a line.
Affirmation of Compliance Code	Conditional	A code used to affirm compliance with FDA requirements.
Affirmation of Compliance Allowable Description Formats	Conditional	Text describing the information required by the FDA. This could include a number or a country code, etc.
Affirmation of Compliance Description	Conditional	Enter the Affirmation of Compliance Description

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the value lot numbers screen. Click Del to delete a line.
Lot Number Qualifier	Optional	Includes Lots and/or Batches IF Government Agency Program Code = TOB THEN Lot Number Qualifier = 3
Lot Number	Optional	The lot number that the manufacturer/ producer/grower assigned to the product
Lot Production Start Date	Optional	The date when the production for the Lot started.
Lot Production End Date	Optional	The date when the production for the Lot started.
Temperature Qualifier	Optional	Temperature Category being reported for quality control or preservation purposes.
Degree Type	Optional	F = Fahrenheit, C = Celsius , K = Kelvin
Actual Temperature	Optional	Reported temperature.
Location of Temperature Recording	Optional	Identifies recorded temperature is for A = product B = container C = conveyance
PGA Line Value	Mandatory	The value associated with the PGA line number in whole dollars. Line Value is needed for enforcement of User Fee Regulations. Failure to pay user fees makes a product adulterated under Section 902 of the FD&C Act in accordance with Section 919.
PGA Unit Value	Mandatory	The value of the lowest unit of measure

Field/Button

Status

Description

Package Quantity

Mandatory

Outermost (largest=1) packages to the innermost (smallest=6) packages. The total quantity for the packaging level.

Packaging UOM

Mandatory

Type of packaging / packaging level.

Field/Button	Status	Description
Arrival Status	Mandatory	A is the ONLY valid code for FDA: A = Anticipated arrival information.
Anticipated Arrival date	Mandatory	Date of the anticipated arrival.
Port No.	Optional	Enter a valid port code.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the remarks screen. Click Del to delete a line.
Remarks Type Code	Optional	A code indicating the type of remarks. FDA uses either NAM or GEN as its valid values.
Remarks Text	Optional	Free form text relevant to the shipment or the commodity.

Once you are at the bottom of the PGA screen, click "Ok" to return to the Line Items screen.

FDA – Veterinary Medications

Field/Button	Status	Description
Agency	Mandatory	Must be FDA.
Program	Mandatory	VME
Processing Code	Mandatory	Enter the appropriate Processing Code (ADE or ADR)
OK/Cancel	Buttons	Click OK to save the PGA Information and move on to the next screen. Cancel will cancel and go back to the PGA screen without saving.

Field/Button	Status	Description
Item Type	Mandatory	Defaulted to P for Product.
Intended Use Code	Conditional	Enter Intended Use Code *** If the Intended Use is unknown, you have the option to choose UNKN-Unknown but if not required, leave blank.
Intended Use Description	Optional	Intended Use Description is optional
Product Code Qualifier	Mandatory	“FDP” (FDA Product)
Product Code Number	Mandatory	FDA Product Code Must be equal to 7 characters

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the constituent elements screen. Click Del to delete a line.
Active Ingredient	Mandatory	Active ingredient = “Y” if yes, blank if no.
Name of Active Ingredient	Mandatory	IF Government Agency Program Code = VME AND Government Agency Processing Code = ADR THEN Constituent Active Ingredient Qualifier and Name of the Constituent Element are Mandatory.
Percent of Active Ingredient	Mandatory	Either the quantity and Unit of Measurement should be entered OR the Percent Constituent Element should be entered.
Quantity of Active Ingredient	Mandatory	Either the quantity and Unit of Measurement should be entered OR the Percent Constituent Element should be entered.
Unit of Measure	Mandatory	Enter the unit of measure.

Field/Button	Status	Description
Source Type Code	Mandatory	Mandatory valid values are 30 (Country of Source) or 39 (Country of Production) is MANDATORY. 294 (Country of Refusal) if previously refused
Source Country	Mandatory	Country of production or source is required for Animal Drugs

Field/Button	Status	Description
Trade Name/Brand Name	Conditional	If Government Agency Program Code = ‘VME’ the Trade/Brand Name of the Animal Drug is MANDATORY.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product characteristics screen. Click Del to delete a line.
Characteristic Description	Mandatory	Free form description, NOT product code description, of the item, either to supplement the above data elements or in place of the above.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the product entities screen. Click Del to delete a line.
Entity Role Codes	Mandatory	Select your Entity Role Codes, one at a time. Under Product Entities, enter all mandatory Entities for VETERINARY MEDICAL. (Mandatory entites are marked *MANDATORY* in the picklist.) HINT: Mandatory entities for VETERINARY MEDICAL MF Manufacturer of goods DEQ Shipper FD1 FDA Importer (Importer of Record) DP Delivered To Party
Entity ID Type	Conditional	Select an Entity ID Type if you have an Entity ID. FDA requires Entity Name and Entity Address. Additionally, FDA prefers to use DUNS numbers for identifying the Entity; IF DUNS is not available THEN FEI
Entity Number	Conditional	Enter the entity number
Name	Conditional	Name of the entity.
Address 1	Conditional	Address 1 of the entity, mandatory if name is entered.
City	Conditional	City of the entity, mandatory if name is entered.
State	Conditional	State of the entity, mandatory if name is entered.
Country	Conditional	Country of the entity, mandatory if name is entered.
Address 2	Conditional	Address 2 of the entity.
Apartment/Suite Number	Conditional	Apartment/Suite Number of the entity.
Postal Code	Conditional	Postal code of the entity, mandatory if name is entered.
Add/Edit/Del	Button	Click Add or Edit to open the Individual Entities screen. Each Entity added must have an Individual Entity added. (This is a point of contact) This CAN be the filer’s contact info. Click Del to delete a line.

Field/Button	Status	Description
Name	Conditional	Name of the individual at the company. MANDATORY for all Roles
Individual Qualifier	Conditional	Individual Qualifier MUST match the Entity Role Code.
Phone Number	Conditional	Phone number of the individual at the company.
Email	Conditional	Email of the individual at the company.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the affirmations of compliance screen. Click Del to delete a line.
Affirmation of Compliance Code	Conditional	A code used to affirm compliance with FDA requirements. There must be at least one PG23 record with the AoC code of REG.
Affirmation of Compliance Description	Conditional	Enter the Affirmation of Compliance Description

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the value lot numbers screen. Click Del to delete a line.
Lot Number Qualifier	Optional	Includes Lots and/or Batches IF Government Agency Program Code = TOB THEN Lot Number Qualifier = 3
Lot Number	Optional	The lot number that the manufacturer/ producer/grower assigned to the product
Lot Production Start Date	Optional	The date when the production for the Lot started.
Lot Production End Date	Optional	The date when the production for the Lot started.
Temperature Qualifier	Optional	Temperature Category being reported for quality control or preservation purposes.
Degree Type	Optional	F = Fahrenheit, C = Celsius , K = Kelvin
Actual Temperature	Optional	Reported temperature.
Location of Temperature Recording	Optional	Identifies recorded temperature is for A = product B = container C = conveyance
PGA Line Value	Mandatory	The value associated with the PGA line number in whole dollars.
PGA Unit Value	Optional	The value of the lowest unit of measure

Field/Button

Status

Description

Package Quantity

Mandatory

Outermost (largest=1) packages to the innermost (smallest=6) packages. The total quantity for the packaging level.

Packaging UOM

Mandatory

Type of packaging / packaging level.

Field/Button

Status

Description

Add/Edit/Del

Button

Click Add or Edit to open the containers screen. Click Del to delete a line.

Container Number (Equipment ID)

Optional

The number of the shipping container as entered in the Bill of Lading.

Field/Button	Status	Description
Arrival Status	Mandatory	A is the ONLY valid code for FDA: A = Anticipated arrival information.
Anticipated Arrival date	Mandatory	Date of the anticipated arrival.
Port No.	Optional	Enter a valid port code.

Field/Button	Status	Description
Add/Edit/Del	Button	Click Add or Edit to open the remarks screen. Click Del to delete a line.
Remarks Type Code	Optional	A code indicating the type of remarks. FDA uses either NAM or GEN as its valid values.
Remarks Text	Optional	Free form text relevant to the shipment or the commodity.

Once you are at the bottom of the PGA screen, click "Ok" to return to the Line Items screen.