Preparing the required information (applies to unique lines only)

The following are examples of Typical Data sets Filers are required to submit to FDA in ACE

for a Biological Product	Data submitted by Filer:
Intended Use Code:	080.000
CBP required: Product Description	Rubella vaccine
Product code:	57CH-99
Country of Production	DE
CBP required Manufacturer (name/address)	Baxter AG, Industriestasse 72, Munich, Germany
CBP required Shipper (name/address):	Baxter AG, Industriestasse 72, Munich Germany
CBP required Consignee (name/address):	Baxter Healthcare Corp. Deerfield, IL 60015
Importer (name/Contact):	Earl, Adolph David 1-800-423-2090 ADEARL@Baxter.com
Specific product data:	BLN 1026 STN 10656

for a Drug Product	Data submitted by Filer:
Intended Use Code:	180.009
CBP required: Product Description	Acetaminophen
Product code:	60LIC01
Country of Production	DE
CBP required Manufacturer (name/address)	Baxter AG, Industriestasse 72, Munich, Germany
CBP required Shipper (name/address):	Baxter AG, Industriestasse 72, Munich Germany
CBP required Consignee (name/address):	Baxter Healthcare Corp. Deerfield, IL 60015
Importer (name/Contact):	Earl, Adolph David 1-800-423-2090 ADEARL@Baxter.com
Specific product data:	IND 058907

for a Medical Device Product	Data submitted by Filer:
Intended Use Code:	081.001
CBP required: Product Description	Myocardial Pacing Lead
Product code:	74N--HW
Country of Production	DE
CBP required Manufacturer (name/address)	Richard Wolf GMBH, Wurttemberg, Germany
CBP required Shipper (name/address):	Greybatch Medical, 2300 Berkshire Lane Minneapolis, MN 55441
CBP required Consignee (name/address):	Greybatch Medical, 2300 Berkshire Lane Minneapolis, MN 55441
Importer (name/Contact):	Earl, Adolph David 1-800-423-2090 ADEARL@Greybatch.com
Specific product data:	DEV 1234567 DFE 2345678 LST E12345

for a Cosmetic Product	Data submitted by Filer:
Intended Use Code:	UNK
CBP required: Product Description	Eye Shadow
Product code:	53CD-03
Country of Production	CA
CBP required Manufacturer (name/address)	Bare Escentualse, 2960 Kingsway Dr. Ont, CA N2C 1X1
CBP required Shipper (name/address):	Bare Escentualse, 2960 Kingsway Dr. Ont, CA N2C 1X1
CBP required Consignee (name/address):	Bare Escentualse, 71 Stevens Dr, SanFrancisco, CA 94105
Importer (name/Contact):	Earl, Adolph David 1-800-423-2090 ADEARL@BareMineral.com
Specific product data:	n/a

for a Tobacco Product	Data submitted by Filer:
Intended Use Code:	UNK
CBP required: Product Description	Cigar tobacco leaves
Product code:	98BAA01
Country of Production	MX
CBP required Manufacturer (name/address)	Excaliber Tobacco, Mexico City, MX 11122
CBP required Shipper (name/address):	General Tobacco Co, 230 Berkshire Ln, San Francisco CA 94105
CBP required Consignee (name/address):	General Tobacco Co, 230 Berkshire Ln, San Francisco CA 94105
Importer (name/Contact):	Earl, Adolph David 1-800-423-2090 ADEARL@GenTobacco.com
Specific product data:	n/a