Affirmation Codes

Summary

The multiple affirmation screen is used to add affirmation codes that need to be send with the FDA data.

YOU ARE RESPONSIBLE FOR ADDING OR DELETING THE NECESSARY CODES

Click for a list of Affirmation Codes and descriptions used by Customs.

To add/delete Multiple Affirmation Codes

Enter the FDA program information and click the Affirmation Codes button.

Field Name	Description
Affirmation Code	A code used to affirm compliance with FDA requirements. If more than one Affirmation of Compliance applies to a single FDA line, the second and others are sent in separate FD05 records. If more than one Affirmation of Compliance is sent they cannot duplicate any other unless differentiated by an Affirmation of Compliance Qualifier. An Affirmation of Compliance and Qualifier combination must be unique in a single FDA line. If the merchandise is subject to BTA prior notice requirements, this data element is mandatory. If the PNC or PND affirmation of compliance codes are used, they must appear in this position first. The affirmation of compliance codes and qualifiers are listed in Appendix O
Affirmation Qualifier	Enter the information that goes with the affirmation code. Using the import of submitter option will fill in most of these fields for you.

Button Name	Description
Ok	Click here to accept save and return to the FDA Data Screen.
Preset Codes	Click here to input preset up affirmation codes by manufacturer
Delete	Click here to delete the entire affirmation file. Single line deletions can be done by right clicking on the affirmation code and clicking clear.
Import Type	Click here to import the default codes for the submitter type you have chosen.
Cancel	Click to return to the FDA Data Screen without saving.

Additional Tips

-All the Fields that appear on the CBCC BTA screen are mandatory (E-mail is mandatory, if you do not have the responsible party’s e-mail put the word “NONE”)

-The Date must be in a format MMDDCCYY (example January 10^th 2004 is input as 01102004)

-Time must be in Military time with no semi-colons. One O’clock PM is 1300

-If the submitter type is a Manufacturer, the State code must be “FN”

-As of right now if you have no PFR or SFR, code 1000000000 made be used, THIS MAY CHANGE AT ANYTIME SO ATTEMPT TO GET THE PROPER INFORMATION

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