Reporting: PMTA submission; amendment; unique identification for new products; validator spreadsheet; periodic reports; change in ownership; supplemental applications; resubmissions; waiver

Validation Tool 2.0
Landing Page –
Form 4057b
OMB Control No. 0910-0879
Expiration Date: xx/xx/20xx
See PRA Statement on bottom of page

Form 3965b
OMB Control No. 0910-0673
Expiration Date: xx/xx/20xx

Form 4057b
OMB Control No. 0910-0879
Expiration Date: xx/xx/20xx
See PRA Statement on bottom of page

Form 3965b
OMB Control No. 0910-0673
Expiration Date: xx/xx/20xx

PMTA Success Path:
File Upload:

Validate File:
Form 4057b
OMB Control No. 0910-0879
Expiration Date: xx/xx/20xx
See PRA Statement on bottom of page

Form 3965b
OMB Control No. 0910-0673
Expiration Date: xx/xx/20xx

Form 4057b
OMB Control No. 0910-0879
Expiration Date: xx/xx/20xx
See PRA Statement on bottom of page

Form 3965b
OMB Control No. 0910-0673
Expiration Date: xx/xx/20xx

OK:

Click Completion Certificate:

Form 4057b
OMB Control No. 0910-0879
Expiration Date: xx/xx/20xx
See PRA Statement on bottom of page

PMTA Certificate:

Form 3965b
OMB Control No. 0910-0673
Expiration Date: xx/xx/20xx

SE Success Path –
Same Screenshots as Above, Certificate is different.

File Fails Validation:

Form 4057b
OMB Control No. 0910-0879
Expiration Date: xx/xx/20xx
See PRA Statement on bottom of page

Form 3965b
OMB Control No. 0910-0673
Expiration Date: xx/xx/20xx

Form 4057b
OMB Control No. 0910-0879
Expiration Date: xx/xx/20xx
See PRA Statement on bottom of page

Form 3965b
OMB Control No. 0910-0673
Expiration Date: xx/xx/20xx

Issue Error Report:

Error Report Example:

Error Messages:
Wrong Excel FileForm 4057b
OMB Control No. 0910-0879
Expiration Date: xx/xx/20xx
See PRA Statement on bottom of page

Wrong PMTA Version –

Form 3965b
OMB Control No. 0910-0673
Expiration Date: xx/xx/20xx

Form 4057b
OMB Control No. 0910-0879
Expiration Date: xx/xx/20xx
See PRA Statement on bottom of page

Form 3965b
OMB Control No. 0910-0673
Expiration Date: xx/xx/20xx

Form 4057b
OMB Control No. 0910-0879
Expiration Date: xx/xx/20xx
See PRA Statement on bottom of page

Form 3965b
OMB Control No. 0910-0673
Expiration Date: xx/xx/20xx

Wrong SE Version –

File is in Use –

Form 4057b
OMB Control No. 0910-0879
Expiration Date: xx/xx/20xx
See PRA Statement on bottom of page

Form 3965b
OMB Control No. 0910-0673
Expiration Date: xx/xx/20xx