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# CDER Offers Online Course for Generic ‘Self Identification’
- URL: https://www.fdaweb.com/cder-offers-online-course-for-generic-self-identification/
- Published: 2016-01-13T12:00:00.000Z
- Updated: 2026-09-15T02:27:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134428

> CDER’s online learning portal, CDERLearn, has added two educational tutorials on generic drug user fee “self identification” electronic (SPL) submissions. The courses offer a comprehensive review of the required data elements and their restrictions for the Self-Identification SPL file. They also guide firms through the successful submission process, including uploading SPL submissions and retrieving acknowledgments.  
>  
> CDER says self-identification is required for two purposes. First, it is necessary to determine the universe of facilities required to pay user fees. Second, self-identification is also one component in promoting global supply chain transparency. “The information provided through self-identification will enable quick, accurate, and reliable surveillance of generic drugs and facilitate inspections and compliance,” CDER says. “Most facilities that self-identify will be required to pay an annual facility user fee. These include facilities manufacturing, or intending to manufacture, API of human generic drugs and/or finished dosage form human generic drugs.”  
>  
> To view the courses, click on the links below:  
> [**GDUFA Self-Identification (SPL) Submission – Part 1**](http://www.accessdata.fda.gov/cder/Submissions%5FPt1/index.htm?ref=fdaweb.com)[**GDUFA Self-Identification (SPL) Submission – Part 2**](http://www.accessdata.fda.gov/cder/Submissions%5FPt2/index.htm?ref=fdaweb.com)