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Assembly of Electronic Packages and Discs
- The e-Dossier method is based on the use of a "builder" application described in "A" below.
- The second requires the manual editing of the XML file as described in "B" below.
In both methods, you will zip the files to be submitted, an XML data file containing information about the files and the submission itself into a single file and place the zip file on a disc (CD/DVD) for submission.
Email Milestone Tracking Notification: Both methods have been further modified in December 2013 to include an additional field. This field is necessary to support PRIA Milestone Tracking email message functionality. For registrants using method B, the new field tag is defined as US_MD14. While EPA can still successfully accept e-Submissions that do not include an email address, such omissions will prevent the generation of milestone tracking emails. Please refer to each method’s guidance for details.
The e-Dossier Builder method uses a “builder” software application to assist the user in the creation of the electronic package. The resulting .zip file produced by the e-Dossier Builder should be copied onto a disc (CD/DVD) to submit to us. Unlike the XML method, the e-Dossier Builder method does not require manual editing of XML and, instead, allows the user to fill in a series of fields and attach the required files. The Builder does the rest.
Note: The .zip and XML files produced by the e-Dossier Builder are unique and not related to the XML guidance provided below. Please do not attempt to make any edits to the e-Dossier Builder output based on the XML guidance from method B. Doing so may result in an electronic package that we cannot use.
The XML method of information exchange from industry to EPA is based on a harmonized XML schema used by Canada's PMRA, which we have adapted. This harmonization assures industry that a documentation package submitted to one participating regulatory agency can also be submitted to the other participating agency, increasing standardization and decreasing the burden on industry.
Instructions for e-submissions using the XML schema method
The e-Submission XML Guidance Document provides instructions to create and submit files containing digitized versions of their submission documents (i.e., studies, labels, and forms) using Pest Management Regulatory Agency e-Index Builder or by using a XML file creation application (i.e., Notepad, Microsoft Word, etc.)
For study files, use the file naming convention of study guideline number, MRID number. For example 850.120.12345600