United States


Extension Type	Associated Attributes	Applied to Assembly Element	Result
US Module 1 folder (v2.01)	— Company Name — Submission Date — Application Number — Product name and type — Application Type — Submission Type — Sequence Number — Related Sequence Number	1 Administrative Information and Prescribing Information folder in US Module 1 assembly template (v2.01)	When applied to folder in an Assembly that is using the us-2-0-1 XML Definition file, triggers the creation of the us-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <admin> element of the us-regional.xml file. Multiple related sequence number values may be added by separating them with commas. The child folder and leaf elements in this folder complete the remainder of the us-regional.xml file.


Extension Type	Associated Attributes	Applied to Assembly Element	Result
US Module 1 folder (DTD v3.3)	— Applicant ID — Company Name — Submission Description — Applicant Contact — Application Number — Application Contains Files? — Application Type — Cross- Reference Application — Sequence Number — Submission ID — Submission Type — Submission Sub-Type — Supplement Effective Date Type	1 Administrative Information folder in US Module 1 assembly template (v3.3)	When applied to a folder in an Assembly that is using the us-3-3 XML Definition file, triggers the creation of the us-regional.xml file during publishing. The values of the attributes populated on this folder are used to complete the values of the elements and attributes in the <admin> element of the us-regional.xml file. The child folders of this folder complete the remainder of the us-regional.xml file.


Extension Type	Associated Attributes	Applied to Assembly Element	Result
US Admin Forms folder	Application Form Type	The following folders in US Module 1 assembly template (v3.3): — 1.1.1 Form FDA 1571: Investigational New Drug Application (IND) — 1.1.2 Form FDA 356h: Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use folders in	Creates the appropriate <form formtype=""> element within the <submission-information> element in us-regional.xml.


Extension Type	Associated Attributes	Applied to Assembly Element	Result
US Forms folder	Application Form Type	The following folders in US Module 1 assembly template (v3.3): — 1.1.3 Form FDA 3397: User Fee Cover Sheet — 1.1.4 Form FDA 2252: Transmittal of Annual Reports for Drugs and Biologics for Human Use — 1.1.5 Form FDA 2253: Transmittal of Advertisements and Promotional Labeling for Drugs and Biologics for Human Use — 1.1.6 Form FDA 2567: Transmittal of Labels and Circulars — 1.1.7 Form FDA 3674: Certification of Compliance — 1.1.8 Form FDA 3792: Biosimilar User Fee Cover Sheet (BsUFA) — 1.1.9 Form FDA 3794: Generic Drug User Fee Cover Sheet (GDUFA)	Creates the appropriate <form formtype=""> element within the <m1-1forms> element in usregional.xml.


Extension Type	Associated Attributes	Applied to Assembly Element	Result
Promotional Material Audience Type folder	Promotional Material Audience Type	1.15 Promotional Material Audience Type folder in US Module 1 assembly template (v3.3)	Creates the appropriate <m1-15promotional-material> element in us-regional.xml. The value of the attribute populated on this folder is used to complete the promotionalmaterial-audience-type attribute of <m1-15-promotional-material> element.
Promotional Material Doc Type folder	Promotional Material Doc Type	1.15.2 Materials folder in US Module 1 assembly template (v3.3)	Creates the appropriate <m1-15-2materials> element in usregional.xml. The value of the attribute populated on this folder is used to complete the promotionalmaterial-doc-type attribute of <m1-15-2-materials> element.
Promotional Material Type folder	— Promotional Material Type — Promotional Material ID — Issue Date	1.15.2.1 Material folder in US Module 1 assembly template (v3.3)	Creates the appropriate <m1-15-2-1material> element in usregional.xml. The values of the attributes populated on this folder are used to complete the attributes <m1-15-2-1-material> element.