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| NEW line(s): 46,47
<!-- Part I --> |
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<xsd:element name="QualifiedClinicalTestExpnssPd" minOccurs="0"> | NEW line(s): 49
<xsd:element name="QualifiedClinicalTestExpnssPd" type="USAmountType" minOccurs="0"> |
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<LineNumber>1</LineNumber> | NEW line(s): 53
<LineNumber>Part I, Line 1</LineNumber> |
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<xsd:complexType> <xsd:simpleContent> <xsd:extension base="USAmountType"> <xsd:attribute name="referenceDocumentId" type="IdListType" /> <xsd:attribute name="referenceDocumentName" type="StringType" fixed="OrphanDrugStatement" /> </xsd:extension> </xsd:simpleContent> </xsd:complexType> | NEW line(s): 55
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<LineNumber>2a</LineNumber> | NEW line(s): 63
<LineNumber>Part I, Line 2a</LineNumber> |
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<LineNumber>2b</LineNumber> | NEW line(s): 81
<LineNumber>Part I, Line 2b</LineNumber> |
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<LineNumber>2c</LineNumber> | NEW line(s): 91
<LineNumber>Part I, Line 2c</LineNumber> |
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<LineNumber>3</LineNumber> | NEW line(s): 102
<LineNumber>Part I, Line 3</LineNumber> |
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<Description>Add lines 2 and 3</Description> <LineNumber>4</LineNumber> | NEW line(s): 111,112
<Description>Add lines 2c and 3</Description> <LineNumber>Part I, Line 4</LineNumber> |
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<LineNumber>5</LineNumber> | NEW line(s): 136
<LineNumber>Part I, Line 5</LineNumber> |
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<LineNumber>6</LineNumber> | NEW line(s): 146
<LineNumber>Part I, Line 6</LineNumber> |
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| NEW line(s): 149,180
</xsd:element> <!-- Part II: Orphan Drug Information --> <!-- Orphan Drug Name --> <xsd:element name="OrphanDrugName" type="TextType" minOccurs="0"> <xsd:annotation> <xsd:documentation> <Description>Orphan drug name</Description> <LineNumber>Part II, Line b</LineNumber> </xsd:documentation> </xsd:annotation> </xsd:element> <!-- Orphan Drug Designation Number --> <xsd:element name="OrphanDrugDesignationNum" type="TextType" minOccurs="0"> <xsd:annotation> <xsd:documentation> <Description>Orphan drug designation number</Description> <LineNumber>Part II, Line c</LineNumber> </xsd:documentation> </xsd:annotation> </xsd:element> <!-- Orphan Drug Designation Dug --> <xsd:element name="OrphanDrugDesignationDr" type="TextType" minOccurs="0"> <xsd:annotation> <xsd:documentation> <Description>Orphan drug designation dug</Description> <LineNumber>Part II, Line d</LineNumber> </xsd:documentation> </xsd:annotation> |