SPL Mapping FHIR R5 Implementation Guide
0.2.1 - Build CI United States of America flag

SPL Mapping FHIR R5 Implementation Guide, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 0.2.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-spl/ and changes regularly. See the Directory of published versions

: GDUFA Facility Business Operations - TTL Representation

Page standards status: Trial-use Maturity Level: 1

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@prefix fhir: <http://hl7.org/fhir/> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

# - resource -------------------------------------------------------------------

 a fhir:ValueSet ;
  fhir:nodeRole fhir:treeRoot ;
  fhir:id [ fhir:v "valueset-gdufaFacilityBusinessOperations"] ; # 
  fhir:text [
fhir:status [ fhir:v "generated" ] ;
fhir:div "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: ValueSet valueset-gdufaFacilityBusinessOperations</b></p><a name=\"valueset-gdufaFacilityBusinessOperations\"> </a><a name=\"hcvalueset-gdufaFacilityBusinessOperations\"> </a><a name=\"valueset-gdufaFacilityBusinessOperations-en-US\"> </a><ul><li>Include these codes as defined in <a href=\"http://terminology.hl7.org/6.1.0/CodeSystem-v3-nciThesaurus.html\"><code>http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl</code></a><table class=\"none\"><tr><td style=\"white-space:nowrap\"><b>Code</b></td><td><b>Display</b></td></tr><tr><td>C101509</td><td>API/FDF ANALYTICAL TESTING</td></tr><tr><td>C82401</td><td>API MANUFACTURE</td></tr><tr><td>C101511</td><td>CLINICAL BIOEQUIVALENCE OR BIOAVAILABILITY STUDY</td></tr><tr><td>C101510</td><td>FDF MANUFACTURE</td></tr><tr><td>C101512</td><td>IN VITRO BIOEQUIVALENCE OR BIOANALYTICAL TESTING</td></tr><tr><td>C84731</td><td>PACK</td></tr><tr><td>C91403</td><td>POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION</td></tr><tr><td>C73606</td><td>REPACK</td></tr></table></li></ul></div>"
  ] ; # 
  fhir:extension ( [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-wg"^^xsd:anyURI ] ;
fhir:value [ fhir:v "brr" ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm"^^xsd:anyURI ] ;
fhir:value [
fhir:v "1"^^xsd:integer ;
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ] ;
fhir:value [
fhir:v "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl>         ]       ] )     ]
  ] [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status"^^xsd:anyURI ] ;
fhir:value [
fhir:v "trial-use" ;
      ( fhir:extension [
fhir:url [ fhir:v "http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom"^^xsd:anyURI ] ;
fhir:value [
fhir:v "http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"^^xsd:anyURI ;
fhir:link <http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl>         ]       ] )     ]
  ] ) ; # 
  fhir:url [ fhir:v "http://hl7.org/fhir/us/spl/ValueSet/valueset-gdufaFacilityBusinessOperations"^^xsd:anyURI] ; # 
  fhir:version [ fhir:v "0.2.1"] ; # 
  fhir:name [ fhir:v "GDUFAFacilityBusinessOperations"] ; # 
  fhir:title [ fhir:v "GDUFA Facility Business Operations"] ; # 
  fhir:status [ fhir:v "active"] ; # 
  fhir:experimental [ fhir:v "false"^^xsd:boolean] ; # 
  fhir:date [ fhir:v "2024-12-10T07:56:13+00:00"^^xsd:dateTime] ; # 
  fhir:publisher [ fhir:v "HL7 International / Biomedical Research and Regulation"] ; # 
  fhir:contact ( [
fhir:name [ fhir:v "HL7 International / Biomedical Research and Regulation" ] ;
    ( fhir:telecom [
fhir:system [ fhir:v "url" ] ;
fhir:value [ fhir:v "http://www.hl7.org/Special/committees/rcrim" ]     ] )
  ] ) ; # 
  fhir:description [ fhir:v "The set of business operations that can be specified for a GDUFA facility."] ; # 
  fhir:jurisdiction ( [
    ( fhir:coding [
fhir:system [ fhir:v "urn:iso:std:iso:3166"^^xsd:anyURI ] ;
fhir:code [ fhir:v "US" ] ;
fhir:display [ fhir:v "United States of America" ]     ] )
  ] ) ; # 
  fhir:compose [
    ( fhir:include [
fhir:system [ fhir:v "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"^^xsd:anyURI ] ;
      ( fhir:concept [
fhir:code [ fhir:v "C101509" ] ;
fhir:display [ fhir:v "API/FDF ANALYTICAL TESTING" ]       ] [
fhir:code [ fhir:v "C82401" ] ;
fhir:display [ fhir:v "API MANUFACTURE" ]       ] [
fhir:code [ fhir:v "C101511" ] ;
fhir:display [ fhir:v "CLINICAL BIOEQUIVALENCE OR BIOAVAILABILITY STUDY" ]       ] [
fhir:code [ fhir:v "C101510" ] ;
fhir:display [ fhir:v "FDF MANUFACTURE" ]       ] [
fhir:code [ fhir:v "C101512" ] ;
fhir:display [ fhir:v "IN VITRO BIOEQUIVALENCE OR BIOANALYTICAL TESTING" ]       ] [
fhir:code [ fhir:v "C84731" ] ;
fhir:display [ fhir:v "PACK" ]       ] [
fhir:code [ fhir:v "C91403" ] ;
fhir:display [ fhir:v "POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION" ]       ] [
fhir:code [ fhir:v "C73606" ] ;
fhir:display [ fhir:v "REPACK" ]       ] )     ] )
  ] . #