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

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: GDUFA Facility Business Operations - XML Representation

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<ValueSet xmlns="http://hl7.org/fhir">
  <id value="valueset-gdufaFacilityBusinessOperations"/>
  <text>
    <status value="generated"/>
    <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>
  </text>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-wg">
    <valueCode value="brr"/>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fmm">
    <valueInteger value="1">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"/>
      </extension>
    </valueInteger>
  </extension>
  <extension
             url="http://hl7.org/fhir/StructureDefinition/structuredefinition-standards-status">
    <valueCode value="trial-use">
      <extension
                 url="http://hl7.org/fhir/StructureDefinition/structuredefinition-conformance-derivedFrom">
        <valueCanonical
                        value="http://hl7.org/fhir/us/spl/ImplementationGuide/hl7.fhir.us.spl"/>
      </extension>
    </valueCode>
  </extension>
  <url
       value="http://hl7.org/fhir/us/spl/ValueSet/valueset-gdufaFacilityBusinessOperations"/>
  <version value="0.2.1"/>
  <name value="GDUFAFacilityBusinessOperations"/>
  <title value="GDUFA Facility Business Operations"/>
  <status value="active"/>
  <experimental value="false"/>
  <date value="2024-12-10T07:56:13+00:00"/>
  <publisher value="HL7 International / Biomedical Research and Regulation"/>
  <contact>
    <name value="HL7 International / Biomedical Research and Regulation"/>
    <telecom>
      <system value="url"/>
      <value value="http://www.hl7.org/Special/committees/rcrim"/>
    </telecom>
  </contact>
  <description
               value="The set of business operations that can be specified for a GDUFA facility."/>
  <jurisdiction>
    <coding>
      <system value="urn:iso:std:iso:3166"/>
      <code value="US"/>
      <display value="United States of America"/>
    </coding>
  </jurisdiction>
  <compose>
    <include>
      <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/>
      <concept>
        <code value="C101509"/>
        <display value="API/FDF ANALYTICAL TESTING"/>
      </concept>
      <concept>
        <code value="C82401"/>
        <display value="API MANUFACTURE"/>
      </concept>
      <concept>
        <code value="C101511"/>
        <display value="CLINICAL BIOEQUIVALENCE OR BIOAVAILABILITY STUDY"/>
      </concept>
      <concept>
        <code value="C101510"/>
        <display value="FDF MANUFACTURE"/>
      </concept>
      <concept>
        <code value="C101512"/>
        <display value="IN VITRO BIOEQUIVALENCE OR BIOANALYTICAL TESTING"/>
      </concept>
      <concept>
        <code value="C84731"/>
        <display value="PACK"/>
      </concept>
      <concept>
        <code value="C91403"/>
        <display value="POSITRON EMISSION TOMOGRAPHY DRUG PRODUCTION"/>
      </concept>
      <concept>
        <code value="C73606"/>
        <display value="REPACK"/>
      </concept>
    </include>
  </compose>
</ValueSet>