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

• Narrative Content
• XML
• JSON
• TTL

: GDUFA Facility Business Operations - JSON Representation

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