<mods xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xmlns="http://www.loc.gov/mods/v3" version="3.3" xsi:schemaLocation="http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-3.xsd" ID="P0b002ee1d51e4cad">
    <name type="corporate">
         <namePart>United States Government Publishing Office</namePart>
         <role>
              <roleTerm authority="marcrelator" type="text">publisher</roleTerm>
              <roleTerm authority="marcrelator" type="code">pbl</roleTerm>
        </role>
         <role>
              <roleTerm authority="marcrelator" type="text">distributor</roleTerm>
              <roleTerm authority="marcrelator" type="code">dst</roleTerm>
        </role>
    </name>
    <name type="corporate">
         <namePart>United States</namePart>
         <namePart>Health and Human Services Department</namePart>
         <namePart>Food and Drug Administration</namePart>
         <role>
              <roleTerm authority="marcrelator" type="text">author</roleTerm>
              <roleTerm authority="marcrelator" type="code">aut</roleTerm>
        </role>
         <description>Government Organization</description>
    </name>
    <typeOfResource>text</typeOfResource>
    <genre authority="marcgt">government publication</genre>
    <language>
         <languageTerm type="code" authority="iso639-2b">eng</languageTerm>
    </language>
    <extension>
         <collectionCode>CMR</collectionCode>
         <category>Executive Agency Publications</category>
         <branch>executive</branch>
         <dateIngested>2025-07-14</dateIngested>
    </extension>
    <originInfo>
         <publisher>Health and Human Services Department, Food and Drug Administration</publisher>
         <dateIssued encoding="w3cdtf">2024-04-19</dateIssued>
         <issuance>continuing</issuance>
         <frequency authority="marcfrequency">Annual</frequency>
    </originInfo>
    <physicalDescription>
         <note type="source content type">deposited</note>
         <digitalOrigin>born digital</digitalOrigin>
         <extent>79 digital object pages</extent>
    </physicalDescription>
    <classification authority="sudocs">HE 20.4002:P 41/3/</classification>
    <identifier type="uri">https://www.govinfo.gov/app/details/CMR-HE20_4000-00195421</identifier>
    <identifier type="local">P0b002ee1d51e4cad</identifier>
    <identifier type="ILS system id">001455479</identifier>
    <recordInfo>
         <recordContentSource authority="marcorg">DGPO</recordContentSource>
         <recordCreationDate encoding="w3cdtf">2025-07-14</recordCreationDate>
         <recordChangeDate encoding="w3cdtf">2025-07-14</recordChangeDate>
         <recordIdentifier source="DGPO">CMR-HE20_4000-00195421</recordIdentifier>
         <recordOrigin>machine generated</recordOrigin>
         <languageOfCataloging>
              <languageTerm type="code" authority="iso639-2b">eng</languageTerm>
        </languageOfCataloging>
    </recordInfo>
    <accessCondition type="GPO scope determination">fdlp</accessCondition>
    <extension>
         <docClass>HE20_4000</docClass>
         <accessId>CMR-HE20_4000-00195421</accessId>
         <reportId>00195421</reportId>
         <submissionId>00195421</submissionId>
         <organization>Department of Health and Human Services - Food and Drug Administration (FDA)</organization>
         <organizationDisplayName>Food and Drug Administration</organizationDisplayName>
         <publicationDate>2024-04-19</publicationDate>
         <reportSubmittedTo>Committee-Subcommittee</reportSubmittedTo>
         <submittedToCongressDate>2024-04-19</submittedToCongressDate>
         <submittedToGpoDate>2025-07-11</submittedToGpoDate>
         <requiredAtGpoDate>2024-06-18</requiredAtGpoDate>
         <isOnTime>false</isOnTime>
         <receivingChamber>HOUSE</receivingChamber>
         <receivingChamber>SENATE</receivingChamber>
         <congress years="2023-2024">118</congress>
         <rtbmtc>
                                
              <legalAuthority>21 U.S.C. 379j-53(a)</legalAuthority>
                                
              <natureOfReport>Progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 401(b) of the Biosimilar User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals</natureOfReport>
                                
              <whenExpected>Annually</whenExpected>
                            
        </rtbmtc>
         <isWithholdingLetter>false</isWithholdingLetter>
         <isReplacement>false</isReplacement>
         <isCurrentEdition>true</isCurrentEdition>
         <agencyCodes>
                                
              <cgacCode>075</cgacCode>
                                
              <aidCode>075</aidCode>
                                
              <treasuryCode>75</treasuryCode>
                                
              <ombAgencyCode>009</ombAgencyCode>
                                
              <ombBureauCode>10</ombBureauCode>
                                
              <cgacAbbreviation>HHS</cgacAbbreviation>
                                
              <frecCode>7500</frecCode>
                                
              <frecAbbreviation>HHS</frecAbbreviation>
                                
              <subtierCode>7524</subtierCode>
                                
              <subtierAbbreviation>FDA</subtierAbbreviation>
                            
        </agencyCodes>
         <congCommittee authorityId="hsif00" chamber="H" congress="118" type="S">
                                
              <name type="authority-standard">Committee on Energy and Commerce</name>
                                
              <name type="authority-short">Energy and Commerce</name>
                            
        </congCommittee>
         <congCommittee authorityId="sshr00" chamber="S" congress="118" type="S">
                                
              <name type="authority-standard">Committee on Health, Education, Labor, and Pensions</name>
                                
              <name type="authority-short">Health, Education, Labor, and Pensions</name>
                            
        </congCommittee>
         <USCode title="21">
                                
              <section detail="(a)" number="379j-53"></section>
                            
        </USCode>
    </extension>
    <titleInfo>
         <title>Performance Report to Congress: Biosimilar User Fee Act FY 2023</title>
    </titleInfo>
    <classification authority="sudocs">HE 20.4002:P 41/3/</classification>
    <name type="corporate">
         <namePart>United States</namePart>
         <namePart>Congress</namePart>
         <role>
              <roleTerm authority="marcrelator" type="text">associated name</roleTerm>
              <roleTerm authority="marcrelator" type="code">asn</roleTerm>
        </role>
    </name>
    <identifier type="uri">https://www.govinfo.gov/content/pkg/CMR-HE20_4000-00195421</identifier>
    <location>
         <url displayLabel="Content Detail" access="object in context">https://www.govinfo.gov/app/details/CMR-HE20_4000-00195421</url>
         <url displayLabel="PDF rendition" access="raw object">https://www.govinfo.gov/content/pkg/CMR-HE20_4000-00195421/pdf/CMR-HE20_4000-00195421.pdf</url>
    </location>
    <subject authority="CRS Legislative Subject Terms">
         <topic>User charges and fees</topic>
    </subject>
    <extension>
         <searchTitle>Performance Report to Congress: Biosimilar User Fee Act FY 2023</searchTitle>
    </extension>
    <name type="corporate">
         <namePart>United States</namePart>
         <namePart>Congress</namePart>
         <namePart>House of Representatives</namePart>
         <namePart>Committee on Energy and Commerce</namePart>
         <role>
              <roleTerm authority="marcrelator" type="text">associated name</roleTerm>
              <roleTerm authority="marcrelator" type="code">asn</roleTerm>
        </role>
    </name>
    <name type="corporate">
         <namePart>United States</namePart>
         <namePart>Congress</namePart>
         <namePart>Senate</namePart>
         <namePart>Committee on Health, Education, Labor, and Pensions</namePart>
         <role>
              <roleTerm authority="marcrelator" type="text">associated name</roleTerm>
              <roleTerm authority="marcrelator" type="code">asn</roleTerm>
        </role>
    </name>
    <relatedItem type="isReferencedBy">
         <titleInfo>
              <title>United States Code</title>
              <partNumber>Title 21 Section 379j-53(a)</partNumber>
        </titleInfo>
         <identifier type="USC citation">21 U.S.C. 379j-53(a)</identifier>
    </relatedItem>
</mods>