<?xml version="1.0" encoding="UTF-8"?><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="id-2012-19498">
    <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>National Archives and Records Administration</namePart>
        <namePart>Office of the Federal Register</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>FR</collectionCode>
        <category>Regulatory Information</category>
        <waisDatabaseName>2012_register</waisDatabaseName>
        <branch>executive</branch>
        <dateIngested>2012-08-09</dateIngested>
    </extension>
    <genre authority="marcgt">article</genre>
    <titleInfo>
        <title>New Animal Drugs; Cephalexin; Fentanyl; Milbemycin Oxime and Praziquantel</title>
        <partName>Rules and Regulations</partName>
    </titleInfo>
    <relatedItem type="otherFormat" xlink:href="https://www.govinfo.gov/content/pkg/FR-2012-08-09/html/2012-19498.htm">
        <identifier type="FDsys Unique ID">D09002ee1c7fc9ca2</identifier>
    </relatedItem>
    <relatedItem type="otherFormat" xlink:href="https://www.govinfo.gov/content/pkg/FR-2012-08-09/pdf/2012-19498.pdf">
        <identifier type="FDsys Unique ID">D09002ee1c7fc9d8f</identifier>
    </relatedItem>
    <name type="corporate">
        <namePart>United States</namePart>
        <namePart>Department of Health and Human Services</namePart>
        <role>
            <roleTerm authority="marcrelator" type="text">originator</roleTerm>
            <roleTerm authority="marcrelator" type="code">org</roleTerm>
        </role>
        <description>United States Government Agency or Subagency</description>
    </name>
    <name type="corporate">
        <namePart>United States</namePart>
        <namePart>Food and Drug Administration</namePart>
        <role>
            <roleTerm authority="marcrelator" type="text">originator</roleTerm>
            <roleTerm authority="marcrelator" type="code">org</roleTerm>
        </role>
        <description>United States Government Agency or Subagency</description>
    </name>
    <abstract>The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.</abstract>
    <identifier type="FR citation">77 FR 47511</identifier>
    <identifier type="uri">https://www.govinfo.gov/app/details/FR-2012-08-09/2012-19498</identifier>
    <identifier type="FR Doc No.">2012-19498</identifier>
    <identifier type="former granule identifier">fr09au12-1</identifier>
    <identifier type="billing code">4160-01-P</identifier>
    <identifier type="department code">Docket No. FDA-2012-N-0002</identifier>
    <location>
        <url displayLabel="Content Detail" access="object in context">https://www.govinfo.gov/app/details/FR-2012-08-09/2012-19498</url>
        <url access="raw object" displayLabel="HTML rendition">https://www.govinfo.gov/content/pkg/FR-2012-08-09/html/2012-19498.htm</url>
        <url access="raw object" displayLabel="PDF rendition">https://www.govinfo.gov/content/pkg/FR-2012-08-09/pdf/2012-19498.pdf</url>
    </location>
    <subject>
        <topic>Administrative Practice and Procedure</topic>
        <topic>Animal Drugs</topic>
        <topic>Labeling</topic>
        <topic>Reporting and Recordkeeping Requirements</topic>
    </subject>
    <physicalDescription>
        <extent>2 p.</extent>
    </physicalDescription>
    <part type="Rules and Regulations">
        <extent unit="pages">
            <start>47511</start>
            <end>47512</end>
        </extent>
    </part>
    <identifier type="preferred citation">77 FR 47511</identifier>
    <relatedItem type="isReferencedBy">
        <titleInfo>
            <title>Code of Federal Regulations</title>
            <partNumber>Title 21 Part 510</partNumber>
        </titleInfo>
        <identifier type="CFR citation">21 CFR Part  510</identifier>
    </relatedItem>
    <relatedItem type="isReferencedBy">
        <titleInfo>
            <title>Code of Federal Regulations</title>
            <partNumber>Title 21 Part 520</partNumber>
        </titleInfo>
        <identifier type="CFR citation">21 CFR Part  520</identifier>
    </relatedItem>
    <relatedItem type="isReferencedBy">
        <titleInfo>
            <title>Code of Federal Regulations</title>
            <partNumber>Title 21 Part 524</partNumber>
        </titleInfo>
        <identifier type="CFR citation">21 CFR Part  524</identifier>
    </relatedItem>
    <extension>
        <searchTitle>New Animal Drugs; Cephalexin; Fentanyl; Milbemycin Oxime and Praziquantel; Federal Register Vol. 77, Issue </searchTitle>
        <granuleClass>RULE</granuleClass>
        <accessId>2012-19498</accessId>
        <agency order="1">DEPARTMENT OF HEALTH AND HUMAN SERVICES</agency>
        <agency order="2">Food and Drug Administration</agency>
        <effectiveDate>2012-08-09</effectiveDate>
        <departmentDoc>Docket No. FDA-2012-N-0002</departmentDoc>
        <billingCode>4160-01-P</billingCode>
        <frDocNumber>2012-19498</frDocNumber>
        <action>Final rule.</action>
        <summary>The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.</summary>
        <dates>This rule is effective August 9, 2012.</dates>
        <contact>George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9019, email: george.haibel@fda.hhs.gov.</contact>
        <cfr title="21">
                                    
            <part number="510"/>
                                    
            <subject>Administrative Practice and Procedure</subject>
                                    
            <subject>Animal Drugs</subject>
                                    
            <subject>Labeling</subject>
                                    
            <subject>Reporting and Recordkeeping Requirements</subject>
                                
        </cfr>
        <cfr title="21">
                                    
            <part number="520"/>
                                
        </cfr>
        <cfr title="21">
                                    
            <part number="524"/>
                                
        </cfr>
        <tocSubject1>New Animal Drugs:</tocSubject1>
        <tocDoc>Cephalexin; Fentanyl; Milbemycin Oxime and Praziquantel
, </tocDoc>
        <emailRef>george.haibel@fda.hhs.gov</emailRef>
        <urlRef>http://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm</urlRef>
    </extension>
    <relatedItem type="host" ID="P0b002ee1833aba95" xlink:href="https://www.govinfo.gov/metadata/pkg/FR-2012-08-09/mods.xml">
        <titleInfo>
            <title>Federal Register</title>
            <partNumber>Vol. 77, no. 154</partNumber>
        </titleInfo>
        <originInfo>
            <publisher>Office of the Federal Register, National Archives and Records Administration</publisher>
            <dateIssued encoding="w3cdtf">2012-08-09</dateIssued>
            <issuance>continuing</issuance>
            <frequency>daily</frequency>
        </originInfo>
        <physicalDescription>
            <note type="source content type">deposited</note>
            <digitalOrigin>born digital</digitalOrigin>
            <extent>264 p.</extent>
        </physicalDescription>
        <tableOfContents xlink:href="https://www.govinfo.gov/app/frtoc/2012-08-09">    
		  Table of Contents: 
		</tableOfContents>
        <classification authority="sudocs">AE 2.7:</classification>
        <classification authority="sudocs">GS 4.107:</classification>
        <classification authority="sudocs">AE 2.106:</classification>
        <classification authority="lcc">KF70.A2</classification>
        <identifier type="uri">https://www.govinfo.gov/app/details/FR-2012-08-09</identifier>
        <identifier type="local">P0b002ee1833aba95</identifier>
        <identifier type="issn">0097-6326</identifier>
        <identifier type="issn">0042-1219</identifier>
        <identifier type="issn">0364-1406</identifier>
        <identifier type="stock number">769-004-00000-9</identifier>
        <identifier type="ILS system id">000582072</identifier>
        <identifier type="former identifier">f:fr09au12</identifier>
        <location>
            <url displayLabel="Content Detail" access="object in context">https://www.govinfo.gov/app/details/FR-2012-08-09</url>
            <url displayLabel="PDF rendition" access="raw object">https://www.govinfo.gov/content/pkg/FR-2012-08-09/pdf/FR-2012-08-09.pdf</url>
            <url displayLabel="XML rendition" access="raw object">https://www.govinfo.gov/content/pkg/FR-2012-08-09/xml/FR-2012-08-09.xml</url>
        </location>
        <accessCondition type="GPO scope determination">fdlp</accessCondition>
        <part type="issue">
            <extent unit="pages">
                <start>47511</start>
                <end>47766</end>
            </extent>
        </part>
        <recordInfo>
            <recordContentSource authority="marcorg">DGPO</recordContentSource>
            <recordCreationDate encoding="w3cdtf">2012-08-09</recordCreationDate>
            <recordChangeDate encoding="w3cdtf">2024-06-03</recordChangeDate>
            <recordIdentifier source="DGPO">FR-2012-08-09</recordIdentifier>
            <recordOrigin>machine generated</recordOrigin>
            <languageOfCataloging>
                <languageTerm type="code" authority="iso639-2b">eng</languageTerm>
            </languageOfCataloging>
        </recordInfo>
        <extension>
            <docClass>FR</docClass>
            <accessId>FR-2012-08-09</accessId>
            <volume>77</volume>
            <issue>154</issue>
        </extension>
    </relatedItem>
</mods>
