<?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-2015-28160">
    <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>2015_register</waisDatabaseName>
        <branch>executive</branch>
        <dateIngested>2015-11-26</dateIngested>
    </extension>
    <genre authority="marcgt">article</genre>
    <titleInfo>
        <title>Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications</title>
        <partNumber>Part IV</partNumber>
        <partName>Rules and Regulations</partName>
    </titleInfo>
    <relatedItem type="otherFormat" xlink:href="https://www.govinfo.gov/content/pkg/FR-2015-11-27/html/2015-28160.htm">
        <identifier type="FDsys Unique ID">D09002ee1c7f6d97e</identifier>
    </relatedItem>
    <relatedItem type="otherFormat" xlink:href="https://www.govinfo.gov/content/pkg/FR-2015-11-27/pdf/2015-28160.pdf">
        <identifier type="FDsys Unique ID">D09002ee1c7f6daa8</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 or we) is adopting regulations to provide for accreditation of third-party certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications, under the FDA Food Safety Modernization Act (FSMA). These certifications will be required for participation in the voluntary qualified importer program (VQIP) established under the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act). In addition, when the Agency has determined that an imported food is subject to certification under FSMA, the Agency may require a certification under this rule as a condition for admitting the food into the United States. FDA also expects that these regulations will increase efficiency by reducing the number of redundant food safety audits.</abstract>
    <identifier type="FR citation">80 FR 74570</identifier>
    <identifier type="uri">https://www.govinfo.gov/app/details/FR-2015-11-27/2015-28160</identifier>
    <identifier type="FR Doc No.">2015-28160</identifier>
    <identifier type="former granule identifier">fr27no15-21</identifier>
    <identifier type="Regulation ID Number">RIN 0910-AG66</identifier>
    <identifier type="billing code">4164-01-P</identifier>
    <identifier type="department code">Docket No. FDA-2011-N-0146</identifier>
    <location>
        <url displayLabel="Content Detail" access="object in context">https://www.govinfo.gov/app/details/FR-2015-11-27/2015-28160</url>
        <url access="raw object" displayLabel="HTML rendition">https://www.govinfo.gov/content/pkg/FR-2015-11-27/html/2015-28160.htm</url>
        <url access="raw object" displayLabel="PDF rendition">https://www.govinfo.gov/content/pkg/FR-2015-11-27/pdf/2015-28160.pdf</url>
    </location>
    <subject>
        <topic>Cosmetics</topic>
        <topic>Drugs</topic>
        <topic>Exports</topic>
        <topic>Food Labeling</topic>
        <topic>Imports</topic>
        <topic>Labeling</topic>
        <topic>Reporting and Recordkeeping Requirements</topic>
        <topic>Administrative Practice and Procedure</topic>
        <topic>Computer Technology</topic>
    </subject>
    <physicalDescription>
        <extent>98 p.</extent>
    </physicalDescription>
    <part type="Part IV">
        <extent unit="pages">
            <start>74570</start>
            <end>74667</end>
        </extent>
    </part>
    <identifier type="preferred citation">80 FR 74570</identifier>
    <relatedItem type="isReferencedBy">
        <titleInfo>
            <title>Code of Federal Regulations</title>
            <partNumber>Title 21 Part 11</partNumber>
        </titleInfo>
        <identifier type="CFR citation">21 CFR Part  11</identifier>
    </relatedItem>
    <relatedItem type="isReferencedBy">
        <titleInfo>
            <title>Code of Federal Regulations</title>
            <partNumber>Title 21 Part 16</partNumber>
        </titleInfo>
        <identifier type="CFR citation">21 CFR Part  16</identifier>
    </relatedItem>
    <relatedItem type="isReferencedBy">
        <titleInfo>
            <title>Code of Federal Regulations</title>
            <partNumber>Title 21 Part 1</partNumber>
        </titleInfo>
        <identifier type="CFR citation">21 CFR Part  1</identifier>
    </relatedItem>
    <relatedItem type="isReferencedBy">
        <titleInfo>
            <title>Regulation Identification Number 0910-AG66</title>
        </titleInfo>
        <identifier type="regulation ID number">RIN 0910-AG66</identifier>
    </relatedItem>
    <extension>
        <searchTitle>Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications; Federal Register Vol. 80, Issue </searchTitle>
        <granuleClass>RULE</granuleClass>
        <accessId>2015-28160</accessId>
        <partNumber>IV</partNumber>
        <agency order="1">DEPARTMENT OF HEALTH AND HUMAN SERVICES</agency>
        <agency order="2">Food and Drug Administration</agency>
        <effectiveDate>2016-01-26</effectiveDate>
        <departmentDoc>Docket No. FDA-2011-N-0146</departmentDoc>
        <rin number="0910-AG66"/>
        <billingCode>4164-01-P</billingCode>
        <frDocNumber>2015-28160</frDocNumber>
        <action>Final rule.</action>
        <summary>The Food and Drug Administration (FDA or we) is adopting regulations to provide for accreditation of third-party certification bodies to conduct food safety audits of foreign food entities, including registered foreign food facilities, and to issue food and facility certifications, under the FDA Food Safety Modernization Act (FSMA). These certifications will be required for participation in the voluntary qualified importer program (VQIP) established under the Federal Food, Drug, and Cosmetic Act (FD&amp;C Act). In addition, when the Agency has determined that an imported food is subject to certification under FSMA, the Agency may require a certification under this rule as a condition for admitting the food into the United States. FDA also expects that these regulations will increase efficiency by reducing the number of redundant food safety audits.</summary>
        <dates>This rule is effective January 26, 2016.</dates>
        <contact>Charlotte A. Christin, Office of Foods and Veterinary Medicine, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-7526.</contact>
        <cfr title="21">
                                    
            <part number="11"/>
                                
        </cfr>
        <cfr title="21">
                                    
            <part number="16"/>
                                
        </cfr>
        <cfr title="21">
                                    
            <part number="1"/>
                                    
            <subject>Cosmetics</subject>
                                    
            <subject>Drugs</subject>
                                    
            <subject>Exports</subject>
                                    
            <subject>Food Labeling</subject>
                                    
            <subject>Imports</subject>
                                    
            <subject>Labeling</subject>
                                    
            <subject>Reporting and Recordkeeping Requirements</subject>
                                    
            <subject>Administrative Practice and Procedure</subject>
                                    
            <subject>Computer Technology</subject>
                                
        </cfr>
        <tocDoc>Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
, </tocDoc>
        <urlRef>http://english.danak.dk/</urlRef>
        <urlRef>http://www.ansi.org/about_ansi/overview/overview.aspx?menuid=1</urlRef>
        <urlRef>http://www.bloomberg.com/news/articles/2012-10-11/food-sickens-millions-as-industry-paid-inspectors-find-it-safe</urlRef>
        <urlRef>http://www.codexalimentarius.org/input/download/standards/37/CXG_020e.pdf</urlRef>
        <urlRef>http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM448558.pdf</urlRef>
        <urlRef>http://www.fda.gov/Food/GuidanceRegulation/GuidancevDocumentsRegulatoryInformation/ucm455328.htm</urlRef>
        <urlRef>http://www.iaf.nu/upFiles/197878.IAF-PR4-2007_Endorsed_NormDocs_Issue_4_Pub.pdf</urlRef>
        <urlRef>http://www.iit.edu/ifsh/alliance/.http://www.iit.edu/ifsh/alliance/</urlRef>
        <urlRef>http://www.iso.org/iso/catalogue_detail.htm?csnumber=26796</urlRef>
        <urlRef>http://www.iso.org/iso/catalogue_detail.htm?csnumber=29316</urlRef>
        <urlRef>http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=29332</urlRef>
        <urlRef>http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=31815</urlRef>
        <urlRef>http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=35466</urlRef>
        <urlRef>http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=39834</urlRef>
        <urlRef>http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=46568</urlRef>
        <urlRef>http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=50675</urlRef>
        <urlRef>http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=52994</urlRef>
        <urlRef>http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=60605</urlRef>
        <urlRef>http://www.iso.org/iso/home/store/publication_item.htm?pid=PUB100353</urlRef>
        <urlRef>http://www.regulations.gov</urlRef>
        <urlRef>http://www.ukas.com/about/</urlRef>
        <urlRef>https://aoprals.state.gov/content.asp?content_id=114&amp;menu_id=78</urlRef>
        <urlRef>https://aoprals.state.gov/Web920/per_diem.asp</urlRef>
        <urlRef>https://www.sqfi.com/wp-content/uploads/SQF-Code_Ed-7.2-July.pdf</urlRef>
    </extension>
    <relatedItem type="host" ID="P0b002ee18e039191" xlink:href="https://www.govinfo.gov/metadata/pkg/FR-2015-11-27/mods.xml">
        <titleInfo>
            <title>Federal Register</title>
            <partNumber>Vol. 80, no. 228</partNumber>
        </titleInfo>
        <originInfo>
            <publisher>Office of the Federal Register, National Archives and Records Administration</publisher>
            <dateIssued encoding="w3cdtf">2015-11-27</dateIssued>
            <issuance>continuing</issuance>
            <frequency>daily</frequency>
        </originInfo>
        <physicalDescription>
            <note type="source content type">deposited</note>
            <digitalOrigin>born digital</digitalOrigin>
            <extent>740 p.</extent>
        </physicalDescription>
        <tableOfContents xlink:href="https://www.govinfo.gov/app/frtoc/2015-11-27">    
		  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-2015-11-27</identifier>
        <identifier type="local">P0b002ee18e039191</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:fr27no15</identifier>
        <location>
            <url displayLabel="Content Detail" access="object in context">https://www.govinfo.gov/app/details/FR-2015-11-27</url>
            <url displayLabel="PDF rendition" access="raw object">https://www.govinfo.gov/content/pkg/FR-2015-11-27/pdf/FR-2015-11-27.pdf</url>
            <url displayLabel="XML rendition" access="raw object">https://www.govinfo.gov/content/pkg/FR-2015-11-27/xml/FR-2015-11-27.xml</url>
        </location>
        <accessCondition type="GPO scope determination">fdlp</accessCondition>
        <part type="issue">
            <extent unit="pages">
                <start>73943</start>
                <end>74672</end>
            </extent>
        </part>
        <recordInfo>
            <recordContentSource authority="marcorg">DGPO</recordContentSource>
            <recordCreationDate encoding="w3cdtf">2015-11-26</recordCreationDate>
            <recordChangeDate encoding="w3cdtf">2024-06-02</recordChangeDate>
            <recordIdentifier source="DGPO">FR-2015-11-27</recordIdentifier>
            <recordOrigin>machine generated</recordOrigin>
            <languageOfCataloging>
                <languageTerm type="code" authority="iso639-2b">eng</languageTerm>
            </languageOfCataloging>
        </recordInfo>
        <extension>
            <docClass>FR</docClass>
            <accessId>FR-2015-11-27</accessId>
            <volume>80</volume>
            <issue>228</issue>
        </extension>
    </relatedItem>
</mods>
