<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-04-06-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0579-AD64</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201410</PUBLICATION_ID>
            <PUBLICATION_TITLE>The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0579</CODE>
            <NAME>Animal and Plant Health Inspection Service</NAME>
            <ACRONYM>APHIS</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0500</CODE>
            <NAME>Department of Agriculture</NAME>
            <ACRONYM>USDA</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Viruses, Serums, Toxins, and Analogous Products; Single Label Claim for Veterinary Biological Products</RULE_TITLE>
        <ABSTRACT><![CDATA[This rulemaking will amend the Virus-Serum-Toxin Act regulations to replace the current label format, which reflects any of four different levels of effectiveness, with a single, uniform label format. It will also require biologics licensees to provide a standardized summary, with confidential business information removed, of the efficacy and safety data submitted to the Animal and Plant Health Inspection Service in support of the issuance of a full product license or conditional license. A single label format along with publicly available safety and efficacy data will help biologics producers to more clearly communicate product performance to their customers.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Final Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>9 CFR 112</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 151 to 159</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>Yes</RPLAN_ENTRY>
        <RPLAN_INFO>
            <STMT_OF_NEED><![CDATA[The intent of this proposal is to address a request made by our stakeholders and to more clearly communicate product performance information to the user by requiring a uniform label format and a summary of efficacy and safety data (with confidential business information removed).]]></STMT_OF_NEED>
            <LEGAL_BASIS><![CDATA[APHIS administers and enforces the Virus-Serum-Toxin Act, as amended (21 U.S.C. 151 to 159). The regulations issued pursuant to the Act are intended to ensure that veterinary biological products are pure, safe, potent, and efficacious when used according to label instructions.]]></LEGAL_BASIS>
            <ALTERNATIVES><![CDATA[We could retain the current APHIS labeling guidance, but maintaining the status quo would not address the concern reported by stakeholders concerning the interpretation of product performance.]]></ALTERNATIVES>
            <COSTS_AND_BENEFITS><![CDATA[APHIS anticipates that the only costs associated with the proposed labeling format would be one-time costs incurred by licensees and permittees in having labels for existing licensed products updated in accordance with the proposed new format. A simpler, uniform label format would allow biologics licensees and permittees to more clearly communicate product performance information to the end user. In addition, the rule would simplify the evaluation of efficacy studies and reduce the amount of time required by APHIS to evaluate study data, thus allowing manufacturers to market their products sooner.]]></COSTS_AND_BENEFITS>
            <RISKS><![CDATA[APHIS has not identified any risks associated with this proposed action.]]></RISKS>
        </RPLAN_INFO>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>Notice</TTBL_ACTION>
                <TTBL_DATE>05/24/2011</TTBL_DATE>
                <FR_CITATION>76 FR 30093</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Comment Period End</TTBL_ACTION>
                <TTBL_DATE>07/25/2011</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>04/21/2014</TTBL_DATE>
                <FR_CITATION>79 FR 22048</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>06/20/2014</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>05/00/2015</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <ADDITIONAL_INFO>Additional information about APHIS and its programs is available on the Internet at http://www.aphis.usda.gov.</ADDITIONAL_INFO>
        <RFA_REQUIRED>Undetermined</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>Businesses</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Donna</FIRST_NAME>
                <LAST_NAME>Malloy</LAST_NAME>
                <MIDDLE_NAME>L.</MIDDLE_NAME>
                <TITLE>Operational Support Section, Center for Veterinary Biologics, Policy, Evaluation, and Licensing, VS</TITLE>
                <AGENCY>
                    <CODE>0579</CODE>
                    <NAME>Animal and Plant Health Inspection Service</NAME>
                    <ACRONYM>APHIS</ACRONYM>
                </AGENCY>
                <PHONE>301 851-3426</PHONE>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Unit 38, 4700 River Road, Unit 148,</STREET_ADDRESS>
                    <CITY>Riverdale</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20737-1231</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
