<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-10-25-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AA97</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>199904</PUBLICATION_ID>
            <PUBLICATION_TITLE>Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0910</CODE>
            <NAME>Food and Drug Administration</NAME>
            <ACRONYM>FDA</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0900</CODE>
            <NAME>Department of Health and Human Services</NAME>
            <ACRONYM>HHS</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>Adverse Drug Reaction Reporting Requirements for Human Drug and Biological Products</RULE_TITLE>
        <ABSTRACT><![CDATA[The proposed rule would amend the expedited and periodic safety reporting regulations for human drugs and biological products to revise certain definitions and reporting formats as recommended by the International Conference on Harmonization and to define new terms; to add to or revise current reporting requirements; to revise certain reporting time frames; and to make other revisions to these regulations to enhance the quality of adverse drug reaction reports received by FDA.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>Undetermined</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>Undetermined</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 20</CFR>
            <CFR>21 CFR 310</CFR>
            <CFR>21 CFR 312</CFR>
            <CFR>21 CFR 314</CFR>
            <CFR>21 CFR 600</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 216</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 262</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 263</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 263a</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 264</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 300aa</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 321</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 331</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 351 to 353</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 355</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 374</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>10/00/1999</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>01/00/2000</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>Undetermined</RFA_REQUIRED>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>Undetermined</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <PRINT_PAPER>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Lee</FIRST_NAME>
                <LAST_NAME>Korb</LAST_NAME>
                <MIDDLE_NAME>D.</MIDDLE_NAME>
                <TITLE>Regulatory Counsel</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>240 276-9258</PHONE>
                <FAX>240 276-7692</FAX>
                <EMAIL>lee.korb@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Suite 3037 (HFD-7), Center for Veterinary Medicine, 7519 Standish Place, Room 164, MPN-4, HFV-200,</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20855</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
        <PROCUREMENT>Not Procurement Related</PROCUREMENT>
        <REINVENT_GOVT>No</REINVENT_GOVT>
    </RIN_INFO>
</REGINFO_RIN_DATA>
