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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-08-26-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AB29</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>199910</PUBLICATION_ID>
            <PUBLICATION_TITLE>The Regulatory Plan and the 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>Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License</RULE_TITLE>
        <ABSTRACT><![CDATA[As a "Reinventing Government" initiative and to amend regulations to implement section 123 of the Food and Drug Administration Modernization Act of 1997, FDA is eliminating the requirement and use of establishment licenses and product licenses for biological products regulated under section 351 of the Public Health Service Act. In lieu of product licenses and establishment licenses, FDA will require submission and approval of a biologics license application in order to market these biologic products in interstate commerce.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Completed Actions</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 3</CFR>
            <CFR>21 CFR 5</CFR>
            <CFR>21 CFR 10</CFR>
            <CFR>21 CFR 20</CFR>
            <CFR>21 CFR 207</CFR>
            <CFR>21 CFR 310</CFR>
            <CFR>21 CFR 312</CFR>
            <CFR>21 CFR 316</CFR>
            <CFR>21 CFR 600</CFR>
            <CFR>21 CFR 601</CFR>
            <CFR>21 CFR 607</CFR>
            <CFR>21 CFR 610</CFR>
            <CFR>21 CFR 640</CFR>
            <CFR>21 CFR 660</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>42 USC 262</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>PL 105-115</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>07/31/1998</TTBL_DATE>
                <FR_CITATION>63 FR 40858</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Public Workshop</TTBL_ACTION>
                <TTBL_DATE>08/11/1998</TTBL_DATE>
                <FR_CITATION>63 FR 42773</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Rule</TTBL_ACTION>
                <TTBL_DATE>10/20/1999</TTBL_DATE>
                <FR_CITATION>64 FR 56441</FR_CITATION>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <PRINT_PAPER>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Robert</FIRST_NAME>
                <LAST_NAME>Yetter</LAST_NAME>
                <MIDDLE_NAME>A.</MIDDLE_NAME>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 827-0373</PHONE>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Suite 200N (HFM-10), Center for Biologics Evaluation and Research, 1401 Rockville Pike,</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20852-1448</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
        <PROCUREMENT>Not Procurement Related</PROCUREMENT>
        <REINVENT_GOVT>Revising Text to Reduce Burden or Duplication, or Streamline Requirements</REINVENT_GOVT>
    </RIN_INFO>
</REGINFO_RIN_DATA>
