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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-04-28-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AF89</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200904</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>Regulations on Fixed-Dose Combination and Co-Packaged Drug and/or Biological Products</RULE_TITLE>
        <ABSTRACT><![CDATA[The proposed rule would amend FDA regulations on fixed-combination prescription and OTC drugs.  The current regulations require, among other things, that the sponsor of a fixed-combination drug demonstrate that each of the components makes a contribution to the drugs claimed effects.  The proposed rule would create a single set of regulations for prescription and OTC combination drugs and codify existing policy on what kinds of studies are needed to show that the combination drug requirements are met.  The proposed rule also would apply these regulations to combinations of biological drug products and to drug-biological product combinations.  In addition, the proposed rule would clarify application of FDAs requirements regarding fixed-dose combinations to certain natural source drugs and certain synthetic drugs.   The regulation would also establish circumstances under which the agency might waive the combination requirements for a particular drug or biological product.  The proposed rule will also address the issue of co-packaging.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Substantive, Nonsignificant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 300.50</CFR>
            <CFR>21 CFR 330.10</CFR>
            <CFR>21 CFR 610.17</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 331</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 351 and 352</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 355</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 262</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 264</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>12/00/2009</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>No</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <ENERGY_AFFECTED>No</ENERGY_AFFECTED>
        <PRINT_PAPER>No</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>No</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Michael</FIRST_NAME>
                <LAST_NAME>Bernstein</LAST_NAME>
                <TITLE>Supervisory Regulatory Counsel</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 796-3478</PHONE>
                <EMAIL>michael.bernstein@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Drug Evaluation and Research, WO Bldg. 51, Rm. 6240, 10903 New Hampshire Avenue,</STREET_ADDRESS>
                    <CITY>Silver Spring</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20993-0002</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
