<?xml version="1.0" encoding="UTF-8" standalone="yes"?>
<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-04-28-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0720-AB23</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200904</PUBLICATION_ID>
            <PUBLICATION_TITLE>Unified Agenda of Federal Regulatory and Deregulatory Actions</PUBLICATION_TITLE>
        </PUBLICATION>
        <AGENCY>
            <CODE>0720</CODE>
            <NAME>Office of Assistant Secretary for Health Affairs</NAME>
            <ACRONYM>DODOASHA</ACRONYM>
        </AGENCY>
        <PARENT_AGENCY>
            <CODE>0700</CODE>
            <NAME>Department of Defense</NAME>
            <ACRONYM>DOD</ACRONYM>
        </PARENT_AGENCY>
        <RULE_TITLE>TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, and Medical Treatments or Procedures</RULE_TITLE>
        <ABSTRACT><![CDATA[This rule revises the definition of "unlabeled or off-label drug" to "off-label use of a drug or device." This revision is consistent with the regulatory framework under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq). Additionally, this rule removes the partial list of examples of unproven drugs, devices, and medical treatments or procedures proscribed under section 199.4(g)(15). As it is determined that reliable evidence demonstrates that previously unproven drugs, devices, and medical treatments or procedures have proven medical effectiveness, TRICARE has removed them from the list and authorized medically necessary care. This removal of the partial list is necessary as the list will never be completely current and is only a partial list of examples. The removal of this partial list does not change or eliminate any benefits that are currently available under the TRICARE program.]]></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>32 CFR 199</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>5 USC 301</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>10 USC ch 55</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>08/10/2004</TTBL_DATE>
                <FR_CITATION>69 FR 48433</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>10/12/2004</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Second NPRM</TTBL_ACTION>
                <TTBL_DATE>11/00/2009</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <RFA_REQUIRED>No</RFA_REQUIRED>
        <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>
        <RELATED_RIN_LIST>
            <RELATED_RIN>
                <RIN>0720-AA88</RIN>
                <RIN_RELATION>Previously reported as</RIN_RELATION>
            </RELATED_RIN>
        </RELATED_RIN_LIST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Rene</FIRST_NAME>
                <LAST_NAME>Morrell</LAST_NAME>
                <AGENCY>
                    <CODE>0720</CODE>
                    <NAME>Office of Assistant Secretary for Health Affairs</NAME>
                    <ACRONYM>DODOASHA</ACRONYM>
                </AGENCY>
                <PHONE>303 676-3618</PHONE>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>1200 Defense Pentagon,</STREET_ADDRESS>
                    <CITY>Washington</CITY>
                    <STATE>DC</STATE>
                    <ZIP>20301</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
