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    <RIN_INFO>
        <RIN>0910-AA37</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>199604</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>Prescription Drug Product Labeling; Medication Guide</RULE_TITLE>
        <ABSTRACT><![CDATA[Inadequate access to appropriate patient information is a major cause of inappropriate use of prescription medications, resulting in serious personal injury and related costs to the health care system. The Food and Drug Administration (FDA) believes that it is essential that patients receive information accompanying dispensed prescription drugs. This information needs to be widely distributed and be of sufficient quality to promote the proper use of prescription drugs. Therefore, FDA is proposing performance standards that would define acceptable levels of information distribution and quality, and to assess supplied information according to these standards. In accordance with the Administration's philosophy of fairly assessing a voluntary approach before imposing requirements through regulations, FDA is proposing that this information be disseminated through voluntary private-sector initiatives. Preliminary evidence suggests recent increases in the distribution of privately produced patient medication information with dispensed prescriptions; however, estimated distribution rates indicate that significant numbers of patients still do not receive information with their medications. FDA analyses also indicate that there is a high variability in the quality of this information. FDA believes that, with greater encouragement and clear objectives, the private sector will substantially improve the quality and distribution of patient information. Therefore, in concert with Healthy People 2000, FDA is proposing that private-sector initiatives meet the goal of distributing useful patient information to 75 percent of individuals receiving new prescriptions by the year 2000 and 95 percent of individuals receiving new prescriptions by the year 2006. FDA is proposing two alternative approaches to help ensure that these goals (performance standards) are achieved. FDA would periodically evaluate and report on achievement of these goals. If the goals are not met in the specified timeframes, FDA would either (a) implement a mandatory comprehensive Medication Guide program, or (b) seek public comment on whether the comprehensive program should be implemented or whether, and what, other steps should be taken to meet patient information goals. ^PRegardless of the approach chosen, a mandatory Medication Guide program would initially be limited to instances where a product poses a serious and significant public health concern requiring immediate distribution of FDA-approved patient information. FDA believes that substantial health care cost savings can be realized by ensuring that consumers obtain the inherent benefits of proper use of prescription drugs, and by reducing the potential for harm caused by inappropriate drug use by the patient.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Final Rule Stage</RULE_STAGE>
        <CFR_LIST>
            <CFR>21 CFR 201</CFR>
            <CFR>21 CFR 208</CFR>
            <CFR>21 CFR 314</CFR>
            <CFR>21 CFR 600</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 321</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 352</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 355</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 262</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <RPLAN_ENTRY>Yes</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>08/24/1995</TTBL_DATE>
                <FR_CITATION>60 FR 44182</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>06/00/1996</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <ADDITIONAL_INFO>Previously reported under RIN 0905-AE43.</ADDITIONAL_INFO>
        <RFA_REQUIRED>Yes</RFA_REQUIRED>
        <SMALL_ENTITY_LIST>
            <SMALL_ENTITY>Businesses</SMALL_ENTITY>
        </SMALL_ENTITY_LIST>
        <GOVT_LEVEL_LIST>
            <GOVT_LEVEL>Federal</GOVT_LEVEL>
            <GOVT_LEVEL>State</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <PRINT_PAPER>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Louis</FIRST_NAME>
                <LAST_NAME>Morris</LAST_NAME>
                <MIDDLE_NAME>A.</MIDDLE_NAME>
                <TITLE>Chief, Marketing Practices &amp; Communication Branch</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 594-6828</PHONE>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>HFD-240, Center for Drug Evaluation and Research, 5600 Fishers Lane,</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20857</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
        <REINVENT_GOVT>No</REINVENT_GOVT>
    </RIN_INFO>
</REGINFO_RIN_DATA>
