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    <RIN_INFO>
        <RIN>0910-AC41</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>200310</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>Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002</RULE_TITLE>
        <ABSTRACT><![CDATA[This rulemaking is one of a number of actions being taken to improve FDA's ability to respond to threats of bioterrorism. Section 801(m) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which was added by section 307 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, authorizes the Secretary, through FDA, to promulgate final regulations by December 12, 2003. Section 801(m) requires notification to FDA prior to the entry of imported food. The required prior notice would provide the identity of the article of food; the manufacturer; the shipper; the grower, if known at the time of notification; the originating country; the shipping country; and the anticipated port of entry. The regulation identifies the parties responsible for providing the notice and explains the information that the prior notice is required to contain, the method of submission of the notice, and the minimum and maximum period of advance notice required. Section 307 also states that if FDA does not receive prior notice or receives inadequate prior notice, the imported food shall be refused admission and held at the port of entry until proper notice is provided.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Economically Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Final Rule Stage</RULE_STAGE>
        <MAJOR>Yes</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 1.276 et seq</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>PL 107-188, sec 307</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST>
            <LEGAL_DLINE_INFO>
                <DLINE_TYPE>Statutory</DLINE_TYPE>
                <DLINE_ACTION_STAGE>Final</DLINE_ACTION_STAGE>
                <DLINE_DATE>12/12/2003</DLINE_DATE>
                <DLINE_DESC>  </DLINE_DESC>
            </LEGAL_DLINE_INFO>
        </LEGAL_DLINE_LIST>
        <LEGAL_DLINE_OVERALL_DESC>The Public Health Security and Bioterrorism Preparedness and Response Act of 2002, section 307, directs the Secretary, through FDA, to issue final regulations establishing prior notice requirements for all imported food by December 12, 2003. If FDA fails to issue final regulations by this date, the statute is self-executing on this date, and requires FDA to receive prior notice of not less than eight hours, nor more than five days until final regulations are issued.</LEGAL_DLINE_OVERALL_DESC>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>02/03/2003</TTBL_DATE>
                <FR_CITATION>68 FR 5428</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Interim Final Rule</TTBL_ACTION>
                <TTBL_DATE>10/10/2003</TTBL_DATE>
                <FR_CITATION>68 FR 58974</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Interim Final Rule Comment Period Reopened</TTBL_ACTION>
                <TTBL_DATE>03/00/2004</TTBL_DATE>
            </TIMETABLE>
        </TIMETABLE_LIST>
        <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_LIST>
        <FEDERALISM>No</FEDERALISM>
        <ENERGY_AFFECTED>No</ENERGY_AFFECTED>
        <PRINT_PAPER>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Gerie</FIRST_NAME>
                <LAST_NAME>Voss</LAST_NAME>
                <TITLE>Senior Regulatory Counsel</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>877 287-1373</PHONE>
                <EMAIL>ctpregulations@fda.hhs.gov </EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>HFS-32, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,</STREET_ADDRESS>
                    <CITY>Silver Spring</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20993</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
