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    <RIN_INFO>
        <RIN>0910-AF27</RIN>
        <PUBLICATION>
            <PUBLICATION_ID>201004</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>Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors</RULE_TITLE>
        <ABSTRACT><![CDATA[The Food and Drug Administration (FDA) is revising its infant formula regulations in 21 CFR parts 106 and 107 to establish requirements for current good manufacturing practices (CGMP), including audits; to establish requirements for quality factors; and to amend FDAs quality control procedures, notification, and record and reporting requirements for infant formula.  FDA is taking this action to improve the protection of infants who consume infant formula products.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Final Rule Stage</RULE_STAGE>
        <MAJOR>No</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 106 and 107</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 321</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 350a</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>...</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>Yes</RPLAN_ENTRY>
        <TIMETABLE_LIST>
            <TIMETABLE>
                <TTBL_ACTION>NPRM</TTBL_ACTION>
                <TTBL_DATE>07/09/1996</TTBL_DATE>
                <FR_CITATION>61 FR 36154</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>12/06/1996</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period Reopened</TTBL_ACTION>
                <TTBL_DATE>04/28/2003</TTBL_DATE>
                <FR_CITATION>68 FR 22341</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period Extended</TTBL_ACTION>
                <TTBL_DATE>06/27/2003</TTBL_DATE>
                <FR_CITATION>68 FR 38247</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>08/26/2003</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period Reopened</TTBL_ACTION>
                <TTBL_DATE>08/01/2006</TTBL_DATE>
                <FR_CITATION>71 FR 43392</FR_CITATION>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>NPRM Comment Period End</TTBL_ACTION>
                <TTBL_DATE>09/15/2006</TTBL_DATE>
            </TIMETABLE>
            <TIMETABLE>
                <TTBL_ACTION>Final Action</TTBL_ACTION>
                <TTBL_DATE>10/00/2010</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>None</GOVT_LEVEL>
        </GOVT_LEVEL_LIST>
        <FEDERALISM>No</FEDERALISM>
        <ENERGY_AFFECTED>No</ENERGY_AFFECTED>
        <PRINT_PAPER>Yes</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Yes</INTERNATIONAL_INTEREST>
        <RELATED_RIN_LIST>
            <RELATED_RIN>
                <RIN>0910-AA04</RIN>
                <RIN_RELATION>Split from</RIN_RELATION>
            </RELATED_RIN>
        </RELATED_RIN_LIST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Benson</FIRST_NAME>
                <LAST_NAME>Silverman</LAST_NAME>
                <TITLE>Staff Director, Infant Formula and Medical Foods</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>240 402-1459</PHONE>
                <EMAIL>benson.silverman@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Center for Food Safety and Applied Nutrition (HFS-850), 5100 Paint Branch Parkway,</STREET_ADDRESS>
                    <CITY>College Park</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20740</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
