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<REGINFO_RIN_DATA xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" RUN_DATE="2026-06-09-04:00" xsi:noNamespaceSchemaLocation="https://www.reginfo.gov/public/xml/REGINFO_XML_Ver10262011.xsd">
    <RIN_INFO>
        <RIN>0910-AB26</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>Blood Initiative</RULE_TITLE>
        <ABSTRACT><![CDATA[In multiple rulemakings, the Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, Source Plasma, and blood-derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. This action is based on FDA's comprehensive review of the biologics regulations. It is also based on reports by the U.S. House of Representatives Committee on Government Reform and Oversight's, Subcommittee on House Resources and Intergovernmental Relations, the General Accounting Office, and the Institute of Medicine, as well as on public comments. The remaining subjects intended to be addressed in the rulemakings include: labeling of blood and blood components and donor eligibility requirements. These actions are intended to help ensure the continued safety of the Nation's blood supply.]]></ABSTRACT>
        <PRIORITY_CATEGORY>Other Significant</PRIORITY_CATEGORY>
        <RIN_STATUS>Previously Published in The Unified Agenda</RIN_STATUS>
        <RULE_STAGE>Proposed Rule Stage</RULE_STAGE>
        <MAJOR>Undetermined</MAJOR>
        <UNFUNDED_MANDATE_LIST>
            <UNFUNDED_MANDATE>No</UNFUNDED_MANDATE>
        </UNFUNDED_MANDATE_LIST>
        <CFR_LIST>
            <CFR>21 CFR 600</CFR>
            <CFR>21 CFR 601</CFR>
            <CFR>21 CFR 606</CFR>
            <CFR>21 CFR 607</CFR>
            <CFR>21 CFR 610</CFR>
            <CFR>21 CFR 630</CFR>
            <CFR>21 CFR 640</CFR>
            <CFR>21 CFR 660</CFR>
            <CFR>21 CFR 680</CFR>
        </CFR_LIST>
        <LEGAL_AUTHORITY_LIST>
            <LEGAL_AUTHORITY>21 USC 321</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 331</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 351 to 353</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 355</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 360</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 371</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>21 USC 374</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 216</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 262</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 263</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 263a</LEGAL_AUTHORITY>
            <LEGAL_AUTHORITY>42 USC 264</LEGAL_AUTHORITY>
        </LEGAL_AUTHORITY_LIST>
        <LEGAL_DLINE_LIST/>
        <RPLAN_ENTRY>No</RPLAN_ENTRY>
        <CHILD_RIN_LIST>
            <CHILD_RIN>
                <RIN>0910-AE89</RIN>
                <RULE_TITLE>Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AF02</RIN>
                <RULE_TITLE>Plasma Derivatives and Similar Recombinant-Based Products; Requirements for Notification of Recalls and Withdrawals</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AE99</RIN>
                <RULE_TITLE>General Requirements for Blood, Blood Components, and Plasma Derivatives; Notification of Deferred Donors</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AE95</RIN>
                <RULE_TITLE>Albumin (Human), Plasma Protein Fraction (Human) and Immune Globulin (Human); Revision of Requirements</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AE98</RIN>
                <RULE_TITLE>Requirements for Testing Human Blood Donors for Evidence of Infection Due to Communicable Disease Agents</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AF00</RIN>
                <RULE_TITLE>Regulations for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use</RULE_TITLE>
            </CHILD_RIN>
            <CHILD_RIN>
                <RIN>0910-AE96</RIN>
                <RULE_TITLE>Revisions to Labeling and Storage Requirements for Blood and Blood Components, Including Source Plasma</RULE_TITLE>
            </CHILD_RIN>
        </CHILD_RIN_LIST>
        <RFA_REQUIRED>No</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>
        <PRINT_PAPER>NA</PRINT_PAPER>
        <INTERNATIONAL_INTEREST>Not Collected</INTERNATIONAL_INTEREST>
        <RELATED_RIN_LIST>
            <RELATED_RIN>
                <RIN>0910-AB76</RIN>
                <RIN_RELATION>Related to</RIN_RELATION>
            </RELATED_RIN>
        </RELATED_RIN_LIST>
        <AGENCY_CONTACT_LIST>
            <CONTACT>
                <FIRST_NAME>Paula</FIRST_NAME>
                <LAST_NAME>McKeever</LAST_NAME>
                <MIDDLE_NAME>S.</MIDDLE_NAME>
                <TITLE>Senior Scientific Policy Analyst</TITLE>
                <AGENCY>
                    <CODE>0910</CODE>
                    <NAME>Food and Drug Administration</NAME>
                    <ACRONYM>FDA</ACRONYM>
                </AGENCY>
                <PHONE>301 827-1520</PHONE>
                <FAX>301 443-9718</FAX>
                <EMAIL>paula.mckeever@fda.hhs.gov</EMAIL>
                <MAILING_ADDRESS>
                    <STREET_ADDRESS>Suite 200N (HFM-17), Office of the Commissioner, Office of Critical Path Programs, 5600 Fishers Lane, Room 14B-45,</STREET_ADDRESS>
                    <CITY>Rockville</CITY>
                    <STATE>MD</STATE>
                    <ZIP>20857-0001</ZIP>
                </MAILING_ADDRESS>
            </CONTACT>
        </AGENCY_CONTACT_LIST>
    </RIN_INFO>
</REGINFO_RIN_DATA>
