<RULE>
            <PREAMB>
                <AGENCY TYPE="N">DEPARTMENT OF HEALTH AND HUMAN SERVICES</AGENCY>
                <SUBAGY>Food and Drug Administration</SUBAGY>
                <CFR>21 CFR Part 510</CFR>
                <SUBJECT>New Animal Drugs; Change of Sponsor's Name</SUBJECT>
                <AGY>
                    <HD SOURCE="HED">AGENCY:</HD>
                    <P>Food and Drug Administration, HHS.</P>
                </AGY>
                <ACT>
                    <HD SOURCE="HED">ACTION:</HD>
                    <P>Final rule.</P>
                </ACT>
                <SUM>
                    <HD SOURCE="HED">SUMMARY:</HD>
                    <P>
                        The Food and Drug Administration (FDA) is amending the 
                        <PRTPAGE P="72921"/>
                        animal drug regulations to reflect a change of sponsor's name from Altana, Inc., to Nycomed US, Inc.
                    </P>
                </SUM>
                <DATES>
                    <HD SOURCE="HED">DATES:</HD>
                    <P>This rule is effective December 26, 2007.</P>
                </DATES>
                <FURINF>
                    <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD>
                    <P>
                        David R. Newkirk, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6967, e-mail: 
                        <E T="03">david.newkirk@fda.hhs.gov</E>
                        .
                    </P>
                </FURINF>
            </PREAMB>
            <SUPLINF>
                <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD>
                <P>Altana, Inc., 60 Baylis Rd., Melville, NY 11747, has informed FDA that it has changed its name to Nycomed US, Inc. Accordingly, the agency is amending the regulations in 21 CFR 510.600(c) to reflect these changes.</P>
                <P>This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.</P>
                <LSTSUB>
                    <HD SOURCE="HED">List of Subjects in 21 CFR Part 510</HD>
                    <P>Administrative practice and procedure, Animal drugs, Labeling, Reporting and recordkeeping requirements.</P>
                </LSTSUB>
                <REGTEXT TITLE="21" PART="510">
                    <AMDPAR>Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 510 is amended as follows:</AMDPAR>
                    <PART>
                        <HD SOURCE="HED">PART 510—NEW ANIMAL DRUGS</HD>
                    </PART>
                </REGTEXT>
                <REGTEXT TITLE="21" PART="510">
                    <AMDPAR>1. The authority citation for 21 CFR part 510 continues to read as follows:</AMDPAR>
                    <AUTH>
                        <HD SOURCE="HED">Authority:</HD>
                        <P>21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.</P>
                    </AUTH>
                </REGTEXT>
                <REGTEXT TITLE="21" PART="510">
                    <AMDPAR>2. In § 510.600 in the table in paragraph (c)(1), remove the entry for “Altana, Inc.” and alphabetically add a new entry for “Nycomed US, Inc.”; and in the table in paragraph (c)(2), revise the entry for “025463” to read as follows:</AMDPAR>
                    <SECTION>
                        <SECTNO>§ 510.600</SECTNO>
                        <SUBJECT>Names, addresses, and drug labeler codes of sponsors of approved applications.</SUBJECT>
                    </SECTION>
                    <STARS/>
                    <P>(c) * * *</P>
                    <P>(1) * * *</P>
                    <GPOTABLE COLS="2" OPTS="L1,i1" CDEF="xs100,xs50">
                        <BOXHD>
                            <CHED H="1">Firm name and address</CHED>
                            <CHED H="1"> Drug labeler code</CHED>
                        </BOXHD>
                        <ROW EXPSTB="01">
                            <ENT I="01" O="oi0">*    *    *    *    *</ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">Nycomed US, Inc., 60 Baylis Rd., Melville, NY 11747</ENT>
                            <ENT>025463</ENT>
                        </ROW>
                        <ROW EXPSTB="01">
                            <ENT I="01" O="oi0">*    *    *    *    *</ENT>
                        </ROW>
                    </GPOTABLE>
                    <P>(2) * * *</P>
                    <GPOTABLE COLS="2" OPTS="L1,i1" CDEF="xls50,xs100">
                        <BOXHD>
                            <CHED H="1"> Drug labeler code</CHED>
                            <CHED H="1">Firm name and address</CHED>
                        </BOXHD>
                        <ROW EXPSTB="01">
                            <ENT I="01" O="oi0">*    *    *    *    *</ENT>
                        </ROW>
                        <ROW EXPSTB="00">
                            <ENT I="01">025463</ENT>
                            <ENT>Nycomed US, Inc., 60 Baylis Rd., Melville, NY 11747</ENT>
                        </ROW>
                        <ROW EXPSTB="01">
                            <ENT I="01" O="oi0">*    *    *    *    *</ENT>
                        </ROW>
                    </GPOTABLE>
                </REGTEXT>
                <SIG>
                    <DATED>Dated: December 12, 2007.</DATED>
                    <NAME>Bernadette Dunham,</NAME>
                    <TITLE>Deputy Director, Center for Veterinary Medicine.</TITLE>
                </SIG>
            </SUPLINF>
            <FRDOC>[FR Doc. E7-24974 Filed 12-21-07; 8:45 am]</FRDOC>
            <BILCOD>BILLING CODE 4160-01-S</BILCOD>
        </RULE>