<SEC-DOCUMENT>0001615774-15-000151.txt : 20150126
<SEC-HEADER>0001615774-15-000151.hdr.sgml : 20150126
<ACCEPTANCE-DATETIME>20150126080022
ACCESSION NUMBER:		0001615774-15-000151
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20150123
ITEM INFORMATION:		Regulation FD Disclosure
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20150126
DATE AS OF CHANGE:		20150126

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NEKTAR THERAPEUTICS
		CENTRAL INDEX KEY:			0000906709
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				943134940
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-24006
		FILM NUMBER:		15546916

	BUSINESS ADDRESS:	
		STREET 1:		455 MISSION BAY BOULEVARD SOUTH
		CITY:			SAN FRANCISCO
		STATE:			CA
		ZIP:			94158
		BUSINESS PHONE:		4154825300

	MAIL ADDRESS:	
		STREET 1:		455 MISSION BAY BOULEVARD SOUTH
		CITY:			SAN FRANCISCO
		STATE:			CA
		ZIP:			94158

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	INHALE THERAPEUTIC SYSTEMS INC
		DATE OF NAME CHANGE:	19980723

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	INHALE THERAPEUTIC SYSTEMS
		DATE OF NAME CHANGE:	19940303
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>s100675_8k.htm
<DESCRIPTION>8-K
<TEXT>
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<P STYLE="margin: 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>UNITED STATES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Washington, D.C.&nbsp;20549</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 18pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>FORM 8-K</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>CURRENT REPORT</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>Pursuant to Section&nbsp;13 or 15(d)
of the Securities Exchange Act of 1934</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Date of report&nbsp;(Date of earliest event
reported): January 23, 2015</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 24pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>NEKTAR THERAPEUTICS</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Exact Name of Registrant as Specified
in Charter)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr>
    <TD STYLE="vertical-align: top; width: 32%; font-size: 10pt; text-align: center"><font style="font-size: 10pt"><b>Delaware</b></font></td>
    <TD STYLE="vertical-align: bottom; width: 2%; font-size: 10pt">&nbsp;</td>
    <TD STYLE="vertical-align: top; width: 32%; font-size: 10pt; text-align: center"><font style="font-size: 10pt"><b>0-24006</b></font></td>
    <TD STYLE="vertical-align: bottom; width: 2%; font-size: 10pt">&nbsp;</td>
    <TD STYLE="vertical-align: top; width: 32%; font-size: 10pt; text-align: center"><font style="font-size: 10pt"><b>94-3134940</b></font></td></tr>
<tr>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>(State or Other Jurisdiction</b></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>of Incorporation)</b></P></td>
    <TD STYLE="vertical-align: bottom; font-size: 10pt">&nbsp;</td>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>(Commission</b></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>File Number)</b></P></td>
    <TD STYLE="vertical-align: bottom; font-size: 10pt">&nbsp;</td>
    <TD STYLE="vertical-align: top">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>(IRS Employer</b></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><b>Identification No.)</b></P></td></tr>
</table>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>455 Mission Bay Boulevard South</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>San Francisco, California 94158</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>(Address of Principal Executive Offices
and Zip Code)</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">Registrant&rsquo;s telephone number, including
area code: (415) 482-5300</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: top">
    <td style="width: 4%; font-size: 10pt"><font style="font: 10pt Wingdings">&uml;</font></td>
    <td style="width: 96%; font-size: 10pt"><font style="font-size: 10pt">Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</font></td></tr>
</table>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: top">
    <td style="width: 4%; font-size: 10pt"><font style="font: 10pt Wingdings">&uml;</font></td>
    <td style="width: 96%; font-size: 10pt"><font style="font-size: 10pt">Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</font></td></tr>
</table>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: top">
    <td style="width: 4%; font-size: 10pt"><font style="font: 10pt Wingdings">&uml;</font></td>
    <td style="width: 96%; font-size: 10pt"><font style="font-size: 10pt">Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</font></td></tr>
</table>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in">&nbsp;</P>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: top">
    <td style="width: 4%; font-size: 10pt"><font style="font: 10pt Wingdings">&uml;</font></td>
    <td style="width: 96%; font-size: 10pt"><font style="font-size: 10pt">Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</font></td></tr>
</table>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: top">
    <td style="width: 10%; font-size: 10pt"><font style="font-size: 10pt"><b>Item&nbsp;7.01</b></font></td>
    <td style="width: 90%; font-size: 10pt"><font style="font-size: 10pt"><b>Regulation FD Disclosure.</b></font></td></tr>
</table>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="background-color: white">On
January 23, 2015, the Drug Enforcement Administration (&ldquo;DEA&rdquo;) published the final rule in the Federal Register removing
naloxegol (brand name Movantik&trade;) and its salts, effective immediately, from the schedules of the Controlled Substances Act.
In general, scheduling actions are effective 30 days from the date of publication of the final rule in the Federal Register. In
the case of naloxegol, the DEA made the final rule effective immediately due to the DEA&rsquo;s findings &ldquo;that the absence
of comparative effective therapeutic treatments for OIC with similar or less adverse effects than naloxegol, coupled with the fact
that this is an action for decontrol, support the finding that conditions of public health require this action to be effective
immediately upon publication in the Federal Register.&rdquo; The full text of the final rule is set forth in Exhibit 99.1 to this
filing. </FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="background-color: white">Movantik&trade;
is part of a global license agreement between AstraZeneca AB and Nektar Therapeutics. Movantik&trade; was developed using Nektar's
oral small molecule polymer conjugate technology. AstraZeneca is planning the commercial launch of Movantik&trade; in the United
States late in the first quarter of 2015 and in the European Union in the second quarter of 2015. </FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="background-color: white">&nbsp;</FONT></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">The information in this report, including the exhibit hereto,
is being furnished and shall not be deemed &ldquo;filed&rdquo; for purposes of Section 18 of the Securities Exchange Act of 1934,
as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933,
as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing
with the Securities and Exchange Commission made by Nektar Therapeutics, whether made before or after the date hereof, regardless
of any general incorporation language in such filing.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<table cellspacing="0" cellpadding="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<tr style="vertical-align: top">
    <td style="width: 9%; font-size: 10pt"><font style="font-size: 10pt"><b>Item&nbsp;9.01</b></font></td>
    <td style="width: 91%; font-size: 10pt"><font style="font-size: 10pt"><b>Financial Statements and Exhibits.</b></font></td></tr>
</table>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%">
<tr style="vertical-align: bottom">
    <TD STYLE="width: 10%; border-bottom: black 1pt solid; text-align: center"><font style="font-size: 10pt"><b>Exhibit</b></font><br>
<font style="font-size: 10pt"><b>No.</b></font></td>
    <TD STYLE="width: 2%">&nbsp;</td>
    <TD STYLE="width: 88%; border-bottom: black 1pt solid"><font style="font-size: 10pt"><b>Description</b></font></td></tr>
<tr>
    <TD>&nbsp;</td>
    <td colspan="2">&nbsp;</td></tr>
<tr>
    <TD STYLE="vertical-align: top; text-align: center"><font style="font-size: 10pt">99.1&nbsp;&nbsp;</font></td>
    <TD STYLE="vertical-align: bottom">&nbsp;</td>
    <TD STYLE="vertical-align: bottom"><font style="font-size: 10pt">21 C.F.R. Part 1308, Schedules of Controlled Substances: Removal of Naloxegol From Control.</font></td></tr>
</table>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.5in"><FONT STYLE="background-color: white">&nbsp;</FONT></P>


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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>SIGNATURES</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.25in">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Pursuant to the requirement of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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    <TD STYLE="width: 52%">&nbsp;</TD>
    <TD STYLE="width: 5%"><FONT STYLE="font-size: 10pt">By:</FONT></TD>
    <TD STYLE="width: 43%; border-bottom: Black 1pt solid"><FONT STYLE="font-size: 10pt">/s/ Gil M. Labrucherie</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt">Gil M. Labrucherie</FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD STYLE="text-align: center"><FONT STYLE="font-size: 10pt"><I>General Counsel and Secretary</I></FONT></TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD>&nbsp;</TD></TR>
<TR STYLE="vertical-align: top">
    <TD>&nbsp;</TD>
    <TD><FONT STYLE="font-size: 10pt">Date:</FONT></TD>
    <TD><FONT STYLE="font-size: 10pt">January 26, 2015</FONT></TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><B>EXHIBIT INDEX</B></P>

<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

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    <TD STYLE="width: 10%; border-bottom: black 1pt solid; text-align: center"><font style="font-size: 10pt"><b>Exhibit</b></font><br>
<font style="font-size: 10pt"><b>No.</b></font></td>
    <TD STYLE="width: 2%">&nbsp;</td>
    <TD STYLE="width: 88%; border-bottom: black 1pt solid"><font style="font-size: 10pt"><b>Description</b></font></td></tr>
<tr>
    <TD>&nbsp;</td>
    <td colspan="2">&nbsp;</td></tr>
<tr>
    <TD STYLE="vertical-align: top; text-align: center"><font style="font-size: 10pt">99.1&nbsp;&nbsp;</font></td>
    <TD STYLE="vertical-align: bottom">&nbsp;</td>
    <TD STYLE="vertical-align: bottom"><font style="font-size: 10pt">21 C.F.R. Part 1308, Schedules of Controlled Substances: Removal of Naloxegol From Control.</font></td></tr>
</table>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>


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<DESCRIPTION>EXHIBIT 99.1
<TEXT>
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<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0; text-align: right"><B>Exhibit 99.1</B></P>

<P STYLE="margin: 0">&nbsp;</P>

<P STYLE="margin: 0"><IMG SRC="logo.jpg" ALT="">&nbsp;</P>

<P STYLE="margin: 0">&nbsp;</P>

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    <TD STYLE="width: 10%; font-size: 10pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>3468 </B></FONT></TD>
    <TD STYLE="width: 80%; font-size: 10pt; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Federal Register </B>/ Vol. 80, No. 15 / Friday, January 23, 2015 / Rules and Regulations </FONT></TD>
    <TD STYLE="width: 10%">&nbsp;</TD></TR>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>

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    <TD STYLE="width: 32%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">with the sulfur content limits of ASTM C1396&ndash;14a and must
        be accompanied by a general certification of compliance (GCC).</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Alberta E. Mills, </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Acting Secretary, Consumer Product Safety Commission. </I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">[FR Doc. 2015&ndash;01051 Filed 1&ndash;22&ndash;15; 8:45 am]</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>BILLING CODE 6355&ndash;01&ndash;P </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">________________________</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>DEPARTMENT OF JUSTICE </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Drug Enforcement Administration </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>21 CFR Part 1308 </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>[Docket No. DEA&ndash;400] </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Schedules of Controlled Substances:</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Removal of Naloxegol
        From Control </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>AGENCY: </B>Drug Enforcement Administration,
        Department of Justice.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B></B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>ACTION: </B>Final
        rule.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0pt; text-align: left; text-indent: 0">________________________</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0"><B>SUMMARY: </B>With the issuance of this final rule,
        the Administrator of the Drug Enforcement Administration removes naloxegol ((5&alpha;,6&alpha;)-17-allyl-6-((20- hydroxy-3,6,9,12,15,18-hexaoxaicos-1-
        yl)oxy)-4,5-epoxymorphinon-3,14-diol) and its salts from the schedules of the Controlled Substances Act (CSA). This scheduling
        action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through
        formal rulemaking. Prior to the effective date of this rule, naloxegol was a schedule II controlled substance because
        it can be derived from opium alkaloids. This action removes the regulatory controls and administrative, civil, and criminal
        sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons
        who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical
        analysis) or propose to handle naloxegol. <B>DATES: </B><I>Effective Date: </I>January 23, 2015.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0">&nbsp;<B>FOR FURTHER INFORMATION CONTACT:
</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;Imelda L. Paredes, Office of Diversion Control,
Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598&ndash;6812.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>SUPPLEMENTARY INFORMATION: </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Legal Authority </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.12in">The Drug Enforcement Administration (DEA)
        implements and enforces titles II and III of the Comprehensive Drug Abuse Prevention and Control Act of 1970, as amended. 21
        U.S.C. 801&ndash;971. Titles II and III are referred to as the &ldquo;Controlled</P></TD>
    <TD STYLE="width: 2%; font-size: 10pt; padding: 0; text-indent: 0">&nbsp;</TD>
    <TD STYLE="width: 32%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Substances Act&rdquo; and the &ldquo;Controlled
        Substances Import and Export Act,&rdquo; respectively, but they are collectively referred to as the &ldquo;Controlled
        Substances Act&rdquo; or the &ldquo;CSA&rdquo; for the purposes of this action. The DEA publishes the implementing
        regulations for these statutes in title 21 of the Code of Federal Regulations (CFR), parts 1300 to 1321. The CSA and its implementing
        regulations are designed to prevent, detect, and eliminate the diversion of controlled substances and listed chemicals into the
        illicit market while providing for the legitimate medical, scientific, research, and industrial needs of the United States. Controlled
        substances have the potential for abuse and dependence and are controlled to protect the public health and safety.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9.35pt">Under the CSA, each controlled
substance is classified into one of five schedules based upon its potential for abuse, its currently accepted medical use in treatment
in the United States, and the degree of dependence the drug or other substance may cause. 21 U.S.C. 812. The initial schedules
of controlled substances established by Congress are found at 21 U.S.C. 812(c) and the current list of scheduled substances is
published at 21 CFR 1308. 21 U.S.C. 812(a).</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9.35pt">Pursuant to 21 U.S.C. 811(a)(2),
the Attorney General may, by rule, &ldquo;remove any drug or other substance from the schedules if he finds that the drug or other
substance does not meet the requirements for inclusion in any schedule.&rdquo; The Attorney General has delegated scheduling authority
under 21 U.S.C. 811 to the Administrator of the DEA. 28 CFR 0.100.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9.35pt">The CSA provides that proceedings for the
        issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on
        his own motion, (2) at the request of the Secretary of the Department of Health and Human Services (HHS),<SUP>1 </SUP>or (3) on
        the petition of any interested party. 21 U.S.C. 811(a). This action was initiated by a petition from the drug sponsor to remove
        naloxegol from the list of scheduled controlled substances of the CSA, and is supported by, <I>inter alia, </I>a recommendation
        from the Assistant Secretary of the HHS and an evaluation</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0"><SUP>&nbsp;</SUP>________________</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9.35pt"><SUP>1 </SUP>As discussed in a memorandum
        of understanding entered into by the Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA), the FDA
        acts as the lead agency within the HHS in carrying out the Secretary&rsquo;s scheduling responsibilities under the CSA, with the
        concurrence of NIDA. 50 FR 9518, Mar. 8, 1985. The Secretary of the HHS has delegated to the Assistant Secretary for Health of
        the HHS the authority to make domestic drug scheduling recommendations. 58 FR 35460, July 1, 1993.</P></TD>
    <TD STYLE="width: 2%; font-size: 10pt; padding: 0; text-indent: 0">&nbsp;</TD>
    <TD STYLE="width: 32%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">of all relevant data by the DEA. This action removes the regulatory
        controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule
        II controlled substances, on persons who handle or propose to handle naloxegol.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Background </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt"><FONT STYLE="font-family: Times New Roman, Times, Serif">Naloxegol,
or PEG-naloxol, is a new molecular entity and is a polyethylene glycolyated (PEGylated) derivative of naloxone. Its chemical names
are (5&alpha;,6&alpha;)-17-allyl-6-((20-hydroxy- 3,6,9,12,15,18-hexaoxaicos-1-yl)oxy)- 4,5-epoxymorphinon-3,14-diol or alpha- 6mPEG7-O-naloxol.
Naloxegol is an antagonist predominantly of peripheral mu opioid receptors. The Food and Drug Administration (FDA) approved naloxegol
for marketing on September 16, 2014, under the brand name Movantik</FONT><SUP>TM</SUP><FONT STYLE="font-family: Times New Roman, Times, Serif">.<SUP>2
</SUP>It is indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Gastrointestinal
adverse events (AEs) effects are commonly experienced by chronic users of opioid analgesics. Opioids delay gastric emptying and
intestinal transport, which over time leads to debilitating constipation. OIC is caused by activation of the mu opioid receptor
in the GI tract. </FONT></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>DEA and HHS Eight Factor Analyses </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">The DEA received a petition from
the drug sponsor dated March 22, 2012, requesting that the DEA amend 21 CFR 1308.12(b)(1) to exclude naloxegol as a schedule II
controlled substance. The petitioner stated that naloxegol is a mu opioid receptor antagonist without mu opioid agonist or partial
agonist properties. The DEA accepted the petition for filing on October 1, 2012.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">On February 7, 2013 the DEA forwarded to the HHS the data
        with the sponsor&rsquo;s petition along with a request for a scientific and medical evaluation and the HHS&rsquo;s recommendation
        as to whether or not naloxegol should be removed from the list of controlled substances. According to the HHS, the sponsor submitted
        a New Drug Application (NDA) for naloxegol on September 16, 2013. Based on the NDA, the HHS summarized that naloxegol is an antagonist
        of peripheral opioid receptors for the treatment of OIC.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">On August 8, 2014, the HHS provided to the DEA a scientific and medical
        evaluation document prepared by the FDA entitled &ldquo;Basis for the</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0">________________</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.13in"><SUP>2 </SUP><I>http://www.accessdata.fda.gov/scripts/cder/
drugsatfda/ index.cfm?fuseaction=Search.DrugDetails </I>(last accessed Sept. 26, 2014).</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P></TD></TR>
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    <TD STYLE="width: 80%; font-size: 10pt; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Federal Register </B>/ Vol. 80, No. 15 / Friday, January 23, 2015 / Rules and Regulations </FONT></TD>
    <TD STYLE="width: 10%; font-size: 10pt; text-align: right"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>3469</B></FONT></TD></TR>
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    <TD STYLE="width: 32%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">Recommendation to Decontrol Naloxegol and its Salts
from Schedule II of the Controlled Substances Act.&rdquo; After considering the eight factors in 21 U.S.C. 811(c), including
consideration of the substance&rsquo;s abuse potential, legitimate medical use, and dependence liability, the Assistant Secretary
of the HHS recommended that naloxegol and its salts be removed from schedule II of the CSA. In response, the DEA conducted its
own eight factor analysis of naloxegol pursuant to 21 U.S.C. 811(c). Both the DEA and HHS analyses are available in their entirety
in the public docket of this rule (Docket Number DEA&ndash;400) at <I>http:// www.regulations.gov </I>under &ldquo;Supporting
and Related Material.&rdquo;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Determination To Decontrol Naloxegol </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">After a review of the available data, including
        the scientific and medical evaluation and the recommendation to decontrol naloxegol from HHS, the Deputy Administrator of the DEA
        published in the <B>Federal Register </B>a notice of proposed rulemaking (NPRM) entitled &ldquo;Schedules of Controlled
        Substances: Removal of Naloxegol from Control&rdquo; which proposed removal of naloxegol and its salts from the schedules
        of the CSA. 79 FR 64349, October 29, 2014. The proposed rule provided an opportunity for interested persons to file a request for
        a hearing in accordance with DEA regulations by November 28, 2014. No requests for such a hearing were received by the DEA. The
        NPRM also provided an opportunity for interested persons to submit written comments on the proposal on or before November 28, 2014.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Comments Received </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">The DEA received seven comments on the proposed
        rule to decontrol naloxegol. Five commenters supported decontrol of naloxegol. Two commenters submitted comments not related to
        the proposed action.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Support </I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">Commenters in support of decontrolling naloxegol
        included two members of industry, a former intensive care unit (ICU) nurse, and two patient advocacy groups, all of whom expressed
        agreement with the DEA&rsquo;s findings that naloxegol does not possess abuse or dependence potential. <I></I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt"></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt"><I>DEA Response: </I>The
        DEA appreciates the comments in support of this rulemaking.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center; text-indent: 9pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Request for Immediate Effective Date </I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">Four of the commenters specifically
requested that a rule decontrolling</P></TD>
    <TD STYLE="width: 2%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 32%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">naloxegol be issued with an immediate effective date. Commenters
        stated that an immediate effective date was warranted because naloxegol does not have an abuse potential and is a new therapeutic
        option for opioid-induced constipation with no alternatives currently on the market. Additionally, a commenter distinguished this
        particular instance of decontrolling a substance that is not yet commercially available and thus would not result in burdens on
        the healthcare system or law enforcement from other DEA actions to control a substance which necessitated lead time for registrants
        to make necessary preparations for compliance. <I></I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I></I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.12in"><I>DEA Response: </I>Generally, DEA scheduling actions are effective 30 days from
        the date of publication of the final rule in the <B>Federal Register</B>. 21 CFR 1308.45; <I>see also </I>5 U.S.C. 553(d). In accordance
        with 21 CFR 1308.45, the DEA finds that the absence of comparative effective therapeutic treatments for OIC with similar or less
        adverse effects than naloxegol, coupled with the fact that this is an action for decontrol, support the finding that conditions
        of public health require this action to be effective immediately upon publication in the <B>Federal Register</B>. Due to adverse
        side effects, the majority of treatment alternatives currently available for OIC have restricted clinical application. By comparison,
        the side effects of naloxegol have been shown to be generally mild and reversible. The addition of the polyethylene glycol group
        decreases the capacity of naloxegol from crossing the blood-brain barrier as compared to naloxone and is therefore expected to
        limit the potential for interference with centrally mediated opioid analgesia.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.12in"></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.12in">In making the determination to make this rule immediately
        effective, the DEA took into consideration the effects of immediate implementation. The DEA agrees that making this rule immediately
        effective is in the best interest of the public health and will not burden registrants, the healthcare system, or law enforcement.
        The DEA notes that its decision to make this rule immediately effective aligns with the exceptions to the 30-day effective date
        requirement of the Administrative Procedure Act (APA). One of the APA&rsquo;s exceptions to the 30-day effective date is for a
        substantive rule granting or recognizing an exemption or which relieves a restriction. 5 U.S.C. 553(d)(3).</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Scheduling Conclusion </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">Based on the consideration of all
comments, the scientific and medical evaluation and accompanying recommendation of the HHS, and based</P></TD>
    <TD STYLE="width: 2%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 32%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">on the DEA&rsquo;s consideration of its own eight-factor analysis,
        the Administrator finds that these facts and all relevant data demonstrate that naloxegol does not meet the requirements for inclusion
        in any schedule, and will be removed from control under the CSA.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Regulatory Analyses </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Executive Orders 12866 and 13563 </I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">In accordance with 21 U.S.C. 811(a), this
        scheduling action is subject to formal rulemaking procedures done &ldquo;on the record after opportunity for a hearing,&rdquo;
        which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or
        other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of
        Executive Order 12866 and the principles reaffirmed in Executive Order 13563.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Executive Order 12988 </I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">This regulation meets the applicable standards
        set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform to eliminate drafting errors and ambiguity,
        minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Executive Order 13132 </I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">This rulemaking does not have federalism implications
        warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship
        between the Federal Government and the States, or the distribution of power and responsibilities among the various levels of government.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Executive Order 13175 </I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">This rule does not have tribal implications
        warranting the application of Executive Order 13175. This rule does not have substantial direct effects on one or more Indian tribes,
        on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between
        the Federal Government and Indian tribes.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Regulatory Flexibility Act </I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">The Administrator, in accordance
with the Regulatory Flexibility Act (5 U.S.C. 601&ndash;612) (RFA), has reviewed this rule and by approving it certifies that
it will not have a significant economic impact on a substantial number of small entities. The purpose of this rule is to remove
naloxegol from the list of schedules of the CSA. This action</P></TD></TR>
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    <TD STYLE="width: 10%; font-size: 10pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>3470 </B></FONT></TD>
    <TD STYLE="width: 80%; font-size: 10pt; text-align: center"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>Federal Register </B>/ Vol. 80, No. 15 / Friday, January 23, 2015 / Rules and Regulations </FONT></TD>
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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 32%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">removes regulatory controls and administrative, civil, and criminal
        sanctions applicable to controlled substances for handlers and proposed handlers of naloxegol. Accordingly, it has the potential
        for some economic impact in the form of cost savings.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 0.12in">Naloxegol is a new molecular entity
and is not currently available or marketed in any country. According to publicly available information reviewed by the DEA, naloxegol
is anticipated to enjoy patent protection for an extended period of time before generic equivalents may be manufactured and marketed
in the United States. Although the number of manufacturers of naloxegol may initially be limited, there is potential for numerous
handlers in various business activities, <I>e.g., </I>distributors, hospitals/clinics, pharmacies, practitioners, etc.&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9.35pt">This rule will affect all persons who would
        handle, or propose to handle, naloxegol. Due to the wide variety of unidentifiable and unquantifiable variables that potentially
        could influence the distribution and dispensing rates of new molecular entities, the DEA is unable to determine the number of entities
        and small entities which might handle naloxegol. However, the DEA estimates that all persons who would handle, or propose to handle,
        naloxegol are currently registered with the DEA to handle schedule II controlled substances. Therefore, the 1.5 million (1,469,418
        as of September 2014) controlled substance registrations, representing approximately 426,714 entities, would be the maximum number
        of entities affected by this rule. The DEA estimates that 417,302 (97.8%) of 426,714 affected entities are &ldquo;small
        entities&rdquo; in accordance with the RFA and Small Business Administration size standards.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9.35pt"></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9.35pt">The DEA estimates all controlled substances
        registrants handle both controlled and non-controlled substances and these registrants are expected to handle naloxegol. Additionally,
        since prospective naloxegol handlers are likely to handle other schedule II controlled substances, the cost savings they would
        receive as a result of the de-control of naloxegol would be nominal. As naloxegol handlers are likely to handle other schedule
        II controlled substances, they will need to maintain their DEA registration and keep the same security, reporting, and recordkeeping
        processes, equipment, and facilities in place and would experience only a nominal reduction in security, reporting, inventory,
        recordkeeping, and labeling costs.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P></TD>
    <TD STYLE="width: 2%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 32%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9.35pt">While the DEA does not have a basis to
        estimate the number of affected entities, the DEA estimates that the maximum number of affected entities is 426,714 of which 417,302
        are estimated to be small entities. Since the affected entities are expected to handle other schedule II controlled substances
        and maintain security, reporting, and recordkeeping facilities and processes consistent with schedule II controlled substances
        handling requirements, the DEA estimates any economic impact (cost savings) will be nominal. Because of these facts, this rule
        will not result in a significant economic impact on a substantial number of small entities.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Unfunded Mandates Reform Act of 1995 </I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9.35pt">On the basis of information contained in
        the &ldquo;Regulatory Flexibility Act&rdquo; section above, the DEA has determined and certifies pursuant to the
        Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1501 <I>et seq., </I>that this action would not result in any federal mandate
        that may result &ldquo;in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector,
        of $100,000,000 or more (adjusted for inflation) in any one year * * *.&rdquo; Therefore, neither a Small Government Agency
        Plan nor any other action is required under provisions of UMRA.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Paperwork Reduction Act </I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9.35pt">This action does not impose a new collection
        of information requirement under the Paperwork Reduction Act, 44 U.S.C. 3501&ndash;3521. This action would not impose recordkeeping
        or reporting requirements on State or local governments, individuals, businesses, or organizations. An agency may not conduct or
        sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control
        number.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Congressional Review Act </I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9.35pt">This rule is not a major rule as defined
        by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will
        not result in: an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual
        industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition,
        employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign- based
        companies in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy</P></TD>
    <TD STYLE="width: 2%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 32%">
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">of this final rule to both Houses of Congress and to the Comptroller
        General.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>List of Subjects in 21 CFR Part 1308 </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">Administrative practice and procedure, Drug
        traffic control, Reporting and recordkeeping requirements.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt"></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">For the reasons set out above, 21 CFR part
        1308 is amended to read as follows:</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>PART 1308&mdash;SCHEDULES OF CONTROLLED SUBSTANCES </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><FONT STYLE="font-family: Times New Roman, Times, Serif">&#9632;</FONT>&nbsp;<FONT STYLE="font-family: Times New Roman, Times, Serif">1.
        The authority citation for 21 CFR part 1308 continues to read as follows: </FONT></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 8pt"><B>Authority: </B>21 U.S.C. 811, 812, 871(b),
        unless otherwise noted.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 8pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&#9632;<FONT STYLE="font-family: Times New Roman, Times, Serif">&nbsp;2.
In &sect; 1308.12, revise the introductory text of paragraph (b)(1) to read as follows: </FONT></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 5.75pt; text-indent: -5.7pt"><FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>&sect;</B></FONT>&nbsp;<FONT STYLE="font: 10pt Times New Roman, Times, Serif"><B>1308.12
        Schedule II. </B></FONT></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 5.75pt; text-indent: -5.7pt"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 9pt; text-indent: -8.95pt">*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 9pt; text-indent: -8.95pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 8.65pt">(b) *&nbsp;&nbsp;*&nbsp;&nbsp;*</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-indent: 9pt">(1) Opium and opiate, and any salt, compound,
        derivative, or preparation of opium or opiate excluding apomorphine, thebaine-derived butorphanol, dextrorphan, nalbuphine, nalmefene,
        naloxegol, naloxone, and naltrexone, and their respective salts, but including the following:</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 22.85pt; text-indent: -22.8pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 22.85pt; text-indent: -22.8pt">*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;*</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 22.85pt; text-indent: -22.8pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 8pt">Dated: January 16, 2015.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 8pt">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Michele M. Leonhart, </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>Administrator. </I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><I>&nbsp;</I></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">[FR Doc. 2015&ndash;01172 Filed 1&ndash;22&ndash;15; 8:45 am]</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>BILLING CODE 4410&ndash;09&ndash;P </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B></B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">________________________________<B></B>___</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>DEPARTMENT OF HOMELAND SECURITY </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Coast Guard </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>33 CFR Part 5 </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>[Docket No. USCG&ndash;1999&ndash;6712] </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>RIN 1625&ndash;AB66 </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>Revision of Auxiliary Regulations </B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>&nbsp;</B></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>AGENCY: </B>Coast Guard, DHS.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>ACTION: </B>Final rule.</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"></P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">________________________________<B></B>___</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>
        <P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><B>SUMMARY: </B>The Coast Guard is amending and reorganizing
        the regulations that govern the operation and administration of the Coast Guard Auxiliary, a uniformed, volunteer, non-military
        organization chartered by Congress. The amendments conform the regulatory language to changes in the laws governing the Coast Guard
        Auxiliary; clarify the Auxiliary&rsquo;s organization, status, and role in Coast Guard</P></TD></TR>
</TABLE>
<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">&nbsp;</P>


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`
end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
