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<div class=Section1>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>FYI…<o:p></o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'><o:p> </o:p></span></font></p>
<p class=MsoNormal><font size=2 color=navy face=Arial><span style='font-size:
10.0pt;font-family:Arial;color:navy'>Stevan Gressitt, M.D.<o:p></o:p></span></font></p>
<blockquote style='margin-top:5.0pt;margin-right:0in;margin-bottom:5.0pt'>
<p class=MsoNormal align=center style='text-align:center'><b><font size=3
color="#006666" face=Verdana><span style='font-size:12.0pt;font-family:Verdana;
color:#006666;font-weight:bold'>Ensure Proper Waste Management<br>
<i><span style='font-style:italic'>Recalled, Rejected and Expired
Pharmaceuticals</span></i></span></font></b><font size=2 face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'> </span></font><o:p></o:p></p>
<p align=center style='text-align:center'><b><font size=2 color=black
face=Verdana><span style='font-size:10.0pt;font-family:Verdana;font-weight:
bold'>An audioconference <br>
Thursday, Jan. 19, 2006 * 1:30 p.m. - 3:00 p.m. EST</span></font></b><o:p></o:p></p>
<p><b><font size=2 color=black face=Verdana><span style='font-size:10.0pt;
font-family:Verdana;font-weight:bold'><a
href="http://www.fdanews.com/wbi/conferences/wastemanagement.html?s=9116&p=061MML">Register
now!</a></span></font></b><o:p></o:p></p>
<p><b><font size=2 color="#006666" face=Verdana><span style='font-size:10.0pt;
font-family:Verdana;color:#006666;font-weight:bold'>Avoid $32,500/day fines,
criminal suits ... and jail time! </span></font></b><o:p></o:p></p>
<p><font size=2 color=black face=Verdana><span style='font-size:10.0pt;
font-family:Verdana'>Ever think of your pharmaceuticals as hazardous waste? EPA
does - and in the wake of massive recalls like Vioxx and Bextra, the agency is
cracking down, holding drugmakers accountable for cradle-to-grave compliance
with the Resource Conservation and Recovery Act (RCRA). In fact, drug disposal
is emerging as a red-hot environmental issue.</span></font><o:p></o:p></p>
<p><font size=2 color=black face=Verdana><span style='font-size:10.0pt;
font-family:Verdana'>But it's not just EPA you need to worry about. DEA, DOT,
and states' attorneys general are in the hunt, too - and everyone from managers
on up could be <i><span style='font-style:italic'>personally liable</span></i>
for violations ... with no statute of limitation. </span></font><o:p></o:p></p>
<p><b><font size=2 color="#006666" face=Verdana><span style='font-size:10.0pt;
font-family:Verdana;color:#006666;font-weight:bold'>Make sure <i><span
style='font-style:italic'>your</span></i> waste management SOPs don't put you
at risk:</span></font></b><b><font size=2 color=blue face=Verdana><span
style='font-size:10.0pt;font-family:Verdana;color:blue;font-weight:bold'> <a
href="http://www.fdanews.com/wbi/conferences/wastemanagement.html?s=9116&p=061MML">register
now!</a> </span></font></b><o:p></o:p></p>
<p><font size=2 color=black face=Verdana><span style='font-size:10.0pt;
font-family:Verdana'>In 90 minutes, pharmaceutical waste experts <b><span
style='font-weight:bold'>Richard Verch</span></b> and <b><span
style='font-weight:bold'>Charlotte Smith</span></b> translate RCRA's
non-industry-specific requirements into clear guidance on how to discard
recalled, rejected and expired pharmaceuticals. </span></font><o:p></o:p></p>
<p><font size=2 color=black face=Verdana><span style='font-size:10.0pt;
font-family:Verdana'>You'll gain a comprehensive perspective on what state and
federal requirements you <i><span style='font-style:italic'>must</span></i>
meet, and how to identify, label, transport and manage waste pharmaceuticals
generated during manufacturing processes. You'll learn how to defuse problems
when products are removed from the market, plus ... you'll discover what
controls are needed to avoid violations on bulk or finished-dose drugs. </span></font><o:p></o:p></p>
<p><b><font size=2 color="#006666" face=Verdana><span style='font-size:10.0pt;
font-family:Verdana;color:#006666;font-weight:bold'>Don't wait! Bring supply
chain policies and procedures into compliance BEFORE violations cost you
devastating fines and personal liability.</span></font></b><o:p></o:p></p>
<p><b><font size=2 color="#006666" face=Verdana><span style='font-size:10.0pt;
font-family:Verdana;color:#006666;font-weight:bold'><a
href="http://www.fdanews.com/wbi/conferences/wastemanagement.html?s=9116&p=061MML">Register
now</a> to learn:</span></font></b><o:p></o:p></p>
<ul type=disc>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l2 level1 lfo1'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>What drugs are on RCRA's
lists of hazardous wastes</span></font> <o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l2 level1 lfo1'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>How to tell if <i><span
style='font-style:italic'>nonlisted</span></i> pharmaceuticals meet other
EPA hazardous waste criteria</span></font> <o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l2 level1 lfo1'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>Today's top 5 disposal
pitfalls - and how to avoid them</span></font> <o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l2 level1 lfo1'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>How to meet DEA requirements
for handling, waste transfer, disposal and the "witnessed burn"
process</span></font> <o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l2 level1 lfo1'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>What you MUST know about
transporting waste pharmaceuticals - even when they're not classified as
hazardous</span></font> <o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l2 level1 lfo1'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>How to steer clear of state
regulations (many are tougher than federal ones!) </span></font><o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l2 level1 lfo1'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>Best management practices for
disposing of <i><span style='font-style:italic'>nonhazardous drugs</span></i></span></font>
<o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l2 level1 lfo1'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>And more</span></font> <o:p></o:p></li>
</ul>
<p><b><font size=3 color="#006666" face=Verdana><span style='font-size:12.0pt;
font-family:Verdana;color:#006666;font-weight:bold'>Meet Your Instructors</span></font></b><font
size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana'> <br>
<b><span style='font-weight:bold'>Richard Verch</span></b> founded Strong
Environmental in 1993 and since then, the company's Pharmaceutical Services
division has become the leading provider of special destruction services to the
pharmaceutical industry. Richard is an engineer, a 10-year master level CHMM,
as well as an REM and CEA. He has worked in the environmental industry since
1982 where, at Air Techniques, he performed EPA source emission testing and
elaborate air filtration design/build systems. He also worked for Fichtner
GmBH, consulting and engineering MSW and incineration designs. Richard
participates and serves on many industry related groups, boards, associations
and committees.</span></font><o:p></o:p></p>
<p><b><font size=2 color=black face=Verdana><span style='font-size:10.0pt;
font-family:Verdana;font-weight:bold'>Charlotte Smith</span></font></b><font
size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana'> is
president of PharmEcology Associates, LLC, a firm she founded in 2000 to help
the healthcare industry reduce and manage pharmaceutical waste. She co-founded
Capital Returns, a nationally known pharmaceutical reverse distributor in 1991,
and for 10 years served as president and chief regulatory adviser. In those
positions, <st1:City w:st="on"><st1:place w:st="on">Charlotte</st1:place></st1:City>
pioneered the application of the EPA's Resource Conservation and Recovery Act
(RCRA) regulations to pharmaceutical waste streams within the reverse
distribution industry and developed management systems to assist healthcare
facilities in reducing and managing pharmaceutical waste. She is a registered
pharmacist and serves on the CDC's NIOSH Hazardous Drug Working Group.</span></font><o:p></o:p></p>
<p><b><font size=2 color=black face=Verdana><span style='font-size:10.0pt;
font-family:Verdana;font-weight:bold'><a
href="http://www.fdanews.com/wbi/conferences/wastemanagement.html?s=9116&p=061MML">Register
now!</a></span></font></b><font size=2 face=Verdana><span style='font-size:
10.0pt;font-family:Verdana'> </span></font><o:p></o:p></p>
<p><b><font size=3 color="#006666" face=Verdana><span style='font-size:12.0pt;
font-family:Verdana;color:#006666;font-weight:bold'>Who Will Benefit</span></font></b><br>
<font size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana'>The
audioconference is a must for informing staff at all levels of their liability
under RCRA, especially:</span></font><o:p></o:p></p>
<ul type=disc>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l0 level1 lfo2'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>Regulatory personnel</span></font>
<o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l0 level1 lfo2'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>Risk managers</span></font> <o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l0 level1 lfo2'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>Corporate officers</span></font>
<o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l0 level1 lfo2'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>Compliance personnel</span></font>
<o:p></o:p></li>
</ul>
<table class=MsoNormalTable border=0 cellpadding=0 width=536 style='width:402.0pt'>
<tr>
<td colspan=4 style='padding:.75pt .75pt .75pt .75pt'>
<p class=MsoNormal><b><font size=3 color="#006666" face=Verdana><span
style='font-size:12.0pt;font-family:Verdana;color:#006666;font-weight:bold'>Audioconference
Details</span></font></b><o:p></o:p></p>
</td>
</tr>
<tr>
<td width="12%" style='width:12.0%;padding:.75pt .75pt .75pt .75pt'>
<p class=MsoNormal><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>Date:</span></font><o:p></o:p></p>
</td>
<td colspan=3 style='padding:.75pt .75pt .75pt .75pt'>
<p class=MsoNormal><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>Thursday, Jan. 19, 2006</span></font><o:p></o:p></p>
</td>
</tr>
<tr>
<td width="12%" style='width:12.0%;padding:.75pt .75pt .75pt .75pt'>
<p class=MsoNormal><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>Location:</span></font><o:p></o:p></p>
</td>
<td colspan=3 style='padding:.75pt .75pt .75pt .75pt'>
<p class=MsoNormal><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>Your office or conference room
(no need to travel!)</span></font><o:p></o:p></p>
</td>
</tr>
<tr>
<td width="12%" valign=top style='width:12.0%;padding:.75pt .75pt .75pt .75pt'>
<p class=MsoNormal><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'>Time:</span></font><o:p></o:p></p>
</td>
<td width="15%" valign=top style='width:15.0%;padding:.75pt .75pt .75pt .75pt'>
<p><font size=2 color=black face=Verdana><span style='font-size:10.0pt;
font-family:Verdana'>1:30 p.m. 12:30 p.m. 11:30 a.m. 10:30 a.m. 6:30 p.m.</span></font><o:p></o:p></p>
</td>
<td width="4%" valign=top style='width:4.0%;padding:.75pt .75pt .75pt .75pt'>
<p align=center style='text-align:center'><font size=2 color=black
face=Verdana><span style='font-size:10.0pt;font-family:Verdana'>-<br>
-<br>
-<br>
-<br>
-</span></font><o:p></o:p></p>
</td>
<td width="69%" valign=top style='width:69.0%;padding:.75pt .75pt .75pt .75pt'>
<p><font size=2 color=black face=Verdana><span style='font-size:10.0pt;
font-family:Verdana'>3:00 p.m. EST<br>
2:00 p.m. CST<br>
1:00 p.m. MST<br>
Noon PST<br>
8:00 p.m. GMT</span></font><o:p></o:p></p>
</td>
</tr>
</table>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt'><o:p> </o:p></span></font></p>
<div align=center>
<table class=MsoNormalTable border=1 cellspacing=0 cellpadding=0 width="62%"
bgcolor=white style='width:62.0%;background:white;border:outset blue 1.0pt'
height=39>
<tr>
<td style='border:inset blue 1.0pt;padding:0in 0in 0in 0in'>
<p class=MsoNormal align=center style='text-align:center'><b><i><font size=2
color=black face=Verdana><span style='font-size:10.0pt;font-family:Verdana;
font-weight:bold;font-style:italic'>Gather your team for maximum benefit!</span></font></i></b><i><font
size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana;
font-style:italic'> Your investment is for one dial-in.<br>
<br>
<b><span style='font-weight:bold'>Interested in registering multiple sites?</span></b></span></font></i><font
size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana'><br>
Call (888) 838-5578 in the <st1:country-region w:st="on"><st1:place w:st="on">U.S.</st1:place></st1:country-region>
or +1 (703) 538-7600 globally<br>
to learn about our special multisite discount.</span></font><o:p></o:p></p>
</td>
</tr>
</table>
</div>
<p style='margin-bottom:12.0pt'><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'><br>
</span></font><b><font color="#006666" face=Verdana><span style='font-family:
Verdana;color:#006666;font-weight:bold'>Four Cost-Effective Tuition Options</span></font></b><font
size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana'><br>
<i><span style='font-style:italic'>All participants of the live session are
eligible to receive a certificate of attendance.</span></i></span></font><o:p></o:p></p>
<table class=MsoNormalTable border=0 cellpadding=0 width="75%"
style='width:75.0%'>
<tr>
<td width="8%" valign=top style='width:8.0%;padding:.75pt .75pt .75pt .75pt'>
<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt'><img border=0 width=72 height=43 id="_x0000_i1025"
src="http://www.fdanews.com/images/ads/StarburstR.gif" align=top NOSEND=1><o:p></o:p></span></font></p>
</td>
<td width="92%" style='width:92.0%;padding:.75pt .75pt .75pt .75pt'>
<ol start=1 type=1>
<li class=MsoNormal style='mso-margin-top-alt:auto;margin-bottom:12.0pt;
mso-list:l3 level1 lfo3'><b><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana;font-weight:bold'>Audioconference
PLUS Audio CD and Transcript:</span></font></b><font size=2
face=Verdana><span style='font-size:10.0pt;font-family:Verdana'> $590 </span></font><i><font
size=2 color=red face=Verdana><span style='font-size:10.0pt;font-family:
Verdana;color:red;font-style:italic'>Best Value! Save $200!</span></font></i><font
size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana'><br>
You'll have access to one dial-in for the live 90-minute audioconference
for <i><span style='font-style:italic'>unlimited participants</span></i>!
You'll also receive all presentation materials and the opportunity to
ask questions by phone and email, PLUS an audio CD and written
transcript of the entire session.</span></font><o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;margin-bottom:12.0pt;
mso-list:l3 level1 lfo3'><b><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana;font-weight:bold'>Audioconference
Only:</span></font></b><font size=2 face=Verdana><span style='font-size:
10.0pt;font-family:Verdana'> $395 <br>
You'll have access to one dial-in for the live 90-minute audioconference
for <i><span style='font-style:italic'>unlimited participants</span></i>!
You'll also receive all presentation materials and the opportunity to
ask questions by phone and email. </span></font><o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;margin-bottom:12.0pt;
mso-list:l3 level1 lfo3'><b><font size=2 color=black face=Verdana><span
style='font-size:10.0pt;font-family:Verdana;font-weight:bold'>Audio CD
and Transcript Only:</span></font></b><font size=2 face=Verdana><span
style='font-size:10.0pt;font-family:Verdana'> $395 <i><span
style='font-style:italic'>(plus shipping and handling)</span></i><br>
You'll receive an audio CD, written transcript of the entire 90-minute
audioconference, including the Q&A period, and all presentation
materials four weeks after the session. </span></font><o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:
auto;mso-list:l3 level1 lfo3'><b><i><font size=2 color=black
face=Verdana><span style='font-size:10.0pt;font-family:Verdana;
font-weight:bold;font-style:italic'>24/7 ENCORE</span></font></i></b><font
size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana'>(tm)
<b><span style='font-weight:bold'>Audio Presentation:</span></b> $395 <br>
You'll have access to one dial-in for an archived recording of the
entire 90-minute audioconference, including the Q&A period, for <i><span
style='font-style:italic'>unlimited participants</span></i>. You can
dial in any time of day or night for three weeks, from Jan. 23 - Feb.
10, 2006. You'll also receive all presentation materials. </span></font><o:p></o:p></li>
</ol>
</td>
</tr>
</table>
<p><b><font size=3 color="#006666" face=Verdana><span style='font-size:12.0pt;
font-family:Verdana;color:#006666;font-weight:bold'>Three Easy Ways to Register</span></font></b><font
size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana'><br>
Please mention priority code <b><span style='font-weight:bold'>061MML </span></b>when
registering.</span></font><o:p></o:p></p>
<ol start=1 type=1>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
mso-list:l1 level1 lfo4'><font size=3 color=black face="Times New Roman"><span
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size=2 color="#006666" face=Verdana><span style='font-size:10.0pt;
font-family:Verdana;color:#006666;font-weight:bold'>Enroll</span></font></b><b><font
size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana;
font-weight:bold'> <a
href="http://www.fdanews.com/wbi/conferences/wastemanagement.html?s=9116&p=061MML">online.</a></span></font></b><font
size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana'> </span></font><o:p></o:p></li>
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size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana'> +1
(703) 538-7600 or toll free (888) 838-5578. Use your American Express,
Visa or MasterCard. </span></font><o:p></o:p></li>
<li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;
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size=2 color="#006666" face=Verdana><span style='font-size:10.0pt;
font-family:Verdana;color:#006666;font-weight:bold'>Mail</span></font></b><font
size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana'>
your check to: <b><span style='font-weight:bold'>FDAnews</span></b>, <st1:address
w:st="on"><st1:Street w:st="on">300 N. Washington St., Suite 200</st1:Street>
<st1:City w:st="on">Falls Church</st1:City>, <st1:State w:st="on">VA</st1:State>
<st1:PostalCode w:st="on">22046-3431</st1:PostalCode></st1:address>. </span></font><o:p></o:p></li>
</ol>
<p><b><font size=3 color="#006666" face=Verdana><span style='font-size:12.0pt;
font-family:Verdana;color:#006666;font-weight:bold'>Satisfaction Guaranteed</span></font></b><font
size=2 face=Verdana><span style='font-size:10.0pt;font-family:Verdana'><br>
You must be 100% satisfied with this learning opportunity or we'll refund your
entire tuition or extend a credit to a future <b><span style='font-weight:bold'>FDAnews</span></b>
audioconference.</span></font><o:p></o:p></p>
<table class=MsoNormalTable border=0 cellspacing=0 cellpadding=0>
<tr>
<td valign=bottom style='padding:0in 0in 0in 0in'>
<p class=MsoNormal><font size=1 color="#999999" face=Verdana><span
style='font-size:7.5pt;font-family:Verdana;color:#999999'>The email address
on file is hunterj@cder.fda.gov.<br>
<a
href="http://www.fdanews.com/cgi-bin/udt/mlm3.unsub?cid=fdanews&uid=8042837&lid=promo&e=hunterj@cder.fda.gov">Click
here</a> to be removed from this mailing list.<br>
<br>
-----------------------<br>
FDAnews, <st1:address w:st="on"><st1:Street w:st="on">300 N. Washington St.,
Suite 200</st1:Street>, <st1:City w:st="on">Falls Church</st1:City>, <st1:State
w:st="on">VA</st1:State> <st1:PostalCode w:st="on">22046-3431</st1:PostalCode></st1:address><o:p></o:p></span></font></p>
</td>
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<p class=MsoNormal><font size=3 color=black face="Times New Roman"><span
style='font-size:12.0pt'><img border=0 width=1 height=1 id="_x0000_i1029"
src="http://www.fdanews.com/images/eletterbtn.gif?fdanews.9116.8042837"
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