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<p class="MsoNormal"><b><font size="2" color="navy" face="Comic Sans MS"><span style="font-size:10.0pt;font-family:"Comic Sans MS";color:navy;font-weight:bold">This is taken directly from the new rule…sadly. Donna Lotzer<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="mso-layout-grid-align:none;text-autospace:none"><b><font size="3" color="#000099" face="TimesNewRoman,Bold"><span style="font-size:12.0pt;font-family:"TimesNewRoman,Bold","serif";mso-bidi-font-family:"TimesNewRoman\,Bold";font-weight:bold"><o:p> </o:p></span></font></b></p>
<p class="MsoNormal" style="mso-layout-grid-align:none;text-autospace:none"><b><font size="3" color="#000099" face="TimesNewRoman,Bold"><span style="font-size:12.0pt;font-family:"TimesNewRoman,Bold","serif";mso-bidi-font-family:"TimesNewRoman\,Bold";font-weight:bold">Issue:
</span></font></b><font face="TimesNewRoman"><span style="font-family:"TimesNewRoman","serif";mso-bidi-font-family:TimesNewRoman">A commenter asked the DEA
</span></font><b style="mso-bidi-font-weight:normal"><font color="red" face="TimesNewRoman"><span style="font-family:"TimesNewRoman","serif";mso-bidi-font-family:TimesNewRoman;color:red;font-weight:bold;mso-bidi-font-weight:normal">to clarify whether or not
the non-retrievable standard of destruction applies to substances disposed from households,
</span></font></b><font face="TimesNewRoman"><span style="font-family:"TimesNewRoman","serif";mso-bidi-font-family:TimesNewRoman">and this commenter stated that the DEA should develop and endorse a practical solution for in-home disposal.</span></font><font color="black" face="TimesNewRoman"><span style="font-family:"TimesNewRoman","serif";mso-bidi-font-family:TimesNewRoman;color:windowtext"><o:p></o:p></span></font></p>
<p class="MsoNormal" style="mso-layout-grid-align:none;text-autospace:none"><b><font size="3" color="#000099" face="TimesNewRoman,Bold"><span style="font-size:12.0pt;font-family:"TimesNewRoman,Bold","serif";mso-bidi-font-family:"TimesNewRoman\,Bold";font-weight:bold"><o:p> </o:p></span></font></b></p>
<p class="MsoNormal" style="mso-layout-grid-align:none;text-autospace:none"><b><font size="3" color="#000099" face="TimesNewRoman,Bold"><span style="font-size:12.0pt;font-family:"TimesNewRoman,Bold","serif";mso-bidi-font-family:"TimesNewRoman\,Bold";font-weight:bold">Response:
</span></font></b><b style="mso-bidi-font-weight:normal"><font color="red" face="TimesNewRoman"><span style="font-family:"TimesNewRoman","serif";mso-bidi-font-family:TimesNewRoman;color:red;font-weight:bold;mso-bidi-font-weight:normal">Ultimate users may continue
to dispose of their own pharmaceutical controlled substances in the manner recommended by other Federal and State agencies, such as the FDA, Office of National Drug Control Policy (<span class="SpellE">ONDCP</span>), and EPA</span></font></b><font face="TimesNewRoman"><span style="font-family:"TimesNewRoman","serif";mso-bidi-font-family:TimesNewRoman">.
The non-retrievable standard is only applicable to inventoried controlled substances (i.e., a registrant’s stock) and collected controlled substances (i.e., substances collected from ultimate users by authorized collectors) to be disposed of by registrants,
pursuant to § 1317.90. </span></font><b style="mso-bidi-font-weight:normal"><font color="red" face="TimesNewRoman"><span style="font-family:"TimesNewRoman","serif";mso-bidi-font-family:TimesNewRoman;color:red;font-weight:bold;mso-bidi-font-weight:normal">The
non-retrievable standard does not apply to non-registrants.<o:p></o:p></span></font></b></p>
<p class="MsoNormal"><b><font size="2" color="navy" face="Comic Sans MS"><span style="font-size:10.0pt;font-family:"Comic Sans MS";color:navy;font-weight:bold"><o:p> </o:p></span></font></b></p>
<p class="MsoNormal"><b><font size="2" color="navy" face="Comic Sans MS"><span style="font-size:10.0pt;font-family:"Comic Sans MS";color:navy;font-weight:bold">It does appear to conflict with this statement from the rule…until you realize the limitation above.<o:p></o:p></span></font></b></p>
<p class="MsoNormal" style="mso-layout-grid-align:none;text-autospace:none"><b style="mso-bidi-font-weight:normal"><i><u><font size="3" color="#000099" face="TimesNewRoman,Italic"><span style="font-size:12.0pt;font-family:"TimesNewRoman,Italic","serif";mso-bidi-font-family:"TimesNewRoman\,Italic";font-weight:bold;mso-bidi-font-weight:normal;font-style:italic"><o:p><span style="text-decoration:none"> </span></o:p></span></font></u></i></b></p>
<p class="MsoNormal" style="mso-layout-grid-align:none;text-autospace:none"><b style="mso-bidi-font-weight:normal"><i><u><font size="3" color="#000099" face="TimesNewRoman,Italic"><span style="font-size:12.0pt;font-family:"TimesNewRoman,Italic","serif";mso-bidi-font-family:"TimesNewRoman\,Italic";font-weight:bold;mso-bidi-font-weight:normal;font-style:italic">Non-Retrievable
Destruction Standard</span></font></u></i></b><b style="mso-bidi-font-weight:normal"><u><font face="TimesNewRoman,Italic"><span style="font-family:"TimesNewRoman,Italic","serif";mso-bidi-font-family:"TimesNewRoman\,Italic";font-weight:bold;mso-bidi-font-weight:normal;mso-bidi-font-style:italic"><o:p></o:p></span></font></u></b></p>
<p class="MsoNormal" style="mso-layout-grid-align:none;text-autospace:none"><b><font size="3" color="#000099" face="TimesNewRoman,Bold"><span style="font-size:12.0pt;font-family:"TimesNewRoman,Bold","serif";mso-bidi-font-family:"TimesNewRoman\,Bold";font-weight:bold">Issue:
</span></font></b><font face="TimesNewRoman"><span style="font-family:"TimesNewRoman","serif";mso-bidi-font-family:TimesNewRoman">Forty
<b style="mso-bidi-font-weight:normal"><span style="font-weight:bold;mso-bidi-font-weight:normal">commenters asked the DEA to outline performance standards and parameters<o:p></o:p></span></b></span></font></p>
<p class="MsoNormal" style="mso-layout-grid-align:none;text-autospace:none"><b style="mso-bidi-font-weight:normal"><font size="3" color="#000099" face="TimesNewRoman"><span style="font-size:12.0pt;font-family:"TimesNewRoman","serif";mso-bidi-font-family:TimesNewRoman;font-weight:bold;mso-bidi-font-weight:normal">for
the “non-retrievable” destruction standard. Although many commenters applauded the DEA for proposing a standard that will permit future innovation, many commenters felt that innovation may be hindered by the uncertain terms. Commenters asked the DEA to list
currently-approved methods, and to outline how the DEA will evaluate new technology intended to render controlled substances “non-retrievable.”<o:p></o:p></span></font></b></p>
<p class="MsoNormal"><b><font size="3" color="#000099" face="TimesNewRoman,Bold"><span style="font-size:12.0pt;font-family:"TimesNewRoman,Bold","serif";mso-bidi-font-family:"TimesNewRoman\,Bold";font-weight:bold"><o:p> </o:p></span></font></b></p>
<p class="MsoNormal"><b><font size="3" color="#000099" face="TimesNewRoman,Bold"><span style="font-size:12.0pt;font-family:"TimesNewRoman,Bold","serif";mso-bidi-font-family:"TimesNewRoman\,Bold";font-weight:bold">Response:
</span></font></b><b style="mso-bidi-font-weight:normal"><font face="TimesNewRoman"><span style="font-family:"TimesNewRoman","serif";mso-bidi-font-family:TimesNewRoman;font-weight:bold;mso-bidi-font-weight:normal">In the
<span class="SpellE">NPRM</span>, the </span></font></b><b style="mso-bidi-font-weight:normal"><font color="#002060" face="TimesNewRoman"><span style="font-family:"TimesNewRoman","serif";mso-bidi-font-family:TimesNewRoman;color:#002060;font-weight:bold;mso-bidi-font-weight:normal">DEA
indicated that incineration and chemical digestion are some examples of current technology that may be utilized to achieve the non-retrievable standard.<u>
</u></span></font></b><b style="mso-bidi-font-weight:normal"><u><font color="red" face="TimesNewRoman"><span style="font-family:"TimesNewRoman","serif";mso-bidi-font-family:TimesNewRoman;color:red;font-weight:bold;mso-bidi-font-weight:normal">The preamble of
the <span class="SpellE">NPRM</span> states that sewering (disposal by flushing down a toilet or sink) and landfill disposal (mixing controlled substances with undesirable items such as kitty litter or coffee grounds and depositing in a garbage collection)
are examples of current methods of disposal that do not meet the non-retrievable standard.<o:p></o:p></span></font></u></b></p>
<p class="MsoNormal"><b><font size="2" color="navy" face="Comic Sans MS"><span style="font-size:10.0pt;font-family:"Comic Sans MS";color:navy;font-weight:bold"><o:p> </o:p></span></font></b></p>
<p class="MsoNormal"><b><font size="2" color="navy" face="Comic Sans MS"><span style="font-size:10.0pt;font-family:"Comic Sans MS";color:navy;font-weight:bold"><o:p> </o:p></span></font></b></p>
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<p class="MsoNormal"><b><font size="2" color="black" face="Tahoma"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif";mso-fareast-font-family:"Times New Roman";color:windowtext;font-weight:bold">From:</span></font></b><font size="2" color="black" face="Tahoma"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif";mso-fareast-font-family:"Times New Roman";color:windowtext">
Volkman, Jennifer (MPCA) [mailto:jennifer.volkman@state.mn.us] <br>
<b><span style="font-weight:bold">Sent:</span></b> Tuesday, September 09, 2014 11:28 AM<br>
<b><span style="font-weight:bold">To:</span></b> pharmwaste@lists.dep.state.fl.us<br>
<b><span style="font-weight:bold">Subject:</span></b> [Pharmwaste] FW: FDA's website guidance conflicts with ONDCP's new program<o:p></o:p></span></font></p>
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<p class="MsoNormal"><font size="3" color="black" face="Calibri"><span style="font-size:12.0pt;font-family:"Calibri","sans-serif";mso-fareast-font-family:"Times New Roman";color:black">These aren't the best messages I've written and I didn't take time to look
up the best address for FDA (I took it from the source view of their web page), but I think more of us need to tell/ask ONDCP and FDA to get rid of FDA's guidance that emphasizes flushing of certain medications. There is consistency between ONDCP's and EPA's
guidance, but FDA must still not be convinced that collection is favorable over flushing? Maybe they are working on it? Seems silly for ONDCP to launch this big media event to promote collection when their disposal guidance links to flushing. <o:p></o:p></span></font></p>
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<p class="MsoNormal" style="margin-bottom:12.0pt;mso-outline-level:1"><b><font size="2" color="black" face="Tahoma"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif";mso-fareast-font-family:"Times New Roman";color:black;font-weight:bold">From:</span></font></b><font size="2" color="black" face="Tahoma"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif";mso-fareast-font-family:"Times New Roman";color:black">
Volkman, Jennifer (MPCA)<br>
<b><span style="font-weight:bold">Sent:</span></b> Monday, September 08, 2014 7:34 PM<br>
<b><span style="font-weight:bold">To:</span></b> <a href="mailto:oipl@ondcp.eop.gov">
oipl@ondcp.eop.gov</a>; <a href="mailto:druginfo@fda.hhs.gov">druginfo@fda.hhs.gov</a><br>
<b><span style="font-weight:bold">Subject:</span></b> RE: FDA's website guidance conflicts with ONDCP's new program</span></font><font color="black"><span style="mso-fareast-font-family:"Times New Roman";color:black"><o:p></o:p></span></font></p>
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<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Hello again,</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">I missed this link! It shows consistency between EPA and ONDCP, but still points to the FDA’s confusing flush
disposal recommendations for certain prescription medications. </span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><a href="http://www.deadiversion.usdoj.gov/drug_disposal/index.html" target="_blank">http://www.deadiversion.usdoj.gov/drug_disposal/index.html</a>
</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">I come at this from the perspective of trying (for 20 years) to get simple information out to families so they
can do their part to reduce poisoning, abuse and environmental impacts. Telling people to put all of their medications in a bag and bring them to a collection box is the simplest way to get them to take action. If they find conflicting information on the label,
websites or in the instructions that come with prescriptions, they are likely to put off trying to figure out how to do the right thing. The very best result of all of this is to raise awareness and get people to act.
</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Thanks for all of your hard work!</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">JV</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"> </span></font><o:p></o:p></p>
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<p class="MsoNormal" style="mso-outline-level:1"><b><font size="2" color="black" face="Tahoma"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif";color:windowtext;font-weight:bold">From:</span></font></b><font size="2" color="black" face="Tahoma"><span style="font-size:10.0pt;font-family:"Tahoma","sans-serif";color:windowtext">
Volkman, Jennifer (MPCA) <br>
<b><span style="font-weight:bold">Sent:</span></b> Monday, September 08, 2014 5:57 PM<br>
<b><span style="font-weight:bold">To:</span></b> 'oipl@ondcp.eop.gov'; 'druginfo@fda.hhs.gov'<br>
<b><span style="font-weight:bold">Subject:</span></b> FDA's website guidance conflicts with ONDCP's new program</span></font><o:p></o:p></p>
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<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Good afternoon,</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">I listened in on the stakeholder Q and A today and someone asked whether ONDCP was going to update its information
on flushing drugs. The ONDCP’s website actually points to the FDA’s website for disposal instructions. It is the information on the FDA’s website that needs updating:
</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Here is where FDA instructs people to flush certain drugs:</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><a href="http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm#MEDICINES" target="_blank">http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm#MEDICINES</a>
</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">I understand the original impetus for the wording of the information back in 2009. It is just something that needs
to be made consistent if at all possible.</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">The
<span class="SpellE">ONDCP</span> site at this link <a href="http://www.whitehouse.gov/ondcp/prescription-drug-abuse" target="_blank">
http://www.whitehouse.gov/ondcp/prescription-drug-abuse</a> still refers people to the FDA website link above. If you scroll down below the graphs, it is in this paragraph, highlighted:</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"> </span></font><o:p></o:p></p>
<h2 style="margin-top:0in"><font size="3" color="black" face="Georgia"><span lang="EN" style="font-size:12.0pt;mso-fareast-font-family:"Times New Roman";mso-ansi-language:EN">“What You Can Do</span></font><span style="mso-fareast-font-family:"Times New Roman""><o:p></o:p></span></h2>
<p class="MsoNormal" style="text-indent:-.25in"><font size="2" color="#333333" face="Symbol"><span lang="EN" style="font-size:10.0pt;font-family:Symbol;color:#333333;mso-ansi-language:EN">·</span></font><font size="1" color="#333333"><span lang="EN" style="font-size:7.0pt;color:#333333;mso-ansi-language:EN">
</span></font><strong><b><font size="1" color="#333333" face="Arial"><span lang="EN" style="font-size:9.0pt;font-family:"Arial","sans-serif";color:#333333;mso-ansi-language:EN">Follow disposal guidelines</span></font></b></strong><font size="1" color="#333333" face="Arial"><span lang="EN" style="font-size:9.0pt;font-family:"Arial","sans-serif";color:#333333;mso-ansi-language:EN">:
No matter who you are, you can help address this issue in your home. By following the guidelines, you reduce the risk of unintentional diversion or harm.
<span style="background:yellow">Learn <a href="http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm" target="_blank">
how to dispose of unused medicines</a>, read</span> the <a href="http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186188.htm" target="_blank">
frequently asked questions</a> about safe drug disposal, and get information on <a href="http://www.cdc.gov/HomeandRecreationalSafety/Poisoning/brief_full_page.htm" target="_blank">
drug poisoning</a>.”</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">The simplest thing might be for you to delete that paragraph because the one you have below it works just fine:</span></font><o:p></o:p></p>
<p class="MsoNormal"><strong><b><font size="1" color="#333333" face="Arial"><span lang="EN" style="font-size:9.0pt;font-family:"Arial","sans-serif";color:#333333;mso-ansi-language:EN">“Take advantage of community take-back programs</span></font></b></strong><font size="1" color="#333333" face="Arial"><span lang="EN" style="font-size:9.0pt;font-family:"Arial","sans-serif";color:#333333;mso-ansi-language:EN">:
Call your city or county government's household <s>trash and recycling service</s>
<u>hazardous waste program</u>, or your local police or sheriff's department to see if a take-back program is available in your community.”
</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#333333" face="Calibri"><span lang="EN" style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#333333;mso-ansi-language:EN">You could update it with a note that you’ve revised rules so that pharmacies may
be able to collect medications in the future, once state and local laws are sorted out. Don’t send people to pharmacies yet!!!</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="1" color="#333333" face="Arial"><span lang="EN" style="font-size:9.0pt;font-family:"Arial","sans-serif";color:#333333;mso-ansi-language:EN">The
<span class="SpellE">FAQs</span> posted by FDA are also in need of updating:</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><a href="http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186188.htm" target="_blank">http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186188.htm</a>
</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">This is what the MPCA’s website tells people to do:</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D"><a href="http://www.pca.state.mn.us/index.php/living-green/living-green-citizen/household-hazardous-waste/disposing-of-unwanted-medications.html" target="_blank">http://www.pca.state.mn.us/index.php/living-green/living-green-citizen/household-hazardous-waste/disposing-of-unwanted-medications.html</a>
</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Please let me know what the plan is for an update.</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Thank you!</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Jennifer Volkman</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Statewide HHW Program Coordinator</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">Minnesota Pollution Control Agency</span></font><o:p></o:p></p>
<p class="MsoNormal"><font size="2" color="#1f497d" face="Calibri"><span style="font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D">651-757-2801</span></font><o:p></o:p></p>
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