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<p class="MsoNormal"><span style="font-size:11.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;;color:#1F497D">Thanks Ed for advertising this! And, while rhetorical, you raise some good questions about the scope of the fellowship (and about us maybe needing more staff&#8230;or
 pay! </span><span style="font-size:11.0pt;font-family:Wingdings;color:#1F497D">J</span><span style="font-size:11.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;;color:#1F497D"> ). A key clarification is that the participant would not be guiding the research/regulation
 of drugs w/E, A, or T activity or the other topics noted. Rather, the appointment is an educational opportunity, as described more at
<a href="http://orise.orau.gov/fda/current-research-participant/nature-of-appointment.htm">
http://orise.orau.gov/fda/current-research-participant/nature-of-appointment.htm</a>, which would involve working with CDER staff as well as with other FDA Centers and other agencies on a variety of research topics, with EAT activity the main focus given the
 new draft guidance. <o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;;color:#1F497D"><o:p>&nbsp;</o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;;color:#1F497D">Regarding the one year appointment, this is routine for ORISE. They can be extended in increments of up to one year, up to a total of four (postgrad.) or five
 (postdoc.) years, contingent upon project needs and funding. See &#8220;How to renew a participant&#8221; in the sidebar of the above link. And yes, health insurance is required, but it can be purchased through ORISE at reasonable rates (see &#8220;Insurance&#8221; at the link above).
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;;color:#1F497D"><o:p>&nbsp;</o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;;color:#1F497D">If anyone has any questions about the position, please let me know.<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;;color:#1F497D"><o:p>&nbsp;</o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;;color:#1F497D">Best,
<o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;;color:#1F497D">Jim<o:p></o:p></span></p>
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<p class="MsoNormal" style="text-autospace:none"><b><span style="font-size:9.0pt;font-family:&quot;Arial&quot;,&quot;sans-serif&quot;;color:#1F497D">James Laurenson
</span></b><span style="font-size:9.0pt;font-family:&quot;Arial&quot;,&quot;sans-serif&quot;;color:#1F497D">/<b>
</b></span><i><span style="font-size:8.0pt;font-family:&quot;Arial&quot;,&quot;sans-serif&quot;;color:#1F497D">Environmental Officer, Toxicologist
</span></i><span style="font-size:8.0pt;font-family:&quot;Arial&quot;,&quot;sans-serif&quot;;color:#1F497D">&nbsp;/ Center for Drug Evaluation &amp; Research / U.S. Food &amp; Drug Administration / 10903 New Hampshire Ave., Bldg. 21, Rm. 1626 / Silver Spring, MD&nbsp; 20993 / 301-796-4872 (office)
 / 703-342-9496 (cell) / <a href="mailto:james.laurenson@fda.hhs.gov">james.laurenson@fda.hhs.gov</a></span><span style="font-size:11.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;;color:#1F497D"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;;color:#1F497D"><o:p>&nbsp;</o:p></span></p>
<p class="MsoNormal"><span style="font-size:11.0pt;font-family:&quot;Calibri&quot;,&quot;sans-serif&quot;;color:#1F497D"><o:p>&nbsp;</o:p></span></p>
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<p class="MsoNormal"><b><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;">From:</span></b><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;">
<a href="mailto:pharmwaste-bounces@lists.dep.state.fl.us">pharmwaste-bounces@lists.dep.state.fl.us</a> [<a href="mailto:pharmwaste-bounces@lists.dep.state.fl.us">mailto:pharmwaste-bounces@lists.dep.state.fl.us</a>]
<b>On Behalf Of </b>Ed Gottlieb<br>
<b>Sent:</b> Tuesday, September 01, 2015 2:29 PM<br>
<b>To:</b> <a href="mailto:pharmwaste@lists.dep.state.fl.us">pharmwaste@lists.dep.state.fl.us</a><br>
<b>Subject:</b> [Pharmwaste] FDA adding reseacher to guide research/regulation of drugs w/ Estrogenic, Androgenic, or Thyroid Activity<o:p></o:p></span></p>
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<p class="MsoNormal"><o:p>&nbsp;</o:p></p>
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<p class="MsoNormal" style="margin-bottom:12.0pt"><a href="http://orise.orau.gov/science-education/internships-scholarships-fellowships/description.aspx?JobId=18495" target="_blank"><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;">http://orise.orau.gov/science-education/internships-scholarships-fellowships/description.aspx?JobId=18495</span></a><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;;color:black"><o:p></o:p></span></p>
<p class="MsoNormal"><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;;color:black">The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impact of their actions. &nbsp;To comply, FDA implements
 21 CFR Part 25, which includes a requirement for an environmental assessment (EA) if &#8220;extraordinary circumstances&#8221; indicate that the specific proposed action may significantly affect the quality of the human environment.
<br>
The new EA&nbsp;draft guidence, Questions and Answers&nbsp;Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity,&nbsp;informs drug applicants that recent research indicates that some drugs with hormonal activity in the environment may exhibit &#8220;extraordinary circumstances&#8221;
 and that the Agency may require additional ecotoxicity testing for applications submitted for drugs with hormonal activity. &nbsp;In addition, antimicrobial, additivity/synergism, nanotechnology, and other properties have been implicated for possible adverse environment
 effects, as well as human effects through environmental pathways. &nbsp;Also, other Centers (e.g., CVM), agencies (e.g., EPA), and regions (e.g., EU) have begun addressing these issues through research, guidance, and regulatory development. &nbsp;The EA Staff requires
 support for research and implementation to address these issues.<o:p></o:p></span></p>
<p class="MsoNormal" style="margin-bottom:12.0pt"><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;;color:black"><br>
Rhetorically, I wonder how big the FDA research staff is that they are only adding one temporary position to help cover the huge range of tasks spelled out in the job announcement (link above)?&nbsp; Who would take on such a daunting task, knowing they have to do
 it in only one year?&nbsp; And, as a consultant, they have to provide their own health insurance.
<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;;color:black">Ed Gottlieb<br>
Chair, Coalition for Safe Medication Disposal<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;;color:black">Industrial Pretreatment Coordinator<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;;color:black">Ithaca Area Wastewater Treatment Facility<br>
525 3</span><sup><span style="color:black">rd</span></sup><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;;color:black"> Street<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;;color:black">Ithaca, NY&nbsp; 14850<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;;color:black">(607) 273-8381<o:p></o:p></span></p>
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<p class="MsoNormal"><span style="font-size:10.0pt;font-family:&quot;Tahoma&quot;,&quot;sans-serif&quot;;color:black">fax: (607) 273-8433<o:p></o:p></span></p>
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