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<HEAD>
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<TITLE>NOT-OD-21-048: Notice of Correction to PAR-20-256: Clarification on Frequency of Usage Reports</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Notice of Correction to PAR-20-256: Clarification on Frequency of Usage Reports NOT-OD-21-048. NIH">
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<META NAME="Keywords" CONTENT="NOT-OD-21-048: Notice of Correction to PAR-20-256: Clarification on Frequency of Usage Reports">
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<div id="page-title" class="heading1" tabindex="0"></div>
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<span class="title">Notice of Correction to PAR-20-256: Clarification on Frequency of Usage Reports</span>
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</div>
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Notice Number:
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</div>
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<div data-element-id="1723" data-element-has-label="true" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="LINKED_ELEMENT">
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<span class="noticenum">NOT-OD-21-048</span>
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</div>
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<div data-element-id="1728" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
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<a name="_Key_Dates"></a><h2 class="heading2">Key Dates</h2>
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<div class="row" data-index="4">
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<div class="col-md-4 datalabel" tabindex="0" data-element-id="1721" data-element-required="false" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
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Release Date:
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<div class="col-md-8 datacolumn">
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<p class="Normal">February 1, 2021</p>
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<a name="_"></a><h2 class="heading2">Related Announcements</h2>
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</div>
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<p class="Normal"><a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-256.html">PAR-20-256 </a>- Limited Competition Emergency Awards: Shared Personal Protective Equipment Resources for COVID-19 Related Vaccine and Treatment Clinical Trials and Clinical Studies (S10 Clinical Trial Not Allowed)</p>
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</div>
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<div data-element-id="1718" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
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<a name="_"></a><h2 class="heading2">Issued by</h2>
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</div>
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<p>Office of The Director, National Institutes of Health (<a href="https://www.nih.gov/institutes-nih/nih-office-director" target="_blank">OD</a>)
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</div>
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<div data-element-id="1727" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
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<a name="_"></a><h2 class="heading2">Purpose</h2>
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</div>
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<div data-element-id="1722" data-element-has-label="false" data-element-required="true" data-element-has-value="true" data-section-code="OI" data-element-type="TEXT">
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<p class="Normal">This Notice clarifies the reporting requirements for Personal protective equipment (PPE) usage such that it is consistent throughout <a href="//grants.nih.gov/grants/guide/pa-files/PAR-20-256.html">PAR-20-256</a>, "Limited Competition Emergency Awards: Shared Personal Protective Equipment Resources for COVID-19 Related Vaccine and Treatment Clinical Trials and Clinical Studies (S10 Clinical Trial Not Allowed)".</p>
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<p class="Normal">Personal protective equipment (PPE) usage reports are required semi-annually. References to quarterly reports were included in error.</p>
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<p class="Normal">The <b>Section I. Funding Opportunity Description</b> of <a href="//grants.nih.gov/grants/guide/pa-files/PAR-20-256.html">PAR-20-256</a> has been modified as follows:</p>
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<p class="Normal"><em>Currently Reads:</em></p>
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<p class="Normal">Each applicant institution must propose a Program Director/Principal Investigator (PD/PI) who will assume administrative and scientific oversight responsibility for the requested PPE. See <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-256.html#_Section_III._Eligibility">Section III.1</a> for qualifications for the PD/PI. The PD/PI also will be responsible for:</p>
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<ul>
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<li class="Normal">Requesting no-cost extensions of the project period, if needed;</li>
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<li class="Normal">At the end of the project period, preparing (and working with the institution to submit) a Final Research Performance Progress Report (Final RPPR) that describes the purchased equipment, lists all users and publications resulting from use of the PPE, and outlines the value of PPE to the investigators and to the institution as a whole, see <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-256.html#_Section_VI._Award">Section VI.3</a>;</li>
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<li class="Normal">Submitting semi-annual usage reports on the PPE to NIH during the project period and each quarter thereafter, until the PPE resources are fully depleted, see <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-256.html#_Section_VI._Award">Section VI.3</a>.</li>
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</ul>
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<p class="Normal">Each PD/PI must develop a PPE use, management and distribution plan (“PPE Usage Plan”). The PD/PI is responsible for:</p>
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<ul>
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<li class="Normal">Implementation of a detailed plan for the day-to-day management and appropriate distribution of the PPE to the clinical trial and clinical study sites and laboratories.</li>
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<li class="Normal">A plan to ensure that access to the PPE is limited to users conducting activities under the COVID-19 clinical trial.</li>
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<li class="Normal">Reviewing and approving quarterly usage reports.</li>
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<li class="Normal">Recommending a new PD/PI, if such a need arises.</li>
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</ul>
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<p class="Normal"><em>Modified to read (changes are shown below in <em><strong>bold italics):</strong></em></em></p>
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<p class="Normal">Each applicant institution must propose a Program Director/Principal Investigator (PD/PI) who will assume administrative and scientific oversight responsibility for the requested PPE. See <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-256.html#_Section_III._Eligibility">Section III.1</a> </span></span>for qualifications for the PD/PI. The PD/PI also will be responsible for:</p>
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<ul>
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<li class="Normal">Requesting no-cost extensions of the project period, if needed;</li>
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<li class="Normal">At the end of the project period, preparing (and working with the institution to submit) a Final Research Performance Progress Report (Final RPPR) that describes the purchased equipment, lists all users and publications resulting from use of the PPE, and outlines the value of PPE to the investigators and to the institution as a whole, see <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-256.html#_Section_VI._Award">Section VI.3</a>;</li>
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<li class="Normal">Submitting semi-annual usage reports on the PPE to NIH during the project period and <em><strong>semi-annually</strong></em> thereafter, until the PPE resources are fully depleted, see <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-256.html#_Section_VI._Award">Section VI.3</a>.</li>
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</ul>
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<p class="Normal">Each PD/PI must develop a PPE use, management and distribution plan (“PPE Usage Plan”). The PD/PI is responsible for:</p>
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<ul>
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<li class="Normal">Implementation of a detailed plan for the day-to-day management and appropriate distribution of the PPE to the clinical trial and clinical study sites and laboratories.</li>
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<li class="Normal">A plan to ensure that access to the PPE is limited to users conducting activities under the COVID-19 clinical trial.</li>
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<li class="Normal">Reviewing and approving <em><strong>semi-annual</strong></em> usage reports.</li>
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<li class="Normal">Recommending a new PD/PI, if such a need arises.</li>
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</ul>
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<p class="Normal">All other aspects of this Funding Opportunity Announcement remain unchanged.</p>
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</div>
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<a name="_"></a><h2 class="heading2">Inquiries</h2>
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<p>Please direct all inquiries to:</p>
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</div>
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<p class="Normal">The point(s) of contact listed in <a href="https://grants.nih.gov/grants/guide/pa-files/PAR-20-256.html">PAR-20-256</a>.</p>
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</div>
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<A HREF="/grants/guide/WeeklyIndex.cfm?02-05-21">Weekly TOC for this Announcement</A><br>
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<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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