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<TITLE>NOT-OD-12-148: Guidance on Departures from the Provisions of the Guide for the Care and Use of Laboratory Animals</TITLE>
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<META NAME="description" CONTENT="NIH Funding Opportunities and Notices in the NIH Guide for Grants and Contracts: Guidance on Departures from the Provisions of the Guide for the Care and Use of Laboratory Animals NOT-OD-12-148. NIH">
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<span class="title">Guidance on Departures from the Provisions of the Guide for the Care and Use of Laboratory Animals</span>
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<hr noshade>
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<p><span class="heading3">Notice Number:</span> <span class="title">NOT-OD-12-148</span></p>
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<p><span class="heading3">Key Dates</span><br>
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<span class="regulartextbold">Release Date: </span>September 10, 2012<br>
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</p>
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<span class="heading3">Related Notices<br>
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</span>
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<p><a href="//grants.nih.gov/grants/guide/notice-files/NOT-OD-21-161.html">NOT-OD-21-161</a> - Request for Information (RFI) on Clarifying the Reporting Requirements for Departures from the Guide for the Care and Use of Laboratory Animals</p>
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<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-020.html">NOT-OD-12-020</a>: Adoption and Implementation of the <em>Guide for the Care and Use of Laboratory Animals: Eighth Edition</em>
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<p><span class="heading3">Issued by</span><br>
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National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)<br>
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</p>
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<p class="heading2">Purpose</p>
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<p>This Notice provides guidance to Public Health Service (PHS) grantee institutions on review and reporting requirements for departures from the Eighth Edition of the <em>Guide for the Care and Use of Laboratory Animals</em> (<a href="http://www.nap.edu/catalog.php?record_id=12910" title="Link to Non-U.S. Government Site" Title="Link to Non-U.S. Government Site">Guide</a>). </p>
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<h4>Background</h4>
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<p>The NIH Office of Laboratory Animal Welfare (OLAW) oversees PHS-funded animal activities according to the PHS Policy on Humane Care and Use of Laboratory Animals (<a href="https://grants.nih.gov/grants/olaw/references/phspol.htm">Policy</a>). The Institutional Animal Care and Use Committee (IACUC) is responsible for oversight of the animal care and use program and its components as described in the PHS Policy and the <em>Guide.</em></p>
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<p>The PHS Policy <a href="https://grants.nih.gov/grants/olaw/references/phspol.htm#FunctionsoftheInstitutionalAnimalCareandUseCommittee">IV.B.3.</a> requires that the IACUC shall prepare reports of their semiannual program reviews and animal facility inspections and submit the reports to the Institutional Official (IO). The reports must contain a description of the nature and extent of the institution's adherence to the <em>Guide</em> and the PHS Policy and must identify specifically any departures from the provisions of the <em>Guide</em> and the PHS Policy, and must state the reasons for each departure. IACUC approval of departures from the <em>Guide</em> must be based on scientific, veterinary medical, or animal welfare issues. PHS Policy <a href="https://grants.nih.gov/grants/olaw/references/phspol.htm#ReportingRequirements">IV.F.3.</a> requires Assured institutions to report noncompliant unapproved departures from the <em>Guide</em> to OLAW. </p>
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<p>Since 1996, NIH had required Assured institutions to base their programs of animal care and use on the Seventh Edition of the <em>Guide</em>. On December 2, 2011, NIH announced that Assured institutions would be expected to implement the Eighth Edition of the <em>Guide</em> in 2012. The Eighth Edition of the <em>Guide</em> emphasizes the use of <a href="https://grants.nih.gov/grants/olaw/positionstatement_guide.htm#performance">performance standards</a>, providing flexibility that empowers institutions to continue to improve and advance the humane care and use of vertebrate animals in research, research training and biological testing.</p>
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<h4>Reporting requirements</h4>
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<p>Institutions are advised to read the Eighth Edition of the <em>Guide</em> carefully; it establishes exceptions in specific situations. These exceptions are not departures from the <em>Guide</em> and are not required to be reported to the IO. Additionally, guidance in the Eighth Edition of the <em>Guide</em> is stated in terms of standards that <strong>must</strong> be met, standards that <strong>should</strong> be met, and standards that <strong>may</strong> be met. <br>
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<br>
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OLAW defines a <strong>must</strong> statement as a minimum standard required of all Assured institutions. Deviation from these standards with IACUC approval is a departure from the <em>Guide</em> and must be reported in the semiannual report. Deviation from a must statement without IACUC approval is a noncompliance that must be reported to OLAW through the IO. </p>
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<p>Reporting requirements for <strong>should</strong> statements in the <em>Guide</em> vary: </p>
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<ul>
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<li> Should statements often involve performance standards. Well-established performance standards are not departures from the <em>Guide</em> and need not be reported in the semiannual report to the IO. <br>
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</li>
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<li> Deviation from a should statement with IACUC approval is a departure from the <em>Guide</em> and must be reported in the semiannual report to the IO. </li>
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<li> Deviation from a should statement without IACUC approval is a noncompliance that must be reported to OLAW through the IO.</li>
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</ul>
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<p><strong>May</strong> statements in the <em>Guide</em> are suggestions that institutions can choose to implement if suitable for their program and deviations are not included in the semiannual report to the IO. </p>
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<p>IACUC approval of departures from the <em>Guide</em> must be based on scientific, veterinary medical, or animal welfare issues. For additional information and examples of departures refer to OLAW <a href="https://grants.nih.gov/grants/olaw/faqs.htm#c7">FAQ C7</a>.</p>
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<p class="heading2">Inquiries</p>
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<p>For questions or further information, contact:</p>
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<p>Office of Laboratory Animal Welfare<br>
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Office of Extramural Research<br>
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National Institutes of Health<br>
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RKL1, Suite 360<br>
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6705 Rockledge Drive<br>
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Bethesda, MD 20892-7982<br>
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Phone: 301-496-7163<br>
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Fax: 301-915-9481<br>
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Email: <a href="/cdn-cgi/l/email-protection#452a292432052a216b2b2c2d6b222a33"><span class="__cf_email__" data-cfemail="67080b061027080349090e0f49000811">[email protected]</span></a><br>
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Web: <a href="http://olaw.nih.gov/">http://olaw.nih.gov/</a></p>
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<A HREF="/grants/guide/index.html">NIH Funding Opportunities and Notices</A>
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