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<TITLE>NOT-OD-16-052: Notice Clarifying SBIR Direct-to-Phase II Eligibility Criteria</TITLE>
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<span class="title">Notice Clarifying SBIR Direct-to-Phase II Eligibility Criteria</span>
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<p><span class="heading3">Notice Number:</span> <span class="title">NOT-OD-16-052</span></p>
<p><span class="heading3">Key Dates</span><br>
<strong>Release Date:</strong> January 12, 2016</p>
<span class="heading3">Related Announcements</span><br>
<a href="https://grants.nih.gov/grants/guide/pa-files/PAR-14-088.html">PAR-14-088</a>
<p><span class="heading3">Issued by</span><br>
National Cancer Institute (<a href="http://www.nci.nih.gov/">NCI</a>)<br>
National Eye Institute (<a href="http://www.nei.nih.gov">NEI</a>)<br>
National Heart, Lung, and Blood Institute (<a href="http://www.nhlbi.nih.gov">NHLBI</a>)<br>
National Human Genome Research Institute (<a href="http://www.nhgrii.nih.gov">NHGRI</a>)<br>
National Institute on Aging (<a href="http://www.nia.nih.gov">NIA</a>)<br>
National Institute on Alcohol Abuse and Alcoholism (<a href="http://www.niaaa.nih.gov">NIAAA</a>)<br>
National Institute of Allergy and Infectious Diseases (<a href="http://www.niaid.nih.gov">NIAID</a>)<br>
National Institute of Arthritis and Musculoskeletal and Skin Diseases (<a href="http://www.niams.nih.gov">NIAMS</a>)<br>
National Institute of Biomedical Imaging and Bioengineering (<a href="http://www.nibib.nih.gov">NIBIB</a>)<br>
<em>Eunice Kennedy Shriver</em> National Institute of Child Health and Human Development (<a href="http://www.nichd.nih.gov">NICHD</a>)<br>
National Institute on Deafness and Other Communication Disorders (<a href="http://www.nidcd.nih.gov">NIDCD</a>)<br>
National Institute on Dental and Craniofacial Research (<a href="http://www.nidcr.nih.gov">NIDCR</a>)<br>
National Institute of Diabetes and Digestive and Kidney Diseases (<a href="http://www.niddk.nih.gov">NIDDK</a>)<br>
National Institute on Drug Abuse (<a href="http://www.nida.nih.gov">NIDA</a>)<br>
National Institute of General Medical Sciences (<a href="http://www.nigms.nih.gov">NIGMS</a>)<br>
National Institute of Mental Health (<a href="http://www.nimh.nih.gov">NIMH</a>)<br>
National Institute of Neurological Disorders and Stroke (<a href="http://www.ninds.nih.gov">NINDS</a>)<br>
National Institute on Minority Health and Health Disparities (<a href="http://www.nimhd.nih.gov/">NIMHD</a>)<br>
National Center for Advancing Translational Sciences (<a href="http://ncats.nih.gov/">NCATS</a>)<br>
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (<a href="http://dpcpsi.nih.gov/orip/index.aspx">ORIP</a>)</p>
<p class="heading2">Purpose</p>
<p>The purpose of this Notice is to clarify the types of applications which can be submitted to the National Institutes of Health Small Business Innovation Research (NIH SBIR) Direct-to-Phase II pilot funding opportunity announcement PAR-14-088. The NIH Direct-to-Phase II program will accept Phase II submissions regardless of the funding source for the Phase I-like proof of principle work on which the proposed Phase II research is based. </p>
<p>NIH <strong>strongly</strong> encourages small businesses to contact the appropriate Institute or Center early in their application planning process to ensure their technology is of priority to the Institute/Center.</p>
<p>Information regarding the funding opportunity submission information is changed as follows:&nbsp;</p>
<p>Part 2. Section I. Funding Opportunity Description</p>
<p>The following text is deleted:&nbsp;</p>
<p><em>The goal of this FOA is to enable a small business that has accomplished the objectives of a Phase I SBIR grant through non-SBIR funds to initiate the Phase II SBIR stage of development, without needing to perform more early stage, Phase-I-SBIR-type research.</em></p>
<p><em>This FOA will also not accept &lsquo;regular&rsquo; Phase II submissions from SBCs that have received a Phase I SBIR or STTR award from NIH or any other agency that participates in the SBIR/STTR programs for projects for which applicants now seek follow-on research and development funding.&nbsp;</em></p>
<p>The following text is added:&nbsp;</p>
<p><em>The NIH Direct-to-Phase II program will accept Phase II submissions regardless of the funding source for the Phase I-like proof of principle work on which the proposed Phase II research is based, with the following exception:&nbsp;</em></p>
<p><em>Small business concerns (SBCs) eligible to submit Phase II applications for projects that were supported with a Phase I SBIR or STTR award from NIH or any other agency are expected to submit the regular Phase II application through SBIR/STTR solicitations as &quot;Renewal&quot; applications based on the awarded Phase I SBIR or STTR project. Only one Phase II application may be awarded for a specific project supported by a Phase I award. </em><em>NIH policies regarding overlapping applications still apply (<a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-082.html">NOT-OD-14-082</a>).</em><em>&nbsp;A Phase II awardee may receive one additional, sequential Phase II award (called the NIH Phase IIB) to continue the work of an initial Phase II award. </em>&nbsp;</p>
<p>All other aspects of these FOAs remain unchanged.</p>
<p class="heading2">Inquiries</p>
<p>Please direct all inquiries to: <br>
<br>
NIH SBIR/STTR Program Office<br>
Telephone: 301-435-2688<br>
Email: <a href="/cdn-cgi/l/email-protection#5b283932291b343f75353233753c342d"><span class="__cf_email__" data-cfemail="b9cadbd0cbf9d6dd97d7d0d197ded6cf">[email&#160;protected]</span></a><br>
Website: <a href="http://sbir.nih.gov">http://sbir.nih.gov</a></p>
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