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<TITLE>NOT-OD-12-005: Request for Information (RFI): To Solicit Input on Partnerships between Extramural and NIH Intramural Investigators Utilizing the NIH Clinical Center</TITLE>
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<span class="title">Request for Information (RFI): To Solicit Input on Partnerships between Extramural and NIH Intramural Investigators Utilizing the NIH Clinical Center</span>
<hr noshade>
<p><span class="heading3">Notice Number:</span> <span class="title">NOT-OD-12-005</span></p>
<p class="regulartext"><b>Update:</b> The following update relating to this announcement has been issued:</p>
<ul>
<li><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-HD-12-025.html">July 25, 2012</a> - See Notice NOT-HD-12-025. The purpose of this Notice is to announce the intention of NIH to issue a Funding Opportunity Announcement (FOA) to solicit applications from teams of extramural (non-NIH) investigators and internal (intramural) NIH investigators to conduct collaborative translational research projects that are aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. </li>
</ul>
<p><span class="heading3">Key Dates</span><br>
<span class="regulartextbold">Release Date: </span>October 12, 2011<strong><br>
</strong>Response Date: December 1, 2011 </p>
<p><span class="heading3">Issued by</span><br>
National Institutes of Health (<a href="http://www.nih.gov">NIH</a>)<br>
</p>
<p><span class="heading2">Purpose</span></p>
<p>The NIH Clinical Center (CC) seeks input from extramural scientists to identify potential opportunities for proposals involving use of the CC, in collaboration with the NIH intramural community, to enhance translation of basic biological discoveries into clinical applications that improve health. Information is sought on potential paradigms for collaborative partnerships, not necessarily on specific projects.<strong></strong></p>
<p><strong>Background</strong></p>
<p>The NIH Clinical Center is a hospital exclusively dedicated to clinical research. Its mission includes the support of clinical studies that are considered intellectually challenging and high-risk but with the potential of high reward with new breakthroughs in medicine. </p>
<p>In December 2010, the Congressionally-mandated Scientific Management Review Board (SMRB) recognized the potential benefits of opening the Clinical Center to extramural investigators. Their final report states, <em>The Clinical Center has boasted a long, distinguished history of significant research accomplishments. It also has served as a home for many of our nation&rsquo;s leading clinical investigators and academic leaders and is considered by many to be the premier institution for training the next generation of clinical researchers. Nonetheless, the traditional perception is that the Clinical Center is a resource intended only for NIH and its intramural program. Given the unique resources, expertise, and patient populations housed within the Center, some have argued that allowing qualified external investigators to conduct research at the Clinical Center could yield tremendous benefits to the clinical research enterprise overall. </em> The SMRB formally recommended that the role of the NIH Clinical Center should be to serve as a state-of-the-art national resource, with resources optimally managed to enable both internal and external investigator use<strong>. SMRB Report on the Clinical Center: pgs. 8 10. </strong>(<a href="http://smrb.od.nih.gov/documents/reports/CC_122010.pdf">http://smrb.od.nih.gov/documents/reports/CC_122010.pdf</a><strong>)</strong> </p>
<p>The special environment of the CC supports collaborative studies with NIH intramural investigators that may not be readily supported elsewhere. This is because the CC is a hospital that is exclusively dedicated to research with such special resources and opportunities as listed below, which may be accessible to extramural investigators via partnerships with intramural investigators:</p>
<ul>
<li>Equipment</li>
<ul>
<li>Functional and Applied Biomechanics for Motion Analysis (<a href="http://www.cc.nih.gov/rmd/fab/index.html">http://www.cc.nih.gov/rmd/fab/index.html</a>) </li>
<li>Innovative Radiology and Imaging Capabilities (<a href="http://www.cc.nih.gov/drd/">http://www.cc.nih.gov/drd/</a>)</li>
<ul>
<li>Magnetic Resonance Imaging (MRI): 3 Tesla, 1.5 Tesla </li>
<li>Intraoperative MRI for Real-Time Imaging During Procedures</li>
<li>Cardiac/Coronary CT Angiography </li>
<li>Whole-Body MRI/PET Multi-Modality Imaging</li>
<li>Research PACS/Clinical PACS Services</li>
<li>Drugs and Devices for Interventional Oncology (http://clinicalcenter.nih.gov/centerio/index.html)</li>
</ul>
<li>Metabolic Studies Clinical Research Program (<a href="http://www2.niddk.nih.gov/Research/ClinicalResearch/MCRU/">http://www2.niddk.nih.gov/Research/ClinicalResearch/MCRU/</a>)</li>
<ul>
<li>Sophisticated Calorimetry</li>
<li>Bodpods </li>
</ul>
</ul>
<li>Goods, Products, and Services</li>
<ul>
<li>Protocol Authoring Tool: ProtoType (<a href="http://www.nihtraining.com/cc/ippcr/current/downloads/Lightfoot021208.pdf" Title="Link to Non-U.S. Government Site">http://www.nihtraining.com/cc/ippcr/current/downloads/Lightfoot021208.pdf</a>)</li>
<li>Cell Processing (<a href="http://clinicalcenter.nih.gov/dtm/our_research.html#laboratory_services">http://clinicalcenter.nih.gov/dtm/our_research.html#laboratory_services</a>)</li>
<ul>
<li>Production and Banking of Bone Marrow Stromal Cells</li>
<li>Novel Cellular Biologics for Phase I/II Trials</li>
</ul>
<li>Biomedical Translational Research Information System, BTRIS (Clinical Research Data Repository ) <a href="http://btris.nih.gov/">http://btris.nih.gov/</a> </li>
<li>Detection and Identification of Microbes Using Mass Spectroscopy and Other Techniques (<a href="http://www.cc.nih.gov/cp/index.html">http://www.cc.nih.gov/cp/index.html</a>)</li>
<li>Drug Formulation Facility (<a href="http://www.cc.nih.gov/phar/development.html">http://www.cc.nih.gov/phar/development.html</a>)</li>
<li>PET Radiotracer/Ligand Synthesis (<a href="http://clinicalcenter.nih.gov/pet/index.html">http://clinicalcenter.nih.gov/pet/index.html</a>)</li>
<ul>
<li>Cyclotron-Produced Radionuclides</li>
<li>Radiopharmaceuticals</li>
</ul>
</ul>
<li>Patient Cohorts</li>
<ul>
<li>Healthy Volunteer Cohorts (<a href="http://clinicalcenter.nih.gov/recruit/volunteers.html">http://clinicalcenter.nih.gov/recruit/volunteers.html</a>)</li>
<li>More Than 400 Rare Disease Cohorts, For Example:</li>
<ul>
<li>Inflammatory Myositis (<a href="http://www.niams.nih.gov/research/ongoing_research/branch_lab/report_individual.asp?id=988&Branch_LabID=63&email=gourleym@mail.nih.gov&includefile=Branch">http://www.niams.nih.gov/research/ongoing_research/branch_lab/report_individual.asp?id=988&Branch_LabID=63&email=gourleym@mail.nih.gov&includefile=Branch</a>)</li>
<li>Progressive Multifocal Leukoencephalopathy (<a href="http://neuroscience.nih.gov/Lab.asp?Org_ID=530">http://neuroscience.nih.gov/Lab.asp?Org_ID=530</a>) </li>
<li>Numerous Genetic Disorders </li>
</ul>
<li>Undiagnosed Diseases Program (<a href="http://rarediseases.info.nih.gov/Resources.aspx?PageID=31">http://rarediseases.info.nih.gov/Resources.aspx?PageID=31</a> </li>
</ul>
<li>Training (<a href="http://clinicalcenter.nih.gov/training/index.html">http://clinicalcenter.nih.gov/training/index.html</a>)</li>
<ul>
<li>Clinical Research Curriculum (Composed of Three Courses)</li>
<li>ACGME Residency/Fellowships </li>
<li>Clinical/Research Electives for Students, Residents, and Clinical Fellows </li>
<li>NIH Institute and Center-Based Training Programs in the Clinical Center</li>
<li>Medical Research Scholars Program: New Year-Long Program For Research-Oriented Medical, Dental, and Veterinary Students</li>
<li>Sabbatical in Clinical Research Management </li>
</ul>
</ul>
<p>To implement the SMRB recommendations and to broaden and accelerate translational research, the NIH is considering the establishment of a new Bench to Bedside program of cooperative agreements between basic and clinical researchers, both within and outside the NIH. Teams will have at least one NIH intramural and one extramural investigator. These investigators will have access to the NIH Clinical Center, leveraging its diverse resources, expertise, and infrastructure to test promising discoveries in the diagnosis, treatment and prevention of disease. </p>
<p><strong>Information Requested</strong></p>
<p>NIH requests responses to all or some of the following items:</p>
<ol>
<li>How would partnering with NIH intramural investigators and use of the NIH Clinical Center resources help advance your research project or enhance your science?</li>
<li>What special Clinical Center resources would you be most interested in using and why? </li>
<li>What current barriers or challenges exist for you in accessing the Clinical Center or in partnering with the NIH intramural community?</li>
<li>What actions should the NIH and Clinical Center consider taking to address these challenges or to make it more feasible for you to access the Clinical Center and NIH intramural investigators? If you have ever utilized the Clinical Center or partnered with an intramural program at the Clinical Center, how did the partnership/utilization work and how satisfied were you with your overall experience?</li>
</ol>
<p><strong> </strong><strong>How to Submit a Response</strong><br>
Response to this RFI is voluntary. Interested extramural investigators and other interested parties are invited to respond. Responders are free to address any or all the above items. Please note that the Government will not pay for response preparation or for the use of any information contained in the response. <br>
<br>
All comments must be submitted electronically to:<br>
<a href="https://grants.nih.gov/grants/guide/rfi_files/clinical_center/add.cfm">https://grants.nih.gov/grants/guide/rfi_files/clinical_center/add.cfm</a> <br>
<br>
Responses to this RFI will be accepted through December 1, 2011. You will receive an electronic confirmation acknowledging receipt of your response, but will not receive individualized feedback on any suggestions. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government&rsquo;s use of such information. <br>
<br>
A summary of responsive input will be made publicly available. Personally identifiable information will be removed to the extent possible prior to making the comments public. We recommend that respondents remove personal identifiers prior to submission and that no proprietary information be included in the response. </p>
<p><span class="heading2">Inquiries</span></p>
<p>Specific questions about this RFI should be directed to the following e-mail address: <a href="/cdn-cgi/l/email-protection#793a151017101a18153a0d0b29180b0d171c0b391418101557171011571e160f"><span class="__cf_email__" data-cfemail="bffcd3d6d1d6dcded3fccbcdefdecdcbd1dacdffd2ded6d391d1d6d791d8d0c9">[email&#160;protected]</span></a>
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