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<TITLE>NOT-OD-12-118: NIH Announces Changes to the eRA Commons Financial Conflict of Interest (FCOI) Module to Accommodate Additional Reporting Requirements Required by the 2011 Revised FCOI Regulation</TITLE>
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<span class="title">NIH Announces Changes to the eRA Commons Financial Conflict of Interest (FCOI) Module to Accommodate Additional Reporting Requirements Required by the 2011 Revised FCOI Regulation</span>
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<hr noshade>
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<p><span class="heading3">Notice Number:</span> <span class="title">NOT-OD-12-118</span></p>
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<p><span class="heading3">Key Dates</span><br>
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<span class="regulartextbold">Release Date: </span>
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<span class="regulartext">June 25, 2012</span></p>
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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><span class="heading2">Purpose</span></p>
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<p class="regulartext">This Notice announces the availability of new features of the FCOI Module in the eRA Commons to accommodate the additional reporting requirements required by the 2011 FCOI regulation, <em>Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought</em> at <a href="http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=f67ea01984581d3934103b5074c05500&rgn=div5&view=text&node=42:1.0.1.4.22&idno=42#42:1.0.1.4.22.6">Title 42, Code of Federal Regulations, Part 50, Subpart F</a> for grants and cooperative agreements. As part of NIH’s continuing efforts to provide useful resources for extramural grant recipients, NIH developed this enhanced FCOI Module to accommodate the submission of the additional FCOI information as required under the 2011 revised FCOI regulation for NIH grants and cooperative agreements. <br>
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</p>
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<p class="regulartext">Grantees are required to implement the requirements of the 2011 revised regulation on or before August 24, 2012. With the eRA software release on June 15, 2012 and during this interim period, NIH grantees will have to choose between submitting FCOI reports for grants and cooperative agreements either under the 1995 FCOI regulation or the 2011 revised regulation. The option to submit FCOI reports provided under the 1995 regulation will be available and permitted only through August 23, 2012. Beginning with the compliance date, August 24, 2012, all FCOI reports must be submitted in compliance with the 2011 revised regulation (see 42 CFR Part 50.605[b]). In addition, the new features of the FCOI Module will accommodate the submission of a Revised FCOI report following a Retrospective Review, if necessary, when there are instances of noncompliance with the regulation. The FCOI Module will also accommodate the submission of a Mitigation Report when bias is found based on the results of the Retrospective Review. <br>
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</p>
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<p class="regulartext">It is important to note that when an FCOI is submitted for the first time under the 2011 revised regulation in the revised FCOI module, the FCOI report should be submitted as a “new” FCOI report. FCOI reports, for a previously reported FCOI in the revised module, will be submitted each subsequent year during the project’s competitive segment as an “annual” FCOI report. The annual FCOI report will address the status of the financial interest and any changes to the management plan. Annual FCOI reports shall address whether the FCOI is still being managed or explain why the FCOI no longer exists. Annual FCOI reports must be submitted through the eRA Commons FCOI Module at the same time as when the Institution is required to submit the annual progress report (i.e., two months prior to the start date or 45 prior to the start date of the noncompeting continuation award), including a multi-year funded progress report, or at the time of the extension (e.g., submission of an extension notification in the eRA Commons or submission of a NIH prior approval request, whichever is applicable.)<br>
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</p>
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<p class="regulartext">For more information regarding the FCOI Module, please visit the <a href="https://grants.nih.gov/grants/policy/coi/">Financial Conflict of Interest</a> page and the <a href="http://era.nih.gov/services_for_applicants/other/fcoi.cfm">FCOI documents</a> page.<br>
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</p>
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<p class="regulartext">Questions regarding the applicability and/or compliance with the revised contract regulation (<a href="https://www.gpo.gov/fdsys/pkg/FR-2011-08-25/pdf/2011-21633.pdf">45 CFR Part 94</a>) should be directed to: <a href="/cdn-cgi/l/email-protection#c2a4a1adaba1adacb6b0a3a1b6b182afa3abaeecacabaaeca5adb4"><span class="__cf_email__" data-cfemail="6c0a0f03050f0302181e0d0f181f2c010d050042020504420b031a">[email protected]</span></a>. </p>
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<p><span class="heading2">Inquiries</span></p>
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<p class="regulartext">General questions concerning using the eRA Commons should be directed to the eRA Commons <br>
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Help Desk at:</p>
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<p class="regulartext">eRA Service Desk<br>
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Web: <a href="http://ithelpdesk.nih.gov/eRA/" target="_blank" Title="Link to Non-U.S. Government Site">http://ithelpdesk.nih.gov/eRA/</a> (Preferred method of contact)<br>
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Toll-free: 1-866-504-9552<br>
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Phone: 301-402-7469<br>
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TTY: 301-451-5939<br>
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Hours: Mon.-Fri., 7a.m. to 8 p.m. Eastern Standard Time <br>
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<strong>Email:</strong> <a href="/cdn-cgi/l/email-protection#c0a3afadadafaeb380afa4eeaea9a8eea7afb6" title="mailto:commons@od.nih.gov"><span class="__cf_email__" data-cfemail="b5d6dad8d8dadbc6f5dad19bdbdcdd9bd2dac3">[email protected]</span></a> (for Commons Support) </p>
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<p class="regulartext">For general inquiries on this Notice or other FCOI-related matters, contact:</p>
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<p><span class="regulartext">Division of Grants Compliance and Oversight<br>
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Office of Policy for Extramural Research Administration<br>
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Office of Extramural Research<br>
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National Institutes of Health <br>
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6705 Rockledge Drive, Suite 350<br>
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Bethesda, MD 20892<br>
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Telephone: 301-435-0949<br>
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FAX: 301-435-3059<br>
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Email: <a href="/cdn-cgi/l/email-protection#80c6c3cfc9c3efedf0ece9e1eee3e5c0ede1e9ecaeeee9e8aee7eff6"><span class="__cf_email__" data-cfemail="91d7d2ded8d2fefce1fdf8f0fff2f4d1fcf0f8fdbffff8f9bff6fee7">[email protected]</span></a>
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<A HREF="/grants/guide/WeeklyIndex.cfm?06-29-12">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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