Notice Number: NOT-OD-12-118

Key Dates
Release Date: June 25, 2012

Issued by
National Institutes of Health (NIH)

Purpose

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, Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought at Title 42, Code of Federal Regulations, Part 50, Subpart F 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.  

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.

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.)

For more information regarding the FCOI Module, please visit the Financial Conflict of Interest page and the FCOI documents page.

Questions regarding the applicability and/or compliance with the revised contract regulation (45 CFR Part 94) should be directed to: [email protected]. 

Inquiries

General questions concerning using the eRA Commons should be directed to the eRA Commons
Help Desk at:

eRA Service Desk
Web: http://ithelpdesk.nih.gov/eRA/ (Preferred method of contact)
Toll-free: 1-866-504-9552
Phone: 301-402-7469
TTY: 301-451-5939
Hours: Mon.-Fri., 7a.m. to 8 p.m. Eastern Standard Time
Email: [email protected] (for Commons Support)

For general inquiries on this Notice or other FCOI-related matters, contact:

Division of Grants Compliance and Oversight
Office of Policy for Extramural Research Administration
Office of Extramural Research
National Institutes of Health
6705 Rockledge Drive, Suite 350
Bethesda, MD  20892
Telephone: 301-435-0949
FAX: 301-435-3059
Email: [email protected]