Notice Number: NOT-OD-12-143

Key Dates
Release Date: August 24, 2012

Issued by
National Institutes of Health (NIH)

Purpose

Institutions are required to implement the requirements of the 2011 revised Financial Conflict of Interest (FCOI) regulation provided at 42 CFR Part 50 Subpart F, "Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought,” which pertains to grants and cooperative agreements, by August 24, 2012.

Due to the timing of the August 24 implementation date, all noncompeting continuation awards issued on or after August 24, 2012, will be required to submit FCOI reports for FY 2012, only at the request of NIH staff. This guidance includes ongoing multi-year funded projects with a budget period anniversary date on or after August 24. This is a one-time guidance to provide specific instructions for noncompeting continuation awards.  Competing awards are not subject to this guidance.

Background
The 2011 revised FCOI regulation applies to Notices of Award issued on or after August 24, 2012 (including noncompeting continuations issued on or after this date).   Grant awards issued prior to August 24, 2012, remain subject to the 1995 FCOI regulation.  In addition to other reporting requirements, the 2011 revised FCOI regulation requires institutions to submit Annual FCOI Reports that are due at the same time as when the Institution is required to submit the annual progress report; at the budget period anniversary date for multi-year funded projects; or at the time of extension. 

Institutions will continue to submit FCOI reports through the eRA Commons FCOI Module, which has been enhanced to accommodate the additional reporting requirements.  To assure that all pertinent information populates the FCOI Module, all first-time FCOI reports submitted under the 2011 revised regulation will be submitted as new reports (Initiate 2011 FCOI Report).

Guidance
Most grantees have already submitted their annual progress report for FY2012 noncompeting continuation awards and multi-year funded projects, which means that the Annual FCOI Report was due before the FCOI implementation date (i.e., 45 or 60 days prior to the start date).   Therefore, out of synch reporting for this subset of FY2012 awards will be necessary to capture FCOI reporting information.  This one-time guidance is intended to shift the burden of out of synch reporting from the grantee to NIH staff.
Therefore, NIH will not require grantees to submit FCOI reports for FY 2012 noncompeting awards issued on or after August 24 until requested by NIH staff.  When requested by NIH, if the FCOI still exists, the grantee Institution will then be required to submit an FCOI report (Initiate 2011 FCOI Report).   Once the FY 2012 FCOI report has been submitted, the next annual FCOI report will be due at the same time as when the annual progress report is due for the FY 2013 award, if the FCOI still exists.

As a resource, NIH has posted two tables on FCOI reporting requirements on the NIH Office of Extramural Research FCOI webpage (see “Reporting”):  one that depicts the regulatory reporting requirements and the other this one-time FCOI reporting guidance that affects certain FY 2012 grant awards.    

Inquiries

General questions concerning using the eRA Commons should be directed to the eRA Service 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]