Clarifying Public Comment Opportunity on Financial Conflict of Interest

Posted

The current 60-day NIH Notice on the collection of information on objectivity in research was issued in compliance with the requirements of the Paperwork Reduction Act (PRA) of 1980.  The purpose of the PRA is to ensure that federal agencies, such as the NIH, do not overburden the public with federally-sponsored data collections. “PRA clearance” as it is commonly called is required whenever an agency collects standardized data from 10 or more respondents within a 12 month period.

In the June 2008 Nexus, we told you that the Department of Health and Human Services is considering gathering public comment on whether to modify the FCOI regulations.  If such an action is taken, you will have an opportunity for comment. It should be noted, however, that this revision of the approved information collection (OMB Control No. 0925-0417) is not part of the proposed process to modify the FCOI regulations.

Comments on the information collection are due September 15, 2008 and may be submitted online at Regulations.gov.