Center for Regulatory Effectiveness - Comment

A Breakdown in the Public Comment Process On January 6, 2011, the FDA issued a proposed rule accompanied by an ICR. The FDA failed to provide an objective basis for the estimated burden. On January 15, 2011, CRE contacted the FDA requesting additional information on how FDA arrived at their estimated burden. At this time, FDA provided no additional information. In the proposed rule, the FDA stated that the comments on the information collection were due to the Office of Information and Regulatory Affairs (OIRA) on February 7, 2011. CRE submitted comments on the ICR on February 7, 2011, via fax and email to OIRA pursuant to the submission criteria contained in the rule. CRE contacted OIRA and the FDA approximately ten times requesting to view the comments received by OIRA. FDA and OIRA stated that no comments were submitted for the ICR and that CRE’s comments had not been received. CRE submitted the fax and email confirmation for its comments and resubmitted its comments to the FDA desk officer on February 21, 2011. As of March 16, 2011, OIRA has not provided CRE with access to the comments it has received, despite CRE’s many attempts. Please comment on this post at http://www.thecre.com/scur/?p=414 Jim Tozzi Center for Regulatory Effectiveness