The OIRA staff was very interested in my analysis and appreciative of the insights I was able to provide, especially as they related to the specific provisions of Executive Order 12866 which I believe the deeming regulations violate.
The Rest of the Story
Here is a link to my public comment. It may be helpful to others as it articulates the specific provisions of Executive Order 12866 which I believe the FDA deeming regulations violate.
Please note that OIRA cannot disapprove the regulation and return it simply because it disagrees with the approach. There are specific criteria that the OIRA must follow in its review, and these are outlined in the Executive Order.
In particular, I believe that the deeming regulations are in violation of the following sections of Executive Order 12866: