Again, I would just caution that I can speak to the broader policy discussions we've been having.
What we've identified is that the requirement for adverse drug reaction reporting is certainly down in the regulations right now. It appears in the architecture of the act in several places. It can occur as a term and condition for a standard authorization, and that's through the regulation-making process. As for how you actually bundle those together, I'm sure the committee has heard a lot about periodic safety update reports, which bundle together and summarize those reports to make them useful. That, too, becomes an ongoing requirement, and its frequency can be set out and determined around the therapy.
So as to your earlier point about not burdening health care professionals and others with therapies on which we don't need as much reporting, you can index those. So that's really the concept we're advancing there. So it does occur in a number....
I would point out that you also need to require information in study form, because just having ADRs can't get us where we need to go.