This ICR is
approved for 2 years as revised. FDA is reminded that ICRs
associated with proposed rules should be submitted twice -- once at
the proposed rule stage and again at the final rule stage. FDA is
also reminded that burdens should be appropriately classified and
should not be attributed to statute if they stem from agency
discretion. Finally, FDA agrees to fold the burden in this ICR into
0910-0014. At that time, FDA shall discontinue this ICR.
Inventory as of this Action
36 Months From Approved
This rule clarifies the circumstancs
in which charging for an investigational drug in a clincial trial
is appropriate, sets forth criteria for charging for an
investigational drug for the different types of expanded access for
treatment use and clarifies what costs can be recovered.