If the applicable clinical trial involves an IND/IDE, the IND holder would generally be considered the sponsor and the responsible party under FDAAA. i.e. If DAIDS is the IND holder for a study, DAIDS would be the responsible party.
If the applicable clinical trial does not involve an IND/IDE, the grantee institution would generally be considered the sponsor and the responsible party under FDAAA. The grantee institution has the option to designate the PI of the trial as the responsible party. i.e. If it is a Non-IND DAIDS study, the Network or Organization is the responsible party.
For more information, visit http://grants.nih.gov/ClinicalTrials_fdaaa/Responsible_Party.htm.