This information collection supports
implementation of statutory and regulatory requirements governing
humanitarian use devices (HUDs) required by the Federal Food, Drug,
and Cosmetic Act. Respondents to the information collection are
manufacturers and/or sponsors of these devices.
Our estimated burden for the
information collection reflects an increase of 360 total burden
hours and a corresponding increase of 5 total annual responses. For
efficiency of Agency operations, we are consolidating the related
information activity and account for burden associated with HDE
regulations currently approved in OMB control number 0910-0661. As
a result, there is an increase in the total number of burden hours
for this information collection.