Extension without change of a currently approved collection
36 Months From Approved
This information collection supports
implementation of section 524 of the Federal Food, Drug, and
Cosmetic Act. The statute provides FDA with authority for awarding
priority review vouchers for future applications to sponsors of
tropical disease product applications that meet the criteria
specified by the Act. We have also developed associated guidance
intended to explain to internal and external stakeholders how we
implement the provisions of section 524.
Based on our evaluation of the
information collection since the last OMB review and approval, the
burden estimate decreased by 34 hours based on receipt of fewer
vouchers request and other information collection activities.