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.
The latest form for Guidance for Industry on Tropical Disease Priority Review Vouchers expires 2022-07-31 and can be found here.
Approved without change
|Revision of a currently approved collection||2019-06-26|
Approved with change
|New collection (Request for a new OMB Control Number)||2015-11-20|
Federal Enterprise Architecture: Health - Health Care Services