OMB control number

Tropical Disease Priority Review Vouchers

OMB 0910-0822 · HHS/FDA.

OMB 0910-0822

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 Tropical Disease Priority Review Vouchers expires 2028-12-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0822 Tropical Disease Vouchers SSA 2025 EXT.docx Supporting Statement A
Attestation regarding clinical investigation reports
Acknowledgeing the Receipt of a Transferred Voucher Other-Guidance
Letters Indicating the Transfer of a Voucher Letter Other-Guidance
Notifications of Intent to Use a Voucher Other-Guidance
Priority Review Voucher Other-Guidance

All Historical Document Collections

202501-0910-009	Extension without change of a currently approved collection	2025-07-30
202203-0910-004 Approved without change	Extension without change of a currently approved collection	2022-06-14
201906-0910-004 Approved without change	Revision of a currently approved collection	2019-06-26
201511-0910-002 Approved with change	New collection (Request for a new OMB Control Number)	2015-11-20

OMB Details

Priority Review Voucher

Federal Enterprise Architecture: Health - Health Care Services