OMB control number
Tropical Disease Priority Review Vouchers
OMB 0910-0822 ยท 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 is listed under ICR 202501-0910-009.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0822 Tropical Disease Vouchers SSA 2025 EXT.docx | Supporting Statement A |
 Attestation regarding clinical investigation reports |
Information collection |
| 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All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202501-0910-009 | Extension without change of a currently approved collection | 2025-07-30 | ||
| 202203-0910-004 | Extension without change of a currently approved collection | 2022-06-14 | Approved without change | |
| 201906-0910-004 | Revision of a currently approved collection | 2019-06-26 | Approved without change | |
| 201511-0910-002 | New collection (Request for a new OMB Control Number) | 2015-11-20 | Approved with change |
OMB Details
Priority Review Voucher
Federal Enterprise Architecture: Health - Health Care Services