OMB control number
Special Protocol Assessment (SPA)
OMB 0910-0470 ยท HHS/FDA.
OMB 0910-0470
The information collection is associated with sponsor requests regarding special protocol assessments and for information relating to agency action on such requests, as governed by section 505(b)(4)(B) of the Federal Food, Drug, and Cosmetic Act and Prescription Drug User Fee Act goals for special protocol assessment and agreement. Respondents to the information collection are sponsors seeking agency action for regulated products.
The latest form for Special Protocol Assessment (SPA) expires 2023-05-31 and is listed under ICR 202004-0910-004.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 0470 SS 2020 REV for FDARA.pdf | Supporting Statement A |
 Requests for Special Protocol Assessment |
Other-Agency Guidance Document |
| Notification for Carcinogenicity Protocols |
Other-Agency Guidance Document |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202004-0910-004 | Revision of a currently approved collection | 2020-04-27 | Approved without change | |
| 201703-0910-006 | Extension without change of a currently approved collection | 2017-03-15 | Approved without change | |
| 201402-0910-003 | Extension without change of a currently approved collection | 2014-02-19 | Approved without change | |
| 201010-0910-005 | Extension without change of a currently approved collection | 2010-10-28 | Approved without change | |
| 200708-0910-002 | Extension without change of a currently approved collection | 2007-08-31 | Approved with change | |
| 200407-0910-006 | Extension without change of a currently approved collection | 2004-07-14 | Approved without change | |
| 200105-0910-002 | New collection (Request for a new OMB Control Number) | 2001-05-18 | Approved without change |
OMB Details
Requests for Special Protocol Assessment
Federal Enterprise Architecture: Health - Consumer Health and Safety