Special Protocol Assessment (SPA)

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 can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
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All Historical Document Collections

202004-0910-004 Approved without change	Revision of a currently approved collection	2020-04-27
201703-0910-006 Approved without change	Extension without change of a currently approved collection	2017-03-15
201402-0910-003 Approved without change	Extension without change of a currently approved collection	2014-02-19
201010-0910-005 Approved without change	Extension without change of a currently approved collection	2010-10-28
200708-0910-002 Approved with change	Extension without change of a currently approved collection	2007-08-31
200407-0910-006 Approved without change	Extension without change of a currently approved collection	2004-07-14
200105-0910-002 Approved without change	New collection (Request for a new OMB Control Number)	2001-05-18

OMB Details

Requests for Special Protocol Assessment

Federal Enterprise Architecture: Health - Consumer Health and Safety