Special Protocol Assessment (SPA)

OMB 0910-0470

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.

OMB Details

Requests for Special Protocol Assessment

Federal Enterprise Architecture: Health - Consumer Health and Safety

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