Expedited Programs for Serious Conditions-Drugs and Biologics

OMB 0910-0765

OMB 0910-0765

This ICR collects information from sponsors and applicants who wish to obtain a priority review designation or breakthrough therapy designation. Respondents to the collection are manufacturers or sponsors of drug and/or biologic products.

The latest form for Expedited Programs for Serious Conditions-Drugs and Biologics expires 2021-04-30 and can be found here.

OMB Details

Priority Review Designation Request

Federal Enterprise Architecture: Health - Consumer Health and Safety


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