Expedited Programs for Serious Conditions-Drugs and Biologics

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.

Latest Forms, Documents, and Supporting Material

Document Name
Clean_0765_Supporting Statement_2024-8-1.docx Supporting Statement A
Premeeting Packages - CBER Other-Agency Guidance
Fast Track Designation Requests - CBER Other-Agency Guidance
Breakthrough Therapy Designation Requests - CBER Other-Agency Guidance
Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CBER Other-Agency Guidance
Accelerated Approval Designation - CDER Other-Agency Guidance
RMAT Designation Requests - CBER Other-Agency Guidance
Premeeting packages - CDER Other-Agency Guidance
Fast Track Designation Requests - CDER Other-Agency Guidance
Breakthrough Therapy Designation Requests - CDER Other-Agency Guidance
Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CDER Other-Agency Guidance

All Historical Document Collections

202408-0910-006	Revision of a currently approved collection	2024-08-23
202407-0910-004 Withdrawn and continue	Extension without change of a currently approved collection	2024-07-22
202309-0910-011 Withdrawn and continue	Revision of a currently approved collection	2024-04-18
202102-0910-008 Approved without change	Extension without change of a currently approved collection	2021-03-26
201809-0910-004 Approved without change	No material or nonsubstantive change to a currently approved collection	2018-09-25
201802-0910-008 Approved without change	Revision of a currently approved collection	2018-02-13
201703-0910-010 Approved without change	Extension without change of a currently approved collection	2017-03-15
201312-0910-015 Approved without change	New collection (Request for a new OMB Control Number)	2013-12-31

OMB Details

Priority Review Designation Request

Federal Enterprise Architecture: Health - Consumer Health and Safety