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
0765_Supporting Statement_2024.docx Supporting Statement A
Premeeting Packages (RMAT Section V) - CBER Other-Agency Guidance
Fast Track Designation Requests (EPSC Section VII) - CBER Other-Agency Guidance
Breakthrough Therapy Designation Request (EPSC Section VI) - CBER Other-Agency Guidance
Priority Review Designation Request (EPSC Section VIII) - CBER Other-Agency Guidance
Accelerated Approval Designation (EPSC Section VII) - CDER Other-Agency Guidance
RMAT Designation Requests (Regenerative Medicine Therapies for Serious Conditions Guidance (RMAT) Section III) - CBER Other-Agency Guidance
Premeeting packages - CDER Other-Agency Guidance
Fast Track Designation Requests (EPSC Section V) - CDER Other-Agency Guidance
Breakthrough Therapy Designation Requests (EPSC Section VI) - CDER Other-Agency Guidance
Priority Review Designation Requests (Expedited Programs for Serious Conditions Guidance (EPSC) Section VIII) - CDER Other-Agency Guidance

All Historical Document Collections

202309-0910-011	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