Expedited Programs for Serious Conditions-Drugs and Biologics

ICR 202309-0910-011

OMB: 0910-0765

Federal Form Document

Forms and Documents

Document Name	Status
0765_Supporting Statement_2024.docx Supporting Statement A	2024-04-18

IC Document Collections

IC ID	Document Title	Status
263126	Premeeting Packages (RMAT Section V) - CBER Other-Agency Guidance	New
263125	Fast Track Designation Requests (EPSC Section VII) - CBER Other-Agency Guidance	New
263124	Breakthrough Therapy Designation Request (EPSC Section VI) - CBER Other-Agency Guidance	New
263123	Priority Review Designation Request (EPSC Section VIII) - CBER Other-Agency Guidance	New
263119	Accelerated Approval Designation (EPSC Section VII) - CDER Other-Agency Guidance	New
233190	RMAT Designation Requests (Regenerative Medicine Therapies for Serious Conditions Guidance (RMAT) Section III) - CBER Other-Agency Guidance	Modified
230039	Premeeting packages - CDER Other-Agency Guidance	Modified
230038	Fast Track Designation Requests (EPSC Section V) - CDER Other-Agency Guidance	Modified
209910	Breakthrough Therapy Designation Requests (EPSC Section VI) - CDER Other-Agency Guidance	Modified
209909	Priority Review Designation Requests (Expedited Programs for Serious Conditions Guidance (EPSC) Section VIII) - CDER Other-Agency Guidance	Modified