Expedited Programs for Serious Conditions-Drugs and Biologics

ICR 202408-0910-006

OMB: 0910-0765

Federal Form Document

Forms and Documents

Document Name	Status
Clean_0765_Supporting Statement_2024-8-1.docx Supporting Statement A	2024-08-23

IC Document Collections

IC ID	Document Title	Status
269542	Premeeting Packages - CBER Other-Agency Guidance	Unchanged
269541	Fast Track Designation Requests - CBER Other-Agency Guidance	Unchanged
269540	Breakthrough Therapy Designation Requests - CBER Other-Agency Guidance	Unchanged
269539	Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CBER Other-Agency Guidance	Unchanged
269538	Accelerated Approval Designation - CDER Other-Agency Guidance	Unchanged
233190	RMAT Designation Requests - CBER Other-Agency Guidance	Unchanged
230039	Premeeting packages - CDER Other-Agency Guidance	Unchanged
230038	Fast Track Designation Requests - CDER Other-Agency Guidance	Unchanged
209910	Breakthrough Therapy Designation Requests - CDER Other-Agency Guidance	Unchanged
209909	Priority Review Designation Requests (Expedited Programs for Serious Conditions) - CDER Other-Agency Guidance	Unchanged