Information Collection Request

Expedited Programs for Serious Conditions-Drugs and Biologics

ICR 202309-0910-011 · OMB 0910-0765 · Received in OIRA

⚠️ Notice: This information collection may be outdated. More recent filings for OMB 0910-0765 can be found here:

Forms and Documents

Forms and supporting documents for this ICR
Document	Type	Status	Availability
0765_Supporting Statement_2024.docx	Supporting Statement A	Uploaded 2024-04-18	Repair queued

Information collection document groups
IC ID	Collection	Type	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

Record metadata
Status	Received in OIRA
Agency/Subagency	HHS/FDA
OMB Control No	0910-0765
Type of Information Collection	Revision of a currently approved collection
Previous ICR Reference No	202102-0910-008
Agency Tracking No	CDER
Date Submitted to OIRA	1969-12-31
Requested Expiration Date	1969-12-31