Premeeting packages - CDER

Expedited Programs for Serious Conditions-Drugs and Biologics

Documents and Forms

Document Name Document Type
0765 GFI Expedited Programs for Drugs and Biologics.pdf Other-Agency Guidance
RMAT Expedited Designation GFI.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Premeeting packages - CDER	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 312; subpart E (To search for a specific CFR, visit the Code of Federal Regulations.)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			0765 GFI Expedited Programs for Drugs and Biologics.pdf		No		Paper Only
Other-Agency Guidance			RMAT Expedited Designation GFI.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 163	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	165	-227	392
Annual IC Time Burden (Hours)	16,500	-22,700	39,200
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.