Premeeting packages

Expedited Programs for Serious Conditions-Drugs and Biologics

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

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

Information Collection (IC) Details

IC Title:	Premeeting packages	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

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: 224	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	392	250	142
Annual IC Time Burden (Hours)	39,200	25,000	14,200
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.