Fast track designation request

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⚠️ Notice: This information collection may be referencing outdated material.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

Information Collection (IC) Details

IC Title:	Fast track designation request	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Unchanged

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation:

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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 140	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Previously Approved
Annual Number of Responses for this IC	187	187
Annual IC Time Burden (Hours)	11,220	11,220
Annual IC Cost Burden (Dollars)	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.