Breakthrough Therapy 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⚠️ Notice: This information collection may be referencing outdated material.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
GFI Expedited Review for Serious conditions Contol No 0765.pdf Other-Agency Guidance
GFI Expedited Review for Serious conditions Contol No 0765.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Breakthrough Therapy Designation Request	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			GFI Expedited Review for Serious conditions Contol No 0765.pdf		No		Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 119	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	156	43	113
Annual IC Time Burden (Hours)	10,920	3,010	7,910
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.