Information Collection

Breakthrough Therapy Designation Request

IC 209910 under ICR 202102-0910-008 · OMB 0910-0765.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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

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:

table that charts list of 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 %

table that charts list of burden
	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

table that charts IC Documents
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.