Breakthrough Therapy Designation Requests - CDER

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⚠️ Notice: This information collection may be referencing outdated material.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_Agency Guidance.pdf Other-Agency Guidance
0765_Agency Guidance.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Breakthrough Therapy Designation Requests - CDER	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_Agency Guidance.pdf		No		Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 71	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	77	-79	156
Annual IC Time Burden (Hours)	5,390	-5,530	10,920
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.