Designation Requests

Guidance for Industry: Fast Track Drug Development Programs - Designation, Development, and Application Review

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0389 can be found here:

Documents and Forms

Document Name Document Type
GUIDANCE 0389 12-29-2014.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Designation Requests	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 356(C) (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-Guidance			GUIDANCE 0389 12-29-2014.pdf		Yes	No	Paper Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 81	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 80 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	115	38	77
Annual IC Time Burden (Hours)	6,900	-800	7,700
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.