Information Collection

FDA Approval to Market a New Drug

IC 5662 under ICR 200608-0910-003 · OMB 0910-0001.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0001 can be found here:

Documents and Forms

Document Name Document Type
0528 Guidance Document.pdf Other-null

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	FDA Approval to Market a New Drug	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-null			0528 Guidance Document.pdf		Yes	Yes	Printable Only

Line of Business:

Subfunction:

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 43,989	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	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	336,956	292,967	1,111	42,878
Annual IC Time Burden (Hours)	2,581,083	208,060	467	2,372,556
Annual IC Cost Burden (Dollars)	0	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.