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⚠️ Notice: This information collection may be referencing outdated material.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

Documents and forms in this information collection
Document Name	Document Type
0528 Guidance Document.pdf	Other-null

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:

table that charts list of 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 %

table that charts list of burden
	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

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.