Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(i) of the Act

Abbreviated New Drug Applications and 505(b)(2) Applications

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Effective date of approval of a 505(b)(2) application or abbreviated new drug application under section 505(i) of the Act	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Removed

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 314.107(e)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 140	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 75 %

	Approved	Program Change Due to New Statute	Program Change Due to Agency Discretion	Change Due to Adjustment in Agency Estimate	Change Due to Potential Violation of the PRA	Previously Approved
Annual Number of Responses for this IC	0	0	0	0	0	0
Annual IC Time Burden (Hours)	0	0	0	0	0	0
Annual IC Cost Burden (Dollars)	0	0	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.