Supplements and Other Changes to an Approved Application

Prescription Drug Product Labeling; Medication Guide Requirements

Documents and Forms

Document Name Document Type

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

Information Collection (IC) Details

IC Title:	Supplements and Other Changes to an Approved Application	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Removed

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 208; 208.20 21 CFR 314.70(b)(2)(v)(B) (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

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 155	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-155	155
Annual IC Time Burden (Hours)	-11,160	11,160
Annual IC Cost Burden (Dollars)	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.