Guidance for Industry on Safety Labeling Changes; Post Approved Labeling on Application Holder's Web site

Guidance for Industry on Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0734 can be found here:

Documents and Forms

Document Name Document Type
FINAL GUIDANCE 0734 1-11-2016.pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Guidance for Industry on Safety Labeling Changes; Post Approved Labeling on Application Holder's Web site	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 314.70

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			FINAL GUIDANCE 0734 1-11-2016.pdf		Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 407	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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	407	210	197
Annual IC Time Burden (Hours)	1,628	840	788
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.