Information Collection

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

IC 204940 under ICR 201211-0910-007 · OMB 0910-0734.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
FINAL GUIDANCE SAFETY LAB CHGS FINAL 1-31-13.doc	Other-Guidance

IC Title:

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

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 314.70

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-Guidance			FINAL GUIDANCE SAFETY LAB CHGS FINAL 1-31-13.doc		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 197

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
Annual Number of Responses for this IC	197	197
Annual IC Time Burden (Hours)	788	788
Annual IC Cost Burden (Dollars)	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.