Safety Labeling Changes; Posting Approved Labeling on Application Holder's website

Labeling Requirements for Human Prescription Drug and Biological Products

Documents and Forms

Document Name Document Type
GFI_Safety Labeling Changes —Implementation of Section 505(o)(4) of the FD&C Act.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-fe Instruction
GFI_Safety Labeling Changes —Implementation of Section 505(o)(4) of the FD&C Act.pdf www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-fe Instruction

Information Collection (IC) Details

IC Title:	Safety Labeling Changes; Posting Approved Labeling on Application Holder's website	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 314 21 CFR 601

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Instruction			GFI_Safety Labeling Changes —Implementation of Section 505(o)(4) of the FD&C Act.pdf	https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-labeling-changes-implementation-section-505o4-federal-food-drug-and-cosmetic-act	Yes	Yes	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 351	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	351	351
Annual IC Time Burden (Hours)	1,404	1,404
Annual IC Cost Burden (Dollars)	105,300	105,300

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.