Information Collection

Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statemen

IC 251544 under ICR 202408-0910-009 · OMB 0910-0572.

Documents and Forms

Documents and forms in this information collection
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

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 601 21 CFR 314

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
Instruction			GFI_Safety Labeling Changes âImplementation 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: 36

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 100 %

table that charts list of burden
	Requested	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	36	0	36
Annual IC Time Burden (Hours)	216	0	216
Annual IC Cost Burden (Dollars)	0	-16,200	16,200

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.