Information Collection

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

IC 251544 under ICR 202202-0910-001 · OMB 0910-0572.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0572 can be found here:

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

View Information Collection (IC)

IC Title:	Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statemen	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 601 21 CFR 314

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 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 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	36	36
Annual IC Time Burden (Hours)	216	216
Annual IC Cost Burden (Dollars)	16,200	16,200

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.