Information Collection

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

IC 204939 under ICR 201903-0910-022 · OMB 0910-0734.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type

No indexed documents/forms are available for this IC yet. A refresh has been queued.

IC Title:

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

Agency IC Tracking Number:

CDER

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 601.12 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

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
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	36	-6	42
Annual IC Time Burden (Hours)	216	-36	252
Annual IC Cost Burden (Dollars)	16,200	16,200	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.