Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 352(x)) and Recommendation to Clarify its Purpose

General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0340 can be found here:

Documents and Forms

Document Name Document Type
GUIDANCE (0910-0641) 2-29-2016 (1).pdf Other-Guidance
GUIDANCE (0910-0641) 2-29-2016 (1).pdf Other-Guidance

Information Collection (IC) Details

IC Title:	Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 352(x)) and Recommendation to Clarify its Purpose	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Removed

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			GUIDANCE (0910-0641) 2-29-2016 (1).pdf		Yes	No	Printable Only

Line of Business: Health

Subfunction: Health Care Services

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 300	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 0 %

	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-900	900
Annual IC Time Burden (Hours)	-3,600	3,600
Annual IC Cost Burden (Dollars)	0	0

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.