Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 502(x)) and Recommendation to Clarify its Purpose

Guidance for Industry on Q. & Answers Re: Labeling of Nonprescription Human Drug Products Marketed w/o an Approved App as Required by the Dietary Supp & Nonpresription Drug Consumer Protection Act

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0641 can be found here:

Documents and Forms

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

Information Collection (IC) Details

IC Title:	Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 502(x)) and Recommendation to Clarify its Purpose	Agency IC Tracking Number:	CDER

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 379aa (To search for a specific CFR, visit the Code of Federal Regulations.)

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.pdf		Yes	No	Paper 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: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	900	-99,100	100,000
Annual IC Time Burden (Hours)	3,600	-396,400	400,000
Annual IC Cost Burden (Dollars)	0	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.