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

Guidance for Industry on Labeling for Products Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Act: Questions and Answers

⚠️ Notice: This information collection may be referencing outdated material.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 OTCADRqa 1-25-13.pdf Other-Guidance

Information Collection (IC) Details

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

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 OTCADRqa 1-25-13.pdf		Yes	No	Paper Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 200	Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 0 %

	Requested	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	100,000	100,000
Annual IC Time Burden (Hours)	400,000	400,000
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.