Information Collection

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

IC 188840 under ICR 201301-0910-008 · OMB 0910-0641.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Guidance OTCADRqa 1-25-13.pdf	Other-Guidance

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:

table that charts list of 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 %

table that charts list of burden
	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

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.