Information Collection

Implementation of Sections 222, 223, and 224 of the Food and Drug Administratin Amendments Act of 2007

IC 184861 under ICR 200812-0910-006 · OMB 0910-0625.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0625 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form 3673 Implementation of Sections 222, 223, and 224 of the Food and Drug Administratin Amendments Act of 2007	Form and Instruction
3673 Device Registration and Listing Module Form FDA 3673.doc	Form and Instruction

IC Title:

Implementation of Sections 222, 223, and 224 of the Food and Drug Administratin Amendments Act of 2007

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

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
Form and Instruction	3673	Device Registration and Listing Module	Form FDA 3673.doc		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 58,973

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

table that charts list of burden
	Approved	Program Change Due to New Statute	Previously Approved
Annual Number of Responses for this IC	58,973	0	58,973
Annual IC Time Burden (Hours)	71,319	40,523	30,796
Annual IC Cost Burden (Dollars)	0	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.