Information Collection

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

IC 184861 under ICR 200805-0910-001 · 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⚠️ Notice: This information collection may be referencing outdated material.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

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 & Listing Module FDA Form 3673 Device Regis. & Listing Module.doc Form and Instruction
Guidance E-Regs. & listing.doc Guidance E-Regs IC Document

Information Collection (IC) Details

View Information Collection (IC)

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: New

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
Form and Instruction	3673	Device Registration & Listing Module	FDA Form 3673 Device Regis. & Listing Module.doc		Yes	Yes	Fillable Printable

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 %

	Approved	Program Change Due to New Statute
Annual Number of Responses for this IC	58,973	58,973
Annual IC Time Burden (Hours)	30,796	30,796
Annual IC Cost Burden (Dollars)	0	0

Documents for IC

Title	Document	Date Uploaded
Guidance E-Regs	Guidance E-Regs. & listing.doc	05/09/2008

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.