Information Collection

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

IC 184862 under ICR 200805-0910-002 · OMB unassigned.

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

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

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 & 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 %

table that charts list of burden
	Requested	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

table that charts IC Documents
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.