Reporting - Annual Initial Registration Requirement for Foreign Establishments To Report Any Changes, Including Agents ,Brokers etc.

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

⚠️ Notice: This information collection may be referencing outdated material.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 Reporting - Annual Initial Registration Requirement for Foreign Establishments To Report Any Changes, Including Agents ,Brokers etc. Form and Instruction
3673 Devic Registration & Listing Module Form FDA 3673 Device Regs & Liasting Module.doc Form and Instruction

Information Collection (IC) Details

IC Title:	Reporting - Annual Initial Registration Requirement for Foreign Establishments To Report Any Changes, Including Agents ,Brokers etc.	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 807.41 ( b )

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	3673	Devic Registration & Listing Module	Form FDA 3673 Device Regs & Liasting Module.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: 11,348	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 99 %

	Requested	Program Change Due to New Statute
Annual Number of Responses for this IC	11,348	11,348
Annual IC Time Burden (Hours)	5,674	5,674
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.