eSubmitter participants

Medical Devices; Reports of Corrections and Removals

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0359 can be found here:

Documents and Forms

Document Name Document Type
0359 806 reports eSubmitter.pdf Other-eSubmitter screenshots

Information Collection (IC) Details

IC Title:	eSubmitter participants	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

Obligation to Respond: Voluntary

CFR Citation: 21 CFR 806 21 CFR 4.102; 4.104; 4.105

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-eSubmitter screenshots			0359 806 reports eSubmitter.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 517	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 50 %

	Approved	Change Due to Adjustment in Agency Estimate
Annual Number of Responses for this IC	517	517
Annual IC Time Burden (Hours)	1,592	1,592
Annual IC Cost Burden (Dollars)	25,850	25,850

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.