Information Collection

Establishments listing less than 10 SUDs

IC 6300 under ICR 201504-0910-002 · OMB 0910-0577.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0577 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Guidance 0910-0577.pdf www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070934.htm	Other-Guidance

IC Title:

Establishments listing less than 10 SUDs

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

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
Other-Guidance			Guidance 0910-0577.pdf	http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070934.htm	Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Public Health Monitoring

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 58

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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	116	22	94
Annual IC Time Burden (Hours)	12	3	9
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.