Information Collection

Request for Determination of Eligibility Criteria--613(b) of FDASIA

IC 206353 under ICR 201304-0910-001 · OMB 0910-0661.

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0661 can be found here:

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
HDE Guidance.pdf www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf	Other-Guidance

IC Title:

Request for Determination of Eligibility Criteria--613(b) of FDASIA

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: New

Obligation to Respond: Required to Obtain or Retain Benefits

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			HDE Guidance.pdf	http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110203.pdf	Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 2

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

table that charts list of burden
	Approved	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	2	2
Annual IC Time Burden (Hours)	20	20
Annual IC Cost Burden (Dollars)	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.