(CDRH/CBER) Q-Submissions using eSTAR - includes eSTAR Setup

Q-Submission and Early Payor Feedback Request Programs for Medical Devices

Documents and Forms

Document Name Document Type
PRAQuestionFieldsforQSub.docx Other-Agency Template
PRAQuestionFieldsforQSub.docx Other-Agency Template

Information Collection (IC) Details

IC Title:	(CDRH/CBER) Q-Submissions using eSTAR - includes eSTAR Setup	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Voluntary

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Template			PRAQuestionFieldsforQSub.docx		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 1,480	Number of Respondents for Small Entity: 7

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

Percentage of Respondents Reporting Electronically: 100 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	1,480	1,389	91
Annual IC Time Burden (Hours)	102,238	89,771	12,467
Annual IC Cost Burden (Dollars)	0	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.