Information Collection

Electronic Submission of Voluntary Allegations to CDRH

IC 211628 under ICR 202310-0910-001 · OMB 0910-0769.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Reporting Allegations of Regulatory Misconduct - Intro Screen.pdf	Instruction
Reporting Allegations of Regulatory Misconduct - Intro Screen.pdf	Instruction
Reporting Allegations of Regulatory Misconduct - Form.pdf	Other-Form
Reporting Allegations of Regulatory Misconduct _ FDA 11-01-23 (002).pdf	Other-Form

IC Title:

Agency IC Tracking Number:

CDRH

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Voluntary

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
Instruction			Reporting Allegations of Regulatory Misconduct - Intro Screen.pdf		Yes	No	Printable Only
Other-Form			Reporting Allegations of Regulatory Misconduct _ FDA 11-01-23 (002).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: 2,500

Number of Respondents for Small Entity: 0

Affected Public: Individuals or Households

Percentage of Respondents Reporting Electronically: 95 %

table that charts list of burden
	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	2,500	900	1,600
Annual IC Time Burden (Hours)	625	225	400
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.