Reporting: Special controls: submission of complaint log; 866.3956(b)(1)(iii) and 866.3957(b)(1)(iii)

Medical Device Reporting

Documents and Forms

Document Name Document Type

no available documents/forms check other ICs listed under this ICR

Information Collection (IC) Details

IC Title:	Reporting: Special controls: submission of complaint log; 866.3956(b)(1)(iii) and 866.3957(b)(1)(iii)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 866

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Special controls; final order: "Microbiology Devices; Reclassification of HIV Serological Diagnostic and Supplemental Tests and HIV Nucleic Acid Diagnostic and Supplemental Tests"					Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 10	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Change Due to Potential Violation of the PRA
Annual Number of Responses for this IC	10	10
Annual IC Time Burden (Hours)	30	30
Annual IC Cost Burden (Dollars)	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.