Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services

Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing

Documents and Forms

Document Name Document Type
Form FDA 3486 Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services Form and Instruction
FDA 3486 Biological Product Deviation Report FDA 3486 3-12-20 Secured.pdf Form and Instruction
FDA 3486 Biological Product Deviation Report FDA 3486 3-12-20 Secured.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 606.171

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA 3486	Biological Product Deviation Report	FDA 3486 3-12-20 Secured.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: 2,008	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	13,821	-32,371	46,192
Annual IC Time Burden (Hours)	27,642	-64,742	92,384
Annual IC Cost Burden (Dollars)	0	-4,157,280	4,157,280

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.