Reporting of Biological Product Deviations by Licensed Manufacturer

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

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0458 can be found here:

Documents and Forms

Document Name Document Type
Form FDA 3486 Reporting of Biological Product Deviations by Licensed Manufacturer Form and Instruction
FDA 3486 Biological Product Deviation Report Form FDA 3486 control no 0910 0458.pdf www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/biological-product-deviations Form and Instruction

Information Collection (IC) Details

IC Title:	Reporting of Biological Product Deviations by Licensed Manufacturer	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 600.14

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	Form FDA 3486 control no 0910 0458.pdf	https://www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/biological-product-deviations	Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 93	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	571	-40	611
Annual IC Time Burden (Hours)	1,142	-80	1,222
Annual IC Cost Burden (Dollars)	51,390	51,390	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.