Information Collection

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

IC 178970 under ICR 201911-0910-003 · OMB 0910-0458.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
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 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

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:

table that charts list of 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: 1,937

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

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	46,192	418	45,774
Annual IC Time Burden (Hours)	92,384	836	91,548
Annual IC Cost Burden (Dollars)	4,157,280	4,157,280	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.