Information Collection

Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A

IC 178970 under ICR 201111-0910-002 · 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⚠️ Notice: This information collection may be referencing outdated material.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 3486 Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A	Form and Instruction
3486 Biological Product Deviation Report 0458 FDA-3486.doc	Form and Instruction

IC Title:

Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms FDA 3486 and 3486A

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	3486	Biological Product Deviation Report	0458 FDA-3486.doc		No	No	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 1,533

Number of Respondents for Small Entity: 0

Affected Public: Private Sector

Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 40 %

table that charts list of burden
	Approved	Previously Approved
Annual Number of Responses for this IC	44,125	44,125
Annual IC Time Burden (Hours)	88,240	88,240
Annual IC Cost Burden (Dollars)	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.