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

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

⚠️ Notice: This information collection may be referencing outdated material.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 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
FDA 3486A BPDR SUPPLEMENTAL INFORMATION 0458 WEB FORM ADDENDUM TO FORM3486A.doc Form and Instruction

Information Collection (IC) Details

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:

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
Form and Instruction	FDA 3486A	BPDR SUPPLEMENTAL INFORMATION	0458 WEB FORM ADDENDUM TO FORM3486A.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: 6,210	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 40 %

	Approved	Previously Approved
Annual Number of Responses for this IC	9,311	9,311
Annual IC Time Burden (Hours)	18,622	18,622
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.