Biological Products: Reporting of Biolgical 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⚠️ Notice: This information collection may be referencing outdated material.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 Biolgical 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
FDA 3486A Recall Classification WEB FORM ADDENDUM TO FORM 3486A Revision.doc Form

Information Collection (IC) Details

IC Title:	Biological Products: Reporting of Biolgical 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	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
Form	FDA 3486A	Recall Classification	WEB FORM ADDENDUM TO FORM 3486A Revision.doc	Yes	Yes	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 6,551	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	Program Change Due to Agency Discretion	Previously Approved
Annual Number of Responses for this IC	2,133	0	2,133
Annual IC Time Burden (Hours)	533	-534	1,067
Annual IC Cost Burden (Dollars)	0	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.