Information Collection

Form FDA 3486A Addendum

IC 178972 under ICR 201312-0910-008 · 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⚠️ Notice: This information collection may be referencing outdated material.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 3486A Form FDA 3486A Addendum	Form and Instruction
3486A Biological Product Deviation Report - Addendum EBPDR_AI_Screen_Shots 12-16-13.doc	Form and Instruction

IC Title:

Form FDA 3486A Addendum

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	3486A	Biological Product Deviation Report - Addendum	EBPDR_AI_Screen_Shots 12-16-13.doc		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 84

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	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	2,747	541	2,206
Annual IC Time Burden (Hours)	687	135	552
Annual IC Cost Burden (Dollars)	0	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.