Information Collection

Reporting of Biological Product Deviations by Licensed Manufacturer

IC 6151 under ICR 202301-0910-014 · OMB 0910-0458.

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
FURLS Screenshot.docx	Other-IT Landing Page Screenshot
FURLS Screenshot.docx	Other-IT Landing Page Screenshot
FDA 3486 Biological Product Deviation Report FDA 3486 3-12-20 Secured.pdf	Form and Instruction
FDA 3486 Biological Product Deviation Report FDA 3486 3-12-20 Secured.pdf	Form and Instruction

IC Title:

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 600.14

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
Other-IT Landing Page Screenshot			FURLS Screenshot.docx		Yes	Yes	Fillable Fileable
Form and Instruction	FDA 3486	Biological Product Deviation Report	FDA 3486 3-12-20 Secured.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records

Title:

FR Citation:

Number of Respondents: 103

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	707	136	571
Annual IC Time Burden (Hours)	1,414	272	1,142
Annual IC Cost Burden (Dollars)	0	-51,390	51,390

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.