Information Collection

Reporting of Biological Product Deviations by Licensed Manufacturers - 600.14

IC 6151 under ICR 201701-0910-007 · 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⚠️ Notice: This information collection may be referencing outdated material.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

Document Name Document Type
Form 3486 Reporting of Biological Product Deviations by Licensed Manufacturers - 600.14 Form and Instruction
3486 Biological Product Deviation Report FORM FDA-3486 12-5-13.pdf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Reporting of Biological Product Deviations by Licensed Manufacturers - 600.14	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 600.14 21 CFR 600

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	FORM FDA-3486 12-5-13.pdf		Yes	Yes	Fillable Printable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 102	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	611	-91	702
Annual IC Time Burden (Hours)	1,222	-182	1,404
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.