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⚠️ Notice: This information collection may be referencing outdated material.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

Documents and forms in this information collection
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

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:

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	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 %

table that charts list of burden
	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

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.