HCT/P deviations

Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing

Documents and Forms

Document Name Document Type
Form FDA 3486 HCT/P deviations Form and Instruction
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

Information Collection (IC) Details

IC Title:	HCT/P deviations	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 1271.350(b)

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
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: 80	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	206	-37	243
Annual IC Time Burden (Hours)	412	-74	486
Annual IC Cost Burden (Dollars)	0	-21,870	21,870

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.