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

OMB 0910-0458

This information collection supports agency regulations regarding the reporting of biological product deviations and human cells, tissues, and cellular and tissue-based product deviations. Respondents to the collection are manufacturers of these products. The information collection supports the agency's mission to protect the public health by safeguarding against the transmission and spread of communicable disease.

The latest form for Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing expires 2023-01-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
Form FDA 3486 Reporting of Biological Product Deviations by Licensed Manufacturer Form and Instruction
Form FDA 3486A Form FDA 3486A; Web-based Addendum Form
Form FDA 3486 HCT/P deviations Form and Instruction
Form FDA 3486 Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services Form and Instruction
0458 Biologics deviations reports SSA 2019 Ext.pdf Supporting Statement A
Reporting of Biological Product Deviations by Licensed Manufacturer Form and Instruction
Form FDA 3486A; Web-based Addendum Form
HCT/P deviations Form and Instruction
Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services Form and Instruction

All Historical Document Collections

201911-0910-003 Approved without change	Extension without change of a currently approved collection	2020-01-10
201701-0910-007 Approved with change	Extension without change of a currently approved collection	2017-01-12
201312-0910-008 Approved without change	Extension without change of a currently approved collection	2013-12-20
201111-0910-002 Approved without change	No material or nonsubstantive change to a currently approved collection	2011-11-02
201006-0910-003 Approved with change	Revision of a currently approved collection	2010-06-28
200810-0910-006 Approved without change	No material or nonsubstantive change to a currently approved collection	2008-10-29
200703-0910-003 Approved without change	Extension without change of a currently approved collection	2007-03-08
200401-0910-001 Approved without change	Extension without change of a currently approved collection	2004-01-05
200103-0910-005 Approved without change	No material or nonsubstantive change to a currently approved collection	2001-03-12
200011-0910-001 Approved without change	New collection (Request for a new OMB Control Number)	2000-11-07

OMB Details

Reporting of Biological Product Deviations by Licensed Manufacturer

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form FDA 3486

Biological Product Deviation Report

www.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/biological-product-deviations

Form and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.