OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

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

OMB 0910-0458 · HHS/FDA.

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 is listed under ICR 201911-0910-003.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
Form FDA 3486A Form FDA 3486A; Web-based AddendumForm
Form FDA 3486 HCT/P deviationsForm and Instruction
Form FDA 3486 Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion ServicesForm and Instruction
0458 Deviation Reports SSA 2023.docxSupporting Statement A
Reporting of Biological Product Deviations by Licensed Manufacturer Other-IT Landing Page Screenshot
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All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202301-0910-014 Extension without change of a currently approved collection 2023-01-24 Approved without change
201911-0910-003 Extension without change of a currently approved collection 2020-01-10 Approved without change
201701-0910-007 Extension without change of a currently approved collection 2017-01-12 Approved with change
201312-0910-008 Extension without change of a currently approved collection 2013-12-20 Approved without change
201111-0910-002 No material or nonsubstantive change to a currently approved collection 2011-11-02 Approved without change
201006-0910-003 Revision of a currently approved collection 2010-06-28 Approved with change
200810-0910-006 No material or nonsubstantive change to a currently approved collection 2008-10-29 Approved without change
200703-0910-003 Extension without change of a currently approved collection 2007-03-08 Approved without change
200401-0910-001 Extension without change of a currently approved collection 2004-01-05 Approved without change
200103-0910-005 No material or nonsubstantive change to a currently approved collection 2001-03-12 Approved without change
200011-0910-001 New collection (Request for a new OMB Control Number) 2000-11-07 Approved without change

OMB Details

Reporting of Biological Product Deviations by Licensed Manufacturer

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
FormNameElectronic accessType
Form FDA 3486Biological Product Deviation Reportwww.fda.gov/vaccines-blood-biologics/report-problem-center-biologics-evaluation-research/biological-product-deviationsForm and instruction

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