Information Collection Request

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

ICR 202301-0910-014 · OMB 0910-0458 · Received in OIRA

Forms and Documents

Document Name	Status
Form FDA 3486A Form FDA 3486A; Web-based Addendum Form	Modified
Form FDA 3486 HCT/P deviations Form and Instruction	Modified
Form FDA 3486 Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services Form and Instruction	Modified
0458 Deviation Reports SSA 2023.docx Supporting Statement A	2023-01-24

IC Document Collections

IC ID	Document Title	Status
6151	Reporting of Biological Product Deviations by Licensed Manufacturer Other-IT Landing Page Screenshot	Modified
178972	Form FDA 3486A; Web-based Addendum Form	Modified
178971	HCT/P deviations Form and Instruction	Modified
178970	Reporting of Product Deviations by Licensed Manufacturers, Unlicensed Registered Blood Establishments, and Transfusion Services Form and Instruction	Modified

ICR Details

Status	Received in OIRA
Agency/Subagency	HHS/FDA
OMB Control No	0910-0458
Type of Information Collection	Extension without change of a currently approved collection
Previous ICR Reference No	201911-0910-003
Agency Tracking No	CBER
Date Submitted to OIRA	1969-12-31
Requested Expiration Date	1969-12-31