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

OMB 0910-0458

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.

OMB Details

Reporting of Biological Product Deviations by Licensed Manufacturer

Federal Enterprise Architecture: Health - Consumer Health and Safety

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.


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