83-c 0458

83-C 0458.doc

Biological Products: Reporting of Biological Product Deviations in Manufacturing; Forms 3486 and 3486A

83-C 0458

OMB: 0910-0458

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0910-0458 – Justification for change


Form FDA 3486A has been revised and decreases the total burden by 534 hours. The proposed new form is attached along with a comparison document.

File Typeapplication/msword
File Title0910-0458 – Justification for change
AuthorJonna Capezzuto
Last Modified ByJonna Capezzuto
File Modified2008-09-26
File Created2008-09-26

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