83-c non substantive change to FDA 3486 and 3486A 11-1-11

NON-SUBSTANTIVE JUSTIFICATION (83-C)

OMB Control Number 0910-0458

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

The changes/redesign for Form FDA 3486 include the following: 

 

• The Distribution, Notification, and Additional Information fields have been moved to the same row as the other fields (Unit #, Collection Date, and Expiration Date).  All fields now appear on one row rather than three rows. 

• The Row # field was added so the information can be entered on one screen rather than entered on separate screens. 

• The Import Button was added above the fields so that saved data can be imported electronically rather than entered manually (See also second bullet above entry fields/buttons). 

 

 

The changes/redesign for Form FDA 3486A inlcude the following: 

 

• The Multiple Selected Row field was added to enable entry of the same value to multiple rows rather than to individual rows. 

• The Row # and Unit # fields were added.  The unit # is automatically populated from Form FDA 3486. 

• The Domestic and Foreign field dropdown menu and Distribution Pattern field were combined into one field (the dropdown menu is now under the Distribution Pattern column heading).

• # of Other field was deleted from the list of fields under the Provide Counts Related to Distribution Pattern heading.