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# AABB Suggests Biologics Forms Modifications
- URL: https://www.fdaweb.com/aabb-suggests-biologics-forms-modifications/
- Published: 2016-08-18T12:00:00.000Z
- Updated: 2026-09-14T21:25:33.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5136551

Responding to an FDA request for comment on its forms FDA-3486 and FDA-3486A used to report biological product deviations and human cells, tissues, and cellular and tissue-based deviations in manufacturing, AABB [asks](https://www.regulations.gov/contentStreamer?documentId=FDA-2013-N-0579-0004&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) that the forms be modified to be easier to use by its members and member facilities. The group asks that FDA reduce the burdens associated with the two forms by: 

- permitting all facilities to attach additional documentation such as a spreadsheet to report a biological product deviation, regardless of the number of products to be reported; and
- incorporating technology to permit barcode scanning for relevant fields that could reduce typographical human errors.

 The group’s letter says that the changes would “establish a more user-friendly interface, minimize the chance for errors, and accommodate a common manufacturing practice in the cell therapy product manufacturing sector.”