> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# CBER Safety Report Specifications Updated
- URL: https://www.fdaweb.com/cber-safety-report-specifications-updated/
- Published: 2021-04-08T12:00:00.000Z
- Updated: 2026-09-14T16:54:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149067

*Federal Register* notice: CBER is announcing the availability of version 2.2 of the “Specifications for Preparing and Submitting Postmarket Individual Case Safety Reports (ICSRS) for Vaccines.” The version update is not applicable to CBER-regulated drug products marketed with approved NDAs and ANDAs; CBER-regulated therapeutic biological products marketed with approved BLAs; whole blood or blood components; or to human cells, tissues, and cellular and tissue-based products regulated solely under the Public Health Service Act. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-07332.pdf?ref=fdaweb.com).