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# Comments Sought on Waiver Requests on Safety Reporting
- URL: https://www.fdaweb.com/comments-sought-on-waiver-requests-on-safety-reporting/
- Published: 2017-05-23T12:00:00.000Z
- Updated: 2026-09-14T22:25:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5138767

*Federal Register* notice: FDA is seeking comments on an information collection extension related to “Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonization E2C (R2) Format.” The guidance is intended to promote a consistent approach to periodic post-marketing safety reporting among the ICH regions and to enhance efficiency by reducing the number of reports generated for submission to the regulatory authorities. It is also intended to provide a common standard for periodic reporting on approved drugs or biologics among the ICH regions. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-05-23/pdf/2017-10537.pdf?ref=fdaweb.com).