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# Comments Sought on BLAs, Postmarketing Reports
- URL: https://www.fdaweb.com/comments-sought-on-blas-postmarketing-reports/
- Published: 2016-07-11T12:00:00.000Z
- Updated: 2026-09-14T21:13:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136141

*Federal Register* Notice: FDA is seeking public comment on the collection of information relating to general licensing provisions for BLAs, changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Form FDA 356h. This form is the “Application to Market a New Drug, Biologic, or an Antibiotic Drug for Human Use” and was developed to harmonize application procedures between CBER and CDER. The application form serves primarily as a checklist for firms to gather and submit certain information to FDA. Comments should be submitted by 9/9\. To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-07-11/pdf/2016-16352.pdf?ref=fdaweb.com)