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# 4 CBER SOPPs on Application Processing
- URL: https://www.fdaweb.com/4-cber-sopps-on-application-processing/
- Published: 2022-10-05T12:00:00.000Z
- Updated: 2026-09-14T18:01:54.000Z
- Author: David McFarland
- Tags: Biologics, Drugs, Devices, #legacy-id-D5152902

CBER has published four Standard Operating Policies and Procedures (SOPPs) relating to the administrative processing of applications. [SOPP 8401](fda.gov/media/85659/download): Administrative Processing of Original BLAs and NDAs includes those subject to the Biosimilar User Fee Act (BsUFA) and Prescription Drug User Fee Act (PDUFA). It does not apply to BLAs subject to the Medical Device User Fee Act (MDUFA), ANDAs subject to the Generic Drug User Fee Act (GDUFA), or annual reports.

[SOPP 8401.1](http://www.fda.gov/media/85301/download?ref=fdaweb.com): Issuance of and Review of Responses to Information Request Communications to Pending Applications applies to BLAs, ANDAs, medical device applications, and their respective amendments and supplements. It applies to products covered by BsUFA, GDUFA, MDUFA, and PDUFA and non-user fee products in these product categories.

[SOPP 8401.2](http://www.fda.gov/media/108895/download?ref=fdaweb.com): Administrative Processing of BLA and NDA Supplements applies to supplements processed by CBER including those subject to PDUFA and BsUFA. It does not apply to supplements for medical device BLAs or those subject to GDUFA.

[SOPP 8401.4](http://www.fda.gov/media/108901/download?ref=fdaweb.com): Review Responsibilities for the CMC Section of Biologic License Applications, New Drug Applications, and Supplements does not address review responsibilities for PMAs, licensed (BLA) *in vitro* diagnostics, or blood and blood components intended for transfusion and for further manufacturing that are reviewed by the Division of Blood Components and Devices/Office of Blood Research and Review.