Biologics License Applications; Procedures & Requirements

ICR 202302-0910-011

OMB: 0910-0338

Federal Form Document

Forms and Documents

Document Name	Status
Form Form FDA 2253 Biologics; Licensing; General Biological Products Standards; and Additional Standards Form and Instruction	Modified
Form 356h Notifications of suspensions Form and Instruction	Unchanged
0338 BLAs Supporting Statement 2023 REV.docx Supporting Statement A	2023-02-26
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx Justification for No Material/Nonsubstantive Change	2022-09-01

IC Document Collections

IC ID	Document Title	Status
5935	Biologics; Licensing; General Biological Products Standards; and Additional Standards Form and Instruction	Modified
209328	Notifications of suspensions Form and Instruction	Unchanged