OOPD has developed over many years both written and unwritten internal policies and guidance to complement the regulations governing the approval of an Orphan Drug designation. Orphan Drug applications are becoming more complicated to review as a result of more complex drug development. Thus, OOPD is in need of establishing a single standard operating policy and procedure (SOPP) document that pulls together existing internal policy and procedural documents and also addresses emerging issues. The goal of this project is to continue to ensure internal consistency while addressing in a timely manner many new and challenging ideas by drug sponsors.A Standard Operating Procedure was developed and put into operation on November 9, 2010 by the Office of Orphan Products Development (OOPD) for the review of applications for orphan drug designation. This is an internal document. This document provides a standard form and a standard process for the review of a request for an orphan drug designation. The document ensures that the office continues to provide a consistent and quality review of requests submitted to OOPD for orphan drug designation. The document provides a template and disseminates to reviewers the standard policies followed by OOPD in making decisions regarding orphan drug designation.A. Initiate SOPP development process1/29/2010Completed1/29/2010B. Charge SOPP Committee2/10/2010Completed2/10/2010C. Draft outline of needed designation SOPP4/16/2010Completed4/16/2010D. Finalize and prioritize content outline of needed designation SOPP6/17/2010Completed6/17/2010E. Issue assignments to draft individual SOPP sections7/16/2010Completed7/16/2010F. Review draft SOPP sections9/17/2010Completed9/17/2010G. Approve and implement SOPP for internal use11/17/2010Completed11/17/2010http://www.fda.gov/AboutFDA/Transparency/track/ucm206293.htmFDA-TRACK Office of Special Medical Programs Dashboard