The Food and Drug Administration (FDA) is proposing to amend the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.   

The period to provide comments to the Orphan Drug Regulations-Proposed Rule closed on January 17, 2012.  Public submission comments to the Orphan Drug Regulations-Proposed Rule may be viewed at www.regulations.gov by searching the Docket No. FDA-2011-N-0583.  The FDA is currently reviewing the comments.

For questions regarding the proposed rule contact: