Clinical Studies of Safety and Effectiveness of Orphan Products; Availability of Grants; Request for Applications

Streszczenie

The Food and Drug Administration (FDA) is announcing the following changes to its Orphan Products Development (OPD) grant program. Previously, the OPD program consisted of two separate requests for applications (RFA's) published simultaneously with one receipt date for all applications. These two RFA's are now combined into one notice with two receipt dates each year. Previously, announcements were published in the Federal Register annually. From now on, a notice will be published annually in the Federal Register referencing this announcement.The notice will remind eligible applicants of the receipt dates, the estimated amount of funds available, the estimated number of awards to be made in that fiscal year (FY), and any changes in programmatic requirements or criteria.