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

الملخص

The Food and Drug Administration (FDA) is announcing the following changes to its Orphan Products Development (OPD) grant program for fiscal year (FY) 1997. The previous announcement of this program, which was published in the Federal Register of August 15, 1994, is superseded by this announcement. In the future, a new announcement will be published annually. This and future announcements will provide the programmatic requirements and criteria, as well as the two dates for receipt of applications, the estimated amount of funds available, and the estimated number of awards to be made in each FY.