Studies of Adverse Effects of Marketed Drugs; Availability of Grants (Cooperative Agreements); Request for Applications

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The Food and Drug Administration (FDA), Center for Drug Evaluation and Research, is announcing the anticipated availability of funds for cooperative agreements to study adverse effects of drugs marketed in the United States and its territories. Subject to the availability of fiscal year 2002 funds, FDA anticipates that approximately $900,000 will be available. FDA anticipates making up to three awards, each for up to $300,000 per year (direct and indirects costs) for general databases that cover U.S. patients only, cover multiple States across the United States, had more than 1.5 million enrolled patients on December 31, 2000, and have the demonstrated ability to obtain paper copies of anonymized patient medical records. Support for these agreements may be for up to 3 years subject to availability of future funds and satisfactory performance during the preceding year. The purpose of these agreements is to conduct drug safety analysis to the benefit of the public's health; respond expeditiously to urgent public safety concerns; provide a mechanism for collaborative pharmacoepidemiological research designed to test hypotheses, particularly those arising from suspected adverse reactio