Request for Proposals for Clinical Trials

NICHD's Approach to the Study of Off-Patent Drugs Mandated by the BPCA

In most instances, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) will issue competitive requests for proposals (RFPs) to solicit offerors capable of conducting studies of off-patent drugs for pediatric use information. NICHD utilizes the information contained in Written Requests (the U.S. Food and Drug Administration's (FDA) formal mechanism for notifying drug manufacturers that additional data are needed, and ascertaining if the manufacturer is interested in conducting the studies) that have been referred from FDA for specific drugs (and indications).

The resultant contracts are awarded to entities that have expertise in conducting pediatric clinical trials, including:

• Qualified universities, hospitals, and Contract Research Organizations (CROs)
• Federally funded networks (such as the Pediatric Pharmacology Research Unit Network, the Neonatal Research Network, and the Maternal Fetal Medicine Units Network)
• Other public or private institutions.

The study sites are called Pediatric Off-Patent Drug Study (PODS) Centers. Lead clinical centers, which subcontract to other clinical sites; pediatric clinical trials networks; CROs; and single academic centers are all eligible for contract awards depending on the overall qualifications, experience in pediatric drug trials, type of drug under study, specific drug indication, and access to target pediatric populations. It is expected that most studies will involve multiple sites. Established pediatric drug trials networks or offerors that have access to multiple sites will be encouraged to apply.

RFPs for Clinical Studies in the Federal Business Opportunities

Find "Federal Business Opportunities" at FedBizOpps