SOLICITATION NOTICE
A -- Pediatric Off-Patent Drug Study (PODS) Center-Lorazepam-Status Epilepticus
- Notice Date
- 3/31/2003
- Notice Type
- Solicitation Notice
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- RFP-NICHD-2003-10
- Archive Date
- 10/31/2003
- Point of Contact
- Virginia DeSeau, Contracting Officer, Phone 301-435-6947, Fax 301-402-3676, - Charles Grewe, Deputy Chief, Contracts Management Branch, Phone 301-435-6957, Fax 301-402-3676,
- E-Mail Address
-
vd9t@nih.gov, cg59b@nih.gov
- Description
- The National Institute of Child Health and Human Development (NICHD) is planning to award a contract for a program entitled, Pediatric Off-Patent Drug Study (PODS) Center ? Lorazepam ? Status Epilepticus. To improve knowledge of safety, efficacy and optimal therapeutic use of off-patent drugs in pediatric populations, the Best Pharmaceuticals for Children Act (BPCA) of 2002 outlines a process whereby the Food and Drug Administration (FDA), in consultation with the National Institutes of Health (NIH), may issue a Written Request for a particular drug to all holders of approved applications [innovator and abbreviated new drug application (ANDA) holders] for drugs approved under section 505 of the Act. If no sponsor agrees to conduct the studies within 30 days of the request, the NIH, in consultation with FDA, will publish a request for contract proposals to conduct studies described in the Written Request (in some instances additional studies will be requested). The FDA did not get responses from current sponsors concerning the use of Lorazepam to treat status epilepticus in pediatric populations. Therefore, the NICHD will proceed with a contract(s) for the conduct of the necessary clinical trial. The contract(s) will be awarded to entities that have expertise in conducting pediatric clinical trials, including qualified universities, hospitals, Contract Research Organizations (CROs), federally funded networks (such as the Pediatric Pharmacology Research Unit Network, the Neonatal Network, the Maternal Fetal Medicine Network, and others), and other public or private institutions. The structure that is spelled out here will be used for other pediatric clinical trials for other drugs that fall under the BPCA guidelines. The study sites will be called Pediatric Off-Patent Drug Study (PODS) Centers. Lead academic 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. A single, competitively awarded BPCA Coordinating Center (BPCA-CC) will perform the logistical and technical support to handle all of the data, and assist the NICHD as needed in the administration of the various multi-site networks of clinical centers (the PODS Centers) for each drug that will be studied. The BPCA-CC will also prepare and submit to the FDA all data from the studies conducted by the PODS Centers and the necessary documentation in the form of a Final Study Report to support labeling of the drugs studied. The BPCA-CC will ensure that the PODS Centers (and its subcontractors, if any) adhere to the study protocols for the drug to be studied. The activities conducted by the BPCA-CC will support both data collection and evaluation prior to submission of the Final Study Report to the FDA. An RFP has been issued for award of the BPCA-CC, but no award has been made to date. The PODS Centers will be funded by competitively awarded contracts to study off-patent drugs. Individual contracts will be awarded to clinical organizations, the choice of which will depend on the specific drug to be studied, the particular indication for use and the specific pediatric studies to be conducted. Thereby, studies for specific drugs/indications will be focused at specific PODS Centers, although some PODS Centers could be sites where more than one drug or drug indication will be studied. It should be noted that while the PODS Centers will be awarded based on the needs for a particular drug and indication, the BPCA-CC will remain unchanged for the life of that particular contract. Offerors who will be responding to the subject Request for Proposal (RFP) will be requested to develop study protocols involving the use of lorazepam for status epilepticus in pediatric populations according to the specifications listed in the Statement of Work, which includes the FDA?s Written Request. After an award has been made, the successful offeror(s) shall meet with staff of the NICHD, BPCA-CC and the FDA in order to agree on the final set of protocols to be implemented in the pediatric populations to be studied, and to provide materials needed for FDA IND approval for the studies. The required service is defined as code 541990 under the North American Industry Classification System (NAICS). The Request for Proposal (RFP) will be available on or before, April 9, 2003 through the web site at http://FedBizOpps.gov . All responses must be submitted on or before July 14, 2003, to: Virginia A. DeSeau, Contracting Officer, NICHD, CMB, 6100 Building, suite 7A07, 6100 EXECUTIVE BLVD MSC 7510, BETHESDA MD 20892-7510 (if sending by overnight carrier, use 6100 Executive Blvd., Suite 7A07, Rockville, MD 20852). Fully electronic copies will not be accepted, but portions of the proposal may be provided on disc. The reference number to be used for this announcement is: RFP NICHD-2003-10. All correspondence must cite the reference number as provided.
- Record
- SN00291555-W 20030402/030331213240 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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