NOT-HD-03-012: PEDIATRIC OFF-PATENT DRUG STUDY (PODS) CENTER - LORAZEPAM

Department of Health
and Human Services (HHS)
NIH... Turning Discovery Into Health^®

PEDIATRIC OFF-PATENT DRUG STUDY (PODS) CENTER - LORAZEPAM - STATUS EPILEPTICUS

RELEASE DATE:  May 13, 2003

NOTICE: NOT-HD-03-012

National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)

RFP AVAILABLE:  RFP-NICHD-2003-10 

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 respond 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, at the address listed below.  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.

INQUIRIES

For further information, and to submit proposals, contact:

Virginia DeSeau
Contracting Officer
National Institute of Child Health and Human Development
6100 Executive Boulevard, Suite 7A07, MSC 7510
Bethesda MD 20892-7510
Rockville MD 20852 (for express/courier service)
Telephone:  (301) 496-6947
Fax:  (301) 420-3676
Email:  [email protected]
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