Pediatric Trials Network

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) intends to solicit proposals to establish an Indefinite-delivery, Indefinite-quantity (IDIQ) Task Order (TO) contract to support clinical activities for a newly evolving Pediatric Trials Network (PTN). The successful offeror shall provide the requisite personnel, facilities and services to establish, conduct, and support pediatric clinical trials and related services including: expert consultation; pediatric clinical pharmacology; product formulation; drug distribution; and device development. Data collected from the PTN will help inform pediatric labeling, and be used to develop publications and other materials that will provide pediatricians and researchers with new information on medication disposition and response in children.

The main objective of this project is to create an environment by which a Contractor can operate an effective infrastructure for conducting safe and effective pediatric clinical trials and for performing ancillary activities in support of these trials. Although the prime focus of this Contract is to support BPCA clinical activities, NICHD also anticipates the need to utilize this Contract to acquire similar types of support for other NICHD pediatric drug development activities.

BPCA 2007 authorizes NICHD to identify therapeutic gaps in pediatrics, which are pediatric diseases, disorders or conditions where more complete knowledge and testing of therapeutics (including drugs, devices and biologics) can be beneficial to the pediatric population. There is currently inadequate infrastructure to perform this pediatric clinical trials research, and inadequate numbers of clinicians trained to perform this research.

NICHD anticipates the need to initiate activities in approximately five (5) to ten (10) therapeutic areas, with multiple therapeutic approaches for each therapeutic area. The work will be performed under individual task orders. It is therefore likely that these activities will require multiple scientific and clinical investigators with expertise in various disease areas.  At the present time, NICHD is anticipating, but will not be limited to, initiating studies in the following therapeutic areas:

§  Cardiovascular diseases, including the treatment of hypertension;

§  Infectious diseases, including the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections;

§  Respiratory diseases, including the treatment of asthma;

§  Gastroenterology, including treatment of gastro-esophageal reflux;

§  Pediatric oncology;

§  Neonatal therapeutic areas.

Additionally, for the purpose of this Contract, NICHD anticipates that with guidance of the PTN Contracting Officer’s Technical Representative (COTR), the Contractor may interact with researchers who either currently are (or will be) performing pre-clinical and clinical trial activities with researchers engaged in other NIH trials, e.g., the National Cancer Institute (NCI), the National Institute of Mental Health (NIMH), and the National Heart Lung and Blood Institute (NHLBI).

As a result of this announcement the NICHD anticipates awarding a single cost reimbursement completion IDIQ type contract with a period of performance of seven (7) years beginning on or about September 23, 2010. The NICHD anticipates the Request for Proposals (RFP) for this study will be available through the Federal Business Opportunities website (https://www.fbo.gov/) on or about April 7, 2010. Proposals will be due approximately 45 days after the RFP issue date. This acquisition has been designated as a full and open competition under North American Industry Classification System (NAICS) code is 541712 with a size standard of 500 employees. Any responsible offeror may submit a proposal that will be considered by the Government. This notice does not commit the Government to award of a contract. No collect calls or facsimile transmissions will be accepted.

Any questions concerning this announcement must be submitted in writing to Alice Pagan, Contract Specialist, at Alice.Pagan@nih.gov. The secondary point of contact is Elizabeth Osinski @ eo43m@nih.gov. The RFP No. is NIH-NICHD-CRMC-2010-02. All correspondence must cite the RFP Number.