LOGISTICS CONTRACT IN SUPPORT OF OBSTETRIC AND PEDIATRIC PHARMACOLOGY AND THERAPEUTICS

Investigators

Abstract

In 2004, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) created the Obstetric and Pediatric Pharmacology and Therapeutics Branch (OPPTB). The objectives of the Branch are to centralize basic, clinical and translational research, including clinical trials and other drug development activities for pediatric and obstetric pharmacology research and training. One of the programs within the OPPTB is related to a congressional mandate called the Best Pharmaceuticals for Children Act (BPCA). BPCA was originally authorized in 2002 and allows the Food and Drug Administration (FDA) to mandate the study of medications in children by pharmaceutical companies through the use of incentives, such as patent extensions for exclusivity. The BPCA also directs the Secretary of HHS, acting through the Director of the National Institutes of Health (NIH), in consultation with the Commissioner of the FDA and experts in pediatric research, to carry out major efforts to improve the information available for the use of medications in children, particularly related to drug label changes (section 409I of the BPCA legislation). The NICHD, specifically the OPPTB, oversees the implementation of the BPCA at the NIH. Efforts in support of BPCA require NICHD to: • Develop and prioritize a list of therapeutic areas and drugs for which pediatric studies are needed. • Develop funding mechanisms that provide researchers with opportunities to submit proposals within these prioritized areas to address gaps in pediatric labeling. • Improve pediatric therapeutics through clinical trials, basic and translational research, and training. • Disseminate study findings to researchers and the general public. To support all of these efforts, the OPPTB established various methods to engage senior government officials, researchers, academicians, and scientific experts throughout the U.S. and Europe to work with the NICHD to accomplish the following: convene experts to review data to help identify gaps in public health and in pediatric and obstetrics therapeutics overall; identify and share information that may lead to prioritizing drugs for further study; provide recommendations that can help determine the need/feasibility for conducting clinical trials; and identify scientific gaps in pediatric and obstetric pharmacology. Additionally, the OPPTB is interested in keeping the general public apprised of funding opportunities and training opportunities that may support both obstetric and pediatric activities. Because of its mandated activities (like BPCA) and broad outreach in many other areas of the branch, logistics support is necessary for OPPTB to achieve the goal and objectives of its research agenda. Significant planning, tracking, review, and reporting are associated with the management of this OPPTB logistics activity. In September 2017NICHD awarded a 3-year Firm Fixed Price Contract, HHSN275201800294U. This project is a continuance of services which are complex in nature and NICHD seeks to initiate a follow-on contract to provide a wide variety of logistical and administrative services in support of the OPPTB. The OPPTB anticipates the activities and level of effort required during the course of this requirement will increase by approximately five percent during each fiscal year.