42 U.S.C. § 284h — Pediatric Research Initiative

(a) Establishment. The Secretary must set up a Pediatric Research Initiative inside the Office of the Director of NIH, to fund research directly related to children's diseases, disorders, and other conditions. The Director of NIH heads the Initiative. (b) Purpose. The Initiative exists to let the Director of NIH: (1) grow support for pediatric biomedical research to keep up with new scientific opportunities; (2) build stronger teamwork between NIH's institutes on the most promising research areas; and (3) work with the FDA to expand pediatric clinical trials and pediatric-use drug information, to make prescription drugs safer and more effective for children. (c) Duties. To carry out subsection (b), the Director of NIH must: (1) consult with the Director of the Eunice Kennedy Shriver Institute, other research institutes, and the Health Resources and Services Administration when weighing requests for new or bigger pediatric research; (2) have wide freedom in deciding how to split Initiative funding among institutes, grant types, and basic versus clinical research, as long as it relates to children's illnesses; and (3) oversee newly appropriated Initiative funds and report each year to Congress and the public on the total funds used for pediatric research across NIH, including specific awards made through the Initiative. (d) National Pediatric Research Network. (1) The Director of NIH, working with relevant institutes and centers, must support a National Pediatric Research Network to make pediatric research more effective and better use federal resources. This network can include the consortia funded under paragraph (2), or other recognized pediatric-research consortia, centers, or networks. (2)(A) The Director must fund — through grants, contracts, or other means — public or private nonprofit groups to run pediatric research consortia, covering both research on unmet pediatric needs and training researchers in pediatric methods. (B) The Director must ensure each consortium does at least one type of that research (and that, together, all consortia cover every type), and that at least one consortium provides the required training. (C) Each consortium must: be formed from cooperating institutions; have a lead institution coordinating it; agree to quickly share findings, including from clinical trials, with other consortia, NIH, the FDA, and other relevant agencies; and meet the Director's other requirements. (D) Consortium funding must supplement, not replace, other public or private support. (E) Support for a consortium lasts up to 5 years, extendable at the Director's discretion. (3) The Director must coordinate consortia activities — including regular communication — and require periodic reports on each consortium's work. (4) A consortium may help the CDC with patient registries and other surveillance systems, if the CDC Director asks. (e) Research on pediatric rare diseases. When awarding consortium funding under subsection (d)(2), the Director must ensure an appropriate number of awards go to consortia that agree to focus on pediatric rare diseases, conditions, or birth defects, and to run or coordinate multi-site clinical trials for preventing, diagnosing, or treating them. (f) Transfer of funds. The Director of NIH may move money appropriated for this section between different Institutes for a given fiscal year, to carry out the Initiative's purposes.