As part of the BPCA mandate, six public assemblies have been convened to develop a generic framework to provide an overall structure to enable pediatric drug development studies. The goal is to develop -- in collaboration with subject matter experts (SMEs) in pediatric care and research -- an annotated, selective, curated collection of resources that will assist drug developers, researchers, and clinicians conducting pediatric drug development research. As part of this process, assembly participants are asked to submit references for best practice and guidance documents for inclusion in the final framework. This online form has been created to streamline this process.
BPCA Framework to Enable Pediatric Drug Development Resource Submission Form
OMB# 0925-0766 Exp Date: 4/2023

Public reporting burden for this collection of information is estimated to average 5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.  An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0648).  Do not return the completed form to this address.