Access to Inpatient Pediatric Drug Utilization Data – Request for Information

Purpose THIS IS A REQUEST FOR INFORMATION (RFI) ONLY. This Request for Information (RFI) is being issued in accordance with Federal Acquisition Regulation Part 10, Market Research. It is for information, planning and market research purposes only and shall not be construed as either a solicitation or obligation on the part of the Food and Drug Administration or its Centers.

The purpose of this RFI is to help the FDA understand industry best practices, technical solutions, and sources capable of meeting the FDA's requirements for evaluating pediatric drug utilization data. Specifically, the Government is seeking verification that its automated, auditable, quantitative data mining requirement is commercially available, and determine if there are any questions about the FDA's requirements.

The government would also like to determine if there are any gaps in pediatric data available to meet the FDA's requirements. Background The FDA has access to multiple drug utilization databases, some of which contain pediatric use patterns, but gaps remain in our ability to fully characterize pediatric drug use nationwide.

Information is lacking from stand-alone pediatric hospitals, where medically complex children may receive different therapeutic treatments compared to children treated in general hospitals or in outpatient settings. Identifying data sources to support a more comprehensive view of nationally representative inpatient pediatric drug utilization patterns could greatly improve our understanding of how drugs are being prescribed to children under real-world conditions to support FDA’s mission.

Objectives The Agency would like to determine sources available to provide continuous access to data containing pediatric inpatient drug utilization, including pediatric specialty hospitals and Emergency Departments (ED) and, if available, treatment procedures and diagnostic information in pediatric patients. Information Requested Interested parties should provide responses to the following questions (where available) regarding their data sources.

Responses to this Request for Information shall be sent to Maeve Xavier, Contract Specialist via email at Maeve.Xavier@fda.hhs.gov as one (1) attachment (Microsoft Word or Adobe Acrobat formats only). The attachment shall be on 8.5” x 11” pages, with 12-point font size in Times New Roman (or equivalent) and single-spaced. Responses should be limited to 10 pages or less. The email subject line shall read, “FDA-RFI-CDER-2024-121421 – Access to Inpatient Pediatric Drug Utilization Data -

(enter name of your company.)” No other information other than what is specifically outlined this section shall be submitted. Please forward all responses to this RFI by the Response Date of Thursday February 15, 2024, no later than 12:00 PM Eastern.. Responses received after the due date may not be considered. Be advised that FDA does not accept documents which contain the use of macros.

When submitting documents via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). Document submissions shall not have macro enabled functionality and any document delivered having that functionality will be deemed delinquent, if not corrected prior to the due date.