A--Data Coordinating Center (DCC) for the Best Pharmaceuticals for Children Act (B
ID: 75N94025R00006Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NICHDBETHESDA, MD, 20817, USA

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH (AN12)

Original Source

https://sam.gov/opp/69932d100f654ffb96470b7b437edeb9/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH) and its National Institute of Child Health and Human Development (NICHD), is seeking qualified small businesses to support the Data Coordinating Center (DCC) for the Best Pharmaceuticals for Children Act (BPCA). The primary objective of this procurement is to provide comprehensive data management, analysis, and regulatory reporting services for pediatric clinical trials, ensuring compliance with FDA regulations and facilitating data submission to the FDA and the NICHD Data Repository. This initiative is crucial for enhancing pediatric health outcomes by addressing therapeutic gaps and conducting necessary clinical studies, as mandated by the reauthorized BPCA. Interested parties must submit their capability statements by January 28, 2025, and can contact Deborah Brock at Deborah.Brock@nih.gov for further information.

    Point(s) of Contact
    BROCK, DEBORAH S
    Deborah.Brock@nih.gov
    Files
    Title
    Posted
    BPCA_DCC_SBSS_1_13_2025_1.doc
    The Best Pharmaceuticals for Children Act (BPCA) Data Coordinating Center (DCC) is seeking qualified small businesses to assist in pediatric drug development, focusing on improving the safety and effectiveness of medications for children. This sources sought announcement outlines the government’s need for agencies to provide data management, analysis, and regulatory reporting for pediatric clinical trials. The BPCA, reauthorized in 2022, mandates the NIH, through NICHD, to identify therapeutic gaps and conduct necessary clinical studies. The DCC will manage data for ongoing and new trials, ensuring compliance with FDA regulations and facilitating data submission to both the FDA and the NICHD Data Repository. Notable responsibilities include developing data management systems, providing regulatory oversight, and ensuring high quality and integrity in data collection for trials. Interested small businesses must demonstrate experience in managing pediatric clinical trials and compliance with data security protocols. The deadline for submissions of capability statements is January 28, 2025. This initiative aligns with federal goals to enhance pediatric health outcomes through collaborative research and regulatory support.
    Lifecycle
    Title
    Type
    A--Data Coordinating Center (DCC) for the Best Pharmaceuticals for Children Act (B
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