A--BPCA Pediatric Trials Network
ID: 75N94024R00008Type: Solicitation
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; BASIC RESEARCH (AN11)

Original Source

https://sam.gov/opp/26eeebd3e68d4bf9888c3aba895b138d/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH), is soliciting proposals for an Indefinite Quantity Contract to establish and manage the Best Pharmaceuticals for Children Act (BPCA) Pediatric Trials Network. This initiative aims to create a robust infrastructure for conducting pediatric clinical trials, emphasizing compliance with federal regulations and ethical standards in research practices. The contract, which has a performance period from May 19, 2025, to May 18, 2033, offers a minimum compensation of $2,500 and a maximum potential value of $149 million, contingent on successful performance. Proposals are due by November 4, 2024, and interested parties can contact Elizabeth J. Osinski at eo43m@nih.gov or 240-550-5028 for further information.

    Point(s) of Contact
    OSINSKI, ELIZABETH J
    (240) 550-5028
    eo43m@nih.gov
    Files
    Title
    Posted
    Amendment_1_to_RFP_75N94024R00008_9-11-24_0001.pdf
    The document is an amendment to the Request for Proposals (RFP) 75N94024R00008 issued by the National Institutes of Health, specifically under the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The amendment, effective September 11, 2024, revises key components of the solicitation in response to inquiries received. Notably, it updates eligibility criteria by encouraging prime contractors to include Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, and other minority-serving institutions among clinical trial sites. The due date for proposals remains unchanged at November 4, 2024. The amendment replaces Attachment #7 with updated instructions for technical and business proposals and clarifies that the solicitation is not limited to higher education institutions. Furthermore, it outlines essential assumptions regarding clinical studies, such as expected effort, travel requirements, and study designs for phases 1 to 3, and emphasizes the need for a draft protocol for pediatric pharmacology trials. Overall, this amendment aims to enhance participation from diverse organizations while providing detailed guidance for prospective offerors regarding proposal preparation and expectations.
    Pre-Sol_Posting_PTN_8-14-2024_2.pdf
    The National Institutes of Health (NIH) plans to issue a request for proposals (RFP) for an Indefinite-delivery, Indefinite-quantity (IDIQ) contract to support pediatric clinical trials. The goal is to establish an infrastructure for safe and effective drug trials, focusing on therapeutic areas where knowledge needs to be developed for treating pediatric diseases and disorders. The contract, anticipated to be awarded in 2025, will support the Best Pharmaceuticals for Children Act Program. It will enable the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) to fill gaps in pediatric research, interacting with various stakeholders. This pre-solicitation notice is a preliminary step, with the actual RFP expected in September 2024. NICHD aims to create an adaptable environment for conducting rigorous pediatric trials, improving drug labeling, and enhancing child health outcomes.
    SB_Sources_Sought_PTN_1-3-24_1.pdf
    Sol_75N94024R00008.pdf
    The National Institutes of Health (NIH) is soliciting proposals for an Indefinite Quantity Contract aimed at creating, operating, and maintaining an infrastructure for conducting pediatric clinical trials under the Best Pharmaceuticals for Children Act. The solicitation (75N94024R00008), issued on September 4, 2024, will accept proposals until November 4, 2024. This contract has a performance period from May 19, 2025, to May 18, 2033, with a minimum compensation of $2,500 and a maximum of $149 million, contingent on successful contract performance. The contractor will be required to adhere to federal guidelines, including ensuring compliance with regulations regarding the protection of human subjects and quality control in clinical trials. A series of reports and documentation will be necessary, including technical progress reports, financial conflict of interest disclosures, and annual summaries of participant inclusion. The contractor must also maintain strict security and privacy controls, conduct safety assessments, and coordinate data management throughout the contract period. In essence, this solicitation emphasizes the NIH's commitment to advancing pediatric drug development and ensuring compliant, effective research practices in clinical trials, with a significant focus on inclusion and ethical standards.
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