A--Best Pharmaceuticals for Children Act (BPCA) Pediatric Trials Network (PTN)
ID: 75N94024R00008Type: Presolicitation
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/70c730deffea46d6bd197d1493047551/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 maintain an infrastructure for conducting pediatric clinical trials under the Best Pharmaceuticals for Children Act (BPCA). The primary objective is to create a Pediatric Trials Network (PTN) that will facilitate the development of safe and effective medications for children, ensuring compliance with federal regulations regarding human subjects and quality control in clinical trials. This initiative is crucial for advancing pediatric drug development and promoting ethical research practices, with a contract performance period from May 19, 2025, to May 18, 2033, and a funding range between $2,500 and $149 million based on performance. Interested contractors must submit their proposals by November 4, 2024, at 4:30 PM EST, and can direct inquiries to Elizabeth J. Osinski at eo43m@nih.gov or call 240-550-5028.

    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.
    Amendment_2_to_the_RFP_-_9-20-24_0002.pdf
    The document is an amendment to solicitation RFP 75N94024R00008 issued by the National Institutes of Health's Eunice Kennedy Shriver National Institute of Child Health and Human Development. The purpose of this amendment is to provide answers to questions received from potential offerors, clarifying details regarding the RFP and related proposals. Key points include the extension of the submission deadline to November 4, 2024, at 4:30 PM EST, and the confirmation that bidders should report costs based on the ceiling amount of $149 million for task orders, rather than the total costs from Task Orders 1-3. Additionally, offerors are permitted to add an 8th year to the cost proposal workbook, despite the original request being for a 7-year plan. The amendment emphasizes that these clarifications serve as guidance and do not alter the original terms of the RFP. Overall, the document maintains the integrity of the solicitation process while providing necessary clarifications to potential bidders.
    Amendment_3_to_the_RFP_-_10-08-2024_0003.pdf
    This document presents Amendment No. 003 to the Request for Proposals (RFP) 75N94024R00008, issued by the National Institutes of Health (NIH) specifically by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Effective from October 8, 2024, this amendment addresses inquiries concerning the proposal and modifies specific attachments related to packaging and delivery. The due date for proposal submission remains unchanged, set for November 4, 2024, at 4:30 PM EST. Key modifications include the addition of new attachments to the RFP, specifically the "Study Record: PHS Human Subjects and Clinical Trials Information" (Form 0925-0001) and an updated "Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption" (Form 0990-0263), effective through June 30, 2024. Notably, responses to common questions are provided, clarifying that the Human Subjects information must be submitted separately and is not included in the technical proposal page counts. The document underscores the importance of submitting the required forms in compliance with NIH guidelines while ensuring the integrity and protection of human subjects in research proposals.
    Amendment_4_to_the_RFP_-_10-11-2024_0004.pdf
    The document outlines Amendment No. 004 to RFP 75N94024R00008 issued by the National Institutes of Health for Task Order 2, focusing on decentralized clinical trials. This amendment provides clarification and modifications to the Statement of Work, specifically revising and deleting several sections related to study requirements and timelines. Key changes include the requirement to submit only a concept proposal and not a full protocol, and it states that the budget must reflect costs associated solely with the concept proposal development. The deadline for submitting offers remains unchanged at November 4, 2024. Additionally, the amendment includes a Q&A section that addresses concerns from potential offerors regarding the requirements of the proposal and budget. It clarifies that no PHS Human Subjects and Clinical Trials Information form is needed at this stage since only a concept proposal is required. Overall, the amendment aims to streamline the proposal process for participating contractors, ensuring clarity on expectations and requirements while maintaining compliance with federal regulations governing clinical trials.
    Amendment_5to_the_RFP_-_10-18-2024_0005.pdf
    The document is an amendment to the Request for Proposals (RFP) No. 75N94024R00008 issued by the National Institutes of Health for the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Effective October 18, 2024, this amendment serves to provide clarification on the inclusion of the Data Sharing Plan. It specifies that this plan should be part of the Technical Proposal and is exempt from the technical proposal's page limits. Additionally, the amendment includes a due date for proposal submissions of November 4, 2024, by 4:30 PM EST. Potential offerors must acknowledge receipt of this amendment to avoid rejection of their proposals. The document outlines the procedural steps for acknowledgment and modification of offers and describes the regulatory authority under which changes are made. The amendment's key aim is to streamline the proposal submission process and address specific queries from potential contractors regarding data management requirements, ensuring clarity and compliance with federal guidelines on proposals for grants or contracts.
    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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