A--Best Pharmaceuticals for Children Act (BPCA) Pediatric Trials Network (PTN)
ID: 75N94024R00008Type: Sources Sought
Overview

Buyer

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

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; BASIC RESEARCH (AN11)

Original Source

https://sam.gov/opp/845036f285ca4e9ebcce92fc4716191c/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.
    Similar Opportunities
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is soliciting proposals for Chemistry, Manufacturing, and Control (CMC) services related to the development of drug substances under RFP number 75N95024R00094. The primary objective is to secure high-quality drug substances to support preclinical and Investigational New Drug (IND)-enabling studies, ensuring compliance with current Good Manufacturing Practices (cGMP) and federal regulations. This initiative is crucial for advancing therapeutic innovations and facilitating collaborations in drug development, with a total funding amount of up to $49.7 million over the contract period from September 1, 2025, to May 14, 2031. Interested parties must submit their proposals by December 3, 2024, and can direct inquiries to primary contact Samson Shifaraw at samson.shifaraw@nih.gov or secondary contact Valerie Whipple at valerie.whipple@nih.gov.
    PREPARATION AND DISTRIBUTION OF RESEARCH DRUG PRODUCTS
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA), is seeking proposals for the "Preparation and Distribution of Research Drug Products" under solicitation number 75N95024R00003. The primary objective of this procurement is to acquire, analyze, create, and distribute a variety of drug compounds essential for drug abuse and addiction research, including controlled and uncontrolled substances, while ensuring compliance with DEA regulations. This contract, structured as an indefinite delivery, indefinite quantity (IDIQ) agreement for a five-year period, aims to enhance research capabilities in the field of drug abuse, with proposals due by November 15, 2024, at 1:00 PM (Eastern Time). Interested parties should contact Scott Duernberger at scott.duernberger@nih.gov or Josh Lazarus at josh.lazarus@nih.gov for further information.
    A--To award Indefinite Delivery Indefinite Quantity (IDIQ) Contract for a Biologic
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified small businesses to fulfill an Indefinite Delivery Indefinite Quantity (IDIQ) contract for the Biological Testing Facility (BTF), which focuses on the preclinical development of contraceptive products. The objective of this procurement is to support the discovery and optimization of anti-fertility agents, ensuring safety and efficacy evaluations that meet regulatory standards for clinical trials, ultimately aiding in the development of high-quality reproductive health products. Interested small businesses must demonstrate their qualifications, including compliance with Good Laboratory Practice and Good Manufacturing Practice, and provide capability statements by November 21, 2024, with the anticipated contract performance period running from September 3, 2025, to September 2, 2032. For further inquiries, interested parties may contact Adelola O. St John at lk202p@nih.gov or call 301-435-6955.
    NIAID PROFESSIONAL, SCIENTIFIC AND TECHNICAL SUPPORT SERVICES (PSTSS)
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH) NIAID, is seeking proposals for Professional, Scientific, and Technical Support Services (PSTSS) to assist with various research initiatives, including basic, translational, and clinical research, as well as vaccine development and laboratory research across multiple biosafety levels. The procurement aims to secure specialized expertise to enhance the effectiveness of ongoing and future research efforts critical to public health. Proposals are due by December 16, 2024, with the contract period set to commence on June 1, 2025, and potentially extend to November 30, 2030, with a total funding cap of $3 billion across all awarded contracts. Interested parties can reach out to Rosemary Gomes at Rosemary.Gomes@nih.gov or Kristel Turansky at Kristel.Turansky@nih.gov for further information.
    A--NIH NeuroBioBank Brain and Tissue Repository
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for the establishment of the NIH NeuroBioBank Brain and Tissue Repository. The objective of this procurement is to create and manage contract collection sites for acquiring, storing, and distributing human brain and central nervous system tissues for research purposes, aimed at advancing the understanding of nervous system disorders. This initiative is critical for enhancing biomedical research by providing well-characterized specimens to researchers, thereby facilitating studies that could lead to improved treatments and interventions. Proposals are due by November 25, 2024, with the anticipated contract performance period starting on May 1, 2025, and extending potentially through multiple option years. Interested vendors should contact Robin D. Knightly at robin.knightly@nih.gov or call +1 301 827 5302 for further information.
    2026 NIAID DMID Omnibus Broad Agency Announcement
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH) and specifically the National Institute of Allergy and Infectious Diseases (NIAID), is soliciting proposals for the 2026 NIAID DMID Omnibus Broad Agency Announcement (BAA) aimed at advancing medical countermeasures against infectious diseases. This opportunity encompasses two primary research areas: the development of therapeutics, vaccines, and diagnostics for antimicrobial-resistant pathogens, and the creation of direct acting antivirals targeting viruses with pandemic potential. The initiative is critical for enhancing public health responses to emerging infectious threats and includes funding estimates of up to $8.5 million for Research Area 001 and $20 million for Research Area 002, with proposals due to be submitted online via the NIAID electronic Contract Proposal Submission (eCPS) platform, starting around November 22, 2024. For further inquiries, interested parties may contact Swee L. Teo at teosl@niaid.nih.gov or Brian Madgey at brian.madgey@nih.gov.
    Clinical Site and Study Monitoring for NIMH Funded Research in Global Settings
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking proposals for clinical site and study monitoring services for research funded by the National Institute of Mental Health (NIMH) in global settings. The primary objective of this procurement is to support efforts aimed at reducing mental health disparities, particularly in low and middle-income countries, through rigorous monitoring practices that comply with federal regulations and Good Clinical Practice. This five-year contract, expected to commence on November 25, 2024, has an anticipated budget of up to $2,000,000, with firm-fixed price task orders awarded as needed. Interested parties should direct inquiries to Cassandra Conley at cassandra.conley@nih.gov or Rieka Plugge at rieka.plugge@nih.gov.
    Democratized Engineering of Cells Informed by Dynamic Evidence (DECIDE) Exploration Topic
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the Democratized Engineering of Cells Informed by Dynamic Evidence (DECIDE) Exploration Topic. This initiative aims to enhance access to clinically validated curative cell therapies for pediatric patients with rare genetic diseases by advancing quality assurance mechanisms at Academic Medical Centers. The program focuses on developing innovative solutions for small-batch manufacturing of autologous cell therapies, addressing production variability, regulatory challenges, and market failures in this critical healthcare area. Proposals are due by November 18, 2024, at 12 PM EST, with the final solicitation released on October 22, 2024. Interested parties can reach out to the designated contact via the provided email for further inquiries.
    A--National Gene Vector Biorepository (NGVB)
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is preparing to issue a Request for Proposals (RFP) for the National Gene Vector Biorepository (NGVB) program, aimed at supporting translational gene therapy research over a five-year period. The selected contractor will be tasked with archiving over 20,000 clinical specimens under Good Laboratory Practices (GLP), developing assays for clinical testing, and maintaining a user-friendly web-based catalogue for gene therapy reagents, all while ensuring compliance with FDA regulations. This initiative underscores the government's commitment to advancing gene therapy research and enhancing the services provided by the NGVB. Interested parties should note that the RFP details are expected to be released on November 22, 2024, and can contact Ethan J. Mueller at ethan.mueller@nih.gov or +1 301 496 2153 for further information.
    Decentralized Clinical Operations for Healthcare and Research (D-COHRe) Partnership Solicitation
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services (HHS), through the Biomedical Advanced Research and Development Authority (BARDA), is soliciting proposals for the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program. This initiative aims to establish partnerships with organizations that provide decentralized healthcare services, such as retail pharmacies and telemedicine, to enhance clinical trial capabilities and support medical countermeasure development during public health emergencies. The program is critical for building a sustainable decentralized clinical research infrastructure, enabling efficient recruitment and participation in clinical studies within community settings. Proposals are due by December 9, 2024, at 12:00 PM EST, with an anticipated funding amount of up to $100 million distributed over a five-year performance period. Interested parties can direct inquiries to LaunchOfficeContracting@hhs.gov.