Clinical Studies of Infectious Agents, Vaccines and Antivirals in Adult and Pediatric Human Subjects
ID: 75N93025R00014Type: Sources Sought
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIAIDBETHESDA, MD, 20892, USA

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

Original Source

https://sam.gov/opp/ccfdd0e8810c4c51871e28c4d59b0685/view
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH) and the National Institute of Allergy and Infectious Diseases (NIAID), is seeking small business contractors to conduct clinical studies focused on infectious agents, vaccines, and antivirals for both adult and pediatric populations. The primary objectives include evaluating the safety, immunogenicity, and efficacy of vaccines against various viruses, including emerging threats like Zika, with a project duration anticipated from August 2026 to August 2033 under a cost-reimbursement IDIQ contract structure. This initiative builds on decades of NIH-led research and aims to advance medical research through strategic partnerships with capable small businesses. Interested parties should submit their capability statements, including prior experience and qualifications, to the primary contact, Uju Obii-Obioha, at uju.obii-obioha@nih.gov, by the specified deadlines.

    Point(s) of Contact
    Uju Obii-Obioha
    (301) 761-6540
    uju.obii-obioha@nih.gov
    christian brown
    christian.brown@nih.gov
    Files
    Title
    Posted
    SSN (Study of Infectious Diseases)_Final.pdf
    The Sources Sought Notice RFP #75N93025R00014, issued by the NIH, seeks small business contractors capable of conducting clinical studies focused on infectious agents, vaccines, and antivirals for both adult and pediatric populations. The aim is to assess safety, immunogenicity, and efficacy of vaccines against various viruses, including emerging threats like Zika. This effort builds on decades of NIH-led research and develops candidates that have progressed towards licensing agreements across multiple countries. The project involves three task areas: evaluating vaccine safety and immunogenicity in children and adults and conducting challenge studies in an inpatient setting. The anticipated contract duration is seven years, from August 2026 to August 2033, structured as a cost-reimbursement IDIQ contract. Responses to this notice should include the capability statement, detailing prior experience, professional qualifications, and the ability to execute the tasks required. Businesses must provide specific details such as UEI number, company information, and confirm registration with SAM. The government emphasizes the voluntary nature of submissions, which will not obligate any contract award. This initiative highlights the NIH's ongoing commitment to advancing medical research through strategic partnerships with capable small businesses.
    Similar Opportunities
    CIVICs Data Management and Coordinating Center (DMCC)
    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 provide services for the renewal of the CIVICs Data Management and Coordinating Center (DMCC). The DMCC will support the CIVICs program by managing data, conducting analyses, and facilitating communication and coordination among various stakeholders, with a focus on advancing influenza vaccine research and development. This initiative is critical for enhancing the immunogenicity and durability of seasonal influenza vaccines and involves the operation of a scalable data management system, maintenance of public and private portals, and comprehensive program coordination. Interested parties must submit their tailored Capability Statements by 3:00 PM (Eastern Time) on January 23, 2025, to Maribel Miranda at maribel.miranda@nih.gov, with the anticipated contract award date around July 2026.
    2026 NIAID DMID Omnibus Broad Agency Announcement
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institute of Allergy and Infectious Diseases (NIAID), is soliciting proposals for the 2026 DMID Omnibus Broad Agency Announcement (BAA) aimed at advancing research and development of medical countermeasures against antimicrobial-resistant pathogens and viruses with pandemic potential. The BAA encompasses two primary research areas: Research Area 001 focuses on developing therapeutics, vaccines, and diagnostics for antimicrobial-resistant bacterial and fungal pathogens, while Research Area 002 targets the creation of Direct Acting Antivirals for viruses of pandemic potential. This initiative is critical for addressing public health challenges related to infectious diseases, with an estimated funding of $28.5 million available for awards in fiscal year 2026. Proposals for Research Area 001 are due by February 21, 2025, and for Research Area 002 by January 21, 2025; interested parties can contact Swee L. Teo at teosl@niaid.nih.gov or Brian Madgey at brian.madgey@nih.gov for further information.
    In Vitro Assessments of Antimicrobial Activity
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking proposals for the In Vitro Assessments of Antimicrobial Activity (IVAAA) program, aimed at evaluating the therapeutic potential of compounds against infectious diseases. The solicitation encompasses multiple task areas, including assessments of bacteria, fungi, viruses, parasites, and the development of culturing techniques for difficult-to-grow pathogens, with the goal of enhancing public health preparedness and response capabilities. This initiative is critical for advancing research on over 270 infectious agents and facilitating the development of medical countermeasures, with a contract value ranging from $2,500 to $15 million through January 14, 2033. Interested offerors must submit their proposals electronically via the NIH electronic Contract Proposal Submission (eCPS) system by March 10, 2025, and can direct inquiries to Alexander Beraud at alexander.beraud@nih.gov.
    NIAID Virology Quality Assurance
    Health And Human Services, Department Of
    The National Institute of Allergy and Infectious Diseases (NIAID) is soliciting proposals for the Virology Quality Assurance (VQA) program under RFP number 75N93024R00030, aimed at providing comprehensive quality assessment for virologic testing related to HIV and other viral pathogens in clinical trials. The program's objectives include ensuring the validity of laboratory data through proficiency testing, real-time assay validation, and the development of performance standards, while also addressing public health emergencies and increasing laboratory demands. This initiative is crucial for maintaining high-quality laboratory practices and supporting ongoing research in virology. Proposals are due by April 8, 2025, and interested parties should direct inquiries to the primary contact, Shawnice Williams, at shawnice.williams@nih.gov or 301-761-5431.
    National Institute of Environmental Health Sciences (NIEHS) Assessment of Immunotoxicity – In Vitro and In Vivo Assessment of Immune Function
    Health And Human Services, Department Of
    The National Institute of Environmental Health Sciences (NIEHS), part of the Department of Health and Human Services, is seeking proposals for a contract focused on the assessment of immunotoxicity through both in vitro and in vivo studies of immune function. The primary objective is to evaluate how selected chemical agents modify immune responses, utilizing established testing models to enhance understanding of immunotoxicity while aiming to reduce animal use in research. This initiative is critical for advancing toxicological assessments and ensuring compliance with federal standards in environmental health research. Interested contractors must submit their proposals by 4:00 PM EST on February 18, 2025, and can direct inquiries to Adam Muhsin at adam.muhsin@nih.gov or Erica Kitzmiller at erica.kitzmiller@nih.gov.
    FY25 Vaccines for Children
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), is seeking manufacturers of pediatric vaccines to participate in the FY25 Vaccines for Children (VFC) program through an Indefinite Delivery Indefinite Quantity (IDIQ) contract. This procurement aims to ensure the availability of standard commercial pediatric vaccines for eligible children, enhancing public health initiatives by providing vaccines at prices below those in the commercial marketplace. The VFC program is crucial for immunizing children who are Medicaid-eligible, uninsured, or underinsured, thereby supporting effective immunization practices and improving overall vaccination coverage. Interested manufacturers should contact James Sprigler at zbs6@cdc.gov or 404.498.3879 for further details, as the solicitation outlines specific requirements for compliance with FDA regulations and operational protocols for vaccine orders.
    ANTIBODY REAGENT KITS
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Allergy and Infectious Diseases (NIAID), is seeking to procure antibody reagent kits from Abcam, Inc. for a technology development project aimed at validating results from mass cytometry panels used to study the human immune system. These antibody kits are crucial for phenotyping the immunome, which is essential for understanding both normal and pathogenic immune responses in various diseases. Interested vendors capable of providing comparable services are invited to submit a capabilities statement via the NIAID electronic Simplified Acquisition Submission System (eSASS) by 9:00 AM EST on January 21, 2025. For further inquiries, vendors may contact Maliaka Pinkney at maliaka.pinkney@nih.gov or Jesse D Weidow at weidowjd@niaid.nih.gov.
    A--Data Coordinating Center (DCC) for the Best Pharmaceuticals for Children Act (B
    Health And Human Services, Department Of
    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.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for Chemistry, Manufacturing, and Controls (CMC) services to support the development of drug products. The objective of this procurement is to ensure the delivery of high-quality formulated drug products for preclinical, IND-enabling, and clinical studies, which are critical for advancing therapeutic development. This opportunity encompasses a wide range of services, including formulation development, manufacturing under current Good Manufacturing Practices (cGMP), and necessary testing to meet regulatory standards. Proposals are due by February 3, 2025, with a contract period extending from September 30, 2025, to July 31, 2031, and a maximum funding amount of $49,885,703. Interested parties can contact Michelle Cecilia at michelle.cecilia@nih.gov or Valerie Whipple at valerie.whipple@nih.gov for further information.
    NUcleic acid Linked Immuno-Sandwich Assay Reagents
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking proposals for the procurement of NUcleic acid Linked Immuno-Sandwich Assay Reagents, aimed at enhancing biomarker discovery for neurodegenerative disease research at the Center for Alzheimer’s Disease and Related Dementias (CARD). The acquisition includes the Alamar NULISAseq Inflammation Panel, with a requirement for 30 units that must demonstrate high sensitivity in analyzing over 250 proteins from minimal sample volumes, ensuring compatibility with the ARGO proteomics platform. This procurement is critical for advancing research capabilities in the detection of biomarkers related to Alzheimer’s Disease and Related Dementias (ADRD). Interested vendors must submit their quotations by January 22, 2025, at 12:00 PM Eastern Time, to Andrea Clay at amcgee@nida.nih.gov, and must comply with all specified federal regulations and provisions outlined in the solicitation.