Evaluation of Semaglutide Safety and Tolerability in Adults with Cocaine Use Disorder with and without HIV and Assessment of Long-Acting Stimulants to Reduce Harm and HIV Transmission in Methamphetamine Use Disorder
ID: 24-009652Type: Presolicitation
Overview

Buyer

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

NAICS

Other Scientific and Technical Consulting Services (541690)

PSC

SUPPORT- PROFESSIONAL: OTHER (R499)
Timeline
    Description

    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to award a non-competitive federal contract for the evaluation of semaglutide safety and tolerability in adults with cocaine use disorder, as well as the assessment of long-acting stimulants to reduce harm and HIV transmission in methamphetamine use disorder. The contract will focus on conducting two clinical research studies in the Baltimore/Washington, DC region, aligning with NIH's priorities to address HIV and related health issues. The anticipated contract will span three years, starting on September 30, 2024, with the University of Maryland Medical Center as the intended recipient. Interested parties may express their capabilities and interest by contacting Susan Nsangou at susan.nsangou@nih.gov, as this opportunity does not involve a competitive proposal process.

    Point(s) of Contact
    Files
    No associated files provided.
    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.
    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.
    Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative – Subject Matter Expert in Medical Device Investment Development
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH) through the National Institute on Drug Abuse (NIDA), intends to award a sole-source contract for consulting services related to medical device development under the Blueprint MedTech Initiative. The objective is to procure a subject matter expert with extensive experience in neurotechnology and mental health product development, who will provide strategic guidance and oversight for projects aimed at accelerating the translation of innovative medical devices for neurological disorders. This initiative, established in 2019 with a funding allocation of $32 million, seeks to facilitate the development of groundbreaking technologies and ensure their progression to clinical studies by 2027. Interested parties may submit their qualifications by November 8, 2024, to the designated contacts, Tracy Cain and Llakim Dubroff, at the NIH.
    NIAID CLINICAL PRODUCTS CENTER (CPC)
    Active
    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 a contract to provide pharmacy and pharmaceutical oversight for clinical trials, both nationally and internationally. The primary objective of this contract is to ensure the integrity of study products, participant safety, and compliance with pharmacy and pharmaceutical regulations throughout various NIH-funded clinical trials. This opportunity is critical for maintaining high standards in public health research, as it encompasses a wide range of services including product management, regulatory document maintenance, and clinical laboratory testing. Proposals are due by January 17, 2025, with the contract expected to commence on April 1, 2026, and run through March 31, 2027, potentially extending through 2033. Interested parties can contact Deborah Blyveis at blyveisd@niaid.nih.gov or Emily Bannister at emily.bannister@nih.gov for further information.
    Scientific Management and Support to the National Institute of Mental Health (NIMH) Repository and Genomics Resource (NRGR)
    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 scientific management and support services for the National Institute of Mental Health Repository and Genomics Resource (NRGR). The objective of this procurement is to sustain, enhance, and enrich the NRGR, which provides critical biospecimens and genomic data for research on psychiatric disorders, thereby facilitating a deeper understanding of the genetic factors associated with mental health. This initiative is vital for advancing research in the genetics of mental disorders and ensuring broad access to valuable biospecimens and data resources for the scientific community. Proposals are due by November 8, 2024, and must be submitted electronically via the NIH's eCPS system; interested parties should contact Sarah Adan at sarah.adan@nih.gov or Valerie Whipple at valerie.whipple@nih.gov for further information.
    HHS ONE PROFESSIONAL SERVICES SOLUTION (HOPSS)
    Active
    Health And Human Services, Department Of
    The U.S. Department of Health and Human Services (HHS), through the National Institute on Drug Abuse (NIDA), is hosting a virtual Market Research Industry Day for the HHS One Professional Services Solution (HOPSS). This initiative aims to gather industry feedback and inform potential contractors about the professional services required to support HHS's strategic goals for 2022-2026, which focus on enhancing healthcare access, improving health outcomes, promoting social equity, and advancing scientific research. The HOPSS contract will encompass two primary task areas: STEM services and business operational support, with the anticipated contract type being a multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) contract set to begin around spring or summer 2026. Interested parties must register for the event by November 15, 2024, and direct any questions to Contract Specialist Kyle Miller at kyle.miller2@nih.gov by November 13, 2024.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH) through the National Center for Advancing Translational Sciences (NCATS), is seeking qualified small businesses to provide Chemistry, Manufacturing, and Controls (CMC) and related services for the development of drug products. The objective of this procurement is to support the Therapeutic Development Branch in ensuring the delivery of drug products of sufficient quality and quantity for preclinical, IND-enabling, and clinical studies, which are critical for advancing therapeutic candidates through the drug development pipeline. This opportunity is part of a Small Business Sources Sought notice, aimed at gathering information on the capabilities of small businesses to fulfill these requirements, with a focus on compliance with applicable regulations and the potential for a multiple-award Indefinite Delivery/Indefinite Quantity (IDIQ) contract. Interested vendors must submit their capability statements by 10:00 AM Eastern Time on July 21, 2024, to Michelle Cecilia at michelle.cecilia@nih.gov.
    CRO Support for NCATS Bioanalytical Method Development for Biologics
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking qualified contractors to provide support for bioanalytical method development for biologics under a Sources Sought notice. The primary objective is to identify capable organizations that can develop and validate bioanalytical methods for quantitative analyses of novel therapeutic biologics and anti-drug antibodies in various biological matrices, as well as manage project administration and quality assurance. This initiative is crucial for advancing drug development processes and ensuring compliance with regulatory standards, ultimately facilitating the transition of therapeutic candidates to clinical trials. Interested parties must submit their capability statements and relevant information by November 8, 2024, to Nick Niefeld at nick.niefeld@nih.gov.
    Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative – Subject Matter Expert in Medical Device Investment
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to award a sole-source contract for consulting services related to medical device development under the Blueprint MedTech Initiative. The objective is to procure a subject matter expert with extensive experience in neurotechnology and mental health product development, who will provide technical guidance and strategic oversight as a member of the Blueprint MedTech External Oversight Committee. This initiative, established in 2019 with a budget of $32 million, aims to facilitate the transition of innovative neurotechnologies to clinical studies, addressing the challenges faced by innovators in the medical device sector. Interested parties may express their capabilities, but the decision to proceed with competition remains at the government's discretion. For inquiries, contact Tracy Cain at tracy.cain@nih.gov or Llakim Dubroff at llakim.dubroff@nih.gov, both reachable at 301-443-6677.
    Consulting Services in relation to Medical Device Development under Blueprint MedTech Initiative – Subject Matter Expert in Neurology
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA), intends to award a sole source contract for consulting services related to medical device development under the Blueprint MedTech Initiative, focusing on the need for a subject matter expert in neurology. The contract aims to procure specialized consulting services from a board-certified neurologist with experience in treating neurological conditions and expertise in medical device regulation, who will provide strategic guidance and technical oversight to enhance medical device projects within the initiative. This procurement is critical as it supports the development of innovative medical devices aimed at addressing neurological disorders, facilitating the translation of novel technologies from early-stage development to clinical studies. Interested parties may express their interest and capability, but the decision to seek competitive proposals remains at the government's discretion, with all submissions due by November 4, 2024. For further inquiries, contact Tracy Cain at tracy.cain@nih.gov or Llakim Dubroff at llakim.dubroff@nih.gov.