PREPARATION AND DISTRIBUTION OF RESEARCH DRUG PRODUCTS
ID: 75N95024R00003Type: Presolicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH NIDABethesda, MD, 20892, 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/fac5db56c40c488aa9a78aefdda2db42/view
Timeline
    Description

    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 a presolicitation notice. The contract will involve acquiring, importing, and exporting drugs and chemical compounds, as well as developing and analyzing various drug dosage forms, including marijuana and nicotine research cigarettes, to support drug abuse and addiction research. This contract is critical for maintaining a reliable supply of authentic controlled and uncontrolled drug compounds for the research community, with an anticipated award of one indefinite delivery, indefinite quantity (IDIQ) contract over a five-year period. Interested parties must possess a current DEA registration and comply with FDA’s current Good Manufacturing Practices, with proposals due approximately 45 days after the release of the RFP, expected on or about September 20, 2024. For further inquiries, contact Scott Duernberger at scott.duernberger@nih.gov or 301-594-0670.

    Files
    Title
    Posted
    SSN_OTSB_Final.pdf
    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 seeking proposals for Chemistry, Manufacturing, and Controls (CMC) services related to the development of drug substances. The primary objective is to ensure the Division of Preclinical Innovation (DPI) receives drug substances of adequate quality and quantity to support preclinical and Investigational New Drug (IND)-enabling studies, adhering to current Good Manufacturing Practice (cGMP) standards. This procurement is crucial for advancing therapeutics from preclinical stages to market readiness, emphasizing a multidisciplinary approach and compliance with regulatory requirements throughout the drug development pipeline. The Request for Proposals (RFP) is expected to be released on or about October 4, 2024, with contract awards anticipated in the second quarter of FY2025. Interested parties may contact Samson Shifaraw at samson.shifaraw@nih.gov for further information.
    A--Request for Proposals - Phase I Clinical Trials
    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 Phase I clinical trials aimed at developing small molecule and biologics therapeutics, as outlined in RFP No. 75N95024R00086. The selected contractor will be responsible for comprehensive services including protocol development, trial management, and reporting to regulatory agencies, with a focus on safety, tolerability, and pharmacokinetics of the investigational therapeutics. This initiative is crucial for advancing therapeutic development in the field of neurology, ensuring compliance with FDA and ICH GCP standards throughout the trial process. Proposals are due by October 3, 2024, with a contract performance period from April 1, 2025, to March 31, 2035, and a maximum contract value of $233,227,446. Interested parties can contact Evan C. Feely at evan.feely@nih.gov or +1 301 827 5301 for further information.
    A--PRECLINICAL MEDICATIONS SCREENING IN DEPENDENCE MO
    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 a contract focused on preclinical medications screening in models of Alcohol Use Disorder (AUD). The objective of this procurement is to conduct blind testing of compounds supplied by developers using mouse models, with the contractor responsible for generating analyses and reports throughout the project. This initiative is crucial for advancing research in alcohol use disorder treatments and ensuring compliance with NIH policies on reproducibility and animal welfare. Proposals are due by September 18, 2024, with the contract period commencing on December 1, 2024, and extending through November 30, 2031. Interested parties can contact Lisa Schaupp at lisa.schaupp@nih.gov or 301-827-8135 for further information.
    Surveys and Cognitive Tasks
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH), is seeking a vendor for a non-competitive contract to provide account management, planning, and maintenance for online crowd-sourced surveys and cognitive tasks related to depression and anxiety. The primary objective is to facilitate participation in these surveys for individuals both with and without mental health conditions, thereby supporting research efforts in this critical area. This procurement falls under NAICS code 541910, with a contract period of one year, and is scheduled for award on or around September 23, 2024. Interested parties must submit their capability statements and proposals by September 23, 2024, at 9:00 a.m. Eastern Standard Time, to Robin Knightly at Robin.Knightly@nih.gov.
    A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) seek proposals from small businesses for innovative research projects under the Small Business Innovation Research (SBIR) program. The upcoming solicitation, PHS-2025-1, will open on August 2, 2024, with a closing date of October 18, 2024, and aims to foster healthcare technological innovation and commercialization. Research topics span cancer research, aging, and various health concerns. Offerors must demonstrate the technical and commercial viability of their proposals. This solicitation invites applications for Phase I, Fast Track, and Direct to Phase II projects, with evaluations based on scientific merit, commercial potential, and performance quality. Successful small businesses could receive funding for their research initiatives, contributing to NIH and CDC mission objectives.
    A--BPCA Pediatric Trials Network
    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 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.
    Sleepworks Service Agreement
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA) and the National Institute of Mental Health (NIMH), intends to award a non-competitive contract for a Sleepworks Service Agreement. This procurement aims to secure a service maintenance agreement for equipment utilized in research focused on identifying electrical activity patterns in the sleeping brain, which is crucial for detecting neurodevelopmental and neuropsychiatric disorders. The contract will support collaborative efforts with various scientific centers to enhance understanding of sleep's role in brain development through advanced recording techniques and biomarker exploration. Interested parties must submit their capability statements by September 23, 2024, at 9:00 a.m. EST, to Robin Knightly at Robin.Knightly@nih.gov, referencing solicitation number 75N95024Q00579.
    Miscellaneous Bulk Gases & Gas Cylinder Tanks
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute of Environmental Health Sciences (NIEHS), is seeking proposals for the procurement of miscellaneous bulk gases and gas cylinder tanks to support its research laboratory operations in Durham, North Carolina. The contract will cover the delivery and maintenance of approximately 900-1050 gas cylinders and related equipment over a five-year period, from October 2, 2024, to October 1, 2029. These gases are critical for conducting research into environmental impacts on human health, emphasizing the importance of reliable supply chains in scientific investigations. Interested vendors must submit their quotations by September 18, 2024, and can direct inquiries to Contracting Officer Charlotte Ange at charlotte.ange@nih.gov.
    Piflufolastat F-18 injection drugs (Pylarify) from Sofie Co. (Notice of Intent to sole source)
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to negotiate a sole-source contract with Sofie Co. for the procurement of Piflufolastat F-18 injection drugs (Pylarify) essential for clinical nuclear medicine procedures at the NIH Clinical Center. This acquisition aims to secure compounded, patient-ready doses of the radiopharmaceutical, which is critical for diagnosing and treating diseases in accordance with patient care protocols. The drugs are FDA-approved and must be compounded and delivered on a time-sensitive basis due to their rapid radiation decay, making Sofie Co. the only authorized provider capable of meeting these specialized requirements. Interested parties may submit capability statements by September 18, 2024, to Lu Chang at lu-chang.lu@nih.gov, as this is not a request for proposals.
    Qiagen Real Time Semi-Quantitative PCR (RT-qPCR) and Digital PCR (dPCR) System or Equal
    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 a Qiagen Real Time Semi-Quantitative PCR (RT-qPCR) and Digital PCR (dPCR) System or an equivalent product. The procurement aims to support research into neurodegenerative diseases and retroviral infections, requiring a system with multiplex capability for detecting five gene targets, automated operation, low variability in results, and a compact size not exceeding 16” x 28” x 20”. Proposals must be submitted by 9:00 a.m. Eastern Time on September 17, 2024, and should include a completed copy of certain FAR clauses and the Unique Entity ID. For further inquiries, interested parties can contact Frederick Weddington at frederick.weddington@nih.gov or by phone at 301-594-6835.