Chemistry, Manufacturing and Controls and Related Services for Development of Drug Products
ID: SBSS75N95025R00005Type: Sources Sought
Overview

Buyer

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

NAICS

Pharmaceutical Preparation Manufacturing (325412)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH (AN12)

Set Aside

Total Small Business Set-Aside (FAR 19.5) (SBA)

Original Source

https://sam.gov/opp/55ed328c613541e4833c0434080a6626/view
Timeline
    Description

    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.

    Point(s) of Contact
    Michelle Cecilia
    (301) 827-7199
    michelle.cecilia@nih.gov
    Valerie Whipple
    13018275218
    valerie.whipple@nih.gov
    Files
    No associated files provided.
    Similar Opportunities
    PREPARATION AND DISTRIBUTION OF RESEARCH 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 Institute on Drug Abuse (NIDA), is seeking proposals for the "Preparation and Distribution of Research Drug Products" under Request for Proposal (RFP) No. 75N95024R00003. The primary objective of this procurement is to acquire, analyze, create, regulate, and distribute a variety of drug compounds essential for advancing research on drug abuse and addiction, including controlled and uncontrolled substances such as morphine, methadone, and various cannabinoid preparations. This contract, structured as an indefinite delivery, indefinite quantity (IDIQ) agreement for a five-year period, is crucial for supporting the drug abuse research community by ensuring the availability of authentic drug products while adhering to federal regulations. Proposals must be submitted electronically by November 15, 2024, and interested parties can contact Scott Duernberger at scott.duernberger@nih.gov or Josh Lazarus at josh.lazarus@nih.gov for further information.
    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) are soliciting proposals from small businesses for the Small Business Innovation Research (SBIR) program, aimed at fostering innovative research that aligns with their mission needs. This solicitation, identified as PHS-2025-1, invites proposals across a wide range of health-related topics, including cancer research, aging, infectious diseases, and mental health, with the goal of stimulating technological innovation and enhancing commercialization in the healthcare sector. Eligible small businesses are encouraged to demonstrate the technical feasibility and commercial potential of their projects, with a closing date for proposal submissions set for October 18, 2024. For further inquiries, interested parties can contact Callie Prassinos at Callie.Prassinos@NIH.gov or Julie Rodriguez at ncioasbir@mail.nih.gov.
    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 soliciting proposals for Phase I Clinical Trials focused on the development of small molecule and biologics therapeutics. The objective is to engage qualified contractors to conduct comprehensive clinical trials, including protocol development, trial management, and reporting to regulatory agencies, with a specific emphasis on safety, tolerability, and pharmacokinetics of investigational drugs. This initiative is crucial for advancing therapeutic development in neurological disorders and ensuring compliance with federal regulations regarding human subjects. Proposals are due by October 11, 2024, with a contract performance period extending from April 1, 2025, to March 31, 2035, and a maximum contract value of $233,227,446. For further inquiries, interested parties may contact Evan C. Feely at evan.feely@nih.gov or +1 301 827 5301.
    NIAID CLINICAL PRODUCTS CENTER (CPC)
    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 seeking proposals for the NIAID Clinical Products Center (CPC) contract, aimed at supporting clinical trials focused on immunologic, infectious, and allergic diseases. The contract will provide essential pharmacy and pharmaceutical oversight for national and international clinical trials, ensuring product integrity, participant safety, and compliance with regulatory standards, while also expanding support for additional NIH-funded trials and emergency public health programs as needed. This initiative is critical for advancing research in various immune-mediated diseases, including asthma, autoimmune disorders, and organ transplant rejection. Interested parties should prepare to submit proposals electronically via the NIAID electronic Contract Proposal Submission (eCPS) website, with the presolicitation notice expected to be published on or around October 18, 2024. For further inquiries, contact Deborah Blyveis at blyveisd@niaid.nih.gov or Emily Bannister at emily.bannister@nih.gov.
    Health Information Management Support Services
    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 provide Health Information Management Support Services at the NIH Clinical Center in Bethesda, Maryland. The procurement involves delivering comprehensive health information management services, including customer service, diagnostic and procedural coding, and transcription of medical reports, to enhance patient care and support clinical research. This contract is vital for maintaining high standards of health information management in a federally funded research hospital, ensuring compliance with federal regulations and quality assurance protocols. Interested vendors must submit their quotes by October 14, 2024, and can direct inquiries to Lu Chang at lu-chang.lu@nih.gov.
    Notice of Intent BD Rhapsody Single-Cell Analysis Reagent Kits
    Active
    Health And Human Services, Department Of
    Notice of Intent BD Rhapsody Single-Cell Analysis Reagent Kits The Department of Health and Human Services, Department of, National Institutes of Health, is planning to procure BD Rhapsody Single-Cell Analysis Reagent Kits. These kits are used for the manufacture of human cells and tissue-based products utilized in phase I/II clinical protocols for transplantation, adoptive immunotherapy, and gene therapy conducted in the Clinical Center at the NIH. The procurement includes a standing order for multi-type sequencing kits and reagents with a short shelf life. The contractor will be responsible for shipping the sufficient reagents and kits following the scheduled delivery dates. The shelf life of the sequencing reagents should be at least 3 months, and the shelf life of library generation kits should be at least 6 months. The contractor is also required to provide technical support for all kits and reagents at no additional cost. The period of performance for this procurement is from 5/1/2024 to 8/30/2024. The delivery schedule is overnight delivery Monday through Thursday to the Center for Cellular Engineering (CCE) at NIH/CC in Bethesda, MD. The vendor will be responsible for ensuring the safe transport of cryopreserved patient cells and maintaining the temperature and other parameters during the shipment of reagents and kits. The contractor will be paid per product delivered and is required to provide hard copies of proofs of each product delivered. Interested parties can submit their capabilities to the Office of Purchasing and Contracts by May 1st, 9:00 AM EST. Please note that this is not a request for proposal.
    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 maintain an infrastructure for conducting pediatric clinical trials under the Best Pharmaceuticals for Children Act (BPCA). The primary objective of this procurement is to advance pediatric drug development by ensuring compliance with federal regulations and ethical standards in clinical research, including the protection of human subjects and quality control measures. This initiative is crucial for enhancing the understanding and safety of medications for children, thereby improving healthcare outcomes in pediatric populations. Proposals are due by November 4, 2024, with a performance period extending from May 19, 2025, to May 18, 2033, and a funding range between $2,500 and $149 million, contingent on successful contract performance. Interested parties can contact Elizabeth J. Osinski at eo43m@nih.gov or by phone at 240-550-5028 for further information.
    SOURCES SOUGHT: Maintenance and Repair Service for a 3730XL DNA Analyzer
    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 provide maintenance and repair services for a 3730XL DNA Analyzer utilized by the National Institute on Aging (NIA). The procurement aims to ensure the continued functionality of this critical laboratory equipment, which supports neurogenetics research, through comprehensive maintenance support, including preventative maintenance, software upgrades, and timely troubleshooting. Interested vendors must submit a capability statement detailing their qualifications, including their business classification under the applicable NAICS code, by October 8, 2024, at 3:00 PM Eastern Time, to Rashiid Cummins at rashiid.cummins@nih.gov. The contract will span one base year from November 2024 to November 2025, with four optional extension years available.
    66--Smart-Kage System
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking information regarding the procurement of a Smart-Kage System. This opportunity is categorized as a Sources Sought notice, aimed at identifying potential vendors capable of providing this analytical laboratory instrument, which falls under the NAICS code 334516. The Smart-Kage System is crucial for laboratory applications, enhancing research capabilities within the NIH's National Heart, Lung, and Blood Institute (NHLBI). Interested parties are encouraged to reach out to Helmut Winffel at helmut.winffel@nih.gov or call 301-435-0330 for further details and to express their interest in this procurement opportunity.
    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 Institute of Mental Health (NIMH), is seeking proposals for scientific management and support services for the National Institute of Mental Health Repository and Genomics Resource (NRGR). The primary objective of this procurement is to sustain, enhance, and enrich the NRGR, which provides critical biospecimens and associated data for research on psychiatric disorders, thereby facilitating genetic and cellular studies. This initiative is vital for advancing scientific understanding of the genetic risk factors and biological mechanisms underlying mental health conditions. Proposals are due by October 21, 2024, with the contract expected to commence on March 1, 2025, and run for a base period of one year, followed by four optional extension periods. Interested parties can direct inquiries to Sarah Adan at sarah.adan@nih.gov or Valerie Whipple at valerie.whipple@nih.gov.