Note of Intent to Award Sole Source
Type: Special Notice
Overview

Buyer

DEPT OF DEFENSEDEFENSE HEALTH AGENCY (DHA)ARMY MED RES ACQ ACTIVITYFORT DETRICK, MD, 21702, USA

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) (541715)

Original Source

https://sam.gov/opp/e0785a23d9b94f699ab3eba86ccaca76/view
Timeline
    Description

    The Department of Defense, through the United States Army Medical Research Acquisitions Activity (USAMRAA), intends to modify an existing contract related to the CryoPreserved Platelets (CPP) project. This modification aims to increase the cost ceiling to accommodate the need for additional subjects in clinical trials, which is critical for advancing to Phase 3 and obtaining FDA licensure for CPP. The contract modification will cover various activities, including the recruitment of up to 400 more subjects, increased consultant and travel expenses, material costs, regulatory expenses, and site activations, with no other FDA-licensed manufacturers for CPP identified in the U.S. Interested suppliers are encouraged to respond in writing within 15 days of this notice, and inquiries can be directed to Peter Mitchell at peter.d.mitchell8.civ@health.mil.

    Point(s) of Contact
    Peter Mitchell
    peter.d.mitchell8.civ@health.mil
    Files
    Title
    Posted
    CPP-Notice of Intent to Sole Source.docx
    The United States Army Medical Research Acquisitions Activity (USAMRAA) announces an intent to modify an existing contract for the CryoPreserved Platelets (CPP) project, increasing the cost ceiling due to the need for more subjects in clinical trials. The modification is based on the performance of the contract research organization (CRO) working on the Phase 2 trial, which is essential for advancing to Phase 3 and seeking FDA licensure for CPP. The contract modification will encompass various additional activities costing up to 400 more subjects, increased consultant and travel expenses, material costs, regulatory expenses, and site activations. Market research reveals no other FDA-licensed companies within the U.S. to manufacture CPP, reinforcing the need for this sole-source modification. Eligible suppliers are invited to respond in writing within 15 days of the notice. The NAICS code for this requirement is 541715, with a size standard of 1,250 employees. Questions can be directed to Peter Mitchell at a specified email address prior to the response deadline.
    ETEC Notice of Intent to Sole Source.docx
    The United States Army Medical Research Acquisitions Activity (USAMRAA) intends to modify an existing contract with Scandinavian Biopharma for the development of a Phase 2 Clinical cGMP manufactured vaccine against Enterotoxigenic Escherichia coli (ETEC). This notice does not request proposals but aims to address a significant gap in infectious disease prevention for Warfighters, as no effective ETEC vaccine is currently available. Scandinavian Biopharma's Etvax vaccine, suitable for adult travelers, has shown safety and efficacy in trials, with the second generation offering improved strain coverage and stability. The contract modification will occur on a sole source basis, identified by NAICS code 325412, and the government's commitment to a competitive procurement process is noted. Interested parties have a fifteen-day window to respond with proof of capability before the contract is awarded. This notice underscores the government's effort to enhance vaccine options and promote public health for military personnel.
    Lifecycle
    Title
    Type
    Note of Intent to Award Sole Source
    Currently viewing
    Special Notice
    Similar Opportunities
    Cryopreserved Platelets (CPP) for US FDA Licensure
    Dept Of Defense
    The Department of Defense, through the Defense Health Agency (DHA), is seeking input from qualified entities for the development of Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP) aimed at enhancing the shelf life of platelet products for military use. This initiative is part of the U.S. Combat Casualty Care Research Program and focuses on creating a biologic product that can be stored for up to two years, significantly improving upon the current five-day storage limit for liquid stored platelets. The project is critical for ensuring the readiness and quality of life for active-duty personnel, with a low-rate initial production goal of 1,500 units anticipated over a 20-month performance period. Interested parties are encouraged to submit a white paper detailing their capabilities and relevant experience by January 20, 2025, and can contact Peter Mitchell at peter.d.mitchell8.civ@health.mil for further information.
    MTEC Solicitation Summary: Fiscal Year 2025 Multi Topic Request for Proposals
    Dept Of Defense
    The Department of Defense, through the Medical Technology Enterprise Consortium (MTEC), is soliciting proposals for the Fiscal Year 2025 Multi Topic Request for Proposals (RPP) aimed at developing innovative medical technologies relevant to military operations. The RPP focuses on a variety of medical prototype solutions addressing battlefield injuries and infections, with specific areas of interest including prophylactics for infection, treatment countermeasures for sepsis, antivirals, musculoskeletal injuries, and sterilization solutions. This initiative is critical for enhancing medical capabilities to ensure force readiness and soldier lethality in future conflicts. Interested parties must submit Enhanced White Papers addressing a single focus area, with funding amounts ranging from approximately $750K to $5M depending on the project scope, and proposals are due as specified on the MTEC website. For further inquiries, contact Chuck Hutti at chuck.hutti@ati.org or 843-760-3795.
    Sources Sought Notice - Cost-Per-Test (CPT) Agreement or Reagent Rental Agreement to include reagents, molecular PCR instrument/equipment, consumables, maintenance support and instrument warranties at BAMC.
    Dept Of Defense
    The Department of Defense, through the Medical Readiness Contracting Office West (MRCO), is seeking potential sources for a Cost-Per-Test (CPT) Agreement or Reagent Rental Agreement to support molecular genetic and infectious disease testing at the Brooke Army Medical Center (BAMC) in Fort Cavazos, Texas. The procurement includes the provision of molecular PCR instruments, reagents, consumables, maintenance support, and instrument warranties, with a base performance period from October 1, 2025, to September 30, 2030. This initiative is critical for enhancing the laboratory's capabilities in conducting various genetic tests, including those for Celiac Disease, Alzheimer’s Disease, and a comprehensive Dermatomycosis Panel, which are essential for informed health assessments and treatment decisions. Interested parties are encouraged to submit their capability statements and relevant information to the primary contact, Medina L. Woodson, at medina.l.woodson.civ@health.mil, by the specified deadlines, as this notice is solely for information and planning purposes and does not constitute a solicitation.
    Bulk Pharma Group B
    Health And Human Services, Department Of
    The Department of Health and Human Services (HHS) is seeking proposals for the procurement of a range of FDA-approved pharmaceuticals as part of the Bulk Pharma Group B initiative. The contract will require the delivery of specific injectable medications, including Acyclovir Sodium, Doxycycline, Levophed, Meropenem, Sodium Chloride, and sterile water, with quantities detailed in the attached Request for Proposal (RFP). This procurement is critical for maintaining the Strategic National Stockpile, ensuring a reliable supply of essential pharmaceuticals for disaster preparedness and response efforts. Interested vendors must submit their proposals by the specified deadline, and inquiries can be directed to primary contact Terri Reed at terri.reed@hhs.gov or secondary contact Kimberly Golden at kimberly.golden1@hhs.gov.
    Synopsis - Armored Multi-Purpose Vehicle for Full Rate Production
    Dept Of Defense
    The Department of Defense, specifically the U.S. Army Contracting Command-Detroit Arsenal (ACC-DTA), intends to modify its existing contract for the Armored Multi-Purpose Vehicle (AMPV) systems to procure up to 309 additional vehicles over three program years. This procurement will be conducted on a Fixed Price Incentive Firm Target (FPIF) basis, with 103 vehicles to be solicited each year for Option Years 3, 4, and 5, and will be awarded solely to BAE Systems Land & Armaments, although subcontracting opportunities may be available. The AMPV systems are critical for enhancing the Army's operational capabilities, and the government will accept capability statements, proposals, or quotations from all responsible sources, although the decision to not compete the contract rests solely with the government. Interested parties can reach out to Chelsea Szostak at chelsea.r.szostak.civ@army.mil or Lisa Roulo-Lo Savio at lisa.r.roulo-losavio.civ@army.mil for further information.
    Department of Defense Pharmacy Uniform Formulary Blanket Purchase Agreement/Uniform Formulary Additional Discount Program
    Dept Of Defense
    The Department of Defense (DoD) is seeking quotations for a Blanket Purchase Agreement (BPA) and Additional Discount Program (ADP) related to the procurement of pharmaceutical agents as part of its Uniform Formulary (UF) initiative. This procurement aims to establish an effective pharmacy benefits program for the Military Health System (MHS), focusing on the clinical and cost-effectiveness of newly approved drugs across various therapeutic classes, including neurological agents, antibiotics, oncological agents, and more. The selected pharmaceutical agents will be evaluated by the Pharmacy and Therapeutics (P&T) Committee during meetings scheduled for February 5-6, 2025, with quotes due by January 16, 2025. Interested manufacturers should submit their quotes and any required documentation to the designated contacts, Tracy Banks and Patricia Tyson, at the provided email addresses.
    NIAID CLINICAL PRODUCTS CENTER (CPC)
    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.
    Nova Benchtop System
    Dept Of Defense
    The Department of Defense, through the United States Army Medical Research Acquisition Activity (USAMRAA), intends to negotiate a sole source contract with Helix Biotech for the acquisition of a Nova Benchtop Microfluidics device. This procurement aims to secure a chip-less, scalable, and highly flexible modular system essential for the encapsulation of mRNA for cellular delivery, including all necessary ancillary components, delivery, self-installation with virtual support, training, and a one-year manufacturer warranty. The device is critical for producing lipid nanoparticles, which play a significant role in various biomedical applications. Interested parties may submit their capability information by 2:00 p.m. Eastern Time on January 16, 2025, to Ms. Natalie Bethel at natalie.l.bethel2.civ@health.mil, as this notice is not a request for competitive quotations.
    Hematology CPRR - Keesler AFB, MS
    Dept Of Defense
    The Department of Defense, through the Defense Health Agency, is soliciting proposals for a hematology system to be delivered to the Keesler Medical Center at Keesler Air Force Base in Mississippi. The procurement requires one hematology system that includes two functioning analyzers, a slide maker stainer, and a digital cell morphology system equipped with advanced software for red blood cell morphology. This system is crucial for enhancing patient care and operational capabilities within military healthcare, as it will facilitate the processing of 31,000 complete blood counts over a five-year period. Interested vendors must ensure that their equipment is FDA-approved, meets specific technical specifications, and complies with cybersecurity standards as outlined in the Medical Device and Equipment Risk Assessment. The deadline for proposals has been extended to January 24, 2025, with the period of performance beginning on April 1, 2025. For further inquiries, interested parties can contact Carolynn Benn at carolynn.j.benn.civ@health.mil or David Erpelding at david.k.erpelding.civ@health.mil.
    Dimethyl Fumarate DR Presolicitation
    Dept Of Defense
    The Defense Logistics Agency (DLA) is planning to issue a solicitation for a national requirements contract for Dimethyl Fumarate DR capsules, specifically 120MG capsules in 14 count bottles and 240MG capsules in 60 count bottles. This procurement aims to establish a reliable national supply source for these pharmaceutical products, which are essential for Department of Defense (DoD) customers through the DLA prime vendor program. The contract will be a firm-fixed price, requirements type contract with a one-year base period and four one-year options, emphasizing compliance with federal regulations and efficient distribution of pharmaceuticals for military healthcare. Interested parties should contact Kevin Rafferty at kevin.rafferty@dla.mil or 215-737-0907 for further inquiries, and the projected solicitation date is February 2021, with an amendment extending the offer submission deadline to October 14, 2021, at 3:00 PM EST.