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
  1. 1
    Posted Aug 13, 2024, 12:00 AM UTC
  2. 2
    Updated Jan 14, 2025, 12:00 AM UTC
  3. 3
    Due Jan 20, 2025, 8:00 PM UTC
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
Jan 14, 2025, 7:19 PM UTC
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
Sep 3, 2024, 7:05 AM UTC
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
Request for Proposal - Materiel Fielding and Medical Liaison Support Services
Buyer not available
The Department of Defense, specifically the Army's Program Executive Office Soldier, is soliciting proposals for Materiel Fielding and Medical Liaison Support Services. This procurement aims to enhance the medical readiness of the Army by providing essential support in the procurement, management, and distribution of medical equipment and supplies. The services are critical for ensuring operational support and healthcare for military personnel, with performance expected to take place primarily at Fort Detrick, MD, and other military installations. Interested small businesses must submit their proposals by April 16, 2025, with a total contract value estimated at $20 million, and can direct inquiries to Patrick Wallace at patrick.j.wallace3.civ@army.mil or Trisha Scott at trisha.r.scott.civ@army.mil.
LCPP Sources Sought
Buyer not available
The Department of Defense, specifically the U.S. Army Contracting Command in New Jersey, is seeking sources for the Life Cycle Pilot Process (LCPP) to address technology gaps in the Industrial Base related to Government Owned, Contractor Operated (GOCO) modernization goals. The initiative aims to enhance manufacturing processes for ammunition, focusing on improving producibility, cost refinement, and supply chain risk mitigation, with particular emphasis on Load, Assembly & Pack (L/A/P) mortars and artillery, as well as novel manufacturing technologies for energetics. Interested companies are encouraged to submit their capabilities and qualifications, including experience in the production of chemical products and large-scale manufacturing operations, by emailing MAJ Yili Chen and Wilson Au no later than 30 days from the notice date. This sources sought notice is for planning purposes only and does not constitute a request for proposal or guarantee of contract award.
Notice of Intent to Sole Source_ CN Bio Innovations
Buyer not available
The Department of Defense, through the U.S. Army Medical Research Acquisition Activity (USAMRAA), intends to award a sole-source contract to CN Bio Innovations Limited for the procurement of a PhysioMimix Organ-on-a-Chip (OOC) Multi-Organ Standard System and a Full System. This specialized equipment is required to support the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) and must facilitate advanced organ modeling, including adjustable perfusion and fluidics, 3D organ model formation, and automation for long-term experiments. The systems will include necessary accessories and training for personnel, with a warranty period of two years post-delivery. Interested vendors may challenge this sole-source determination by submitting a capability statement by April 14, 2025, and inquiries should be directed to Matthew Gembe at matthew.w.gembe.civ@health.mil or by phone at 301-619-1350.
6505--Aprepitant Capsules
Buyer not available
The Department of Veterans Affairs is soliciting proposals for the supply of Aprepitant capsules, a pharmaceutical product essential for various government health facilities, including those under the Department of Defense and Indian Health Service. Offerors are required to provide pricing for multiple line items covering a base year and four option years, adhering to specific conditions such as a 0.5% Cost Recovery Fee and compliance with the Drug Supply Chain Security Act (DSCSA). The contract emphasizes the importance of maintaining current Good Manufacturing Practices (cGMP) and ensuring proper labeling and packaging of the products. Interested contractors should contact Contract Specialist Matthew S. Poulin at Matthew.Poulin@va.gov for further details and must submit their proposals in accordance with the outlined requirements.
Ambr 250 High Throughput Bioreactor System
Buyer not available
The Department of Defense, through the Defense Health Agency, is seeking to procure an Ambr 250 High Throughput Bioreactor System for the Pilot Bioproduction Facility at the Walter Reed Army Institute of Research in Silver Spring, Maryland. This procurement aims to enhance capabilities for monoclonal antibody production, allowing for simultaneous testing of multiple conditions to accelerate the manufacturing of vaccines and biologics for military-relevant infectious diseases. The system must meet specific Minimum Essential Characteristics, including the ability to process up to 12 cultures, automated controls for critical parameters, and compliance with FDA regulations, particularly 21 CFR Part 11 for data integrity. Interested vendors should note that the anticipated solicitation release is on April 10, 2025, with a contract performance period from June 1, 2025, to May 31, 2029. For further inquiries, contact Ms. Brenda Mena at brenda.i.mena.civ@health.mil or Ms. Sharew Hailu at sharew.hailu.civ@health.mil.
Request for Proposal - Materiel Fielding and Medical Liaison Support Services
Buyer not available
The Department of Defense, specifically the U.S. Army's ACC-APG Natick Division, is soliciting proposals for Materiel Fielding and Medical Liaison Support Services under Request for Proposal W911QY-25-R-A001. The objective of this procurement is to enhance medical material readiness for the Army through effective logistics support, program management, and medical liaison services, primarily at Fort Detrick and other military locations. This initiative is crucial for maintaining operational readiness and ensuring efficient medical logistics within the military framework. Interested small businesses must submit their proposals, including past performance information, by the specified solicitation due date, with a total contract value estimated at $20 million. For further inquiries, potential offerors can contact Patrick Wallace at patrick.j.wallace3.civ@army.mil or Trisha Scott at trisha.r.scott.civ@army.mil.
Food and Drug Administration (FDA) Regulatory Compliance Training
Buyer not available
The Department of Defense, through the Army Medical Research Acquisition Activity, is seeking proposals for FDA Regulatory Compliance Training aimed at enhancing the competency of personnel involved in FDA-regulated research activities. The training will cover essential areas such as Good Clinical Practices (GCP), Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), and Quality Systems Regulations (QSR), ensuring compliance with federal and Department of Defense regulations. This initiative is critical for the U.S. Army Medical Research and Development Command (USAMRDC) as it supports the development of FDA-approved pharmaceuticals and devices for military personnel. Interested contractors should contact Matthew Gembe at matthew.w.gembe.civ@health.mil or 301-619-1350 for further details, with proposals due in alignment with the specified timelines in the solicitation documents.
Solicitation W81K00-25-Q-A019 for a Cost-Per-Test (CPT) Agreement to conduct testing for four (4) pathogen panels: Respiratory Virus, Gastrointestinal, Meningitis, and Blood Culture Identification at BAMC.
Buyer not available
The Department of Defense, specifically the Department of the Army, is soliciting proposals for a Cost-Per-Test (CPT) Agreement to conduct testing for four pathogen panels: Respiratory Virus, Gastrointestinal, Meningitis, and Blood Culture Identification at Brooke Army Medical Center (BAMC) in Fort Cavazos, Texas. Offerors are required to provide equipment, reagents, consumables, maintenance services, and telephonic support, ensuring compliance with cybersecurity and Risk Management Framework (RMF) requirements as outlined by the Defense Health Agency (DHA). This procurement is crucial for enhancing diagnostic capabilities and public health initiatives within military healthcare settings. Proposals are due by April 17, 2025, at 1:00 PM Central Standard Time, and interested parties should direct inquiries to Medina L. Woodson or Salameya Paulouskaya via the provided email addresses.
Department of Defense Pharmacy Uniform Formulary Blanket Purchase Agreement/Uniform Formulary Additional Discount Program
Buyer not available
The Department of Defense (DoD) is soliciting quotes for a Blanket Purchase Agreement (BPA) and an Additional Discount Program (ADP) related to pharmaceutical agents under the Uniform Formulary (UF) for the Military Health System (MHS). This procurement aims to establish an effective pharmacy benefits program, ensuring the selection of clinically and cost-effective pharmaceutical agents as mandated by law (10 U.S.C. § 1074g). The upcoming Pharmacy and Therapeutics (P&T) Committee meeting, scheduled for May 7-8, 2025, will review newly approved drugs, with quotes due by April 17, 2025. Interested manufacturers should submit their proposals, including a signed quote and National Drug Code (NDC) price list, to the primary contact, Keith Marasigan, at keith.b.marasigan2.ctr@health.mil, or the secondary contact, Stephanie Erpelding, at stephanie.j.erpelding.civ@health.mil.
Pyridostigmine Bromide Tablets
Buyer not available
The Defense Logistics Agency (DLA) Troop Support is seeking sources capable of providing Pyridostigmine Bromide Tablets (PB Tabs), specifically the USP 30 MG formulation, in compliance with FDA specifications. The procurement involves an estimated annual requirement of 27,000 packages, with each package containing 210 individually sealed tablets, and deliveries will be made to the Defense Distribution Center in Norfolk, VA. Pyridostigmine Bromide Tablets are critical for military use, and the contract will include a base year with four one-year option periods, allowing for adjustments based on service requirements. Interested vendors should submit their responses electronically to Contracting Specialist Rosbert Jones at rosbert.jones@dla.mil, ensuring all information remains confidential as per federal regulations.