This Solicitation opportunity from Department Of Health And Human Services was posted on September 8, 2025. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Office of Clinical Pharmacology / Division of Applied Regulatory Science (DARS) - Critical DARS Laboratory Supplies

Closed

FDA-CDER-25-130555Federal

Submission Closed09/12/2025, 06:00:00 PM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

Active Opportunities Like This One

NAICS: 541714

New

Federal

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AJ12--Development/Production - Kidney GEC-Specific AAV Vector

Solicitation # 36C24E27Q0009

The Department of Veterans Affairs is issuing a Sources Sought notice to identify capable vendors for the development and production of a kidney glomerular endothelial cell specific adeno-associated virus AAV vector. This project, funded by a VA ORD Merit award, aims to create a homing peptide enabled vector platform to target the glomerular endothelium to treat kidney injury and disease while reducing off target transduction. The scope of work is divided into three primary tasks: the engineering and incorporation of targeting peptides into the AAV capsid, testing vector binding and internalization in kidney tissue slices, and evaluating the specificity and efficiency of the modified vector through bioluminescence imaging and in vivo biodistribution studies. Qualified contractors must possess extensive onsite resources, including BSL 2 laboratories, specialized DNA and RNA facilities, and advanced instrumentation such as the Agilent Fragment Analyzer and various qPCR platforms. Vendors must demonstrate proven success in animal and human cell vector delivery and maintain full compliance with AAALAC and FELASA health standards. The government requires quarterly reporting, weekly videoconferences, and biannual face to face meetings. All generated data will be subject to Government Purpose Rights, and contractors must adhere to strict federal records management and information security protocols. Interested parties must submit a capability statement, relevant literature, and socio economic status details under NAICS 541714 by November 4, 2026.

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MPS Platform Development & EngineeringThis subcontract focuses on the development and engineering of Microphysiological Systems and Organ-on-a-Chip platforms to support prime contractors on NIH/NIAID infectious disease projects. The scope of work involves engineering microfluidic devices, optimizing tissue-chip interfaces, and utilizing biocompatible polymers and precision pumps to integrate human variability into hardware and biological interfaces. The ultimate goal is to deliver a validated and reproducible platform that aligns with NIH and FDA guidance regarding New Approach Methodologies. Managed under the National Institutes of Health within the Department of Health and Human Services, the project falls under NAICS code 541714. The solicitation was posted on October 20, 2026, with a response deadline set for January 29, 2027.

National Institutes Of Health

POSTED

DEADLINE

Translational Centers Using Microphysiological Systems for Infectious Diseases (U54 Clinical Trial Not Allowed)

Solicitation # RFA-AI-28-012

The National Institute of Allergy and Infectious Diseases (NIAID) has issued solicitation RFA-AI-28-012 to establish a consortium of Translational Centers Using Microphysiological Systems for Infectious Diseases (TCMID). The primary objective is to refine and validate human tissue models using Microphysiological Systems (MPS) to a level consistent with regulatory qualifications, thereby promoting their adoption by product developers and reducing reliance on laboratory animals. This initiative aligns with NIH and FDA guidance on New Approach Methodologies (NAMs) to accelerate the development of safer medical interventions by capturing human variability and patient-specific characteristics. The program is structured around an Administrative Core, a Qualification Core, and Scientific Cores, with a heavy emphasis on technical readiness, reproducibility, and regulatory acceptance. Key deliverables include the validation of assays for specific endpoints and the submission of regulatory packages. Applicants must be domestic entities, as foreign organizations and foreign subawards are strictly prohibited. Required personnel must possess deep expertise in infectious diseases, MPS platforms, bioinformatics, and FDA submission processes. Applications are due by January 29, 2027, and must be submitted via the NIH ASSIST system or approved institutional system-to-system solutions. Evaluation is based on an overall impact score considering the project's significance, the suitability of the investigators, and the quality of the institutional environment. Mandatory application components include a Data Management and Sharing Plan and a Benchmarks and Timeline PDF not exceeding six pages. Awardees must also adhere to strict cybersecurity incident reporting guidelines, notifying HHS within 48 hours of any discovery.

National Institutes Of Health

POSTED

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Immune Tolerance Network (UM1 Clinical Trial Required)

Solicitation # RFA-AI-28-005

The National Institutes of Health, under the Department of Health and Human Services, is seeking applications through solicitation RFA-AI-28-005 to continue the Immune Tolerance Network (ITN). This cooperative agreement aims to develop tolerogenic therapies for immune-mediated disorders, specifically focusing on autoimmune diseases, allergic diseases and asthma, and the immune-mediated consequences of transplantation. The network operates through four integrated functional areas: Leadership, Clinical Operations, Core Laboratory, and Bioinformatics. Its primary objectives include designing and conducting clinical trials, performing integrated mechanistic studies, and sharing research results. Eligible applicants include small businesses and other for-profit organizations, though non-domestic entities are ineligible. Applications are evaluated based on scientific and technical merit, with a primary focus on significance and the likelihood of exerting a sustained influence on the research field. Key requirements include maintaining active registrations in SAM.gov, eRA Commons, and Grants.gov, as well as adhering to strict cybersecurity incident reporting and human subject protection protocols. The project requires a minimum effort of 3.6 person months per year for the PD/PI and mandates participation in a kick-off meeting in Bethesda, Maryland, and bi-annual steering meetings. Applications must follow specific page limits for the research strategy subsections and include detailed plans for clinical trial implementation, data management, and biorepository services.

National Institutes Of Health

POSTED

DEADLINE

Pre-Clinical Models of Infectious Diseases

Solicitation # 75N93027R00003

The National Institute of Allergy and Infectious Diseases (NIAID) is issuing a ramp-on solicitation to award multiple IDIQ base contracts for the Preclinical Models of Infectious Diseases program. This initiative aims to expand the existing pool of contractors capable of developing and refining animal and animal replacement models to evaluate medical countermeasures, such as vaccines, therapeutics, and diagnostics. The program bridges the gap between in vitro testing and clinical evaluation, supporting regulatory submissions and the advancement of countermeasures against priority biodefense and emerging infectious agents. Successful offerors will be eligible to compete for task orders across four specific areas: Small Animal Models, Non-Human Primate Models, Animal Replacement and Non-traditional Animal Models, and the Generation and Distribution of Specialized Reagents. The scope of work emphasizes a wide array of pathogens, including pandemic-potential RNA viruses, antimicrobial-resistant infections, fungal diseases, and neglected tropical diseases. Proposals must be submitted electronically via the NIAID eCPS website, and applicants are required to have a valid NIH eRA Commons account for authentication and secure transmission.

National Institutes Of Health Niaid

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DEADLINE

Alternative Protein Technologies for Military Field Feeding

Solicitation # W911QY27ALTPROTEINS

The US Army Combat Capabilities Development Command Soldier Center is seeking information from Massachusetts-based offerors to identify innovative alternative protein technologies for integration into military rations. The objective is to enhance food supply chain resilience and provide nutrient-dense, lightweight food options for warfighters. Areas of interest include fermentation and biomanufacturing processes, innovative product development for shelf-stable rations, consumer research for military acceptability, and the optional provision of GRAS-certified food samples. Specifically, the government is excluding any solutions involving cell-cultured, lab-grown meat, or insect proteins, focusing instead on technologies between TRL 4 and 6. This is a Sources Sought Announcement for market research purposes and not a formal solicitation or a promise of future funding. Interested parties must submit a BAA preproposal by November 23, 2026, including a technical approach, past performance, and a rough order of magnitude cost estimate. Submissions must be sent via email to the designated points of contact and include the offeror's business size, NAICS code, and CAGE code to verify their Massachusetts location.

POSTED

DEADLINE

USDA SBIR/STTR Topic 8.2 — Plant Production and Protection - Biology

Solicitation # USDA-NIFA-TOPIC-8.2

The USDA National Institute of Food and Agriculture is soliciting proposals under Topic 8.2 for Plant Production and Protection - Biology. This initiative focuses on advancing crop production and protection through the development of innovative plant breeding methods, diagnostic technologies for diseases, and the creation of new food and non-food crop plants. Research efforts are directed toward improving plant characteristics to mitigate biotic and abiotic stresses, developing new genotypes for commercial applications, and creating tools to support the health of natural and domesticated pollinators. This opportunity is a total small business set-aside under the SBIR/STTR mandate, restricting eligibility to companies with fewer than 500 employees. Managed by the United States Department of Agriculture, the program is led by Dr. Christopher Philips. Interested parties can find further details and application guidelines through the NIFA website.

National Institute of Food and Agriculture

POSTED

DEADLINE

Artificial Blood and Medical Consumable InnovationThe Artificial Blood and Medical Consumable Innovation subcontract supports the Defense Advanced Research Projects Agency within the Department of Defense. The scope of work involves providing innovative medical consumables and conducting biochemical research specifically focused on the development of artificial blood for prime contractors on DARPA Biological Technologies Office projects. The contractor is responsible for engineering scalable manufacturing processes for these consumables using sterile manufacturing facilities and bio-reactors. Key deliverables include the production of artificial blood prototypes and the implementation of scalable medical consumable solutions. This effort falls under NAICS code 541714, with a response deadline set for November 15, 2026.

Defense Advanced Research Projects Agcy

POSTED

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Pre-Award Synopsis Texas Shield

Solicitation # DARPA-SN-27-07

The Defense Advanced Research Projects Agency (DARPA), through its Biological Technologies Office (BTO), intends to enter into an agreement with The University of Texas System consortium of universities for the Texas Shield Program. This integrated research initiative, identified by solicitation number DARPA-SN-27-07 and NAICS code 541714, focuses on developing autonomous and semi-autonomous medical technologies and scalable solutions for critical medical consumables. The primary goal is to support lifesaving medical care in contested, austere, and resource-limited environments. Key technical areas of focus include autonomous medical and robotic surgical systems, casualty evacuation, artificial-blood and supply innovation, AI-enabled clinical decision support, and mass-casualty science and simulation. This notice is a pre-award synopsis and is not a request for proposals or a competitive solicitation. Interested entities are invited to submit information by November 15, 2026, to TexasShieldxBTO@darpa.mil detailing their technical expertise, integrated research infrastructure, clinical-validation capabilities, and multi-institutional coordination capacity. Additionally, respondents must describe their consortium organizational structure, commercialization capabilities, facility clearance levels, and their ability to handle Controlled Unclassified Information. The government will not reimburse any costs associated with the preparation or submission of information in response to this notice.

Defense Advanced Research Projects Agcy

POSTED

DEADLINE

Q--AMPLICON SEQUENCING SERVICES

Solicitation # 140G0226Q0047

Solicitation 140G0226Q0047 is a firm-fixed-price request for a Blanket Purchase Agreement (BPA) to provide next generation amplicon sequencing services for the USGS Upper Midwest Water Science Center’s Michigan Bacteriological Research Laboratory. The scope of work includes providing all equipment, labor, travel, and materials necessary to support research on bacterial pathogens, harmful algal blooms, microbial ecology, antibiotic resistance, and microbial source tracking. Key technical requirements include the use of Illumina MiSeq or AVITI sequencing technologies and the potential for library preparation for 16S V4 amplicon sequencing. The BPA has a total not-to-exceed value of 250,000 dollars with an estimated period of performance from September 17, 2026, to September 16, 2031. The award process prioritizes non-priced factors significantly over cost, focusing on the offeror's qualifications and technical performance. Evaluation criteria include a detailed listing of on-site equipment and calibration dates, personnel experience, internal quality assurance procedures, and a technical narrative not exceeding two pages. Performance will be executed in Lansing, Michigan, with delivery terms set as FOB Destination. Administrative requirements include electronic invoicing via the Internet Payment Platform and compliance with various federal regulations, including the Buy American Act and specific security prohibitions regarding telecommunications equipment. Proposals must be submitted to the USGS OAG Denver Acquisition Branch by September 11, 2026.

Ofc Of Acquisition Grants-Denver

POSTED

5 days ago

DEADLINE

in 2 days

AI Contract Overview

This contract involves the procurement of cryopreserved human hepatocytes for a research project conducted by the Division of Applied Regulatory Science (DARS) within the FDA's Office of Clinical Pharmacology. The study aims to investigate how female sex hormones influence drug metabolism and transport in vitro. To ensure the validity of the results, the hepatocyte lots must originate from multiple female donors across two age groups—three donors aged 20-35 years and three aged 50-70 years—with each vial containing at least 5 million viable, platable hepatocytes that remain functional for 4-5 days post-plating. The hepatocytes must meet specific qualification standards for key metabolic enzymes (CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4) and transporters (OATP1B1, OATP1B3, and potentially OAT2 and OCT1). The supplier is required to provide detailed protocols for thawing, plating, and culturing the hepatocytes, including media composition and sourcing, which must be submitted as PDF files before shipment. Up to 72 vials from 6 or 12 donors will be supplied, depending on qualification status, to support the study's objectives. The solicitation is posted under the NAICS code 541714, with a response deadline of September 12, 2025, and the contract will be managed by Rodney D. Aytch at the FDA.

General Info

Procure cryopreserved female hepatocytes, specific ages, functional enzymes, detailed protocols, delivery by 2025.

Agency

Department Of Health And Human Services → FDA Office Of Acq Grant Svcs

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Documents

CAAC Letter 2020-05 FAR Class Deviation - USMCA

27 pages · modification

High

HHS FAR Class Deviation 2020-02

modification

High

RFQ FDA-CDER-25-130555 - Cryopreserved Human Hepatocytes

23 pages · rfq

High

AI Contract Breakdown

Uniform Contract Format

Contract not broken down yet

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Timeline

PhaseClosed

PostedSep 8

Solicitation

Response DeadlineSep 12

Deadline has passed

Submission Closed

09/12/2025, 06:00:00 PM UTC

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Organization & Contact Information

AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Contacts1 person available

OfficeBeltsville, MD, 20705, USA

Organization / AgencyDepartment Of Health And Human Services → FDA Office Of Acq Grant Svcs

Office AddressBeltsville, MD, 20705, USA

Contacts

Rodney D. Aytch

contact@example.gov

+1 (555) 000-0000

Full Description

The Division of Applied Regulatory Science (DARS) OCP/OTS/CDER is conducting a research project to examine the effect of female sex hormones on in vitro drug metabolism and transport. As part of this process, DARS needs to acquire cryopreserved human hepatocytes from multiple female donors of different age groups to conduct this research. For successful metabolism and transporter function to occur the following quality characteristics are essential for the study: Single female donor lots Three donors aged 20-35 years and three donors aged 50-70 years A minimum of 5 - 106 (5 million) viable hepatocytes per vial Must be platable in 12-well plates and remain functional for 4-5 days post-plating Metabolism- and/or transporter-qualified Metabolism qualifications: CYP1A2, CYP2B6, CYP2C9, CYP2C19, CYP2D6, CYP3A4 Transporter qualifications: OATP1B1, OATP1B3 (OAT2 and OCT1 if available) The supplier is to provide protocol(s) for the thawing, plating and culturing the hepatocytes. This is to include the media composition and source for all these stages for the hepatocytes. The protocol(s) are to be sent to Donna Volpe (donna.volpe@fda.hhs.gov) as .pdf files prior to shipping the hepatocyte vials. The supplier will provide up to a total of 72 vials of cryopreserved human hepatocytes from 6 or 12 different female donors, depending on how the hepatocytes are qualified/certified for metabolism and transporter activity.