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This Government Contract opportunity from Department Of Health And Human Services was posted on June 3, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

Clinical Trial Design and Execution (Phase 1)

Closed
Federal

Contract Overview

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

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NAICS: 541711
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NAICS: 541711
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Clinical Research Organization (CRO) ServicesThis subcontract for Clinical Research Organization (CRO) Services supports the Department of Defense and the Department of the Army USAMRAA. The selected provider will perform end-to-end management and execution of clinical trials for prime contractors on OCRP projects, with a primary focus on patient recruitment, site monitoring, and clinical data analysis. The contractor is responsible for delivering completed clinical trial data and statistical analysis reports while ensuring strict adherence to GCP, GLP, and GMP guidelines. This opportunity falls under NAICS code 541711 and has a response deadline of October 1, 2026.
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NAICS: 541711
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FA8652 Afrl Hq Afrl/pk

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SLED
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AI Contract Overview

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The contract involves the design and execution of Phase 1 clinical trials to evaluate the safety, appropriate dosage, and initial immunogenicity of pandemic influenza vaccine candidates in human subjects. It is a subcontract opportunity issued by the Department of Health and Human Services through the Barda division, with a focus on advancing vaccine development during a public health emergency. The solicitation was posted on June 3, 2026, with a response deadline set for July 15, 2026. The work is to be performed in Washington, DC, under the NAICS code 541711, which pertains to research and development in biotechnology. The contract emphasizes the early-stage clinical evaluation critical to moving pandemic influenza vaccines forward toward regulatory approval and widespread use.

General Info

Design and conduct Phase 1 clinical trials for pandemic influenza vaccine safety and dosage.

Agency

Department Of Health And Human Services → Barda - Aspr / Daappo / Barda DcmaView Agency

NAICS

541711 - Research and Development in BiotechnologyView NAICS

Place of Performance

Washington, DC, 20024, USA

Set-Aside

NONE

Documents

This scope was carved out of RFI-26-08-PBD1.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

RFI - Protection Before Day One Vaccine: Seasonal Influenza Vaccines with Pandemic Coverage

AI Contract Breakdown

Uniform Contract Format

No contract breakdown available.

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Timeline

PhaseClosed
Posted

subcontract

Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
ContactsNo contacts available
OfficeN/A
Organization / Agency
Department Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
View Agency Profile
Office AddressN/A
ContactsNo contact information available

Full Description

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Design and conduct Phase 1 clinical trials to assess safety, dosage, and preliminary immunogenicity in human subjects for pandemic influenza vaccine candidates.

More opportunities from Department Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma

Same awarding agency

NAICS: 541714
New
Federal
Request for Proposals (RFP) - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response
Solicitation # 75A50126R00001_RFP_NPIVS_27
BARDA is seeking contractors to support the Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response Program. The selected providers will be responsible for furnishing all necessary personnel, materials, and facilities to produce vaccines, antigens, and adjuvants for pandemic preparedness and public health emergencies. This includes generating and submitting critical analytical, clinical, and manufacturing data to the FDA to ensure rapid regulatory decisions and manufacturing readiness. To be eligible for this award, offerors must have experience producing vaccines against influenza and strains with pandemic potential. Mandatory qualifications include either holding a U.S. influenza vaccine license or demonstrating the development of an influenza vaccine through the submission of a Biologics License Application for seasonal or pandemic vaccines. This solicitation is managed by the Department of Health and Human Services with a response deadline of October 30, 2026.
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about 22 hours ago

DEADLINE

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NAICS: 325412
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Vaccine Lot Production (Research, Investigational, and Commercial)This subcontract involves the production of influenza vaccine antigens and vaccines across research, investigational, and commercial bulk scales to support prime contractors on BARDA pandemic preparedness projects. The work is performed within cGMP compliant facilities to ensure all investigational and commercial lots meet strict regulatory alignment and quality standards. Managed by the Department of Health and Human Services under the Barda agency, the contract focuses on delivering bulk vaccine lots across three distinct production scales. The opportunity is categorized under NAICS code 325412, with a response deadline set for October 30, 2026, and performance based in Washington.
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cGMP Vaccine Seed Lot ManufacturingThis subcontract for cGMP Vaccine Seed Lot Manufacturing involves the production of yield-optimized Master Virus Seed, Working Virus Seed lots, or bacterial cell banks to support BARDA pandemic preparedness projects. The work is performed for prime contractors using qualified CVV reference strains within cGMP certified facilities that align with FDA-licensed vaccines or submitted BLAs. All seeds are characterized according to qualified internal standard operating procedures to ensure the delivery of certified lots. Managed by the Department of Health and Human Services under Barda, the contract falls under NAICS code 325412. The performance location is based in Washington, DC, with a response deadline of October 30, 2026.
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NAICS: 541714
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Candidate Vaccine Virus (CVV) Development & CharacterizationThis subcontract, titled Candidate Vaccine Virus Development and Characterization, supports BARDA pandemic preparedness projects by preparing and characterizing both non-GLP and GLP influenza Candidate Vaccine Viruses. The scope of work includes performing HA/NA sequencing, genetic stability testing, ferret pathogenicity, two-way antigenicity, HA titer, sterility, and exclusivity. Additionally, the contractor is responsible for conducting plaque assays and chicken embryo lethality for HPAI strains within a BSL-2 environment, culminating in the delivery of final reports and Certificates of Analysis or Compliance. Managed by the Department of Health and Human Services under the Barda - Aspr agency, the project is categorized under NAICS code 541714. The performance location is based in Washington, DC. The solicitation was posted on August 17, 2026, with a response deadline set for October 30, 2026.
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NAICS: 326199
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Specialized Material Supply (Vials, Stoppers, Seals)This subcontract for Specialized Material Supply focuses on providing critical medical-grade components, including vials, stoppers, seals, and crimps, to support prime contractors on BARDA pandemic preparedness projects. The scope of work requires the delivery of physical inventory and the provision of comprehensive supply chain narratives that detail the country of origin and tariff exposure for all containment and closure materials. Managed by the Department of Health and Human Services under the agency Barda - Aspr / Daappo / Barda Dcma, the contract is categorized under NAICS code 326199. The place of performance is located in Washington, DC, with a response deadline set for October 30, 2026.
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DEADLINE

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NAICS: 493110
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Labeling, Packaging, and Cold Chain StorageThis subcontract, managed by the Department of Health and Human Services under BARDA, focuses on providing essential labeling, packaging, and specialized stability storage for bulk and final vaccine products. The scope of work involves supporting prime contractors on pandemic preparedness projects by managing cold chain logistics and stability monitoring for commercial scale bulk antigens, final containers, and bulk adjuvants. The contractor is responsible for the delivery of packaged products and the provision of detailed stability reports. This opportunity is categorized under NAICS code 493110 and is based in Washington, DC. The response deadline for this requirement is October 30, 2026.
General Warehousing and Storage

POSTED

26 days ago

DEADLINE

in about 2 months
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NAICS: 325412
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Formulation, Filling, and Finishing ServicesThis subcontract for Formulation, Filling, and Finishing Services supports BARDA pandemic preparedness projects by providing final formulation and filling of antigens, adjuvants, or co-formulated products into final containers. The work is performed under cGMP compliant processes within sterile filling environments to ensure the delivery of high-quality filled vials and containers for prime contractors. The opportunity is managed by the Department of Health and Human Services under the Barda - Aspr / Daappo / Barda Dcma agency and is categorized under NAICS code 325412. The project is based in Washington, DC, with a response deadline of October 30, 2026.
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26 days ago

DEADLINE

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NAICS: 325412
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cGMP Adjuvant ManufacturingThis subcontract, titled cGMP Adjuvant Manufacturing, involves the production of clinical or commercial scale bulk lots of vaccine adjuvants to support BARDA pandemic preparedness projects. The primary objective is to manufacture these adjuvants within cGMP certified facilities to enhance the efficacy of influenza vaccines as part of United States Government efforts. The contract is managed by the Department of Health and Human Services under the agency Barda - Aspr / Daappo / Barda Dcma, with the place of performance located in Washington. The solicitation was posted on August 17, 2026, with a response deadline of October 30, 2026, and falls under NAICS code 325412.
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POSTED

26 days ago

DEADLINE

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NAICS: 541715
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Animal Model Development for Phosphine & Cyanide ExposureThis contract involves the development and validation of animal models designed to accurately replicate human exposure to phosphine and cyanide. These models are intended to be used for testing medical countermeasures under the FDA Animal Rule, which provides regulatory pathways for drugs and biologics when human trials are not ethical or feasible. The work falls under the subcontract category and is associated with the Department of Health and Human Services, specifically managed by BARDA (Biomedical Advanced Research and Development Authority) and affiliated offices. The focus of the effort is to create reliable and scientifically robust animal models that can simulate the toxicological and pharmacological effects of phosphine and cyanide exposure in humans. This will facilitate the evaluation and approval of medical treatments aimed at counteracting these toxic agents in emergency or threat scenarios. The contract aligns with NAICS code 541715, which involves research and development in the physical, engineering, and life sciences sectors. The solicitation was posted in April 2026, and although specific details on location and points of contact are not provided, the contract is accessible through official government procurement platforms.
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NAICS: 541620
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Expanded Biological Sample Analysis (Toxicology & Biomarkers)The contract involves the comprehensive analysis of biological samples, including blood, serum, and urine, to identify toxicological markers, conduct metabolomic profiling, and gather pharmacokinetic data. This work is aimed at assessing the safety and efficacy of medical countermeasures (MCM), supporting efforts to ensure that these interventions meet required safety standards and perform effectively in relevant scenarios. The contract falls under the NAICS code 541620, which relates to environmental consulting services, indicating specialized scientific and analytical work. Awarded by the Department of Health and Human Services through the Biomedical Advanced Research and Development Authority (BARDA), the subcontract focuses on advanced biological sample analysis as part of ongoing health protection initiatives. Although specific solicitation and contact details are not provided, the contract was posted in April 2026 and is intended to bolster toxicological and biomarker research critical to public health preparedness and response efforts. The work is conducted under the oversight of BARDA programs, underscoring its strategic importance in developing therapeutic and diagnostic solutions.
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5 months ago

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View Details
NAICS: 541380
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5 months ago

DEADLINE

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NAICS: 541611
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Administrative Management and General Management Consulting Services

POSTED

5 months ago

DEADLINE

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View Details

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