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This Government Contract opportunity from Department Of Health And Human Services was posted on September 29, 2022. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

BARDA Nonclinical Development Biological Network

Awarded
75A50122R00008Federal

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
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.
Rpo East (36C24E)

POSTED

about 10 hours ago

DEADLINE

in 14 days
NAICS: 541714
New
Grant
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

1 day ago

DEADLINE

in 3 months
NAICS: 541714
New
Grant
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

1 day ago

DEADLINE

in 3 months

AI Contract Overview

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The Biomedical Advanced Research and Development Authority, under the Department of Health and Human Services, is establishing a Nonclinical Services Network to advance the development of medical countermeasures against chemical, biological, radiological, and nuclear threats. This initiative focuses on providing technical and regulatory assistance to developers, specifically through the creation of well-characterized nonclinical models of infection and exposure that meet Animal Rule regulatory requirements. The program aims to validate assays that bridge animal data to human responses and conduct controlled animal efficacy studies to provide primary evidence of effectiveness for candidate countermeasures. This specific award, identified by solicitation number 75A50122R00008, focuses on Capability Area 1, which pertains to Animal Model Development and MCM Testing for biological agents. By leveraging a network of laboratories, the agency seeks to expand its expertise and capacity to address 21st-century health security threats and support ongoing innovation activities. The effort builds upon a framework established in 2011 to ensure the United States has the necessary vaccines, drugs, and diagnostic tools to respond to public health emergencies and emerging infectious diseases.

General Info

Contract Value

$75,000

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

DC, GBR

Set-Aside

NONE

Awardee

MRIGLOBAL

Award Issued Date

Documents

0

No documents available

Documents will appear here when they are available.

AI Contract Breakdown

Uniform Contract Format

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Timeline

3 updates
PhaseAwarded
Posted

Sources Sought

Type Changed

Sources Sought → Presolicitation

Type Changed

Presolicitation → Solicitation

Notice updated

Notice details unchanged. Attachments may have changed.

Notice updated

Notice details unchanged. Attachments may have changed.

Notice updated

Notice details unchanged. Attachments may have changed.

Awarded

Contract was awarded

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → Barda - Aspr / Daappo / Barda Dcma
Contacts2 people available
OfficeWASHINGTON, DC, 20515, USA

Full Description

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The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases. Together with our industry partners, BARDA promotes the advanced development of medical countermeasures (MCM) to protect Americans and respond to 21st century health security threats. The Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) MCM Review (2010) recommended that PHEMCE partners provide not only financial help to medical countermeasure developers but also technical and regulatory assistance. BARDA's Strategic Plan (2011) set a goal to provide assistance to developers through core assistance programs in critical areas including nonclinical and clinical services to obtain safety and efficacy data supporting MCM development. In May 2011, BARDA awarded multiple contracts using the Indefinite Delivery, Indefinite Quantity (IDIQ) contract mechanism to establish a Nonclinical Development Network in support of the chemical, biological, radiological, and nuclear countermeasures in BARDA's portfolio. The primary goals of the program were to - develop well-characterized nonclinical models of infection and/or exposure to priority CBRN threats and ensure these models meet the regulatory requirements supporting MCM product development under the Animal Rule; - develop and validate assays to monitor response and bridge animal data to humans; and - design and conduct adequate and well-controlled animal efficacy studies intended to provide the primary evidence of effectiveness of candidate MCMs. In 2015 and 2016, the Nonclinical Development Network was expanded, and distinct networks were established addressing chemical agent threats, radiologic and nuclear agent threats, and biological agent threats, respectively. Since 2011, over 100 task orders were issued across these threat area networks. To meet the demands for MCM development and support an ever-increasing need for nonclinical services including those required to address 21st Century Threats and BARDA's innovation activities, this requirement seeks to establish a Nonclinical Services Network of laboratories providing expertise, capacity, and program management across the capability area: Capability Area 1: Animal Model Development and MCM Testing (Biological Agents)

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Electromedical and Electrotherapeutic Apparatus Manufacturing

POSTED

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DEADLINE

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NAICS: 541714
Federal
Request for Proposals (RFP) - BARDA Vaccine Medical Countermeasures for Pandemic Influenza Preparedness & Response
Solicitation # 75A50126R00001_RFP_NPIVS_27
The Biomedical Advanced Research and Development Authority (BARDA) is soliciting proposals for the Vaccine Medical Countermeasures for Pandemic Influenza Preparedness and Response Program. The primary objective is to maintain a permanent readiness posture and commercially sustainable warm-base production capacity for the rapid manufacture of vaccines, antigens, and adjuvants during public health emergencies. Selected contractors will be responsible for producing countermeasures against influenza and other viruses with pandemic potential, generating necessary analytical, nonclinical, clinical, and chemistry, manufacturing, and controls data for FDA submission, and preparing candidate vaccine viruses. To be eligible, offerors must demonstrate successful experience in influenza vaccine manufacturing, evidenced by holding a U.S. influenza vaccine license or having submitted a Biologics License Application to the FDA. The contract is structured as an IDIQ with a five-year base period and a five-year option, totaling a potential 120-month ordering period. Award decisions will be based on the Highest Technically Rated Offerors with a Fair and Reasonable Price methodology, with a critical requirement for offerors to achieve a High Confidence rating in capabilities. Key deliverables include the submission of comprehensive manufacturing and supply chain continuity plans, surge readiness assessments, and strict adherence to CGMP guidelines and ASPR security requirements. Performance is monitored through a BARDA dose tracker, and final acceptance is contingent upon the submission of final reports and verified temperature control documentation during delivery. Invoicing is conducted quarterly via the Department of Treasury Invoice Processing Platform.
Research and Development in Biotechnology (except Nanobiotechnology)

POSTED

about 1 month ago

DEADLINE

in about 1 month
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