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This Solicitation opportunity from Department Of Health And Human Services was posted on May 24, 2022. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

PRECLINICAL SERVICES FOR BIOPHARMACEUTICAL PRODUCT DEVELOPMENT

Closed
RFP-NIH-AI-75N93022R00004Federal

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
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
NAICS: 541714
New
Federal
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

5 days ago

DEADLINE

in 25 days
NAICS: 541714
New
Federal
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

General Info

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

MD

Set-Aside

NONE

Documents

7

RFP-NIAID-75N93022R00004 Amendment No. 3

PDF, High priority: read this firstamendment
High

Amendment+Five+5.16.22.pdf

PDF

Amendment+Four+5.5.22.pdf

PDF

Amendment+One+2_10_22.pdf

PDF

Amendment+Six+5.24.22.pdf

PDF

Amendment+Two+3_22_2022.pdf

PDF

RFP-NIH-AI-75N93022R00004.pdf

PDF

AI Contract Breakdown

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Timeline

8 updates
PhaseClosed
Posted

Solicitation

Notice updated

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Deadline changed

Response deadline changed from Apr 18, 2022 to Jun 13, 2022.

Notice updated

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Notice updated

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Notice updated

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Response Deadline

Deadline has passed

Submission Closed

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Niaid
Contacts2 people available
OfficeBETHESDA, MD, 20892, USA

Full Description

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The aim of this solicitation is to create a multiple award Indefinite Delivery/Indefinite Quantity (IDIQ) type contract. The development and introduction of new therapeutic products against potential agents of bioterrorism, drug-resistant pathogens, emerging and re-emerging infectious diseases, as well as infectious diseases prevalent in resource-limited countries remain a high public health priority. To assist in filling these public health gaps, the NIAID requires a nontraditional, proactive, and product development-oriented program to provide preclinical product development support for promising biopharmaceutical therapeutic candidates for human infectious diseases or diseases caused by infectious agents. The suite of services included in this IDIQ contract will encompass those activities commonly associated with the development of biopharmaceutical products for treating or diagnosing infectious disease that are required for Investigational New Drug (IND) application and/or Biologic License Application (BLA) and/or other FDA submissions including 510(k) application and Investigational Device Exemption (IDE) application. These services are available for therapeutic candidates arising from academia, the private sector or other sources. While the overall suite of services provided is comprehensive, this resource is intended to be applied to any/multiple product(s) at any/multiple stage(s) requiring access to services in support of a diverse collection of biopharmaceutical candidates, rather than to carry a single product candidate through the entire preclinical development pathway. These services are intended to help a wide variety of investigators in a number of scientific areas obtain critical data needed to acquire additional funding, gain prospective partnerships (either for further development or to support Phase I trials), fulfill regulatory requirements, and complete studies needed to apply for an IND and enter a Phase I trial. Furthermore, the rapid diagnosis of infectious disease-causing pathogens and/or toxins is crucial for implementing proper treatment and patient management. The commercial development of new diagnostics is a high priority. For that purpose, this solicitation includes services supportive of new diagnostics for infectious disease-causing pathogens and/or toxins. This IDIQ will be administered and used primarily to support DMID initiatives as necessary to help the Division accomplish its mission. However, other NIAID programs may initiate Task Orders under this IDIQ as necessary to accomplish their mission.

More opportunities from Department Of Health And Human Services → National Institutes Of Health Niaid

Same awarding agency

NAICS: 541715
Federal
2027 NIAID DMID Omnibus Broad Agency Announcement: Development of Medical Interventions for Infectious Diseases
Solicitation # HHS-NIH-NIAID-BAA2026-1
The National Institute of Allergy and Infectious Diseases (NIAID) is soliciting proposals under Broad Agency Announcement HHS-NIH-NIAID-BAA2026-1 to advance the research and development of medical interventions for infectious diseases. This initiative focuses on three primary research areas: the development of needle-free vaccine candidates through early-phase clinical trials; the creation of safe and effective therapeutic candidates for serious infectious diseases, including those resistant to current antimicrobial therapy; and the innovation of in vitro diagnostic technology platforms capable of rapid, automated detection of a broad panel of priority viral pathogens. The program emphasizes alignment with NIH priorities regarding biosafety, biosecurity, and the use of non-animal testing methods. Proposals must be submitted electronically via the NIAID eCPS website by December 8, 2026, at 3:00 PM Eastern Time. Technical proposals are limited to 75 pages and will be evaluated by a peer review group based on technical merit, with the technical plan and personnel qualifications being of paramount consideration. Awards are not based on a common Statement of Work; instead, offerors must propose their own technical plans, milestones, and cost structures using a base and option period format. The resulting contracts will require an accounting system compliant with generally accepted accounting principles and will involve rigorous government inspection and acceptance based on the successful completion of critical milestones.
Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

POSTED

12 days ago

DEADLINE

in about 2 months
View Details

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