Top

FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science

Awarded

FDABAA-25-00123_AwardFederal

Contract Overview

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

General Info

Agency

Department Of Health And Human Services → FDA Office Of Acquisitions And Grants Services

Contract Value

$16,737,952.78

NAICS

541714 - Research and Development in Biotechnology (except Nanobiotechnology)

Place of Performance

Silver Spring, MD, 20993, USA

Set-Aside

NONE

Awardee

Please_see_Spreadsheet

Award Issued Date

09/30/2025, 12:00:00 AM UTC

Documents

AwardsFY25Data - FY25 Award Summary

award

Low

BAA Tracking Sheet Awards FY25 Data (11-20-25)

award

Low

AI Contract Breakdown

Uniform Contract Format

Timeline

PhaseAwarded

PostedNov 24

Award Notice

AwardedSep 30

Contract was awarded

Ready to pursue this opportunity?

Start your free trial to track this contract, build proposals with AI assistance, and manage your pipeline.

Organization & Contact Information

AgencyDepartment Of Health And Human Services → FDA Office Of Acquisitions And Grants Services

Contacts1 person available

OfficeRockville, MD, 20857, USA

Organization / AgencyDepartment Of Health And Human Services → FDA Office Of Acquisitions And Grants Services

Office AddressRockville, MD, 20857, USA

Contacts

Ian Weiss

contact@example.gov

+1 (555) 000-0000

Full Description

Amendment 02 - updated Spreadsheet to include an additional Award

Amendment 01- updated Spreadsheet to include an additional Award

Please see attached Spreadsheet for all contracts awarded in this oppertunity. A total of 15 Contracts were awarded in FY25 from this BAA Announcement.

Similar Contracts

Same NAICS industry code

NAICS: 541714

New

Federal

Pre-solicitation Notice: On-Ramp for the Department of Defense OMNIBUS IV Multiple-Award Contract

Solicitation # HT942627RE002

The Defense Health Agency Contracting Activity intends to issue a Request for Proposal in early November 2026 for an on-ramp to the OMNIBUS IV Multiple Award, Indefinite Delivery, Indefinite Quantity contract vehicle. This opportunity is specifically set aside for small businesses certified under the Small Business Administration 8(a) Program and will focus on providing military medical research and development services. Multiple new awards are expected, all of which will align with the existing unrestricted contract vehicle. The OMNIBUS IV vehicle operates with a cumulative ceiling of 10 billion dollars and a performance period extending through June 19, 2032, including option years. To date, the contract has seen over 690 million dollars awarded across 61 task orders to various end users, including the Naval Supply Systems Command and the Uniformed Services University of the Health Sciences. Task orders may be competed via fair opportunity or through specific exceptions such as small business set-asides.

Defense Health Agency

POSTED

DEADLINE

Pre-solicitation Notice: On-Ramp for the Department of Defense OMNIBUS IV Multiple-Award Contract

Solicitation # HT942626RE002

The Defense Health Agency Contracting Activity is issuing a pre-solicitation notice for an on-ramp to the OMNIBUS IV Multiple Award, Indefinite Delivery, Indefinite Quantity (IDIQ) contract vehicle. This initiative aims to expand the pool of eligible contractors providing military medical research and development services, including laboratory and technical support, regulatory process expertise, and translational science services. The eventual Request for Proposal will be set aside exclusively for small businesses certified under the Small Business Administration 8(a) Program. Due to the need to implement recent FAR Overhaul guidance, the anticipated posting timeframe for the solicitation has been extended to late September 2026. The OMNIBUS IV vehicle operates with a base ordering period from June 20, 2022, through June 19, 2027, and an option ordering period extending to June 19, 2032. It features a cumulative ceiling of 10 billion dollars, with over 630 million dollars already awarded across 55 task orders to various end users, including the Naval Supply Systems Command and the Uniformed Services University of the Health Sciences. New awards from this on-ramp will align with the existing unrestricted vehicle. Prospective offerors must be registered in SAM.gov and will be required to submit proposals through the Procurement Integrated Enterprise Environment solicitation module once the formal RFP is released.

Defense Health Agency

POSTED

DEADLINE

Centers for Structural Biology of HIV and Other Infectious Diseases (U54 Clinical Trial Not Allowed)

Solicitation # RFA-AI-28-031

The National Institutes of Health, under the Department of Health and Human Services, is soliciting applications for the Centers for Structural Biology of HIV and Other Infectious Diseases (RFA-AI-28-031). This funding opportunity seeks to establish multidisciplinary consortia of structural biologists and microbiologists to solve complex biological structures necessary for the prevention, treatment, and cure of HIV and other infectious diseases. The program emphasizes the use of advanced experimental approaches, including hybrid imaging, artificial intelligence, protein design, and dynamic computational modeling. NIAID intends to commit 33 million dollars in FY 2028, with individual application budgets not expected to exceed 3.5 million dollars in direct costs. The program is structured around a cooperative agreement requiring several functional components: an Administrative Core, a Workforce Development Core, two to four Scientific Cores, and three Research Projects. A Service and Resource Core is required for Infectious Disease Centers but prohibited for HIV Centers. Applications will be evaluated based on scientific and technical merit, relevance to program priorities, and the availability of funds, with a specific focus on multidisciplinary integration and innovation. Clinical trials are not allowed under this notice. Applicants must maintain active registrations in the System for Award Management and eRA Commons, and all Principal Investigators must have a linked ORCID ID. Required documentation includes a Data Management and Sharing Plan, a Resource Sharing Plan, and letters of institutional support. Strict cybersecurity requirements are in place, including multifactor authentication and a 48-hour incident notification window. The response deadline for this solicitation is May 28, 2027.

National Institutes Of Health

POSTED

DEADLINE

Commercial Suborbital Flight Payload Integration and LaunchThe Commercial Suborbital Flight Payload Integration and Launch subcontract supports NASA Science Mission Directorate projects by providing essential launch vehicles and integration services for prime contractors. The scope of work includes integrating instruments onto launch vehicles, such as the PPSLV, and managing payload configuration and flight performance. To ensure mission success, the contractor is responsible for conducting Continuing Investigation Reviews for safety and product assurance while adhering strictly to NASA safety and mission assurance standards. The primary objectives of this engagement are the successful execution of launches, the recovery of research payloads, and the delivery of critical flight data. This opportunity is categorized under NAICS code 541714 and was posted on October 2, 2026, with a response deadline of November 16, 2026.

Science Mission Directorate

POSTED

DEADLINE

Biobanking, Laboratory Analytics, and Associated Informatics Services for NIH Biorepositories

Solicitation # 75N98026R00175SB

The National Institutes of Health is issuing a Small Business Sources Sought Notice to identify qualified small businesses capable of providing biobanking, laboratory analytics, and informatics services for NIH biorepositories starting in fiscal year 2028. The scope of work includes the management and secure storage of at least 3.5 million biospecimens, data curation and harmonization, and advanced laboratory capabilities such as high-throughput sequencing and CRISPR/Cas9 gene editing. Additionally, the contractor must provide informatics support to develop and maintain web portals, APIs, and secure cyberinfrastructure compliant with FISMA and NIH requirements. This notice is for market research purposes to determine the availability of small businesses under NAICS code 541714 and does not constitute a solicitation for proposals. Interested firms must submit a detailed capability statement by October 20, 2026, outlining their previous experience, personnel qualifications, and facility capabilities. The government is specifically looking for firms that can maintain a strict chain of custody, adhere to Good Laboratory Practice, and collaborate with NIH Data Centers to support large-scale research studies.

National Institutes Of Health Nida

POSTED

DEADLINE

Biobanking, Laboratory Analytics, and Associated Informatics Services for NIH Biorepositories

Solicitation # 75N98026R00175

The National Institutes of Health is issuing a Sources Sought Notice to identify qualified research and development firms, small businesses, and subcontractors capable of providing biobanking, laboratory analytics, and informatics services for NIH biorepositories starting in fiscal year 2028. The primary objective is to support the operation and potential consolidation of repositories, specifically including the NIDA Center for Genetic Studies and the NIH Brain Development Cohorts Biobank. This is a market research effort to determine the availability of technically capable sources and to inform the government's decision on the appropriate acquisition method and potential small business set-asides. The required scope of work involves the secure storage and tracking of at least 3.5 million biospecimens, comprehensive data curation and management using auditable LIMS, and advanced laboratory capabilities such as high-throughput sequencing and CRISPR/Cas9 gene editing. Additionally, the contractor must provide informatics support to develop and maintain web portals, APIs, and secure cyberinfrastructure compliant with FISMA standards. Interested parties must submit a detailed capability statement, including experience, personnel qualifications, and facility descriptions, to the designated contract specialists by October 20, 2026.

National Institutes Of Health Nida

POSTED

DEADLINE

Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS)

Solicitation # ARPA-H-SOL-26-164

The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals for the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program under solicitation ARPA-H-SOL-26-164. This five-year initiative aims to create a reusable blueprint for future adaptive seamless platform trials through the integration of three technical areas: a Phaseless Design Engine, Continuous Inference, and Agentic Operations. The program is divided into two stages, with Stage I focusing on capability buildout, FDA engagement, and the onboarding of at least three intervention arms over 24 months, followed by a 36-month Stage II dedicated to validation and deployment. A critical go/no-go milestone is obtaining FDA authorization for the platform Master Protocol IND and at least one investigational arm by the end of Stage I. The government intends to make multiple awards via Other Transaction Agreements to proposers offering the most advantageous solutions based on innovation, feasibility, and technical merit at reasonable prices. Eligible entities must possess a Unique Entity Identifier and active SAM registration. Proposals are submitted in a phased approach, beginning with a Solution Summary and potentially progressing to a Solution Pitch package. Performance will be measured by the successful integration of the three technical areas and the achievement of specific program metrics. All work must adhere to ICH E6(R3) Good Clinical Practice and strict regulatory standards to ensure inspection readiness and participant safety.

Advanced Research Projects Agency For Health (arpa-H)

POSTED

DEADLINE

SURPASS Webinar and Proposers' Day Information

Solicitation # ARPA-H-SN-26-164

The Advanced Research Projects Agency for Health (ARPA-H), under the Department of Health and Human Services, has issued Special Notice ARPA-H-SN-26-164 regarding the Simulation-augmented, Real-time Platform Adaptive Seamless Trials (SURPASS) program. This initiative aims to modernize clinical research by transforming drug and biologics development into a continuous learning system, with the goal of reducing development timelines from over ten years to fewer than four. The program focuses on creating disease-specific multi-arm platforms that integrate AI-powered operational infrastructure, in silico modeling, and advanced adaptive designs to enable a seamless transition from first-in-patient evaluation to confirmatory assessment. Key outputs include a reusable blueprint for future trials, simulation-based design tools, and continuous inference and adaptation approaches, all aligning with the goals of HHS Operation TrialBlazer. This specific notice serves as an informational announcement and does not constitute a formal solicitation for proposals. It invites interested parties to an informational webinar on October 15, 2026, and a two-day Proposers Day on November 6 and 9, 2026. Potential participants may optionally submit teaming profiles, lightning talk slides, and posters to showcase their expertise. Full program details and formal solicitation requirements are located under solicitation ARPA-H-SOL-26-164. All inquiries are directed to the SURPASS team, with Daria Fedyukina serving as the Technical Point of Contact.

Advanced Research Projects Agency For Health (arpa-H)

POSTED

DEADLINE

Neuroimaging Analysis and Data CollectionThis subcontract for Neuroimaging Analysis and Data Collection supports National Institutes of Health research projects focused on assessing synaptic integrity and central nervous system outcomes in individuals living with HIV. The scope of work involves performing advanced brain scans using PET or MRI modalities, processing the resulting neuroimaging data, and conducting detailed analyses to identify therapeutic target engagement. The selected provider must ensure strict compliance with 45 CFR Part 46 and obtain necessary IRB approval to conduct the research. Key deliverables include the provision of processed neuroimaging data and comprehensive analytical reports. The opportunity was posted on September 30, 2026, with a response deadline of October 28, 2027, falling under NAICS code 541714.

National Institutes Of Health

POSTED

DEADLINE

ARPA-H Comprehensive Organ System Modeling in Outer Space (COSMOS) Innovative Solutions Opening

Solicitation # ARPA-H-SOL-26-165

The Advanced Research Projects Agency for Health (ARPA-H) is seeking proposals under solicitation ARPA-H-SOL-26-165 for the Comprehensive Organ System Modeling in Outer Space (COSMOS) initiative. This program aims to determine if microgravity in Low Earth Orbit (LEO) accelerates tissue aging across brain, cardiac, uterine, and kidney tissues compared to terrestrial rates. If the Tissue Aging Rate in Space (TARIS) is found to significantly exceed the Tissue Aging Rate on Earth (TAROE), the initiative intends to establish a high-throughput, autonomous drug screening platform in LEO to make biomedical research and development more cost-effective and faster than Earth-based methods. The project is structured into two sequential phases: a 27-month Phase I focused on establishing and validating microphysiological systems (MPS) to quantify aging rates, and a 15-month Phase II dedicated to developing age-related pathology models for pro-regenerative drug testing. Key requirements include the use of MPS or organoids for at least 75 percent of experimental samples, the creation of LEO twin experiments, and the establishment of a contractual partnership with at least one Fortune 100 biopharmaceutical company. The program schedule spans FY27 through FY30 and includes two planned space launches in months 39 and 41. Awards will be granted via multiple Other Transaction (OT) Agreements to the most advantageous proposers, including universities, non-profits, and businesses. Evaluation is based primarily on the innovation and feasibility of the technical approach, the potential to transform biomedicine, and the team's expertise in managing costs and schedules. Proposers must adhere to strict administrative requirements, including the BIOSECURE Act, NIH Genomic Data Sharing policies, and specific research security and cybersecurity disclosures. Full proposals are due by October 7, 2026.

Advanced Research Projects Agency For Health (arpa-H)

POSTED

DEADLINE

ARPA-H Emerging Health Innovators (EHI) Initiative

Solicitation # ARPA-H-SOL-26-150

The Advanced Research Projects Agency for Health (ARPA-H) Emerging Health Innovators (EHI) initiative, solicitation ARPA-H-SOL-26-150, is a mentorship program designed to identify and engage early-career investigators for cutting-edge biomedical, health, and community-engaged research. Eligible principal investigators must be within eight years of completing their first terminal degree. The program focuses on 16 specific topic areas and utilizes a two-step submission process, beginning with an anonymized solution summary due October 30, 2026, followed by full proposals due February 10, 2027. Awards are issued as Other Transaction (OT) agreements with a tentative start date of June 30, 2027. Each award has a total value not to exceed 1,050,000 dollars over a three-year period, consisting of a two-year base period capped at 700,000 dollars and an optional third year capped at 350,000 dollars. Funding is structured around a fixed-price milestone payment schedule, with 12 total quarterly milestones and payments processed through the Payment Management Services (PMS) system. Performance is monitored via monthly one-hour virtual reviews with the ARPA-H program team. Evaluation is based on technical merit, innovativeness, feasibility, and alignment with the ARPA-H mission, with a strong emphasis on risk mitigation and the potential to impact national health research.

Advanced Research Projects Agency For Health (arpa-H)

POSTED

DEADLINE

Imaging Biomarker Research & AnalysisThis subcontract focuses on the development and testing of imaging-based biomarkers designed to identify pancreatic cancer and its precursor lesions. Working in support of prime contractors on NIH and NCI research projects, the scope of work involves utilizing advanced imaging modalities including MRI, CT, PET, and endoscopic ultrasound to characterize lesions and establish specialized protocols for identifying high-risk patients. Because the work involves human subject research, all activities must be conducted under appropriate IRB approval. The primary deliverables for this engagement consist of finalized imaging biomarker protocols and comprehensive analyzed imaging datasets. This opportunity is categorized under NAICS code 541714 and is associated with the National Institutes of Health within the Department of Health and Human Services. Interested parties must note the response deadline of November 5, 2029, to participate in this research and analysis initiative.

National Institutes Of Health

POSTED

8 days ago

DEADLINE

in about 3 years

View Details

More opportunities from Department Of Health And Human Services → FDA Office Of Acquisitions And Grants Services

Same awarding agency

NAICS: 541990

Federal

Regulatory Decision Frameworks and Predictive ModelingThe contract involves the development of AI and machine learning-driven predictive models and decision support tools aimed at enhancing regulatory decision-making processes. Leveraging both high-quality scientific data and real-world data, the objective is to improve the accuracy and efficiency of regulatory evaluations. This initiative is critical for advancing the FDA's ability to assess and manage health-related risks more effectively. This subcontract falls under the NAICS code 541990 and is managed by the FDA Office of Acquisitions and Grants Services within the Department of Health and Human Services. The work will be performed in Silver Spring, Maryland, and focuses on creating frameworks that support regulatory decisions through sophisticated data analysis and predictive modeling techniques. The contract was posted in January 2026 and seeks specialized expertise to integrate innovative technologies into regulatory workflows.

All Other Professional, Scientific, and Technical Services

POSTED

DEADLINE

Clinical and Surrogate Endpoint Development for Regulatory ApprovalThis contract involves conducting research aimed at defining and validating clinical or surrogate endpoints to support regulatory submissions, with a particular focus on facilitating accelerated approval pathways. The work is designed to provide critical data that aids in meeting regulatory requirements, helping to streamline the approval process for new therapies or medical products. The subcontract, issued by the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services, falls under the NAICS code 541715, which typically includes research and development in the physical, engineering, and life sciences. The place of performance is located in Silver Spring, with the contract posted for potential subcontracting opportunities on January 13, 2026. The emphasis on endpoint development highlights the importance of scientific validation in advancing medical innovation through regulatory channels.

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

POSTED

DEADLINE

Patient Preference Information (PPI) Quantification StudiesThis contract involves designing and conducting studies to measure patient preferences in clinical decision-making, with a particular focus on rare diseases. The work will employ structured survey techniques alongside statistical methodologies to quantitatively assess how patients weigh different treatment options and outcomes, providing valuable insights to inform regulatory and healthcare decisions. The contract is a subcontract managed by the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services, with the place of performance in Silver Spring, Maryland. The effort falls under the NAICS code 541611, which pertains to administrative management and general management consulting services. The project aims to enhance understanding of patient perspectives to support more patient-centered healthcare and regulatory processes.

Administrative Management and General Management Consulting Services

POSTED

DEADLINE

Digital Health Integration and Real-World Evidence (RWE) AnalyticsThe contract focuses on the development and validation of digital health tools along with the integration of real-world data into regulatory frameworks. This involves utilizing predictive modeling and data science techniques to enhance the analysis and application of real-world evidence in healthcare settings. The work aims to support regulatory decision-making by leveraging advanced analytics to better interpret and utilize data collected outside traditional clinical trials. Awarded by the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services, the subcontract is classified under the NAICS code 541715, which pertains to research and development in physical, engineering, and life sciences. The place of performance is located in Silver Spring, and the contract was posted in January 2026. This initiative underscores the agency’s commitment to harnessing innovative digital technologies and data-driven methodologies to improve public health outcomes through more effective regulatory science.

Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

POSTED

DEADLINE

Botanical Drug Safety and Quality EvaluationThe contract involves conducting comprehensive analytical and preclinical studies to evaluate the safety, composition, and quality control of botanical drug products. This includes performing toxicology screenings and employing standardization methods to ensure the botanical drugs meet established safety and quality standards. The work is focused on supporting regulatory compliance and scientific validation of these products. Awarded by the FDA Office of Acquisitions and Grants Services under the Department of Health and Human Services, this subcontract falls under the NAICS code 541990, which pertains to specialized scientific services. The principal place of performance is located in Silver Spring, with the contract posted on January 13, 2026. The scope and nature of the contract emphasize the critical role of rigorous quality assessment for botanical drugs, contributing to public health protection and regulatory oversight.

All Other Professional, Scientific, and Technical Services

POSTED

DEADLINE

Regulatory Science Research in Tobacco Product AssessmentThe contract focuses on conducting comprehensive public health research related to tobacco product use, encompassing behavioral studies, clinical observations, and analysis of policy impacts. The research aims to generate evidence that will inform and support regulatory decisions made by the FDA, ensuring that the agency’s regulatory actions are grounded in robust scientific data. It addresses multiple facets of tobacco use and its implications, which is critical for evaluating products under FDA oversight. This subcontract, issued by the FDA Office of Acquisitions and Grants Services within the Department of Health and Human Services, is identified under NAICS code 541990 and will be performed in Silver Spring. The contract prioritizes research activities that contribute to tobacco product assessment through a regulatory science lens, facilitating the FDA’s mission to protect public health. The focus on evidence-driven analysis highlights the importance of integrating behavioral, clinical, and policy-related research elements to comprehensively understand tobacco product impacts.

All Other Professional, Scientific, and Technical Services

POSTED

9 months ago

DEADLINE

N/A

View Details

Ready to Pursue This Opportunity?

Get AI-powered intelligence on this solicitation and the ones like it

Every page of the solicitation package shredded into a compliance breakdown

AI-powered matching based on your capabilities and past performance

Competitor and incumbent history on the requirement

Automated alerts on amendments, Q&A deadlines, and award

Join 750+ contractors already using CLEATUS