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ACUCELA INC.

UEI: FNW1T78KSWC1CAGE: 46NV0

ACUCELA INC. is a federal contractor, registered under UEI FNW1T78KSWC1 and CAGE code 46NV0. It has been awarded $1,833,212 in federal contracts. Primary work spans Unknown NAICS. Top awarding agencies include Department Of Health And Human Services.

Contact Information

Registration and classification details

Websitehttp://www.kubotavision.com

Address

Registration

UEI Code

FNW1T78KSWC1

CAGE Code

46NV0

Entity Structure

Corporate Entity (Not Tax Exempt)

Established

N/A

Business Classifications

For Profit OrganizationForeign Owned

NAICS Codes

541714Research and Development in Biotechnology (except Nanobiotechnology)(Primary)

Federal Contracting Overview

Award totals, agency breakdown, NAICS distribution, and geographic footprint.

AI Capability Profile

Acucela Inc. specializes in advanced scientific research and development, with a primary focus on computational biology, bioinformatics, and data-driven life sciences innovation. Leveraging expertise in algorithmic modeling, high-performance computing, and molecular data analysis, the company delive...

Key performance metrics

Award counts and award dollars by type, as prime and as subcontractor.

Awards Count

3

All time

Active

0

Currently performing

Completed

3

Past period of performance

Total Awards

All time

Contracts

Prime · all time

Subcontracts

Sub · all time

Grants

Prime · all time

Subgrants

Sub · all time

Award analytics

Awards by agency, industry, year, award type, size, and place of performance.

Awards by Agency

Department Of Health And Human Services$1.8M100%

Awards by NAICS

Awards by Agency Over Time

Awards by Place of Performance

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Repatriation Case Management and Financial Support Services

Solicitation # 47QTCA25D007Q-7571MN26F80127

This special notice announces the transfer of a contract for Repatriation Case Management and Financial Support Services from the Department of the Interior to the Department of Health and Human Services. Originally awarded to Respones AI, LLC on September 24, 2025, as contract number 47QTCA25D007Q - 140D0425F1000, the agreement transitioned to the new contract number 47QTCA25D007Q - 7571MN26F80127 effective September 29, 2026. The transfer maintains all original terms and conditions, specifically preserving the ultimate contract value and the period of performance. This project is designated as a total small business set-aside under NAICS code 541519, with the place of performance located in Virginia.

Department Of Health And Human Services

POSTED

about 1 month ago

DEADLINE

OHS Region 11 Training and Technical Assistance Network

Solicitation # 7571MN26C00013

The Department of the Interior’s existing contract with ICF Incorporated, LLC, numbered 140D0425C0027, has been administratively transferred to the Department of Health and Human Services under a new task order, 7571MN26C00013, effective July 1, 2026. This transfer is purely administrative and does not alter the original contract’s scope of work, deliverables, ultimate value, or period of performance. The work continues under the same terms and conditions, now managed by HHS to support the OHS Region 11 Training and Technical Assistance Network, with performance based in Reston, Virginia, and administrative oversight from Washington, DC. The contract, classified under NAICS code 541611, remains unrestricted with no set-aside requirements and is fully maintained under the original contractor’s responsibility. Point of contact for inquiries includes Carla Carter and Hamed Hassanzadeh Makou at HHS.

Department Of Health And Human Services

POSTED

DEADLINE

Portfolio Management System (OPS)

Solicitation # 7571MN26F80053

The Department of the Interior’s contract GS35F523BA/140D0422F0466, originally awarded to the Community Development Institute on May 11, 2022, for the Portfolio Management System (OPS), has been administratively transferred to the Department of Health and Human Services under the new contract number GS35F523BA/7571MN26F80053, effective June 12, 2026. This transfer does not modify any existing terms, including the ultimate contract value or the period of performance, and all scope of work, deliverables, and contractual obligations remain unchanged. The contract, identified by NAICS code 541511, is managed by HHS with the primary point of contact being Amber Harris at [email hidden], and the work is performed in Madison, Wisconsin, while the contracting office is located in Washington, D.C. The contract notice was posted on June 15, 2026, and the change is purely administrative, with no impact on the contractor or the execution of the project.

Department Of Health And Human Services

POSTED

DEADLINE

Clinical Research Organization (CRO)This subcontract opportunity with the Department of Health and Human Services is for a Clinical Research Organization to manage and execute clinical trials for small businesses on NIH STTR projects. The selected provider will be responsible for patient recruitment, trial monitoring, clinical data management, and regulatory submission support, utilizing specialized management software and medical monitoring equipment. All operations must maintain strict FDA compliance and obtain necessary IRB approvals to deliver comprehensive clinical trial reports, patient outcome data, and regulatory filings. The procurement is designated as a Total Small Business Set-Aside under the SBIR/STTR mandate for companies with fewer than 500 employees, falling under NAICS code 541715. The solicitation was posted on May 28, 2026, with a response deadline of April 6, 2027.

Department of Health and Human Services

POSTED

DEADLINE

Specialized Scientific/Technical ConsultantThis subcontract opportunity with the Department of Health and Human Services seeks a Specialized Scientific/Technical Consultant to provide niche technical services for small businesses on NIH STTR projects. The scope of work includes performing specialized assays, toxicity testing, laboratory tests, data analysis, and the fabrication of specialized components using high-precision instrumentation and specific chemical or biological reagents. Deliverables consist of test results, analyzed data sets, or fabricated prototype components, with a requirement for GLP or GMP certifications if clinical trials are involved. The contract is a total small business set-aside under the SBIR/STTR mandate for firms with fewer than 500 employees, falling under NAICS code 541715. It was posted on May 28, 2026, with a response deadline of April 6, 2027.

Department of Health and Human Services

POSTED

DEADLINE

Non-Profit Research Institution PartnerThis subcontract opportunity with the Department of Health and Human Services seeks a recognized non-profit research institution to partner with small business concerns on NIH STTR projects. The selected partner will be responsible for establishing technical merit, conducting feasibility studies, and executing full-scale research, development, and prototype creation. To fulfill these requirements, the institution must provide access to specialized medical and scientific equipment, laboratory facilities, and academic research archives. The project requires the delivery of validated prototypes, comprehensive technical reports, research data, and peer-reviewed publications. This is a total small business set-aside under the SBIR/STTR mandate for organizations with fewer than 500 employees, falling under NAICS code 541715. The response deadline for this opportunity is April 6, 2027.

Department of Health and Human Services

POSTED

DEADLINE

Clinical Research Coordination and EnrollmentThis subcontract for Clinical Research Coordination and Enrollment supports prime contractors on clinical trials for the NIH, CDC, and FDA. The scope of work involves participant recruitment, enrollment, and administrative management using electronic medical records, Electronic Data Capture systems, and practice-based research networks. All activities must adhere to GCP standards, HIPAA compliance, and require IRB approval to deliver patient cohorts and clinical trial data reports. The opportunity is issued by the Department of Health and Human Services under NAICS code 541715. It is designated as a Total Small Business Set-Aside for firms with fewer than 500 employees. The solicitation was posted on May 28, 2026, with a response deadline of April 6, 2027.

Department of Health and Human Services

POSTED

DEADLINE

Commercial Product PrototypingThis subcontract opportunity with the Department of Health and Human Services focuses on the supply and manufacture of early stage prototypes and proof of concept hardware for prime contractors working on NIH, CDC, and FDA research and development projects. The scope of work includes rapid prototyping, 3D printing, CNC machining, and PCB design, specifically utilizing biocompatible materials and medical grade plastics to deliver functional models of commercial products. The contract is designated as a total small business set aside under NAICS code 339113, requiring firms to have fewer than 500 employees. A critical requirement for eligibility is ISO 13485 certification for medical devices. Interested parties must submit their responses by April 6, 2027.

Department of Health and Human Services

POSTED

DEADLINE

R&D Laboratory Testing and AnalysisThis subcontract opportunity with the Department of Health and Human Services focuses on providing specialized scientific testing, assays, and laboratory analysis to support prime contractors on R&D projects for the NIH, CDC, and FDA. The scope of work includes conducting feasibility studies, biological or chemical analysis, sample testing, and data validation utilizing mass spectrometers, bio-analytical tools, and high-throughput screening equipment. All work must adhere to GLP or ISO/IEC 17025 standards, with the final deliverables consisting of validated data sets and technical reports. The project is categorized under NAICS code 541715 and is designated as a Total Small Business Set-Aside, specifically adhering to SBIR/STTR mandates for companies with fewer than 500 employees. The solicitation was posted on May 28, 2026, and the deadline for responses is April 6, 2027.

Department of Health and Human Services

POSTED

DEADLINE

FDA/NIH Regulatory Affairs ConsultingThis subcontract opportunity with the Department of Health and Human Services focuses on providing expert regulatory affairs consulting for prime contractors working on innovation projects for the NIH, CDC, and FDA. The selected provider will be responsible for developing regulatory strategies, creating compliance roadmaps, and preparing critical documentation, including 510(k) submissions, PMA applications, and Investigational Device Exemptions using specialized submission software. A deep expertise in FDA CFR is required to ensure all delivery packages meet strict federal standards. The contract is designated as a total small business set-aside under NAICS code 541611, specifically catering to firms with fewer than 500 employees in alignment with SBIR/STTR mandates. Interested parties must submit their responses by April 6, 2027, following the posting date of May 28, 2026.

Department of Health and Human Services

POSTED

DEADLINE

Intellectual Property (IP) Strategy ConsultingThis subcontract for Intellectual Property Strategy Consulting supports prime contractors receiving NIH SBIR/STTR grants through the Department of Health and Human Services. The selected provider must be a licensed Patent Attorney or IP Strategist capable of performing IP audits, developing protection strategies, and conducting patent landscape analyses. Key deliverables include the drafting and filing of patent applications, the execution of freedom-to-operate searches, and the comprehensive management of IP portfolios, culminating in a formal IP Strategy Report. The opportunity is designated as a Total Small Business Set-Aside under NAICS code 541110, requiring the contractor to have fewer than 500 employees. The solicitation was posted on May 28, 2026, with a response deadline of April 6, 2027.

Department of Health and Human Services

POSTED

DEADLINE

Regulatory Strategy and Submission ConsultingThis subcontract for Regulatory Strategy and Submission Consulting supports prime contractors receiving NIH SBIR/STTR grants by providing expert regulatory analysis and submission preparation. The scope of work includes developing regulatory strategies, managing clinical trial filings, and preparing 510(k) or PMA submissions to ensure full compliance with FDA and EMA standards. The selected provider must possess deep expertise in medical device and drug approval pathways to deliver a formal regulatory roadmap and completed submission packages. The opportunity is issued by the Department of Health and Human Services and is designated as a Total Small Business Set-Aside for firms with fewer than 500 employees. It falls under NAICS code 541611, with a response deadline of April 6, 2027.

Department of Health and Human Services

POSTED

DEADLINE

Independent R&D Replication/Confirmation ServicesThis subcontract opportunity with the Department of Health and Human Services involves providing independent R&D replication and confirmation services for prime contractors receiving NIH SBIR/STTR grants. The selected provider will be responsible for conducting independent replication studies and validation tests to confirm research findings and prove technical efficacy, ultimately delivering a formal Validation Report or Independent Study Results. The contract is a total small business set-aside under NAICS code 541715, requiring the provider to have fewer than 500 employees. Eligible candidates must possess CRO status or operate within CLIA/CAP accredited laboratory facilities. The solicitation was posted on May 28, 2026, with a response deadline of April 6, 2027.

Department of Health and Human Services

POSTED

DEADLINE

Market Research and Commercialization AnalysisThis subcontract opportunity with the Department of Health and Human Services focuses on providing third-party market analysis and commercialization strategies for prime contractors receiving NIH SBIR/STTR grants. The selected provider will be responsible for identifying target customers, analyzing competitive positioning, conducting customer interviews, and defining TAM, SAM, and SOM market sizes. The final deliverables include a comprehensive Market Research Report and a detailed Commercialization Plan. Eligible candidates must possess specialized experience in the biotech, med-tech, or healthcare sectors. This is a Total Small Business Set-Aside under NAICS code 541613, requiring the contractor to have fewer than 500 employees. The solicitation was posted on May 28, 2026, with a response deadline of April 6, 2027.

Department of Health and Human Services

POSTED

DEADLINE

Manufacturing Technical AssistanceThis subcontract for Manufacturing Technical Assistance, issued by the Department of Health and Human Services, provides engineering and operational expertise to help prime contractors transition prototypes into scalable commercial manufacturing for NIH SBIR/STTR grants. The scope of work includes designing manufacturing processes, identifying mass production vendors, optimizing Quality Management Systems, and developing scale-up protocols. The successful provider must possess GMP and industrial engineering expertise to deliver a comprehensive manufacturing plan and a validated production process. The opportunity is designated as a Total Small Business Set-Aside under NAICS code 541330, specifically targeting firms with fewer than 500 employees. It was posted on May 28, 2026, with a response deadline of April 6, 2027.

Department of Health and Human Services

POSTED

DEADLINE

NIH Small Business Technology Transfer Grant (Parent STTR [R41/R42] Clinical Trial Optional)

Solicitation # PA-27-102

The NIH Small Business Technology Transfer (STTR) grant, solicitation PA-27-102, provides early-stage funding to United States small business concerns (SBCs) to conduct research and development for commercial products in formal collaboration with non-profit research institutions. The program is designed to enhance health and reduce illness through a phased approach: Phase I focuses on establishing technical merit and feasibility, while Phase II advances the research toward commercialization. Eligible applicants include U.S.-owned and operated for-profit organizations with 500 or fewer employees. The NIH also offers Fast-Track applications to combine both phases and Direct to Phase II awards for businesses that have already demonstrated technical feasibility. Funding limits vary by the awarding NIH Institute or Center, with Phase I budgets typically ranging from 400,000 to 700,000 dollars and Phase II budgets reaching up to 3,000,000 dollars. Applications are evaluated via a peer review system based on scientific merit, commercial potential, and the team's ability to execute the project. While clinical trials are generally optional, they require a specific regulatory plan and adherence to strict safety and registration guidelines. Additionally, recipients must maintain active SAM and UEI registrations and comply with federal cybersecurity incident reporting requirements, including notifying the HHS of any breaches within 48 hours.

Department of Health and Human Services

POSTED

DEADLINE

NIH, CDC and FDA Small Business Innovation Research Grant (Parent SBIR [R43/R44] Clinical Trial Optional)

Solicitation # PA-27-100

The NIH, CDC, and FDA Small Business Innovation Research (SBIR) Grant, solicitation PA-27-100, provides early-stage funding to United States small business concerns (SBCs) to conduct research and development for commercial products. The program is structured in phases, with Phase I focusing on technical merit and feasibility and Phase II advancing the technology toward commercialization. Eligible applicants include for-profit U.S. businesses with no more than 500 employees. The funding opportunity accepts Phase I, Phase II, Direct to Phase II, and Fast-Track applications, with budget limits varying by participating institute, typically ranging from 400,000 to 700,000 dollars for Phase I and up to 3,000,000 dollars for Phase II. Applications are evaluated through a peer review system based on scientific and technical merit, significance, and the suitability of the business environment. While clinical trials are generally optional, they are prohibited for specific components, including all FDA participating components and several NIH institutes. Recipients must adhere to strict compliance requirements, including maintaining active SAM registration, disclosing foreign relationships, and implementing cybersecurity incident reporting procedures that notify agencies within 48 hours of discovery. The current solicitation remains open for applications until April 6, 2027.

Department of Health and Human Services

POSTED

DEADLINE

SBIR/STTR Commercialization Readiness Pilot (CRP) Program (Parent SB1 Clinical Trial Optional)

Solicitation # PAR-27-098

The SBIR/STTR Commercialization Readiness Pilot (CRP) Program, under solicitation PAR-27-098, is a funding opportunity provided by the National Institutes of Health (NIH) to help U.S.-based small business concerns transition technology from late-stage development to full commercialization. This program specifically targets recipients of prior active or ended NIH SBIR/STTR Phase II or Phase IIB Strategic Breakthrough awards. The CRP supports activities that bridge the gap to market, including late-stage research and development, independent replication of key studies, manufacturing scale-up, and technical assistance such as regulatory strategy, intellectual property planning, and market research. While significant outsourcing to contract research organizations is permitted, the small business must maintain a substantial role in project oversight and management. Eligible projects may have a maximum performance period of three years, with budget ceilings varying by the participating NIH Institute or Center, ranging from 500,000 dollars to 2 million dollars, or following SBA guidelines for certain institutes. Applications are evaluated via the NIH peer review system based on scientific and technical merit, commercial potential, and relevance to program priorities. Key requirements for applicants include maintaining active SAM and UEI registrations and submitting a detailed regulatory plan and progress report. It is important to note that while clinical trials are generally optional, several NIH components, including the NHLBI, NIAID, and NIDDK, do not accept clinical trials under this specific funding opportunity. Additionally, funds cannot be used for patent or FDA filing fees, nor can they include separate Technical and Business Assistance funding.

Department of Health and Human Services

POSTED

DEADLINE