FDA RFA-FD-26-012 | Digital Health Technologies for Drug Development Funding (U01)

Quick Answer:

FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are jointly funding a U01 Research Project Cooperative Agreement focused on using digital health technologies (DHTs) — actigraphy, photography, contactless sensors — for remote data acquisition in drug and biologic clinical trials. CDER intends to fund up to 2 awards, totaling $2.2 million in FY2026, with each award providing up to $1.1M/year across a 2-year project period. Unlike a standard SBIR, this is a cooperative agreement, meaning FDA scientific staff will be substantially involved in protocol review and study design throughout the project.

Applications are due August 20, 2026, by 11:59 PM local time.

What Does This Opportunity Fund?

Four illustrative (non-exclusive) project types:

• Comparing digital measurements to traditional clinical trial measurements

• Developing novel DHT-based endpoints for unmet drug development needs (e.g., contactless sensors detecting pediatric apnea)

• Comparing continuous measurement metrics (e.g., activity/stamina)

• Capturing early manifestations of chronic disease through DHTs (e.g., balance or reaction-time testing for early dementia signs)

What Makes This Different From a Standard NOFO?

• Cooperative agreement (not a grant) — FDA retains substantial programmatic involvement, including protocol review at milestones

• Clinical Trial Optional — applicants can propose a trial or non-trial project

• Applies to drugs/biologics only, not devices

• Research Strategy section capped at 12 pages (FDA does not follow standard NIH page limits)

How Is It Reviewed?

Standard FDA Objective Review Process, scored across five weighted criteria:

• Significance (20 pts)

• Investigator(s) (20 pts)

• Innovation (25 pts)

• Approach (25 pts)

• Environment (10 pts)

Who Is Eligible?

Broad eligibility — universities, nonprofits, small businesses, other for-profits, and eligible government entities. Foreign organizations and foreign components are not eligible. No cost-sharing required. Multiple applications allowed if scientifically distinct.

Key Dates

• Posted: July 20, 2026

• Open Date: July 20, 2026

• Application Due: August 20, 2026

• Expiration: August 21, 2026

How Can BW&CO Help?

This is a cooperative agreement, not a typical grant — framing the Research Strategy to anticipate FDA's ongoing programmatic involvement (not just initial review) is critical. Our approach helps clients position DHT-based endpoints and study designs that align with FDA's DHT Framework priorities from the outset.

DOE Genesis Mission | SBIR/STTR Phase I Funding Opportunity

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Quick Answer:

DOE's Office of Technology Commercialization, working through ConnectWerx, is opening the first Phase I SBIR/STTR opportunity under its new Genesis Mission umbrella. The opportunity targets four AI-driven topic areas: biotechnology, quantum computing, materials design, and autonomous laboratories. DOE intends to make approximately 40 awards totaling $10,000,000, representing up to $44,000,000 in cumulative funding across the projects' full lifecycles. Unlike a standard SBIR proposal, this program requires a short Pitch application first; only companies invited after Pitch review can submit a full application.

Pitch applications are due September 10, 2026, at 2:00 PM ET.

What Topics Does This Opportunity Cover?

Four topic areas are open under this Genesis Mission Phase I opportunity:

• Scaling the Biotechnology Revolution — AI tools for biomolecular design, genotype-phenotype relationships, predictive microbiome engineering, and accelerated bioreactor design and biomanufacturing.

• Realizing Quantum Systems for Discovery — AI for qubit decoherence characterization, quantum error correction, quantum processing unit control, resource estimation, and hybrid classical-quantum-AI workflow management.

• Designing Materials with Predictable Functionality — AI frameworks enabling inverse design, where materials are engineered from the start to meet specific property requirements.

• Achieving AI-Driven Autonomous Laboratories — AI integrated directly into experimental workflows, including advanced robotics, remote handling, diagnostics, and neuromorphic computing circuit primitives.

What Is the Pitch-First Process?

All applicants must first submit a short Pitch application before gaining access to the full application. Only Pitch applications selected in review are invited to submit a full proposal. The Pitch consists of four open-text questions, each with strict word-count limits, plus an optional bibliography. DOE recommends drafting responses outside the application portal before pasting them in.

How Is a Pitch Evaluated?

Pitch applications are scored across four equally weighted areas:

• Summary, Topic, and Mission Alignment — fit with the chosen topic and DOE's mission priorities.

• Technical Promise — significance of the problem, novelty of the approach, and feasibility within the proposed timeline and budget.

• Commercialization Potential — value proposition, competitive landscape, and go-to-market strategy including supply chain and sales channels.

• Team Qualifications — relevant company experience, strength of partnerships, and a credible plan for follow-on funding.

Beyond reviewer scores, the DOE Selection Official retains discretion to weigh additional program policy factors in final funding decisions.

[Complimentary Assessment]

What Is the Funding Amount and Timeline?

DOE intends to make approximately 40 awards from a combined $10,000,000 Phase I budget, representing up to $44,000,000 in potential cumulative funding across Phase I, Phase II, Phase II.2, and Strategic Breakthrough Awards over each project's lifecycle. Selection for award negotiations is not a funding commitment; DOE may cancel negotiations at any point before an award is issued. Later-phase awards depend on milestone performance and future funding availability.

What Is the Application Timeline?

• July 22, 2026 — Opportunity announced; Acquisition Management Portal (AMP) access requests open.

• Mid-August 2026 — AMP applications open; two virtual Office Hours sessions with DOE and ConnectWerx.

• September 10, 2026, 2:00 PM ET — Pitch application deadline. Late submissions are not accepted, though submitted Pitches can be updated up to the deadline.

How Do I Submit a Pitch?

Pitches are submitted through the Acquisition Management Portal (AMP). Applicants download the Pitch Development Guide, answer four questions within the specified word limits, optionally attach a bibliography, and submit through AMP. All files must be print-ready PDFs under 5MB, without passwords, and free of special characters in filenames.

Who Is Eligible?

Eligibility follows standard SBIR/STTR Phase I requirements. Applicants should confirm specific criteria on DOE's eligibility page before applying.

Key Dates

Pitch due date: September 10, 2026, 2:00 PM ET

Anticipated AMP access requests open: July 22, 2026

Office Hours sessions: Mid-August 2026

How Can BW&CO Help With a Genesis Mission Pitch?

This will be a competitive opportunity. Our “Back Door” approach will help you understand what DOE is really looking for and how to frame your project to give you a competitive edge.

Contact BW&CO Consulting to discuss DOE Genesis Mission SBIR/STTR Phase I eligibility and Pitch strategy.

NASA ROSES | C.4 Planetary Science Enabling Facilities

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Quick Answer:

NASA's Planetary Science Enabling Facilities (PSEF) program element, amended July 21, 2026, funds experimental and analytical research facilities that support the planetary science community. This is a new addition to ROSES-2025, previously listed as not solicited for the year. Proposals are due November 10, 2026, and unlike prior PSEF cycles, no Step-1 submission or Notice of Intent is required this year. Proposals will be evaluated for the first time under NASA's dual-anonymous peer review process. The program expects to fund about 2 to 8 new awards from an annual budget of roughly 5 million dollars, with awards running up to 4 years.

What Is a Planetary Science Enabling Facility?

NASA defines a Planetary Science Enabling Facility as a combination of equipment, instrumentation, infrastructure, and staff, typically supporting complex or challenging experiments or measurements, that is not otherwise widely available to the research community. Facilities must enable or enhance research funded under Solar System Science, Interdisciplinary Consortia for Astrobiology Research, the Exoplanets Research Program, or the Planetary Science Internal Scientist Funding Model.

What Types of Facilities Can Be Proposed?

Eligible facilities must be dedicated to one or more of four activities: characterization of chemical, isotopic, or physical properties of materials; experimentation on materials under defined environmental conditions; synthesis of new materials under defined conditions; or sample preparation, which must also pair with one of the other three activities. Proposed activities can include acquiring instruments or equipment, supporting technicians and operational personnel, developing new laboratory instruments or analytical methods and standards, and supporting instrument maintenance.

What Is Excluded From This Program?

PSEF does not fund scientific research itself, reference dataset acquisition, development of new flight instruments, facilities primarily supporting mission development rather than fundamental research, computing facilities, astronomical or observing facilities, data archiving facilities, laboratory construction and outfitting, or sample curation and repository facilities.

What Priorities Does NASA Emphasize This Year?

Three priority areas are specifically emphasized for ROSES-2025: facilities enhancing lunar science in the Artemis era, with particular encouragement for proposals pushing technology limits such as quantum sensors, artificial intelligence, integrated systems, parallel sensing, robotics and automation, and cold or cryogenic analysis capabilities; facilities enhancing Mars science aligned with Mars Exploration Program Analysis Group goals; and facilities enhancing astrobiology and planetary protection research, including bioburden detection, terrestrial microbe classification, and contaminant transport studies.

Who Is Eligible?

Proposals are welcomed from all research institutions, including emerging research institutions, institutions that have rarely or never received Planetary Science Division funding, and Primarily Undergraduate Institutions and Community Colleges. Institution type may be considered as a programmatic factor in selection. Institutions may participate as proposing organizations, sub-awardees, or unfunded partners.

How Are Proposals Structured and Formatted?

This year's PSEF uses a single-step submission process with one deadline, replacing the two-step process used in PSEF22 and PSEF24. The anonymized Science/Technical/Management section is capped at 13 pages total, made up of Technical Capabilities (up to 12 pages), Anticipated Userbase (up to 1 page), and an optional Facility-Relevant Training Opportunities section (up to 2 pages). Proposals requesting equipment or instrumentation over 50,000 dollars must include a descope plan showing how the facility would operate without that equipment if it is not funded. An anonymized Open Science and Data Management Plan of up to 2 pages and an anonymized Table of Work Effort are also required, followed by references with no page limit.

What Goes in the Non-Anonymized Expertise and Resources Document?

A separate Expertise and Resources document includes a Facility Management Plan of up to 2 pages covering user access priority, access procedures, costs, and safety practices; a non-anonymized Table of Personnel and Work Effort; Biographical Sketches and Current and Pending Support in SciENcv format for all PIs and Co-Is spending 10 percent or more time on the project; facilities and equipment descriptions; and, if applicable, a High-End Computing request.

Is Research Security Training Required?

Yes. Any PI or Co-I dedicating 10 percent or more time to a proposed award must certify completion of research security training, satisfied by either the four NSF Research Security Training modules or the SECURE Center's condensed equivalent, effective August 5, 2026.

How Are Proposals Evaluated?

NASA evaluates PSEF proposals on three criteria: scientific and technical merit of the proposed facility, including the Open Science and Data Management Plan, appropriateness of equipment and staff, facility uniqueness, and expected volume of use; relevance to Planetary Science Division research priorities; and cost reasonableness, covering both proposed work effort and other direct costs such as supplies, equipment, travel, and anticipated tariff costs. The Facility Management Plan is also assessed for whether it ensures adequate community access and sound user request procedures. Cost sharing is not required or scored but may be a tiebreaker between proposals of otherwise equal merit.

What Is the Funding Amount and Timeline?

NASA expects to fund approximately 2 to 8 new awards from an annual budget of about 5 million dollars. There is no explicit cap on individual award size. Awards run up to 4 years, with funding expected to begin about 9 months after the proposal due date.

How Do I Submit a Proposal?

Proposals are submitted electronically through NSPIRES at nspires.nasaprs.com. No hard copies are accepted. Applicants who need to submit through Grants.gov must request access at least 30 days before the due date from the point of contact below, copying sara@nasa.gov. The Grants.gov funding opportunity number is NNH25ZDA001N-PSEF.

Key Dates

Proposal due date: November 10, 2026 No Step-1 or Notice of Intent required this year Anticipated funding start: approximately 9 months after the proposal due date

Program Contact

Michael Lienhard Email: HQ-PSEF@mail.nasa.gov

How Can BW&CO Help With a PSEF Proposal?

BW&CO Consulting helps research teams position competitive facility proposals for ROSES, including dual-anonymous peer review compliance, facility scope and userbase justification, cost reasonableness narrative, and NSPIRES submission logistics, so applicants can meet the November 10, 2026 deadline with a complete, evaluation-ready package.

Contact BW&CO Consulting to discuss NASA ROSES C.4 Planetary Science Enabling Facilities eligibility and proposal strategy.

NASA ROSES A.14: Atmosphere Research Program

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Quick Answer:

NASA's Atmosphere program element (A.14) is a new addition to ROSES-2025, amended July 20, 2026, that funds data analysis and modeling of NASA-supported airborne campaign data to advance understanding of atmospheric composition, air quality, and weather dynamics. Proposals must use NASA airborne campaign data as a required foundation, with satellite and ground-based data allowed only as a complement, not a substitute. A mandatory Notice of Intent is due August 20, 2026, and full proposals are due October 20, 2026. Proposals not preceded by an on-time NOI will be declined without review.

Program Background

In late 2025, NASA's Earth System Science Research Program replaced its prior six Focus Areas with six new Earth science research spheres: Atmosphere, Biosphere, Cryosphere, Geosphere, Hydrosphere, and Enabling Capabilities. NASA now plans to issue an annual ROSES funding opportunity for each sphere, with specific themes changing year to year. The Atmosphere sphere absorbed several prior programs, including the Upper Atmosphere Research Program, Tropospheric Composition Program, Radiation Science Program, Atmospheric Composition Modeling and Analysis Program, and elements of the former Weather and Atmospheric Dynamics Focus Area.

What Science Questions Does This Program Address?

The Atmosphere program funds research that improves process-level understanding of phenomena not yet sufficiently observed or modeled, organized around four questions: how atmospheric composition is changing, how composition and solar radiation influence the Earth system, how composition and Earth system changes affect air quality, and how dynamic and thermodynamic structures tied to weather events evolve across spatial and temporal scales. Relevant science includes stratospheric ozone recovery and UV radiation impacts, tropospheric ozone and trace gas evolution, aerosol and cloud lifecycle effects on the radiation budget, and atmospheric dynamics tied to air quality.

What Data Must Proposals Use?

Use of NASA-supported sub-orbital (airborne) campaign data is mandatory. Proposals relying primarily on space-based remote sensing without airborne campaign data will be deemed unresponsive and returned without review. Preference goes to proposals that also pair airborne data with satellite remote sensing, ground-based observations, or modeling, and to proposals that draw on multiple field campaigns together. Illustrative airborne campaigns include ACCLIP, ACTIVATE, AEROMMA/STAQS, APMAC, ARCSIX, ASIA-AQ, ATom, CAMP2Ex, CPEX-AW, CPEX-CV, DCOTTS, IMPACTS, MAGEQ, MOOSE, PACE-PAX, SCOAPE, TRACER-AQ, and WHy2MSIE/APEX. Proposals tied to future campaigns such as NURTURE or EVS-4, or focused primarily on algorithm and model development without campaign data, are not solicited and will be returned without review.

What Are the Five Sub-Elements?

Proposers must select one primary sub-element for review panel assignment: Aerosols, Clouds, and Radiative Forcing; Tropospheric Composition and Dynamics; Upper Tropospheric and Stratospheric Composition and Dynamics; Atmospheric Physics, which is narrowed specifically to studies using NASA remote sensing assets targeting the planetary boundary layer; and Cross-Cutting Research, for proposals spanning multiple Atmosphere sub-elements or reaching into other Earth science spheres, provided atmospheric science remains the main focus.

Who Is Eligible?

The program follows standard ROSES eligibility. NASA center researchers already funded through the Internal Scientist Funding Model for matching work should not submit a proposal for that same activity, though they may participate as unfunded collaborators with program scientist approval. Federal agencies other than NASA cannot receive funding through this element but may participate as unfunded collaborators. Non-U.S. organizations may participate on a no-exchange-of-funds basis, with their portion of work funded through other sources.

What Are the Proposal Format Requirements?

The Science/Technical/Management section is limited to 10 pages. The anonymized technical proposal includes the S/T/M section, an anonymized Table of Work Effort, and references, all prepared for dual-anonymous peer review with numerical in-text reference callouts. A separate, non-anonymized Expertise and Resources document contains personnel details, biographical sketches and Current and Pending Support in SciENcv format, letters of support, facilities and equipment descriptions, and the Open Science and Data Management Plan, capped at two pages. A separately uploaded, unredacted Total Budget file is also required, along with an optional High-End Computing request.

What Is Dual-Anonymous Peer Review?

All proposals go through NASA's dual-anonymous peer review process, meaning proposers do not know reviewer identities and reviewers do not know proposer identities during evaluation. Proposals that violate anonymization or formatting rules may have material redacted or be returned without review; violations discovered later can result in a proposal being declined after review.

Is Research Security Training Required?

Effective August 5, 2026, any PI or Co-I dedicating 10 percent or more time to a proposed award must certify completion of research security training, satisfied by either the four NSF Research Security Training modules or the SECURE Center's condensed equivalent.

How Are Proposals Evaluated?

NASA divides the expected annual budget across the five sub-element panels before review begins, so proposals in different sub-elements do not compete against each other for the same funds. Each proposal is independently scored by three reviewers before the panel meeting, and proposals scoring below a general adjectival rating of Good may be triaged and not discussed in the full panel session, though written summaries are still prepared.

What Is the Funding Amount and Timeline?

NASA expects to fund approximately 30 to 50 new awards from an annual budget of about 8 million dollars, split across the five sub-elements after proposals are submitted. Awards run up to 3 years, with an anticipated investigation start about 6 months after the proposal due date.

How Do I Submit a Proposal?

Proposals are submitted electronically through NSPIRES at nspires.nasaprs.com. No hard copies are accepted. Applicants who need to submit through Grants.gov must request access at least 30 days before the due date from the points of contact listed in the solicitation, copying sara@nasa.gov. The Grants.gov funding opportunity number is NNH25ZDA001N-ATMOS.

Key Dates

Mandatory Notice of Intent: August 20, 2026 Proposal due date: October 20, 2026 Anticipated investigation start: approximately 6 months after the proposal due date

Program Contacts

Ken Jucks, Sphere Lead, kenneth.w.jucks@nasa.gov Emma Knowland, k.e.knowland@nasa.gov Will McCarty, will.mccarty@nasa.gov Ed Nowottnick, edward.p.nowottnick@nasa.gov John Sullivan, john.t.sullivan@nasa.gov

How Can BW&CO Help With an Atmosphere Proposal?

BW&CO Consulting helps research teams position competitive ROSES proposals, including anonymization compliance for dual-anonymous peer review, sub-element selection strategy, technical narrative development, and NSPIRES submission logistics, so applicants can meet the August 20, 2026 NOI deadline and October 20, 2026 proposal deadline with a complete, evaluation-ready package.

Contact BW&CO Consulting to discuss NASA ROSES A.14 Atmosphere eligibility and proposal strategy.

NASA SBIR/STTR Civilian Commercialization Readiness Pilot Program (CCRPP), Program Year 2026

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The NASA Civilian Commercialization Readiness Pilot Program (CCRPP) is a post-Phase II opportunity that matches private or non-SBIR government investment with additional SBIR/STTR program funds to accelerate a technology's transition to commercial or mission use. Eligible small businesses must have a completed, ongoing, or sequential NASA SBIR/STTR Phase II award and must secure an external investor willing to co-fund the maturation effort. NASA matches investor funds dollar-for-dollar, up to $2.5 million in SBIR/STTR funds against $2.5 million in outside investment, for a total award of up to $5 million.

Applications close August 19, 2026 at 5:00 PM ET.

This is a matching-funds pilot program requiring a secured external investor, a Letter of Commitment, and a 30-page technical application submitted through ProSAMS.

How much funding would I receive?

NASA matches SBIR/STTR program funds between $500,000 and $2.5 million per award, matched 1:1 by external investment, for a combined award of up to $5 million.

Eligibility Pathways (must meet one):

A completed NASA SBIR/STTR Phase II award (issued from NASA solicitations in approximately the last 10 years) with the Phase II period of performance complete by August 19, 2026

NASA SBIR/STTR Phase II-E options resulting from Phase I awards starting in Program Year 2014 or later, regardless of when their period of performance ends

An ongoing or completed NASA SBIR/STTR Phase II Sequential award

Investor Requirement:

Must secure one or more investors external to the SBIR/STTR program (a company, VC firm, individual investor, or non-SBIR government program)

Owners, family members, and affiliates of the small business do not qualify as external investors

A signed Letter of Commitment from each investor is required at application, with matching funds transferred within 45 calendar days of selection notification

Other Key Requirements:

Small business must have 500 or fewer employees, combined with affiliates

Businesses majority-owned by multiple VC firms, hedge funds, or private equity firms are not eligible

Principal Investigator must be primarily employed by the small business; co-PIs are not allowed

NAICS code must be 541713 or 541715 at time of award

Active SAM.gov registration required at submission and award

Are there any additional benefits I would receive? Yes, non-dilutive and strategic benefits include:

Equity-free matching funds to accelerate commercialization beyond Phase II

Access to NASA's Technology Available (TAV) patent and software portfolio for use in the project

Optional participation in the NSF I-Corps™ program, with up to $30,000 in additional support

External validation of commercial potential through a qualified third-party investor

What is the timeline to apply and when would I receive funding? Application deadline: August 19, 2026 at 5:00 PM ET, submitted via ProSAMS

Anticipated period of performance: 24 months (may not exceed 30 months)

Investor funds must be transferred within 45 calendar days of selection notification; NASA does not accept investments obligated more than 60 days (non-government) or 90 days (federal/state government) prior to selection notification

No formal timeline for award and disbursement is specified in the solicitation beyond the negotiation process following selection

Where does this funding come from?

NASA SBIR/STTR Program, matched with funds from an external, non-SBIR/STTR investor

Applications processed by the NASA SBIR/STTR Program Management Office (NASA Ames) with contracting through the NASA Shared Services Center (NSSC)

Who is eligible to apply?

U.S.-based small business concerns with a qualifying NASA Phase II history, as described above

Must register with the SBA Company Registry and SAM.gov, and submit via ProSAMS at https://prosams.nasa.gov/

What companies and projects are likely to win?

Applications are evaluated across four factors:

Scientific/Technical Merit and Feasibility — originality and feasibility of the proposed R&D, plus a review of prior Phase II results and objectives met

Experience, Qualifications, and Facilities — technical capability of the PI, key personnel, and any subcontractors, plus adequacy of instrumentation and facilities

Effectiveness of the Proposed Work Plan — comprehensiveness of the maturation strategy, schedule, resource allocation, and path beyond CCRPP toward NASA mission infusion

Commercial Potential and Feasibility — market segmentation, competitive landscape, commercialization plan, IP protection strategy, and prior commercialization track record

Are there any restrictions I should know about?

CCRPP funds may only be used to build on the firm's Phase II work; duplicative or unrelated effort is not eligible

Firms may not have already received a CCRPP or equivalent award (e.g., Commercialization Readiness Program) for the same Phase II technology

Subcontracting, including consultants, may not exceed 50 percent of the research effort

Technical application is capped at 30 pages, 1-inch margins, 10-point type minimum

How long will it take me to prepare an application?

The application requires a 30-page technical application (Customer Objectives, Additional Commercialization Information, and Implementation Approach), a detailed budget covering both SBIR/STTR and investor funds, a Briefing Chart, and a signed Letter of Commitment from each investor. Firms without an already-committed investor should expect the investor search and commitment process to be the longest lead item.

How can BW&CO help?

BW&CO can support:

Identifying and vetting appropriate external investors and structuring compliant Letters of Commitment

Translating your Phase II results into a Commercialization Plan aligned to the four-factor evaluation rubric

Building a credible budget and maturation schedule that satisfies NASA's matching-fund timing rules

Positioning past performance and IP strategy for NASA evaluators

Review solicitation here.

NIH Highlighted Topic: Advancing Nutrition Research to Inform Regulatory Practice

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on advancing gold standard nutrition and food science to inform regulatory practice, with participation from experts spanning nutrition, toxicology, risk analysis, behavioral science, infant and child development, and chronic disease research. This highlighted topic aims to address rising diet-related chronic disease rates through a cross-governmental research agenda co-developed by NIH and FDA to safeguard the health of all Americans.

Priority research spans three major areas: ultra-processed foods, early life nutrition and feeding practices, and nutrition-related toxicology. NIH is particularly interested in identifying which characteristics of highly processed foods, such as specific additives, processing steps, or food matrix alterations, are most predictive of adverse health outcomes, and whether objective biomarkers of exposure to these foods exist. On early life nutrition, NIH highlights the need to understand physiological differences between formula-fed and breastfed infants, the role of Human Milk Oligosaccharides in immune and neurocognitive development, and variability in human milk composition across lactation phases.

Areas of interest include mechanisms linking ultra-processed food consumption to metabolic health and satiety hormone regulation, standardized approaches for evaluating bioactive infant formula ingredient safety, exposure of infants and young children to heavy metals and contaminants in the food supply, moderating effects of nutrients on heavy metal toxicity in child health, relationships between infant feeding practices and oral health outcomes including dental caries, and identification of environmental contaminants such as PFAS and microplastics introduced during food growing, processing, and packaging.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported primarily by the Office of Nutrition Research (ONR), with additional participation from the National Cancer Institute (NCI), National Institute on Aging (NIA), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Environmental Health Sciences (NIEHS), National Institute of Nursing Research (NINR), Office of Behavioral and Social Sciences Research (OBSSR), Office of Disease Prevention (ODP), Office of Dietary Supplements (ODS), Office of Data Science Strategy (ODSS), and Office of Research on Women's Health (ORWH), all of which are seeking rigorous nutrition science to inform food and regulatory policy.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Accelerating Otitis Media Research and Workforce Development

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research and workforce development focused on accelerating basic, clinical, and translational research into otitis media (OM), one of the most common childhood illnesses and a leading cause of pediatric antibiotic prescriptions. This highlighted topic aims to build research capacity by cultivating the next generation of OM investigators alongside advancing the science itself.

More than 80% of children experience at least one episode of OM by age three, and NIH notes that recurrent or chronic disease can substantially affect development, including prolonged conductive hearing loss and delays in speech, language, and learning, with annual U.S. healthcare costs estimated at over $4.5 billion. Current prevention relies primarily on the pneumococcal conjugate vaccine, which has had only modest effects due to pathogen replacement, and NIH notes that the factors distinguishing OM-susceptible from OM-resistant children remain poorly understood. NIH is particularly interested in expanding treatment options beyond antibiotics and pressure equalization tubes.

Areas of interest include mentored research training experiences for pre- and post-doctoral trainees focused on OM, support for early-stage researchers building OM research programs, and opportunities for investigators at any career stage to redirect existing expertise in biofilm, metabolomics, genomics, pathogenesis, immunity, pharmacology, infectious disease, epidemiology, or bioinformatics toward OM-specific questions. Scientific topics of interest span the epidemiology, etiology, pathophysiology, diagnosis, prevention, and treatment of OM.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures. Given the explicit workforce/training framing, this topic is also a strong fit for fellowship (F-series), career development (K-series), and training grant (T-series) mechanisms alongside standard R-series awards.

This highlighted topic is supported by the National Institute on Deafness and Other Communication Disorders (NIDCD), with additional participation from the National Institute of Allergy and Infectious Diseases (NIAID), both of which are seeking to expand research capacity and innovation in understanding and treating this high-burden childhood illness.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Strengthening Biomedical Research, Promoting Trust, and Improving Health through Bioethics Research

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on integrating bioethics principles across the full spectrum of biomedical and behavioral research, from fundamental science through clinical research and dissemination of findings. This highlighted topic aims to advance actionable bioethics projects that build public trust, promote participant autonomy, and sustain community engagement in science.

NIH notes that integrating bioethics considerations strengthens research rigor and impact, helping ensure that evidence-based products are more readily adopted by the communities they serve. NIH is particularly interested in projects spanning artificial intelligence ethics and transparency, effective community engagement and co-development of research priorities, informed consent strategies for emerging data sources like wearables and electronic health records, approaches for returning aggregate and individual research results, and cross-cutting issues in data sharing and biosecurity.

Areas of interest include ethical implications of broad access to emerging neurotechnologies and invasive neural techniques, ethical, legal, and social implications of genomics across research design and healthcare delivery, bioethical aspects of gene editing and organ transplant shortages for heart and lung conditions, informed consent approaches tailored to older adults with cognitive or sensory limitations, stigma's impact on clinical trial recruitment for alcohol use disorder, community acceptance of controlled human infection trials and genome editing for infectious disease research, ethical frameworks for biomedical technology development including AI/ML and point-of-care devices, and neuroethical issues around brain organoid research, neuroimaging, and populations with limited consent capacity.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported by an exceptionally broad coalition of ICOs and initiatives, including the Office of Science Policy (OSP), the BRAIN Initiative, National Cancer Institute (NCI), National Eye Institute (NEI), National Human Genome Research Institute (NHGRI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institute on Drug Abuse (NIDA), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR), Office of AIDS Research (OAR), Office of Behavioral and Social Sciences Research (OBSSR), and Office of Data Science Strategy (ODSS), reflecting how foundational bioethics considerations have become across virtually every domain of NIH-supported research.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Advancing Autoimmune Disease Research: Integrating Genetic, Environmental, and Immunological Factors to Improve Diagnosis and Treatment

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on integrating genetic, environmental, and immunological factors to advance understanding of autoimmune disease development, progression, and treatment. This highlighted topic aims to improve diagnosis and health outcomes for the 23.5-50 million Americans affected by more than 140 different autoimmune diseases and conditions.

A common feature of many autoimmune diseases is an asymptomatic prodromal period marked by autoantibodies and immune activation markers, and NIH notes that people with one autoimmune disease face elevated likelihood of developing additional ones, suggesting shared pathogenic mechanisms and risk factors. While genetics contributes to susceptibility, it cannot explain the rapidly rising incidence and prevalence of autoimmune diseases, pointing to the exposome as a critical but understudied factor complicated by exposure latency and life-stage-dependent effects. NIH is particularly interested in projects that integrate exposome research into longitudinal studies spanning the pre-clinical period through disease course, and that develop New Approach Methodologies exploring shared mechanisms across co-occurring autoimmune disorders.

Areas of interest include studying immune surveillance breakdown at the cancer-autoimmunity intersection and immune-related adverse events from cancer immunotherapy, advancing diagnosis and treatment of ocular autoimmune diseases like uveitis and Sjogren's syndrome, developing generalizable genomic and computational methods applicable across multiple autoimmune diseases, investigating immunosenescence and autoimmune disease's impact on brain aging and Alzheimer's risk, understanding autoimmune inner ear disease and sudden hearing loss, characterizing autoimmune manifestations in oral and craniofacial tissues, examining links between autoantibodies and pediatric neuropsychiatric syndromes like PANDAS/PANS, addressing health disparities in autoimmune disease incidence across U.S. regions and populations, and developing point-of-care technologies, wearables, and imaging tools for autoimmune disease monitoring.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported by an exceptionally broad coalition of ICOs, including the Office of Research on Women's Health (ORWH)/Office of Autoimmune Disease Research, National Cancer Institute (NCI), National Eye Institute (NEI), National Human Genome Research Institute (NHGRI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Biomedical Imaging and Bioengineering (NIBIB), NICHD, National Institute on Deafness and Other Communication Disorders (NIDCD), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Environmental Health Sciences (NIEHS), National Institute of Mental Health (NIMH), National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR), and National Library of Medicine (NLM), reflecting how autoimmune disease intersects with nearly every organ system and NIH mission area.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Training and Career Development in Dissemination and Implementation Science

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research training focused on dissemination and implementation (D&I) science to build capacity for translating evidence-based innovations into clinical practice and everyday life. This highlighted topic aims to advance career development through Fellowships, Career Development Awards, Institutional Research Training Grants, and Education Projects that build expertise in D&I theories, strategies, outcome measurement, and analytical methods.

D&I research remains an emerging area across many health specialties, and NIH notes that fields need to build capacity for high-quality research examining how evidence-based practices, programs, and policies get adopted, distributed, and sustained in real-world settings. NIH is particularly interested in training that spans D&I theories and frameworks, community-engaged research approaches, qualitative and mixed methods, human-centered design, pragmatic and hybrid effectiveness-implementation trial designs, and methods to understand and reduce health disparities.

Areas of interest include building D&I expertise in sensory and communication disorder research where theory-guided studies remain scarce, training scientists to integrate complementary and integrative health approaches into real-world care settings, advancing mechanistic D&I methods across the cancer care continuum, preparing genomic medicine researchers for evidence-based information dissemination, developing implementation science expertise for heart, lung, blood, and sleep disorder interventions, building dual expertise in substance use and implementation science, training in D&I methods for pediatric, reproductive health, and disability populations, and developing HIV-focused implementation science training emphasizing mentorship and community engagement.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures. Given the training/career-development framing, this topic is also a strong fit for institutional training grant (T-series) and individual fellowship (F-series) mechanisms specifically, alongside R-series awards.

This highlighted topic is supported by an unusually broad coalition of ICOs, including the National Institute on Deafness and Other Communication Disorders (NIDCD), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), National Human Genome Research Institute (NHGRI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NICHD, National Institute on Drug Abuse (NIDA), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Mental Health (NIMH), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR), Office of AIDS Research (OAR), Office of Behavioral and Social Sciences Research (OBSSR), and Office of Disease Prevention (ODP), reflecting the widespread recognition across NIH that D&I science training capacity needs strengthening.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Biology- and Physics-Informed Explainable AI Across the Lifespan

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on applying explainable artificial intelligence (XAI) that is mechanistically grounded in physics-based or biology-based principles across the lifespan. This highlighted topic aims to advance interpretable AI approaches that enhance understanding of biological and health-related mechanisms, heterogeneity, and temporal dynamics, while supporting robust prediction of health and disease risks across the life course.

While AI and machine learning have demonstrated utility in predicting health-related outcomes, NIH notes that many existing approaches function as black boxes, limiting mechanistic insight, biological interpretability, and translational relevance. NIH is particularly interested in projects that move beyond purely statistical prediction to incorporate mechanistic constraints, causal or dynamical systems models, domain-informed priors, or hybrid models integrating data-driven learning with first-principles knowledge, ensuring reproducibility and enabling hypothesis generation.

Areas of interest include XAI approaches that model within-person aging dynamics and identify critical transitions or inflection points tied to underlying mechanisms, methods characterizing inter-individual variability and aging subtypes with interpretable explanations of resilience and vulnerability, interpretable models that predict future health and functional decline while enabling retrospective interpretation of prior exposures, and explainable integration of molecular, cellular, physiological, behavioral, environmental, and clinical data across time.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported primarily by the National Institute on Aging (NIA), which is seeking mechanistically grounded, interpretable AI research that advances understanding of aging trajectories and health dynamics across the lifespan.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Epidemiological Studies of Vaccination and Health Outcomes Across the Lifespan

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on comprehensively evaluating the relationships between vaccination and both positive and negative long-term health outcomes across the lifespan. This highlighted topic aims to advance large-scale epidemiological studies that move beyond the short-term outcomes examined in most prior adverse event research, using newer data sources and more robust study designs.

NIH notes that prior reports, including the 2013 Institute of Medicine report on the childhood immunization schedule and CDC's Vaccine Safety Datalink white paper, have identified a need to evaluate various aspects of vaccination schedules, including limited ability to compare schedule variations and insufficient integration of clinical outcomes with biological and environmental data. This topic is issued as part of the Make America Healthy Again initiative, aligning with HHS's new vaccine injury research program at the NIH Clinical Center. NIH is particularly interested in projects that combine real-world data, large-scale longitudinal cohorts, and biomarker identification to support causal inference and precision vaccination strategies for vulnerable subpopulations, with careful attention to confounding bias and multiple comparisons.

Areas of interest include leveraging large-scale longitudinal cohorts and real-world data to assess rare or delayed vaccine-associated events, evaluating vaccine schedules, components, platforms, and timing including cumulative and interacting exposures, identifying biomarkers and immune signatures underlying heterogeneous long-term responses, integrating multi-omics and systems biology data to understand vaccines' effects on the immune system over time, and studying interactions between vaccine exposures and environmental factors such as air pollutants, endocrine-disrupting chemicals, and microplastics.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported primarily by the National Institute of Allergy and Infectious Diseases (NIAID), with additional participation from the National Institute of Environmental Health Sciences (NIEHS) and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), all of which are seeking rigorous, data-driven epidemiological research into vaccine benefits and potential adverse outcomes.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Using Clinical Studies and Human-Based Models to Understand Vaccine Mechanisms Impacting Efficacy and Safety

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on using clinical studies and human-based models to understand the biological mechanisms underlying vaccine efficacy, safety, non-target effects, and susceptibility to adverse events. This highlighted topic aims to advance New Approach Methodologies (NAMs), including human cell-based systems, organoids, microphysiological systems, and computational models, to move beyond descriptive associations toward causal, mechanistic understanding of vaccine responses.

Traditional animal models are limited in capturing human-specific pathways, susceptibility factors, and long-term health effects, and NIH notes that existing post-market surveillance systems generally capture disease outcomes without exploring the biomarkers that could illuminate mechanistic pathways. This topic is issued as part of the Make America Healthy Again initiative, aligning with NIH's expanded commitment to NAMs alongside the EPA and FDA, and with HHS's new vaccine injury research program at the NIH Clinical Center. NIH is particularly interested in projects that identify susceptibility factors such as genetic background, sex, and developmental stage, and that integrate NAMs with clinical and epidemiological data.

Areas of interest include validation and regulatory alignment of NAM approaches, elucidating immune activation pathways and reactogenicity mechanisms, modeling neuroimmune and neurodevelopmental effects, characterizing maternal-fetal and early-life immune interfaces, evaluating cumulative and schedule-related vaccine effects, distinguishing protective from atypical or exaggerated immune responses linked to adverse outcomes, and studying interactions between vaccine mechanisms and environmental exposures such as air pollutants, endocrine-disrupting chemicals, and microplastics.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported primarily by the National Institute of Allergy and Infectious Diseases (NIAID), with additional participation from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Environmental Health Sciences (NIEHS), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), all of which are seeking mechanistic, human-relevant research into vaccine safety and efficacy.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Food Is Medicine

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on rigorously evaluating Food is Medicine (FIM) approaches to prevent and address diet-related chronic diseases and associated health disparities across the lifespan, including cardiovascular disease, diabetes, obesity, certain cancers, and mental health disorders. This highlighted topic aims to advance the evidence base for FIM interventions through high-quality research measuring clinical and health outcomes within well-designed programs.

FIM approaches are expanding across the U.S. and show promise for improving diet quality and food security, but NIH notes their impact on clinical and health outcomes remains limited due to inconsistent results or insufficient magnitude. This topic is issued as part of the Make America Healthy Again initiative, aligning with NIH's Chronic Disease Initiative, Real World Data Platform, Food for Health collaboration with the VA and USDA, and expanded precision nutrition research. NIH is particularly interested in projects that assess economic impact and cost-effectiveness of FIM programs, validate biomarkers of dietary response, and develop training programs in culinary medicine for healthcare professionals.

Areas of interest include clinical trials combining FIM with other multi-domain interventions to address diet-related chronic disease, precision nutrition interventions to mitigate cancer treatment-related toxicities like malnutrition and sarcopenia, testing FIM effectiveness for hypertension, heart failure, and respiratory disease management, examining food's role in managing rheumatic, musculoskeletal, and skin conditions, incorporating FIM into oral health treatment strategies and early childhood dental caries prevention, mechanistic trials linking FIM interventions to psychiatric symptom domains, adapting and scaling FIM programs for populations experiencing health disparities, and testing dietary interventions for autoimmune disease onset, progression, and symptom management.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported by an unusually broad coalition of ICOs, including the Office of Nutrition Research (ONR), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Mental Health (NIMH), National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Nursing Research (NINR), Office of AIDS Research (OAR), Office of Behavioral and Social Sciences Research (OBSSR), Office of Disease Prevention (ODP), and Office of Research on Women's Health (ORWH), reflecting how central Food is Medicine has become to NIH's chronic disease prevention strategy under the MAHA initiative.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Oral Health and Aging

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on the relationship between oral health and aging-related systemic and chronic disease. This highlighted topic aims to advance understanding of how oral diseases, which increase in frequency and severity with age, connect to cardiovascular, metabolic, respiratory, musculoskeletal, and neurological conditions across the lifespan.

The oral cavity serves as a key interface between the external environment and the body, and NIH notes that oral bacteria and their byproducts can enter circulation during routine activities, potentially reaching distant organs and tissues. Chronic oral inflammation, microbial translocation, and host immune responses have been proposed as pathways influencing systemic inflammation and cellular aging, though causal relationships remain incompletely understood. NIH is particularly interested in projects that integrate oral health measures into aging and chronic disease research, address gaps in longitudinal data, and develop harmonized oral health assessments across studies.

Areas of interest include epidemiological and mechanistic research linking oral health to cognitive decline and Alzheimer's disease/related dementias, studying the oral microbiome's role in cancer risk and periodontal disease's connection to cancer outcomes, examining oral disease as a driver of autoimmunity and immune-mediated conditions following organ transplantation, investigating causal links between oral health and arthritis, musculoskeletal, and skin diseases, characterizing age-associated changes in oral microbiome homeostasis and dental implant outcomes among elderly populations with polypharmacy and dry mouth, and evaluating interventions to improve screening and prevention of dental caries, periodontal disease, and tooth loss across the lifespan.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported primarily by the National Institute on Aging (NIA), with additional participation from the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Dental and Craniofacial Research (NIDCR), Office of Behavioral and Social Sciences Research (OBSSR), and Office of Disease Prevention (ODP), all of which are seeking research connecting oral health to systemic aging-related disease outcomes.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Implementation Science to Optimize HIV Prevention and Treatment

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on implementation strategies to deliver biomedical HIV prevention and treatment options toward ending the HIV epidemic. This highlighted topic aims to advance the uptake and adoption of long-acting therapeutic options, behavioral interventions for viral suppression, and practices that integrate and sustain evidence-based HIV prevention and care across diverse settings.

Effective HIV prevention and treatment tools already exist, but NIH notes that uptake and adoption remain suboptimal, widening the gap between those who benefit from scientific advances and those who don't. NIH is particularly interested in projects that address provider, clinic, and systems-level barriers to adoption, document implementation costs in comparative trials, and engage meaningful partnerships with communities, public health providers, and people living with or impacted by HIV from idea generation through dissemination. As people with HIV age and experience more comorbid conditions, implementation research addressing this intersection is a growing priority.

Areas of interest include integrating cancer control interventions and care coordination into HIV healthcare settings, overcoming barriers to HIV intervention adoption among older adults, combining alcohol-focused behavioral and pharmacological interventions given elevated Alcohol Use Disorder rates among people with HIV, preparing for implementation of next-generation interventions like long-acting injectable antiretroviral therapy, scaling up evidence-based strategies from single sites to county- or state-wide catchment areas, addressing HIV and oral disease burden through cross-sector community partnerships, and developing female-specific and dual-purpose HIV prevention modalities and community-led implementation projects for women across the life course.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported by an especially broad coalition of ICOs, including the Office of AIDS Research (OAR), National Cancer Institute (NCI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NICHD, National Institute on Drug Abuse (NIDA), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institute of Mental Health (NIMH), National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Nursing Research (NINR), National Library of Medicine (NLM), Office of Disease Prevention (ODP), Office of Research Infrastructure Programs (ORIP), and Office of Research on Women's Health (ORWH), reflecting the scale of NIH's coordinated effort to end the HIV epidemic through real-world implementation research.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Environmental Contributors to Infertility

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on how environmental exposures contribute to infertility in males and females, including longer time to conception and pregnancy loss. This highlighted topic aims to advance understanding of the molecular and cellular mechanisms by which hazardous physical, chemical, and biological agents disrupt reproductive function, and to support development of tools to identify and mitigate that risk.

Environmental exposures have been linked to declining male fertility through impaired sperm count, quality, hormonal balance, and genetic integrity, while conditions such as endometriosis, polyendocrine metabolic ovarian syndrome (formerly PCOS), and uterine fibroids are common female-specific conditions tied to environmental and endocrine-disrupting exposures. NIH is particularly interested in projects spanning fundamental mechanisms, epigenetics and small RNA regulation of germ cell development, New Approach Methodologies such as organoids and organ-on-chip systems, exposure science and biomonitoring, extracellular vesicle signaling in reproductive communication, and assisted reproductive technology outcomes in exposed populations.

Areas of interest include characterizing known and emerging exposures such as pesticides and micro/nanoplastics in fertility-relevant biological samples, defining core signaling pathways and DNA repair mechanisms governing gametogenesis and meiosis, applying sex as a biological variable to uncover hormonal disruption and oxidative stress pathways affecting implantation and ovarian reserve, studying autoimmune diseases linked to infertility such as autoimmune oophoritis and antiphospholipid syndrome, and examining environmental exposures and reproductive health disparities among American Indian and Alaska Native communities through culturally grounded, Tribe-specific research.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported primarily by the National Institute of Environmental Health Sciences (NIEHS), with additional participation from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of General Medical Sciences (NIGMS), Office of Research on Women's Health (ORWH), and the Tribal Health Research Office (THRO), all of which are seeking mechanistic and exposure-based research into environmental drivers of infertility.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Integrating Environmental Science and Engineering with Biomedical Research for Effective Exposure Prevention and Disease Intervention

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on multidisciplinary team science that pairs environmental science and engineering (ESE) innovators with biomedical researchers to prevent harmful chemical exposures and reduce disease burden. This highlighted topic aims to close the gap between technologies that remove contaminants from water, air, and soil and the biomedical research needed to validate that these solutions actually reduce toxicity and health risk.

Humans are routinely exposed to mixtures of chemicals, including heavy metals, PFAS, pesticides, and phthalates, through air, water, food, and everyday products, and NIH notes these harmful exposures pose risks across the entire lifespan. NIH is particularly interested in team-based projects where ESE researchers develop exposure-reduction or sensor technologies while biomedical researchers evaluate their effectiveness through validated toxicology models, or where communities affected by hazardous substances partner directly with biomonitoring teams and sensor developers to refine exposure measurement.

Areas of interest include hypothesis-driven research to reduce the amount and toxicity of hazardous substances in environmental media, developing sensor technologies for improved personal and community exposure monitoring, confirming hazard reduction through novel toxicology assays and internal dose biomonitoring, improved clean-up and monitoring approaches at Superfund and other hazardous substance sites, and interdisciplinary research to detect, characterize, and remediate chemical mixtures with attention to sex-specific biology, women-relevant health outcomes, and autoimmune disease risk across the lifespan.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported primarily by the National Institute of Environmental Health Sciences (NIEHS), including its Superfund Research Program, with additional participation from the Office of Research on Women's Health (ORWH), both of which are seeking team-based ESE/biomedical collaborations that translate exposure-reduction technology into measurable health impact.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Computational Modeling of Complex Processes Across Biological Scales

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on developing multiscale computational models that integrate biological processes across spatial and temporal levels, from molecular to organismal to epidemiologic scales. This highlighted topic aims to build a collaborative research community that improves the replicability and reproducibility of these models, advancing their reuse across the biomedical research enterprise.

Multiscale computational models offer a comprehensive understanding of complex systems by revealing how molecular and cellular interactions influence larger population-, geographical-, or global-scale phenomena. NIH is particularly interested in projects that leverage these models as Novel Alternative Methods (NAMs) to investigate the mechanism and safety of medical interventions in preclinical, translational, and clinical development, reducing reliance on animal studies while accelerating discovery.

Areas of interest include modeling infection and transmission mechanisms and immune system regulation for allergic and infectious diseases, developing whole-person computational frameworks for complementary and integrative health outcomes, building scalable modeling capabilities for cancer biomarker discovery and patient stratification, integrating sex differences and heterogeneous data to simulate heart, lung, blood, and sleep disease trajectories, modeling aging clocks and hallmark interactions relevant to Alzheimer's disease, linking molecular changes to systemic effects in alcohol use disorder and fetal alcohol spectrum disorders, developing brain-body models of substance use disorder and HIV, modeling dental and craniofacial disease processes from molecular to population levels, and building digital phenotypes that mechanistically link genetic and circuit-level processes to mental health outcomes.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported by an unusually broad coalition of ICOs, including the National Institute of Allergy and Infectious Diseases (NIAID), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institute on Drug Abuse (NIDA), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Mental Health (NIMH), National Library of Medicine (NLM), Office of Data Science Strategy (ODSS), and Office of Research on Women's Health (ORWH), reflecting how foundational multiscale modeling has become across nearly every corner of NIH's research mission.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.

NIH Highlighted Topic: Health and Extreme Weather: Advancing Critical Research to Address the Direct and Indirect Health Impacts of Weather-Related Natural Disasters and Emerging Weather-Related Harms

Below is a brief summary. Please check the full solicitation before applying (link in resources section).

Executive Summary:

The National Institutes of Health (NIH) is encouraging innovative research focused on understanding and mitigating the direct and indirect health impacts of extreme weather, weather-related natural disasters, and emerging weather-related harms. This highlighted topic, part of the NIH Health and Extreme Weather (HEW) Program, aims to advance mechanistic research, interventions, and prevention strategies that protect communities and populations at heightened risk for mortality, chronic disease, and lifelong health impacts.

The HEW Program's scope spans temperature and precipitation extremes, wildfires, hurricanes, droughts, floods, heatwaves, harmful algal blooms, and snowpack loss, along with weather's downstream influence on other environmental exposures. NIH is particularly interested in projects spanning the full translational continuum, from in vivo, in vitro, and in silico mechanistic models to evidence-based interventions, with strong emphasis on populations at heightened risk such as children, pregnant women, outdoor workers, older adults, military personnel, and those with limited economic resources. Methods to aggregate and link health and weather-related data, along with training and community engagement, are also priorities.

Areas of interest include characterizing weather-related environmental exposures like airborne pollutants and heavy metals within the broader exposome, understanding extreme weather's effects on cancer risk and treatment delivery for patients and survivors, studying cumulative environmental exposure impacts on heart, lung, blood, and sleep conditions, examining how extreme weather affects aging processes and caregiver wellbeing, investigating weather-related variations in infectious and allergic disease incidence and severity, identifying biomarkers linking extreme weather to flares in arthritis, lupus, and skin conditions, measuring mental health impacts of extreme weather on children and at-risk populations, addressing health disparities in outdoor workers and rural or coastal residents, and evaluating how extreme weather and displacement affect women's health across reproductive stages.

Note: as with prior topics, this is a Highlighted Topic rather than a standalone NOFO, so applicants apply through an appropriate NIH Parent Funding Announcement or other broad opportunity on Grants.gov rather than a dedicated solicitation with its own SBIR/STTR dollar figures.

This highlighted topic is supported by an unusually broad coalition of ICOs, including the National Institute of Environmental Health Sciences (NIEHS), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI), National Institute on Aging (NIA), National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institute of Mental Health (NIMH), National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Nursing Research (NINR), Office of Behavioral and Social Sciences Research (OBSSR), Office of Disease Prevention (ODP), and Office of Research on Women's Health (ORWH), reflecting how far-reaching extreme weather's health impacts are across NIH's research mission.

How much funding would I receive?

Awards provide up to $323,090 for Phase I projects (up to 2 years) and $2,153,927 for Phase II projects (up to 3 years). Some topics approved by NIH may exceed these limits. Fast-Track and Phase IIB (follow-on) options allow continuous or extended funding beyond Phase II.

What could I use the funding for?

Funding may support the research, development, validation, and commercialization of technologies, clinical tools, software platforms, and evidence-based interventions related to augmentative and alternative communication (AAC).

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

• Assistive technologies supporting autism, ALS, cerebral palsy, and related conditions

• Research evaluating quality-of-life and well-being outcomes for AAC users

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

Funding may also support personnel, software development, usability studies, clinical testing, cloud infrastructure, AI model development, accessibility design, data collection, intellectual property protection, regulatory preparation, and commercialization activities necessary to advance a scalable and commercially viable AAC solution aligned with NIH priorities.

Are there any additional benefits I would receive?

Beyond the formal funding award, awardees gain several strategic advantages:

• Government Validation and Credibility:
  Being selected for an NIH-backed SBIR grant signals technical excellence and alignment with national health and biomedical priorities. This validation builds investor and partner confidence.

• Enhanced Visibility and Market Recognition:
  Awardees are featured in NIH and HHS announcements, helping attract partnerships, media attention, and future contracting opportunities.

• Access to the Federal Innovation Ecosystem:
  Recipients join a national network of researchers and agencies advancing life science innovation, often opening doors to collaborations with NIH laboratories and federal health programs.

• Stronger Commercial and Exit Potential:
  By maturing technology through nondilutive funding, companies strengthen valuation, de-risk commercialization, and increase attractiveness for acquisition or follow-on private investment.

What is the timeline to apply and when would I receive funding?

Applications are accepted each year on January 5th, April 5th, and September 5th. Funding is received approximately 9 months after submission.

Where does this funding come from?

Funding comes from the U.S. Department of Health and Human Services, with statutory set-asides requiring NIH, CDC, and FDA to devote portions of their extramural R&D budgets (3.2% for SBIR, 0.45% for STTR) to support small business innovation.

Who is eligible to apply?

Applicants must be U.S. small business concerns (SBCs) that:

• Are organized for profit with a U.S. place of business.

• Have ≤ 500 employees including affiliates.

• Are > 50% owned by U.S. citizens or permanent residents, qualifying U.S. entities, or combinations thereof.

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

• High commercialization potential, supported by a realistic market and regulatory strategy, and

• Alignment with an NIH Institute’s or CDC/FDA Center’s specific research mission (e.g., infectious disease, digital health, diagnostics, therapeutics, or data analytics).

Competitive applicants often have an early prototype, preliminary data, and a defined path to market adoption.

Are there any restrictions I should know about?

• Companies must complete multiple federal registrations (SAM.gov, Grants.gov, eRA Commons, SBA Company Registry) before applying.

• Foreign entities are not eligible.

• Disclosure of foreign affiliations and compliance with national security screening are mandatory. Currently we do not recommend any sort of foreign affiliation.

How long will it take me to prepare an application?

For a first-time applicant, preparing a competitive submission will likely take 120–200 hours in total.

How can BW&CO help?

Our team specializes in complex federal R&D proposals and can:

• Triple your likelihood of success through proven strategy and insider-aligned proposal development

• Reduce your time spent on the proposal by 50–80%, letting your team focus on technology and operations

• Ensure you are targeting the best opportunity for your project and positioning your company for long-term growth.

Review solicitation here.