PCORI Broad Pragmatic Studies PFA: Cycle 3 2026

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

Quick Answer

The Patient-Centered Outcomes Research Institute (PCORI) will open its Broad Pragmatic Studies (BPS) PCORI Funding Announcement (PFA) for Cycle 3 2026 on August 4, 2026. This funding opportunity supports patient-centered comparative clinical effectiveness research (CER) that compares two or more existing health treatments, services, or care delivery strategies. PCORI will commit up to $120 million in direct costs across three funding categories, with individual awards ranging from under $5 million to as much as $12 million and project periods of up to five years. The Letter of Intent (LOI) is due September 9, 2026, and the full application deadline is January 12, 2027. This opportunity is open to research teams, clinicians, health systems, and organizations conducting patient-centered CER, rather than early-stage product development, so it is best suited for applicants with an established research infrastructure and patient partnership plan already in place.

What Is the PCORI Broad Pragmatic Studies PFA?

The BPS PFA is one of PCORI's core recurring funding mechanisms, issued three times per year, designed to fund large-scale, high-impact comparative clinical effectiveness research. Unlike early-stage federal SBIR/STTR awards focused on technology development, PCORI funding is built around answering real-world clinical questions: which of two or more available treatments, services, or care delivery approaches produces better outcomes for patients. Studies must directly compare interventions already in use or shown to be efficacious, not develop new drugs, devices, or diagnostics from scratch.

Applicants are strongly encouraged to propose individual- or cluster-randomized controlled trials, though well-designed natural experiments and observational studies will also be considered. PCORI expects proposed outcomes to be clinically meaningful, validated, and important to patients themselves, and every application must meaningfully incorporate patient and stakeholder partnership consistent with PCORI's Foundational Expectations for Partnerships in Research.

Key Dates

PFA opens: August 4, 2026

Applicant Town Hall: August 13, 2026, 11:30 am ET

Letter of Intent deadline: September 9, 2026, 5 pm ET

LOI status notification: October 14, 2026

Full application deadline: January 12, 2027, 5 pm ET

Merit review: March 2027

Awards announced: August 2027 (subject to change)

Earliest start date: December 2027

Funding Amounts and Categories

PCORI will commit up to $120 million in direct costs across all categories in this cycle. The BPS PFA is structured into three distinct funding categories, and applicants must select the category that matches the scale and design of their proposed study.

Category 1 supports research projects with direct costs up to and including $5 million. This is the standard entry point for most single-site or moderately scaled pragmatic trials.

Category 2 supports research projects with direct costs greater than $5 million, up to a maximum of $12 million. Applicants pursuing Category 2 funding must provide additional justification in both the LOI and full application explaining why the scale, scope, and complexity of the research question requires the larger budget, and must include planned subgroup analyses that generate clinically actionable information.

Category 3 supports research projects with direct costs up to $12 million that use PCORnet, PCORI's national clinical research network, to conduct observational studies or pragmatic trials at a national scale. Category 3 studies must involve two or more Clinical Research Networks and are expected to leverage the PCORnet Common Data Model, along with sharing study progress and performance metrics across the network.

All three categories allow project periods of up to five years, and applicants may request coverage of patient care costs, including medical products, procedures, and care services, as part of the overall direct cost budget.

Special Areas of Emphasis for Cycle 3 2026

PCORI has identified five Special Areas of Emphasis (SAEs) it is particularly interested in for this cycle. These SAEs are meant to encourage, not restrict, applications, so proposals outside these areas remain eligible and competitive.

Mental health and substance use outcomes in pregnant and postpartum populations. PCORI is prioritizing research comparing efficacious or widely used interventions addressing mental health and substance use during pregnancy and through 12 months postpartum, including pharmacological approaches to perinatal mental health, suicide prevention strategies, and substance use treatment tailored to this population. Applicants proposing retrospective-only observational designs requesting more than $2 million in direct costs will receive lower funding priority.

Post-treatment follow-up care for cancer survivors. PCORI is interested in comparing different models of post-treatment follow-up care, including risk-based stratified approaches and models integrating rehabilitation and mental health services. Priority populations include adolescent and young adult survivors, older survivors with multiple chronic conditions, metastatic cancer survivors, long-term survivors, and studies addressing rural care settings or pediatric-to-adult care transitions.

Diabetes prevention, care, and treatment. This SAE covers pharmacological interventions and combination therapies, multi-component approaches integrating lifestyle and medication strategies, advanced diabetes technologies such as continuous glucose monitoring and automated insulin delivery, and care delivery or coordination models across settings and populations, including patients with multiple chronic conditions.

Management of neuropathic pain. PCORI seeks comparative research on strategies to improve screening, diagnosis, treatment, and management of pain associated with neuropathy, including painful diabetic neuropathy and neuropathy resulting from cancer treatment. Applications are encouraged to include at least one validated primary pain outcome.

Management of pain in individuals with intellectual and developmental disabilities or Alzheimer's disease and related dementias. This SAE covers comparative strategies for prevention, screening, diagnosis, treatment, and management of pain in these populations, again with a validated primary pain outcome encouraged.

Structured Mentorship

Applicants to any category of this PFA may propose coverage of structured mentorship activities to support early- or mid-career investigators, investigators transitioning into patient-centered CER, or patient and community partners. Specific criteria apply, and PCORI notes that funding for requested mentorship activities is not guaranteed even if proposed.

Application Deferral Policy

Applicants who submit an LOI and are invited to submit a full application may defer their submission one time to the immediate next PFA cycle, and this deferral may cross calendar years if needed. This gives teams additional runway to strengthen study design, secure partnerships, or finalize budgets without losing their place in the pipeline.

Research Project Agenda Topic Themes

Applicants may select up to three Topic Themes from PCORI's broader Research Project Agenda that best align with their proposed study, or select "other" if their research does not map cleanly to an existing theme. Selecting a Topic Theme or SAE is intended to help PCORI route and prioritize review, not to limit who can apply.

Who Should Apply

This opportunity is best suited for research teams, academic medical centers, health systems, and clinician-scientists with an existing capacity to conduct rigorous comparative effectiveness research at scale, along with genuine patient and stakeholder partnerships already established or in development. It is not the right mechanism for early-stage technology development, new drug or device discovery, or studies focused solely on implementation science, dissemination, or research methods development, as PCORI explicitly excludes these from consideration under this PFA.

Frequently Asked Questions

What is the PCORI Broad Pragmatic Studies PFA Cycle 3 2026?

It is a funding announcement from the Patient-Centered Outcomes Research Institute supporting large-scale, patient-centered comparative clinical effectiveness research comparing existing treatments, services, or care delivery strategies, with up to $120 million available across three funding categories.

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When does the PFA open and when is the Letter of Intent due?

The PFA is expected to open August 4, 2026. The Letter of Intent deadline is September 9, 2026, at 5 pm ET, with LOI status notifications sent October 14, 2026.

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When is the full application due?

The full application deadline is January 12, 2027, at 5 pm ET. Merit review takes place in March 2027, with awards expected to be announced in August 2027 and an earliest project start date of December 2027.

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How much funding is available?

PCORI will commit up to $120 million in direct costs across Category 1, Category 2, and Category 3 combined. Category 1 supports awards up to $5 million, Category 2 supports awards between $5 million and $12 million, and Category 3 supports awards up to $12 million for PCORnet-based national studies.

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What is the maximum project period?

Up to five years for all three funding categories.

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Does this PFA fund new product or device development?

No. This PFA funds comparative effectiveness research on treatments, services, or care delivery approaches that are already in use or already shown to be efficacious. It does not fund early-stage technology development, new drug discovery, or studies focused only on implementation, dissemination, or research methods.

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What are the Special Areas of Emphasis for Cycle 3 2026?

Perinatal mental health and substance use, post-treatment follow-up care for cancer survivors, diabetes prevention and care, management of neuropathic pain, and pain management in individuals with intellectual and developmental disabilities or Alzheimer's disease and related dementias.

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Is patient partnership required?

Yes. All applicants must address PCORI's Foundational Expectations for Partnerships in Research, ensuring patients and other research partners meaningfully contribute lived experience or professional expertise throughout the study.

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Can applicants defer a submission to a later cycle?

Yes. Applicants invited to submit a full application after an LOI may defer once to the immediate next PFA cycle, even across calendar years.

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Where can applicants get more information or ask questions?

Questions about Cycle 3 2026 can be directed to pfa@pcori.org. PCORI is also hosting an Applicant Town Hall on August 13, 2026, at 11:30 am ET.

CIRM RAPID: Funding for Rare Disease Platform Projects

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

Quick Answer

CIRM's RAPID program (Rare Disease Acceleration Through Platform Innovation and Delivery) funds California organizations developing platform-based in vivo genetic therapies for rare diseases (fewer than 200,000 US patients). There is no maximum award amount. The program has two tracks: RAPID Innovation (pre-IND through IND clearance, up to 3.5 years) for earlier-stage platforms, and RAPID Validation (IND-enabling through first-in-human trial completion, up to 6 years) for platforms with completed FDA Pre-IND alignment. Applicants must propose at least three in vivo genetic therapy candidates sharing common development infrastructure, commit a Principal Investigator (15% effort minimum) and Project Manager (50% effort minimum), and complete a mandatory pre-application consultation with CIRM before submitting. CIRM expects to fund 2–3 awards in the FY 26-27 cycle.

What Is the CIRM RAPID Program?

The California Institute for Regenerative Medicine (CIRM) launched RAPID to accelerate the development of platform-based genetic therapies for rare diseases. Rather than funding one therapy at a time, RAPID supports platforms: a shared set of technologies, manufacturing processes, and clinical infrastructure that can be reused across multiple related therapeutic candidates. The goal is to reduce per-indication development cost and timeline by letting each new candidate leverage work already done for the platform, ultimately advancing 4–7 rare disease programs toward a Biologics License Application (BLA).

CIRM positions itself as an active development partner, not just a funder — awardees gain access to the CIRM Awardee Knowledge Network, the CIRM Product Development (PDEV) Expert Network of contracted CMC, clinical, nonclinical, and regulatory advisors, and optional use of the CIRM Clinical Network (Alpha Clinics) and CIRM Cell and Gene Therapy Manufacturing Network.

RAPID Validation vs. RAPID Innovation: Which Track Fits Your Program?

RAPID Innovation is for earlier-stage platforms spanning pre-IND through IND-enabling activities. It requires that an FDA INTERACT meeting has been completed, or that the meeting request has been submitted, at the time of application. The expected outcome is Master Protocol IND clearance for at least three in vivo candidates, and the maximum award duration is 3.5 years. RAPID Innovation does not fund clinical trial conduct — only start-up activities are allowable, with no patient recruitment, screening, or enrollment.

RAPID Validation is for more advanced platforms that have already completed an FDA Pre-IND meeting covering the platform and all proposed candidates. It supports activities spanning IND-enabling studies through full conduct of a first-in-human (FIH) master protocol clinical trial, with a maximum award duration of 6 years. The expected outcome is a completed FIH trial demonstrating clinical proof of concept for the platform.

Neither track specifies a maximum award amount. Both require the platform to maintain at least three shared in vivo genetic therapy candidates throughout the project period.

Who Is Eligible to Apply?

To be considered, an application must satisfy all 13 eligibility criteria in the RFA, most notably:

1. Platform scope — at least three in vivo genetic therapy candidates for rare diseases sharing preclinical, CMC, and clinical development elements.

2. Stage readiness — reproducible disease-modifying activity demonstrated in a relevant preclinical model for at least one candidate, plus a plausible mechanism of action for the additional candidates.

3. Regulatory readiness — a completed FDA Pre-IND meeting (RAPID Validation) or a submitted/completed FDA INTERACT meeting request (RAPID Innovation) covering the full platform.

4. Study design aligned to the applicable track's expected outcome (IND clearance for Innovation; completed FIH trial for Validation).

5. Principal Investigator committing a minimum of 15% effort.

6. Project Manager with relevant experience, committing a minimum of 50% effort.

7. Data Project Manager on the team (role may be shared with other Key Personnel).

8. IND sponsorship — the CIRM applicant organization (or PI, for an investigator-sponsored IND) must be the named IND sponsor.

9. California trial site — at least one clinical trial site located in California, with justification required for any out-of-state sites.

10. 90-day start — the applicant must be ready to initiate award activities within 90 days of ARS approval.

11. Complete, accurate application with no false or inaccurate information.

12. California Organization status per CIRM's standard definition.

13. Solvency (for-profit applicants) and good standing for all applicants and affiliates.

Both non-profit and for-profit California organizations may apply. An institution may submit more than one RAPID application per funding cycle.

What Does CIRM Fund — and What Won't It Fund?

Fundable activities span both tracks and include:

• IND-enabling nonclinical GLP studies (pharmacodynamics, pharmacokinetics, safety/toxicology, mechanism-of-action and efficacy confirmation)

• Platform expansion studies requested by FDA to add candidates or indications

• GMP process development, technology transfer, and manufacturing of therapeutic candidates

• Analytical assay development and qualification, QTPP/CQA/CPP development

• Clinical protocol development, clinical operations planning, and (for RAPID Validation) full conduct of the FIH master protocol trial

• Preparation for and conduct of FDA Pre-IND/INTERACT meetings and master protocol IND submission

• Patient access, market access, and reimbursement strategy planning

• Data management, preservation, and sharing activities

Not funded under RAPID:

• Clinical trial conduct beyond start-up activities under RAPID Innovation (no patient recruitment, screening, or enrollment)

• Activities already budgeted, paid, or funded under another CIRM award or outside funder

• Costs for work performed by an out-of-state organization that retains independent IP or publication rights to project outputs

• Costs incurred on or before the date of ICOC (CIRM governing board) approval

See Appendix A of the RFA for a full category-by-category breakdown of allowable nonclinical, CMC, clinical, regulatory, and patient-access-planning activities by track.

How to Apply: Step by Step

1. Complete a mandatory pre-application consultation. Email preclinical@cirm.ca.gov with the subject line "RAPID Consultation Request" to receive and submit the online Consultation Form (core team, project title, award type, platform description, mechanism of action, indication, prior regulatory interactions, prior CIRM funding, and an Eligibility Upload Document using CIRM's template). This step is required before the online application will open to you.

2. Create a login at the CIRM Grants Management Portal (https://grants.cirm.ca.gov). Only the PI can access and submit the application, and a PI may submit only one RAPID application per review cycle.

3. Complete the online application, including the eligibility form, Key Personnel listing, and budget.

4. Prepare the Application Proposal using CIRM's required templates, covering: Project Summary, Target Product Profile, Value Proposition, Scientific Rationale, Preclinical and Clinical Studies summaries, Project Plan (preclinical, CMC, clinical), Milestones and Gantt timeline, FDA Correspondence summary, Patient Access and Commercialization Plans, Team Organization, Risk Mitigation and Financial Contingency plans, Resources and Project Environment, and a Data Sharing Overview.

5. Build an activities-based budget with justification detailed enough for CIRM budget staff to assess reasonableness; subcontracts over $500,000 require at least three comparative proposals or a sole-source justification.

Review Process and Timeline

The GWG — fifteen outside-California scientific experts plus patient advocate/nurse members of CIRM's governing board (ICOC) — scores applications 1–100 on scientific and technical merit. A median score of 85 or above is required to be recommended for funding, subject to fund availability. Patient advocate and nurse GWG members separately assign a 1–5 Patient Perspective Score, which does not determine the funding recommendation directly but can influence GWG discussion and the ARS's final funding decision.

Scientific review criteria cover five areas: Value Proposition, Rationale, Project Plan & Design, Project Team and Resources, and Population Impact. Patient Perspective criteria cover Relevance, Patient Benefit, Patient Centeredness, Patient Engagement, and California Benefit.

Award Size, Duration, and Budget Rules

• No maximum award amount for either track; total costs must be justified and are subject to adjustment by the GWG, CIRM staff, or the ARS.

• RAPID Innovation: up to 3.5 years. RAPID Validation: up to 6 years.

• CIRM expects to fund 2–3 awards in the FY 26-27 cycle.

• Supplemental funding may be requested at defined milestones (e.g., after a pre-IND meeting, or to add new candidates) but is not guaranteed.

• Direct Facilities Costs: limited to federally negotiated rates for non-profits with an existing agreement; capped at 35% of direct project costs for for-profit applicants or non-profits without a negotiated rate.

• Indirect Costs: capped at 20% of allowable direct research funding costs for non-profits; for-profit organizations may not claim indirect costs.

Ongoing Awardee Obligations

• 90-day start rule: award activities must begin within 90 days of ARS approval.

• Operational Milestones: funds are disbursed against CIRM-defined milestones; missing a milestone by more than four months (without CIRM-approved resolution) can result in termination.

• Data and knowledge sharing: awardees must manage, preserve, and share Applicable Data under a Data Sharing and Management Plan (DSMP), participate in the CIRM Awardee Knowledge Network, and publicly share FDA regulatory feedback (e.g., Pre-IND meeting minutes) within 90 days of receipt.

• PDEV Expert Network review: all regulatory strategies and submission packages must be reviewed with CIRM and PDEV advisors before FDA submission; non-participation can result in termination.

• Reporting: periodic written progress and financial reports; RAPID Validation awardees must also report clinical trial enrollee demographic data.

Frequently Asked Questions

Is there a maximum RAPID award amount? No. CIRM does not specify a funding cap for RAPID Validation or RAPID Innovation awards; the total requested amount must be well-justified and is subject to review and adjustment.

How many in vivo genetic therapy candidates must be included in a platform? At least three, maintained throughout the entire project period, sharing preclinical, CMC, and clinical development elements.

Do I need an FDA meeting before applying? Yes. RAPID Validation requires a completed FDA Pre-IND meeting covering the platform and all candidates. RAPID Innovation requires that an FDA INTERACT meeting request has been submitted (or completed) at the time of application.

Can RAPID Innovation funds be used to run a clinical trial? No. RAPID Innovation supports activities through Master Protocol IND clearance and trial start-up only — patient recruitment, screening, and enrollment are not allowable.

Who can apply? Non-profit or for-profit organizations that meet CIRM's definition of a California Organization, with at least one clinical trial site located in California.

Is a pre-application consultation really required? Yes — CIRM requires applicants to complete a consultation with the Preclinical Development team, including submission of an Eligibility Upload Document, before the online application becomes accessible.

How is scientific merit scored? The Grants Working Group scores applications 1–100. A median score of 85 or above is needed for a funding recommendation, subject to available funds.

What happens to FDA feedback shared with CIRM? RAPID has enhanced knowledge-sharing requirements: FDA Pre-IND meeting feedback must generally be shared publicly within 90 days of receipt to support broader regulatory learning across the field.

BW&CO Consulting advises deep-tech, biotech, and healthtech companies on non-dilutive federal and state funding strategy, including CIRM, SBIR/STTR, and other non-contingency-fee funding pathways. Contact us to evaluate your platform's fit for the RAPID program.

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.

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.

NIH Highlighted Topic: Enhancing Data Usage and Utility to Advance Biomedical 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 maximizing the utilization of publicly accessible, high-quality datasets to enhance reproducibility, enable data-driven hypothesis generation, and accelerate scientific discovery. This highlighted topic aims to advance computational methods, novel biostatistical approaches, and privacy-preserving strategies that turn NIH's substantial investments in data infrastructure and FAIR data management into improved disease prevention, diagnosis, and treatment.

NIH notes that while multiple institutes have independently invested in demonstrating the value of data sharing and reuse, greater strategic alignment and coordination across NIH is needed to address ongoing data underutilization. NIH is particularly interested in projects that develop AI/ML methods for data discovery and integration across distributed ecosystems, enhance rigor and reproducibility through cross-cohort validation, and implement privacy-preserving strategies such as federated learning and differential privacy to enable responsible data sharing.

Areas of interest include secondary analyses elucidating tumor initiation and therapeutic resistance mechanisms, harmonizing eye imaging modalities across devices and institutions, leveraging genomic and multi-omic datasets to improve rare disease diagnostic yield, secondary analyses of longitudinal cohorts to identify drivers of Alzheimer's disease and aging-related conditions, integrating clinical and omics data using established cohorts like All of Us and ABCD to study alcohol use disorder, harmonizing datasets for arthritis and musculoskeletal disease research, leveraging environmental exposure and geospatial data for exposome characterization, and incorporating sex as a biological variable and developing female-specific common data elements across research designs.

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 Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH), National Eye Institute (NEI), National Human Genome Research Institute (NHGRI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), 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 Environmental Health Sciences (NIEHS), 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 central secondary data analysis and data infrastructure have become across nearly every NIH institute's research priorities.

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.