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.

NIH Highlighted Topic: Behavioral and Cognitive Signals of Aging in Real-World Contexts

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 identifying reproducible, interpretable behavioral and cognitive signals from real-world data to advance understanding of aging, disease progression, and functional decline. This highlighted topic aims to translate computational models of temporally structured human behavior into life span developmental and aging research through the development of "cognitive vital signs" and behavioral pattern analysis.

Recent computational advances have highlighted the value of studying recurring behavioral patterns, such as sequences, transitions, and rhythms of daily activity, rather than isolated events or aggregate summary measures. NIH notes that growing interest in continuous, real-world cognitive assessment has motivated development of longitudinal indicators derived from everyday behavior, speech, and interaction patterns that complement traditional clinic-based assessments. NIH is particularly interested in projects that ensure these behavioral and cognitive signals are interpretable, robust, and valid across diverse real-world settings, populations, and contexts.

Areas of interest include characterizing recurring behavioral patterns like sleep-wake cycles, navigation routines, and social interaction rhythms as indicators of functional change with aging, developing and validating cognitive vital signs from speech, response timing, and repeated task performance, building computational methods to extract and compare temporally structured behavioral patterns, detecting early or preclinical stages of dementia through subtle daily cognition changes, identifying behavioral signals linked to cancer-related cognitive impairment and accelerated aging in survivors, and validating interpretable digital biomarkers from passive sensing and speech for mental health risk and resilience.

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), Office of Behavioral and Social Sciences Research (OBSSR), and National Institute of Mental Health (NIMH), all of which are seeking research that translates real-world behavioral and cognitive signals into meaningful markers of aging, disease, and functional change.

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: Data Science and Artificial Intelligence Approaches for Biomedical, Biobehavioral and Social Science 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 developing and validating AI and data science approaches that harmonize, decipher, and extract complex patterns from the massive multimodal, high-dimensional data generated by biomedical research and electronic health records. This highlighted topic aims to advance interpretable, reproducible, and scalable AI methods that improve modeling of risk and resilience trajectories, disease mechanisms, and integrated prevention and treatment services.

Data science and AI hold significant promise for addressing complex biomedical problems, yet NIH notes that heterogeneous, fragmented data lacking uniform standards remains a major barrier to widespread adoption in research and clinical practice. This topic is issued as part of the Make America Healthy Again initiative, aligning with NIH's expanded focus on mental health and addiction research, screentime effects in children and adolescents, and an AI-driven approach to pediatric cancer research and clinical trials. NIH is particularly interested in projects that make large-scale biomedical data AI-ready and integrate disparate systems, such as EHRs, surveillance, and community services, for coordinated longitudinal care.

Areas of interest include interpretable and explainable AI for mechanistic insight, AI modeling of longitudinal risk and disease trajectories across substance use, HIV, and comorbidities, generative AI applications for chronic recurrent eye disorders and precision diagnostics, multimodal data integration for Alzheimer's disease and aging biology, AI/ML models for alcohol use disorder prevention using real-world environmental and social data, computational tools for complementary and integrative health approaches, AI applications across hearing, balance, taste, smell, voice, speech, and language disorders, and sex-based biology modeling for chronic disease risk, relapse, and treatment response in women.

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 National Institute on Drug Abuse (NIDA), National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), National Eye Institute (NEI), National Institute on Aging (NIA), National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute of Biomedical Imaging and Bioengineering (NIBIB), 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 Nursing Research (NINR), National Library of Medicine (NLM), Office of Data Science Strategy (ODSS), and Office of Research on Women's Health (ORWH), reflecting how foundational AI and data science approaches have 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: Digital Health and Artificial Intelligence Tools for Biomedical and Behavioral Research: Validity and Utility

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 evaluating the validity and clinical utility of digital health and artificial intelligence (AI) tools across biomedical and behavioral research. This highlighted topic aims to advance rigorous validation of computing platforms, sensors, wearables, telehealth, and AI-based risk assessment and diagnostic algorithms used in healthcare and health-related research.

Rapidly evolving digital and AI technologies have accelerated scientific breakthroughs and surpassed human performance on several task-specific benchmarks, yet NIH notes their analytical validity, clinical validity, reliability, and utility in real-world research and clinical settings have often not been thoroughly examined. NIH is particularly interested in projects that assess these tools' impact and utility across the lifespan and among populations with limited access to traditional healthcare, with strong emphasis on risk assessment, data security, AI governance, and minimizing bias in underlying datasets.

Areas of interest include validating digital and AI tools for cancer risk factor measurement and cancer control continuum applications, assessing AI/ML tools for heart, lung, blood, and sleep condition diagnosis and monitoring, evaluating multimodal AI analysis of aging biology and Alzheimer's disease/related dementias biomarkers, validating smartphone and wearable sensing tools for alcohol use and relapse risk detection, developing AI clinical decision support tools for mental health and HIV prevention with attention to bias and model drift, validating digital tools for substance use disorder treatment (including SBIR/STTR-eligible commercialization pathways), and building generalizable, disease-agnostic benchmarking frameworks for digital health AI.

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. That said, NIDA explicitly calls out SBIR/STTR applications as encouraged where market need and commercialization potential are well defined, so this topic may be worth flagging for wearable medtech or digital health clients with clear commercial pathways.

This highlighted topic is supported by an unusually broad coalition of ICOs, including the Office of Behavioral and Social Sciences Research (OBSSR), 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 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 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 digital health and AI validation has 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.

NIH Highlighted Topic: Research on the Role of Post-Translational Modifications in Human Health and Disease

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 mechanistic roles of understudied post-translational modifications (PTMs) and PTM crosstalk in human health and disease, including cancer, aging, and substance use disorders. This highlighted topic aims to broaden the field beyond a narrow set of well-characterized modifications and reveal previously overlooked roles and functions of PTMs.

More than 400 different kinds of PTMs have been detected, yet only about a quarter have been linked to human disease, with phosphorylation, acetylation, methylation, and ubiquitination accounting for the largest share of known disease-associated modifications while others such as glycosylation, lactylation, and sumoylation remain understudied. NIH notes that current research also concentrates narrowly on a few substrate types like histones, transcription factors, and signaling molecules, leaving a knowledge gap around how varied PTMs crosstalk to influence protein function and cellular state. NIH is particularly interested in projects that leverage recent technological breakthroughs, including mass spectrometry enrichment, single-cell omics, and AlphaFold protein structure databases, to study diverse PTMs and their coordinated roles.

Areas of interest include dissecting mechanisms of understudied PTMs and PTM crosstalk in cancer initiation and progression, defining the role of PTM readers, writers, and erasers, evaluating PTM-based biomarkers for cancer risk assessment and early detection, mapping PTM landscapes across tissues, cell types, sex, and lifespan in aging and Alzheimer's disease/related dementias, studying PTMs that drive drug-seeking behavior and addiction-relevant neuronal plasticity, and examining sex-specific differences and comorbid conditions such as HIV infection affecting PTM-mediated substance use vulnerability.

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 Cancer Institute (NCI), with additional participation from the National Institute on Aging (NIA), National Institute on Drug Abuse (NIDA), and National Institute of Dental and Craniofacial Research (NIDCR), all of which are seeking mechanistic research into understudied PTMs and their disease relevance.

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: Cellular Quiescence, Senescence, and Cell Death in Aging and Disease

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 the mechanistic and functional interrelationships among cellular quiescence, senescence, regulated cell death, and other cell-fate decisions. This highlighted topic aims to uncover the molecular logic governing cell fate under stress and during aging, moving beyond simple classification to establish a foundation for next-generation therapeutics targeting aging and age-related diseases.

While a decade of senescence research has revealed extraordinary heterogeneity among senescent cells shaped by stressors, tissue origin, and organismal age, NIH notes that fundamental mechanistic questions remain unresolved, including whether quiescence, senescence, and apoptosis represent separate endpoints, a continuum, or probabilistic outcomes of cell-cycle re-entry. NIH is particularly interested in projects that clarify how aging reshapes these decision pathways and whether they can be therapeutically redirected to prevent or delay age-related disease and extend healthspan.

Areas of interest include determining whether quiescence and senescence are discrete or continuum-based cell fates, defining molecular factors governing senescence versus apoptosis, identifying cell fate decisions that can be selectively promoted or redirected during aging, examining cell fate determination in brain aging including post-mitotic neurons and glial populations, evaluating how senolytics affect quiescent and reprogramming cell populations, and characterizing cell-cycle exit and re-entry mechanisms in quiescent, senescent, stem, progenitor, and dormant tumor or stromal cells relevant to cancer initiation, progression, and therapy response.

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), both of which are seeking mechanistic research into cell-fate decision pathways relevant to aging, cancer, and age-related disease.

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: New Approach Methodologies (NAMs) for Dietary Supplement and Nutrition 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 human-relevant new approach methodologies (NAMs)—such as organoids, tissue chips, microphysiological systems, multi-omics technologies, and computational models—to evaluate the safety and efficacy of foods, food components, and dietary supplements for health optimization and chronic disease risk reduction across the lifespan.

Traditional diet-related health research has relied heavily on animal studies and population-level endpoints, which NIH notes have limited relevance to human biology and metabolism, poor sensitivity for detecting subtle or life-stage-specific effects, and an inability to assess complex foods, novel ingredients, or matrix effects. NIH is particularly interested in projects that develop and validate human-based NAMs to investigate nutrient absorption, distribution, and metabolic processes, and to simulate health-relevant interactions between cellular, organ, and body systems in response to complex food or supplement matrices. This topic is issued as part of the Make America Healthy Again initiative, and the EPA, FDA, and NIH have all committed to expanding use of NAMs moving forward.

Areas of interest include identifying and validating bioactive compound exposure biomarkers, quantifying bioaccessibility and bioavailability of nutrients in multi-ingredient supplements or processed foods, modeling diet-related chronic diseases such as obesity, diabetes, and cystic fibrosis, examining nutrition's role in ocular health and vision-loss conditions, capturing age-related changes in nutrient metabolism among older adults, validating dietary assessment methodologies and noninvasive biomarkers relevant to heart, lung, blood, and sleep outcomes, assessing dietary supplement interactions in cancer risk and treatment contexts, and characterizing dietary bioactive substances' impact on fetal and early childhood neurodevelopment.

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 Dietary Supplements (ODS), with additional participation from the National Center for Complementary and Integrative Health (NCCIH), National Cancer Institute (NCI), National Eye Institute (NEI), National Institute on Aging (NIA), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Nutrition Research (ONR), and National Heart, Lung, and Blood Institute (NHLBI), all of which are seeking human-relevant methodologies to advance nutrition and dietary supplement science.

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: Breaking Barriers: Integrating Immunology and Neuroscience to Transform AD/ADRD Research and Bring a Better Understanding of the Aging Brain

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 immunology, neuroscience, and biogerontology to advance the prevention, treatment, and understanding of Alzheimer's disease (AD) and Alzheimer's Disease-Related Dementias (ADRD). This highlighted topic aims to accelerate discovery at the intersection of immune-nervous system interactions across the aging lifespan and support development of improved diagnostics, risk stratification tools, and immunotherapeutic strategies.

Accumulating evidence implicates dysregulation of both innate and adaptive immune responses in the aging brain as a significant contributor to AD/ADRD pathogenesis, with clinical studies reporting changes in T-cells, B-cells, the complement system, and disease-specific autoantibodies in individuals living with AD/ADRD. NIH notes that a major obstacle to progress has been insufficient sustained collaboration between immunologists, infectious disease experts, and neuroscientists, leaving critical knowledge gaps around the links between autoimmunity, infectious disease, and neurodegeneration. NIH is particularly interested in projects using cutting-edge technology, including AI and novel model systems such as organoids and microphysiological systems, to close these gaps.

Areas of interest include innate and adaptive immunity crosstalk in healthy aging and AD/ADRD, links among immunosenescence, neuroinflammation, infection, and autoimmunity, mechanisms of immune dysfunction underlying neuropsychiatric symptoms, novel biomarker discovery and validation, environmental exposure effects on the immune-brain axis, sex-specific and lifespan immunophenotype changes, and chronic immune dysregulation accelerating neuroimmune senescence in the context of people with HIV.

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 Institute of Allergy and Infectious Diseases (NIAID), National Institute of Environmental Health Sciences (NIEHS), and National Institute of Mental Health (NIMH), all of which are seeking interdisciplinary research that bridges immunology and neuroscience to transform understanding of the aging brain and AD/ADRD.

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: School Mental and Behavioral Health: Expanding Access to Evidence-Based Interventions and Services

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 optimizing and testing mental and behavioral health interventions and service delivery models within school and afterschool settings. This highlighted topic aims to advance approaches that can be rapidly deployed and sustained using existing school personnel, contracted providers, and referral networks, rather than requiring extensive new infrastructure.

Schools function as de facto points of service for health promotion in many communities, and NIH is particularly interested in research that validates sustainable strategies for detecting at-risk students, matching them to appropriate interventions, and building decision-support tools to guide selection of research-informed approaches based on available resources. Projects addressing the full multitiered system of supports continuum, from universal prevention to indicated treatment, are of interest, along with strategies to promote adoption and sustained fidelity of evidence-based practices, including the judicious use of non-specialty providers to extend a stretched mental health workforce.

Areas of interest include community-engaged research addressing access barriers, workforce shortages, and privacy concerns in schools, research-practice partnerships leveraging existing infrastructure such as SAMHSA-supported behavioral health services, substance use risk screening and prevention programming for high-risk youth, nurse-led preventive interventions incorporating students' daily living conditions, sex-specific strategies for detecting and treating at-risk girls and young women, and rigorous multi-site or cluster randomized trials evaluating school-based service delivery models.

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 Mental Health (NIMH), with additional participation from the 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 on Minority Health and Health Disparities (NIMHD), National Institute of Nursing Research (NINR), Office of Disease Prevention (ODP), and Office of Research on Women's Health (ORWH), all of which are seeking research that expands sustainable, evidence-based mental and behavioral health access in school settings.

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 Alcohol Misuse Prevention and Treatment in the Criminal Justice System

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 preventing alcohol misuse and treating alcohol use disorder (AUD) within the U.S. criminal justice and juvenile justice systems. This highlighted topic aims to advance prevention interventions, treatment approaches, and implementation strategies that address the under-detection and under-treatment of alcohol problems in these settings.

Criminal justice populations, including jail, parole, probation, juvenile justice, and prison populations, report elevated levels of AUD and high-risk drinking compared to the general population, often alongside co-morbid drug use disorders. NIH notes that alcohol misuse research in these settings is challenging given rapid cycling of detainees back into the community, and that individuals face a critical gap in care upon release, where relapse risk increases with renewed exposure to people, places, and things tied to substance use. NIH is particularly interested in projects that build on promising approaches such as brief motivational interviewing-based interventions and extended-release naltrexone, which require confirmation through larger, longer-duration studies combined with behavioral interventions.

Areas of interest include developing and testing brief motivational interviewing-based alcohol interventions for integration into criminal justice settings, optimizing Screening, Brief Intervention and Referral to Treatment (SBIRT) models for these populations, evaluating pre-release motivational interventions to reduce substance use and relapse risk post-release, combining motivational enhancement with cognitive behavioral therapy, building implementation strategies for care linkages as individuals return to the community, developing remote intervention technology adapted for correctional settings, and creating cost-effective prevention and treatment approaches for corrections officials themselves.

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 Alcohol Abuse and Alcoholism (NIAAA), with additional input from the Office of Disease Prevention (ODP), both of which are seeking implementation science that closes gaps in alcohol misuse prevention and treatment across criminal justice settings.

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: Increasing Engagement in Treatment for Behavioral Health

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 increasing engagement with treatment among individuals with psychiatric disorders, particularly conditions with significant treatment gaps. This highlighted topic aims to advance outreach strategies, care design, and access improvements that help patients both initiate and sustain evidence-based treatment.

Psychiatric disorders affect an estimated 1-20% of the U.S. population depending on diagnosis, yet the majority of affected individuals never receive specific treatment, worsening prognosis and increasing burden on individuals and communities. Alcohol use disorder illustrates this gap starkly, impacting roughly 10% of U.S. adults while fewer than 20% receive treatment, and NIH notes that many psychiatric conditions have lengthy prodromal phases that offer a window for preventive intervention before severe disease onset. NIH is particularly interested in projects that address not just initial engagement but sustained retention in care, given high dropout rates for chronic mental illness.

Areas of interest include qualitative research and provider education to identify best practices for treatment engagement, screening and brief intervention models embedded in general mental health settings, digital and telehealth interventions for alcohol-related and co-occurring disorders, integration of complementary and integrative health approaches into primary care for mild-to-moderate symptoms, implementation-effectiveness studies of integrated care models, and AI- and technology-based approaches to reach rural, underserved, and high-risk youth populations.

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 Alcohol Abuse and Alcoholism (NIAAA), the National Center for Complementary and Integrative Health (NCCIH), and the National Institute on Drug Abuse (NIDA), with additional behavioral and social science input from the Office of Behavioral and Social Sciences Research (OBSSR), all of which are seeking strategies to close persistent gaps in behavioral health treatment engagement.

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.