PCORI Broad Pragmatic Studies PFA: Cycle 3 2026

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

Quick Answer

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

What Is the PCORI Broad Pragmatic Studies PFA?

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

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

Key Dates

PFA opens: August 4, 2026

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

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

LOI status notification: October 14, 2026

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

Merit review: March 2027

Awards announced: August 2027 (subject to change)

Earliest start date: December 2027

Funding Amounts and Categories

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

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

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

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

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

Special Areas of Emphasis for Cycle 3 2026

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

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

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

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

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

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

Structured Mentorship

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

Application Deferral Policy

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

Research Project Agenda Topic Themes

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

Who Should Apply

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

Frequently Asked Questions

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

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

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

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

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When is the full application due?

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

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How much funding is available?

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

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What is the maximum project period?

Up to five years for all three funding categories.

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Does this PFA fund new product or device development?

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

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

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

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Is patient partnership required?

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

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Can applicants defer a submission to a later cycle?

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

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Where can applicants get more information or ask questions?

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

CIRM RAPID: Funding for Rare Disease Platform Projects

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

Quick Answer

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

What Is the CIRM RAPID Program?

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

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

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

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

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

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

Who Is Eligible to Apply?

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Fundable activities span both tracks and include:

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

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

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

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

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

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

• Patient access, market access, and reimbursement strategy planning

• Data management, preservation, and sharing activities

Not funded under RAPID:

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

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

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

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

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

How to Apply: Step by Step

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

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

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

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

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

Review Process and Timeline

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

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

Award Size, Duration, and Budget Rules

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

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

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

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

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

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

Ongoing Awardee Obligations

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

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

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

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

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

Frequently Asked Questions

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

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

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

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

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

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

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

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

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

Navy ManTech sBAA N0001426SB002: What Startups Need to Know Before Applying

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

The Office of Naval Research (ONR) has released Special Broad Agency Announcement N0001426SB002, "Accelerating Maritime Modernization: Innovation in Naval Manufacturing, Sustainment, and Industrial Base Capability." This is a contract vehicle, not a grant, run through the Navy Manufacturing Technology (ManTech) Program, and it directly supports the Navy's Golden Fleet Initiative to build ships faster, repair them faster, and strengthen the naval industrial base.

For deep-tech, robotics, and dual-use startups, this is a rare non-dilutive funding opportunity with a clear commercialization thesis: the Navy wants technology that is close to production-ready and can transition into an actual shipyard or maintenance depot within a defined timeline.

What Is This Opportunity?

This sBAA funds two categories of work:

• 6.2 Applied Research: proof-of-concept development bridging science and defense application. ONR expects to fund 3 to 5 awards valued at $500K to $3M.

• 6.3 Advanced Technology Development: maturing and demonstrating technology in operationally relevant environments, targeting Technology Readiness Level (TRL) and Manufacturing Readiness Level (MRL) 6 to 7. ONR expects to fund 5 to 10 awards valued at $1.5M to $5M.

Periods of performance run 1 to 2 years. Awards are procurement contracts, not grants or cooperative agreements.

Technology Areas ONR Wants

ONR is prioritizing innovations that support the Golden Fleet Initiative across five priority areas: speed/throughput/availability, advanced manufacturing, sustainment and repair, industrial base modernization, and supply chain capacity and logistics. Named priority platforms include the new BBG(X)/BBGN battleship, the FF(X) next-generation frigate, and unmanned surface vessels, though other Navy platforms may also be considered.

Specific technical focus areas span:

• Novel materials, non-metallic materials, and materials scale-up

• Advanced sensor integration and structural health monitoring

• Robotics, automation, and advanced manufacturing (including cobots and human augmentation)

• Digital tools, model-based engineering, and digital twins

• AI/ML for shipbuilding decision-making and predictive maintenance

• Autonomous systems for inspection and maintenance

• Advanced electronics, SOSA/MOSA modular design

• Non-destructive testing and advanced inspection

• Supply chain and logistics platforms, including additive manufacturing digital part libraries

• Cybersecurity for industrial control systems and operational technology

Two-Phase Structure and Key Dates

This sBAA runs on two tracks:

• Phase I: White papers are due 60 days after publication of the sBAA. Selected offerors submit a full proposal within 45 days of notification. Award decisions follow roughly 60 days after full proposal submission.

• Phase II: Opens the day after Phase I closes and stays open for one year from publication, so companies that miss the Phase I window still have a path in. Phase II full proposals follow the same 45-day submission clock after notification, with award decisions targeted in 45 days.

Missing the Phase I white paper deadline does not eliminate a startup from this opportunity. It shifts the company to the Phase II track, which is a meaningful difference from most SBIR-style solicitations with a single hard close.

Who Can Apply

All responsible sources from industry and academia are eligible, including both small and large businesses. There is no dollar amount set aside specifically for small business or socioeconomic categories, so startups compete on technical merit rather than in a reserved lane. Navy laboratories, warfare centers, and FFRDCs cannot apply directly, though teaming with them is allowed.

Before submitting, a company must be registered in SAM.gov with an active Unique Entity Identifier and CAGE code, and that registration must stay current through the life of any award.

What Gets Evaluated

Four criteria carry equal weight:

1. Scientific and technical merit: ManTech appropriateness and soundness of the technical approach

2. Naval relevance and contribution: how clearly the proposal defines the Navy need, quantifies impact and ROI, and lays out a credible transition plan to a named platform or facility

3. Organizational capability and teaming: this section explicitly weighs whether the team holds an active DD-2345 Joint Certification Program certification and the appropriate CMMC cybersecurity level

4. Financial and schedule feasibility: whether the proposed cost and milestones are realistic for the scope of work

Two details deserve early attention. First, for 6.3 Advanced Technology Development efforts, evaluators require a strict transition path to TRL/MRL 6 through 7, so proposals pitched at an earlier maturity level should target the 6.2 Applied Research category instead. Second, Intellectual Property and Data Rights assertions are evaluated directly, since ONR is checking whether the proposed rights (for example, Government Purpose Rights) support scaling across the naval industrial base without creating vendor lock. This is worth deciding deliberately, not defaulting to whatever a template suggests.

Cybersecurity Requirements to Plan For Early

This sBAA requires CMMC Level 2 (Self) status entered in the Supplier Performance Risk System for any contractor information system that will process, store, or transmit Federal Contract Information or Controlled Unclassified Information. Companies that have not started a CMMC self-assessment should begin that process well before a white paper is due, since award cannot proceed without a current CMMC status and affirmation of continuous compliance in SPRS.

White Paper Requirements

Phase I and Phase II both start with a 5-page white paper (12-point Times New Roman, one-inch margins) plus a one-page Project Lead resume. The white paper must cover, in this order: project classification and Golden Fleet alignment, organization background and teaming strategy, technical concept and appropriateness, Navy need and impact, path to transition (including IP and data rights posture), and a rough order of magnitude cost and schedule estimate.

Because ONR reviews white papers on a rolling basis rather than against each other in a single competition, a well-scoped white paper submitted early in the Phase II window is not disadvantaged relative to one submitted near the one-year close.

How BW&CO Consulting Helps

BW&CO Consulting helps deep-tech, robotics, and dual-use companies position competitive Navy ManTech proposals, including:

• Determining whether a technology fits the 6.2 Applied Research or 6.3 Advanced Technology Development category based on current TRL/MRL

• Mapping a company's technology to a specific Golden Fleet platform or industrial facility for a credible transition narrative

• Structuring IP and Data Rights assertions that satisfy ONR's transition and anti-vendor-lock evaluation criteria

• Coordinating CMMC and SAM.gov readiness ahead of submission

• Drafting the white paper and full proposal package, including the Statement of Work and cost proposal

Contact BW&CO Consulting to discuss Navy ManTech sBAA N0001426SB002 eligibility and proposal strategy.

DOE DE-FOA-0003634: Advancing Oil and Natural Gas Production and Delivery ($81.9M NOFO)

Quick Answer

The U.S. Department of Energy's Hydrocarbons and Geothermal Energy Office (HGEO) issued Notice of Funding Opportunity DE-FOA-0003634, "Advancing Oil and Natural Gas Production and Delivery," on July 22, 2026. The opportunity makes up to $81,875,000 available ($65,500,000 in federal funding plus a required 20% cost share) across four topic areas addressing natural gas flaring reduction, sour gas treatment, infrastructure resilience, and AI-enabled digital transformation of upstream and midstream oil and gas operations. Applications are due September 22, 2026, by 5:00 p.m. ET, submitted through DOE's NETL eXCHANGE portal. The NOFO uses cooperative agreements or Other Transaction Agreements and may remain open for up to 72 months with annual review cycles.

What Is DE-FOA-0003634?

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DE-FOA-0003634 is a Financial Assistance Notice of Funding Opportunity issued by DOE's Hydrocarbons and Geothermal Energy Office, Division of Transport and Storage. It funds research, development, and field validation of technologies that improve the efficiency, reliability, and resilience of the U.S. oil and natural gas supply chain, spanning extraction through processing, transport, and delivery.

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The program specifically targets three long-standing problems in the sector: natural gas that is flared or vented instead of captured, aging infrastructure prone to corrosion and unplanned downtime, and slow adoption of digital technologies such as AI, machine learning, digital twins, IoT, and edge computing in upstream and midstream operations.

Who Is Eligible to Apply for DE-FOA-0003634?

Eligible applicants are domestic entities, including:

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• Institutions of higher education

• For-profit organizations

• Nonprofit organizations

• State and local government entities

• Indian Tribes, as defined under 25 U.S.C. § 5304

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To qualify, an entity must be organized or incorporated under U.S. or state law, be majority domestically owned and controlled, and maintain a physical place of business in the United States.

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Important eligibility limitations:

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• DOE and non-DOE Federally Funded Research and Development Centers (FFRDCs) may participate only as subrecipients, not as the prime recipient, and FFRDC effort cannot exceed 20% of total project cost.

• The National Energy Technology Laboratory (NETL) is not eligible as a recipient or subrecipient. Including NETL in either role makes an application non-responsive.

• Foreign entities are generally ineligible but may apply with an approved written waiver.

• All project work must be performed in the United States unless a waiver is granted.

• Entities debarred or suspended from federal programs, those on the OFAC Specially Designated Nationals list, and 501(c)(4) nonprofits that lobbied after 1995 are ineligible.

• Entities of Concern are prohibited from participating.

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Applicants may submit more than one application, provided each describes a scientifically distinct project.

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How Much Funding Is Available, by Topic Area?

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DOE structured DE-FOA-0003634 around four topic areas, each with its own funding pool, award size, and project period.

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Topic Area 1a: Laboratory Validation of Catalysts and Unit Operations

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• Federal funding available: $7,500,000

• Anticipated number of awards: 5

• Typical award size: $1,500,000 federal (plus 20% cost share)

• Project period: approximately 24 months

• Starting TRL: 3 | Ending TRL: 5

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Topic Area 1b: Field Validation of Full System Prototypes

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• Federal funding available: $18,000,000

• Anticipated number of awards: 3

• Typical award size: $6,000,000 federal

• Project period: approximately 48 months

• Starting TRL: 5 | Ending TRL: 7

• Requires a letter of intent from an industry partner providing field site access, and a project team member committed to commercialization

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Topic Area 2: Resilient Infrastructure Technologies Enhancement (RITE)

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• Federal funding available: $12,000,000

• Anticipated number of awards: 4

• Typical award size: $3,000,000 federal

• Project period: approximately 48 months

• Starting TRL: 5 | Ending TRL: 7

• Also requires an industry field-site letter of intent and a commercialization-focused team member

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Topic Area 3: Hydrocarbon Infrastructure Test Sites (HITS)

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• Federal funding available: $28,000,000

• Anticipated number of awards: 4

• Typical award size: $7,000,000 federal

• Project period: approximately 60 months

• Requires a defined physical field test site and an industry letter of intent providing site access

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All topic areas require a minimum 20% cost share from nonfederal sources.

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What Technologies Is DOE Looking to Fund?

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Topic Area 1: Enhanced Resource Utilization and Production Technologies (ERUPT)

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This topic area targets the roughly $15 billion in natural gas value lost to flaring and venting over the past decade, along with stranded sour gas and stranded natural gas liquids (NGLs). DOE is interested in:

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• AI- and quantum-scale simulation-driven catalyst and reactor design to convert associated gas and NGLs into valuable products

• Modular, low-cost sour gas treatment systems capable of handling hydrogen sulfide (H2S) concentrations found across the Permian Basin, where more than 85% of gas contains some H2S and over 40% contains up to 10,000 ppm

• Novel separation technologies and chemical pathways that improve the economics of NGL recovery

• Sub-topic 1a covers laboratory-to-prototype-scale validation (TRL 3 to 5); sub-topic 1b covers field validation of full system prototypes (TRL 5 to 7) and requires an industry field-testing partner

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Topic Area 2: Resilient Infrastructure Technologies Enhancement (RITE)

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This topic area addresses the roughly $875 million in annual product losses and $1.37 billion in annual corrosion-related costs facing U.S. oil and gas infrastructure. Areas of interest include:

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• High-efficiency engines and compressors, including retrofit solutions, targeting a 10% increase in compressor performance and 25% increase in engine thermal efficiency

• AI/ML-driven, digital-twin-enabled real-time optimization of legacy compressor and engine performance, targeting a 20% reduction in maintenance costs

• Corrosion- and friction-resistant materials such as advanced coatings, composites, and alloys, targeting a 2 to 3% increase in pipeline deliverability

• Requires field testing and an industry partner letter of intent

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Topic Area 3: Hydrocarbon Infrastructure Test Sites (HITS)

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Modeled on the successful Hydraulic Fracture Test Sites (HFTS) program, HITS funds the establishment of physical field test sites, at existing operator assets, university facilities, private consortium facilities, national labs, or public-private partnerships, where applicants validate:

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• Digital twin development for surface production, processing, and transportation assets

• Predictive analytics for anomaly detection, remaining useful life prediction, and production forecasting

• Edge computing and cybersecurity for the edge-to-cloud continuum

• Autonomous and robotic inspection and maintenance systems

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Target outcomes include a 10 to 20% increase in hydrocarbon throughput, a 20% reduction in pipeline and facility downtime, and a 15% reduction in operating costs. Applications must include both a defined physical test site and an industry letter of intent providing site access.

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What Are DOE's Expected Performance Outcomes for This Program?

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DOE has set specific, quantifiable targets applicants should address in their technical volumes:

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• Increase natural gas utilization to 80% by 2035

• Reduce annual flaring losses by approximately $1.5 billion

• Unlock production from an estimated 7,500 remaining wells in the eastern Delaware Basin currently limited by sour gas

• Reduce sour gas treatment costs by more than 20%

• Increase U.S. natural gas delivery system efficiency from 92% to 94% by 2030

• Increase pipeline deliverability by 2 to 3%

• Reduce operational disruptions and maintenance costs by at least 20%

• Increase saleable hydrocarbon throughput by 10 to 20% and reduce OPEX by 15% or more through digital and physical optimization

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What Applications Will DOE Not Consider?

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DOE will not review applications that:

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• Fall outside the technical scope defined in the Topic Areas

• Rely on approaches inconsistent with established scientific principles

• Fail to articulate impact on U.S. energy security, economic competitiveness, domestic manufacturing, or job creation

• Lack cost share commitment letters at submission

• Propose technologies that are already commercially mature and widely deployed without demonstrating a genuine advancement

• Propose chemical conversion to fuels such as gasoline or diesel (Topic Area 1)

• Propose traditional, centralized amine treatment or cryogenic NGL recovery without a novel, modular, or cost-reducing angle (Topic Area 1)

• Focus solely on sensor hardware without system-level integration (Topic Areas 2 and 3)

• Fall outside the specified beginning or ending TRL range for the topic area

• Omit a required industry letter of intent for field site access (Topic Areas 1b, 2, and 3)

What Does an Application Require?

Applications are submitted as a single phase through NETL eXCHANGE. Core components include:

• Technical Volume (20-page limit): covers project objectives, Buy America/Buy America (BABA) applicability, discussion of each technical review criterion, relevance and expected outcomes, participant roles, facilities, and equipment

• Statement of Project Objectives (SOPO): 8-page limit, Word format

• Project Management Plan (PMP): 8-page limit

• SF-424 and SF-424A: standard federal assistance and budget forms

• Budget Justification Workbook and, if applicable, Subrecipient Budget Justification

• Letters of Commitment/Intent: 1 page each, required for Topic Areas 1b, 2, and 3 to demonstrate field site access

• Biographical Sketch and Current and Pending (Other) Support for every Covered Individual, produced via SciENcv, consistent with NSPM-33 disclosure requirements

• Impacted Indian Tribes Documentation, where applicable

• Locations of Work, Environmental Questionnaire, Summary for Public Release, and Summary Slide

Applicants are strongly encouraged to submit at least 48 hours before the deadline. DOE does not extend deadlines for server or connectivity issues.

How Will DOE Evaluate Applications?

Applications are scored against three weighted technical review criteria:

1. Scientific and Technical Merit, 45%: technical soundness, degree of advancement over baseline technologies, and alignment with topic area performance targets

2. Technical Approach and Understanding, 25%: quality of the Statement of Project Objectives, completeness of the Project Management Plan, and financial viability of the proposed budget

3. Technical and Management Capabilities, 30%: organizational structure, relevant corporate experience, key personnel qualifications, and adequacy of facilities and field sites

DOE may also weigh other selection factors, including technological diversity relative to its existing portfolio, industry involvement and commercialization potential, domestic manufacturing and job creation impact, and geographic distribution of upstream and midstream assets.

Why This Matters for Deep-Tech and Energy Innovators

DE-FOA-0003634 is one of the larger non-dilutive funding opportunities currently open for hydrocarbon-adjacent technology developers, and it explicitly rewards teams that pair strong science with a credible path to commercialization. Every topic area beyond 1a requires DOE's Technology Maturation Plan, Techno-Economic Analysis, and Adoption Readiness Level framework, meaning applicants need to show DOE not just that a technology works, but that it can be adopted and scaled by small and mid-size operators.

For companies working in catalysis, separations, sour gas treatment, corrosion-resistant materials, industrial AI/ML, digital twins, or autonomous field robotics, this NOFO represents a substantial, multi-year funding pathway, with the caveat that Topic Areas 1b, 2, and 3 all require a committed industry partner willing to provide field site access before an application can even be considered responsive.

Need Help With Your DE-FOA-0003634 Application?

BW&CO Consulting helps deep-tech, energy, and infrastructure companies secure non-dilutive federal funding through programs like this one. If your team is evaluating a Topic Area 1, 2, or 3 submission, including securing an industry field-site partner or building out your Technology Maturation Plan, contact BW&CO to discuss fit and strategy before the September 22, 2026 deadline.

Frequently Asked Questions

What is DE-FOA-0003634? DE-FOA-0003634 is a DOE Notice of Funding Opportunity titled "Advancing Oil and Natural Gas Production and Delivery," issued by the Hydrocarbons and Geothermal Energy Office to fund technologies that improve efficiency, reliability, and digital transformation across the U.S. oil and gas supply chain.

How much funding is available under DE-FOA-0003634? Up to $81,875,000 total, made up of $65,500,000 in federal funding and $16,375,000 in required cost share, spread across four topic areas.

When is the DE-FOA-0003634 application deadline? Applications are due September 22, 2026, at 5:00 p.m. ET, submitted through DOE's NETL eXCHANGE portal.

Who can apply for DE-FOA-0003634? Domestic institutions of higher education, for-profit and nonprofit organizations, state and local government entities, and Indian Tribes. FFRDCs may only participate as subrecipients, and NETL is barred from participating in any role.

Is cost share required? Yes. A minimum 20% cost share of total project costs is required from nonfederal sources, and applications without a cost share commitment letter at submission will not be reviewed.

Does this NOFO require an industry partner? Yes, for Topic Areas 1b, 2, and 3. Each requires a letter of intent from an industry partner providing access to a field test site, and a project team member committed to pursuing commercialization.

When will DOE announce selections and make awards? DOE anticipates notifying selected applicants by December 11, 2026, with an anticipated award date of March 1, 2027.

Chain Reaction Innovations 2027 Cohort: DOE-Funded Entrepreneurship Program at Argonne National Laboratory

Quick Answer

Chain Reaction Innovations (CRI) is a Department of Energy entrepreneurship program at Argonne National Laboratory that embeds individual innovators in physical science and energy technology fields for up to two years. Selected innovators receive a personal stipend, travel allowance, and health benefits through an ORISE fellowship, along with lab space, technical collaboration, and structured mentorship at Argonne. The program is open to individuals, not companies, and applicants must have at least five years of technology R&D experience and be a U.S. citizen or lawful permanent resident. Applications are submitted through the CRI online portal at chainreaction.anl.gov.

What Is Chain Reaction Innovations?

Chain Reaction Innovations was created at Argonne National Laboratory to accelerate the applied research, development, and deployment of physical science-based technologies, including materials and manufacturing innovations, capable of transforming the nation's energy systems. The program addresses a specific gap in the innovation pipeline: early-stage technologies that are too scientifically or technically uncertain for venture capital funding, but that hold significant potential for energy and manufacturing impact.

Rather than funding a company or research proposal directly, CRI funds the innovator. The program embeds selected entrepreneurial researchers within Argonne National Laboratory, pairing them with scientific and technical mentorship, unique R&D assets, and national laboratory expertise. The goal is to help innovators move their technology from proof-of-concept to proof-of-product within a defined period, while simultaneously developing the entrepreneurial skills needed to commercialize it.

CRI is a Lab-Embedded Entrepreneurship Program (LEEP), a DOE Office of Technology Transitions initiative that places entrepreneurs inside national laboratories. Argonne is currently recruiting its 2027 cohort through this solicitation.

Program Benefits

Selected innovators may receive up to 24 months of program resources, subject to performance reviews and availability of funding. Benefits include:

A personal stipend, travel allowance, and health benefits through an Oak Ridge Institute for Science and Education (ORISE) fellowship for up to 24 months

Lab space and technical collaboration support from Argonne National Laboratory for up to 24 months

Structured Chain Reaction Innovations programming and mentorship

Participation is governed by a Cooperative Research and Development Agreement (CRADA) between Argonne and the innovator's company. Either party may terminate the CRADA with sixty days written notice. All benefits are contingent on funding availability, negotiation of a mutually agreeable scope of work, innovator performance, DOE selection and site access approval, and CRADA approval by DOE, including any required reviews under DOE O 142.3 (Unclassified Foreign National Access Program) and DOE P 485.1 (Foreign Engagements with DOE National Laboratories).

At the end of the first year, innovators undergo a midpoint review to confirm their performance and progress meet the minimum criteria to continue into the second year of the CRADA period.

Program Structure: Two Budget Periods

Scope and Planning Phase (Budget Period 1): Typically lasting less than six months, this phase involves paper-based analysis such as market studies, refinement of the research scope alongside Argonne personnel, and a survey of the intellectual property landscape surrounding the innovator's technology. During this phase, innovators must develop an Intellectual Property (IP) Management Plan, which requires approval from the DOE Technology Manager with concurrence from DOE Patent Counsel before the project can proceed. Innovators must obtain a license or option to license any necessary background IP no later than the one-year review, or risk termination from the program. In some cases, this phase may be shortened or skipped entirely.

Research and Development Phase (Budget Period 2): Once the Scope and Planning phase is complete, or deemed unnecessary, the R&D phase proceeds subject to DOE approval. This is the core technical development period of the CRADA.

Who Is Eligible

Eligibility for the CRI 2027 cohort is specific and individual-based:

Applicants apply as individuals, not as companies or organizations, although a CRADA will ultimately be established between Argonne and the selected innovator's company

Technical leads must have a minimum of five years of technology R&D experience

Technical leads must be a U.S. citizen or a lawful permanent resident at the time of initial application submission

The proposed work must have the potential for broad impact aligned with DOE's mission to advance the national, economic, and energy security of the United States

Only individuals may apply; incorporated entities may not apply, though applicants may have an incorporated entity associated with their work

Innovators who have raised more than $2 million in private-sector equity at the time of application are not eligible

Current Argonne National Laboratory employees are not eligible to participate while directly employed by the Laboratory; Argonne employees may apply but must take Entrepreneurial Leave or terminate their employment with the Laboratory to participate if selected

What CRI Looks For: Selection Criteria

Argonne evaluates applicants across three core dimensions:

Project Leader. Reviewers look for outcome-oriented, entrepreneurial technical innovators capable of building a foundational technology vision and leading a team. Ideal candidates demonstrate technical strength (detailed knowledge and conceptual depth), outcome orientation (systems-level thinking, risk evaluation, commercial awareness), and personal excellence (drive, resourcefulness, communication skills, integrity, and adaptability).

Project Concept. While concepts may evolve over the course of the program, the initial idea should be technically sound, reasonably differentiated, and framed around a well-defined problem with significant long-term impact potential. Reviewers assess economic impact potential, technical merit and differentiation, business idea maturity (market research, IP position, understanding of barriers to entry and incumbents), and CRI fit, meaning how much the program's support would change the innovator's timeline or probability of success.

Technology Fit. Proposed innovations must align with the technology mission space of the CRI program sponsors. Additional detail is available through the DOE Lab-Embedded Entrepreneurship Program (LEEP) website and the Chain Reaction Innovations application page.

All applicants are reviewed by Argonne National Laboratory and must ultimately be selected by a Federal Official from the Department of Energy.

Required Application Materials

Applicants must submit the following through the CRI online portal at chainreaction.anl.gov:

1. Innovator narrative: Background on the applicant and their project, including the origin of the idea, current status of the technology and team, and the applicant's motivation and qualifications

2. Innovator's vision: A description of the technology concept, with commentary on its potential impact on U.S. energy and manufacturing competitiveness

3. Why Chain Reaction Innovations: An explanation of what attracts the applicant to the program specifically, why CRI is the ideal home for the project compared to alternative paths, and which Argonne people or facilities would be most valuable to the work

4. Business idea: A description of how the applicant envisions commercializing the technology, including target market, customers, potential suppliers and distributors, relevant intellectual property status, barriers to entry, and market incumbents

5. Argonne affiliation disclosure: A statement identifying any affiliation with Argonne National Laboratory, UChicago Argonne LLC, or the University of Chicago, or confirmation that no affiliation exists

6. Optional additional materials: Anything else the applicant chooses to include

7. One-page resume for the innovator

8. Technical deck: A five-page high-level overview of the proposed innovation's technical components

Intellectual Property Considerations

Argonne makes no claim to any background intellectual property an innovator brings into the program. Under the CRADA, selected innovators may copyright and publish materials developed during the program, subject to national security considerations and a royalty-free license retained by the government. Innovators generally retain principal worldwide patent rights to inventions they develop under the CRADA, subject to a reserved government use license and the limitations set out in 37 CFR 401.

For inventions developed by Argonne itself under the CRADA, the innovator does not own the invention but receives an option for up to an exclusive license for the term of the CRADA plus six months.

Every participant is required to establish an IP Management Plan that sets clear, mutual expectations for handling both background IP and any IP developed during the program.

Conflict of Interest and Confidentiality Notes

Work conducted through CRI must comply with Argonne's Prime Contract and its conflict of interest policies. Innovators affiliated with Argonne, UChicago Argonne LLC, or the University of Chicago are subject to an organizational conflict of interest management plan.

Applicants should also be aware that the CRI application review involves independent advisors external to Argonne and DOE, and that CRI finals and related events are open to the public. No proprietary information should be included in any application, since submitted information is treated as non-proprietary and not subject to any obligation of disclosure.

How BW&CO Consulting Can Help

Navigating a program like Chain Reaction Innovations involves more than a strong technology story. It requires positioning an individual innovator's narrative, business case, and technical deck to meet DOE's mission alignment criteria, structuring an IP Management Plan that will satisfy DOE Patent Counsel, and understanding how a CRADA fits alongside other non-dilutive funding sources like SBIR and STTR. BW&CO Consulting helps deep-tech and energy technology innovators build application materials that speak the language federal reviewers are looking for, and helps applicants understand how a lab-embedded entrepreneurship award like CRI can complement a broader federal funding strategy.

Frequently Asked Questions

Is Chain Reaction Innovations a grant to my company? No. Innovators apply as individuals, not as companies or organizations. Once selected, Argonne establishes a CRADA with the innovator's company, but the initial application and eligibility criteria apply to the individual.

Can I apply if I already have a company? Yes. Individuals with an incorporated entity may apply, but the incorporated entity itself cannot be the applicant. However, innovators who have raised more than $2 million in private-sector equity at the time of application are not eligible.

How much funding does CRI provide? CRI does not provide a lump-sum grant. Instead, selected innovators receive up to 24 months of an ORISE fellowship stipend, travel allowance, and health benefits, plus Argonne lab space, technical collaboration, and mentorship, contingent on funding availability and performance.

Can current Argonne employees apply? Yes, but they cannot participate while directly employed by Argonne. Selected Argonne employees must take Entrepreneurial Leave or terminate their employment with the Laboratory to participate in the program.

What happens after the first year? Innovators undergo a midpoint review at the end of year one to confirm their progress meets the minimum criteria required to continue into the second year of the CRADA period.

Who owns the intellectual property I develop at Argonne? Innovators generally retain principal worldwide patent rights to inventions they personally develop under the CRADA, subject to a reserved government use license. If Argonne itself develops an invention under the CRADA, the innovator instead receives an option for up to an exclusive license for the CRADA term plus six months.

Where do I apply? Applications are submitted through the online portal at chainreaction.anl.gov.

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

Quick Answer:

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

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

What Does This Opportunity Fund?

Four illustrative (non-exclusive) project types:

• Comparing digital measurements to traditional clinical trial measurements

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

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

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

What Makes This Different From a Standard NOFO?

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

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

• Applies to drugs/biologics only, not devices

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

How Is It Reviewed?

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

• Significance (20 pts)

• Investigator(s) (20 pts)

• Innovation (25 pts)

• Approach (25 pts)

• Environment (10 pts)

Who Is Eligible?

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

Key Dates

• Posted: July 20, 2026

• Open Date: July 20, 2026

• Application Due: August 20, 2026

• Expiration: August 21, 2026

How Can BW&CO Help?

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

DOE Genesis Mission | SBIR/STTR Phase I Funding Opportunity

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

Quick Answer:

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

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

What Topics Does This Opportunity Cover?

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

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

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

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

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

What Is the Pitch-First Process?

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

How Is a Pitch Evaluated?

Pitch applications are scored across four equally weighted areas:

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

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

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

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

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

[Complimentary Assessment]

What Is the Funding Amount and Timeline?

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

What Is the Application Timeline?

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

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

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

How Do I Submit a Pitch?

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

Who Is Eligible?

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

Key Dates

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

Anticipated AMP access requests open: July 22, 2026

Office Hours sessions: Mid-August 2026

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

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

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

NASA ROSES | C.4 Planetary Science Enabling Facilities

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

Quick Answer:

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

What Is a Planetary Science Enabling Facility?

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

What Types of Facilities Can Be Proposed?

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

What Is Excluded From This Program?

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

What Priorities Does NASA Emphasize This Year?

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

Who Is Eligible?

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

How Are Proposals Structured and Formatted?

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

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

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

Is Research Security Training Required?

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

How Are Proposals Evaluated?

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

What Is the Funding Amount and Timeline?

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

How Do I Submit a Proposal?

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

Key Dates

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

Program Contact

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

How Can BW&CO Help With a PSEF Proposal?

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

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

NASA ROSES A.14: Atmosphere Research Program

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

Quick Answer:

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

Program Background

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

What Science Questions Does This Program Address?

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

What Data Must Proposals Use?

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

What Are the Five Sub-Elements?

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

Who Is Eligible?

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

What Are the Proposal Format Requirements?

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

What Is Dual-Anonymous Peer Review?

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

Is Research Security Training Required?

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

How Are Proposals Evaluated?

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

What Is the Funding Amount and Timeline?

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

How Do I Submit a Proposal?

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

Key Dates

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

Program Contacts

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

How Can BW&CO Help With an Atmosphere Proposal?

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

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

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

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

Executive Summary:

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

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

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

How much funding would I receive?

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

Eligibility Pathways (must meet one):

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

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

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

Investor Requirement:

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

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

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

Other Key Requirements:

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

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

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

NAICS code must be 541713 or 541715 at time of award

Active SAM.gov registration required at submission and award

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

Equity-free matching funds to accelerate commercialization beyond Phase II

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

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

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

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

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

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

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

Where does this funding come from?

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

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

Who is eligible to apply?

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

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

What companies and projects are likely to win?

Applications are evaluated across four factors:

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

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

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

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

Are there any restrictions I should know about?

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

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

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

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

How long will it take me to prepare an application?

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

How can BW&CO help?

BW&CO can support:

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

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

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

Positioning past performance and IP strategy for NASA evaluators

Review solicitation here.

NIH Highlighted Topic: Advancing Nutrition Research to Inform Regulatory Practice

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

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

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

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Accelerating Otitis Media Research and Workforce Development

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

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

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

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

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

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

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

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

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

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

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

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

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

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

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

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

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

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

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

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

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

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

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

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

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

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

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

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

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

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

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

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

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

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Food Is Medicine

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

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

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

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.

NIH Highlighted Topic: Oral Health and Aging

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

Executive Summary:

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

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

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

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

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

How much funding would I receive?

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

What could I use the funding for?

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

Eligible activities may include:

• Development of speech-generating devices and AAC communication platforms

• AI and machine learning tools for adaptive communication support

• Personalized AAC assessment and recommendation systems

• Precision measurement tools for tracking communication outcomes

• Digital health platforms supporting AAC users and caregivers

• Literacy instruction technologies for AAC users

• Mobile applications supporting non-speaking and minimally verbal individuals

• Predictive analytics and communication profiling systems

• User-centered design and accessibility research for AAC technologies

• Tools supporting communication partner engagement and training

• Clinical software for AAC implementation and therapy management

• Mixed-methods research platforms for communication needs analysis

• Technologies supporting lifelong AAC adaptation and personalization

• Remote monitoring and telehealth solutions for speech and communication therapy

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

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

• Prototype development, validation studies, and usability testing

• Commercialization planning and implementation strategy development

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

Are there any additional benefits I would receive?

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

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

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

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

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

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

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

Where does this funding come from?

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

Who is eligible to apply?

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

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

• Have ≤ 500 employees including affiliates.

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

What companies and projects are likely to win?

Projects that demonstrate:

• A clear unmet medical or public-health need,

• Strong scientific rationale and feasibility,

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

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

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

Are there any restrictions I should know about?

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

• Foreign entities are not eligible.

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

How long will it take me to prepare an application?

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

How can BW&CO help?

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

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

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

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

Review solicitation here.