NIH Highlighted Topic: Health and Extreme Weather: Advancing Critical Research to Address the Direct and Indirect Health Impacts of Weather-Related Natural Disasters and Emerging Weather-Related Harms
Executive Summary
The National Institutes of Health has published a Highlighted Topic titled "Health and Extreme Weather: Advancing Critical Research to Address the Direct and Indirect Health Impacts of Weather-Related Natural Disasters and Emerging Weather-Related Harms." It is issued under the NIH Health and Extreme Weather Program, led by NIEHS, and eleven NIH Institutes award grants under it while four additional offices participate without awarding.
For a small business, the practical translation is this: there is no new application portal and no new deadline attached to this topic. A Highlighted Topic is a demand signal, not a Notice of Funding Opportunity. You capture the funding by submitting to the NIH SBIR or STTR parent announcement, requesting assignment to one of the eleven awarding Institutes, and aligning your Specific Aims to that Institute's stated interests.
Say the hard part first. This is the least small-business-native NIH Highlighted Topic in the current cycle. The great majority of what is described is epidemiology, cohort analysis, natural experiments, community-engaged research, and implementation science, all of which belong in R01 and related mechanisms rather than SBIR or STTR. A company that reads the topic broadly and writes a proposal to match will lose a cycle.
That said, there are real product lanes, and they are unusually concrete where they exist. NIAMS names wearable devices and environmental sensors for personal exposure assessment. NIDDK names the health effects of care discontinuity from lack of medications or electricity-dependent treatments. The topic purpose names methods to advance the aggregation, linking, accessibility, and interpretation of health and weather-related data. NHLBI names integration of environmental and health datasets, NIMH names measurement methods and data sharing methods, and NIAID names vector-borne and waterborne pathogen behavior including changes in susceptibility to anti-infective interventions. Those are sensors, diagnostics, medical device resilience, and data platforms, all of which a company can own and sell.
The topic was posted on September 1, 2026 and expires on May 1, 2028, which is a notably short window and makes April 5, 2028 the last available submission cycle. NIEHS is the only Institute that made both available funding statements, saying it may dedicate available funds and may give special consideration.
At a Glance
Topic title: Health and Extreme Weather
Program: NIH Health and Extreme Weather (HEW) Program, with a published HEW Strategic Framework available on the NIH site
Issuing agency: National Institutes of Health, U.S. Department of Health and Human Services
Awarding Institutes: NIEHS, NCCIH, NCI, NHLBI, NIA, NIAID, NIAMS, NIDDK, NIMH, NIMHD, and NINR
Non-awarding participating offices: OBSSR, ODP, ORWH, and THRO
Central scientific contact: Ashlinn Quinn, ashlinn.quinn@nih.gov, who is also the NIEHS contact
Type: NIH Highlighted Topic. This is not a Notice of Funding Opportunity.
Post date: September 1, 2026
Expiration date: May 1, 2028. Shorter than the usual two-year window.
Recommended small business mechanism: NIH SBIR (R43 and R44) or NIH STTR (R41 and R42) parent announcement
Current parent announcements: PA-27-100 for SBIR, PA-27-102 for STTR, PA-27-101 for the Phase IIB Strategic Breakthrough Award, and PAR-27-098 for the Commercialization Readiness Pilot
Standard annual due dates: January 5, April 5, and September 5
SBA statutory guidelines this cycle: $323,090 Phase I, $2,153,927 Phase II, $4,191,495 CRP
Institute limits vary widely and several published Institute pages still show older SBA figures. Use the current guideline for the dollar amount and treat Institute pages as authoritative for policy.
Clinical trials: NIAMS accepts none under either parent. NIAID, NIDDK, and NIMHD do not accept them under STTR. NIDDK accepts them under SBIR. NCCIH restricts efficacy and effectiveness trials at Phase I. NIAID directs small business clinical trials to a separate cooperative agreement. Confirm before designing.
Cost share: none for Phase I or Phase II. Phase IIB requires 100 percent third-party matching funds.
Equity dilution: none. This is non-dilutive federal funding.
Profit or fee: allowable, must be in the budget at submission, and normally will not exceed 7 percent of total costs
Funding signals: NIEHS stated both that it may dedicate available funds and that it may give special consideration. NIMHD stated it may dedicate available funds. NCCIH, NIDDK, and NINR each stated they may give special consideration. NCI, NHLBI, NIA, NIAID, NIAMS, and NIMH made no statement.
Initiative alignment: none stated. This topic is not issued under the Make America Healthy Again initiative, so there is no policy framing to reference.
What This Opportunity Actually Is
An NIH Highlighted Topic is a published statement of scientific interest from one or more NIH Institutes, Centers, and Offices. It tells the research community that an area of science is a priority without creating a separate funding announcement, deadline, or review process. There is no topic-specific number to search on Grants.gov, and applications are not scored against other applications to the topic.
This one is unusual in being tied to a standing NIH program rather than a one-off priority statement. The Health and Extreme Weather Program has its own Strategic Framework published on the NIH site, and NIEHS effectively runs it, supplying both the central scientific contact and its own Institute contact in the same person. That matters practically: reading the Strategic Framework before writing gives you the program's own language, and a single call to the central contact can help route you among eleven Institutes.
Six Institutes went on record with a funding advantage. NIEHS is the only one making both available statements, which is consistent with it being the lead. NIMHD stated it may dedicate available funds. NCCIH, NIDDK, and NINR each stated they may give special consideration. The remaining six made no statement.
Note also what is absent. Most NIH Highlighted Topics in this cycle are issued under the Make America Healthy Again initiative and list named policy alignments. This one does not, despite the obvious thematic overlap with chronic disease and environmental health. Do not reference an initiative alignment the topic does not claim.
Is This Topic a Fit for a Small Business?
For most companies, no. For a specific set, yes and clearly so. This section is the most useful part of the page, and it is worth being blunt.
Work in this topic that is not a small business fit. Assessing short and long-term health risks across the life course. Analysis of NIA-supported cohorts, which NIA strongly encourages. Natural experiments evaluating naturally occurring events, which NINR names. Epidemiological and mechanistic studies of disease development and progression. Community-engaged research where the company would be a subcontractor. Health disparities characterization. Training and capacity building across disciplines. Research translation and collaboration as ends in themselves. All of this is wanted by NIH and none of it is an SBIR project, because the deliverable is knowledge rather than a commercial product with unresolved technical risk that a company will own and sell.
Work in this topic that is a genuine small business fit.
Wearables and environmental sensors for personal exposure assessment. NIAMS names this explicitly, asking for studies using personal exposure assessment methodologies including wearable devices and environmental sensors to provide stronger causal evidence linking extreme weather and other environmental exposures to disease outcomes. This is the single clearest product invitation in the topic and it comes with a stated scientific rationale you can quote.
Exposure biomarkers. NIAMS asks for biomarkers of environmental exposures such as temperature extremes, air pollution, and wildfires that are associated with worsened disease status, naming flares in psoriasis, atopic dermatitis, and lupus. An assay or panel is a product.
Care continuity and medical device resilience. NIDDK names observational studies and clinical trials addressing health effects of care discontinuity from lack of medications or electricity-dependent treatments. The topic body separately names patients using electricity-dependent equipment as a heightened-risk population, and NCI asks about effects on healthcare delivery among patients undergoing cancer treatment. Backup power, portable or off-grid therapy delivery, medication cold chain, and treatment-interruption management tools all sit here.
Health and environmental data linkage platforms. The topic purpose names methods to advance aggregation, linking, accessibility, and interpretation of health and weather-related data. NHLBI names integration of environmental and health-related datasets. NIMH names data sharing methods supporting rigorous and reproducible findings. NCCIH names integrating health and environmental data. Five separate parts of this topic ask for the same category of software product, which is a strong signal.
Measurement instruments and methods. NIMH asks for methods to accurately measure short and long-term mental illness attributable to extreme weather events. A validated instrument, screener, or digital assessment is a product with a customer.
Digital and remote intervention delivery. NIMH names intervention development and testing to reduce weather-related mental health sequelae and evidence-based practices in real-world settings including communities and schools. NIA names interventions and educational resources for specific older adult populations including within care facilities. NCCIH names multicomponent whole-person interventions and scalable delivery.
Infectious disease diagnostics and anti-infective susceptibility tools. NIAID names zoonotic, food, water, and vector-borne pathogens with respect to reproductive capacity, transmissibility, epidemiology, and virulence, including changes in susceptibility to anti-infective interventions. Detection, surveillance, and resistance testing are products.
In vitro and in silico models. The topic purpose names in vivo, in vitro, and in silico models to understand mechanistic underpinnings. A company with a modeling platform, organ-on-chip system, or computational exposure model has a lane, and this overlaps directly with the NIH New Approach Methodologies push.
The pattern is worth naming: the fundable products here are instruments, assays, sensors, devices, and software. Where the topic asks for understanding, it is asking academics. Where it asks for measurement, detection, linkage, or delivery, it is describing something a company can build.
Which Institute Should You Target?
Eleven awarding Institutes makes the assignment request the highest-leverage decision on the application. Group by what you sell.
Sensors, wearables, and exposure assessment: NIAMS is the primary door and the only Institute naming wearables and environmental sensors outright. NIEHS is the natural second, given its interest in identifying, characterizing, and quantifying the influence of weather and natural disasters on environmental exposures and how weather-related exposures contribute to the exposome across the life course. NHLBI for cardiopulmonary and sleep outcomes.
Data platforms and analytics: NHLBI for integration of environmental and heart, lung, blood, and sleep datasets. NIMH for measurement methods and data sharing. NIEHS for computational studies. NCCIH for integrating health and environmental data. NIA for economic and systems research on healthcare preparedness and health services delivery.
Care continuity, devices, and treatment delivery: NIDDK is the clearest, naming care discontinuity from lack of medications or electricity-dependent treatments, plus acute kidney injury, chronic kidney disease, and kidney stones. NCI for effects on healthcare delivery and outcomes among patients undergoing cancer treatment and survivors. NIA for healthcare preparedness and interventions within care facilities.
Diagnostics and infectious disease: NIAID for airway disease, atopic dermatitis, food allergy, autoimmune and autoinflammatory disease under pollutant, heat, and humidity exposure, and separately for zoonotic, food, water, and vector-borne pathogens including anti-infective susceptibility.
Behavioral health and community intervention: NIMH for mental health measurement, intervention, and resilience. NCCIH for complementary and integrative health interventions targeting stress-related, multisystem, and chronic consequences. NINR for community and organization-level interventions. NIMHD for interventions in populations experiencing disparities, subject to its specific requirement below.
A requirement specific to NIMHD. NIMHD states that projects must focus on NIH-designated populations experiencing disparities and must include validated behavioral, clinical, or biomedical outcomes. That is written as a requirement rather than a preference. It also emphasizes academic-community partnerships and names outdoor workers and rural or coastal residents as example high-risk communities. If you cannot satisfy both the population focus and the validated outcome requirement, target a different Institute.
Quick reference: awarding Institutes, funding signals, and contacts
NIEHS. Lead Institute. Environmental exposures associated with weather phenomena, exposome, epidemiology, mechanistic and computational studies, and interventions including implementation science. May dedicate available funds and may give special consideration, the only Institute making both statements. Contact: Ashlinn Quinn, ashlinn.quinn@nih.gov
NCCIH. Complementary and integrative health interventions for stress-related, multisystem, and chronic consequences, whole-person interventions, community partnership, data integration. May give special consideration. Restricts efficacy and effectiveness trials at Phase I. Contact: NCCIHDERFunding@nih.gov
NCI. Weather-related exposures and cancer etiology and outcomes, susceptibility of patients and survivors, and effects on healthcare delivery during treatment. No stated signal. Contact: Curt Dellavalle, Ph.D.
NHLBI. Cumulative exposures and heart, lung, blood, and sleep health, naming sickle cell disease, anemias, asthma, COPD, heart failure, myocardial infarction, arrhythmias, and hypertension, with emphasis on children, older adults, and pregnant women. No stated signal. Contact: nhlbihighlightedtopics@mail.nih.gov
NIA. Older individuals and caregivers, aging-related processes, pace of aging, functional and cognitive ability, preparedness behavior, healthcare preparedness economics, and interventions in care facilities. Analysis of NIA-supported cohorts strongly encouraged. No stated signal. Contact: Emerald Nguyen, Ph.D., and three additional program contacts
NIAID. Airway and allergic disease, atopic dermatitis, food allergy, autoimmune and autoinflammatory disease, and zoonotic, food, water, and vector-borne pathogens. No stated signal. Directs small business clinical trials to a separate cooperative agreement. Contacts: Adriana Costero-Saint Denis for microbiology and infectious diseases, Patrice Becker for allergy, immunology, and transplantation
NIAMS. Arthritis, musculoskeletal, and skin disease onset, severity, and treatment response, with explicit interest in wearable devices, environmental sensors, and exposure biomarkers. No stated signal. Accepts no clinical trials under either parent. Contact: Rebecca Lenzi, PhD
NIDDK. Care discontinuity from lack of medications or electricity-dependent treatments, plus acute kidney injury, chronic kidney disease, and kidney stones. May give special consideration. Accepts clinical trials under SBIR but not STTR. Contact: Susan Mendley, M.D.
NIMH. Mental health measurement, children and adolescents, intervention development, risk and resilience in at-risk populations, real-world evidence-based practices, and data sharing methods. No stated signal. Contact: Laura Thomas, Ph.D.
NIMHD. Solution-oriented disparities research with a mandatory focus on NIH-designated populations experiencing disparities and validated outcomes. May dedicate available funds. Does not accept clinical trials under STTR. Contact: NIMHDDIBBSScientificTeam@mail.nih.gov
NINR. Community and organization-level interventions, conditions of daily life such as housing stability and neighborhood environments, and natural experiments. Explicitly welcomes scientists from any discipline. May give special consideration. Contact: CDR Nadra Tyus, DrPH, MPH
Which NIH Mechanism Should a Small Business Use?
Small businesses should apply through the NIH SBIR or STTR parent announcement and request assignment to the Institute whose interests match. On this topic, resolve the clinical trial question before you choose either.
NIH Parent SBIR, currently PA-27-100 (R43 and R44). The default route. Accepts Phase I, Phase II, Direct to Phase II, and Fast-Track. Use it when your company performs the majority of the research and your Principal Investigator is primarily employed by the company.
NIH Parent STTR, currently PA-27-102 (R41 and R42). Requires a formal collaboration with a nonprofit research institution, with at least 40 percent of the research at the small business and at least 30 percent at a single partner institution. STTR permits the Program Director or Principal Investigator to be employed by either the small business or the partnering nonprofit while the award still goes to the small business, which is useful here because the exposure science, atmospheric science, and epidemiology expertise this topic calls for usually sits in universities. Note that companies more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination are not eligible for STTR.
The clinical trial picture for this topic. This is where applications become non-responsive.
NIAMS accepts no clinical trials under either parent announcement, despite asking for causal-evidence studies using wearables and sensors. Design around this or use a NIAMS-specific announcement.
NIDDK names clinical trials twice in its published interests for this topic and accepts them under the parent SBIR announcement but not under STTR. A project with an academic PI and a trial component cannot use STTR here.
NIMHD does not accept clinical trials under STTR.
NCCIH operates a Phase-specific policy: it will not support clinical trials aiming to test efficacy or effectiveness as part of an SBIR or STTR Phase I application, meaning a study powered on a primary clinical outcome. It does accept basic experimental studies in humans, human mechanistic studies, and pilot feasibility testing at Phase I, and accepts clinical trials of all types at Phase II and Fast-Track. Given that NCCIH's entire interest here is rigorous intervention evaluation, this shapes how you stage the work.
NIAID requires direct confirmation. NIAID is not on the exclusion list in the parent SBIR announcement, but NIAID's own small business program guidance states that it supports clinical trial research performed by small businesses only through a separate NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement, and that other Institutes may fund small business clinical trials through the parent announcements while NIAID does not. These two sources point in different directions, so anyone planning a trial with NIAID must confirm the current position with NIAID program staff rather than relying on the parent announcement alone.
A distinction worth stating. NIH small business phases are separate from and not aligned with clinical trial phases. An SBIR Phase I is a feasibility award, not a clinical Phase I trial. Run the NIH clinical trial determination against your actual design first, then pick the Institute, then pick the announcement.
Direct to Phase II. Available if you already hold the feasibility data a Phase I would generate and never received a Phase I award for that project. SBIR only. For a sensor or software company with a validated product in another exposure context, this is often the fastest route into this topic.
Fast-Track. Phase I and Phase II submitted together, reviewed once. Poor fit where Phase I results would change the Phase II design. Note that Fast-Track is also the point at which NCCIH accepts trials of all types.
Phase IIB Strategic Breakthrough Award, currently PA-27-101 (R44). For companies that completed an NIH SBIR or STTR Phase II and need a commercialization bridge. Requires documentation of not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award. Award periods must not exceed 4 years.
Commercialization Readiness Pilot, currently PAR-27-098 (SB1). Late-stage technical assistance and product development not fundable through Phase II or Phase IIB, including Investigational New Drug and Investigational Device Exemption enabling studies, independent replication of key studies, clinical studies, manufacturing costs, and regulatory assistance. Relevant here for a sensor, diagnostic, or device requiring regulatory clearance.
Funding Allowance
Layer one, the SBA statutory guidelines for the current cycle:
Phase I: up to $323,090 in total costs, for a project period of 6 months to 2 years
Phase II: up to $2,153,927 in total costs, for a project period of 1 to 3 years
Commercialization Readiness Pilot: up to $4,191,495 in total costs, for a project period of up to 3 years
Total funding support means direct costs, indirect costs, and fee combined. A reasonable profit or fee is allowable but must be in the budget at submission and normally will not exceed 7 percent of total costs. NIH does not adjust budgets after submission, so a request at the wrong level cannot be corrected later.
A practical warning about published Institute figures. Several Institute small business pages, including NIDDK's and NIAID's, still display older SBA guideline amounts such as $314,363 for Phase I and $2,095,748 for Phase II, and some NIEHS-specific announcements reference figures older still. The SBA adjusts these annually. Use the current guideline for the dollar amount and treat Institute pages as authoritative for policy, waiver eligibility, and per-year constraints rather than for the headline number. When the two conflict, ask program staff.
Layer two, Institute-specific guidance for participants in this topic:
Higher Phase I headroom. The participating component table in the parent SBIR announcement lists Phase I limits above the statutory guideline for several Institutes here, reaching $700,000 at the top tier, which includes NCI, NIA, NIAID, NIMH, and NCCIH. Others list $400,000 and some hold to the SBA guideline.
NCI. Generally funds waiver-eligible Phase I up to $400,000 across up to 2 years and considers Phase II up to $2,250,000 across up to 3 years. NCI's separate Phase IIB Bridge Award, announced through its own solicitation, provides funding support up to $4,500,000 in total costs and accepts technologies previously funded under SBIR or STTR Phase II from any federal agency, which is a broader eligibility base than most bridge programs.
NIAID. Applies a per-year constraint that reshapes budgets more than a total ceiling: NIAID will not generally allow Phase II or Phase IIB awards of any duration exceeding $1,000,000 in total costs per year. NIAID also notes that applicants are not limited to NIAID's own SBA-approved topic list, since all topics on the NIH list can be funded at a higher budget without a separate waiver request.
NIDDK. Generally considers Phase I up to $350,000 across up to 2 years, Phase II up to $2,200,000 across up to 3 years, and Phase IIB up to $3,000,000, with Phase II and Phase IIB generally not exceeding $1,100,000 in any single year.
NIEHS. Beyond the parent announcements, NIEHS runs targeted small business announcements that carry materially different terms, including some that accept Phase I applications only and some with substantially lower caps, such as its Superfund Research Program small business track. If NIEHS is your target, confirm which announcement you are applying under and what its budget language says before you build a budget, because the parent guideline may not apply.
NCCIH, NHLBI, NIA, NIAMS, NIMH, NIMHD, NINR. Refer to the participating component table in the current parent announcement and confirm with program staff. These Institutes do not all maintain standing published SBIR budget pages, and NHLBI publishes its guidance through NOT-HL notices.
Two general cautions. A ceiling in a component table is not the number that gets awarded. BW&CO's analysis of a fiscal year 2026 NCI SBIR award slice found Phase I level awards ranging from roughly $305,000 to $404,000, with not one award in 44 records reaching the $700,000 headroom. And an Institute may reduce the recommended budget or shorten the award period for budgetary, administrative, or programmatic reasons even after a strong review score.
Timeline
The topic window runs from September 1, 2026 through May 1, 2028. That expiration is well short of the usual two years and sits between two standard due dates.
Standard annual due dates: January 5, April 5, and September 5. When a due date falls on a weekend or federal holiday, NIH moves it to the next business day. Applications are due by 5:00 p.m. local time of the applicant organization.
Cycles available under this topic:
September 2026 cycle: the September 5, 2026 date shifted to Tuesday, September 8, 2026 because of the weekend and the Labor Day holiday. Since the topic posted on September 1, this cycle is not realistically available.
January 5, 2027: the first realistic cycle for a company beginning preparation now.
April 5, 2027
September 5, 2027
January 5, 2028
April 5, 2028, the final cycle. The topic expires May 1, 2028, before the September 2028 date.
What the runway looks like: plan on roughly 9 months from submission to funds in the door. An application submitted in the January 2027 cycle typically reaches an earliest possible start date in the fall of 2027. Council decisions for the September and January cycles are often handled together, so deferring a cycle is not costless. With five cycles remaining and a May 2028 expiration, the effective planning horizon here is shorter than on most topics.
Work backwards from your target date:
16 to 18 weeks out: read the HEW Strategic Framework, identify your target Institute, run the NIH clinical trial determination, confirm the Institute's clinical trial policy for your chosen mechanism, contact program staff, and start or verify federal registrations
12 weeks out: lock the Specific Aims page and circulate to program staff
8 weeks out: complete the research strategy, commercialization plan, community or Tribal partnership documentation if applicable, data use agreements for any linked datasets, letters of support, and human subjects planning
4 weeks out: full internal review, budget finalization, and subaward paperwork for any STTR or academic partner
1 week out: submit early to leave room for eRA Commons error correction
Registrations are the most common cause of a missed deadline. You need SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on the SBA Company Registry being complete first. Allow six weeks or more and begin before you write.
Also note the current SBIR parent, PA-27-100, closes in early April 2027, before this topic expires, so applicants targeting later cycles must confirm the active announcement number at submission.
Detailed Overview of What NIH Is Looking For
Program aims and scope
The HEW Program aims to support research increasing understanding of how extreme weather, including weather-related natural disasters and emerging weather-related harms, affects human health. Beyond mechanistic processes, the program prioritizes research to develop, test, implement, and evaluate interventions and prevention strategies protecting the health of communities and those at heightened risk for mortality, chronic disease, and lifelong health risks. It also prioritizes research connecting health and environmental data, training and capacity building, community engagement, research translation, and collaboration, and aims to promote collaborative science across biological sciences, atmospheric science, health economics, implementation science, and other disciplines.
The defined scope of extreme weather is broad and worth quoting in your Significance section because it is wider than most applicants assume. It covers extremes in temperature, precipitation, humidity, wind velocity, and other meteorological variables; wildfires, hurricanes, droughts, floods, heatwaves, harmful algal blooms, snowpack loss, and extreme storms; and weather's downstream influence on other environmental exposures and health-relevant outcomes.
That third element is the most useful for a company. A product that addresses a downstream exposure, air quality after wildfire smoke, waterborne pathogens after flooding, algal toxins, or heat-driven changes in medication stability, is in scope even if the product never measures weather directly.
The translational continuum
The topic states that projects may sit at different nodes on the translational continuum and names three application types: using in vivo, in vitro, and in silico models to understand mechanistic underpinnings; assessing short and long-term health risks across the life course and among populations at heightened risk; and developing, testing, implementing, and evaluating evidence-based interventions to prevent or reduce impacts.
It then adds two further categories: methods to advance the aggregation, linking, accessibility, and interpretation of health and weather-related data, and efforts to provide training and build capacity across disciplines. Community engagement, interdisciplinary collaboration, and research translation are encouraged throughout.
For a small business, the first and third of the named application types plus the data methods category are where products live. The second, risk assessment across populations, is epidemiology.
Priority populations, and why the list matters commercially
The topic names an unusually specific set of populations at heightened risk: children, people with chronic pre-existing medical conditions, pregnant women, newborns, agricultural and other outdoor workers, older adults, military personnel and veterans, first responders, patients using electricity-dependent equipment, residents of rural and urban areas, and those with limited economic resources.
Several of these are also identifiable customers or channels, which is unusual. Outdoor and agricultural workers imply an employer purchaser and an occupational health channel. First responders and military personnel imply institutional procurement and a possible bridge to Department of Defense funding. Patients using electricity-dependent equipment imply a payer, a durable medical equipment channel, and a device manufacturer partner. Care facilities, which NIA names directly, imply a facility purchaser. A commercialization plan that connects your named priority population to the entity that would actually pay is doing something most applications on this topic will not.
Institute reads worth acting on
NIAMS is the most product-friendly language in the topic. It asks for personal exposure assessment using wearable devices and environmental sensors specifically to provide stronger causal evidence, and adds that research advancing beyond associations and integrating cutting-edge exposure assessments, mechanistic insights, and longitudinal designs is encouraged. It names concrete disease endpoints, flares in psoriasis, atopic dermatitis, and lupus, which gives a sensor company a measurable clinical outcome to anchor to rather than a vague exposure metric. The constraint is that NIAMS accepts no clinical trials under either parent announcement, so the study design must stay observational, mechanistic, or technical.
NIDDK offers the clearest device and logistics problem. Care discontinuity from lack of medications or electricity-dependent treatments is a defined failure mode with identifiable products attached: backup power, off-grid or portable therapy delivery, cold chain integrity, and interruption management. NIDDK also names acute kidney injury, chronic kidney disease, and kidney stones, where heat and dehydration effects are well established. NIDDK stated it may give special consideration and accepts clinical trials under SBIR.
NIEHS is the lead and made the strongest funding statements, but its interests are the most academic. Exposome characterization, epidemiology, and mechanistic and computational studies dominate. The intervention bullet, studies focused on interventions to reduce health impacts of environmental exposures driven or exacerbated by weather including implementation science approaches, is the one to write against if NIEHS is your target. Also confirm which NIEHS announcement applies, since its targeted tracks carry different terms.
NIMH offers a measurement product opportunity that is easy to miss. Its first bullet asks for methods to accurately measure short and long-term mental illness attributable to extreme weather events. That is instrument development, not intervention research, and it is a distinct product category from the intervention bullets that follow. NIMH also names data sharing methods to support rigorous and reproducible findings.
NIAID splits into two very different lanes. The allergy and airway lane concerns immune responses under pollutant, heat, and humidity exposure across asthma, allergic rhinitis, chronic rhinosinusitis, respiratory viral susceptibility, atopic dermatitis, food allergy, and autoimmune or autoinflammatory disease. The infectious disease lane concerns zoonotic, food, water, and vector-borne pathogens, their reproductive capacity, transmissibility, epidemiology, and virulence, including changes in susceptibility to anti-infective interventions. That last clause is a resistance and susceptibility testing product. NIAID lists separate contacts for each lane, so call the right one.
NINR is the most discipline-open. It states that it supports research aligned with its mission conducted by scientists from any discipline, which is a lower barrier than most Institutes present, and it stated it may give special consideration. Its interest in conditions of daily life such as housing stability and neighborhood environments shaping resilience and recovery is largely academic, but community and organization-level intervention development and evaluation can support a delivery product.
What the non-awarding offices add
Four offices participate without awarding: OBSSR, ODP, ORWH, and THRO. Your application must be relevant to the objectives of at least one of the eleven awarding Institutes, and their interests function as additional strength.
ODP is the most directly useful to a product company, naming projects that develop, test, and implement preparedness, prevention, and recovery interventions, particularly for populations at heightened risk, and projects that evaluate strategies to prevent disruptions to screening and healthcare services following extreme weather events. That second bullet pairs precisely with the NIDDK care continuity and NCI healthcare delivery interests, and screening disruption is a defined operational problem.
ORWH gives priority to multidisciplinary studies using sex-disaggregated data, and names how extreme weather affects chronic conditions in women with risk varying by age, reproductive stage, and menopausal status; evaluation of disaster preparedness plans addressing women's mental health, chronic disease management, and reproductive health needs; resilience among women in rural and medically underserved communities; and effects of environmental displacement and changed living conditions. Sex-disaggregated analysis is a low-cost design decision that most applications will handle minimally.
THRO supports research on how extreme weather affects the health of American Indian and Alaska Native peoples, encouraging studies exploring Tribe and community-specific weather exposures, focusing on AI/AN people at heightened risk such as those who work outside or live in areas with severe weather, tapping existing resources and strengths, employing culturally grounded research approaches and health measures, and including AI/AN participants, practices, and ways of knowledge as much as possible. Claiming THRO alignment requires documented Tribal partnership, not an assertion of intent.
OBSSR participates without publishing specific interests for this topic.
Eligibility Requirements
To apply for an NIH SBIR or STTR award, your company must meet the core SBA criteria:
Organized for profit, with a place of business located in the United States, and the primary research performed in the United States
More than 50 percent directly owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens, by other for-profit small business concerns each majority owned by such individuals, or by a combination. Certain venture capital, hedge fund, and private equity structures may qualify for SBIR under specific conditions, but companies more than 50 percent owned by multiple such firms in combination are not eligible for STTR. Complex cap tables should be checked against 13 CFR Part 121.
No more than 500 employees including all affiliates. A subsidiary counts its parent's employees.
For SBIR, the Principal Investigator's primary employment must be with the small business at the time of award and for the duration of the project. For STTR, the PD/PI may be primarily employed by either the small business or the partnering nonprofit research institution, with the award still made to the small business.
For SBIR Phase I, the small business must perform at least two thirds of the research or analytical effort. For SBIR Phase II, at least half. For STTR, the small business performs at least 40 percent and a single partner nonprofit research institution performs at least 30 percent.
Additional constraints. NIH will not accept similar applications with essentially the same research focus from the same applicant organization, including derivative applications proposing a single product applicable to multiple purposes with non-substantive modification, which is a live risk on a topic where one sensor or data platform could plausibly be pitched to five Institutes. You may not simultaneously submit identical or essentially identical applications under both parent announcements, and duplicate or highly overlapping applications under simultaneous review are not accepted. Applicants must disclose overlapping federal work under the essentially equivalent work rule. Companies with a substantial award history should confirm they meet the Phase I to Phase II Transition Rate and commercialization benchmarks. Heightened screening of foreign ownership and foreign influence applies under the 2026 reauthorization.
What a Competitive Application Looks Like
A product, stated plainly, in the first paragraph. Most applications to this topic will propose research. Reviewers assigned to a small business application are looking for a commercial product with unresolved technical risk. Make the product unmistakable early, because the surrounding topic language invites drift toward a study.
A named priority population that maps to a payer. The topic lists eleven heightened-risk populations, several of which come with an obvious purchaser: employers for outdoor workers, institutions for first responders and military personnel, durable medical equipment channels and payers for patients using electricity-dependent equipment, facilities for older adults in care settings. Connecting the population to the payer is a commercialization argument almost no competing application will make.
Causal evidence, not association. NIAMS asks for stronger causal evidence and for research advancing beyond associations. NIMHD requires validated behavioral, clinical, or biomedical outcomes. If your product generates exposure data, state what clinical outcome it is validated against and how.
Data linkage handled as engineering, not aspiration. Five parts of this topic ask for health and environmental data integration. Naming the specific datasets, the linkage method, the spatial and temporal resolution problem, and the data use agreements you will need reads as a technical plan rather than a wish.
The clinical trial determination resolved before the mechanism is chosen. Five participating Institutes carry restrictions and NIAID's position requires direct confirmation.
The HEW Strategic Framework read and reflected. The program publishes its own framework. Using its language is free and most applicants will not bother.
Program officer contact before writing. Eleven Institutes, six different funding signals, five clinical trial complications, and a central contact who can route you. This call is worth more here than on almost any topic.
Common Reasons Applications Miss
Treating the Highlighted Topic as a NOFO and searching Grants.gov for a topic-specific number that does not exist
Bringing an epidemiology, cohort analysis, or natural experiment project to a small business mechanism, where the deliverable is knowledge rather than a product the company will own and sell
Proposing a clinical trial to NIAMS, which accepts none under either parent announcement
Proposing a clinical trial to NIDDK or NIMHD through STTR, which neither accepts, when SBIR would have worked at NIDDK
Proposing an efficacy or effectiveness trial to NCCIH at Phase I, which NCCIH does not support at that phase but does accept at Phase II and Fast-Track
Planning a clinical trial with NIAID on the strength of the parent announcement alone, when NIAID's own guidance directs small business trials to a separate cooperative agreement
Targeting NIMHD without a designated disparity population focus and validated behavioral, clinical, or biomedical outcomes, both of which NIMHD states as requirements
Building a budget from an Institute page still displaying an older SBA guideline figure rather than the current amount
Budgeting to the $700,000 Phase I ceiling rather than the roughly $400,000 that Institutes actually award, or concentrating Phase II costs in one year at NIAID, which will not generally allow more than $1,000,000 in total costs per year
Applying to NIEHS under the parent guideline when a targeted NIEHS announcement with different terms and a lower cap actually governs
Pitching one sensor or data platform to several Institutes at once, which runs into the prohibition on derivative applications proposing a single product applicable to multiple purposes
Claiming THRO alignment without documented Tribal partnership, or community engagement without named partners and letters
Referencing a Make America Healthy Again alignment that this topic, unlike most in the cycle, does not claim
Starting federal registrations after drafting begins, then missing the receipt date on an eRA Commons validation error
Frequently Asked Questions
Is this a grant I can apply to directly?
No. This is an NIH Highlighted Topic, which is a statement of scientific priority rather than a Notice of Funding Opportunity. You apply through a broad NIH announcement, and for small businesses that means the NIH SBIR or STTR parent announcement, requesting assignment to one of the eleven awarding Institutes.
Which funding opportunity number do I actually use?
For most small businesses it is PA-27-100, the NIH, CDC, and FDA Parent SBIR announcement covering R43 and R44 awards. If your project depends on a formal university or nonprofit research partner, use PA-27-102, the Parent STTR announcement covering R41 and R42. If NIEHS is your target, confirm whether a targeted NIEHS announcement governs instead, since its terms and caps can differ.
Is this topic actually a fit for a small business?
For most companies, no. The majority of the described work is epidemiology, cohort analysis, natural experiments, community-engaged research, and implementation science, which belong in R01 and related mechanisms. Genuine small business lanes include wearables and environmental sensors for personal exposure assessment, exposure biomarkers, care continuity and medical device resilience for electricity-dependent treatments, health and environmental data linkage platforms, mental health measurement instruments, digital and remote intervention delivery, infectious disease diagnostics and anti-infective susceptibility testing, and in vitro or in silico models.
Which of the eleven Institutes should I target?
Sensors and exposure assessment point to NIAMS first, then NIEHS and NHLBI. Data platforms point to NHLBI, NIMH, NIEHS, NCCIH, or NIA. Care continuity and devices point to NIDDK, then NCI and NIA. Diagnostics and infectious disease point to NIAID. Behavioral health and community intervention point to NIMH, NCCIH, NINR, or NIMHD. NIEHS leads the program and is the only Institute that made both available funding statements.
How much money can my company request?
The SBA statutory guidelines this cycle are $323,090 for Phase I and $2,153,927 for Phase II in total costs, including direct costs, indirect costs, and fee. Several participating Institutes list Phase I headroom to $700,000. NCI generally funds waiver-eligible Phase I near $400,000 and Phase II up to $2,250,000, and its separate Phase IIB Bridge Award provides up to $4,500,000. NIDDK publishes $350,000 and $2,200,000. NIAID applies a per-year constraint of $1,000,000 in total costs on Phase II and Phase IIB. Note that several Institute pages still display older SBA figures, so confirm the current amount.
When is the deadline?
There is no deadline specific to this topic. You submit on the NIH standard small business receipt dates of January 5, April 5, and September 5 each year, with dates falling on weekends or federal holidays moving to the next business day. The topic expires May 1, 2028, which is earlier than the usual two-year window and makes April 5, 2028 the final available cycle.
Can I include a clinical trial?
It depends on the Institute and the mechanism, and this topic has more complications than most. NIAMS accepts none under either parent announcement. NIDDK and NIMHD do not accept them under STTR, though NIDDK does under SBIR. NCCIH will not support efficacy or effectiveness trials at Phase I but accepts trials of all types at Phase II and Fast-Track. NIAID's own guidance directs small business clinical trials to a separate cooperative agreement, so confirm directly with NIAID before planning one. Run the NIH clinical trial determination against your design first.
How long until I receive funding?
Plan on approximately 9 months from submission to award start. An application submitted in the January 2027 cycle would typically have an earliest possible start date in the fall of 2027.
Do I have to give up equity or match the funds?
No. NIH SBIR and STTR Phase I and Phase II awards are non-dilutive and require no cost share. The exception is the Phase IIB Strategic Breakthrough Award, which requires not less than 100 percent matching funds from new private capital or from a government source other than a Phase I or Phase II SBIR or STTR award.
What counts as extreme weather under this topic?
The defined scope is broad: extremes in temperature, precipitation, humidity, wind velocity, and other meteorological variables; wildfires, hurricanes, droughts, floods, heatwaves, harmful algal blooms, snowpack loss, and extreme storms; and weather's downstream influence on other environmental exposures and health-relevant outcomes. That third element means a product addressing a downstream exposure, such as post-wildfire air quality, post-flood waterborne pathogens, or algal toxins, is in scope even if it never measures weather directly.
Does my project have to involve a specific population?
Not universally, but the topic names eleven heightened-risk populations including children, people with chronic conditions, pregnant women, newborns, agricultural and other outdoor workers, older adults, military personnel and veterans, first responders, patients using electricity-dependent equipment, rural and urban residents, and those with limited economic resources. NIMHD, separately, requires a focus on NIH-designated populations experiencing disparities plus validated behavioral, clinical, or biomedical outcomes.
Does any Institute set aside dedicated funding for this topic?
Not guaranteed, but six made statements. NIEHS, the lead Institute, stated both that it may dedicate available funds and that it may give special consideration. NIMHD stated it may dedicate available funds. NCCIH, NIDDK, and NINR each stated they may give special consideration. NCI, NHLBI, NIA, NIAID, NIAMS, and NIMH made no statement. Treat these as a favorable tilt rather than a reserved pool.
I already have feasibility data. Do I still need a Phase I?
Not necessarily. SBIR Direct to Phase II allows a company that has demonstrated the scientific and technical merit and feasibility normally expected from a Phase I, without having received a Phase I award for that project, to apply directly for Phase II. This authority is available for SBIR only and is not available under STTR. A sensor or software product already validated in another exposure context is a common qualifying profile.
Does this topic align with the Make America Healthy Again initiative?
No. Unlike most NIH Highlighted Topics published in this cycle, this one lists no initiative alignment and no named policy efforts. It is instead tied to the NIH Health and Extreme Weather Program and its published Strategic Framework, which is what applicants should read and reference.
Do OBSSR, ODP, ORWH, and THRO award grants?
No. All four participate without awarding. Your application must be relevant to the objectives of at least one of the eleven awarding Institutes. ODP's interests are the most useful to a product company, particularly its focus on preventing disruptions to screening and healthcare services after extreme weather events.
What registrations do I need, and how long do they take?
SAM.gov with a Unique Entity ID, the SBA Company Registry, eRA Commons, and Grants.gov. eRA Commons access depends on completing the SBA Company Registry first, so the sequence matters. Allow at least six weeks, and start before you begin writing.
How BW&CO Helps
BW&CO is a non-dilutive federal funding advisory firm. We help deep-tech, biotech, medtech, and health technology founders convert agency priority signals like this one into funded awards.
On a topic this broad and this academically weighted, the first job is an honest fit assessment. If your project is research rather than product development, we will tell you so and point you at the right mechanism. If it is a sensor, diagnostic, device, or data platform, the work is Institute selection across eleven options with six different funding signals, resolving the clinical trial determination and the several Institute restrictions attached to it, confirming which NIEHS announcement governs, program officer engagement, Specific Aims development, full proposal build, budget and fee construction, commercialization planning that connects the priority population to an actual payer, and Phase IIB and CRP sequencing. Our team has helped clients secure more than $350 million in funding. Innovation Funding Simplified.
If you are building a product that measures, prevents, or manages the health effects of extreme weather and want a straight answer on whether this topic fits your company and whether you are competitive for the January 5, 2027 cycle, contact us for a fit assessment.
