Small Business Innovation Research (SBIR) - NIAID Drug Delivery Systems

Small Business Innovation Research (SBIR) - NIAID Drug Delivery Systems is sponsored by National Institute of Allergy and Infectious Diseases (NIAID/NIH). Supports development of implantable devices for sustained drug release to combat infectious diseases, with emphasis on long-term delivery efficacy. This program should be reviewed carefully against your organization's mission, staffing capacity, timeline, and compliance readiness before you commit resources to a full application. Strong submissions usually translate sponsor priorities into concrete objectives, clear implementation milestones, and measurable public benefit.

For planning purposes, treat rolling deadlines or periodic funding windows as your working submission target unless the sponsor publishes an updated notice. A competitive project plan should include a documented need statement, implementation approach, evaluation framework, risk controls, and a realistic budget narrative. Even when a grant allows broad program design, reviewers still expect credible evidence that the proposed work can be executed within the grant period and with appropriate accountability.

Current published award information indicates $50,000 - $1,800,000 Organizations should verify the final funding range, matching requirements, and allowability rules directly in the official opportunity materials before preparing a budget. Finance and program teams should align early so direct costs, indirect costs, staffing assumptions, procurement timelines, and reporting obligations all remain consistent throughout drafting and post-award administration.

Eligibility guidance for this opportunity is: U.S. small businesses If your organization has partnerships, subrecipients, or collaborators, define responsibilities and compliance ownership before submission. Reviewers often look for implementation credibility, so letters of commitment, prior performance evidence, and a clear governance model can materially strengthen the application narrative and reduce concerns about delivery risk.

A practical approach is to begin with a focused readiness review, then build a workback schedule from the sponsor deadline. Confirm required attachments, registration dependencies, and internal approval checkpoints early. This reduces last-minute issues and improves submission quality. For the most accurate requirements, always rely on the official notice and primary source links associated with Small Business Innovation Research (SBIR) - NIAID Drug Delivery Systems.

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Some links will work for NIAID staff only. To fund small business grants with set-aside funds to support research and development of products or services that improve public health in areas relevant to NIAID. NIAID awards Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants with set-aside funds mandated by Congress.

Recipients of small business awards must meet the Small Business Eligibility Criteria . Only for-profit Small Business Concerns (SBCs) that have a majority ownership by U. S.

citizens or permanent resident aliens can apply for small business awards. If a legal action occurs—such as a merger, acquisition, or successor-in-interest—that changes your organization status so that it is no longer eligible for the SBIR/STTR programs, existing SBIR/STTR awards cannot be awarded additional funds. Your organization would also no longer be eligible for any new SBIR/STTR grants.

Contact the NIH awarding office in advance of legal actions that may affect organizational eligibility. For more information, refer to the NIH Grant Policy Statement , Section 8. 1.

2. 8. Change in Recipient Organizational Status .

NIH will negotiate bi-lateral terminations with recipients that are ineligible to continue to receive SBIR/STTR funding. Applicants must submit SBIR and STTR applications electronically using either the NIH Application Submission System and Interface for Submission Tracking (ASSIST) or another of the NIH Submission Options . Refer to How to Submit, Track, and View Your Application .

Read the SF 424 Application Guide and the notice of funding opportunity (NOFO) for detailed instructions. Also check Apply for a Grant . Budget: Hard Caps, Small Business Administration (SBA) Waiver, and NIAID Budget Request Limitations Total funding support (direct costs + indirect costs + fee) normally may not exceed $314,363 for Phase I awards and $2,095,748 for Phase II awards.

Budget requests at or near these hard caps should be well justified. Phase II/IIB applicants should note that NIAID will not generally allow awards (of any duration) that exceed $1 million total costs per year. NIH has received a waiver from the Small Business Administration (SBA), as authorized by the statute, to exceed the hard cap for specific topics.

Applicants can find the list of approved topics at SBA-Approved Topics List for Awards over Statutory Budget Limitations . NIAID Budget Request Limitations Unless the NOFO states otherwise, NIAID will allow Phase I applications with budgets of up to $314,363 total costs per year for up to 2 years; and Phase II or Phase IIB applications with budgets of up to $1 million total costs per year for up to 3 years.

Requests for these budget levels must be very well justified. In all cases, applicants should propose a budget that is reasonable and appropriate for completing the research project. Applications exceeding NIAID budget caps may be withdrawn from funding consideration.

Applicants are strongly encouraged to contact the NIAID Small Business Program Team before submitting any application in excess of the hard caps. NIAID staff cannot provide prior approval to exceed hard caps. At the time of award, the applicant’s grants management specialist and program officer will confirm compliance with a pre-approved topic.

That does not mean that NIAID will automatically award the higher budget. Applicants must provide an appropriate budget and justification for a budget that exceeds the SBIR/STTR hard caps.

The budgets of SBIR and STTR applications will be evaluated to assess the appropriateness of the budget to the timeliness of the research goals and may be reduced on a case-by-case basis as recommended by peer reviewers, Institute/Center Advisory Board/Council, or program staff. When making awards, NIH reserves the right to withhold or reduce grant funding on applications at any ranking based on program priority.

NIH’s list eliminates the need for NIH staff to request waivers from SBA to pay awards that are greater than the hard cap for topics on the list. As referenced above under "Waiver," NIH has received approval from SBA for specific topics for budgets that exceed the hard caps.

The following are key references regarding such topics: Program Descriptions and Research Topics Document SBA-Approved Topics List for Awards over Statutory Budget Limitations The applicant is not limited to topics on the NIAID research topics list approved by SBA. All topics on the NIH list can be funded at a higher budget without a separate waiver request.

Note that NIAID supports clinical trial research performed by small businesses only through the NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) . Go to Does your human subjects research study meet the NIH Definition of a clinical trial? to determine whether your study is a clinical trial.

Other institutes may fund clinical trials conducted by small businesses through other programs—look for NOFOs titled “Clinical Trial Required” or “Clinical Trial Optional”—but NIAID does not. Applicants, Recipients, and PIs Learn about NIAID Small Business Programs . To find a NOFO that best matches your intended research, go to NIH’s SBIR and STTR Funding Opportunities .

Note: NIAID offers contract opportunities for small businesses. To find out what’s available, go to Extramural R&D Solicitations . To identify the SBIR/STTR funding opportunities in which NIAID participates, check Current Small Business Notices of Funding Opportunities .

Identify what phase of research you are pursuing and check "Application Types Allowed" within Section II of the NOFO to verify that it supports that stage of research. Read a NOFO's recommendations on budget and length of award. Check High-Priority Areas of Interest for NIAID’s Small Business Program for application ideas.

Find SBIR and STTR application guidance on NIH’s Applying page and NIAID’s Small Business Grant Application Process . To identify an appropriate program officer to discuss scientific issues related to your proposal, email the NIAID Small Business Program Team with a brief, non-confidential summary of your planned project.

They will consult with the extramural divisions to confirm your project fits with NIAID’s mission and provide you with a contact for further discussion. If your research involves the use of federal facilities or personnel, contact the Grants Management Program to discuss requirements for collaboration with federal facilities. Advise applicants to include both science and business goals in the application.

Encourage applicants to review Small Business Programs , Types of Funding Opportunities , and the NIAID Apply for a Grant portal before preparing their applications. Direct applicants to the NIH SBIR/STTR website, which contains important information about these programs, including Comparing the Small Business Programs – SBIR and STTR , Frequently Asked Questions , and Small Business Eligibility Criteria .

For more information on funding opportunities, check SBIR/STTR Find Funding . Discuss with applicants the relevance of their project to NIAID's mission. Identify NIAID resources that may help applicants with their research.

Identify additional funding opportunities that might be useful to applicants. Advise your division's small business representative on unfunded SBIR and STTR applications that other institutes may fund. Identify other institutes that may be scientifically appropriate for applications.

Inform divisional representatives if you have discussed a possible transfer with other institutes. If applicants or recipients needs further guidance, refer them to the relevant divisional small business representative. Grants Management Specialists Verify that an applicant organization qualifies as a small business.

Send SBIR Funding Agreement Certification or STTR Funding Agreement Certification to the applicant. If a grant is ineligible, remove it from NPARS and notify the lead SBIR or STTR grants management staff and Director of the Office of Research Training and Special Programs. Provide applicants with advice on NIH mandatory requirements (e.

g. , budget and finance, human subjects, animal welfare). Limit most awards to the caps above.

Office of Research Training and Special Programs Advise potential small business applicants. Coordinate small business awards with the NIAID Small Business Program Team and divisional small business representatives. Create an Excel spreadsheet listing all NIAID competitive SBIR and STTR applications for the fiscal year with overall impact scores and notes on intent to pay.

Send the spreadsheet to divisional small business representatives. Track the funding of competitive small business awards and share data with divisional small business representatives and DEA management.

NIAID Small Business Program Team Divisional Small Business Representatives DAIT—Michael Minnicozzi (grants); Karina Allbritton (contracts); Carmen Rios (Radiation and Nuclear Countermeasures) DMID—Barbara Mulach; Alyssa Werner Grants Management Program—Chernay Rogers; Sufiyan Saeed HHS Small Business Program Lead—Stephanie Fertig NIH Small Business Find Funding NIH Small Business Frequently Asked Questions NIAID Small Business Programs Team Roles and Agreements Resources for NIAID Staff NIAID Planning and Reporting System (NPARS) NIAID Planning and Reporting System (NPARS) SOP Release of Funds for Solicited, Opportunity Pool, and Career Transition (K99/R00) Awards SOP Repooling and Reprogramming SOP Content last reviewed on March 27, 2025 Website Policies & Notices Freedom of Information Act (FOIA) HHS Vulnerability Disclosure Policy Related Government Websites National Institutes of Health Health and Human Services