National Institutes of Health SBIR/STTR

Introduction to the application (required only for Resubmission or Revision applications) is limited to 1 page for SBIR/STTR (R41-R44). (The Table notes a 3-page limit only for certain training/career codes T, D43, D71, K12, R25, which do not apply to SBIR/STTR.)

Research Strategy for SBIR/STTR Phase II (R44/R42) is limited to 12 pages, including all tables, graphs, figures, diagrams, and charts. The Table of Page Limits lists R42 and R44 in the 12-page row. The FOA or a Guide notice overrides this if different.

Specific Aims is limited to 1 page for all activity codes that use a form with a Specific Aims section (includes SBIR/STTR Phase I and Phase II), unless the funding opportunity or a Guide notice specifies otherwise.

Follow the page limits in the Table of Page Limits unless the funding opportunity (NOFO) or a related NIH Guide notice states a different limit. FOA instructions always supersede the application guide, and NIH Guide notice information supersedes both.

Research Strategy for SBIR/STTR Phase I (R43/R41) is limited to 6 pages, including all tables, graphs, figures, diagrams, and charts. The Table of Page Limits lists R41 and R43 in the 6-page row. The FOA or a Guide notice overrides this if different.

Recommended fonts are Arial, Georgia, Helvetica, and Palatino Linotype. Other fonts (serif or non-serif) are acceptable if they meet the size, density, spacing, and legibility requirements.

Font size must be 11 points or larger. Smaller text in graphics, figures, graphs, diagrams, and charts is acceptable only if it remains legible when the page is viewed at 100%.

There is no restriction on text color, but black or other high-contrast colors are recommended because they print well and are legible to the largest audience; text must remain legible.

Type density, including characters and spaces, must be no more than 15 characters per linear (horizontal) inch.

Provide at least one-half inch (0.5") margins on top, bottom, left, and right of every page. No applicant-supplied information may appear in the margins.

Paper (page) size must be no larger than standard letter paper size (8 1/2" x 11"). Attachments must be submitted as flattened PDF files.

Line spacing must be no more than six lines per vertical inch.

Per NOT-OD-26-025, applications must be complete and compliant with all submission requirements and NIH policies at the time of submission. Placeholder attachments are prohibited; NIH may withdraw applications that are incomplete or noncompliant with the SF424 (R&R) Application Guide, the NOFO, or relevant Guide notices.

Do not include headers or footers in your attachments; NIH adds headers, footers, page numbers, bookmarks, and a table of contents when assembling the application.

Applicant must be a Small Business Concern: organized for profit with a place of business located in the U.S., operating primarily in the U.S. or making a significant contribution to the U.S. economy, and (including affiliates) no more than 500 employees.

SBIR: the Contact PD/PI must have primary employment (more than one-half of their time) with the small business concern at the time of award and during the conduct of the project. Other (Multiple) PD/PIs are not required to meet this requirement.

Per NOT-OD-25-132, NIH will accept no more than six new, renewal, resubmission, or revision applications per PD/PI (or per MPI) across all council rounds in a calendar year. The notice states the policy applies to all activity codes except T activity codes and R13 conference grant applications.

STTR (Phase I and II): the SBC must formally partner with a single nonprofit research institution; at least 40% of the work must be performed by the SBC and at least 30% by the partnering research institution (measured by total direct and indirect cost). These percentages are statutorily mandated and not waivable.

SBIR Phase I: a minimum of two-thirds (67%) of the research or analytical effort must be carried out by the small business concern.

The SBC must be at least 51% owned and controlled by one or more individuals who are U.S. citizens or permanent resident aliens (or by another for-profit SBC that is itself at least 51% so owned/controlled). When the SBC is a joint venture, there must be less than 50% (i.e., no more than 49%) participation by foreign business entities.

Applicant organization and the PD/PI must be registered in eRA Commons; registrations must be active at time of submission. The full organization registration process can take six weeks or more.

Applicant organization must have an active Grants.gov registration (which requires an active SAM registration first) to submit the application.

Applicant organization must have a valid, active full System for Award Management (SAM.gov) registration at the time of application and award (renewed at least annually). SAM issues the 12-character Unique Entity Identifier (UEI), which is required for eRA Commons registration and used on the application.

Required for SBIR/STTR: register in the SBA Company Registry. The resulting SBC Control ID (format SBC_#########) must be entered in the SBIR/STTR Information Form (G.440) of the application.

Per NOT-OD-25-132, NIH will not consider applications that are either substantially developed by AI, or that contain sections substantially developed by AI, to be the original ideas of applicants. AI may assist only with limited aspects. AI use resulting in plagiarism, fabricated citations, or other research misconduct may be referred to the Office of Research Integrity and trigger enforcement actions.

Standard SBIR/STTR new-application due dates are Sept 5 (Cycle I), Jan 5 (Cycle II), and Apr 5 (Cycle III). Specific NOFOs may set different dates; always verify against the current funding opportunity.

Applications are due by 5:00 PM local time of the applicant organization on the due date. If the due date falls on a weekend or federal holiday, it extends to the next business day. Late applications are generally not accepted (limited two-week consideration window only under extenuating circumstances).