Small Business Innovation Research and Small Business Technology Transfer Grants SOP

This standard operating procedure (SOP) includes the following sections: Purpose, Procedure, Contacts, and Links.

Some links will work for NIAID staff only.

Purpose

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.

Procedure

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.

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. See the Electronic Submission Process. Read the SF 424 Application Guide and the funding opportunity announcement (FOA) for detailed instructions. Also see Apply for a Grant.

Budget: Hard Caps, Small Business Administration (SBA) Waiver, and NIAID Budget Request Limitations

Hard Caps

Total funding support (direct costs + indirect costs + fee) normally may not exceed $259,613 for Phase I awards and $1,730,751 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.

Waiver

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 PHS 2020-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA.

NIAID Budget Request Limitations

Unless the FOA states otherwise, NIAID will allow Phase I applications with budgets of up to $300,000 total costs per year for up to two years; and Phase II or Phase IIB applications with budgets of up to $1 million total costs per year for up to three 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.

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:

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 FOAs titled “Clinical Trial Required” or “Clinical Trial Optional”—but NIAID does not.

Applicants, Grantees, and PIs

To find a FOA that best matches your intended research, go to NIH’s SBIR/STTR Clinical Trials Funding Opportunity Decision Tree.
- Note: NIAID offers contract opportunities for small businesses that are not linked in the NIH decision tree. To see what’s available, go to Extramural R&D Solicitations.
To identify the SBIR/STTR funding opportunities in which NIAID participates, see Current Small Business Funding Opportunity Announcements.
- Identify what phase of research you are pursuing and check "Application Types Allowed" within Section II of the FOA to verify that it supports that stage of research.
Read a FOA's recommendations on budget and length of award.
See High-Priority Areas of Interest for NIAID’s Small Business Program for application ideas.
Review Electronic Submission Process and follow the guidance to submit your SBIR or STTR application.
To identify an appropriate program officer to discuss scientific issues related to your proposal, email the NIAID Small Business Program Coordinator and 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.

Program Officers

Advise applicants to include both science and business goals in the application.
Encourage applicants to view 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 SBIR and STTR Critical Differences, Frequently Asked Questions, and Small Business Eligibility Criteria. Review SBIR/STTR Funding for the SBIR/STTR Omnibus solicitations, Direct to Phase II solicitations, and Targeted SBIR/STTR solicitations.
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 grantees 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.
GMP staff can see the GMP SBIR and STTR Grants SOP for more responsibilities.

Office of Research Training and Special Programs

Advise potential small business applicants.
Coordinate small business awards with the NIAID Small Business Program Coordinator 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.

Contacts

NIAID Small Business Program Coordinator—Natalia Kruchinin

Divisional Small Business Representatives

DAIDS—Brigitte Sanders
DAIT— Michael Minnicozzi (grants); Karina Allbritton (contracts); Carmen Rios (Radiation and Nuclear Countermeasures)
DMID—Barbara Mulach; Alyssa Werner

Grants Management Program— Jason Lundgren; Chernay Rogers

HHS Small Business Program Lead—Stephanie Fertig

Use the contacts listed above for questions about your specific situation. If you have a general question or a suggestion to improve this page, email the Office of Knowledge and Educational Resources at deaweb@niaid.nih.gov.