Frequently Asked Questions
Small Business Innovation Research (SBIR)
Small Business Technology Transfer (STTR)
What are the main goals of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs?
The SBIR and STTR programs are congressionally-mandated set-aside programs for domestic small business concerns to engage in Research/Research and Development (R/R&D) that has the potential for commercialization. The SBIR Program includes the following objectives: using small businesses to stimulate technological innovation; strengthening the role of small business in meeting federal R/R&D needs; increasing private sector commercialization of innovations developed through federal SBIR R&D; increasing small business participation in federal R/R&D; and fostering and encouraging participation by socially and economically disadvantaged small business concerns and women-owned business concerns in the SBIR program.
What are the differences between the SBIR and STTR programs?
There are 2 major differences- one relates to the PI and the other relates to a research partner. Under SBIR, the PI must be primarily employed with the small business concern at the time of award and for the duration of the project period, unless a waiver is granted by the NIH. Under the STTR Program, primary employment is not stipulated so the PD/PI may be from the small business or the collaborating non-profit research institution.
With regard to the research partner, SBIR permits, and in fact, encourages, research partnerships. However, STTR requires that the small business concern formally collaborate with a non-profit research institution. Under STTR, the SBC must perform at least 40 percent of the work and the research institution must perform at least 30 percent. The remaining 30 percent may be with the SBC, the single collaborating non-profit research institution, or an additional third party. The basis for determining the percentage of work to be performed by each of the cooperative parties will be the total of direct and F&A/indirect costs attributable to each party, unless otherwise described and justified in “Consortium/Contractual Arrangements” of the PHS398 Research Plan component of the SF424 SBIR/STTR (R&R) Application Forms, located here.
What is a Fast-track award?
Fast-track incorporates a submission and review process in which both Phase I and Phase II grant applications are submitted and reviewed together as one application. Because both phases undergo review at the same time, the NIH Fast-track mechanism can reduce or eliminate the funding gap between phases.
What is a SBIR Direct Phase II award?
As part of the SBIR and STTR Reauthorization of 2011, NIH may ‘issue a Phase II award to a small business concern that did not receive a Phase I award for that research/research & development'. This 'phase flexibility' is called a ‘Direct-to-Phase II’ SBIR award. This permits small businesses to receive a Phase II award even if they have not previously received a Phase I award for the research/research and development of their technology. In order to be eligible for the SBIR Direct Phase II award, the small business must have performed the Phase I stage-type of research through other funding sources.
The Direct-to-Phase II authority is not available to the STTR program and not available for the CDC, FDA, and ACL SBIR programs.
The prior program had specific SBIR Direct-to-Phase II funding opportunity announcements (FOAs). The transition to FORMS-E allows NIH to track SBIR Direct-to-Phase II applications at the Application level, as there is a new check-box on the SBIR/STTR Information Form for Direct Phase II.
As a result of this, NIH does not need to issue separate SBIR Direct-to-Phase II FOAs as before, but can offer Direct-to-Phase II as an allowable Application Type on any SBIR FOA. SBIR Direct-to-Phase II application are 'New' submissions and are not Renewals.
Applicants are strongly advised to discuss this option with their Program Officer well in advance of any due date.
Do the NIH SBIR and STTR programs make awards in the form of grants or contracts?
The NIH SBIR and STTR programs support research using both grants and contracts. About 95 percent of NIH SBIR awards are in the form of grants, and about 10 percent of NIH SBIR awards are made through contract procurement.
Small business concerns are invited to submit Phase I grant applications in any area within the mission of the awarding components identified in the SBIR/STTR grant solicitation. Contract proposals are accepted only if they respond specifically to a research topic within the contract solicitation. The topics are not the same as those in a grant solicitation. They are much more focused and specific. Also, not all Institutes/Centers (ICs) within NIH post topics to the Contract Solicitation while all 24 ICs post topics in the grant solicitation.
As the primary award mechanism is the grant instrument, NIH, CDC, FDA, and ACF issue 3 receipt dates for SBIR/STTR Grant Applications (Phase I or Phase II) and only one receipt date for SBIR Contract Proposals.
Small business grants can be SBIR or STTR, but contracts are only SBIR (not STTR). NIH SBIR and STTR grants and SBIR contracts must be submitted electronically.
To learn more about the differences between SBIR grants and contracts, please view the Apply page.
What is the single most importance piece of advice if my small business is interested in applying for an NIH SBIR or STTR award?
Talking to an NIH Program Officer at the Institute or Center (IC) that is most closely related to your research topic is a critical step for success. Program Officers are subject-matter experts and will offer invaluable information about your application, including the relevance to the IC’s mission and any technical submission questions you may have. Program Officer contact information can be found here.
If you have questions about which IC representative to contact, email the NIH SBIR/STTR Program Office (email@example.com) and the team will direct you to the appropriate person.
How do I become an NIH SBIR/STTR application reviewer?
The NIH Center for Scientific Review (CSR) organizes peer review groups that evaluate the majority of NIH’s applications, including SBIR/STTR. CSR welcomes researchers who volunteer to serve on peer review groups. Small business applications are reviewed by special SBIR/STTR panels.
The process for becoming a CSR reviewer is the same for academic grants and SBIR/STTR grants. If you are an established investigator, the best way to become an SBIR/STTR reviewer is to send your CV to a CSR Scientific Review Officer or email firstname.lastname@example.org. A CSR Scientific Review Officer will contact you if there is an opportunity for you.
Please review CSR’s “Become a Reviewer” for more information.
What do I do if I want to propose a NIH-defined clinical trial in a SBIR/STTR application?
- What is a parent funding opportunity announcement?
What is a targeted/special funding opportunity announcement?
These targeted FOAs are periodically issued by one or more Institutes and Centers (ICs) and focus on specific areas of science that are priorities to the issuing institutes or centers. Special nuances and/or requirements (i.e., amount of funds that may be requested) may be imposed under these announcements.
When may I submit an application?
Receipt dates and related policies are posted on the NIH Grants website and here. If a receipt date falls on a weekend or holiday, the receipt date is the following business day. The standard due dates are September 5, January 5, and April 5 for applications submitted in response to a parent funding opportunity announcement. Submission dates for targeted/special announcements vary so you must check the announcement for its specific date(s).
If I am unable to submit my application by the due date, may I submit it late?
If an application is submitted after the required date, it must be accompanied by a cover letter explaining the reasons for the delay. Late applications are handled on an individual basis, considering the length of delay and the reasons provided. It is generally not possible to accommodate late applications for RFAs or other special receipt dates. Contacting Division of Receipt and Referral staff, review staff, or Institute program staff in advance will not result in permission to submit a late application. More information concerning NIH’s late policy is available can be found here.
Where do I find the SBIR/STTR application submission package and instruction guide?
The simplest way is to click the “Apply for Grant Electronically” button within the funding opportunity announcement to which you are responding. Both are also available from Grants.gov.
What are the steps for preparing a Fast-Track application?
First, speak with an NIH SBIR Program Officer to find out if Fast-Track is the most appropriate for your project. Once it is deemed the best option for your technology, you should begin working on the Fast-Track application. You will need to prepare a 1-page Specific Aims page and a 12-page Research Strategy for both Phases, and a 12-page Commercialization Plan that covers Phase II.
Do I need to identify the Institute or Center to which I would like to submit my application?
No, the Receipt and Referral Office of the NIH Center for Scientific Review (CSR) will assign each application to an appropriate Institute/Center (IC) for funding consideration. When the scientific areas and the research proposed in a grant application are sufficiently relevant to the research areas of two or more awarding institutes, CSR may assign your application to all such ICs. If your application is scientifically meritorious but the primary institute does not select your application for award, then the other assigned ICs may consider your application for funding. You are encouraged to contact program staff to discuss the appropriateness of your research area for a particular IC or review group.
You may use the optional Assignment Request Form in the SF424 Forms-D to request a specific institute or study section assignment: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-d/general/g.600-phs-assignment-request-form.htm https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-008.html
How do I know what the estimated start date of my project is?
To select an appropriate beginning date for an application, consult the following schedule:
SBIR and STTR Due Dates
Phase I and Phase II
September or December
What funding opportunities are available after completion of my Phase II project?
Some NIH Institutes/Centers offer Phase IIB Competing Renewal awards for those projects that require extraordinary time and effort in the R&D phase and may or may not require FDA approval for the development of projects such as drugs, devices, vaccines, therapeutics, and medical implants. Depending on the IC, the budget may be requested for up to $1M per year for up to 3 years. See the Omnibus Solicitation Program Descriptions and Research Topics for a full listing of those ICs that accept Phase II competing renewals. Prospective applicants are strongly encouraged to contact NIH program staff prior to submission.
Can Phase I or II awardees from other federal organizations apply for NIH Phase II or Phase IIB as long as the specific aim of the project aligns with the mission of the Institute or Center?
Yes, as long as the NIH Institute with whom you would apply is interested in receiving a Phase II or IIB. If the applicant SBC has a Phase I or a Phase II award from another agency, and they want to apply for a Phase II or Phase IIB at the NIH, the applicant must receive buy-in from the Program Officer ahead of time. The Program Officer is required to do internal paperwork to make sure the application can be submitted successfully, so it is imperative that the SBC and Program Officer have a conversation before the application is submitted.
What is the difference between a “resubmission” and a “revision?”
Resubmissions are applications that were previously submitted and reviewed but not selected for an award and are being resubmitted for evaluation again. These applications include an introduction addressing the comments of the previous reviewers. Revisions are competing supplemental applications to request support for a significant expansion of a project’s scope or research protocol.
I’m submitting a Phase II. Is this a New, Renewal, or Continuation?
It is a Renewal.
If my Fast-Track application is not approved, can I resubmit?
Yes, as a Fast-Track is a ‘New’ application you may submit as New or resubmit after a revising the application, but you may only resubmit once. Read more about Resubmission Applications.
How long does a grantee have to submit the Phase II application after the Phase I project ends?
The grantee may submit a Phase II application either before or after expiration of the Phase I budget period. To maintain eligibility to seek Phase II support, a Phase I grantee should submit a Phase II application within the first six receipt dates following the expiration of the Phase I budget period. If the grantee is outside of the six receipt period timeframe, they must contact their Phase I Program Officer and if the Program Officer is willing to receive an application, a waiver may be granted.
What is a Commercialization Plan and why is it required?
The Commercialization Plan is a highly detailed report summarizing the actions and timeline you plan to follow to bring your technology from research to production to market. This is in addition to the Research Strategy. All Phase II, Fast-Track and CRP applications require a Commercialization Plan. For assistance, review this guide for Writing A Good Commercialization Plan.
A Commercialization Plan is required for the Fast-Track application, does this mean I need to create one for Phase I and Phase II?
No, a Commercialization Plan is required for Phase II, Fast-Track, and CRP applications, but it is not allowed for Phase I applications.
What is the current NIH policy on resubmissions?
Before April 16, 2014, NIH permitted one resubmission (A1) of an unfunded application (see NOT-OD-09-016). The extension on the NIH grant number could follow the pattern (A0, A1). A first-time submission is informally referred to as an A0, and the first resubmission is known as an A1. Any virtual A2s would be flagged by the NIH Center for Scientific Review.
For all application due dates after April 16, 2014, following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate new application due date (see NOT-OD-18-197).
Resubmissions (A1) must be submitted within 37 months of the new (A0) application (see NOT-OD-10-140). For more details on the Resubmission Policy, visit the Resubmissions webpage and the Guide Notice, NOT-OD-18-197.
How does NIH’s current resubmission policy affect SBIR/STTR Applicants?
For all Phases, when submitting or re-submitting between an RFA and an investigator-initiated funding opportunity (PA, including Omnibus, PAR, PAS) see the below guidance found in https://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-100.html.
- When an application that was submitted in response to an RFA is not funded and the investigator wishes to submit an application on this topic as an investigator-initiated application (PA, PAR, PAS), it is to be submitted as a New application, unless provision for a resubmission is clearly delineated in the RFA. In addition, if a subsequent RFA specifically solicits resubmissions of unfunded applications from a previous RFA, the instructions in the second RFA should be followed. In all other cases, an application submitted in response to an RFA and then resubmitted as an investigator-initiated application must be prepared as a New application.
- When a previously unfunded application that was originally submitted as an investigator-initiated application is to be submitted in response to an RFA, it is to be prepared as a New application.
In all other cases see the below guidance.
Please review the four case studies for Phase I, Phase II/Phase IIB, Fast-Track, and Direct Phase II to understand how the current NIH resubmission policy relates to SBIR/STTR applicants.
- A Phase I application is a “Type 1” or “New” application. When the applicant submits a New Phase I application (A0) and it is not funded, the applicant can address reviewer comments and submit as a Resubmission A1 for the next appropriate application due date, or they can submit a New application (A0).
- A Fast-track application is also a “Type 1” or “New” application and follows the same rules as a Phase I. If a New Fast-track (A0) is not funded, the applicant can address reviewer comments and submit as a Resubmission Fast-track A1, or they can submit a New Fast-track (A0) for the next appropriate application due date.
- If the Fast-track (A0 or A1) was not funded, the applicant can also revise down the scope of their application and submit as a New Phase I (A0).
Phase II/Phase IIB
- A Phase II and Phase IIB are considered “Type 2” or “Renewal” applications. If an applicant does not get funded on the first submission (A0), they can re-submit an A1 for a Phase II/IIB.
- If a Phase II or Phase IIB resubmission (Type 2, A1) is not funded, the applicant may submit a New Phase I, Fast-track, or SBIR Direct Phase II (Type 1, A0). However, the project will lose any association with the previously funded grant, and the New project must be substantially different than the previous project to avoid duplicative funding. If the applicant decides to submit a SBIR Direct Phase II, they must also have previously completed the Phase I equivalent work without any SBIR/STTR funds.
Direct Phase II
- A Direct Phase II application is considered a “Type 1” or “New” application, but in order to be eligible for a Direct Phase II, the small business applicant must demonstrate the Phase I equivalence of their preliminary data in their Direct Phase II application. If a New SBIR Direct Phase II (A0) is not funded, the applicant can address reviewer comments and submit as a Resubmission SBIR Direct Phase II A1, or they can submit a SBIR New Direct Phase II (A0) for the next appropriate application due date. The small business applicant is not able to apply for a new Phase I or Fast-track (A0) unless they substantially change their project scope to prevent funding for a Phase I-like work already completed by the applicant.
How much time do I have after the submission deadline to correct errors in my application and still submit for the same deadline?
NIH has eliminated the error correction window from the application submission process. See NOT-OD-10-123. Please submit your application several days early to allow time to correct errors before the deadline. Your application must be submitted AND error-free by 5 PM your organization’s local time on the receipt date.
If I incur problems with my electronic submission, who should I contact?
Contact the Helpdesks for grants.gov and/or the eRA Commons:
- Web: http://grants.nih.gov/grants/ElectronicReceipt/support.htm#desk
- Toll-free: 1-866-504-9552
- Phone: 301-402-7469
- Hours: Mon-Fri, 7a.m. to 8 p.m. Eastern Time (closed on federal holidays)
- Where might I find a sample application?
Who needs to be registered in the eRA Commons from my company?
The small business concern and the Project Director/Principal Investigator (PD/PI) must complete a one-time registration in the eRA Commons in order to submit applications to NIH. Organizational officials are responsible for registering the PD/PI in the eRA Commons. To find out if your organization is already Commons-registered, a "List of Commons Registered Organizations" can be found here.
The PD/PI registration must be done by an organization official or their delegate who is already registered in the Commons. The PD/PI should work with their Authorized Organizational Representative (also known as Signing Official in the eRA Commons) to determine their institutional process for registration. For a step-by-step account, view the SBIR/STTR Annotated Form Set and the SBIR/STTR SF424 (R&R) Application Guide that can be found on this page.
The eRA Commons is the discrete information exchange system where NIH and the applicant/grantee community are able conduct their extramural research administration business electronically. Please note:
- It is vital that all Applicant/Grantee Organizations, Principal Investigators are registered in the eRA Commons and e-mail addresses are checked periodically for accuracy to avoid delays in the e-notification process
- Special Note for STTR applicants: The STTR applicant organization must officially affiliate the PD/PI with the small business concern in the Commons if the PD/PI is not an employee of the small business concern.
Following are the steps to affiliate a PD/PI to the applicant organization/institution:
- PD/PI gives Commons user ID and email address to the administrator of the applicant institution. (The email address must be the one that is contained in the Personal Profile for the PI.)
- Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the Accounts Administrator.)
- Administrator selects "Administration" tab and then "Accounts" tab.
- Administrator selects "Create Affiliation" tab.
- Administrator enters the Commons User ID and Email address into the appropriate fields and clicks "Submit."
Note: The account cannot have any other roles attached to it other than the PD/PI.
If I'm employed by a university and own a small business, do I need two distinct eRA Commons names for each entity?
A PI does not need two distinct eRA Commons names for each entity. An individual only needs one eRA Commons PI account, which will follow them throughout their career. A PI may have multiple affiliations with a university and a small business. However, a small business official at the small business concern must have a separate organizational eRA Commons account for the small business.
When I try to submit any phase SBIR or STTR application using ASSIST or Workspace, I get a Global Validation Error that states my company is not eligible to submit to this FOA. All of our required registrations are valid, why is this happening?
Call the eRA Commons Service Desk as soon as possible for advice and to confirm your eligibility. The signing official must access the company institutional eRA Commons profile, where they will find a new checkbox that needs to be checked, stating that you are eligible to apply.
For Question #8 of the SBIR/STTR Information component, "Have you received SBIR Phase II awards from the Federal Government," how do I answer if my business has received less than 15 Phase II awards? If more than 15 Phase II awards?
If your company has received any SBIR Phase II awards from the federal Government (including NIH), check the YES box. Then attach a file that includes either:
- a statement indicating that the applicant small business has not received more than 15 SBIR Phase II awards from the federal Government during the preceding five fiscal years; or
a company commercialization history if you have received more than 15 Phase II SBIR awards from the federal Government during the preceding five fiscal years. The history must document the extent to which the company was able to secure Phase III funding to develop concepts resulting from previous Phase II SBIR awards, and for each Phase II award the history must include:
- name of awarding agency;
- award number and date;
- amount of award;
- title of project;
- source, date, and amount of Phase III funding agreement; and
- commercialization status of each Phase II award.
If you have not received SBIR Phase II awards, then check the NO box.
Is SAM the only registration that's annual? Do we have to worry about the other registrations also expiring?
SAM is the only registration that must be renewed annually, which requires the SBC to log into SAM and renew their registration. The other registrations (DUNS, Grants.gov, eRA Commons and the SBA Company Registry) are one time and should only be updated if information changes. If the SBC moves or changes their address, they will have to go into all of the systems and update their information.
My organization is applying for an STTR grant, and the PI on the grant application works in a different organization. On the SBIR/STTR SF424 (R&R) Cover component, the PI information in Item 15 reflects his organization, which is different than the applicant organization information in Item 5. When I go to the budget forms for period 1, the "Enter name of organization" is already pre-filled with the PI's organization name. This field does not allow edits; therefore I cannot change this field to reflect my organization name. What do I do?
The Research and Related Budget component is incorrectly pre-populating the Organization Name. In order to proceed with your submission, please just ignore this field. The applicant organization should prepare its Research & Related Budget pages, making sure they indicated “Project” for the Budget Type. If a subaward/consortium is involved, the consortium grantee should complete their budget pages, making sure they indicate “Subaward/Consortium” for the Budget Type. The Budget Type field will help NIH staff properly distinguish between the 2 budgets until this glitch in the forms is fixed.
Will you please explain the five-step registration process?
Applicant organizations must complete and maintain the following registrations as described in the SF424 SBIR/STTR (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible.
- Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM, SBA Company registry, and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
- System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
- SBA Company Registry – New requirement as per the Reauthorization. See “SF424(R&R) Other Project Information Component” for instructions on how to register and how to attach proof of registration to your application package. Applicants must have a DUNS number to complete this registration. SBA Company registration is NOT required before SAM, Grants.gov or eRA Commons registration.
- eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
- Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.
My organization is applying for an STTR and the PI works for the partnering non-profit research organization. On the SBC budget pages, the PI is automatically entered, even though the PI is employed by the research organization. What should I do?
The STTR form incorrectly prepopulates the research organization PI’s information. The applicant should put zero salary and zero effort for the academic PI on the SBC budget and relist them on the subaward budget page with the appropriate effort and dollar amount for salary.
Is there anything that you should not discuss with the NIH SBIR or STTR Program Officer?
This question brings up the differences between grants and contracts. Over 95 percent of NIH’s SBIR and STTR awards are in the form of grants; however, NIH also awards contracts. For grant awards, the applicant can call their Program Officer and discuss anything that is relevant to their application. There is no blackout period, and the applicant can discuss pre-review and post-review. The Program Officer might not have any updates or information to share at certain times, but the applicant is never barred from calling them.
For contracts, the applicant’s only point of contact is the contracting officer before award. Applicants may not ask a Program Officer any information specific to their application while preparing or submitting a proposal or when it is under technical review.
My organization has an NIH SBIR contract and would like to apply for an NIH SBIR/STTR Phase II or Phase IIB award. What should I enter for the Federal Identifier on the SF 424 (R&R) application page?
In this scenario, the applicant should submit a New application (as opposed to a Renewal) with a predetermined ‘alternative’ Grant Number used for the Federal Identifier. The Federal Identifier will be the awarding IC code, followed by six 0s. For example, if the applicant would like for NHLBI to be the awarding institute, they’d enter HL000000.
It is critically important for the applicant to inform the appropriate NIH SBIR/STTR Program Manager before they submit an application. The applicant should also include a cover letter indicating that the application is a Phase II or Phase IIB, and that the Phase I was from an NIH SBIR contract.
Please contact eRA Help Desk with questions.
My organization has received an SBIR/STTR award from another agency and would like to apply for an NIH Phase II or Phase IIB award. What should I enter for the Federal Identifier on the SF 424 (R&R) application page?
In this scenario, the applicant should submit a New application (as opposed to a Renewal) with a predetermined ‘alternative’ Grant Number used for the Federal Identifier. The Federal Identifier will be the awarding IC code, followed by six 0s. For example, if the applicant would like for NHLBI to be the awarding institute, they’d enter HL000000.
It is critically important for the applicant to inform the appropriate NIH SBIR/STTR Program Manager before they submit an application. The applicant should also include a cover letter indicating that the application is a Phase II or Phase IIB and indicate which agency funded their Phase I award.
Please contact eRA Help Desk with questions.
What are clinical trials?
NIH defines clinical trials here: https://grants.nih.gov/policy/clinical-trials/definition.htm
What are the clinical trial requirements for grants and contracts?
NIH policies for grants and contracts requiring clinical trials changed in January 2018. Review updated requirements here: https://grants.nih.gov/policy/clinical-trials.htm
Under which funding opportunity should a small business apply if the research project includes a clinical trial?
The NIH Office of Extramural Research – Clinical Trial Requirements page explains the requirement(s) for submitting applications through an FOA designated specifically for clinical trials: https://grants.nih.gov/policy/clinical-trials/specific-funding-opportunities.htm.
- Funding Opportunity Announcements (FOAs) for Omnibus/Parent Solicitations: Researcher-initiated ideas are proposed via the SBIR and STTR Omnibus grant solicitations (also called funding opportunity announcements or FOAs) and can be found here: https://sbir.nih.gov/funding#omni-sbir
- Funding Opportunity Announcements (FOAs) for Targeted Solicitations: Targeted SBIR/STTR grant solicitations are focused on specific research areas can be found here: https://sbir.nih.gov/funding/individual-announcements
- Is Good Clinical Practice (GCP) training required?
- Are there additional review criteria for research projects including a clinical trial?
What are the requirements for registering and reporting NIH-funded clinical trials in ClinicalTrials.gov?
All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov. Resources for understanding and complying with this policy are here: https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Are small businesses that have won federal SBIR/STTR Phase I or Phase II funds eligible to be a sole source provider to the government? How would this provision work?
Yes, any small business that has received an SBIR or STTR Phase I or Phase II award from any federal agency is eligible to become a sole source provider to the government without having to go through an open contract competition.
This enables the small business to propose a business solution or directly sell the product that was developed with the SBIR or STTR funding to any governmental agency. If the proposal meets the government’s needs and the agency wants to purchase the technology, the small business does not have to compete for the contract with other vendors in the open market. Instead, the government agency works internally with their acquisition experts to negotiate a contract agreement with the small business who can be the sole bidder for any business opportunity that does not have to be formally issued in FedBizOpps.gov. Normally, the government requires a full competition for the issuance of any Federal funds, thus the primary purpose of this sole source provision is to support the growth of small business.
As a small business outside the government, it can be challenging to understand what the needs of the government are. The best way for the small business to know this is to leverage their networks and collaborate with the government agency or institute.
The small business is not limited to offer their services and products only to the government agency which funded their SBIR/STTR project. For example, if a small business won an NIH SBIR Phase I or II award, they can be a sole source provider to any other federal agency like the Departments of Defense, Energy, Homeland Security, etc.
The legal provision cited below can be found within each NIH SBIR or STTR solicitation, listed under the second paragraph of "Section I. Funding Opportunity Description" in "Part 2. Full Text of Announcement."
"The competition for SBIR/STTR Phase I and Phase II awards satisfies the competition requirement of the Armed Services Procurement Act, the Federal Property and Administrative Services Act, and the Competition in Contracting Act. Therefore, an agency that wishes to fund an SBIR/STTR Phase III project is not required to conduct another competition in order to satisfy those statutory provisions. As a result, in conducting actions relative to a Phase III SBIR/STTR award, it is sufficient to state for purposes of a Justification and Approval pursuant to FAR 6.302-5 that the project is a SBIR/STTR Phase III award that is derived from, extends, or logically concludes efforts performed under prior SBIR/STTR funding agreements and is authorized under 10 U.S.C. 2304(b)(2) or 41 U.S.C. 253(b)(2)."
Do we have to be a formal company before we apply for a SBIR/STTR?
The grants.gov submission/registration process requires that an applicant be a formal entity in order to submit an application to the federal government. However applicants need not meet the SBIR and STTR eligibility requirements until the time of award.
Who may apply to the NIH SBIR and STTR programs?
Only those small businesses that meet the SBIR/STTR eligibility criteria opportunity announcements may apply. Collaborating research institutions, i.e., universities, are subcontractors to the small businesses and may not apply as applicants.
What is a Women-Owned Small Business (WOSB)?
As defined by the Small Business Administration (SBA), a Women Owned Small Business (WOSB) must be at least 51 percent owned and controlled by one or more women, and primarily managed by one or more women (who must be US citizens). The firm must be “small” in its primary industry in accordance with SBA’s size standards. Small businesses that meet this criteria should self-certify that they are women-owned when they apply to NIH and every other federal agency. Applicants will find a check box on the application that will ask if they are a WOSB. If so, applicants should check this box.
The government collects this information solely for tracking purposes. NIH must report this information in aggregate to the SBA and to Congress each year. One of the goals of the SBIR/STTR programs is to increase participation by WOSB and Socially and Economically Disadvantaged Business (SDB), so this information helps the SBIR agencies coordinate targeted outreach to these populations. NIH strongly encourages applicants to find out if they are a WOSB or SDB and check the appropriate boxes consistently on the applications. Checking the appropriate box consistently is important, as it will help NIH keep more accurate records which will help inform the agency’s communication strategy.
What is a Socially and Economically Disadvantaged Business (SDB)?
As defined by the Small Business Administration (SBA), a Socially and Economically Disadvantaged Business, also known as a Small Disadvantaged Business (SDB), must be 51 percent or more owned and control by one or more disadvantaged persons. The disadvantaged person or persons must be socially disadvantaged and economically disadvantaged, and the firm must be small, according to SBA’s size standards. The small business concern must self-certify by registering their business in the System for Award Management. Also, they should check a box on the application that is located next to the Women Owned Small Business (WOSB) check box. Businesses can be either, both or neither WOSB and SDB.
As with the WOSB tracking, this information is used for reporting purposes only and all SBIR agencies encourage applicants to include this information if it is applicable to them.
Are Women-Owned Small Businesses (WOSB) or Small Disadvantaged Businesses (SDB) given any advantage in the application process?
No, a small business is never hurt nor helped by checking the WOSB or SDB application box. The government is congressionally-mandated to collect this information to report the statistics of awards. For this reason, it is very important that businesses know their WOSB and SDB status and correctly and consistently indicate this on every SBIR/STTR application. However, SBIR and STTR awards are reviewed on their scientific merit and funding decisions are based on scientific merit, available budget, and program priority.
However, a WOSB or SDB designation can help small business applicants with federal government service contracts. For more information, please click here.
Must the Principal Investigator be a U.S. citizen?
No. The PI, the individual who is responsible for the scientific and technical direction of the project, is not required to have US citizenship, but the PI must legally reside in the United States and must be available to perform the research proposed for the duration of the project.
May multiple PD/PIs be included on SBIR and STTR applications?
Yes, more than one PD/PI, or multiple PDs/PIs, may be designated on the application for projects that require a “team science” approach that clearly does not fit the single-PD/PI model. Each PD/PI must have a PD/PI role and a leadership plan is required. All PDs/PIs must be registered in the NIH eRA Commons prior to the submission of the application. The decision of whether to apply for a single PD/PI or multiple PD/PI grant is the responsibility of the investigators and applicant organizations and should be determined by the scientific goals of the project.
Please also refer to the SF424 SBIR/STTR (R&R) Application Guide for more information about the requirements for multiple PD/PIs.
Does the NIH Early Stage Investigator Policy apply to SBIR/STTR awards?
No, the advantages of Early State Investigator (ESI) status apply only to applicants for traditional NIH research grants (R01s) and NIH Director’s New Innovator Grants (DP2s). More information about the ESI status can be found on the NIH New and Early Stage Investigator (ESI) Policies page.
Do all the Project Directors/Principal Investigators (PD/PIs) on a multiple PI SBIR grant have to meet the SBIR primary employment requirement? What about STTRs?
SBIR projects: The individual who serves as the Contact PD/PI must be from the Small Business and meet the primary employment requirement, but other PDs/PIs need not meet this requirement. Primary employment means that more than one half of the PD/PI's time is spent in the employ of the SBC at the time of award and during the conduct of the proposed project. Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator’s Office.
STTR projects: As is the case for an STTR project with a single PD/PI, the PD/PI is not required to be employed by the SBC. However, the Contact PD/PI, the first PD/PI listed, must have a formal appointment with, or commitment to, the SBC, which must be in the form of an official relationship between the parties, but need not include a salary or other form of remuneration. If the Contact PD/PI is not an employee of the SBC, the applicant organization must officially affiliate the PD/PI with the SBC in the Commons.
Under the Multi-PI model, is there a minimum person-months requirement to qualify as a PD/PI?
SBIR Applications: No. There is no minimum person-months requirement for individuals identified as PD/PIs. The reviewers will assess whether the level of effort is adequate to achieve the proposed goals. If there are deficiencies in this regard, it will negatively impact the score.
STTR Applications: Yes. Each PD/PI must commit a minimum of 1.2 calendar months (10 percent effort) to the project and each PD/PI must have a formal appointment with or commitment to the applicant small business concern (SBC), which is characterized by an official relationship between the SBC and that individual. Use the Person Months website and calculator as a reference.
Under the Multi-PI model, which PD/PIs must be registered in the eRA Commons?
All PD/PIs must be registered and be assigned the PD/PI role in the eRA Commons prior to the submission of the application. Note: While each PD/PI must hold a PD/PI account in the Commons, PDs/PIs do not register with Grants.gov. Only the applicant organization registers with Grants.gov.
In addition, all PDs/PIs at the applicant organization must be affiliated with that organization. When PDs/PIs are located at another organization, only the contact PI (the PI named on the SF424 SBIR/STTR (R&R) Cover) must be affiliated with the applicant small business concern (SBC); other PD/PIs need not be affiliated with the SBC, but must be affiliated with their own organization to be able to access the Commons. This affiliation must be done by the AOR/SO or their designee who is already registered in the Commons.
All PD/PIs will have equal access to information related to the application or grant (e.g., Summary Statement, Notice of Grant Award)
To affiliate the PD/PI with the small business concern, please follow instructions in the SF424 SBIR/STTR (R&R) Application Guide or use the directions below:
- PD/PI gives Commons user ID and email address to the administrator of the applicant organization/institution. (The email address must be the one that is contained in the Personal Profile for the PD/PI.)
- Administrator logs into the Commons. (The administrator can be the Signing Official, Administrative Official, or the Accounts Administrator.)
- Administrator selects "Administration" tab and then "Accounts" tab.
- Administrator selects "Create Affiliation" tab.
- Administrator enters the Commons User ID and Email address into the appropriate fields and clicks "Submit."
- On the Research & Related Senior/ Key Person Profile, in the Credential, (e.g., agency login) Field, the Commons UserName must be provided for all individuals assigned the PD/PI Role.
Does it matter in what order the Multiple PD/PIs are listed on the application?
Yes. The Contact PD/PI who must be affiliated with the applicant small business concern (SBC) submitting the application will be listed first. For both the SBIR Phase I and SBIR Phase II, the primary employment of the “Contact PD/PI” must be with the SBC at the time of award and during the conduct of the proposed project. Occasionally, deviations from this requirement may occur. Such deviations must be approved in writing by the grants management officer after consultation with the NIH SBIR/STTR Program Coordinator.
What “Project Role” should be assigned to the multiple PD/PIs?
All such individuals must be assigned the PD/PI role. Do not assign any individual the role of “Co-PD/PI” as this role is not currently used by NIH and other PHS agencies. If including individuals classified as “Other Significant Contributors (OSCs),” use the “Other” category and indicate “Other Significant Contributor” as the role in the “Other Project Role Category.” OSCs should be listed last after all other Senior/Key Persons have been listed.
For a Multi-PI application under the SBIR/STTR Program, must the applicant organization always be the small business concern or may a collaborating research institution be so designated? Which organization/institution should be designated as the lead?
The small business concern (SBC) is ALWAYS the applicant/awardee organization, regardless of whether the project is submitted as an SBIR, STTR, single-PD/PI or multiple PD/PI application. The SBC submitting the application is ALWAYS lead organization and any other organizations (including research institutions) subcontract to the SBC.
Is there a special review criteria for resubmission applications and Phase IIB Competing Renewal applications submitted under the Multi-PI model?
For all competing applications including revised applications and Competing Renewal (Phase IIB) applications, peer reviewers will consider whether the designated PD/PIs have appropriate training and experience to carry out the proposed study. A Phase IIB Competing Renewal submitted as a multiple-PD/PI application requesting support for a project that was previously supported through a single-PD/PI award should state the changes in the project's direction and management that led the PD/PIs to now propose the multiple-PD/PI model. In addition, the application should state how the research will be enhanced through the multiple-PD/PI approach.
Our company recently just went public, does this affect our ability to apply for SBIR or STTR?
No, public companies are eligible, but they have to ensure they are more than 50 percent directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States.) When a firm goes public, they must include their shareholders in their ownership determinations.
Please review SBA’s Eligibility Guide for more detailed information.
Must all of the work on an SBIR project be completed by the small business?
No, on an SBIR Phase I project, normally, a minimum of two-thirds (67 percent) of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual agreements to third parties for portions of the scientific and technical effort normally may not exceed 33 percent of the total amount requested. For Phase II or Phase IIB, normally, a minimum of 50 percent of the research or analytical effort must be carried out by the small business concern. The total amount of all consultant and contractual agreements to third parties for portions of the scientific and technical effort generally may not exceed 50 percent of the total amount requested. Applicants are strongly encouraged to discuss deviations from these guidelines with NIH program staff listed in the Funding Opportunity Announcement.
How much effort must be performed by the collaborating non-profit research institution on an STTR project?
The single, collaborating research institution must perform a minimum of 30 percent of the effort and the small business must perform a minimum of 40 percent. The remaining 30 percent may be attributed to either of these organizations or an additional third party.
Are subcontractors on an SBIR or STTR application required to provide a letter of support?
Yes. Each individual and/or collaborating organization must include a letter confirming their role on the proposed project. For STTR, a letter from the collaborating institution must be included.
Can a small business concern subcontract with a foreign entity?
No, all work on the SBIR project must be conducted in the US, per statute. Only exceptional circumstances can be considered and possibly granted a waiver by the NIH. Please read the exception in the foreign involvement section of the FAQs.
However, if the company is US owned and operated, the PI can be foreign. There is no US citizenship requirement for PIs; however, the PIs must have a legal residency and work status in the US.
Is it permissible to submit a budget that deviates from the time and dollars normally awarded to Phase I or Phase II?
Yes, according to statutory guidelines, total funding support (direct costs, indirect costs, fee) normally may not exceed $150,000 for Phase I awards and $1,000,000 for Phase II awards. Reauthorization required that budgets that exceed the hard caps ($225,000 for Phase I and $1,500,000 for Phase II) receive a waiver of approval from SBA. The agency – not the applicant – must apply for this waiver. SBA has recently approved a topics list, located on this page, which allows budgets to exceed the hard caps as long as the project topics are included on the list.
Applicants are strongly encouraged to contact program officials prior to submitting any application. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project.
My company does not have a negotiated F&A (overhead) rate with NIH. What am I permitted to charge?
The payment of facilities & administrative (F&A) costs is based upon rates established through a formal agreement between the grantee organization and the Federal agency. Phase I applicants who do not have a negotiated rate with a Federal agency should propose an estimated rate not to exceed 40 percent of the total direct costs. If awarded at a rate of 40 percent or less, the rate used to charge actual F&A may not exceed the awarded rate. NIH will not negotiate F&A rates for Phase I awards.
Phase II/IIB applicants who propose a rate of 40 percent of total direct costs or less will not be required to provide further justification if selected for an award. The F&A costs will be awarded at the requested rate. The NIH Division of Financial Advisory Services will only negotiate rates with applicants who request more than 40 percent of total direct costs on a Phase II award. See notice NOT-OD-09-038.
Please explain what is meant by the “fee.” Is this a direct cost or an indirect cost?
A reasonable fee, not to exceed 7 percent of total costs (direct and indirect) for each Phase (I and II/IIB) of the project, is available to small business concerns receiving awards under the SBIR/STTR program. The fee is intended to be a reasonable profit factor available to for-profit organizations, consistent with normal profit margins provided to profit-making firms for research and development work. The amount requested for the fee should be based on the following guidelines: (1) it must be consistent with that paid under contracts by the PHS for similar research conducted under similar conditions of risk; (2) it must take into account the complexity and innovativeness of the research to be conducted under the SBIR/STTR project; and (3) it must recognize the extent of the expenditures for the grant project for equipment and for performance by other than the grantee organization through consultant and subaward agreements.
The fee is not a direct or indirect "cost" item and may be used by the small business concern for any purpose, including additional effort under the SBIR/STTR award. The fee applies solely to the small business concern receiving the award and not to any other participant in the project. However, the grantee may pay a profit/fee to a contractor providing routine goods or services in accordance with normal commercial practice
May foreign work be proposed on an SBIR or STTR application?
In rare and unique circumstances, for example, if a supply or material or the study design (e.g., patient population) is not available in the United States, NIH may allow a small portion of the research /R&D work to be performed by a foreign organization. Foreign involvement will be considered on a case-by-case basis and must be thoroughly justified in the application. Applicants should discuss their unique situations with NIH program staff prior to submission of the application. Whenever possible, non-SBIR/STTR funds should be used for other work outside of the United States that is necessary to the overall completion of the project.
May grantees use grant funds to pay a foreign consultant’s travel to and from the U.S. site?
While grant funds may be used to pay for services performed by the foreign consultant on site in the U.S., travel costs for consultants to and from the U.S. performance site must come from non-grant sources.
If I subcontract ALL of the Human Subjects work to a University do I still need to address the points in the Research Plan/Strategy?
Yes, be sure to review the “Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan” in the SF424 SBIR/STTR (R&R) Application Guide.
I will be using Human Subjects in my research but do not have approval by an Institutional Review Board (IRB) yet. Is this required at the time of submission?
No, your company will be required to obtain an Assurance (typically a Single Project Assurance) by the time an award is made. Our NIH staff will initiate that process if you do not have an assurance, and you will work closely with your NIH program director and OHRP staff to negotiate such an assurance.
If the Human Subjects work will be performed by a subcontractor, do I need a Federal Wide Assurance (FWA) also?
Yes, any institution engaged in non-exempt human subjects research conducted or supported by HHS must submit a written assurance of compliance to the Office for Human Research Protections (OHRP). The Federalwide Assurance (FWA) is the only type of assurance of compliance accepted and approved by OHRP.
When do I need Institutional Animal Care and Use Committee (IACUC) approval?
IACUC approval must be obtained prior to award. NIH does not require IACUC approval of the proposed research before NIH peer review of an application. The applicant must address the points under the Vertebrate Animal section of the Other Research Plan section.
Our project includes vertebrate animal work at our subcontractor site; they have an IACUC approval for the animal work, but we were told by our Grants Specialist that we will need an Interinstitutional Agreement before an award is made. Why is this needed?
The NIH’s Office of Laboratory Animal Welfare (OLAW) negotiates Interinstitutional Agreement Assurances of Compliance when an awardee institution without an animal care and use program will rely on a research partner to conduct the animal work. This agreement insures that all involved parties are aware of their responsibilities regarding animal use and proper procedures are followed.
Please explain the NIH peer review scoring system?
NIH uses a rigorous dual peer review system to ensure only the most meritorious scientific proposals are funded. Please see our NIH SBIR/STTR Review page for more specific information about the first and second round of review, and the scoring criteria.
Who is included in the small business peer-review study sections?
Small business study sections in the Center for Scientific Review (CSR) are specific to SBIR and STTR applications, meaning that SBIR and STTR applications are not reviewed in NIH’s standard academic study sections alongside R01s and R21s. The make-up of the small business study sections includes both academic and industry professionals who have a robust knowledge about the SBIR and STTR programs. CSR aims to have around 25 – 50 percent representation of industry professionals on the review panel. The academic professionals on the panel are also very familiar with the SBIR and STTR programs and frequently collaborate with small businesses on SBIR and STTR awards.
What are the page limit requirements?
The page limits are included in the SF424 SBIR/STTR (R&R) Application Guide. The specific aims are limited to one page, research strategy to 6 pages for Phase I and 12 pages for Phase II/IIB and Fast Track applications, and the commercialization plans for Phase II/IIB and Fast Track applications are limited to 12 pages. Each biosketch is limited to 5 pages (new format). Resubmission introductions are limited to one page for all applications. Please review the Page Limits webpage for more information.
Does my Business have the right to file a patent if the work was funded by an NIH SBIR/STTR grant?
Small business concerns normally retain the principal worldwide patent rights to any invention it develops with Government support, consistent with 35 USC 200-212 and its implementing regulations. Under existing regulations, 37 CFR 401, the Government receives a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States the subject invention throughout the world, reserves the right to require the patent-holder to license others in certain circumstances, and requires that anyone exclusively licensed to use or sell the invention in the United States must normally substantially manufacture in the United States any product embodying or product through use of the subject invention. To the extent authorized by 35 U.S.C. 205, the Government will not make public any information disclosing a Government-supported to allow the awardee a reasonable time for filing a patent application, nor will the Government release any information that is part of a patent application. For more information, read about the Bayh-Dole Act.
Is the inclusion of proprietary information in an application considered disclosure and disqualify my company for applying for patents?
Applications are submitted for evaluation purposes only and are reviewed in closed private (non-public) sessions by reviewers who are under strict confidentiality agreements with the federal government. Therefore, information contained in applications would normally not be considered as a public disclosure and should not affect the applicant’s ability to apply for patents. However, filing patent applications prior to submission of a funding application is something an applicant should consider in conjunction with their legal counsel. Also, it should be noted that the submitted abstract would be published upon award of the grant, so the abstract should be drafted carefully so as not to be considered as an enabling disclosure. Please review NIH’s Guide Notice (NOT-OD-14-073) about maintaining confidentiality during review.
Also, according to NIH Grants Policy and Federal law, NIH recipient organizations must promptly report all inventions that are either conceived or first actually reduced to practice using NIH funding. Invention reporting compliance is described at http://www.iedison.gov. Grantees and contractors are required to submit all invention disclosures, related reports and documents electronically via Interagency Edison (iEdison). Paper reporting is not allowed. (See NOT-OD-15-080.) Information from these reports is retained by the NIH as confidential and submission does not constitute any public disclosure. Failure to report as described at 37 CFR Section 401.14 is a violation of 35 U.S.C. 202 and may result in loss of the rights of the recipient organization.
Inquiries or correspondence should be directed to:
Division of Extramural Inventions and Technology Resources,
Office of Policy for Extramural Research Administration, OER, NIH,
6705 Rockledge Drive, Suite 310, MSC 7980,
Bethesda, MD 20892-7980,
Telephone: (301) 435-1986
What do I need to submit to NIH at the end of the grant budget period? When are these reports due?
The NIH requires that SBIR/STTR grantees submit the following reports within 90 days of the end of the grant budget period unless the grantee is under an extension.
- Final Progress Report (requirements have changed - please see the NOT-OD-12-152)
- Final Invention Statement and Certification (HHS 568)
- Annual Invention Utilization Reports
- Federal Financial Report (FFR) – replaced the Final Cash Transaction Report (PSC 272)
- Phase II Data Collection Requirement for Government Tech-Net Database
Failure to submit timely final reports may affect future funding to the organization or awards with the same PD/PI.
For details about each specific required report, see the section on “Award Guidelines, Reporting Requirements, and Other Considerations,” in the SF424 (R&R) SBIR/STTR Application Guide.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of federal grants to report information about first-tier subawards and executive compensation under federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
If my small business employs a subcontractor to do certain work under our SBIR/STTR award and the subcontractor makes a subject invention under that subaward, may our small business require the subcontractor to assign rights to that subject invention to our small business as part of the consideration for awarding the subcontract?
No. 37 CFR 401.14 (a)(g) states "The subcontractor will retain all rights provided for the contractor in this clause, and the contractor will not, as part of the consideration for awarding the subcontract, obtain rights in the subcontractor's subject inventions." Therefore, if the subject invention is solely invented by subcontractor staff, the small business cannot require assignment of rights from the subcontractor as noted above. However, if the subject invention is jointly made by an employee of the small business and an employee of the subcontractor, both the small business and the subcontractor would already be co-owners of the subject invention by virtue of their respective employee's co-inventorship (assuming appropriate employment agreements are in place that requires assignment to the respective employer).
Are patent costs allowable under an SBIR/STTR funding award?
Patent costs are generally not allowable under an SBIR/STTR funding award. For more detailed information about the allowability of certain costs and activities under NIH funding awards, view the NIH Grants Policy Statement (GPS). NIH will typically not negotiate patent costs into F&A rates per the NIH Division of Financial Advisory Services (DFAS).
While patent costs are generally unallowable, it should be noted that there is a reasonable fee/profit available to small business concerns receiving awards under the SBIR/STTR program which can be used for any purpose, such as covering patent expenses; however, this profit/fee must be included in the budget request at the time of application.
Does my small business need intellectual property agreements as part of my SBIR/STTR grant application?
A primary goal of the SBIR/STTR programs is the commercialization of technologies under the SBIR/STTR award. When accepting monies under an SBIR/STTR award, the small business is certifying that it is able to conduct the funded research toward commercialization. Therefore, a small business should ensure its ability to achieve that goal under its grant application and to freely move forward with the research. For example, under an STTR award which requires collaboration between a small business and a nonprofit research institution, it is expected that intellectual property issues between the partners that should be addressed early on to ensure that the flow of the research, development, and commercialization of the project continues unimpeded. Accordingly, small businesses and nonprofit research institutions should consider using the "Model STTR Intellectual Property Agreement" to address the allocation of rights in intellectual property and rights to carry out follow-on research, development, or commercialization https://sbir.nih.gov/sites/default/files/STTRModelAgreement.doc for an STTR award. This model agreement may also be considered for addressing similar situations under SBIR awards which may involve subcontractors. While IP agreements/arrangements should be worked out to ensure what the small business is proposing in its SBIR/STTR grant application will be achievable, these need not be submitted as part of the grant application.
Does the Bayh-Dole Act require patenting under NIH SBIR/STTR funding awards?
If the small business makes a subject invention under an NIH funding award, the funded organization is required to choose whether it will either elect or not elect title to the subject invention. If the organization chooses to elect title, then the Bayh-Dole Act does require the funded organization to file a patent application on the subject invention in a timely manner. However, if the organization chooses not to elect title, then the organization need not file a patent application under the Bayh-Dole Act.
Where can I find out what projects in my research topic area have been supported by NIH?
The Research Portfolio Online Reporting Tool (RePORT) provides the public access to reports, data, and analyses of NIH research activities, including information on NIH expenditures and the results of NIH-supported research.
How can I find out the success rates for different institutes and programs?
The Research Portfolio Online Reporting Tool provides a link to success rates. Success rates are shown by specific activity codes (mechanisms). The Small Business Program consists of two Phases. The STTR Phase I uses the R41 mechanism and Phase II uses the R42 mechanism. The SBIR program Phase I uses the R43 mechanism and Phase II uses the R44 mechanism.
Does an applicant have to have a Phase II award to apply for a Phase IIB or CRP award?
Yes, an applicant needs to have been awarded a Phase II, which includes a Phase II as part of a Fast-Track, in order to apply for a Phase IIB or CRP award.
A Phase IIB is intended to provide follow-on funding to Phase II awardees for those Phase II projects that require extraordinary time and effort in the research and development phase. A Phase IIB is awarded after the Phase II has ended, although the Phase IIB can be submitted while a Phase II is active.
A CRP award is intended to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and, in some cases, later stage research and development not typically supported through Phase II or Phase IIB grants or contracts. A CRP can be awarded while the Phase II or Phase IIB is active or after it has ended.
Does an applicant need to meet SBIR eligibility requirements to receive a Phase IIB or CRP award?How can I find out the success rates for different institutes and programs?
Yes, an applicant must be an SBIR eligible small business (https://sbir.nih.gov/about/eligibility-criteria) at the time of award to receive a Phase IIB or CRP award.
How many Phase IIB and/or CRP awards can be connected to a Phase II project?
A Phase II project may be awarded one Phase IIB (i.e. one renewal of the Phase II). Only one CRP is allowed per Phase II or Phase IIB project. A project that is awarded a CRP in the Phase II cannot be awarded an additional CRP during the Phase IIB.
How many Phase IIB and/or CRP application submissions can be connected to a Phase II project? Can a Phase IIB and CRP application be submitted at the same time?How can I find out the success rates for different institutes and programs?
A Phase IIB is considered a renewal of the Phase II. Per NIH policy (https://grants.nih.gov/grants/policy/amendedapps.htm), only a single resubmission of a renewal application will be accepted. Submission of a “new” Phase IIB after an unsuccessful A1 is not allowed. Similarly, only a single resubmission of a CRP application will be accepted. The CRP does utilize the “new” application designation to allow active Phase II or Phase IIB grants or contracts to receive a CRP concurrently with their active award. This does not allow for a “new” CRP application after an unsuccessful resubmission of a CRP application.
NIH will not accept Phase IIB and CRP applications for the same Phase II project concurrently, i.e. Phase IIB and CRP applications for the same Phase II project cannot be under review at the same time, even if they are scientifically distinct.
Is matching funding required for a Phase IIB? What constitutes matching funding for a Phase IIB?
Matching funding is encouraged, but not required for a Phase IIB. Commercial potential (i.e. the probability that an application will result in a commercial product) will be strongly considered in review (refer to Section V. Application Review Information) and making funding decisions. Applicants are encouraged (but not required) to secure substantial independent third-part investor funds (i.e., third-party funds that equal or exceed the requested NIH funds). An applicant's ability to secure substantial independent third-party investor funds will help validate the commercial potential of the proposed SBIR Phase IIB project.
Examples of third-party investors include, but are not limited to, another company, a venture capital firm, an angel investor, a foundation, a university, a research institution, or a State or local government, or any combination of the above.
What are the significant differences between the Phase IIB and CRP program?How can I find out the success rates for different institutes and programs?
There are several significant differences between the Phase IIB and CRP program.
R44 (SBIR) or R42 (STTR)
Timing in relation to Phase II
Awarded after Phase II project has ended, although the Phase II can be active when the Phase IIB is submitted
Awarded concurrent with or after the Phase II or Phase IIB award has ended
The total amount of all consultant and contractual agreements to third parties for portions of the scientific and technical effort generally may not exceed 50 percent of the total amount requested. Applicants are strongly encouraged to discuss deviations from these guidelines with NIH program staff listed in the Funding Opportunity Announcement.
A substantial portion of the CRP award may be subcontracted to third parties through consultant and contractual arrangements. The small business must perform a substantive role in the conduct of the planned research and not merely serve as a conduit of funds to another party or parties. This includes being able to provide appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant.
Applications are accepted through the Omnibus (IC must accept Phase II competing renewals) or specific funding opportunities (https://sbir.nih.gov/funding#targeted)
Specific funding opportunities (https://sbir.nih.gov/funding#crp)
Matching funding is strongly encouraged to indicate commercial potential
Not specifically mentioned in the funding opportunities
Not all NIH Institutes and Centers participate in the Phase IIB or CRP program. FDA and CDC do not participate in the Phase IIB or CRP program. Applicants are encouraged to speak with their program officer about the best options for their project.
Can TABA costs exceed $6,500 per year for a Phase I and $50,000 for a Phase II or IIB?
No. According to the SBIR/STTR Policy Directive, requested TABA costs may not exceed:
- SBIR/STTR Phase I: $6,500 in additional funding per year;
- SBIR/STTR Phase II/IIB: $50,000 in additional funding per project period. TABA funding may be requested in Phase II and again in Phase IIB.
Commercialization Readiness Pilot (CRP) Program awards (SB1) are not eligible for TABA.
Are TABA costs included in the total cost SBIR/STTR budget cost caps?
In line with the NIH Grants Policy Statement Section 184.108.40.206 Program Levels (Total Costs), Institutes and Centers (ICs) have the discretion to set individual budget guidelines for their SBIR/STTR programs above and below the SBA mandated budget caps. Budget guidelines for individual ICs may include restrictions on the total cost of the project (direct cost, indirect costs, fees and TABA costs). Specific funding opportunity announcements may include available funds under these TABA amounts dependent upon availability of funds at an Institute/Center level.
Applicants are strongly encouraged to contact program staff prior to submitting any application in excess of the SBA budgetary guidelines.
How should applicants request TABA costs within an application?
Applicants must label the requested cost “Technical Assistance” on one of the lines from 8-10 under Section F. Other Direct Costs. Applicants should include the following information in the budget justification:
- Name of the vendor(s)
- Detailed description of the technical or business assistance the vendor(s) will provide
- Expected benefits and results of the technical or business assistance
Can a company request TABA costs for a service provided by the SBIR/STTR applicant (or a division within the applicant’s firm) or subcontractor on the application/award?
No. Proposed TABA costs are only allowable if the proposed cost cannot be provided internally. Services provided by the SBIR/STTR applicant, affiliate of the SBIR/STTR applicant, an investor of the SBIR/STTR applicant, or a subcontractor or consultant of the requesting firm otherwise required as part the paid portion of the research effort cannot be included as TABA costs.
Can a company request filing costs as part of TABA funds?
An applicant cannot directly request filing costs as part of TABA. However, applicants can request funds to support intellectual property protection, including development of patent applications, performing freedom-to-operate and patentability searches, and analysis of existing IP and competitor products, and filing fees.
Applicants can utilize the SBIR/STTR fee to pay for patent filing costs.
What costs are considered research and development (R&D) versus TABA??
Costs for services that are considered research and development as identified in the SBIR/STTR application or award are not allowable under TABA. TABA costs cannot be allocable to the aims of a specific award and costs must qualify as indirect costs in line with NIH Grants Policy Statement Section 7.4 – Reimbursement of Facilities and Administrative Costs.
What monitoring is required for TABA?
Recipients are required to report on TABA in their progress reports, including benefits and results of the technical or business assistance.
Can awardees rebudget TABA funds? Can overall TABA funds for a project be increased or decreased by rebudgeting?
Recipients can rebudget TABA funds within TABA budget category by 25% without prior approval. Significant rebudgeting, defined as rebudgeting by 25% or more within the TABA budget category, require prior approval.
Rebudgeting to include TABA costs when not originally requested and without NIH prior approval is not allowed. Rebudgeting to increase or decrease TABA funding is not allowed.
Can awardees who request TABA utilize centralized NIH TABA services?
No. Awardees who request and receive TABA through the grant award cannot utilize centralized NIH TABA services for the phase of the SBIR/STTR that TABA services are requested. For fast-track applications, centralized NIH TABA services may be used for any phase of the project that did not request TABA funds. However, both awardees who utilize centralized TABA services and awardees who receive TABA through the grant award can utilize non-TABA SEED innovator support, including I-Corps, Concept to Clinic: Commercializing Innovation (C3i), regulatory assistance, or pitch coaching from Entrepreneurs in Residence (EIRs).