|Funding Opportunities (RFAs, PAs) & Notices|
|Unsolicited Applications (Parent Announcements)|
|Research Training & Career Development|
|Small Business (SBIR/STTR)|
|Transitioning to Phase III|
|Presentations / Conferences|
|New and Early Stage Investigators|
|Stem Cell Information|
|NIH Common Fund|
|OppNet (Behavioral & Social Sciences)|
|NIH Reports (RePORT)
Search NIH Awards (RePORTER)
|NIH Staff FAQs|
Initial Posting: March 8, 2010
Last Revised: February 19, 2014
|Related NIH Staff FAQs|
|On This Page:|
A. General Questions
As part of the SBIR and STTR Reauthorization of 2011, NIH issued a pilot SBIR Direct to Phase II solicitation (PAR-14-088), which 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 Pilot 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 ACF SBIR programs. Only the NIH Institutes and Centers listed in Components of Participating Organizations within the solicitation will accept Direct-to-Phase II SBIR submissions.
Applicants are strongly advised to discuss this option with their program officer well in advance of any due date.
B. Application Preparation & Submission
| SBIR and STTR Due Dates |
Phase I and Phase II
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-14-082).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-14-074.
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.
In addition to registering with Grants.gov, both the small business concern and the Project Director/Principal Investigator (PD/PI) must also 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, see eRA Commons Registered Organizations.
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, click on Grantee Registration Steps for Commons (PDF - 105 KB). (Note: This applies to applicants as well as grantees despite the reference to “Grantee”.)
The eRA Commons is so important because this is now THE discrete information exchange system where NIH and the applicant/grantee community are able conduct their extramural research administration business electronically. As announced in a recent NIH Guide Notice, the following changes are currently in place:
In order to avoid delays in the e-notification process, 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.
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:
All SBIR and STTR applicants are required to register with the Company Registry Database at http://www.sbir.gov/registration at the time of application, and attach proof of registration to the application. This applies to all HHS SBIR/STTR programs, including NIH, CDC, FDA, and ACF.
SBIR and STTR applicants applying to solicitations issued after 1/28/2013 are required to register with SBA through the http://sbir.gov registration web site and must attach their registration confirmation files to their applications. The confirmation file (with the original file name from the SBA in 'SBCxxxxxx.pdf' format) must be attached as a PDF file to the Other Attachments section of the R&R Other Project Information form. For additional information on SBA Registration requirements please refer to section IV of the parent funding opportunity announcement (FOA): SBIR - PA-13-234 or STTR - PA-13-235.
If applying to SBIR/STTR solicitations issued prior to 1/28/2013, it is safe to ignore this warning. This warning will not stop the application from being received and processed and will not affect its peer review. However, you will be required to submit the SBA registration confirmation prior to award.
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:
Applicants must apply through the general NIH Direct Phase II FOA or any other targeted Direct Phase II FOA. Applicants cannot submit a standard Phase II or a Fast-Track application to a Direct Phase II FOA.
Preliminary data commensurate with what would be accomplished during a Phase I award should be submitted in a Direct Phase II FOA application. Applicants should have “…demonstrated the scientific and technical merit and feasibility of the prototype stage of developing a biomedical technology that has commercial potential, R&D that is characteristic of Phase-I (R43) SBIR projects.” Applicants must demonstrate Phase I equivalence of their preliminary data.
No, applications will not be screened for responsiveness. There is an additional Review Criterion designed to cover the Phase I equivalence: “How well did the applicant demonstrate feasibility of the methodology or technology equivalent to meeting Phase I-level objectives, and providing a solid foundation for the proposed Phase II activity?”
Yes, but you cannot be funded for both awards.
The Phase I to Phase II Transition Rate Benchmark only applies to companies that have received 20 or more Phase I AWARDS in the past five years, excluding the most recently completed fiscal year.
Strictly speaking, this only applies to new Phase I applications, but NIH is seeking guidance. Please contact your program officer for specific questions.
The Transition Rate Benchmark applies to AWARDS, not applications. Companies that have received more than 20 Phase I AWARDS, must meet the Transition Rate Benchmark.
The budget cap waivers apply to all awards in FY2014 and FY2015 made in response to all FOAs, including the Direct Phase II FOA, as long as the research topic is on the pre-approved waiver topic list.
The Reauthorization only authorized NIH to make Direct Phase II SBIR awards. Many prospective STTR applicants would also be able to apply to the SBIR program and are encouraged to speak with their program official to discuss the differences between the programs.
Yes, providing the NIH Institute or Center (IC) for which your Phase I project is applicable agrees to accept your Phase II application. Using the contact list provided in the SBIR and STTR parent funding opportunity announcements (available from the NIH SBIR/STTR website), contact an appropriate IC program officer and discuss the possibility of submitting a Phase II application.
As a result of the SBIR and STTR Reauthorization Act of 2011, you may also switch between the SBIR and STTR programs. If you received an SBIR Phase I award from another agency, your Phase II to NIH could be STTR and vice versa.
As a result of the SBIR and STTR Reauthorization Act of 2011, NIH SBIR and STTR applicants may now switch programs at Phase II or Phase IIB to any active and open NIH SBIR or STTR solicitation, including SBIR and STTR Omnibus Solicitations and any SBIR or STTR targeted funding opportunity. Applicants must follow the all the rules and policies for the program and solicitation for which they are applying. The employment status of the PI, sub-contracting rules, etc., must be adhered to for the Phase II or IIB application to the opposite program. Applicants are also strongly advised to discuss this option with their program officer well in advance of any due date.
This means that:
C. Company/Investigator Eligibility
Concerns which are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are called VC-backed companies. Starting from July 2013, VC-backed companies can apply for NIH SBIR program. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern. VC-backed companies cannot apply to the CDC, FDA, ACF or to the NIH STTR program.
For more information about eligibility, please refer to section IV of the parent funding opportunity announcement (FOA) for SBIR program - PA-13-234.
Here are the extra steps to follow for submitting an SBIR application for a VC-backed company:
For SBIR and STTR Solicitations Issued Prior to 1/28/13:
The Small Business Administration defines "small business concern" for purposes of the SBIR Program as one that on the date of award for both Phase I and Phase II/IIB funding agreements meets all of the following criteria:
- is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;
- is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture there can be no more than 49 percent participation by foreign business entities in the joint venture;
- is at least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and,
- has, including its affiliates, not more than 500 employees.
For SBIR and STTR Solicitations Issued After 1/28/13:
A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:
ii. NIH only and SBIR-only. Be a concern which is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern; OR
iii. SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements.
Note: NIH only. If the concern is more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.
If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner. If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.
If you have questions about size standards, each area office in SBA’s Office of Government Contracting has a designated Size Specialist. Contact the office nearest you using the following Web site: < http://www.sba.gov/content/guide-size-standards > (Note: the contact list is at the end of the document)
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.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.
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% 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. (Person Months website and calculator: http://grants.nih.gov/grants/policy/person_months_faqs.htm#q2)
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 (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.
NOTE: 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:
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.
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. In accordance with the SBIR and STTR Reauthorization of 2011, budget hard caps were set that prevented awards from being over 50% of the award guideline (ie: the hard cap was set at $225,000 for SBIR and STTR Phase I awards, and $1,500,000 for SBIR and STTR Phase II awards.)
For awards that go over these recommended guidelines, SBA will need to issue a waiver approving the budget or the topic must be listed on the SBA pre-approved waiver topics list. This list of topics with the waiver must be approved by SBA annually.
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.
A reasonable fee, not to exceed 7% 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
F. Foreign Involvement
G. Human Subjects and Animal Research
H. Scoring System
I. Page Limits
J. Intellectual Property Protection & Confidentiality
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.
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 are encouraged to submit reports electronically using Interagency Edison (http://www.iedison.gov). 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
K. Award Information