NIH Grants Policy Statement
Revised October 2017. This document applies to all NIH grants and cooperative agreements for budget periods beginning on or after October 1, 2017.
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18.5 Small Business Innovation Research and Small Business Technology Transfer Programs

NIH is required by statute to reserve a portion of its annual extramural budget for projects under the SBIR and STTR programs. These programs primarily are intended to encourage private-sector commercialization of technology and to increase small business participation in federally funded R&D.

The SBIR and STTR programs were reauthorized by Congress in P.L. 112-81, December 31, 2011. The reauthorization will modify several aspects of the programs, including small business eligibility requirements, upon implementation. Updates on reauthorization implementation will be posted on http://sbir.nih.gov. NIH will issue Guide Notice/s to advise the community about the impact on NIH's SBIR and STTR programs.

Both the SBIR and STTR programs consist of the following three phases:

Some NIH ICs offer Phase II SBIR/STTR awardees the opportunity to apply for Phase IIB Competing Renewal awards. These are available 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 such projects, including drugs, devices, vaccines, therapeutics, and medical implants related to the mission of the IC. Some ICs have announced this opportunity through the NIH Guide for Grants and Contracts and some are using the Omnibus SBIR/STTR Grant Solicitation. Only those small business concerns who have been awarded a Phase II are eligible to apply for a Phase IIB Competing Renewal award. Prospective applicants are strongly encouraged to contact NIH staff prior to submission. Additional requirements and instructions (e.g., submission of a letter of intent) are available in the specific IC research topics section and in the specific IC Program Funding Opportunity Announcements.

There are two major differences between the SBIR and STTR programs:

SBIR/STTR program policy now allows the following:

Applicants may 'switch' programs to any active and open NIH SBIR or STTR solicitation, including the Omnibus and any targeted funding opportunity.

Note: There are distinct policies for each program-SBIR and STTR-and each phase within these programs. Applicants that 'switch' programs must comply with the policies for the program and FOA to which they submit the application. See 18.5.5.4 SBIR Life Cycle Certification and Sec. 18.5.5.5 STTR Life Cycle Certification for further information.

18.5.1 NIH Fast-Track Application Process

The NIH Fast-Track application process expedites award decisions and funding of SBIR and STTR Phase II applications for scientifically meritorious projects that have a high potential for commercialization. The Fast-Track process allows Phase I and Phase II grant applications to be submitted and reviewed together. Fast-Track applications receive a single rating. Before submitting applications for Fast-Track review, applicants are strongly encouraged to consult with cognizant NIH program staff to assure Fast-Track is appropriate. For additional information on the submission of Fast-Track applications, see the SF424 (R&R) SBIR/STTR Application Guide available at http://sbir.nih.gov.

18.5.2 Eligibility

Only United States small business concerns (SBCs) are eligible to submit SBIR and STTR applications. A small business concern is one that, at the time of award for both Phase I and Phase II SBIR awards, meets all of the following criteria. If it appears that an applicant organization does not meet the eligibility requirements, NIH will request a size determination by the SBA. If eligibility is unclear, NIH will not make an SBIR or STTR award until the SBA provides a determination.

On December 27th, 2012, SBA issued revised eligibility regulations (called the Size Rule) that went into effect for all new SBIR and STTR funding opportunity announcements (FOA) issued after January 28, 2013. Since NIH has multiple SBIR/STTR FOAs issued at any given time, the new, as well as old, eligibility criteria are in effect, depending on when the FOA was issued.

1. For all SBIR FOAs Issued Prior to 1/28/2013:

  1. 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;
  2. 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;
  3. At least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or it must be a for-profit business concern that is at least 51% owned and controlled by another for-profit business concern that is at least 51% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States -- (except in the case of a joint venture);
  4. Has, including its affiliates, not more than 500 employees and meets the other regulatory requirements found in 13 CFR 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.

2. For all STTR FOAs Issued Prior to 1/28/2013:

  1. 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;
  2. 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;
  3. At least 51 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States;
  4. Has, including its affiliates, not more than 500 employees and meets the other regulatory requirements found in 13 CFR 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.

3. For all SBIR FOAs Issued After 1/28/2013:

  1. 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;
  2. 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 must be less than 50 percent participation by foreign business entities in the joint venture;
  3.  
    1. Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR
    1. 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
    1. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph c(i) or c(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 application requirements.
  4. Has, including its affiliates, not more than 500 employees and meets the other regulatory requirements found in 13 CFR 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.

4. For all STTR FOAs Issued After 1/28/2013:

  1. 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;
  2. 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 must be less than 50 percent participation by foreign business entities in the joint venture;
  3.  
    1. Be a concern which is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; OR
    1. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph c(i) of this section.
  4. Has, including its affiliates, not more than 500 employees and meets the other regulatory requirements found in 13 CFR 121. Business concerns, other than investment companies licensed, or state development companies qualifying under the Small Business Investment Act of 1958, 15 U.S.C. 661, et seq., are affiliates of one another when either directly or indirectly, (a) one concern controls or has the power to control the other; or (b) a third-party/parties controls or has the power to control both.

Control can be exercised through common ownership, common management, and contractual relationships. The term "affiliates" is defined in greater detail in 13 CFR 121.3-2(a). The term "number of employees" is defined in 13 CFR 121.3-2(t).

Business concerns include, but are not limited to, any individual (sole proprietorship), partnership, corporation, joint venture, association, or cooperative. Further information may be obtained by contacting the Small Business Administration Size District Office at http://sba.gov/size.

18.5.2.1 Place of Performance

For both Phase I and Phase II SBIR/STTR awards, the research or R&D project activity must be performed in its entirety in the United States. (The United States is defined as the 50 States, the territories and possessions of the United States, the Commonwealth of Puerto Rico, the Federated States of Micronesia, the Republic of Palau, the Republic of the Marshall Islands, and the District of Columbia.)

In those rare instances where the study design requires use of a foreign site (e.g., to conduct testing of specific patient populations), the investigator must provide compelling scientific justification in the application for the need/use of a foreign site. Similarly, in those rare instances where it may be necessary to purchase materials from other countries, investigators must thoroughly justify the request. NIH will consider these instances on a case-by-case basis, and they should be discussed with cognizant NIH staff before submitting an application. Approval will not be considered unless the application is being considered for an award. IC GMOs have the authority to approve these waiver requests. Whether the request is approved or disapproved, it will be explicitly addressed in the NoA if an award is made. Whenever possible, work outside the United States, which is necessary to the completion of the project, should be supported by funding other than SBIR/STTR.

18.5.2.2 Change in Organization Status & Change of Recipient Institution Actions

Applicant organization eligibility is determined at the time of the initial SBIR/STTR award. If a legal action occurs such as a merger or successor-in-interest, that changes the organization status so that they are no longer eligible for the SBIR/STTR programs, existing SBIR/STTR grants can continue. However, the organization would no longer be eligible for any new SBIR/STTR grants.

When there is a desire to transfer an SBIR/STTR grant to a different organization, the new organization must continue to meet the SBIR/STTR program eligibility requirements. Recipients should contact the NIH awarding office to discuss options when considering a move to a new organization.

18.5.2.3 Minimum Level of Effort

Generally, under SBIR Phase I awards, a minimum of two-thirds or 67 percent of the research or analytical effort must be carried out by the SBC. Payments, in the aggregate, to consultants, consortium participants and contractors for portions of the scientific/technical effort generally may not exceed 33 percent of the total requested amount.

Generally under SBIR Phase II awards a minimum of one-half or 50 percent of the research or analytical effort must be carried out by the SBC. In addition, payments, in the aggregate, to consultants, consortium participants, and contractors for portions of the scientific/technical effort generally may not exceed 50 percent of the total requested amount.

For STTR awards (both Phase I and Phase II), at least 40 percent of the work must be performed by the SBC and at least 30 percent of the work must be performed by the single, non-profit research institution. These percentages are Congressionally mandated and waivers are not permitted. The basis for determining the percentage of work to be performed by each of the cooperating parties is the total cost ( direct and F&A costs, and fee) attributable to each party, unless otherwise described and justified in the "Consortium/Contractual Arrangements" portion of the of the grant application.

18.5.2.4 Multiple Program Director/Principal Investigator Applications and Awards

The Multiple Program Director/Principal Investigator (multiple PD/PI) option is available for NIH SBIR/STTR applicants for team science efforts. All of the policy and requirements described in Multi PD/PI apply to SBIR/STTR projects, with the exception of sections that are not relevant to the SBIR/STTR program (e.g., new investigators, multi-project applications). In addition, the following criteria apply to multiple PD/PI SBC applicants and awards:

18.5.3 Public Policy Requirements and Objectives

For-profit organizations receiving SBIR/STTR awards generally are subject to the same public policy requirements as non-profit organizations. However, the requirements concerning reporting of financial conflicts of interest (see Public Policy Requirements, Objectives, and Other Appropriation Mandates-Financial Conflict of Interest in IIA) do not apply to applications or awards under Phase I of the SBIR/STTR programs. The requirements do, however, apply to Phase II applications and awards.

Consistent with SBA program policy directives and NIH's omnibus FOAs for SBIR and STTR, when purchasing equipment or a product under the SBIR/STTR award, the small business concern should purchase only American-made items whenever possible.

18.5.4 Allowable Costs and Fee

18.5.4.1 Program Levels (Total Costs)

SBA SBIR and STTR Policy Directives provide program levels for SBIR and STTR programs based on statutory guidelines. However, these directives also give agencies discretion to exceed these levels up to 50% over the guideline (Hard Cap) when the proposed budget and requested period of support are fully justified and scientifically appropriate in relation to the proposed research. The Small Business Administration may adjust award guidelines annually. The current levels are:

HARD CAPS

As written in the statute and under appropriate circumstances, NIH can apply for a waiver from SBA to issue an award exceeding the Hard Cap ($225,000 for Phase I or $1,500,000 for Phase II) if this cap will interfere with NIH's ability to meet its mission. Award waivers from the SBA are not guaranteed and may delay the release of funds.

Some ICs offer Phase II SBIR/STTR awardees the opportunity to apply for Phase IIB Competing Renewal awards. These are available 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 such projects, including drugs, devices, vaccines, therapeutics, and medical implants related to the mission of the IC. Only those small business concerns who have been awarded a Phase II are eligible to apply for the Phase IIB award. Program levels are:

Applicants must request an appropriate level in the competing application; applications will not be adjusted after submission. See the NIH Special Announcements for Small Business Research Opportunities for a list of these unique SBIR funding opportunities.

18.5.4.2 Profit or Fee

A reasonable profit or fee may be paid to a SBC receiving an award under Phase I or Phase II of the SBIR and STTR programs. However, this profit or fee must be included in the budget request at the time of application. The profit or fee is not considered a "cost" for purposes of determining allowable use, program income accountability, or audit thresholds. The profit or fee may be used by the SBC for any purpose, including additional effort under the SBIR/STTR award. It is intended to provide a reasonable profit consistent with normal profit margins for for-profit organizations for R&D work; however, the amount of the profit or fee normally will not exceed seven (7) percent of total costs (direct and F&A) for each phase of the project. The profit or fee should be drawn from PMS in increments proportional to the drawdown of funds for direct and F&A costs. The profit or fee applies solely to the SBC receiving the SBIR/STTR award and not to any other participant; however, in accordance with normal commercial practice, the SBC may pay a profit or fee to a contractor providing routine goods or services to the SBC under the grant.

18.5.4.3 Facilities and Administrative Costs (Indirect Costs)

18.5.4.3.1 Phase I

If the applicant SBC has a currently effective F&A cost rate(s) with a Federal agency, such rate(s) should be used when calculating proposed F&A costs for an NIH application. NIH ICs use the term F&A costs for all types of applicants and recipients; however, for-profit organizations will find that DFAS and organizations external to NIH refer to these costs as indirect costs. (However, the rates(s) must be adjusted for IR&D expenses, which are not allowable under HHS awards.) If the applicant SBC does not have a currently effective negotiated indirect cost rate with a Federal agency, the applicant should propose estimated F&A costs at a rate not to exceed 40 percent of the total direct costs. However, SBCs are reminded that only actual F&A costs are to be charged to projects. (If awarded at a rate of 40 percent or less, the rate used to charge actual F&A costs to projects cannot exceed the awarded rate unless the SBC negotiates an indirect cost rate(s) with a Federal agency.) NIH will not negotiate indirect cost rates for Phase I awards.

18.5.4.3.2 Phase II

If the applicant SBC has a currently effective negotiated indirect cost rate(s) with a Federal agency, such rate(s) should be used when calculating proposed F&A costs for an NIH application. (However, the rates(s) must be adjusted for IR&D expenses, which are not allowable under HHS awards.) If the applicant SBC does not have a currently effective negotiated indirect cost rate with a Federal agency, the applicant should propose an estimated F&A rate in the application. If the requested F&A cost rate is 40 percent of total direct costs or less, no further justification is required at the time of award, and F&A costs will be awarded at the requested rate. However, SBCs are reminded that only actual F&A costs may be charged to projects. If awarded at a rate of 40 percent or less of total direct costs, the rate used to charge actual F&A costs to projects cannot exceed the awarded rate unless the SBC negotiates an indirect cost rate(s) with DFAS. DFAS-the office authorized to negotiate indirect cost rates with SBC's receiving NIH SBIR/STTR awards-will negotiate indirect cost rates for SBCs receiving Phase II awards that requested a rate greater than 40 percent of total direct costs.

Upon request, the applicant SBC should provide DFAS with an indirect cost proposal and supporting financial data for its most recently completed fiscal year. If financial data is not available for the most recently completed fiscal year, the applicant should submit a proposal showing estimated rates with supporting documentation. Further information about DFAS is available at its Web site or by telephone (see Part III).

18.5.5 Administrative Requirements

For-profit organizations that receive SBIR/STTR awards generally are subject to the same administrative requirements as non-profit organizations. (See 45 CFR 75 for further.)

18.5.5.1 Market Research

NIH will not support market research, including studies of the literature that lead to a new or expanded statement of work, under the grant. For purposes of the SBIR/STTR programs, "market research" is the systematic gathering, editing, recording, computing, and analyzing of data about problems relating to the sale and distribution of the subject of the proposed research. It includes various types of research, such as the size of potential markets and potential sales volume, the identification of consumers most apt to purchase the products, and the advertising media most likely to stimulate their purchases. However, "market research" does not include activities under a research plan or protocol that include a survey of the public as part of the objectives of the project to determine the impact of the subject of the research on the behavior of individuals.

18.5.5.2 Intellectual Property

Rights to data, including software developed under the terms of any funding agreement resulting from an NIH award, shall remain with the recipient except that any such copyrighted material shall be subject to a royalty-free, nonexclusive and irrevocable license to the Federal government to reproduce, publish or otherwise use the material, and to authorize others to do so for Federal purposes. In addition, under the SBIR/STTR programs, in contrast to awards to for-profit organizations under other support mechanisms, such data shall not be released outside the Federal government without the recipient's permission for a period of 4 years from completion of the project.

Rights in Data Developed Under SBIR Funding Agreement. The Small Business Innovation Research Program Reauthorization Act of 2000, Public Law 106-554, amended section 9 of the Act (15 U.S.C. 638), referred to as the "Act" provides for "retention by an SBC of the rights to data generated by the concern in the performance of an SBIR award."

  1. Each agency must refrain from disclosing SBIR technical data to outside the Government (except reviewers) and especially to competitors of the SBC, or from using the information to produce future technical procurement specifications that could harm the SBC that discovered and developed the innovation.
  2. SBIR agencies must protect from disclosure and non-governmental use all SBIR technical data developed from work performed under an SBIR funding agreement for a period of not less than four years from delivery of the last deliverable under that agreement (either Phase I, Phase II, or Federally-funded SBIR Phase III) unless, subject to (b)(3) of this section, the agency obtains permission to disclose such SBIR technical data from the awardee or SBIR applicant. Agencies are released from obligation to protect SBIR data upon expiration of the protection period except that any such data that is also protected and referenced under a subsequent SBIR award must remain protected through the protection period of that subsequent SBIR award. For example, if a Phase III award is issued within or after the Phase II data rights protection period and the Phase III award refers to and protects data developed and protected under the Phase II award, then that data must continue to be protected through the Phase III protection period. Agencies have discretion to adopt a protection period longer than four years. The Government retains a royalty-free license for Government use of any technical data delivered under an SBIR award, whether patented or not. This section does not apply to program evaluation.
  3. SBIR technical data rights apply to all SBIR awards, including subcontracts to such awards, that fall within the statutory definition of Phase I, II, or III of the SBIR Program, as described in Section 4 of this Policy Directive. The scope and extent of the SBIR technical data rights applicable to Federally-funded Phase III awards is identical to the SBIR data rights applicable to Phases I and II SBIR awards. The data rights protection period lapses only: (i) Upon expiration of the protection period applicable to the SBIR award, or (ii) by agreement between the awardee and the agency.
  4. Agencies must insert the provisions of (b)(1), (2), and (3) immediately above as SBIR data rights clauses into all SBIR Phase I, Phase II, and Phase III awards. These data rights clauses are non- negotiable and must not be the subject of negotiations pertaining to an SBIR Phase III award, or diminished or removed during award administration. An agency must not, in any way, make issuance of an SBIR Phase III award conditional on data rights. If the SBIR awardee wishes to transfer its SBIR data rights to the awarding agency or to a third party, it must do so in writing under a separate agreement. A decision by the awardee to relinquish, transfer, or modify in any way its SBIR data rights must be made without pressure or coercion by the agency or any other party. Following issuance of an SBIR Phase III award, the awardee may enter into an agreement with the awarding agency to transfer or modify the data rights contained in that SBIR Phase III award. Such a bilateral data rights agreement must be entered into only after the SBIR Phase III award, which includes the appropriate SBIR data rights clause, has been signed. SBA must immediately report to the Congress any attempt or action by an agency to condition an SBIR award on data rights, to exclude the appropriate data rights clause from the award, or to diminish such rights.

The STTR program requires that the small business recipient and the single, non-profit research institution execute an agreement allocating between the parties intellectual property rights and rights, if any, to carry out follow-on research, development, or commercialization of the subject research. (A model agreement, entitled "Allocation of Rights in Intellectual Property and Rights to Carry Out Follow-On Research, Development, or Commercialization," is available at the NIH Web site at http://grants.nih.gov/grants/funding/sbir.htm.) By signing the face page of the grant application, the SBC's AOR certifies that the agreement with the research institution will be effective at the time the grant award is made. A copy of the agreement must be furnished upon request to the NIH awarding IC.

SBIR/STTR recipients are covered by 35 U.S.C. 200-212 and 37 CFR 401 with respect to inventions and patents (see Grants to For-Profit Organizations-Administrative Requirements-Intellectual Property in this chapter).

18.5.5.3 Data Sharing

Applicants for SBIR Phase II funding of $500,000 or more of direct costs in any single year must comply with the NIH policy on data sharing as modified by the Small Business Act. If the final data would not be amenable to sharing, e.g., proprietary data, the SBC should explain that in the application. In addition, as indicated under Intellectual Property in this chapter, whether or not the award meets the threshold for data sharing, NIH will not release data outside the Federal government without the recipient's permission for a period of 4 years from completion of the project. The entire policy may be found at http://grants.nih.gov/grants/policy/data_sharing.

18.5.5.4 SBIR Life Cycle Certification

All SBIR Phase I and Phase II awardees must complete a Life Cycle Certification at all times set forth in the Notice of Award (see §8(h) of the SBIR Policy Directive). This includes checking all of the boxes on the actual certification document and having an authorized officer of the awardee sign and date the certification each time it is required. Awardees are not required to submit a certification directly to NIH but must instead complete a certification and maintain it on file in accordance with the records and retention policy in Section 8.4.2 of the NIH Grants Policy Statement.

A certification is required at the following times:

In addition, SBIR awardees indicate compliance with these certification requirements by drawing or requesting funds from the Payment Management System. If the recipient cannot complete the certification or cannot ensure compliance with the certification process, it should notify the GMO immediately. If resolution cannot be reached, the GMO will void or terminate the grant, as appropriate.

The certification form is available in fillable format at: https://grants.nih.gov/grants/forms/manage_a_small_business_award.htm. However, the requirements are outlined below.

Overview Certification Information. The Federal government relies on this information to determine whether the business is eligible for a Small Business Innovation Research (SBIR) Program award. The definitions for the terms used in the certification are set forth in the Small Business Act, SBA regulations (13 C.F.R. Part 121), the SBIR Policy Directive and also any statutory and regulatory provisions references in those authorities.

If the Grants Management Officer believes, after award, that the business is not meeting certain funding agreement requirements, the agency may request further clarification and supporting documentation in order to assist in the verification of any of the information provided.

Even if correct information has been included in other materials submitted to the Federal government, any action taken with respect to the certification does not affect the Government's right to pursue criminal, civil, or administrative remedies for incorrect or incomplete information given in the certification. Each person signing a certification may be prosecuted if they have provided false information.

Recipients will verify and certify the following provisions:

  1. The principal investigator spent more than half of his/her time as an employee of the awardee or has requested and received a written deviation from this requirement from the Grants Management Officer. When a deviation has been approved by the NIH, the certification will also document the adjusted percentage of time approved.
  2. All, essentially equivalent work, or a portion of the work performed under this project:
    • Has not been submitted for funding by another Federal agency.
    • Has been submitted for funding by another Federal agency but has not been funded under any other Federal grant, contract, subcontract, or other transaction.
    • A portion has been funded by another grant, contract, or subcontract as described in detail in the proposal and approved in writing by the Grants Management Officer.
  3. Upon completion of the award it will have performed the applicable percentage of work, unless a deviation from this requirement is approved in writing by the Grants Management Officer. Options on the certification document will include:
    • SBIR Phase I: at least two-thirds (66 2/3%) of the research
    • SBIR Phase II: at least half (50%) of the research
    • Percent deviation approved in writing by the Grants Management Officer
  4. The work is completed and it has performed the applicable percentage of work, unless a deviation from this requirement is approved in writing by the Grants Management Officer. Options on the certification document will include:
    • SBIR Phase I: at least two-thirds (66 2/3%) of the research
    • SBIR Phase II: at least half (50%) of the research
    • Percent deviation approved in writing by the Grants Management Officer
    • N/A because work is not completed
  5. The research/research and development is performed in the United States unless a deviation is approved in writing by the Grants Management Officer.
  6. The research/research and development is performed at my facilities with my employees, except as otherwise indicated in the SBIR application and approved in the Notice of Award.

The recipient will notify the Federal agency immediately if all or a portion of the work proposed is subsequently funded by another Federal agency.

The recipient will further certify that they understand that the information submitted may be given to Federal, State and local agencies for determining violations of law and other purposes.

Finally, the individual certifying on behalf of the recipient will certify they are:

  1. An officer of the business concern authorized to represent it and sign the certification on its behalf.
  2. Representing on his/her own behalf, and on behalf of the business concern, that the information provided in the certification, the application, and all other information submitted in connection with the award, is true and correct as of the date of submission.
  3. Acknowledging that any intentional or negligent misrepresentation of the information contained in the certification may result in criminal, civil or administrative sanctions, including but not limited to: (1) fines, restitution and/or imprisonment under 18 U.S.C. § 1001; (2) treble damages and civil penalties under the False Claims Act (31 U.S.C. § 3729 et seq.); (3) double damages and civil penalties under the Program Fraud Civil Remedies Act (31 U.S.C. §3801 et seq.); (4) civil recovery of award funds; (5) suspension and/or debarment from all Federal procurement and nonprocurement transactions (FAR Subpart 9.4 or 2 C.F.R. part 180); and (6) other administrative penalties including termination of SBIR/STTR awards.

18.5.5.5 STTR Life Cycle Certification

All STTR Phase I and Phase II awardees must complete a Life Cycle Certification at all times set forth in the Notice of Award (see §8(h) of the SBIR Policy Directive). This includes checking all of the boxes on the actual certification document and having an authorized officer of the awardee sign and date the certification each time it is required. Awardees are not required to submit the certification directly to NIH but must instead complete a certification and maintain it on file in accordance with the records and retention policy in Section 8.4.2 of the NIH Grants Policy Statement.

A certification is required at the following times:

In addition, STTR awardees indicate compliance with these certification requirements by drawing or requesting funds from the Payment Management System. If the recipient cannot complete the certification or cannot ensure compliance with the certification process, it should notify the GMO immediately. If resolution cannot be reached, the GMO will void or terminate the grant, as appropriate.

The certification is available in fillable format at: http://grants.nih.gov/grants/forms.htm#sbir. However, the requirements are outlined below.

Overview Certification Information. Please read carefully the following certification statements. The Federal government relies on this information to determine whether the business is eligible for a Small Business Technology Transfer Research (STTR) Program award. The definitions for the terms used in the certification are set forth in the Small Business Act, SBA regulations (13 C.F.R. Part 121), the STTR Policy Directive and also any statutory and regulatory provisions references in those authorities.

If the Grants Management Officer believes, after award, that the business is not meeting certain funding agreement requirements, the agency may request further clarification and supporting documentation in order to assist in the verification of any of the information provided.

Even if correct information has been included in other materials submitted to the Federal government, any action taken with respect to the certification does not affect the Government's right to pursue criminal, civil, or administrative remedies for incorrect or incomplete information given in the certification. Each person signing a certification may be prosecuted if they have provided false information.

Recipients will verify and certify the following provisions:

  1. The principal investigator spent more than half of his/her time as an employee of the awardee or the research institution, or the awardee has requested and received a written deviation from this requirement from the Grants Management Officer. When a deviation has been approved by the NIH, the certification will also document the adjusted percentage of time approved.
  2. All, essentially equivalent work, or a portion of the work performed under this project:
    • Has not been submitted for funding by another Federal agency.
    • Has been submitted for funding by another Federal agency but has not been funded under any other Federal grant, contract, subcontract, or other transaction.
    • A portion has been funded by another grant, contract, or subcontract as described in detail in the proposal and approved in writing by the Grants Management Officer.
  3. Upon completion of the award it will have performed the applicable percentage of work, unless a deviation from this requirement is approved in writing by the Grants Management Officer. Options on the certification document will include:
    • STTR Phase I: at least forty (40%) of the research
    • STTR Phase II: at least forty (40%) of the research
    • Percent deviation approved in writing by the Grants Management Officer
  4. The small business concern, and not the single, partnering Research Institution, is exercising management direction and control of the performance of the STTR funding agreement.
  5. The work is completed and it has performed the applicable percentage of work, unless a deviation from this requirement is approved in writing by the Grants Management Officer. Options on the certification document will include:
    • STTR Phase I: at least forty (40%) of the research
    • STTR Phase II: at least forty (40%) of the research
    • Percent deviation approved in writing by the Grants Management Officer
    • N/A because work is not completed
  6. The research/research and development is performed in the United States unless a deviation is approved in writing by the Grants Management Officer.
  7. The research/research and development is performed at my facilities with my employees, except as otherwise indicated in the STTR application and approved in the Notice of Award.

The recipient will notify the Federal agency immediately if all or a portion of the work proposed is subsequently funded by another Federal agency.

The recipient will further certify that they understand that the information submitted may be given to Federal, State and local agencies for determining violations of law and other purposes.

Finally, the individual certifying on behalf of the recipient will certify they are:

  1. An officer of the business concern authorized to represent it and sign the certification on its behalf.
  2. Representing on his/her own behalf, and on behalf of the business concern, that the information provided in the certification, the application, and all other information submitted in connection with the award, is true and correct as of the date of submission.
  3. Acknowledging that any intentional or negligent misrepresentation of the information contained in the certification may result in criminal, civil or administrative sanctions, including but not limited to: (1) fines, restitution and/or imprisonment under 18 U.S.C. § 1001; (2) treble damages and civil penalties under the False Claims Act (31 U.S.C. § 3729 et seq.); (3) double damages and civil penalties under the Program Fraud Civil Remedies Act (31 U.S.C. §3801 et seq.); (4) civil recovery of award funds; (5) suspension and/or debarment from all Federal procurement and nonprocurement transactions (FAR Subpart 9.4 or 2 C.F.R. part 180); and (6) other administrative penalties including termination of SBIR/STTR awards.

Phase I Final RPPR: If a Phase I awardee does not intend to submit a Phase II application within four months of the Phase I project period end date, then Phase I Final RPPR must be submitted to the Grants Management Office of the Awarding Component within 120 days of the completion date of the Phase I grant period. An Interim-RPPR is required if an application for a Phase II or Phase IIB, respectively, is submitted before a final report for the Phase I award would otherwise be due. In the event that the Type 2/Phase II/Phase IIB application is funded, NIH will treat the Interim –RPPR as the annual performance report for the final year of the previous competitive segment. If the Type 2 is not funded, the Interim-RPPR will be treated by NIH staff as the institution's Final-RPPR.

Instructions for the Final RPPR are found at: https://grants.nih.gov/grants/rppr/index.htm. See in particular, Chapter 7.3, SBIR/STTR RPPRs.

Phase II Data Collection Requirement for Government SBIR Reporting Database: The SBA maintains a Database System on SBIR.gov to track and report on statistics regarding the SBIR and the STTR programs. Each small business concern applying for a Phase II award is required to update the appropriate information in the reporting database on SBIR.gov for any of its prior Phase II awards.

In meeting this requirement, the small business concern may apportion sales or additional investment information relating to more than one Phase II award among those awards, if it notes the apportionment for each award. Each Phase II awardee is required to update the appropriate information in the SBIR.gov database on that award upon completion of the last deliverable (e.g., Final RPPR, Federal Financial Report, Final Invention Statement) under the funding agreement. In addition, the awardee is requested to voluntarily update the appropriate information on that award in the SBIR.gov database annually thereafter for a minimum period of 5 years.

Questions about this requirement may be submitted to SBA directly through the Contact Us/Send Feedback link on SBIR.gov. To register on and use the database system, visit http://sbir.gov. Online help is available. SBA will minimize the data reporting requirements of small business concerns, make updating available electronically, and provide standardized procedures.

Project commercialization and sales data can only be viewed by Congress, General Accounting Office (GAO), agencies participating in the SBIR/STTR programs, Office of Management and Budget (OMB), Office of Science and Technology Policy (OSTP), Office of Federal Procurement Policy (OFPP), and other authorized persons (for example, authorized contractors) who are subject to a use and nondisclosure agreement with the Federal Government covering the use of the database. Pursuant to 15 U.S.C. 638(k)(4), information provided to the SBIR.gov database is privileged and confidential and not subject to disclosure pursuant to 5 U.S.C. 552 (Government Organization and Employees); nor must it be considered to be publication for purposes of 35 U.S.C. 102 (a) or (b).

Examples of the data to be entered by applicants into SBIR.gov include revenue from the sale of new products or services resulting from the research conducted under each Phase II award or additional investment from any source, other than Phase I or Phase II awards, to further the research and development conducted under each Phase II award.