For-profit, for profit, administrative requirements, sbir, sttr, market research, intellectual property, data sharing, SBIR life cycle certification, STTR life cycle certification, small business

18.5.5 Administrative Requirements

Commercial organizations An organization, institution, corporation, or other legal entity, including, but not limited to, partnerships, sole proprietorships, and limited liability companies, that is organized or operated for the profit or benefit of its shareholders or other owners. The term includes small and large businesses and is used interchangeably with "for-profit organization." that receive SBIR/STTR awards generally are subject to the same administrative requirements as non-profit organizations. (See 2 CFR Part 200 and 45 CFR Part 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 except for the Technical and Business Assistance (TABA) funds or with the Commercialization Readiness Pilot. No SBIR/STTR funds (direct or indirect costs Necessary costs incurred by a recipient for a common or joint purpose benefitting more than one cost objective, and not readily assignable to the cost objectives specifically benefitted, without effort disproportionate to the results achieved. To facilitate equitable distribution of indirect expenses to the cost objectives served, it may be necessary to establish a number of pools of F&A (indirect) costs. F&A (indirect) cost pools must be distributed to benefitted cost objectives on bases that will produce an equitable result in consideration of relative benefits derived.) can be used to support commercialization. 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 commercial organizations An organization, institution, corporation, or other legal entity, including, but not limited to, partnerships, sole proprietorships, and limited liability companies, that is organized or operated for the profit or benefit of its shareholders or other owners. The term includes small and large businesses and is used interchangeably with "for-profit organization." under other support mechanisms, such data shall not be released outside the Federal government without the recipient's permission for a period of 20 years from completion of the project.

Rights in Data Developed Under SBIR Funding Agreement. Section 9 of the Small Business Act, as amended (15 U.S.C. 638) provides for "retention by a small business concern of the rights to data generated by the concern in the performance of an [SBIR/STTR] award for a period of not less than 4 years."

  1. The Act provides for retention by a small business concern (SBC) award recipient of the rights to data generated by the concern in the performance of an SBIR/STTR award. These data rights provide an incentive for SBCs to participate in Federally-funded research projects and contribute to the ability of small business recipients to commercialize the technology developed under the program. The central purpose of SBIR/STTR data rights is to provide the Federal Government with the degree of access to a recipient's SBIR/STTR data needed to evaluate the work and effectively utilize the results and at the same time ensure that the Federal Government or other concerns cannot use SBIR/STTR data in ways (e.g., for commercial purposes or to produce future technical procurement specifications) that would inappropriately diminish the rights or associated economic opportunities of the small business that developed the data. The SBIR/STTR data rights provisions and definitions are designed to ensure that, for properly marked SBIR/STTR data, during the SBIR/STTR protection period, the Federal Government provides effective protection of the data that is comparable to and at least as strong as the protection the Federal Government gives to delivered proprietary data that is developed exclusively at private expense.
  2. SBIR/STTR participating agencies must ensure that recipients of an SBIR/STTR funding agreement retain appropriate proprietary rights for all SBIR/STTR data generated in the performance of the award. In general, this results in the Government receiving SBIR/STTR data rights in all SBIR/STTR data during the SBIR/STTR protection period, except for certain types of data that are not subject to such data rights restrictions due to the nature of the data (e.g., Form, Fit, and Function Data or OMIT Data). SBIR/STTR data rights apply to all SBIR/STTR awards, including subcontracts or subgrants to such awards, that fall within the statutory definition of Phase I, II, or III of the SBIR/STTR programs, as described in § 4 of the SBA Policy Directive effective May 2, 2019. The scope and extent of the SBIR/STTR data rights applicable to Federally-funded Phase III awards are identical to the SBIR/STTR data rights applicable to Phases I and II SBIR/STTR awards. SBIR/STTR data rights provide license rights to the Federal Government. SBIR/STTR data rights restrict the Federal Government's use and release of properly marked SBIR/STTR data only during the SBIR/STTR protection period; after the protection period, the Federal Government has a royalty-free license to use, and to authorize others to use on its behalf, these data for government purposes, and is relieved of disclosure prohibitions related to such government purposes, and assumes no liability for unauthorized use of these data by third parties. The Federal Government receives unlimited rights in Form, Fit, and Function Data, OMIT Data, and all unmarked SBIR/STTR data.
  3. 3. SBIR/STTR Data Rights - Main Elements:
    1. An SBC retains title and ownership of all SBIR/STTR data it develops or generates in the performance of an SBIR/STTR award. The SBC retains all rights in SBIR/STTR data that are not granted to the Government in accordance with the SBA Policy Directive. These rights of the SBC do not expire.
    2. The Government receives SBIR/STTR data rights during the SBIR/STTR protection period on all appropriately marked SBIR/STTR data. These rights enable the Federal Government to use SBIR/STTR data in limited ways within the Government, such as for project evaluation purposes, but are intended to prohibit uses and disclosures of the SBIR/STTR data that may undermine the SBC's future commercialization of the associated technology. The Government receives unlimited rights in Form, Fit, and Function Data, OMIT Data, and all unmarked SBIR/STTR data.
    3. After the SBIR/STTR protection period has expired, the Federal Government may use, and authorize others to use on its behalf, for government purposes, SBIR/STTR data that was subject to SBIR/STTR data rights during the SBIR/STTR protection period.
  4. The SBIR/STTR protection period begins with award of an SBIR/STTR funding agreement and ends twenty years, or longer at the discretion of the participating agency, from the date of award of an SBIR/STTR funding agreement (either Phase I, Phase II, or Federally-funded SBIR/STTR Phase III) unless subsequent to the award, the agency and the SBC negotiate for some other protection period for the SBIR/STTR data.
  5. To receive the protections accorded to SBIR/STTR data pursuant to SBIR/STTR data rights, any SBIR/STTR data that is delivered must be marked with the appropriate SBIR/STTR data rights legend or notice, in accordance with agency procedures. The Government assumes no liability for the access, use, modification, reproduction, release, performance, display, disclosure, or distribution of SBIR/STTR data without markings. If SBIR/STTR data is delivered without the required legend or notice, the SBIR/STTR recipient may, within 6 months of such delivery (or a longer period approved by the agency for good cause shown), request to have an omitted SBIR/STTR data legend or notice, as applicable, placed on qualifying data. If SBIR/STTR data is delivered with an incorrect or nonconforming legend or notice, the agency may correct or permit correction at the recipient's expense of such incorrect or nonconforming notice(s).
  6. Negotiated Rights:
    1. An agency must not, in any way, make issuance of an SBIR/STTR award conditional upon the recipient negotiating or consenting to negotiate a specially negotiated license or other agreement regarding SBIR/STTR data. The negotiation of any such specially negotiated license agreements shall be permitted only after award.
    2. Following issuance of an SBIR/STTR award, the recipient may enter into a written agreement with the awarding agency to modify the license rights that would otherwise be granted to the agency during the SBIR/STTR protection period. However, any such agreement must be entered into voluntarily and by mutual agreement of the SBIR/STTR recipient and agency, and not a condition for additional work under the funding agreement or the exercise of options. Such a bilateral data rights agreement must be entered into only after the subject SBIR/STTR award (which award must include an appropriate SBIR/STTR data rights clause) has been signed. Any such specially negotiated license must be in writing under a separate agreement after the SBIR/STTR funding agreement is signed. A decision by the recipient to relinquish, transfer, or modify in any way its rights in SBIR/STTR data must be made without pressure or coercion by the agency or any other party. Any provision in a competitive non-SBIR or SBIR solicitation that would have the effect of diminishing SBIR/STTR data rights shall have no effect on the provision of SBIR/STTR data rights in a resulting Phase I, Phase II, or Phase III award.
  7. To ensure that SBIR/STTR recipients receive the applicable data rights, all SBIR and STTR solicitations and resulting funding agreements must fully implement all of the policies, procedures, and requirements set forth in the SBA Policy Directive in appropriate provisions and clauses incorporated into the SBIR/STTR solicitations and awards. Paragraph (5)(d)(3) of Appendix I: Instructions for Preparation of SBIR/STTR Program Solicitations in the SBA Policy Directive provides a sample SBIR/STTR data rights clause containing the key elements that must be reflected in the clause used in Federal Agency solicitations. SBA will report to the Congress any attempt or action by an agency, that it is aware of, to condition an SBIR or STTR award on the negotiation of lesser data rights or to exclude the appropriate data rights clause from the award.

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. By signing the face page of the grant application, the SBC's AOR certifies that the agreement with the research institution is satisfactory to the SBC and will be effective at the time the grant award is made. Prior to award a copy of the agreement must be furnished to the NIH awarding IC The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC," or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award..

SBIR/STTR recipients are covered by 35 U.S.C. 200-212 and 37 CFR Part 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 Costs that can be identified specifically with a particular sponsored project, an instructional activity, or any other institutional activity, or that can be directly assigned to such activities relatively easily with a high degree of accuracy. in any single year must comply with NIH DMS policy 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 20 years from completion of the project.

18.5.5.4 SBIR Life Cycle Certification

All SBIR Phase I and Phase II recipients must complete a Life Cycle Certification at all times set forth in the Notice of Award "The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system." (see §8(j) of the SBIR Policy Directive). This includes checking all of the boxes and having an authorized officer of the recipient sign and date the certification each time it is required.

A certification is required at the following times:

SBIR grant recipients are required to submit the Life Cycle Certifications within the I-RPPR and the F-RPPR under Section G.1: Special Notice of Award "The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system." and Funding Opportunity Announcement A publicly available document by which a Federal Agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds. Funding opportunity announcements may be known as program announcements, requests for applications, notices of funding availability, solicitations, or other names depending on the Agency and type of program. Funding opportunity announcements can be found at Grants.gov/FIND and in the NIH Guide for Grants and Contracts. Reporting Requirements. SBIR recipients should not select the "Nothing to Report" box in this section. The F-RPPR and I-RPPR must be submitted via eRA Commons no later than 120 calendar days from the period of performance end date. I-RPPR or F-RPPR will not be accepted unless all completed Life Cycle Certification(s) are received. Failure to provide all required completed certification(s) may cause NIH to take one or more actions that may include, but are not limited to, corrective actions, withholding of further awards, suspension or termination.

This does not impact the SBIR Funding Agreement Certification required by all SBIR applicants for new or renewal grants that is required prior to award of a new award or a competing renewal award.

In addition, SBIR recipients indicate compliance with these certification requirements by drawing or requesting funds from the Payment Management System The HHS centralized grants payment system operated by the Payment Management Service, Program Support Center. Most HHS (and some other Federal government agencies') recipients receive grant payments through this 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. However, the requirements are outlined below.

Overview Certification Information. The Federal government relies on this information ensure compliance with specific program requirements during the life of the award.. The definitions for the terms used in the certification are set forth in the Small Business Act, the SBIR Policy Directive and also any statutory and regulatory provisions referenced in those authorities.

If the Grants Management Officer An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition. 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 their time (based on a 40-hour work week) as an employee of the recipient or has requested and received a written deviation from this requirement from the Grants Management Officer An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.. When a deviation has been approved by 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:
    1. Has not been submitted for funding to NIH or another Federal agency.
    2. Has been submitted for funding to NIH or another Federal agency but has not been funded under any other grant, contract, subcontract, or other transaction.
    3. 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 An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition..
  3. Upon completion of the award the recipient will have performed the applicable percentage of work, unless a deviation from this requirement is approved in writing by the Grants Management Officer An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.. Options on the certification document will include:
    1. SBIR Phase I: at least two-thirds (66 2/3%) of the research
    2. SBIR Phase II: at least half (50%) of the research
    3. Percent deviation approved in writing by the Grants Management Officer An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.
  4. The work is completed and the small business recipient has performed the applicable percentage of work, unless a deviation from this requirement is approved in writing by the Grants Management Officer An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.. Options on the certification document will include:
    1. SBIR Phase I: at least two-thirds (66 2/3%) of the research
    2. SBIR Phase II: at least half (50%) of the research
    3. Percent deviation approved in writing by the Grants Management Officer An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.
    4. 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 An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition..
  6. The research / research and development is performed at recipient's facilities with the recipient's employees, except as otherwise indicated in the SBIR application and approved in the Notice of Award "The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system.".

The recipient will notify the Federal agency immediately if all or a portion of the work authorized and funded under the award 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 their 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 recipients must complete a Life Cycle Certification at all times set forth in the Notice of Award "The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system." (see §8(j) of the SBIR Policy Directive). This includes checking all the boxes on the actual certification document and having an authorized officer of the recipient sign and date the certification each time it is required.

A certification is required at the following times:

STTR grant recipients are required to submit the Life Cycle Certifications within the I-RPPR and the F-RPPR under Section G.1: Special Notice of Award "The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system." and Funding Opportunity Announcement A publicly available document by which a Federal Agency makes known its intentions to award discretionary grants or cooperative agreements, usually as a result of competition for funds. Funding opportunity announcements may be known as program announcements, requests for applications, notices of funding availability, solicitations, or other names depending on the Agency and type of program. Funding opportunity announcements can be found at Grants.gov/FIND and in the NIH Guide for Grants and Contracts. Reporting Requirements. STTR recipients should not select the "Nothing to Report" box in this section. The F-RPPR and I-RPPR must be submitted via eRA Commons no later than 120 calendar days from the period of performance end date. I-RPPR or F-RPPR will not be accepted unless all completed Life Cycle Certification(s) are received. Failure to provide all required completed certification(s) may cause NIH to take one or more actions that may include, but are not limited to, corrective actions, withholding of further awards, suspension or termination.

This does not impact the STTR Funding Agreement Certification required by all STTR applicants for new or renewal grants that is required prior to award of a new award or a competing renewal award.

In addition, STTR recipients indicate compliance with these certification requirements by drawing or requesting funds from the Payment Management System The HHS centralized grants payment system operated by the Payment Management Service, Program Support Center. Most HHS (and some other Federal government agencies') recipients receive grant payments through this 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, 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 An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition. 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 their time as an employee of the recipient or the research institution, or the recipient has requested and received a written deviation from this requirement from the Grants Management Officer An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.. When a deviation has been approved by 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:
    1. Has not been submitted for funding by another Federal agency.
    2. Has been submitted for funding by another Federal agency but has not been funded under any other Federal grant, contract, subcontract, or other transaction.
    3. 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 An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition..
  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 An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.. Options on the certification document will include:
    1. STTR Phase I: at least forty (40%) of the research
    2. STTR Phase II: at least forty (40%) of the research
    3. Percent deviation approved in writing by the Grants Management Officer An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.
  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 An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.. Options on the certification document will include:
    1. STTR Phase I: at least forty (40%) of the research
    2. STTR Phase II: at least forty (40%) of the research
    3. Percent deviation approved in writing by the Grants Management Officer An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition.
    4. 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 An NIH official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions. GMOs are delegated the authority from the CGMO to obligate NIH to the expenditure of funds and permit changes to approved projects on behalf of NIH. Each NIH IC that awards grants has one or more GMOs with responsibility for particular programs or awards. See also Chief Grants Management Officer definition..
  7. The research / research and development is performed at Recipient's facilities with Recipient's employees, except as otherwise indicated in the STTR application and approved in the Notice of Award "The official, legally binding document, signed (or the electronic equivalent of signature) by a Grants Management Officer that: (1) notifies the recipient of the award of a grant; (2) contains or references all the terms and conditions of the grant and Federal funding limits and obligations; and, (3) provides the documentary basis for recording the obligation of Federal funds in the NIH accounting system.".

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 their 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 recipient 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.

Final RPPR Phase I, Phase II, Phase IIB, CRP: Instructions for the Final RPPR are found on NIH's web site. 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 recipient 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 recipient 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 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.