47QFCA24R0036_Amend 0002_Solic ARPA-H.pdf

PROGRAMSOLICITATION

47QFCA24R0036

Amendment 0002

SBIR/STTR Phase I and II in support of:

ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH (ARPA-H)

This is a Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Solicitation in accordancewith SBIR/STTR Policy Directive (May 3, 2023).

Issued by:

U.S General Services Administration (GSA)

Federal Acquisition Service (FAS) Assisted Acquisition Services (AAS) Innovation

(June 26, 2024)

Controlled by: Suzanne.kixmiller@gsa.gov

Amendment 0002

IMPORTANT

Please read the entire solicitation carefully prior to submitting questions and/or a proposal.

Only Procurement contracts will be awarded resulting from this solicitation; Grants will not be awarded. The attached forms reference “Grants” throughout the documentation and should be replaced with the term “Contract.” This solicitation is only for the award of procurement contracts and not grants, however the applicable NIH/HHS/ARPA-H forms may not account for this difference.

ARPA-HWebinar: All potential offerors are encouraged to attend the ARPA-H Webinar for this solicitation. The webinar will highlight important aspects of the SBIR/STTR Program, ARPA-H’s mission, Topic Areas, and important elements of this solicitation. The Webinar is being held on July 2, 2024. Please see the webinar specific announcement for more details.

Deadline for Questions: Solicitation questions must be received by 11:00AM ET July 15, 2024.

All questions shall be submitted via email to GSA-ARPA-H-SBIR@gsa.gov and in accordance with Section 6 of this Solicitation.

Deadline for Receipt: All written proposals shall be received by 11:00AM ET on July 26, 2024.

The offeror shall submit its written proposal via email to GSA-ARPA-H-SBIR@gsa.gov in accordance with Section 6 of this Solicitation. Hard copies/Paper proposals will not be accepted.

All potential offerors, new to the Small Business Administration’s SBIR/STTR program, are highly encouraged to read the SBIR/STTR Policy Directive issued by the Small Business Administration with special attention directed to the inclusion of a newproposal requirements found in Section 2.2.1 – Disclosure of Foreign Relationships. The SBIR/STTR Policy Directive can be found here:

https://www.sbir.gov/sites/default/files/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.pdf https://grants.nih.gov/grants/forms.htm?filter=small-business https://grants.nih.gov/grants/forms.htm?filter=small-business https://grants.nih.gov/grants/forms.htm?filter=small-business https://grants.nih.gov/grants/forms.htm?filter=small-business mailto:GSA-ARPA-H-SBIR@gsa.gov mailto:GSA-ARPA-H-SBIR@gsa.gov https://www.sbir.gov/sites/default/files/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.pdf

PROGRAMSOLICITATION

Table of Contents

SECTION 1:ProgramDescription .................................................................................................PAGE 4 SECTION 2: Certifications............................................................................................................. PAGE 23 SECTION 3: Proposal Preparation Instruction ......................................................................... PAGE 36 SECTION 4: Method of Selection and Evaluation Criteria ...................................................... PAGE 62 SECTION 5: Considerations.......................................................................................................... PAGE 66 SECTION 6: Submission of Proposals ........................................................................................PAGE 87 SECTIONS 7: Scientific and Technical Information Sources...................................................PAGE 88* SECTION 8: Submission Forms…………………………………………………………………………………………..……..PAGE 88 Section 9: SBIR/STTR Research Topics………………………….……………………………………………….…..……PAGE 88

*If performing Human or Animal Research, please refer to Appendices A.1 and A.2

SECTION 1: PROGRAMDESCRIPTION

1.1 Introduction

The U.S. General Services Administration (GSA), Federal Acquisition Service (FAS), Assisted Acquisition Service - Innovation (AAS) in direct support of The Advanced Research Projects Agency for Health (ARPA-H) invites small business concerns (SBCs) to submit innovative research proposals under this Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Contract Solicitation. The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are highly competitive programs that encourage domestic small businesses to engage in Federal Research/Research and Development (R/R&D) with the potential for commercialization. Through a competitive awards-based program, SBIR and STTR enable small businesses to explore their technological potential and provide the incentive to profit from its commercialization. By including qualified small businesses in the nation's R&D arena, high-tech innovation is stimulated, and the United States gains entrepreneurial spirit as it meets its specific research and development needs. Firms with the capability to conduct research and development (R&D) in any of the health-related topic areas described in Section 9, and to commercialize the results of that innovative R&D, are encouraged to participate.

This solicitation contains opportunities to submit a proposal under a variety of different Topics, which are summarized in Section 9 below. AAS in direct support of ARPA-H is under no obligation to fund any proposals or any specific number of proposals in a given topic. It may also elect to fund several or none of the proposed approaches to a given topic. All awards are subject to the availability of funds. The Government is not responsible for any monies expended by the offeror before award of any contract. Only Procurement contracts will be awarded resulting from this solicitation; Grants will not be awarded.

The mission of ARPA-H is to accelerate better health outcomes for everyone by supporting the development of high-impact solutions to society’s most challenging health problems. Awardees will develop groundbreaking new ways to tackle health-related challenges through high potential, high-impact biomedical and health research. With a scope spanning the molecular to the societal, ARPA-H seeks SBIR/STTR proposals that aim to rapidly achieve better health outcomes across patient populations, communities, disease, and health conditions, including in support of the Cancer Moonshot. Proposals are expected to use innovative approaches to enable revolutionary advances in science, technology, or systems. Specifically excluded are proposals that represent an evolutionary or incremental advance in the current state of the art. Additionally, proposals directed towards policy changes, traditional education and training, or center coordination and construction of physical infrastructure are outside the scope of the ARPA-H mission.

1.2 ARPA- H ProgramBackground

The basic design of the ARPA-H SBIR/STTR program is in accordance with the Small Business Administration (SBA) SBIR/STTR Program Policy Directive dated May 3, 2023. This SBIR/STTR solicitation strives to encourage scientific and technical innovation in areas specifically identified by ARPA-H. The potential contributions of the proposed effort are relevant to health outcomes for all Americans.

Specifically, ARPA-H’s mission is to benefit the health of all Americans by catalyzing health breakthroughs that cannot readily be accomplished through traditional research or commercial activity. The guidelines presented in this solicitation reflect the flexibility provided in the SBIR/STTR Policy Directive to encourage proposals based on scientific and technical approaches most likely to yield results important to ARPA-H and to the private sector.

1.3 Phased Program

1.3.1 SBIR/STTR Phased Program

The SBIR/STTR program consists of three separate phases as detailed below. Note: This solicitation is not accepting Phase III proposals. Please refer to the individual topics above as to which phase is being considered.

Phase I: Feasibility The objective of Phase I is to determine the scientific or technical feasibility and commercial merit of the proposed research or R&D efforts.

Phase II: Full R/R&D Effort The objective of Phase II is to further develop the research or R&D efforts initiated in Phase I. If your project has already demonstrated feasibility, you may prepare a Direct-to-Phase II proposal and begin your Federal SBIR/STTR award at Phase II.

Phase III: Commercialization stagewithout SBIR/STTR funds Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR/STTR Funding Agreements, but is funded by sources other than the SBIR/STTR programs. Each of the following types of activity constitutes SBIR/STTR Phase III work:

(i) Commercial application of SBIR/STTR funded R/R&D that is financed by non-Federal sources of capital.

(ii) SBIR/STTR derived products or services intended for use by the Federal Government, funded by non-

SBIR/STTR sources of Federal funding.

(iii) Continuation of SBIR/STTR work, funded by non-SBIR/STTR sources of Federal funding including R/R&D. For HHS SBIR/STTR projects, Phase III is primarily financed by non-Federal sources of capital.

The competition for SBIR Phase I and Phase II awards satisfies the competition requirements of the Competition in Contracting Act. Therefore, an agency that wishes to fund an SBIR project beyond the Phase II and the project is derived from, extends, or logically concludes efforts performed under prior SBIR funding agreements may award a Phase III contract on a sole source basis.

1.3.2 ARPA-H Phased Approach

For purposes of this solicitation , the following phased approaches will be used:

1) Phase I Proposals As part of this solicitation, the Government may award a Phase I contract to an offeror that believes it has a concept that might provide a solution to one of the Topics listed in Section 9, but has not built a prototype and tested its technical feasibility. The purpose of the Phase I contract will be to determine the scientific or technical feasibility and commercial merit of the proposed research or R&D effort.

2) Direct to Phase II Proposals As part of this solicitation, the Government may award a Direct to Phase II contract to an offeror whose project has already demonstrated feasibility (i.e. determined to succeed via a feasibility study), but the offeror has not received a Phase I SBIR or STTR award. The offeror can apply for a Direct to Phase II award and bypass Phase I. Offerors applying for Direct to Phase II awards must have already built a technology prototype and tested its technical feasibility. The purpose of the Phase II R&D contract will be to test the functional viability of the prototype according to scientific methods and potential for commercial development. Refer to Section 9 list of topics for notation of Topics allowing Direct to Phase II proposals.

3) Fast Track Proposals As part of this solicitation, the Government may award a Fast Track contract to an offeror whose Fast Track proposal may result in an initial award for a Phase I contract with a contractual option that the Government may exercise to continue the effort into Phase II without the need to re-solicit the topic. This mechanism allows for streamlined processes that have the potential to significantly minimize the funding gap between Phase I and Phase II. However, it shall be noted the Government is not obligated to fund the Phase II contractual option. The awardee may only start performing the Phase II effort unless and until the Government exercises that option.

If a Topic notes that Fast Track proposals will be accepted, a Phase I proposal and a Phase II proposal may be submitted simultaneously. As described in Section 3, Proposal Instructions, a Fast Track submission consists of one complete Phase I proposal and one complete Phase II proposal, separately paginated. The Phase I proposal and Phase II proposal will be separately evaluated as set forth in Section 4, Method of Selection and Evaluation Criteria

1.4 Offeror Eligibility and Performance Requirements

1.4.1 Offeror Eligibility

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity.

To receive SBIR or STTR funds, each awardee of a SBIR/STTR Phase I or Phase II award must qualify as a small business concern (SBC) at the time of award and at any other time set forth in SBA's regulations at

13 CFR 121.701-121.705.

A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria:

1) 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;

2) 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 must be less than 50 percent participation by foreign business entities in the joint venture;

3) i. SBIR and STTR. 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), an Indian tribe, ANC or NHO (or a wholly owned business entity of such tribe, ANC or NHO), or any combination of these; OR

ii. 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, unless that single venture capital operating company, hedge fund, or private equity firm qualifies as a small business concern that is more than 50% directly owned and controlled by individuals who are citizens or referee permanent resident aliens of the United States; 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.

4) Has, including its affiliates, not more than 500 employees.

5) 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 2. for additional instructions regarding required application certification. NOTE: SBC that are more than 50% owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these are NOT eligible to apply to the NIH STTR program.

6) If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner.

7) If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.

8) SBCs must also meet the other regulatory requirements found in 13 C.F.R. Part 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. Business concerns include, but are not limited to, any individual

(sole proprietorship) partnership, corporation, joint venture, association, or cooperative. The SF424 (R&R)

SBIR/STTR Application Guide should be referenced for detailed eligibility information.

1.4.1.1 Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.

1.4.2 SBIR/STTR Performance Benchmarks for Progress towards Commercialization

In accordance with Section X of the SBIR/STTR Policy Directive, and as required by the SBIR/STTR Reauthorization Act of 2011, the following two performance benchmarks have been established for companies participating in SBIR programs.

Companies will not be eligible to submit a proposal for a new SBIR/STTR project for a period of one year from the time that SBA issues a determination of failure to meet a performance benchmark. A company that fails to meet a performance benchmark may continue working on its current or ongoing SBIR/STTR projects, including submitting a proposal to transition a Phase I award to a Phase II award.

For more information on benchmark requirements, refer to https://www.sbir.gov/performance-benchmarks and/or the SBIR/STTR Policy Directive referenced on the first page of this solicitation.

Phase I to Phase II Transition Rate Benchmark:

In accordance with guidance from the SBA, the HHS SBIR/STTR Program is implementing the Phase I to Phase II Transition Rate benchmark required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022.The benchmark establishes a minimum number of Phase II awards the company must have received relative to a given number of Phase I awards received during the 5-fiscal year time period. The Transition Rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently-completed year. The Transition Rate requirement, agreed upon and

Amendment 0002 https://grants.nih.gov/grants/guide/url_redirect.php?id=11118 https://www.sbir.gov/performance-benchmarks established by all 11 SBIR agencies, was published for public comment in a Federal Register Notice on October 16, 2012 (77 FR 63410) and amended on May 23, 2013 (78 FR 30951).

For SBIR and STTR Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0.25 will not be eligible to apply for a Phase I, Fast-Track, or Direct

Phase II (if available) award for a period of one year from the date of the application submission. This requirement does not apply to companies that have received 20 or fewer Phase I awards over the prior

5-fiscal year period.

For application deadlines that fall on or after April 5, 2023: For SBIR and STTR Phase I applicants that have received more than 50 Phase I awards over the past 5 fiscal years (excluding the most recently-completed fiscal year): Companies that do not meet or exceed the benchmark minimum Transition Rate of 0.5 will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase I awards over the 5-fiscal year period.

On June 1 of each year, SBA will identify the companies that fail to meet minimum performance requirements.

SBA calculates individual company Phase I to Phase II Transition Rates using SBIR and STTR award information across all federal agencies. SBA will notify companies and the relevant officials at the participating agencies.

More information on the Phase I to Phase II Transition Rate requirement is available at SBIR.gov.

For more information on performance standards for the Phase I to Phase II Transition Rate Benchmark, refer to https://www.sbir.gov/performance-benchmarks and/or the SBIR/STTR Policy Directive referenced on the first page of this solicitation.

Phase II to Commercialization Benchmark:

In accordance with guidance from the SBA, the HHS SBIR/STTR Programs are implementing the Phase II to Commercialization Rate benchmark for Phase I applicants, as required by the SBIR/STTR Reauthorization Act of 2011 and the SBIR and STTR Extension Act of 2022. The Commercialization Rate Benchmark was published in a Federal Register notice on August 8, 2013 (78 FR 48537), with a reopening of the comment period published on September 26, 2013 (78 FR 59410).

Prior SBIR Phase II Awards. If the SBC has received more than 15 Phase II awards in the prior 5 fiscal years, the

SBC must submit in its Phase I proposal: name of the awarding agency; date of award; Funding Agreement number; amount of award; topic or subtopic title; follow-on agreement amount; source and date of commitment; and current Commercialization status for each Phase II award. (This required proposal information will not be counted toward the proposal pages limitation.)For application deadlines that fall on or after April 5, 2023: For companies that have received more than 50 Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed Fiscal Year): Companies that meet this criterion must show an average of at least $250,000 of aggregated sales and investment per Phase II award

Amendment 0002 https://www.sbir.gov/performance-benchmarks http://www.gpo.gov/fdsys/pkg/FR-2013-08-08/pdf/2013-19247.pdf over the past 10-fiscal year period. Applicants that fail this benchmark will not be eligible to receive more than

20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 50 or fewer Phase II awards over the

10-fiscal year period, excluding the two most recently-completed fiscal years.

For application deadlines that fall on or after April 5, 2023: For companies that have received more than 100

Phase II awards from all agencies over the past 10-fiscal years (excluding the two most recently completed

Fiscal Year): Companies that meet this criterion must show an average of at least $450,000 of aggregated sales and investment per Phase II award over the past 10-fiscal year period. Applicants that fail this benchmark will not be eligible to receive more than 20 total Phase I and Phase II awards for a period of one year from the date on which such determination is made. This requirement does not apply to companies that have received 100 or fewer Phase II awards over the 10-fiscal year period, excluding the two most recently-completed fiscal years.

For more information on performance standards for the Phase II to Commercialization Rate Benchmark, refer to https://www.sbir.gov/performance-benchmarks and/or the SBIR/STTR Policy Directive referenced on the first page of this solicitation.

1.4.3 Eligible Individuals (ProgramDirector/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the

Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder:

Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial

Groups as well as Individuals with Disabilities, NOT-OD-22-019.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal

Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424

(R&R) Application Guide.

For the STTR program, the PD(s)/PI(s) may be employed with the SBC or the single, partnering non-profit research institution as long as s/he has a formal appointment with or commitment to the applicant SBC, which is characterized by an official relationship between the SBC and that individual.

Each PD/PI must commit a minimum of 10% effort to the project and the PD/PI must have a formal appointment with or commitment to the applicant small business concern, which is characterized by an official relationship https://grants.nih.gov/grants/guide/notice-files/NOT-OD-22-019.html between the small business concern and that individual. Such a relationship does not necessarily involve a salary or other form of remuneration.

The SF424 (R&R) SBIR/STTR Application Guide should be referenced for specific details on eligibility requirements.

For institutions/organizations proposing multiple PDs/PIs, see Multiple Principal Investigators section of the SF424

(R&R) SBIR/STTR Application Guide.

1.4.3.1 Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an NIH’s ASSIST account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in NIH’s ASSIST.

If the PD/PI is also the organizational Signing Official, they must have two distinct ASSIST accounts, one for each role. NOTE: Obtaining an NIH’s ASSIST account can take up to 2 weeks.

1.4.4 Performance Requirements:

All offerors are required to adhere to the following performance requirements throughout the duration of any contract awarded to the company through this solicitation:

1) For SBIR Phase I- A minimum of two-thirds of the research or analytical effort must be performed by the awardee. The percentage of work will be measured by total award dollars.

2) For SBIR Phase II - A minimum of one-half of the research or analytical effort must be performed by the awardee. The percentage of work will be measured by total award dollars.

3) For STTR Phase I/II a minimum of 40% must be performed by small business and 30% by the research institution partner. The remaining work may be done by either or outsourced.

4) For both SBIR Phase I and II - the principal investigator must be primarily employed with the SBC at the time of award and during the conduct of the proposed project. Primary employment means that more than one half (50%) of the employee's time is spent with the small business. Primary employment with the SBC precludes full-time employment at another organization.

5) For STTR Phase I and II - the PI must be employed by either the partnering research institution or small business.

6) For both Phase I and Phase II, all research or research and development work must be performed by the SBC and its subcontractors in the United States.

Based on rare and unique circumstances, deviations from these performance requirements may be considered on a case-by-case basis. Deviations must be approved in writing by the AAS Contracting Officer after consultation with the agency SBIR/STTR Program Manager/Coordinator.

1.5. Definitions

The following definitions from the SBA Policy Directive and the Federal Acquisition Regulation (FAR) apply for the purposes of this solicitation:

8(a) firm. A small business concern (SBC) that is participating in the Small Business Administration’s 8(a) Business Development Program for firms that are owned and controlled at least 51% by socially and economically disadvantaged individuals.

Applicant. The organizational entity that qualifies as an SBC at all pertinent times and that submits a contract proposal or a grant application for a funding agreement under the SBIR Program.

Affiliate. This term has the same meaning as set forth in 13 CFR part 121—Small Business Size Regulations, section 121.103. How does SBA determine affiliation? (Available at https://www.ecfr.gov/current/title-13/chapter-I/part-121/subpart-A/subject-group-ECFRd133f03f6d8398b/s ection-121.103 .Further information about SBA's affiliation rules and a guide on affiliation is available at www.SBIR.gov and www.SBA.gov/size.

ANC. Alaska Native Corporation.

Animal. Any live, vertebrate animal used or intended for use in research, research training, experimentation, or biological testing or for related purposes.

Awardee. The organizational entity receiving an SBIR Phase I award, SBIR Phase II award, or follow-on non-SBIR Federal funding agreement.

Child For the purpose of this solicitation, a child is defined as an individual under the age of 18 years.

Commercialization. The process of developing products, processes, technologies, or services and the production and delivery (whether by the originating party or others) of the products, processes, technologies, or services for sale to or use by the Federal government or commercial markets.

Consultant. An individual who provides professional advice or services for a fee, but normally not as an employee of the engaging party. In unusual situations, an individual may be both a consultant and an employee of the same party, receiving compensation for some services as a consultant and for other work as a salaried employee. To prevent apparent or actual conflicts of interest, awardees and consultants must establish written guidelines indicating the conditions of payment of consulting fees. Consultants may also include firms that provide paid professional advice or services.

Contract. An award instrument establishing a binding legal procurement relationship between a funding agency and the recipient, obligating the latter to furnish an end product or service and binding the agency to provide payment therefore.

Covered Small Business Concern. A small business concern that:

(1) Was not majority-owned by multiple venture capital operating companies (VCOCs), hedge funds, or private equity firms on the date on which it submitted an application in response to a solicitation under the SBIR program; and

Amendment 0002 https://www.ecfr.gov/current/title-13/chapter-I/part-121/subpart-A/subject-group-ECFRd133f03f6d8398b/section-121.103 https://www.ecfr.gov/current/title-13/chapter-I/part-121/subpart-A/subject-group-ECFRd133f03f6d8398b/section-121.103 http://www.sbir.gov http://www.sba.gov/size

(2) Is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms on the date of the SBIR award.

Essentially EquivalentWork.Work that is substantially the same research, which is proposed for funding in more than one contract proposal or grant application submitted to the same Federal agency or submitted to two or more different Federal agencies for review and funding consideration; or work where a specific research objective and the research design for accomplishing the objective are the same or closely related to another proposal or award, regardless of the funding source.

Feasibility. The practical extent to which a project can be performed successfully.

Federal Agency. An executive agency as defined in 5 U.S.C. § 105, and a military department as defined in 5 U.S.C. 102. (Department of the Army, Department of the Navy, Department of the Air Force), except that it does not include any agency within the Intelligence Community as defined in Executive Order 12333, section 3.4(f), or its successor orders.

Federal Laboratory. As defined in 15 U.S.C. § 3703, means any laboratory, any federally funded research and development center, or any center established under 15 U.S.C. §§ 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.

Fraud,Waste, and Abuse.

Fraud includes any false representation about a material fact or any intentional deception designed to deprive the United States unlawfully of something of value or to secure from the United States a benefit, privilege, allowance, or consideration to which an individual or business is not entitled.

Waste includes extravagant, careless or needless expenditure of Government funds, or the consumption of Government property, that results from deficient practices, systems, controls, or decisions.

Abuse includes any intentional or improper use of Government resources, such as misuse of rank, position, or authority or resources.

Funding Agreement. Any contract, grant, or cooperative agreement entered into between any Federal agency and any SBC for the performance of experimental, developmental, or research work, including products or services, funded in whole or in part by the Federal Government.

Funding Agreement Officer. A contracting officer https://www.govinfo.gov/app/details/USCODE-2011-title5/USCODE-2011-title5-partI-chap1-sec102

Hedge fund. Has the meaning given that term in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The hedge fund must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.

HUBZone Small Business Concern. A small business concern that appears on the List of Qualified HUBZone (Historically Underutilized Business Zone) Small Business Concerns maintained by the Small Business Administration (13 CFR 126.103).

Innovation. Something new or improved, having marketable potential, including: (1) development of new technologies, (2) refinement of existing technologies, or (3) development of new applications for existing technologies. Innovation encompasses the full commercialization pathway.

Intellectual Property. The separate and distinct types of intangible property that are referred to collectively as “intellectual property,” including but not limited to: (1) Patents; (2) trademarks; (3) copyrights;

(4) trade secrets; (5) SBIR technical data (as defined in this section); (6) ideas; (7) designs; (8) know-how;

(9) business; (10) technical and research methods; (11) other types of intangible business assets; and (12) all types of intangible assets, either proposed or generated by an SBC as a result of its participation in the SBIR Program.

Joint Venture. A joint venture is an association of individuals and/or concerns with interests in any degree or proportion consorting to engage in and carry out no more than three specific or limited-purpose business ventures for joint profit over a two year period, for which purpose they combine their efforts, property, money, skill, or knowledge, but not on a continuing or permanent basis for conducting business generally. See 13 CFR 121.103(h)for further information.

Key Personnel. The principal investigator/project manager and any other person considered to be essential to work performance.

NHO. Native Hawaiian Organization.

Portfolio company. Any company that is owned in whole or part by a venture capital operating company, hedge fund, or private equity firm.

Principal Investigator/Project Manager. The one individual designated by the applicant to provide the scientific and technical direction to a project supported by the funding agreement.

Private equity firm. Has the meaning given the term private equity fund in section 13(h)(2) of the Bank Holding Company Act of 1956 (12 U.S.C. 1851(h)(2)). The private equity firm must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.

ProgramSolicitation. A formal solicitation for proposals issued by a Federal agency that notifies the small business community of its R/R&D needs and interests in broad and selected areas, as appropriate to the agency, and requests proposals from SBCs in response to these needs and interests.

Proprietary Information. Information that constitutes a trade secret or other confidential commercial or financial information.

Prototype. A model of something to be further developed, which includes designs, protocols, questionnaires, software, and devices.

SBIR Participants. Business concerns that have received SBIR awards or that have submitted SBIR proposals/applications.

SBIR Technical Data. All data generated during the performance of an SBIR award.

SBIR Technical Data Rights. The rights an SBIR awardee obtains in data generated during the performance of any SBIR Phase I, Phase II, or follow-on award that an awardee delivers to the Government during or upon completion of a Federally-funded project, and to which the Government receives a license.

Service-Disabled Veteran-Owned Small Business Concern. A small business concern note less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and, the management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such a veteran. Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

Small Business Concern (SBC). A concern that meets the requirements set forth in 13 CFR 121.702:

To be eligible for award of funding agreements in the SBA's Small Business Innovation Research (SBIR) program, a business concern must meet the requirements of paragraphs (a) and (b) below:

(a) Ownership and control.

(1) An SBIR awardee must:

(i) 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 small 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

(ii) 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 (for agencies electing to use the authority in 15 U.S.C. 638(dd)(1)); OR

(iii) Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph (a)(1)(i) or (a)(1)(ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (a)(1)(ii) of this section must comply with § 121.705(b) concerning registration and proposal requirements

(2) No single venture capital operating company, hedge fund, or private equity firm may own more than 50% of the concern.

(3) If an Employee Stock Ownership Plan owns all or part of the concern, each stock trustee and plan member is considered an owner.

(4) If a trust owns all or part of the concern, each trustee and trust beneficiary is considered an owner.

Size. An SBIR awardee, together with its affiliates, will not have more than 500 employees.

Small Disadvantaged Business Concern.Consistent with 13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that: is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by one or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States; and, each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2); and, the management and daily business operations of which are controlled (as defined at 13 CFR 124.106) by individuals who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

Socially and Economically Disadvantaged Individual. See 13 CFR 124.103 and 124.104.

Subcontract. Any agreement, other than one involving an employer-employee relationship, entered into by an awardee of a funding agreement calling for supplies or services for the performance of the original funding agreement.

United States.Means the 50 states, the territories and possessions of the Federal Government, the Commonwealth of Puerto Rico, the District of Columbia, the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau.

Venture capital operating company. Means an entity described in 121.103(b)(5)(i), (v), or (vi). The venture capital operating company must have a place of business located in the United States and be created or organized in the United States, or under the law of the United States or of any State.

Women-Owned Small Business Concern. A small business concern that is at least 51% owned by one or more women, or in the case of any publicly owned business, at least 51% of the stock is owned by women, and women control the management and daily business operations.

Definitions (Relating to R&D)

AutopsyMaterials. The use of autopsy materials is governed by applicable Federal, state, and local law and is not directly regulated by 45 CFR part 46.

Child. The NIH Policy on Inclusion of Children defines a child as an individual under the age of 18 years (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-010.html). The intent of the NIH policy is to provide the opportunity for children to participate in research studies when there is a sound scientific rationale for including them, and their participation benefits children and is appropriate under existing Federal guidelines. Thus, children must be included in NIH conducted or supported clinical research unless there are scientific or ethical reasons not to include them. This policy is separate from considerations of protections and consent for children to participate in research.

Clinical Research. NIH defines human clinical research as research with human subjects that is:

(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes:

(a) mechanisms of human disease,

(b) therapeutic interventions, (c) clinical trials, or

(d) development of new technologies.

(2) Epidemiologic and behavioral studies.

(3) Outcomes research and health services research.

Note: Studies falling under Exemption 4 for human subjects research are not considered clinical research by this definition.

Clinical Trial. NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

If the answers to all four questions below are yes, the study meets the definition of a Clinical Trial:

- Does the study involve human participants?

- Are the participants prospectively assigned to an intervention?

- Is the study designed to evaluate the effect of the intervention on the participants?

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-010.html

- Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

See Instructions, Human Subjects and Clinical Trials Information Form, Section 1.4. Clinical Trial Questionnaire, for further information and references for understanding this definition.

Human Subjects. The HHS regulations “Protection of Human Research Subjects” 45 CFR part 46, (administered by OHRP) define a human subject as a living individual about whom an investigator conducting research obtains: • Data through intervention or interaction with the individual; or,

• Identifiable private information.

Individually Identifiable Private Information. According to its guidance for use of coded specimens, OHRP generally considers private information or specimens to be individually identifiable as defined at 45 CFR 46.102(f) when they can be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. Conversely, OHRP considers private information or specimens not to be individually identifiable when they cannot be linked to specific individuals by the investigator(s) either directly or indirectly through a coding system.

Interaction includes communication or interpersonal contact between investigator and subject. (45 CFR 46.102(f)).

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. (45 CFR 46.102(f)).

Investigational Device Exemption (IDE). An IDE is a regulatory submission that permits clinical investigation of devices. This investigation is exempt from some regulatory requirements. The term “IDE” stems from the description in 21 CFR 812.1.

Investigator. The OHRP considers the term investigator to include anyone involved in conducting the research. OHRP does not consider the act of solely providing coded private information or specimens (for example, by a tissue repository) to constitute involvement in the conduct of the research. However, if the individuals who provide coded information or specimens also collaborate on other activities related to the conduct of the research with the investigators who receive such information or specimens, they will be considered to be involved in the conduct of the research. (See OHRP’s Guidance on Research Involving Coded Private Information on Biological Specimens.)

Manufacturing-related R&D as a result of Executive Order 13329. Encompasses improvements in existing methods or processes, or wholly new processes, machines or systems. Four main areas include:

● Unit process level technologies that create or improve manufacturing processes including:

○ Fundamental improvements in existing manufacturing processes that deliver substantial productivity, quality, or environmental benefits.

○ Development of new manufacturing processes, including new materials, coatings, methods, and associated practices.

● Machine level technologies that create or improve manufacturing equipment, including:

○ Improvements in capital equipment that create increased capability (such as accuracy or repeatability), increased capacity (through productivity improvements or cost reduction), or increased environmental efficiency (safety, energy efficiency, environmental impact).

○ New apparatus and equipment for manufacturing, including additive and subtractive manufacturing, deformation and molding, assembly and test, semiconductor fabrication, and nanotechnology.

● Systems level technologies for innovation in the manufacturing enterprise, including:

○ Advances in controls, sensors, networks, and other information technologies that improve the quality and productivity of manufacturing cells, lines, systems, and facilities.

○ Innovation in extended enterprise functions critical to manufacturing, such as quality systems, resource management, supply change integration, and distribution, scheduling and tracking.

● Environment or societal level technologies that improve workforce abilities, productivity, and manufacturing competitiveness, including:

○ Technologies for improved workforce health and safety, such as human factors and ergonomics.

○ Technologies that aid and improve workforce manufacturing skill and technical excellence, such as educational systems incorporating improved manufacturing knowledge and instructional methods.

○ technologies that enable integrated and collaborative product and process development, including computer-aided and expert systems for design, tolerancing, process and materials selection, life-cycle cost estimation, rapid prototyping, and tooling.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. (45 CFR 46.102(f))

● Coded.With respect to private information or human biological specimens, coded means that:

o Identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol or combination thereof (i.e., the code); and o A key to decipher the code exists, enabling linkage of the identifying information with the private information or specimens.

Research that involves only coded private information/data or coded human biological specimens may not constitute human subjects research under the HHS human subjects regulations (45 CFR 46) if:

○ The specimens and/or information/data are not obtained from an interaction/intervention with the subject specifically for the research; and

○ The investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain (e.g., the researcher's access to subject identities is prohibited).

Individuals who provide coded information or specimens for proposed research and who also collaborate on the research involving such information or specimens are considered to be involved in the conduct of human subjects research.

(See the following guidance from the Office for Human Research Protections (OHRP) for additional information and examples: http://www.hhs.gov/ohrp/policy/cdebiol.html.)

Research or Research and Development (R/R&D). Any activity that is:

● A systematic, intensive study directed toward greater knowledge or understanding…