FY26 SBIR Concept Solicitation - Updated by SEED.pdf

Page i

NATIONAL CANCER INSTITUTE (NCI) SMALL BUSINESS INNOVATION RESEARCH (SBIR)

INNOVATIVE CONCEPT AWARD PROGRAM

SOLICITATION NO. 75N91025R00005

Closing Date: October 17, 2025

IMPORTANT DEADLINES AND INSTRUCTIONS

Deadline for Receipt of Proposals: Proposals must be received before 5:00 PM Eastern Daylight Time on October 17, 2025. All proposals must be submitted using the electronic contract proposal submission (eCPS) website, as discussed in Section 7 of this solicitation. Please read the entire solicitation carefully prior to submitting your proposal.

Deadline for Receipt of White Papers: White Papers must be received before 5:00 PM Eastern Daylight Time, July 11, 2025. White Papers must be submitted via e-mail to ncioasbir@mail.nih.gov, as discussed in Section 7 of this solicitation.

Deadline for Receipt of Questions: As discussed in Section 7 of this solicitation, all questions should be submitted by September 1, 2025 via e-mail to ncioasbir@mail.nih.gov. After that time, questions will be addressed as time permits, and at the discretion of the NCI Office of Acquisitions. Questions will be shared with the public through a solicitation amendment to ensure fair competition. Do not include sensitive information in questions submitted.

For additional information, read the SBIR/STTR Policy Directive issued by the Small Business Administration:

https://www.sbir.gov/about/policies

Please note the inclusion of a new proposal requirement: Appendix J – Disclosure of Foreign Relationships. Reference SECTION 12 – APPENDICES within this solicitation, read the document in full, and include a completed disclosure form within your business proposal.

For information about this solicitation, the primary point of contact is listed below:

Tanya Renwick, SBIR Contracts Analyst (Contractor) Office of Acquisitions, National Cancer Institute ncioasbir@mail.nih.gov

Issued by: Andrew Carr, Office of Acquisitions, National Cancer Institute.

mailto:ncioasbir@mail.nih.gov

Page ii

Table of Contents

1 INTRODUCTION

2 PROGRAM DESCRIPTION

2.1 Objectives

2.2 Three Phase Program

2.3 I-Corps™ at NIH

3 DEFINITIONS

3.1 General Definitions

3.2 Definitions (Relating to R&D)

4 PROPOSAL FUNDAMENTALS

4.1 Introduction

4.2 Offeror Eligibility and Performance Requirements

4.3 SBIR/STTR Performance Benchmarks for Progress towards Commercialization

4.4 Multiple Principal Investigators

4.5 Joint Ventures and Limited Partnerships

4.6 Majority Ownership in Part by Multiple Venture Capital, Hedge Fund, and Private Equity Firms

4.7 Conflicts of Interest

4.8 Market Research

4.9 Debriefing

4.10 Registrations and Certifications

4.11 Promotional Materials, URLs, and Other Media

4.12 Prior, Current, or Pending Support of Similar Proposals or Awards

4.13 Reporting Matters Involving Fraud, Waste, and Abuse

4.14 Technical and Business Assistance / State Assistance

4.15 Payment

4.16 Proprietary Information

4.17 Identification and Marking of SBIR Technical Data in Contract Reports and Deliverables

5 CONTRACT REQUIREMENTS

5.1 NIH Policy on Enhancing Reproducibility Through Rigor and Transparency

5.2 CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015)

5.3 Animal Welfare

5.4 PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015)

5.5 Required Education in the Protection of Human Research Participants

5.6 Copyrights

5.7 Technical Data Rights

5.8 Patents and Invention Reporting

5.9 Management and Sharing of Research Data

5.10 Other Contract Requirements

6 METHOD OF EVALUATION

6.1 Evaluation Process

6.2 Award Decisions

Page iii

6.3 Technical Evaluation Criteria

7 PROPOSAL SUBMISSION

7.1 White Paper / Letter of Intent

7.2 Questions

7.3 Limitation on the Length of the Technical Proposal

7.4 Submission, Modifications, Revision, and Withdrawal of Proposals

8 PROPOSAL PREPARATION AND INSTRUCTIONS

8.1 Introduction

8.2 Proposal Instructions

8.3 Technical Proposal Cover Sheet

8.4 Abstract of Research Plan and Public Health Relevance

8.5 Technical Proposal Content Generated by Small Business Offeror

8.6 Enhancing Reproducibility through Rigor and Transparency

8.7 Research Involving Vertebrate Animals

8.8 Human Subjects and Clinical Trials Information Form

1) Human Specimens and/or Data

2) Human Subjects Research with an Exemption from Federal Regulations

3) Protection of Human Subjects

8.9 Content of the Pricing Proposal

9 ANTICIPATED SCHEDULED AND NUMBER OF AWARDS

10 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES

11 TECHNICAL TOPIC DESCRIPTION(S)

National Cancer Institute (NCI)

12 ATTACHMENT(S) AND APPENDICES

1 INTRODUCTION

The National Cancer Institute (NCI) invites small business concerns to submit research proposals under this Phase I Small Business Innovation Research (SBIR) contract solicitation. Firms with the capability to conduct research and development (R&D) in the health-related topic areas referred to below and described more fully in Section 11.0, and to commercialize the results of that R&D, are encouraged to participate.

The topic areas that are being sought under this solicitation are:

The National Cancer Institute is soliciting proposals from small business concerns who are looking for an opportunity to perform a few key activities to demonstrate proof-of-concept and feasibility of untested but potentially transformative, game-changing research and development (R&D) technologies to help cancer patients, providers and caregivers, in conjunction with Small Business Innovation Research (SBIR) program objectives. The NCI has established a high-risk, high-reward SBIR “Innovative Concept Award” Program for this purpose.

Preliminary data is not required; however, the ideas should have sound scientific premise either based on the offeror’s own research or literature evidence. Proposals will need to identify an anticipated product that will be developed and clearly lay out the anticipated development path. Proposals will need to clearly identify the clinical problem and cancer type(s) that the proposal will focus on with adequate justification. In addition, the offerors should propose experiments to obtain initial de-risking and proof-of-concept data.

Note: Non-exempt Human subjects research will not be supported under this solicitation.

All firms submitting a proposal for an SBIR Concept Award must also include potential participation in the I-Corps™ at National Institutes of Health (NIH) program in its proposal. See more information about I-Corps™ at NIH in Section

2.3 of this solicitation.

Phase I Concept Award contractors will be informed of the opportunity to apply for Phase II. Only one Phase II award may result from a single Phase I SBIR contract. The United States Department of Health and Human Services (HHS) is not obligated to make any awards under this solicitation. All awards are subject to the availability of funds. HHS is not responsible for any monies expended by the offeror before award of any contract.

• Topic 1: Development of therapeutic or preventative technologies for treatment or prevention of Pediatric Cancers and/or Rare Cancers.

For this solicitation rare cancers with a 5-year survival rate of less than 50% are encouraged.

• Topic 2: Development of devices, diagnostic technologies, or digital health tools for treatment, detection, and diagnosis of Pediatric Cancers and/or Rare Cancers.

For this solicitation, rare cancers with a 5-year survival rate of less than 50% are encouraged.

2 PROGRAM DESCRIPTION

2.1 Objectives

The statutory purpose of the SBIR program is to strengthen the role of innovative SBCs in Federally-funded research or research and development (R/R&D). Specific program purposes are to: (1) stimulate technological innovation; (2) use small business to meet Federal R/R&D needs; (3) foster and encourage participation by emerging and undercapitalized SBCs in technological innovation and, (4) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth.

The basic design of the NCI SBIR program is in accordance with the Small Business Administration (SBA) SBIR Program Policy Directive dated May 3, 2023. This Phase I SBIR contract solicitation strives to encourage scientific and technical innovation in areas specifically identified by the NCI. The guidelines presented in this solicitation reflect the flexibility provided in the Policy Directive to encourage proposals based on scientific and technical approaches most likely to yield results important to the NCI and to the private sector.

2.2 The Concept Award and Three Phase Program

The Concept Award program is unique to the NCI. The objective of the NCI Concept Award Program is to support exploration of untested but potentially transformative ideas that may radically change the way the cancer community can prevent, diagnose, treat, and manage pediatric and/or rare cancers. This initial $300,000 Concept Award funding is intended to allow small businesses to perform key de-risking research activities and generate proof-of-concept and feasibility data that lay the groundwork to support additional Federal funding opportunities. Phase I Concept Award contractors will be informed of the opportunity to apply for Phase II.

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 and the quality of performance of the small business concern, prior to providing further Federal support in Phase II.

Phase II: Full R/R&D Effort

The objective of Phase II is to continue the research or R&D efforts initiated in Phase I. Funding shall be based on the results of Phase I and the scientific and technical merit and commercial potential of the Phase II proposal.

Phase III: Commercialization Stage without SBIR Funds

The objective of Phase III is for the small business concern to pursue, with non-SBIR funds, the commercialization objectives resulting from the outcomes of the research or R&D funded in Phases I and II. Phase III may be funded by non- Federal sources of capital or may be funded by follow-on non-SBIR Federal funding agreements.

Additionally, the NCI offers a Phase IIB program:

NCI Phase IIB Bridge Award

Successful transition of SBIR research and technology development into the commercial marketplace is difficult, and SBIR Phase II awardees often encounter significant challenges in navigating the regulatory approval process, raising capital, licensure, and production, as small business concerns try to advance their projects towards commercialization.

The Phase IIB Bridge Award supports the next stage of development for federally funded SBIR Phase II projects in the areas of cancer therapeutics, imaging technologies, interventional devices, diagnostics, and prognostics. With this award, the NCI aims to address the funding gap, known as the “valley of death,” between the end of the SBIR Phase II award and the subsequent round of financing needed to advance a product or service toward commercialization. To achieve this goal, the Bridge Award funding opportunity is specifically designed to incentivize partnerships between federally funded SBIR Phase II awardees and third-party investors and/or strategic partners. For any single year of the project period, applicants can request a budget of up to $2.25 million in total costs. The combined budget requested for the entire project period must not exceed $4.5 million in total costs.

https://www.sbir.gov/sites/default/files/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.pdf https://www.sbir.gov/sites/default/files/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.pdf

The specific requirements for the previously offered Phase IIB Bridge Award can be reviewed in the full RFA announcement:

https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-24-022.html.

In FY2011, the NCI expanded the Phase IIB Bridge Award program to allow previous SBIR Phase II contract awardees to compete for SBIR Phase IIB Bridge Award grants. Provided it is available in the future, the Phase IIB Bridge Award program will be open to contractors that are successfully awarded a Phase II contract (or have an exercised Phase II option under a Fast-Track contract). NIH SBIR Phase II contractors who satisfy the above requirements may be able to apply for a Phase IIB Bridge Award under a future Phase IIB Bridge Award grant funding opportunity announcement (FOA), if they meet the eligibility requirements detailed therein. Selection decisions for a Phase IIB Bridge Award will be based both on scientific/technical merit as well as business/commercialization potential.

2.3 I-Corps™ at NIH

Any offeror submitting a proposal must include potential participation in the I-Corps™ at NIH program.

The I-Corps™ at NIH program is designed to complement activities within the scope of an initial SBIR award. This opportunity is specifically aligned with the statutorily mandated purpose of the SBIR program to “increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity, and economic growth” (48 CFR 1819.7301).

The I-Corps™ at NIH program is selective, with each NIH cohort consisting of up to 24 companies, split amongst current grant and contract SBIR award recipients throughout the NIH, for a firm fixed price option amount not to exceed $55,000 (in addition to the price for performing the base research project). Companies selected to participate in this program will perform additional requirements and develop additional deliverables related to participation in the I-Corps™ program, so that I-Corps™ at NIH participation runs concurrently with the performance of the SBIR research.

Participants must assemble a three-member I-Corps™ team that will work collaboratively to complete the program’s required activities and assignments. Offerors should designate teams consisting of the 3 member roles bulleted below.

Please include a list of the proposed three member I-Corps team in the I-Corps Pricing Proposal (see Section 8.9 and Appendix C) and include an NIH Biosketch for each member in the technical proposal form (see Section 8.2).

• Chief-Level Corporate Officer (CEO of the SBIR awardee company strongly preferred)

• Industry Expert (internal, such as a Business Development Manager or Board Member, or external, such as a consultant or mentor)

• Program Director/Principal Investigator (PD/PI) (or, in the case that the PD/PI is also the CEO, an additional technical/scientific expert)

To successfully complete the I-Corps™ at NIH Program, the entire I-Corps™ team must be deeply committed and dedicated to the time-intensive curriculum. Each team member should plan to spend at least 20 hours per week on I- Corps™ activities for the full duration of the 8-week program. Attendance of all 3 team members is mandatory for a 3-day immersion ‘kickoff’ workshop and a 2-day closing workshop, where team members will give presentations as well as participate in lectures and training sessions. There will also be weekly webinar sessions and requirements to get “out of the lab” and gather information by conducting at least 100 discovery interviews with potential customers, strategic partners, and other third-party stakeholders.

The program teaches researchers how to gain a clearer understanding of the value of their inventions in the marketplace, and ultimately how to advance their technologies from the research lab into the commercial world, helping to accelerate the commercialization of new products and services derived from NIH SBIR awards.

See https://sbir.cancer.gov/programseducation/icorps for further information on this program.

Application Process

The first step in the I-Corps™ at NIH application process is submitting an additional, separate “Appendix C – Contract Pricing Proposal,” in your Business Proposal. Specify “I-Corps” in the “Title of Proposal” field. This separate budget must not exceed $55,000 in total direct costs – indirect costs may not be included. Of that amount, $27,500 must go towards https://grants.nih.gov/grants/guide/rfa-files/RFA-CA-24-022.html.

https://sbir.cancer.gov/programseducation/icorps covering workshop registration fees, which should be listed in field 4.e.

OTHER of Appendix C. Remaining budget should be allocated as appropriate to cover personnel time for the I- Corps™ team members – at least 20 hours per week for 8 weeks for the 3 team member roles discussed above – as well as travel costs as necessary to conduct in person kick-off and close-out meetings as well as on-site customer development interviews within the U.S.

Dates and times for NIH 8-week cohorts in 2025-2026 have not yet been finalized. The Government will notify awardees once these determinations have been made.

Contracts resulting from this solicitation will contain an option for I-Corps™ participation; however, this is not a guarantee of funding unless and until the option is exercised by the Government. Upon exercise of the I-Corps™ option, awardees must successfully enroll into the I-Corps™ program and complete the deliverables defined in the contract.

The second step in the I-Corps™ registration process will take place during performance of the SBIR research project, when the Government will notify awardees of the definitized details for the planned cohorts and ask awardees to prepare a brief application to be considered for I-Corps™ selection among various SBIR awardees from around the NIH and CDC, subject to availability of funds. The application will consist of components such as those discussed below (not required at the time of submission of this proposal):

• Executive Summary of Predicate SBIR/STTR Contract and Team (1 page only)

• I-Corps™ Team and Project Plan (up to 5 pages) o I-Corps™ Team Description of the I-Corps™ team; indication of commitment to meet time-intensive requirements; discussion of team’s willingness to modify/refine the overall commercialization strategy based on knowledge gained during the course of the I-Corps™ Program.

o Potential Commercial Impact Description of what has led team to believe that a commercial opportunity exists for the project; profile of typical customer; description of the customer’s need that the proposed innovation will meet and how the customer is currently meeting that need; discussion of competitive advantage offered by the proposed product/service; discussion of how much a customer would pay for the solution.

o Project Plan Description of the current stage of development for the product/service and what objectives will be achieved by the end of the Concept Award; description of next steps the company will take to advance the project toward commercialization.

Finally, after NIH reviews written I-Corps™ applications, phone interviews will be conducted to determine which companies will be invited to join the planned I-Corps™ cohort(s). The NIH selection committee will consider the ability of the proposed I-Corps™ effort to increase the overall success of the SBIR research project. Specific criteria will be discussed in the notification provided by the Government containing finalized application due dates and cohort participation dates.

If a company is selected, the I-Corps™ option in the contract may be exercised (pending availability of funds), increasing funding to the contract and incorporating I-Corps™ program participation requirements and associated deliverables into the contract, including:

• Participation in all Opening Workshop lectures/sessions;

• 3 team presentations at the Opening Workshop;

• Participation in weekly faculty office hour meetings;

• Participation in 6 Webex sessions;

• Completion of at least 100 customer discovery interviews;

• Participation in all Closing Workshop lectures/sessions

• Final Lessons Learned team presentation; and,

• Team presentation of final video.

3 DEFINITIONS

3.1 General 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 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 http://www.ecfr.gov/cgi-bin/text-idx?SID=b02d16dbfcddf646e5c0728d5e632a61&mc=true&node=se13.1.121_1103&rgn=div8). Further information about SBA's affiliation rules and a guide on affiliation is available at www.SBIR.gov and www.SBA.gov/size.

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.

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.

Computer Software - Computer programs, source code, source code listings, object code listings, design details, algorithms, processes, flow charts, formulae, and related material that would enable the software to be reproduced, recreated, or recompiled. Computer Software does not include Computer Databases or Computer Software Documentation.

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.

Cooperative Agreement - A financial assistance mechanism used when substantial Federal programmatic involvement with the awardee during performance is anticipated by the issuing agency. The Cooperative Agreement contains the responsibilities and respective obligations of the parties.

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

Is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms on the date of the SBIR award.Data - All recorded information, regardless of the form or method of recording or the media on which it may be recorded. The term does not include information incidental to contract or grant administration, such as financial, administrative, cost or pricing or management information.

eCPS - The Electronic Contract Submission (eCPS) website is a component of the Government’s integrated, secure system for the electronic submission, capture, tracking, and review of contract proposals. The eCPS website will be the only way to submit proposals under this solicitation. See the Section on Proposal Submissions for further information.

Essentially Equivalent Work - Work that is substantially the same research, which is proposed for funding in more than one http://www.ecfr.gov/cgi-bin/text-idx?SID=b02d16dbfcddf646e5c0728d5e632a61&mc=true&node=se13.1.121_1103&rgn=div8 http://www.ecfr.gov/cgi-bin/text-idx?SID=b02d16dbfcddf646e5c0728d5e632a61&mc=true&node=se13.1.121_1103&rgn=div8 https://www.sbir.gov/ http://www.sba.gov/size 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.

Form, Fit, and Function Data - Data relating to items, components, or processes that are sufficient to enable physical and functional interchangeability, and data identifying source, size, configuration, mating and attachment characteristics, functional characteristics, and performance requirements. For Computer Software it means data identifying source, functional characteristics, and performance requirements, but specifically excludes the source code, algorithms, processes, formulas, and flow charts of the software.

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, a grants officer, or a cooperative agreement officer.

Grant - A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the Federal agency anticipates no substantial programmatic involvement with the awardee during performance.

Government Purpose - Any activity in which the United States Government is a party, including cooperative agreements with international or multi-national defense organizations or sales or transfers by the United States Government to foreign governments or international organizations. Government Purposes include competitive procurement, but do not include the rights to use, modify, reproduce, release, perform, display, or disclose Technical Data or Computer Software for commercial purposes or authorize others to do so.

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, that includes the development of new technology, the refinement of existing technology, or the development of new applications for existing technology.

Intellectual Property - The separate and distinct types of intangible property that are referred to collectively as “Intellectual Property,” including but not limited to: patents, trademarks, copyrights, trade secrets, and mask works.

Joint Venture - A joint venture is an association of individuals and/or concerns with interests in any degree or proportion http://www.gpo.gov/fdsys/granule/USCODE-2011-title5/USCODE-2011-title5-partI-chap1-sec102/content-detail.html 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.

Operations, Maintenance, Installation, or Training Purposes (OMIT) Data - Data that is necessary for operation, maintenance, installation, or training purposes (but not including detailed manufacturing or process data).

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.

Program Solicitation - 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 product, material, object, system, or process, or a model thereof, that is in development, regardless of whether it is in tangible, electronic, graphic or other form, at any stage of development prior to its intended ultimate commercial production and sale. The term “Prototype” includes Computer Programs embedded in hardware or devices.

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

SBIR/STTR Computer Software Rights. The Federal Government’s rights during the SBIR/STTR Protection Period in specific types of SBIR/STTR Data that are Computer Software.

A. The Federal Government may use, modify, reproduce, release, perform, display, or disclose SBIR/STTR Data that are Computer Software within the Government. The Federal Government may exercise SBIR/STTR Computer Software Rights within the Government for:

a. Use in Federal Government computers;

b. Modification, adaptation, or combination with other Computer Software, provided that the Data incorporated into any derivative software are subject to the rights in § 3(ee) of the SBIR/STTR Policy Directive and that the derivative software is marked as containing SBIR/STTR Data;

c. Archive or backup; or

d. Distribution of a computer program to another Federal agency, without further permission of the Awardee, if the

Awardee is notified of the distribution and the identity of the recipient prior to the distribution, and a copy of the SBIR/STTR Computer Software Rights included in the Funding Agreement is provided to the recipient.

B. The Federal Government shall not release, disclose, or permit access to SBIR/STTR Data that is Computer Software for commercial, manufacturing, or procurement purposes without the written permission of the Awardee. The Federal Government shall not release, disclose, or permit access to SBIR/STTR Data outside the Government without the written permission of the Awardee unless:

a. The non-Governmental entity has entered into a non-disclosure agreement with the Government that complies with the terms for such agreements outlined in § 8 of the SBIR/STTR Policy Directive; and

b. The release or disclosure is—

i. To a Federal Government support service contractor or their subcontractor for purposes of supporting

Government internal use or activities, including evaluation, diagnosis and correction of deficiencies, and adaptation, combination, or integration with other Computer Software provided that SBIR/STTR Data incorporated into any derivative software are subject to the rights in § 3(ee) of the SBIR/STTR Policy Directive; or

ii. Necessary to support certain narrowly-tailored essential Government activities for which law or regulation permits access of a non-Government entity to a contractors’ data developed exclusively at private expense, non-SBIR/STTR Data, such as for emergency repair and overhaul.

SBIR Data - All Data developed or generated in the performance of an SBIR or STTR award, including Technical Data and Computer Software developed or generated in the performance of an SBIR or STTR award. The term does not include information incidental to contract or grant administration, such as financial, administrative, cost or pricing or management information.

http://www.ecfr.gov/cgi-bin/text-idx?SID=fc49fc7e1268cd0891cc2dde9abe523f&mc=true&node=se13.1.121_1103&rgn=div8

SBIR/STTR Data Rights - The Government’s license rights in properly marked SBIR/STTR Data during the SBIR/STTR Protection Period as follows: SBIR/STTR Technical Data Rights in SBIR/STTR Data that are Technical Data or any other type of Data other than Computer Software and SBIR/STTR Computer Software Rights in SBIR/STTR Data that is Computer Software.

Upon expiration of the protection period for SBIR/STTR Data, the 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 all disclosure prohibitions and assumes no liability for unauthorized use of these Data by third parties. The Government receives Unlimited Rights in all Form, Fit, and Function Data, OMIT Data, and unmarked SBIR/STTR Data.

SBIR/STTR Protection Period - The period of time during which the Government is obligated to protect SBIR/STTR Data against unauthorized use and disclosure in accordance with SBIR/STTR Data Rights. The SBIR/STTR Protection Period begins at award of an SBIR/STTR Funding Agreement and ends not less than twenty years from that date. (See § 8(b)(4) of this Policy Directive).

SBIR Technical Data Rights - The Federal Government’s rights during the SBIR/STTR Protection Period in SBIR/STTR Data that are Technical Data or any other type of Data other than Computer Software. 15 (1) The Government may, use, modify, reproduce, perform, display, release, or disclose SBIR/STTR Data that are Technical Data within the Federal Government; however, the Federal Government shall not use, release, or disclose the data for procurement, manufacture or commercial purposes; or release or disclose the SBIR/STTR Data outside the Government except as permitted by paragraph

(2) below or by written permission of the Awardee. (2) SBIR/STTR Data that are Technical Data may be released outside the Federal Government without any additional written permission of the Awardee only if the non-Governmental entity or foreign government has entered into a non-disclosure agreement with the Federal Government that complies with the terms for such agreements outlined in § 8 of this Policy Directive and the release is: (i) Necessary to support certain narrowly-tailored essential Government activities for which law or regulation permits access of a non-Government entity to a contractors’ data developed exclusively at private expense, non-SBIR/STTR Data, such as for emergency repair and overhaul; (ii) To a Government support services contractor in the performance of a Government support services contract for internal Government use or activities, including evaluation, diagnosis or modification provided that SBIR/STTR Technical Data incorporated into any derivative Data are subject to the rights in paragraph (ii), and the release is not for commercial purposes or manufacture; (iii) To a foreign government for purposes of information and evaluation if required to serve the interests of the U.S. Government; or (iv) To non-Government entities or individuals for purposes of evaluation.

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 http://www.ecfr.gov/cgi-bin/text-idx?SID=ddf55574cd923f5ebaefd02bf517d956&mc=true&node=se13.1.121_1702&rgn=div8 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.

(b) 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.

Technical Data - Recorded information, regardless of the form or method of the recording, of a scientific or technical nature (including Computer Software Documentation and Computer Databases). The term does not include Computer Software or financial, administrative, cost or pricing, or management information, or other data incidental to contract or grant administration. The term includes recorded Data of a scientific or technical nature that is included in Computer Databases.

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.

Unlimited Rights - The Government’s rights to access, use, modify, prepare derivative works, reproduce, release, perform, display, disclose, or distribute Data in whole or in part, in any manner and for any purpose whatsoever, and to have or authorize others to do so

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.

3.2 Definitions (Relating to R&D)

Autopsy Materials - 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.

http://www.ecfr.gov/cgi-bin/text-idx?SID=ddf55574cd923f5ebaefd02bf517d956&mc=true&node=se13.1.124_1103&rgn=div8 http://www.ecfr.gov/cgi-bin/text-idx?SID=ddf55574cd923f5ebaefd02bf517d956&mc=true&node=se13.1.124_1104&rgn=div8 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-010.html

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?

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

See Appendix H.1 Instructions, Human Subjects, and Clinical Trials Information Form, Section 1.4. Clinical Trial Questionnaire, for further information and references for understanding this definition. Appendix H.1. is located in Section 12 – Appendices of this solicitation.

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 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:

o Fundamental improvements in existing manufacturing processes that deliver substantial productivity, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.hhs.gov/ohrp/policy/cdebiol.html quality, or environmental benefits.

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

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

o 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).

o 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:

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

o 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:

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

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

o 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…