PHS_2023-1.pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS), THE NATIONAL INSTITUTES OF

HEALTH (NIH) AND THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) SMALL BUSINESS

INNOVATION RESEARCH (SBIR) PROGRAM

PROGRAM SOLICITATION PHS 2023-1

Closing Date: November 4, 2022 5:00 PM Eastern Daylight Time

Participating HHS Components:

• The National Institutes of Health (NIH)

• The Centers for Disease Control and Prevention (CDC)

IMPORTANT

Deadline for Receipt: Proposals must be received by November 4, 2022, 5:00 PM Eastern Daylight

Time. Please read the entire solicitation carefully prior to submitting your proposal.

IMPORTANT: All proposals must be submitted using the electronic contract proposal submission (eCPS) website.

Paper proposals will not be accepted.

Please go to https://www.sbir.gov/sites/default/files/SBA_SBIR_STTR_POLICY_DIRECTIVE_OCT_2020_v2.pdf to read the SBIR/STTR Policy Directive issued by the Small Business Administration for further information.

https://www.sbir.gov/sites/default/files/SBA_SBIR_STTR_POLICY_DIRECTIVE_OCT_2020_v2.pdf

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Table of Contents

1 INTRODUCTION

2 PROGRAM DESCRIPTION

2.1 Objectives

2.2 Phased Program

2.3 Fast Track Proposals (NIH Only)

2.4 Direct to Phase II Proposals (NIH Only)

2.5 I-Corps™ at NIH

2.6 Grant Opportunity - Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP)

Program (INFORMATION ONLY)

2.7 Awarding Components

3 DEFINITIONS……………………………………………………………………………………………………………..9

3.1 General Definitions…………………………………………………………………………………………...9

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 Phase I Award Information

4.11 Phase II Award Information

4.12 Registrations and Certifications

4.13 Promotional Materials

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

4.15 Reporting Matters Involving Fraud, Waste, and Abuse

4.16 State Assistance and Technical Assistance

4.17 Payment

4.18 Proprietary Information

4.19 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 Inclusion of Women and Minorities in Research Involving Human Subjects

5.7 Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects……..25

5.8 Good Clinical Practice Training for NIH Awardees Involved in NIH-Funded Clinical Trials

5.9 Clinical Trial Registration and Results Information Submission

5.10 Posting Clinical Trial Informed Consent Forms to Clinicaltrials.gov………………………………………26

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5.11 Certificate of Confidentiality………………………………………………………………………………..27

5.12 Single Institutional Review Board (sIRB)

5.13 Human Materials (Assurance of OHRP Compliance)………………………………………………………28

5.14 Research Involving Recombinant or Synthetic Nucleic Acid (Including Human Gene Transfer Research) 29

5.15 Copyrights

5.16 NIH Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research.29

5.17 Technical Data Rights

5.18 Patents and Invention Reporting

5.19 Salary Rate Limitation

5.20 Other Contract Requirements

6 METHOD OF EVALUATION

6.1 Evaluation Process

6.2 Award Decisions

6.3 Phase I Technical Evaluation Criteria

6.4 Phase II Technical Evaluation Criteria

7 PROPOSAL SUBMISSION

7.1 Questions

7.2 Pre-Proposal Conference

7.3 Limitation on the Length of the Technical Proposal (Item 1)

7.4 Submission, Modifications, Revision, and Withdrawal of Proposals

8 PROPOSAL PREPARATION AND INSTRUCTIONS

8.1 Introduction

8.2 Fast Track Proposal Instructions (NIH Only)

8.3 Phase I Proposal Instructions

8.4 Phase II Proposal Instructions

8.5 Technical Proposal Cover Sheet (Item 1)

8.6 Table of Contents (Item 1)

8.7 Abstract of Research Plan (Item 1)

8.8 Content of Technical Element (Item 1)

8.9 Enhancing Reproducibility through Rigor and Transparency

8.10 Research Involving Vertebrate Animals

8.11 Dual Use Research of Concern

8.12 Human Subjects and Clinical Trials Information Form

8.12.1 Human Specimens and/or Data

8.12.2 Human Subjects Research with an Exemption from Federal Regulations

8.12.3 Protection of Human Subjects

8.12.4 Required Education in the Protection of Human Research Participants

8.12.5 Inclusion of Women and Minorities in Research Involving Human Subjects and Inclusion of

Children in Research Involving Human Subjects

8.12.6 Research Involving Prisoners as Subjects…………………………………………………………55

8.12.7 Public Health Surveillance Exclusion……………………………………………………………..55

8.12.8 Data and Safety Monitoring in Clinical Trials

8.12.9 Plan for the Dissemination of Information of NIH-Funded Clinical Trial (ClinicalTrials.gov)

8.12.10 Plan for Single Institutional Review Board (sIRB)

8.12.11 Research Involving Recombinant or Synthetic Nucleic Acid Molecules (Including Human Gene

Transfer Research)

8.12.12 Human Stem Cell Research

8.13 Content of the Pricing Proposal (Item Two)

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8.14 Reminders

9 SUMMARY OF HHS COMPONENTS ANTICIPATED NUMBER OF AWARDS

10 CONTRACTING OFFICER POINTS OF CONTACT FOR QUESTIONS RELATED TO SPECIFIC TOPICS 64

National Institutes of Health (NIH)

National Center for Advancing Translational Sciences (NCATS) National Cancer Institute (NCI) National Institute on Aging (NIA) National Institute of Allergy and Infectious Diseases (NIAID) National Heart, Lung, and Blood Institute (NHLBI) National Institute on Drug Abuse (NIDA)

Centers for Disease Control and Prevention (CDC)

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID) National Center for HIV, Viral Hepatitis, STD, and TB Prevention (NCHHSTP)

11 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES

12 COMPONENT INSTRUCTIONS AND TECHNICAL TOPIC DESCRIPTIONS

National Institutes of Health

NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES (NCATS)

NATIONAL CANCER INSTITUTE (NCI)

NATIONAL INSTITUTE ON AGING (NIA)

NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)

NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI)

NATIONAL INSTITUTE ON DRUG ABUSE (NIDA)

Centers for Disease Control and Prevention (CDC)

NATIONAL CENTER FOR EMERGING ZOONOTIC AND INFECTIOUS DISEASES (NCEZID)

NATIONAL CENTER FOR HIV, VIRAL HEPATITIS, STD, AND TB PREVENTION (NCHHSTP) .. 119

13 APPENDICES

1 INTRODUCTION

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) invite small business concerns (SBCs) to submit research proposals under this Small Business Innovation Research (SBIR) Contract Solicitation. Firms with the capability to conduct research and development (R&D) in any of the health-related topic areas described in Section 12.0, and to commercialize the results of that R&D, are encouraged to participate.

Coronavirus Disease 2019 (COVID-19) (INFORMATION ONLY): Information for NIH Applicants and Recipients of NIH funding, including funding opportunities specific to COVID-19, can be found at Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding. Information for CDC Applicants and Recipients of CDC funding, including funding opportunities specific to COVID-19, can be found at Financial Resources | CDC. This is a rapidly evolving situation and NIH/CDC will provide updated guidance and information as it becomes available.

This solicitation contains opportunities to submit a proposal under a variety of different Topics, which are summarized below.

Some Topics allow for only a Phase I proposal to be submitted at this time. Some Topics allow for only a Phase II proposal to be submitted, through the ‘Direct to Phase II’ process. Some Topics allow for ‘Fast Track’ proposals, which include both a Phase I proposal and a Phase II proposal. For more information on the SBIR program, including the Fast Track and Direct to Phase II processes, refer to Section 2.

TOPIC NUMBER PHASE I

ALLOWED?

FAST TRACK

ALLOWED?

(A Phase I proposal and a Phase II proposal submitted simultaneously)

DIRECT TO

PHASE II

ALLOWED?

(Includes only a Phase II Proposal)

TOPIC TITLE

NIH/NCATS 023 Yes No No Development of Automated Cell Culture Flask Cleaning Instrument

NIH/NCI 446 Yes Yes Yes Development of Senotherapeutic Agents for Cancer Treatment

NIH/NCI 447 Yes Yes No Non-invasive Device Technology Research & Development for Chemotherapy-Induced Peripheral Neuropathy Management

NIH/NCI 448 Yes Yes Yes Wearable Devices for Dosimetry of Radiopharmaceutical Therapy

NIH/NCI 449 Yes Yes Yes Wearable Technologies to Facilitate Remote Monitoring of Cancer Patients Following Treatment

NIH/NCI 450 Yes Yes No Technology Platforms for Circulating Tumor- Macrophage Hybrid Cells

NIH/NCI 451 Yes Yes Yes Rapid and Affordable Point-of-Care HPV Diagnostics for Cervical Cancer Control

NIH/NCI 452 Yes Yes Yes Translation of Novel Cancer-Specific Imaging Agents and Techniques to Mediate Successful Image-Guided Cancer Interventions

NIH/NCI 453 Yes Yes Yes Digital Tools to Integrate Cancer Prevention Within Primary Care

NIH/NCI 454 Yes No No Software to Evaluate Artificial Intelligence/Machine Learning Medical Devices in Oncology Settings

NIH/NIA 007

Yes

High Throughput CHIP (clonal hematopoeisis of indeterminate potential) Assay as a Powerful Tool to Study CHIP Related Age Associated Diseases https://grants.nih.gov/policy/natural-disasters/corona-virus.htm https://grants.nih.gov/policy/natural-disasters/corona-virus.htm https://www.cdc.gov/coronavirus/2019-ncov/php/financial-resources.html

ALLOWED?

FAST TRACK

ALLOWED?

(A Phase I proposal and a Phase II proposal submitted simultaneously)

DIRECT TO

PHASE II

ALLOWED?

(Includes only a Phase II Proposal)

TOPIC TITLE

NIH/NIA 008 Yes Yes Yes Improving Microphysiological Systems for AD/ADRD Therapy Development

NIH/NIA 009 Yes Yes Yes AI/ML Tool for Visualizing Behavioral and Social Science Research

NIH/NIAID 113 No Yes No Development of a Simian Immunodeficiency Virus (SIV) and Simian Human Immunodeficiency Virus (SHIV) Database

NIH/NIAID 114 Yes Yes No Point-of-Care HIV Viral Load, Drug Resistance, and Adherence Assays

NIH/NIAID 115 Yes Yes No Development of Diagnostics to Differentiate HIV Infection from Vaccine Induced Seropositivity

NIH/NIAID 116 Yes Yes Yes Adjuvant Discovery for Vaccines for Infectious and Immune-Mediated Diseases

NIH/NIAID 117 Yes Yes Yes Adjuvant Development for Vaccines for Infectious and Immune-Mediated Diseases

NIH/NIAID 118 Yes Yes Yes Reagents for Immunologic Analysis of Non-mammalian and Underrepresented Mammalian Models

NIH/NIAID 119 Yes Yes No Adaptation of CRISPR-based in vitro diagnostics for rapid detection of select eukaryotic pathogens

NIH/NIAID 120 Yes Yes No Modular Sample Preparation for In-Field Viral Discovery

NIH/NIAID 121 Yes Yes No Artificial Intelligence to Improve Clinical Microscopy for Diagnosis of Infectious Diseases

NIH/NIAID 122

Yes Advanced and Immersive Visualization Tools for

Infectious and Immune-mediated Disease Research

NIH/NIAID 123 Yes Yes Yes Data Science Tools for Infectious and Immune-mediated Disease Research

NIH/NHLBI 113 Yes Yes Yes Clinical Instrument for Para-Hydrogen (pH2) Based Signal Amplification by Reversible Exchange (SABRE) for Hyperpolarizing 13C-Pyruvate and Other Probes for MRI Imaging

NIH/NHLBI 114 Yes Yes Yes Device to Permit Continuous Self-Monitoring of Blood Oxygen Saturation During Activities of Daily Living for Individuals at Risk for Desaturation During Physical Exertion

NIH/NIDA 167

Cause of Death Elucidated (CODE) in Drug Overdose: research and development of new postmortem toxicology screening devices that are portable, rapid, accurate, affordable, and accessible

ALLOWED?

FAST TRACK

ALLOWED?

(A Phase I proposal and a Phase II proposal submitted simultaneously)

DIRECT TO

PHASE II

ALLOWED?

(Includes only a Phase II Proposal)

TOPIC

TITLE

CDC/NCEZID 030

No

No

Developing an Over-the-Counter Diagnostic Test for Valley Fever

CDC/NCHHSTP 054 Yes No No School Illness-Related Absenteeism and Learning Modality Surveillance

All firms that are awarded Phase I contracts originating from this solicitation will be eligible to participate in Phases II and III.

Awarding Components (see Section 2.7) will notify Phase I awardees of the Phase II proposal submission requirements. Submission of Phase II proposals will be in accordance with dates provided by individual Awarding Component instructions. The details on the due date, content, and submission requirements of the Phase II proposal will be provided by the Awarding Component either in the Phase I award or by subsequent notification.

The HHS is not obligated to make any awards under Phase I, Phase II or provide additional non-SBIR funding. 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.

2 PROGRAM DESCRIPTION

2.1 Objectives

The objectives of the SBIR program include stimulating technological innovation in the private sector, strengthening the role of small business in meeting Federal research or research and development (R/R&D) needs, increasing private sector commercialization of innovations developed through Federal SBIR R&D, increasing small business participation in Federal R&D, and fostering and encouraging participation by socially and economically disadvantaged small business concerns and women-owned small business concerns in the SBIR program.

The basic design of the NIH/CDC SBIR program is in accordance with the Small Business Administration (SBA) SBIR Program Policy Directive dated October 1, 2020. This SBIR contract solicitation strives to encourage scientific and technical innovation in areas specifically identified by the NIH/CDC awarding components. 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 NIH/CDC and to the private sector.

The NIH is interested in developing products and services via the SBIR program that improve the health of the American people. In its commitment to also support Executive Order 13329, encouraging innovation in manufacturing-related research and development, NIH seeks, through the SBIR program, biomedical research related to advanced processing, manufacturing processes, equipment and systems, or manufacturing workforce skills and protection. This solicitation includes some topic areas that are considered relevant to manufacturing-related R&D. Additional information will be posted on the NIH Small Business Research Funding Opportunities Web site and in the NIH Guide for Grants and Contracts as it becomes available. Small businesses may be interested in reading a U.S.

Department of Commerce 2004 report, "Manufacturing in America: A Comprehensive Strategy to Address the Challenges to U.S.

Manufacturers."

2.2 Phased Program

The SBIR program consists of separate phases.

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 I contractors will be informed of the opportunity to apply for Phase II, if a Phase II proposal was not submitted concurrently with the initial Phase I proposal under the Fast Track procedure. Only one Phase II award may result from a single Phase I SBIR contract.

Phase III: Commercialization stage without SBIR 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 primary 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, for an agency that wishes to fund an SBIR project beyond the Phase II, it is sufficient to state for purposes of a Justification and Approval pursuant to FAR 6.302-5 that the project is derived from, extends, or logically concludes efforts performed under prior SBIR funding agreements and is authorized under 10 U.S.C. 2304(b)(2) or 41 U.S.C. 253(b)(2).

2.3 Fast Track Proposals (NIH Only)

If a Topic notes that Fast Track proposals will be accepted, a Phase I proposal and a Phase II proposal may be submitted http://www.gpo.gov/fdsys/pkg/FR-2004-02-26/pdf/04-4436.pdf http://grants.nih.gov/grants/funding/sbir.htm http://grants.nih.gov/grants/funding/sbir.htm http://grants.nih.gov/grants/guide/ http://www.nist.gov/tpo/sbir/upload/DOC_MFG_Report_Complete-2.pdf http://www.nist.gov/tpo/sbir/upload/DOC_MFG_Report_Complete-2.pdf simultaneously. As described in Section 8.2 “Fast Track 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 6.0 “Method of Evaluation.”

A Fast Track submission may result in award for Phase I with a contractual option for Phase II. The Government is not obligated to fund the Phase II portion unless and until the awarding HHS Component exercises that option. This mechanism allows for streamlined processes that have the potential to significantly minimize the funding gap between Phase I and Phase II.

If the Phase II proposal of a Fast Track submission is not found suitable to include as a contractual option, the Phase I proposal will still be considered for Phase I only award. In this instance, the small business concern is treated as other Phase I awardees are in regards to submitting a Phase II proposal in accordance with Section 1.0, “Introduction.”

Refer to the table in Section 1.0 “Introduction” and Section 12.0 “Research Topics,” for notation of Topics allowing Fast Track proposals.

2.4 Direct to Phase II Proposals (NIH Only)

If a Topic notes that Direct to Phase II proposals will be accepted, a small business concern that has already performed Phase I stage-type research through other, non-SBIR/STTR funding sources may submit a Phase II only proposal. Direct to Phase II awards allow a small business concern that has already built a technology prototype and tested its feasibility (i.e., completed Phase I type R&D) to move directly into Phase II type R&D that tests the functional viability of the prototype according to scientific methods and potential for commercial development. Refer to the table in Section 1.0 “Introduction” and Section 12.0 “Research Topics,” for notation of Topics allowing Direct to Phase II proposals.

2.5 I-Corps™ at NIH

The following NIH/CDC awarding components are offering the opportunity for companies performing Phase I SBIR contracts to further develop the project’s commercialization strategy by applying for participation in the I-Corps™ at NIH program:

- All NIH awarding components (NCATS, NCI, NIA, NIAID, NHLBI, and NIDA), as well as CDC/NCEZID.

Any offeror submitting a proposal to a Topic falling under the above awarding components may include potential participation in the I-Corps™ at NIH program within its Phase I proposal.

The I-Corps™ at NIH program is designed to complement activities within the scope of a Phase I 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/CDC cohort consisting of up to 24 companies, split amongst current grant and contract SBIR Phase I award recipients throughout the NIH and CDC. 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 which will ultimately provide the resources to submit a refined Commercialization Plan within the Final Report for an SBIR Phase I award, meaning that Corps™ at NIH participation runs concurrently with the performance of the SBIR Phase I research.

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

• 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 with the National Innovation Network)

• Technical Lead/Expert (TL) (or, the PD/PI of the predicate award is strongly preferred however, in the case that 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 https://venturewell.org/i-corps/nin/ time-intensive curriculum. Each team member should plan to spend at least 25 hours per week on I-Corps™ activities for the full duration of the 8-week program. In-person attendance of all 3 team members is mandatory for a 3-day immersion ‘kickoff’ workshop and a 2-day closing workshop, location to be determined (within the United States, however, currently virtual due to the COVID-19 pandemic), 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/CDC Phase I SBIR contract awards.

See https://sbir.cancer.gov/programseducation/icorps for further information on this program. Example timelines for the selection process and for course components may be viewed here, although specific dates are subject to change:

https://sbir.cancer.gov/programseducation/icorps/cohortcurriculum.

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 costs. Of that amount, $22,000 must go towards 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 25 hours per week for 8 weeks for the 3 team member roles discussed above – as well as travel costs (when appropriate) to participate in the in-person workshops and conduct on-site customer development interviews within the U.S.

Dates, times, and locations for NIH/CDC 8-week cohorts in 2023 have not yet been finalized. The Government will notify companies with the I-Corps™ contractual option once these determinations have been made. For the purpose of preparing a budget only, assume a cohort spanning April to May in 2023 with travel to Los Angeles, California for a three day workshop in April and travel to Bethesda, Maryland for a two day workshop in May. Depending on the evolving Covid-19 pandemic situation, the cohorts may be completely virtual.

Companies who submit this initial budget for consideration may have an option included in their SBIR Phase I contract for I- Corps™ participation – however, this option is not a guarantee of funding unless and until the Government exercises the option at a later date. The Government may exercise the option in the event that the company is ultimately selected for I- Corps™ participation and funds are available.

The second step in the I-Corps™ application process will take place several months into Phase I project performance, when the Government will notify companies with the I-Corps™ contractual option and allow them the opportunity to prepare a brief application to be considered for I-Corps™ selection, subject to availability of funds. The estimated deadline for this application is early January 2023 and the application will consist of components such as those discussed below:

• Executive Summary of Predicate SBIR/STTR Phase I 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 Phase I project; description of next steps the company will take to advance the project toward commercialization.

https://sbir.cancer.gov/programseducation/icorps https://sbir.cancer.gov/programseducation/icorps/cohortcurriculum

Finally, after NIH/CDC reviews written I-Corps™ applications, it will conduct phone interviews to determine which companies will be invited to join the I-Corps™ cohort. The NIH/CDC awarding component selection committee will consider the ability of the proposed I-Corps™ effort to increase the overall success of the Phase I 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:

• In-person 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;

• In-person participation in all Closing Workshop lectures/sessions

• Final Lessons Learned team presentation; and,

• Team presentation of final video.

Information obtained through the above I-Corps™-related efforts must be incorporated into the Commercialization Plan component of the Phase I Final Report.

2.6 Grant Opportunity - Phase IIB Competing Renewal Awards and Commercialization Readiness Pilot (CRP) Program

(INFORMATION ONLY)

Phase IIB Competing Renewal Awards (NIH ONLY): Some NIH Institutes/Centers (ICs) offer Phase II SBIR/STTR awardees the opportunity to apply for Phase IIB Competing Renewal grant awards. Phase II contract awardees are eligible to apply for Phase IIB grants offered by those participating NIH ICs. The Phase II contract must be completed prior to award of a Phase IIB grant, although the Phase II contract need not be completed prior to application. Phase IIB Competing Renewal grant awards are available for those projects that require extraordinary time and effort, including those requiring regulatory approval or development complex instrumentation, clinical research tools, and behavioral interventions. NIH ICs that accept Phase IIB applications, either through the Omnibus SBIR/STTR grant funding opportunity announcements or other specific funding opportunity announcements, are listed in the PHS 2022 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. Additional requirements and instructions (e.g., submission of a letter of intent) are available in the specific IC research topics section and in the NIH Targeted Funding Opportunities that allow Phase IIB applications.

Commercialization Readiness Pilot (CRP) Program (NIH ONLY): Some NIH ICs offer Phase II SBIR/STTR awardees the opportunity to apply for the Commercialization Readiness Pilot (CRP) Program. The goal of the CRP is to facilitate the transition of previously funded SBIR/STTR Phase II/IIB projects to the commercialization stage by providing additional support for later stage technical assistance and, in some cases, research and development (R&D) not typically supported through Phase II or Phase IIB grants or contracts, often because they are normally outsourced to CROs. NIH ICs that accept CRP applications accept them through specific CRP funding opportunity announcements listed in NIH Targeted Funding Opportunities.

2.7 Awarding Components

The following awarding components are participating in this SBIR Solicitation for Contract Proposals.

National Institutes of Health (NIH) Components:

National Center for Advancing Translational Sciences (NCATS)

National Cancer Institute (NCI)

National Institute on Aging (NIA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Heart Lung and Blood Institute (NHLBI)

National Institute on Drug Abuse (NIDA) https://seed.nih.gov/sites/default/files/HHS_Program_Descriptions.pdf https://sbir.nih.gov/funding/individual-announcements https://sbir.nih.gov/funding/individual-announcements https://sbir.nih.gov/funding/individual-announcements

Centers for Disease Control and Prevention (CDC) Components:

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)

National Center for HIV, Viral Hepatitis, STD and TB Prevention (NCHHSTP)

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 (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 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.

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

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

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 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.

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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, 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.

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.

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.

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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.

(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.

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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.

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. 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 13 – 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.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-010.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

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.)

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