PHS2019-1_-_Rev._8.6.18_(Corrected).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 2019-1

Closing Date: October 22, 2018, 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 October 22, 2018, 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/sbir_pd_with_1-8-14_amendments_2-24-14.pdf to read the SBIR/STTR Policy Directive issued by the Small Business Administration for further information.

https://www.sbir.gov/sites/default/files/sbir_pd_with_1-8-14_amendments_2-24-14.pdf

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Table of Contents

1 INTRODUCTION

2 PROGRAM DESCRIPTION

2.1 Objectives

2.2 Three Phase Program

2.3 Fast Track Proposals (NIH Only)

2.4 Direct to Phase II Proposals

2.5 I-Corps™ at NIH

2.6 Grant Opportunity - Phase IIB Competing Renewal Awards (INFORMATION ONLY)

2.7 Awarding Components

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

5.8 Clinical Trial Registration and Results Information Submission

5.9 Single Institutional Review Board (sIRB)

5.10 Research Involving Recombinant or Synthetic Nucleic Acid (Including Human Gene Transfer Research) 27

5.11 Copyrights

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5.12 Technical Data Rights

5.13 Patents and Invention Reporting

5.14 Salary Rate Limitation

5.15 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 (NIH Only – For Fast Track Submissions)

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 Data and Safety Monitoring in Clinical Trials

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

8.12.8 Plan for Single Institutional Review Board (sIRB)

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

Transfer Research)

8.12.10 Human Stem Cell Research

8.13 Content of the Pricing Proposal (Item Two)

8.14 Reminders

9 SUMMARY OF HHS COMPONENTS ANTICIPATED NUMBER OF AWARDS

10 CONTRACTING OFFICER POINTS OF CONTACT FOR QUESTIONS RELATED TO SPECIFIC TOPICS 62

11 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES

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12 COMPONENT INSTRUCTIONS AND TECHNICAL TOPIC DESCRIPTIONS

National Institutes of Health

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

Centers for Disease Control and Prevention (CDC)

Center for Global Health (CGH) National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) National Center for Emerging Zoonotic and Infectious Diseases (NCEZID) National Center for Environmental health (NCEH) Office of Public Health Preparedness and Response (OPHPR)

13 APPENDICES

1 INTRODUCTION

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) invite small business concerns 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.

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. Other Topics allow for ‘Fast Track’ submissions, which include both a complete Phase I proposal and a complete Phase II proposal. For more information on the three-phase program and the Fast Track process, refer to Section 2.

TOPIC NUMBER PHASE I

PROPOSAL

ALLOWED?

FAST TRACK

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

TOPIC TITLE

NIH/NCATS 016 Yes No Synthetic Technologies for Advancement of Research and Therapeutics (START)

NIH/NCATS 017 Yes No Universal Medium/Blood Mimetic for Use in Integrated Organs-on-Chips

NIH/NCATS 018 Yes No Non-PDMS Biocompatible Alternatives for Organs-On- Chips

NIH/NCI 382 Yes Yes Integrated Subcellular Microscopy and ‘Omics in Cancer Cell Biology

NIH/NCI 383 Yes Yes Smart, Multi-Core Biopsy Needle

NIH/NCI 384 Yes Yes Digital Healthcare Platform to Reduce Financial Hardship for Cancer Patients

NIH/NCI 385 Yes Yes Leveraging Connected Health Technologies to Address and Improve Health Outcomes of Long-Term Cancer Survivors

NIH/NCI 386 Yes Yes Novel Approaches for Local Delivery of Chemopreventive Agents

NIH/NCI 387 Yes Yes Multiplexed Preclinical Tools for Longitudinal Characterization of Immunological Status in Tumor and its Microenvironment

NIH/NCI 388 Yes Yes In vitro Diagnostic for the Liver Flukes Opisthorchis viverrini and Clonorchis sinensis

NIH/NCI 389 Yes No Development of Artificial Intelligence (AI) Tools to Understand and Duplicate Experts’ Radiation Therapy Planning for Prostate Cancer

NIH/NCI 390 Yes Yes Clonogenic High-Throughput Assay for Screening Anti- Cancer Agents and Radiation Modulators

NIH/NCI 391 Yes Yes Drugs or Devices to Exploit the Immune Response Generated by Radiation Therapy

NIH/NCI 392 No Yes Clinical Trials of Systemic Targeted Radionuclide Therapies

NIH/NCI 393 Yes Yes Sensing Tools to Measure Biological Response to Radiotherapy

TOPIC NUMBER PHASE I

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

TOPIC TITLE

NIH/NCI 394 Yes Yes Combinatory Treatment Modalities Utilizing Radiation to Locally Activate or Release Systemically Delivered Therapeutics

NIH/NCI 395 Yes Yes Targeted Therapy for Cancer- and Cancer Therapy-Related Cachexia

NIH/NCI 396 Yes Yes Imaging for Cancer Immunotherapies

NIH/NHLBI 106 Yes Yes Active MRI Needle

NIH/NHLBI 107 Yes Yes Transcatheter Potts Shunt

NIH/NHLBI 108 Yes Yes Device System for Transcatheter Repair of Postinfarction Ventricular Septal Defect

NIH/NIAAA 016 No Yes A Wearable Alcohol Biosensor that Quantifies Blood Alcohol Concentration in Real Time

NIH/NIAAA 017 Yes No Data Science Tools for Alcohol Research

NIH/NIAID 063 Yes Yes In Vivo Targeted Degradation of HIV Proteins

NIH/NIAID 064 Yes Yes Particle-Based Delivery of HIV Env Immunogens

NIH/NIAID 065 Yes Yes Co-Delivery and Formulation of Adjuvants for HIV Vaccines

NIH/NIAID 066 Yes Yes Effective Targeted Delivery of RNA-based Vaccines and Therapeutics

NIH/NIAID 067 Yes Yes Methods Improving HIV Protein Expression: Cell Substrate and Protein Purification

NIH/NIAID 068 Yes Yes Reagents for Immunologic Analysis of Non-mammalian and Underrepresented Mammalian Models

NIH/NIAID 069 Yes No B Cell Receptor and T Cell Receptor Repertoire Computational Tools

NIH/NIAID 070 Yes No Development of Sample Sparing Assay

NIH/NIAID 071 Yes Yes Adjuvant Discovery for Vaccines and for Autoimmune and Allergic Diseases

NIH/NIAID 072 Yes Yes Adjuvant Development for Vaccines and for Autoimmune and Allergic Diseases

NIH/NIAID 073 Yes Yes Mobile Health Point-of-Care Diagnostics

NIH/NIAID 074 Yes Yes Development of POC Assays to Quantify anti-Tuberculosis Antibiotics in Blood

NIH/NIAID 075 Yes Yes POC Diagnostic for Gonorrhea and Determination of Antimicrobial Susceptibility

TOPIC NUMBER PHASE I

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

TOPIC TITLE

NIH/NIDA 165 Yes Yes

DEA-Compliant Drug Detection and Deactivation Technology to Deter Opioid Theft in Hospitals for Next Generation Controlled Substance Diversion Prevention Program (CSDPP)

NIH/NIDA 166 Yes Yes Leveraging Health IT Solutions to Combat Opioid Misuse

CDC/CGH 010 Yes No Multiplex Detection of Recent and Prior Exposure to Pathogens

CDC/CGH 011 Yes No Preservation of Supply Quality During Unmanned Aerial Vehicle (UAV) Transport

CDC/CGH 012 Yes No Improving Global Health with a Novel Handheld Counterfeit Drug Identifier

CDC/NCCDPHP 041 Yes No Community Based Worksite Wellness App Linking Employees to Wellness Resources

CDC/NCCDPHP 042 Yes No Objective Measurement of Opioid Withdrawal in Newborns

CDC/NCEZID 020 Yes No Novel Coatings/Surfaces on Indwelling Medical Devices to Prevent Biofilms

CDC/NCEH 01 Yes No Rapid Field Test to Improve Swimming Pool Water/Air Quality

CDC/OPHPR 03 Yes No Rapid Test for Simultaneous Detection of Influenza (types A and B) and Streptococcus (Group A)

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 Phase III. 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 February 24, 2014. 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 Three Phase Program

The SBIR program consists of three 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

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.

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 Phase III project, it is sufficient to state for purposes of a Justification and Approval pursuant to FAR 6.302-5 that the project is a SBIR Phase III award that 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).

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

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 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 SBC 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

This solicitation will not accept Direct Phase II proposals. The congressional authority for Direct to Phase II proposals has expired.

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, NHLBI, NIAAA, NIAID, 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 $50,000 (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 I-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) https://venturewell.org/i-corps/nodes-and-sites/

• Program Director/Principal Investigator (PD/PI) (or, 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 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. 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), 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 $50,000 in total direct costs – indirect costs may not be included. Of that amount, $20,000 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 20 hours per week for 8 weeks for the 3 team member roles discussed above – as well as travel costs 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 2020 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 from April 6, 2020 to May 29, 2020 with travel to Los Angeles, California for a workshop April 6-9, 2020 and travel to Bethesda, Maryland for a workshop May 28-29, 2020.

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 2020 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 https://sbir.cancer.gov/programseducation/icorps https://sbir.cancer.gov/programseducation/icorps/cohortcurriculum 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.

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 (INFORMATION 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 in the R&D phase and may or may not require FDA approval for the development of such projects, including drugs, devices, vaccines, therapeutics, and medical implants related to the mission of the IC. Some ICs have announced this opportunity through the NIH Guide for Grants and Contracts (see link below), and some are using this Omnibus SBIR/STTR Grant Solicitation. Prospective applicants are strongly encouraged to contact NIH staff prior to submitting an application. Additional requirements and instructions (e.g., submission of a letter of intent) are available in the specific IC research topics section and in the specific IC Program Funding Opportunity Announcements.

The following NIH ICs will accept applications for Phase IIB Competing Renewal awards: NIA, NIAAA, NIAID (SBIR only), NICHD (SBIR only and only Competing Renewals of NICHD-supported Phase II awards), NIDA (SBIR only), NIDCD, NIDDK (only Competing Renewals of NIDDK-supported Phase II awards), NEI (SBIR only), NIGMS (SBIR only), NIMH (SBIR only), NCATS (SBIR only and only Competing Renewals of NCATS-supported Phase II awards), and ORIP (SBIR only and only Competing Renewals of ORIP-supported Phase II awards). NCI offers Phase IIB opportunities that focus on the commercialization of SBIR-developed technologies. Contact the NCI SBIR Development Center at 301-594- 7709, NCISBIR@mail.nih.gov for additional information. NHLBI offers Phase IIB Competing Renewals that focus on the commercialization of technologies requiring regulatory approval through the NHLBI Phase IIB Bridge Awards and the Phase IIB Small Market Awards: https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/small-business-program. Contact Gary Robinson, Ph.D., at gary.robinson@nih.gov for additional information. NINDS accepts Phase IIB SBIR/STTR Competing Renewal applications through specific opportunities that focus on the commercialization of SBIR and STTR developed technologies. These opportunities can be found on the NINDS Funding Opportunities webpage:

http://grants.nih.gov/grants/funding/sbir_announcements.htm mailto:NCISBIR@mail.nih.gov https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/small-business-program https://www.nhlbi.nih.gov/grants-and-training/funding-opportunities-and-contacts/small-business-program mailto:gary.robinson@nih.gov https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities Contact Stephanie Fertig, M.B.A., at fertigs@ninds.nih.gov for additional information.

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 Heart, Lung, and Blood Institute (NHLBI)

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute on Drug Abuse (NIDA)

Centers for Disease Control and Prevention (CDC) Components:

Center for Global Health (CGH)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP)

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)

National Center for Environmental Health (NCEH)

Office of Public Health Preparedness and Response (OPHPR) https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities mailto:fertigs@ninds.nih.gov

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, Phase II, or Phase III award.

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.

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

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

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

Fraud, Waste, and Abuse.

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

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

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

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

Funding Agreement Officer. A contracting officer, 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.

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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 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 Phase III 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.

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(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.

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.

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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.

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:

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

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

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

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

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

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html http://www.hhs.gov/ohrp/policy/cdebiol.html

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

○ Advances in controls, sensors, networks, and other information technologies that improve the quality and productivity of…