PHS2017-1.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 2017-1

Closing Date: October 21, 2016, 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 21, 2016, 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

Page ii

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 (NIH Only)

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

2.6 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 Multiple Principal Investigators

4.4 Joint Ventures and Limited Partnerships

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

4.6 Conflicts of Interest

4.7 Market Research

4.8 OMB Clearance

4.9 Research Involving Human Subjects

4.10 Inclusion of Women, Minorities, and Children in Clinical Research

4.11 Care of Vertebrate Animals

4.12 Research Involving Recombinant or Synthetic Nucleic Acid Molecules

4.13 Debriefing

4.14 Phase I Award Information

4.15 Phase II Award Information (For Fast Track and Direct to Phase II Proposals)

4.16 Registrations and Certifications

4.17 Promotional Materials

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

4.19 Fraud and False Statements

4.20 State and Other Assistance Available

4.21 Payment

4.22 Proprietary Information

4.23 Identification and Marking of SBIR Technical Data in Proposals

5 CONTRACT REQUIREMENTS

5.1 Other Contract Requirements

5.2 Human Subjects Contract Requirements

5.3 Vertebrate Animals Contract Requirements

5.4 NIH Policy on Enhancing Reproducibility Through Rigor and Transparency

5.5 Copyrights

5.6 Technical Data Rights

5.7 Patents and Invention Reporting

Page iii

6 METHOD OF EVALUATION

6.1 Evaluation Process

6.2 Phase I Technical Evaluation Criteria

6.3 Phase II Technical Evaluation Criteria

6.4 Award Decisions

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 Human Subjects Research and Protection from Risk

8.11 Inclusion of Women, Minorities, and Children in Clinical Research

8.11.1 Additional Instructions and Requirements When NIH-Defined Phase III Clinical Trials Are Proposed

8.12 Instructions for Completing the PHS Inclusion Enrollment Report(s) for Sex/Gender, Race, and Ethnicity 55

8.12.1.1 When Completing each PHS Inclusion Enrollment Report(s) provide the following information: 55

8.13 Research Involving Human Fetal Tissue

8.14 Research Involving Vertebrate Animals

8.15 Dual Use Research of Concern

8.16 Content of the Pricing Proposal (Item Two)

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

Centers for Disease Control and Prevention (CDC)

National Center for Chronic Disease and Health Promotion (NCCDPHP)

Page iv

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)

11 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES

12 COMPONENT INSTRUCTIONS AND TECHNICAL TOPIC DESCRIPTIONS

National Institutes of Health

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

Centers for Disease Control and Prevention (CDC)

National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP) National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)

13 APPENDICES

APPENDIX A — PROPOSAL COVER SHEET - USE FOR PHASE I AND FAST-TRACK PROPOSALS

APPENDIX B — ABSTRACT OF RESEARCH PLAN - USE FOR PHASE I, PHASE II, AND FAST-TRACK

PROPOSALS

APPENDIX C — PRICING PROPOSAL - USE FOR PHASE I, PHASE II AND FAST-TRACK PROPOSALS 140 APPENDIX D — PHASE II TECHNICAL PROPOSAL COVER SHEET - USE FOR PHASE II AND FAST-

TRACK PROPOSALS

APPENDIX E — STATEMENT OF WORK SAMPLE FORMAT - USE FOR PHASE II AND FAST-TRACK

PROPOSALS

APPENDIX F — SUMMARY OF RELATED ACTIVITIES - USE FOR PHASE I, PHASE II AND FAST-

TRACK PROPOSALS

APPENDIX G — PROPOSAL SUMMARY AND DATA RECORD - USE FOR PHASE II AND FAST-TRACK

PROPOSALS

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. 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 three phrase program and the Fast Track and Direct to Phase II processes, refer to Section 2.

TOPIC

NUMBER

PHASE I

PROPOSAL

ALLOWED?

(Includes only a Phase I Proposal)

FAST TRACK

PROPOSAL

ALLOWED?

(Includes a Phase I Proposal and a

Phase II Proposal)

DIRECT TO

PHASE II

ALLOWED?

(Includes only a Phase II Proposal)

TOPIC TITLE

NIH/NCI 355 Yes Yes Yes Cell and Animal-Based Models to Advance Cancer Health Disparity Research

NIH/NCI 356 Yes No No Tools and Technologies for Monitoring RNA

NIH/NCI 357 Yes Yes Yes Innovative Tools for Interrogating Tumor Microenvironment Dynamics

NIH/NCI 358 Yes No No Modulating the Microbiome to Improve Therapeutic Efficacy of Cancer Therapeutics

NIH/NCI 359 Yes No No Technologies for Differential Isolation of Exosomes and Oncosomes

NIH/NCI 360 Yes Yes No Manufacturing Innovation for the Production of Cell- Based Cancer Immunotherapies

NIH/NCI 361 Yes No No Highly Innovative Tools for Quantifying Redox Effector Dynamics in Cancer

NIH/NCI 362 Yes Yes No Informatics Tools to Measure Cancer Care Coordination

NIH/NCI 363 Yes Yes No Connecting Cancer Caregivers to Care Teams:

Digital Platforms to Support Informal Cancer Caregiving

NIH/NCI 364 Yes Yes No Methods and Software for Integration of Cancer Metabolomic Data with Other –Omic and Imaging Data

NIH/NCI 365 Yes Yes No Imaging Informatics Tools and Resources for Clinical Cancer Research

NIH/NCI 366 Yes No No Clonogenic High-Throughput Assay for Screening Anti-Cancer Agents and Radiation Modulators

NIH/NCI 367 Yes Yes No Predictive Biomarkers to Improve Radiation Treatment

TOPIC

NUMBER

PHASE I

PROPOSAL

ALLOWED?

(Includes only a Phase I Proposal)

FAST TRACK

PROPOSAL

ALLOWED?

(Includes a Phase I Proposal and a

Phase II Proposal)

DIRECT TO

PHASE II

ALLOWED?

(Includes only a Phase II Proposal)

TOPIC TITLE

NIH/NCI 368 Yes Yes No Molecularly Targeted Radiation Therapy for Cancer Treatment

NIH/NCI 369 Yes Yes No Development of Pediatric Cancer Drug Delivery Devices

NIH/NCATS

015 Yes No No Development of a Drone to be used in Laboratory

Automation Projects

NIH/NHLBI

098 No Yes Yes

Testing and Validation of Technologies for Inclusion in the CART Demonstration Project for Collaborative Aging Research

NIH/NHLBI

099 Yes Yes No Inhalational 5A Apolipoprotein A-I Mimetic Peptide for the Treatment of Asthma (SBIR-TT)

NIH/NHLBI

100 Yes Yes Yes MRI Myocardial Needle Chemoablation Catheter

NIH/NHLBI

101 Yes Yes Yes Membranous Ventricular Septal Defect (pmVSD)

Transcatheter Occluder System

NIH/NHLBI

102 Yes Yes Yes Transcatheter Occluder Device for Paravalvular

Leaks

NIH/NIAID

040 Yes No Yes Effective Targeted Delivery of RNA-based Vaccines and Therapeutics

NIH/NIAID

041 Yes Yes No Simplified Sequencing for TB Drug Resistance

Testing

NIH/NIAID

042 Yes No Yes Qualitative HIV RNA Home Test

NIH/NIAID

043 Yes No Yes Adjuvant Development

NIH/NIAID

044 Yes No Yes Vaccine Adjuvant Screening and Discovery

NIH/NIAID

045 Yes No Yes Database Resources Integration

NIH/NIAID

046 Yes Yes Yes Rapid Point-of-Care Diagnostics to Detect Serologic

Status of Individuals for Select Viral Infections

NIH/NIAID

047 Yes Yes Yes Development of Microbiome-based Products for

Infectious Diseases

NIH/NIAID

048 Yes Yes Yes Non-Invasive Rapid Diagnostics for Respiratory

Diseases in Children

TOPIC

NUMBER

PHASE I

PROPOSAL

ALLOWED?

(Includes only a Phase I Proposal)

FAST TRACK

PROPOSAL

ALLOWED?

(Includes a Phase I Proposal and a

Phase II Proposal)

DIRECT TO

PHASE II

ALLOWED?

(Includes only a Phase II Proposal)

TOPIC TITLE

NIH/NIAID

049 Yes Yes Yes Phage-based Diagnostic Platforms for Rapid

Detection of Bacterial Pathogens

NIH/NIDA 161 Yes No No Virtual Reality Tools to Enhance Evidence Based Treatment of Substance Use Disorders

NIH/NIDA 162 Yes Yes Yes Analytical Tools and Approaches for (Multidimensional) Scholarly Research Assessment and Decision Support in the Biomedical Enterprise.

CDC/

NCCDPHP 038 Yes No No Improve Contextual Awareness using Social

Network Data

CDC/

NCEZID 014 Yes No No Multiplexed Digital Counting of Single Molecules for Advanced Molecular Diagnosis

All firms that are awarded Phase I contracts originating from this solicitation will be eligible to participate in Phases II and III. HHS Components 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 Component instructions. The details on the due date, content, and submission requirements of the Phase II proposal will be provided by the awarding HHS 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, and 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.

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, where appropriate, 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 involve follow-on, non-SBIR funded R&D, or production contracts for products or processes intended for use by the U.S.

Government.

The competition for SBIR Phase I and Phase II awards satisfies any competition requirement of the Armed Services Procurement Act, the Federal Property and Administrative Services Act, and the Competition in Contracting Act. Therefore, an agency that wishes to fund an SBIR Phase III project is not required to conduct another competition in order to satisfy those statutory provisions. As a result, in conducting actions relative to a Phase III SBIR award, 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).

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.

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/

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".

2.3 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 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 an 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 (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 funding sources (not SBIR/STTR Phase I funding) may submit a Phase II only proposal. Direct to Phase II awards allow a SBC 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 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. These 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. Only those small business concerns who have been awarded a Phase II are eligible to apply for a Phase IIB Competing Renewal award.

Prospective applicants are strongly encouraged to contact NIH staff prior to submission. 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, NIDCD, NIDDK (only Competing Renewals of NIDDK-supported Phase II awards), NEI (SBIR only), NIGMS (SBIR only), NIMH (SBIR only), NCATS (SBIR only), and ORIP (SBIR only). NCI offers Phase IIB opportunities that focus on the commercialization of SBIR-developed technologies. Contact the NCI SBIR Development Center at 240-276-5300 or 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 Bridge Award (RFA-HL-16-009) and the NHLBI Small Market Award (RFA-HL-17-012). Contact Jennifer Shieh, Ph.D., at 301-496-2149 or jennifer.shieh@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 SBIR webpage: http://www.ninds.nih.gov/funding/small-business/small_business_funding_opportunities.htm. Contact Stephanie Fertig, M.B.A., at 301-496-1779 or fertigs@ninds.nih.gov for additional information.

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 http://grants.nih.gov/grants/funding/sbir_announcements.htm http://grants.nih.gov/grants/funding/sbir_announcements.htm mailto:NCISBIR@mail.nih.gov http://1.usa.gov/1q9yTyP mailto:RFA-HL-17-012 mailto:jennifer.shieh@nih.gov http://www.ninds.nih.gov/funding/small-business/small_business_funding_opportunities.htm mailto:fertigs@ninds.nih.gov

2.6 Awarding Components

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

National Institutes of Health (NIH) Components:

National Cancer Institute (NCI)

National Center for Advancing Translational Sciences (NCATS)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Allergy and Infectious Diseases (NIAID)

National Institute on Drug Abuse (NIDA)

Centers for Disease Control and Prevention (CDC) Components:

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

National Center for Emerging Zoonotic and Infectious Diseases (NCEZID)

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, grantees 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 http://www.ecfr.gov/cgi-bin/text-idx?SID=b02d16dbfcddf646e5c0728d5e632a61&mc=true&node=se13.1.121_1103&rgn=div8 http://www.ecfr.gov/cgi-bin/text-idx?SID=b02d16dbfcddf646e5c0728d5e632a61&mc=true&node=se13.1.121_1103&rgn=div8 https://www.sbir.gov/ http://www.sba.gov/size agencies for review and funding consideration; or work where a specific research objective and the research design for accomplishing the objective are the same or closely related to another proposal or award, regardless of the funding source.

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

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

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

Fraud, Waste, and Abuse.

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

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

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

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

Funding Agreement Officer. A contracting officer, 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.

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 Individual. The principal investigator/project manager and any other person named as a “key” employee in a proposal submitted in response to a program solicitation.

http://www.gpo.gov/fdsys/granule/USCODE-2011-title5/USCODE-2011-title5-partI-chap1-sec102/content-detail.html http://www.ecfr.gov/cgi-bin/text-idx?SID=fc49fc7e1268cd0891cc2dde9abe523f&mc=true&node=se13.1.121_1103&rgn=div8

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. Announcements in the Federal Register or the GPE are not considered an SBIR Program solicitation.

Proprietary Information. Proprietary information is information that you provide which constitutes a trade secret, proprietary commercial or financial information, confidential personal information or data affecting the national security.

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.

Senior/Key Personnel. The PD/PI and other individuals who contribute to the scientific development or execution of the project in a substantive, measurable way, whether or not salaries or compensation are requested under the contract.

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

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

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

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

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

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

and, the management and daily business operations of which are controlled (as defined at 13 CFR 124.106) by individuals who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

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

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

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.

HHS Regulations (45 CFR part 46, Subpart D, Sec.401-409) provide additional protections for children involved as subjects in research, based on this definition: "Children are persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted."

Generally, state laws define what constitutes a “child.” Consequently, the age at which a child's own consent is required and sufficient to participate in research will vary according to state law. For example, some states consider a person age 18 to be an adult and therefore one who can provide consent without parental permission.

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

(1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.

http://www.ecfr.gov/cgi-bin/text-idx?SID=ddf55574cd923f5ebaefd02bf517d956&mc=true&node=se13.1.124_1103&rgn=div8 http://www.ecfr.gov/cgi-bin/text-idx?SID=ddf55574cd923f5ebaefd02bf517d956&mc=true&node=se13.1.124_1104&rgn=div8 http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-010.html http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual.

Patient-oriented research includes:

(a) mechanisms of human disease,

(b) therapeutic interventions,

(c) clinical trials, or

(d) development of new technologies.

(2) Epidemiologic and behavioral studies.

(3) Outcomes research and health services research. Note: Studies falling under Exemption 4 for human subjects research are not considered clinical research by this definition.

Clinical Trial. The NIH defines a clinical trial as a research study1 in which one or more human subjects2 are prospectively assigned3 to one or more interventions4 (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes5.

1 See Common Rule definition of research at 45 CFR 46.102(d).

2 See Common Rule definition of human subject at 45 CFR 46.102(f).

3 The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

4 An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

5 Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status, or quality of life.

Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and positive or negative changes to quality of life.

For additional information see NOT-OD-15-015.

○ Phase I clinical trials test a new biomedical intervention in a small group of people (e.g., 20-80) for the first time to evaluate safety (e.g., to determine a safe dosage range and to identify side effects).

○ Phase II clinical trials study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and to further evaluate its safety.

○ Phase III studies investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html

○ Phase IV studies are conducted after the intervention has been marketed. These studies are designed to monitor effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

○ NIH-Defined Phase III Clinical Trial. For the purpose of the Guidelines an NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.

Data and Safety Monitoring Plan. For each clinical trial, NIH requires a data and safety monitoring plan that will provide oversight and monitoring to ensure the safety of participants and the validity and integrity of the data. The level of monitoring should be commensurate with the risks and the size and complexity of the clinical trial. A detailed data and safety monitoring plan must be submitted to the contractor’s IRB and subsequently to the funding IC for approval prior to the accrual of human subjects. Adverse Events must be reported to the IRB, the NIH funding Institute or Center, and other required entities. This policy requirement is in addition to any monitoring requirements imposed by 45 CFR part 46.

Data and Safety Monitoring Board (DSMB). NIH requires the establishment of a Data and Safety Monitoring Board (DSMB) for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for Phase III clinical trials.

Human Subjects. The HHS regulations “Protection of Human 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 21Code of Federal Regulations (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:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

A key to decipher the code exists, enabling linkage of the identifying information with the private information or specimens.

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

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

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

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

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

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

1. A systematic, intensive study directed toward greater knowledge or understanding of the subject studied;

2. A systematic study directed specifically toward applying new knowledge to meet a recognized need; or

3. A systematic application of knowledge toward the production of…