2021-NIST-SBIR-02 NOFO 4.7.2021.pdf

FY 2021 NIST Small Business Innovation Research Program Phase II

Notice of Funding Opportunity April 7, 2021

FY 2021

Small Business Innovation Research (SBIR) Program Phase II

Notice of Funding Opportunity (NOFO)

ANNOUNCEMENT

FUNDING OPPORTUNITY NUMBER: 2021-NIST-SBIR-02

Catalog of Federal Domestic Assistance (CFDA) Number:

11.620, Science, Technology, Business and/or Education Outreach

U.S. DEPARTMENT OF COMMERCE

National Institute of Standards and Technology

Opening Date of NOFO: April 7, 2021

Closing Date: June 7, 2021 http://www.nist.gov/sbir http://www.nist.gov/sbir

TABLE OF CONTENTS

1.0 PROGRAM DESCRIPTION AND FEDERAL AWARD INFORMATION …………………………………………… 5

1.01 Introduction

1.02 Three-Phase Program

1.03 SBIR Applicant Eligibility and Limitations

1.04 Contact with NIST

1.05 Definitions

1.06 Fraud, Waste and Abuse ………………………………………………………………………………………………….16

1.07 Other Information ………………………………………………………………………………………………………..…18

2.0 CERTIFICATIONS ………………………………………………………………………………………………………………. 19

2.01 Funding Agreement Certification ………………………………………………………………………………….…19

2.02 Research Activities Involving Human Subjects, Human Tissue, Data or Recordings Involving Human Subjects Including Software Testing …………………………………………………………………………. 19

2.03 Research Applications Involving Live Vertebrate Animals or Pre-Existing Cell Lines/Tissues from Vertebrate Animals

3.0 APPLICATION PREPARATION INSTRUCTIONS AND REQUIREMENTS

3.01 Phase II Application Requirements

3.02 Phase II Application

4.0 METHOD OF SELECTION AND EVALUATION CRITERIA

4.01 Introduction

4.02 Phase II Screening Criteria

Notice of Funding Opportunity

4.03 Phase II Evaluation Criteria

4.04 Phase II Award Selections

5.0 CONSIDERATIONS

5.01 Awards

5.02 Reporting Requirements

5.03 Payment Schedule

5.04 Innovations, Inventions and Patents

5.05 Cost Sharing

5.06 Profit or Fee

5.07 Joint Ventures or Limited Partnerships

5.08 Research and Analytical Work

5.09 Awardee Commitments

5.10 Summary Statements

5.11 Additional Information

5.12 Technical and Business Information (TABA)……………………………………………………………………..53

5.13 Technical Assistance for Application Preparation and Project Conduct

6.0 SUBMISSION OF APPLICATIONS

6.01 Deadline for Applications

6.02 Address to Request Application Package

6.03 Application Submission

Notice of Funding Opportunity April 7, 2021

7.0 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES

8.0 SUBMISSION FORMS AND CERTIFICATIONS

8.01 Required Forms and Documents

8.02 Attachment of Required Application Documents

8.03 Verifying the Submission and Tracking the Application ……………………………………………………66

8.04 Unique Entity Identifier and System for Award Management (SAM)………………………………. 66

9.0 RESEARCH AREAS ……………………………………………………………………………………………………………...67

Appendix A. COVER SHEET

Appendix B. CERTIFICATIONS

Notice of Funding Opportunity April 7, 2021

US DEPARTMENT OF COMMERCE

NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

FY 2021 SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM

PHASE II NOTICE OF FUNDING OPPORTUNITY (NOFO)

1.0 PROGRAM DESCRIPTION AND FEDERAL AWARD INFORMATION

1.01 Introduction

The National Institute of Standards and Technology (NIST) invites FY 2020 NIST SBIR Phase I awardees to submit Phase II research applications under this Notice of Funding Opportunity (NOFO). Only FY 2020 NIST SBIR Phase I awardees are eligible to submit applications in response to this NOFO for Phase II of their projects.

The Small Business Innovation Research (SBIR) program was originally established in 1982 by the Small Business Innovation Development Act (P.L. 97-219), codified at 15 U.S.C. § 638.

It was then expanded and extended by the Small Business Research and Development (R&D) Enhancement Act of 1992 (P.L. 102-564), and received subsequent reauthorization and extensions, the most recent of which extends the SBIR program through 2022. (P.L.

114-328).

Eleven Federal agencies implement SBIR by setting aside a portion of their extramural research and development budget each year to fund research applications from small science and technology-based firms. The statutory purpose of the SBIR Program is to strengthen the role of innovative small business concerns (SBCs) in Federally-funded research or research and development (R/R&D). Specific program goals are to:

(1) stimulate technological innovation; (2) use small business to meet Federal R/R&D needs;

(3) foster and encourage participation by socially and economically disadvantaged small businesses and by women-owned small businesses in technological innovation; and (4) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity, and economic growth.

The NIST FY 2021 SBIR program identifies and solicits applications in topics that fall within NIST’s mission and allow collaboration between NIST scientists and the SBIR awardees whenever possible.

When reviewing applications, NIST gives high priority to SBCs that participate in or conduct energy efficiency or renewable energy system R&D projects, consistent with Executive

Notice of Funding Opportunity April 7, 2021

Order (EO) 13329 (http://www.gpo.gov/fdsys/pkg/FR-2004-02-26/pdf/04-4436.pdf) “Encouraging Innovation in Manufacturing,” the Energy Independence and Security Act of 2007 (P.L. 110-140 § 1203(e), codified at 15 U.S.C. § 638(z)), and the Small Business Administration (SBA) Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Program Policy Directive, § 9.

For any SBIR award that requires a license to use a NIST-owned invention covered by a patent or patent application, the SBIR awardee will need to contact NIST’s Technology Partnerships Office for a license to use the NIST-owned invention. Such awardees will be granted a non-exclusive research license and will be given the opportunity to negotiate a non-exclusive or an exclusive commercialization license to the NIST-owned invention, in accordance with the Federal patent licensing regulations, set forth in 37 C.F.R. Part 404, and to the extent that such NIST-owned invention is available for licensing and has not otherwise been exclusively licensed to another party. It is the goal of this program to position the SBIR awardee to use and build upon such licensed NIST-owned invention with the awardee’s own innovation to develop a commercially viable product based on the NIST-owned invention.

1.02 Three-Phase Program

The SBIR statute (15 U.S.C. § 638) requires the Department of Commerce to establish a three-phase SBIR program by reserving a percentage of its extramural R&D budget to be awarded to SBCs for innovation research. SBIR policy is provided by the SBA through the SBIR/STTR Policy Directive.

The funding vehicles for NIST’s SBIR program in both Phase I and Phase II are cooperative agreements. NIST’s authority to implement its SBIR program through cooperative agreements is 15 U.S.C. § 272(b)(4). NIST programmatic authorities for the research areas listed in this NOFO are found at 15 U.S.C. § 272(b) and (c). The nature of NIST’s “substantial involvement” will generally be collaboration with the awardees in carrying out the projects’ approved scope of work. Grants and agreements administrative requirements set forth at 2 C.F.R. Part 200 will apply to NIST SBIR awards.

1.02.01 Phase I - Feasibility Research

The purpose of Phase I is for NIST to determine the technical feasibility of the research, preliminary commercialization merit of the proposed effort, and the quality of the awardee’s performance. The application should concentrate on describing research that http://www.gpo.gov/fdsys/pkg/FR-2004-02-26/pdf/04-4436.pdf http://www.gpo.gov/fdsys/pkg/FR-2004-02-26/pdf/04-4436.pdf https://www.sbir.gov/sites/default/files/SBA_SBIR_STTR_POLICY_DIRECTIVE_OCT_2020_0.pdf https://www.sbir.gov/sites/default/files/SBA_SBIR_STTR_POLICY_DIRECTIVE_OCT_2020_0.pdf

Notice of Funding Opportunity April 7, 2021 will significantly contribute to proving the feasibility of the proposed Phase II research and commercialization potential, prerequisites to receiving further support in Phase II.

Each Phase I award is for up to $100,000 and up to a six (6) month period of performance. Up to an additional $6,500 may be requested for Technical and Business Assistance (TABA); see Section 5.12 for more information about TABA.

This NOFO is not soliciting applications for Phase I research.

1.02.02 Phase II - Research and Development

This NOFO provides an opportunity to all NIST FY 2020 SBIR I awardees to submit a Phase II application following the completion of Phase I. This NOFO provides instructions for FY 2021 NIST SBIR Phase II application preparation and submission requirements.

In Phase II, work from Phase I that exhibits potential for commercial application is further developed. Phase II is the R&D or prototype development phase. To apply for a Phase II award, each Phase I awardee will be required to submit a comprehensive application outlining the proposed research and a detailed plan to commercialize the final product.

Each NIST Phase II award is for up to $400,000 and up to a 24-month period of performance. One year after completing the Phase II R&D activity, the awardee shall be required to report on its commercialization activities.

1.02.03 Phase III - Commercialization

Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. Phase III work is typically oriented towards commercialization of SBIR research or technology and may be for products, production, services, R/R&D or a combination thereof.

1.02.04 Commercialization Readiness Pilot Program

As allowed in Section 5123 of the SBIR/STTR Reauthorization Act of 2011, Division E of Pub.

L. 112-81, codified in 15 U.S.C. § 638(gg), NIST has received authorization to establish a Commercialization Readiness Pilot Program (CRPP). NIST may provide follow-on funding (up to an additional $100,000) to selected awardees after completion of Phase II. The funding would be used to further develop Phase II technologies, to support advancement toward Phase III, and to increase the likelihood of commercialization. NIST is under no obligation to make any CRPP awards.

Notice of Funding Opportunity

1.03 SBIR Applicant Eligibility and Limitations

1.03.01 Applicant Qualifications

Under this NOFO, only FY 2020 NIST SBIR Phase I awardees are eligible to submit applications.

Applications received from entities other than FY 2020 NIST SBIR Phase I awardees will not be reviewed or considered for award. Each applicant must qualify as an SBC for R/R&D purposes, as defined in Section 1.05 of this NOFO, at the time of award. In addition, the primary employment of the principal investigator must be with the small business at the time of the award and during the conduct of the proposed research. Primary employment means that more than one-half of the principal investigator's time is spent working with the small business. Primary employment with a small business precludes full-time employment with another organization. Occasionally, deviations from this requirement may occur, which must be approved in writing by the NIST Grants Officer after consultation with the SBIR Program Manager. Further, a small business may only replace the principal investigator on an SBIR Phase II award if the NIST Grants Officer provides prior written approval. Personnel obtained through a Professional Employer Organization or other similar personnel leasing company may be considered employees of the awardee.

The R/R&D work must be performed in the United States. Requests for an exemption must be submitted in writing at the time of application submission. Only rare and unique circumstances will be considered for an exemption. The NIST Grants Officer must approve each exemption and its terms in writing.

NIST has elected to not use the authority that would allow venture capital operating companies (VCOCs), hedge funds or private equity firms to participate in the SBIR Program.

Therefore, applications in which work would be performed by VCOCs will not be considered for award.

For Phase II, a minimum of one-half of the research and/or analytical effort must be performed by the awardee. The total cost for all consultant fees, facility leases, usage fees, and other subcontract/subaward or purchase agreements, excluding funds requested for TABA (see Section 5.12), may not exceed one-half of the total award.

Each applicant will be required to provide certain information via www.sbir.gov as well as other information required by the SBIR/STTR Policy Directive (see Appendices V-VI), found at Small Business Innovation Research (SBIR) Program Policy Directive Appendices. Each SBC applying for an award is required to update the appropriate information in the SBA database on SBIR.gov for any of its existing and prior Phase II awards.

http://www.sbir.gov/ https://www.sbir.gov/sites/default/files/SBIR_Appendices.pdf

Applicants may not participate in the review of applications.

The statement of work of an SBIR award awarded under this NOFO cannot overlap with the statement of work of an existing NIST Cooperative Research and Development Agreement (CRADA) with the awardee. NIST will consider the issue of any potential overlap on a case-by-case basis.

1.03.02 Company Registry Requirements

SBA maintains and manages a Company Registry at http://www.sbir.gov/registration to track ownership and affiliation requirements for all companies applying to the SBIR Program. Each Phase II applicant must register in the Company Registry prior to submitting an application. The applicant must save its information from the registration in a .pdf document and append this document to the SF-424 (R&R) form as described in Section 8.02. of this NOFO. All applicants are required to report and/or update their registration information in the SBA Company Registry prior to each SBIR application submission or if any information changes prior to an award.

1.04 Contact with NIST

For general programmatic, electronic submission, or grants questions, please contact the appropriate individual:

Subject Area Point of Contact

Programmatic Questions Mary Clague Phone: (301) 975-4188 E-mail: mary.clague@nist.gov or

J’aime Maynard Phone: (301) 975-8408 E-mail: jmaynard@nist.gov http://www.sbir.gov/registration mailto:mary.clague@nist.gov mailto:jmaynard@nist.gov

Notice of Funding Opportunity April 7, 2021

Electronic Application Submission through Grants.gov

Grants.gov

(800) 518-4726 E-mail: support@grants.gov

Grant Rules and Regulations Dean Iwasaki Phone: (301) 975-8449 E-mail: dean.iwasaki@nist.gov

Applicants may also contact the NIST Hollings Manufacturing Extension Partnership (MEP) for technical assistance with application preparation. More information on obtaining technical assistance from MEP Centers for application preparation can be found in Section 5.13 of this NOFO.

1.05 Definitions

(a) General Definitions

Except as specifically noted by citation or reference, all definitions below are excerpted from the SBA SBIR/STTR Policy Directive.

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/STTR Programs.

Awardee – The organizational entity that receives an SBIR or STTR Phase I, Phase II, or Phase III award. An “SBIR/STTR Awardee.”

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.

mailto:support@grants.gov mailto:dean.iwasaki@nist.gov

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Contract, 2 CFR §200.22 - A legal instrument by which a non-Federal entity purchases property or services needed to carry out the project or program under a Federal award.

The term as used in this part does not include a legal instrument, even if the non-Federal entity considers it a contract, when the substance of the transaction meets the definition of a Federal award or subaward (see §200.92 Subaward).

Cooperative Agreement, 2 CFR §200.24 - A legal instrument of financial assistance between a Federal awarding agency or pass-through entity and a non-Federal entity that, consistent with 31 U.S.C. 6302-6305:

(a) Is used to enter into a relationship the principal purpose of which is to transfer anything of value from the Federal awarding agency or pass-through entity to the non-Federal entity to carry out a public purpose authorized by a law of the United States (see 31 U.S.C. 6101(3));

and not to acquire property or services for the Federal Government or pass-through entity's direct benefit or use;

(b) Is distinguished from a grant in that it provides for substantial involvement between the Federal awarding agency or pass-through entity and the non-Federal entity in carrying out the activity contemplated by the Federal award.

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.

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.

Joint Venture – See 13 C.F.R. § 121.103(h).

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

(1) a systematic study directed toward greater knowledge or understanding of the subject studied;

(2) a systematic study directed specifically toward applying knowledge and innovation to meet a recognized but unmet need; or

(3) a systematic application of knowledge and innovation toward the production of http://www.law.cornell.edu/cfr/text/13/121.103

Notice of Funding Opportunity April 7, 2021 useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements.

Small Business Concern (SBC) – A concern that meets the SBIR/STTR program eligibility requirements set forth in 13 C.F.R. 121.702, “What size and eligibility standards are applicable to the SBIR and STTR programs?” (available at https://www.ecfr.gov/cgi-bin/text-idx?SID=3ccaf429aac93292cdf7afdc1689514e&mc=true&node=se13.1.121_1702&rgn=div8.

Socially and Economically Disadvantaged SBC (SDB) - See 13 C.F.R. Part 124, Subpart B.

Socially and Economically Disadvantaged Individual - See 13 C.F.R. §§ 124.103 and 124.104.

Subaward, 2 CFR §200.92 - An award provided by a pass-through entity to a subrecipient for the subrecipient to carry out part of a Federal award received by the pass-through entity. It does not include payments to a contractor or payments to an individual that is a beneficiary of a Federal program. A subaward may be provided through any form of legal agreement, including an agreement that the pass-through entity considers a contract.

Women-Owned Small Business (WOSB) - An SBC 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.

(b)Definitions related to rights in data developed under the SBIR program. These definitions are also included in Section 5.04.02 of this NOFO.

All definitions below are excerpted from the SBA SBIR/STTR Policy Directive.

Computer Database - A collection of data recorded in a form capable of being processed by a computer. The term does not include Computer Software.

Computer Programs - A set of instructions, rules, or routines recorded in a form that is capable of causing a computer to perform a specific operation or series of operations.

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

https://www.ecfr.gov/cgi-bin/text-idx?SID=3ccaf429aac93292cdf7afdc1689514e&mc=true&node=se13.1.121_1702&rgn=div8 https://www.ecfr.gov/cgi-bin/text-idx?SID=3ccaf429aac93292cdf7afdc1689514e&mc=true&node=se13.1.121_1702&rgn=div8 https://www.federalregister.gov/select-citation/2012/08/06/13-CFR-124 https://www.federalregister.gov/select-citation/2012/08/06/13-CFR-124.103

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Computer Software Documentation - Owner's manuals, user's manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the Computer Software or provide instructions for using the software.

Data - All recorded information, regardless of the form or method of recording or the media on which it may be recorded. The term does not include information incidental to contract or grant administration, such as financial, administrative, cost or pricing or management information.

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

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

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

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

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

Notice of Funding Opportunity April 7, 2021

(i) Use in Federal Government computers;

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

(iii) Archive or backup; or

(iv) Distribution of a computer program to another Federal agency, without further permission of the Awardee, if the Awardee is notified of the distribution and the identity of the recipient prior to the distribution, and a copy of the SBIR/STTR Computer Software Rights included in the Funding Agreement is provided to the recipient.

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

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

(ii) The release or disclosure is—

(A) To a Federal Government support service contractor or their subcontractor for purposes of supporting Government internal use or activities, including evaluation, diagnosis and correction of deficiencies, and adaptation, combination, or integration with other Computer Software provided that SBIR/STTR Data incorporated into any derivative software are subject to the rights in § 3(ee) of the SBIR/STTR Policy Directive; or

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

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

SBIR/STTR Data Rights - The Federal Government’s license rights in properly marked SBIR/STTR Data during the SBIR/STTR Protection Period are as follows: SBIR/STTR Technical Data Rights in SBIR/STTR Data that are Technical Data or any other type of Data other than Computer Software; and SBIR/STTR Computer Software Rights in SBIR/STTR Data that is Computer Software. Upon expiration of the protection period for SBIR/STTR Data, the Federal Government has a royalty free license to use, and to authorize others to use on its behalf, these data for Government Purposes, and is relieved of all disclosure prohibitions and assumes no liability for unauthorized use of these data by third parties. The Federal Government receives Unlimited Rights in Form Fit, and Function Data, OMIT Data, and all unmarked SBIR/STTR Data.

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

SBIR/STTR Technical Data Rights - The Federal Government’s rights during the SBIR/STTR Protection Period in SBIR/STTR Data that are Technical Data or any other type of Data other than Computer Software.

(1) The Federal Government may, use, modify, reproduce, perform, display, release, or disclose SBIR/STTR Data that are Technical Data within the Government; however, the Government shall not use, release, or disclose the data for procurement, manufacturing, or commercial purposes; or release or disclose the SBIR/STTR Data outside the Government except as permitted by paragraph (B) below or by written permission of the Awardee.

(2) SBIR/STTR Data that are Technical Data may be released outside the Federal Government without any additional written permission of the Awardee only if the non-Governmental entity or foreign government has entered into a non-disclosure agreement with the Federal Government that

Notice of Funding Opportunity April 7, 2021 complies with the terms for such agreements outlined in § 8 of the SBIR/STTR Policy Directive and the release is:

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

(ii) To a Government support services contractor in the performance of a Government support services contract for internal Government use or activities, including evaluation, diagnosis or modification, provided that SBIR/STTR Technical Data incorporated into any derivative Data are subject to the rights in § 3(ii) of the SBIR/STTR Policy Directive, and the release is not for commercial purposes or manufacture;

(iii) To a foreign government for purposes of information and evaluation if required to serve the interests of the U.S. Government; or

(iv) To non-Government entities or individuals for purposes of evaluation.

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

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

1.06 Fraud, Waste and Abuse

As defined in the SBIR/STTR Policy Directive section 9(f), 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

Notice of Funding Opportunity April 7, 2021 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.

Examples of fraud, waste, and abuse relating to the SBIR/STTR Program include, but are not limited to:

(i) misrepresentations or material, factual omissions to obtain, or otherwise receive funding under, an SBIR/STTR award;

(ii) misrepresentations of the use of funds expended, work done, results achieved, or compliance with program requirements under an SBIR/STTR award;

(iii) misuse or conversion of SBIR/STTR award funds, including any use of award funds while not in full compliance with SBIR/STTR Program requirements, or failure to pay taxes due on misused or converted SBIR/STTR award funds;

(iv) fabrication, falsification, or plagiarism in applying for, carrying out, or reporting results from an SBIR/STTR award;

(v) failure to comply with applicable federal costs principles governing an award;

(vi) extravagant, careless, or needless spending;

(vii) self-dealing, such as making a sub-award to an entity in which the Principal Investigator (PI) has a financial interest;

(viii) acceptance by agency personnel of bribes or gifts in exchange for grant or contract awards or other conflicts of interest that prevents the Government from getting the best value; and

(ix) lack of monitoring, or follow-up if questions arise, by agency personnel to ensure that awardee meets all required eligibility requirements, provides all required certifications, performs in accordance with the terms and conditions of the award, and performs all work proposed in the application.

Report any allegations of fraud, waste and abuse using the online Department of Commerce Office of Inspector General Complaint Form, available at https://www.oig.doc.gov/Pages/online-hotline-complaint-form.aspx

Notice of Funding Opportunity April 7, 2021 https://www.oig.doc.gov/Pages/Hotline.aspx#complainthotline. Contact information for the Office of Inspector General is available at: https://www.oig.doc.gov/pages/Contact- Us.aspx. Please do not include Personally Identifiable Information (PII) through the website.

PII is considered to be items containing Social Security numbers, dates of birth, credit card and passport numbers, or other personally identifying information that could adversely affect an individual. Should you desire to provide this information, it is strongly recommended that you contact the Hotline by telephone at the number listed below.

Phone:

Toll Free 800-424-5197

Mail:

Office of Inspector General Hotline

HCHB 7709

1401 Constitution Avenue, N.W.

Washington, DC 20230

1.07 Other Information

1.07.01 Personal and Business Information

The applicant acknowledges and understands that information and data contained in applications for financial assistance, as well as information and data contained in financial, performance and other reports submitted by applicants, may be used by the Department of Commerce in conducting reviews and evaluations of its financial assistance programs. For this purpose, applicant information and data may be accessed, reviewed and evaluated by Department of Commerce employees, other Federal employees, and also by Federal agents and contractors, and/or by non-Federal personnel, all of whom enter into appropriate conflict of interest and confidentiality agreements covering the use of such information. As may be provided in the terms and conditions of a specific financial assistance award, applicants are expected to support program reviews and evaluations by submitting required financial and performance information and data in an accurate and timely manner, and by cooperating with Department of Commerce and external program evaluators. In accordance with 2 C.F.R. § 200.303(e), applicants are reminded that they must take reasonable measures to safeguard protected personally identifiable information and other confidential or sensitive personal or business information created or obtained in connection with a Department of Commerce financial assistance award.

https://www.oig.doc.gov/Pages/Hotline.aspx#complainthotline https://www.oig.doc.gov/pages/Contact-Us.aspx https://www.oig.doc.gov/pages/Contact-Us.aspx

Notice of Funding Opportunity April 7, 2021

In addition, Department of Commerce regulations implementing the Freedom of Information Act (FOIA), 5 U.S.C. § 552, are found at 15 C.F.R. Part 4, Public Information.

These regulations set forth rules for the Department regarding making requested materials, information, and records publicly available under the FOIA. Applications submitted in response to this Notice of Funding Opportunity may be subject to requests for release under the Act. In the event that an application contains information or data that the applicant deems to be confidential commercial information that should be exempt from disclosure under FOIA, that information should be identified, bracketed, and marked as Privileged, Confidential, Commercial or Financial Information. In accordance with 15 CFR § 4.9, the Department of Commerce will protect from disclosure confidential business information contained in financial assistance applications and other documentation provided by applicants to the extent permitted by law.

2.0 CERTIFICATIONS

2.01 Funding Agreement Certification

Awardees will be required to certify size, ownership and other SBIR Program requirements at the time of award and during the funding agreement life cycle using the SBIR Funding Agreement Certification and the SBIR Funding Agreement Certification – Life-Cycle Certification, which are provided in Appendix B of this NOFO.

2.02 Research Activities Involving Human Subjects, Human Tissue, Data or Recordings Involving Human Subjects Including Software Testing

Any application that includes research activities involving human subjects, human tissue/cells, or data or recordings from or about human subjects, must satisfy the requirements of the Common Rule for the Protection of Human Subjects (“Common Rule”), codified for the Department of Commerce at 15 C.F.R. Part 27. Research activities involving human subjects that fall within one or more of the classes of vulnerable subjects found in 45 C.F.R. Part 46, Subparts B, C and D must satisfy the requirements of the applicable subpart(s).

In addition, any such application that includes research activities on these subjects must be in compliance with all applicable statutory requirements imposed upon the Department of Health and Human Services (DHHS) and other Federal agencies, all regulations, policies and guidance adopted by DHHS, the Food and Drug Administration (FDA), and other Federal agencies on these topics, and all Executive Orders and Presidential statements of policy on applicable topics. (Regulatory Resources:

http://www.hhs.gov/ohrp/humansubjects/index.html which includes links to FDA regulations, but may not include all applicable regulations and policies).

http://www.hhs.gov/ohrp/humansubjects/index.html

NIST uses the following Common Rule definitions for research and human subjects research:

Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.

For example, some demonstration and service programs may include research activities.

Human Subject: A living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

(1) Intervention includes both physical procedures by which information or biospecimens are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

(2) Interaction includes communication or interpersonal contact between investigator and subject.

(3) 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 which 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 associated with the information) in order for obtaining the information to constitute research involving human subjects.

(4) Identifiable biospecimen includes a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

See 15 C.F.R. § 27.102 (Definitions).

1) Requirement for Federalwide Assurance. If the application is accepted for [or awarded] funding, organizations that have an Institutional Review Board (IRB) are required to follow the procedures of their organization for approval of exempt and

Notice of Funding Opportunity April 7, 2021 non-exempt research activities that involve human subjects. Both domestic and foreign organizations performing exempt research requiring limited IRB review or non-exempt research activities involving human subjects will be required to have protocols approved by a cognizant, active IRB currently registered with the Office for Human Research Protections (OHRP) within the DHHS that is linked to the engaged organizations. All engaged organizations must possess a currently valid Federalwide Assurance (FWA) on file from OHRP. Information regarding how to apply for an FWA and register an IRB with OHRP can be found at http://www.hhs.gov/ohrp/assurances/index.html. See 15 C.F.R. § 27.103. NIST relies only on OHRP-issued FWAs and IRB Registrations for both domestic and foreign organizations for NIST supported research involving human subjects. NIST will not issue its own FWAs or IRB Registrations for domestic or foreign organizations.

2) Administrative Review. The NIST Research Protections Office (RPO) reserves the right to conduct an administrative review1 of all applications that potentially include research involving human subjects and were approved by an authorized non-NIST institutional entity (an IRB or entity analogous to the NIST RPO) under 15 C.F.R. § 27.112 (Review by Institution). If the NIST RPO determines that an application includes research activities that potentially involve human subjects, the applicant will be required to provide additional information to NIST for review and approval. The documents required for funded proposals are listed in each section below. Most documents will need to be produced during the proposal review process; however, the Grants Officer may allow final versions of certain required documents to be produced at an appropriate designated time post-award.

Research involving human subjects may not start until the NIST Grants Officer issues an award explicitly authorizing such research. In addition, all amendments, modifications, or changes to approved research and requests for continuing review and closure will be reviewed by the NIST RPO. Please note that the NIST IRB is unable to serve as the IRB for financial assistance recipients.

3) Required documents for proposal review. All applications involving human subjects research must clearly indicate, by separable task, all research activities believed to

1 Conducting an “administrative review” means that the NIST RPO will review and verify the performing institution’s determination for research not involving human subjects or exempt human subjects research. In addition, for exempt research requiring limited IRB review and non-exempt human subjects research, the NIST RPO will review and confirm that the research and performing institution(s) are in compliance with 15 C.F.R.

Part 27, which means RPO will 1) confirm the engaged institution(s) possess, or are covered under a Federalwide Assurance, 2) review the research study documentation submitted to the IRB and verify the IRB’s determination of level of risk and approval of the study for compliance with 15 C.F.R. Part 27, 3) review and verify IRB-approved substantive changes to an approved research study before the changes are implemented, and 4) review and verify that the IRB conducts a continuing review at least annually, as appropriate.

http://www.hhs.gov/ohrp/assurances/index.html

Notice of Funding Opportunity April 7, 2021 be exempt or non-exempt research involving human subjects, the expected institution(s) where the research activities involving human subjects may be conducted, and the institution(s) expected to be engaged in the research activities.

a. Not research determination. If an activity/task involves human subjects as defined in the Common Rule, but the applicant participant(s) indicates to NIST that the activity/task is not research as defined in the Common Rule, the following information may be requested for that activity/task:

(1) Justification, including the rationale for the determination and such additional documentation as may be deemed necessary by NIST to review and/or support a determination that the activity/task in the application is not research as defined in the Common Rule.

(2) If the applicant participant(s) used a cognizant IRB that provided a determination that the activity/task is not research, a copy of that determination documentation must be provided to NIST. The applicant participant(s) is not required to establish a relationship with a cognizant IRB if they do not have one.

NIST will review the information submitted and may coordinate further with the applicant before determining whether the activity/task will be defined as research under the Common Rule in the applicable NIST financial assistance program or project.

b. Research not involving human subjects. If an activity/task is determined to be research and involves human subjects, but is determined to be not human subjects research (or research not involving human subjects) under the Common Rule, the following information may be requested for that activity/task:

(1) Justification, including the rationale for the determination and such additional documentation as may be deemed necessary by NIST to review and/or support a determination that the activity/task in the application is not research as defined in the Common Rule.

(2) If the applicant participant(s) used a cognizant IRB that provided a determination that the activity/task is research not involving human subjects, a copy of that determination documentation must be provided to NIST. The applicant participant(s) is not required to establish a relationship with a cognizant IRB if they do not have one.

c. Exempt research determination with no IRB. If the application appears to NIST to include exempt research activities that do not meet the criteria for requiring a limited IRB review, and the performer of the activity or the supplier and/or the receiver of the information or

Notice of Funding Opportunity April 7, 2021 biospecimens from human subjects does not have a cognizant IRB to provide an exemption determination, the following information may be requested during the review process so that NIST can evaluate whether an exemption under the Common Rule applies (see 15 C.F.R. § 27.104(b) and (d)):

(1) The name(s) of the institution(s) where the exempt research will be conducted.

(2) The name(s) of the institution(s) providing the biospecimens or information from human subjects.

(3) A copy of the protocol for the research to be conducted; and/or the biospecimens or information from human subjects to be collected/provided, not pre-existing samples (i.e., will proposed research collect only information without personal identifiable information, will biospecimens or information be de-identified and when and by whom was the de-identification performed, how were the materials or data originally collected).

(4) For pre-existing biospecimens or information from human subjects, provide copies of the consent forms used for collection and a description of how the biospecimens or information were originally collected and stripped of personal identifiers. If copies of consent forms are not available, explain.

(5) Any additional clarifying documentation that NIST may deem necessary in order to make a determination whether the activity/task or use of biospecimens or information from human subjects is exempt under the Common Rule.

d. Research review with an IRB. If the application appears to NIST to include research activities (exempt or non-exempt) involving human subjects, the proposed performer of the activity must have a relationship with a cognizant IRB registered with OHRP, and linked to their Federalwide Assurance. The following information may be requested during the review process:

(1) The name(s) of the institution(s) where the research will be conducted.

(2) The name(s) and institution(s) of the cognizant IRB(s), and the IRB registration number(s).

(3) The FWA number of the applicant linked to the cognizant IRB(s).

(4) The FWAs associated with all organizations engaged in the planned research activity/task, linked to the cognizant IRB.

(5) If the IRB review(s) is pending, the estimated start date for research involving human subjects.

(6) The IRB approval date (if currently approved for exempt or non-exempt research).

(7) If any of the engaged organizations has applied for or will apply for an FWA or IRB registration, those details should be clearly provided for each engaged organization.

If the application includes research activities involving human subjects to be performed in the first year of an award, additional documentation may be requested by NIST during pre-award review for those performers, and may include the following for those research activities:

(1) A copy of each applicable final IRB-approved protocol.

(2) A signed and dated approval letter from the cognizant IRB(s) that includes the name of the institution housing each applicable IRB, provides the start and end dates for the approval of the research activities, and any IRB-required interim reporting or continuing review requirements.

(3) A copy of any IRB-required application information, such as documentation of approval of special clearances (i.e., biohazard, HIPAA, etc.) conflict-of-interest letters, or special training requirements.

(4) A brief description of which portions of the IRB submitted protocol are specifically included in the application submitted to NIST, if the protocol includes tasks not included in the application, or if the protocol is supported by multiple funding sources.

For protocols with multiple funding sources, NIST will not approve the study without a non-duplication-of-funding letter indicating that no other federal funds will be used to support the tasks proposed under the proposed research or ongoing project.

(5) If a new protocol will only be submitted to an IRB if an award from NIST is issued, a draft of the proposed protocol.

(6) Any additional clarifying documentation that NIST may request during the review process to perform the NIST administrative review of research involving human subjects. (See 15 C.F.R. § 27.112 (Review by Institution)).

This clause reflects the existing NIST policy and requirements for Research Involving Human Subjects. Should the policy be revised prior to award, a clause reflecting the policy current at time of award may be incorporated into the award.

If the policy is revised after award, a clause reflecting the updated policy may be incorporated into the award.

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