2020-NIST-SBIR-02.pdf

FY 2020 NIST Small Business Innovation Research Program Phase II

Notice of Funding Opportunity March 27, 2020

FY 2020

Small Business Innovation Research (SBIR) Program Phase II

Notice of Funding Opportunity (NOFO)

ANNOUNCEMENT

FUNDING OPPORTUNITY NUMBER: 2020-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: March 27, 2020

Closing Date: May 26, 2020 http://www.nist.gov/sbir http://www.nist.gov/sbir

Notice of Funding Opportunity March 27, 2020

1.0 PROGRAM DESCRIPTION AND FEDERAL AWARD INFORMATION ............................................ 5 1

1.01 Introduction ............................................................................................................................ 5 2

1.02 Three-Phase Program ............................................................................................................. 6 3

1.03 SBIR Applicant Eligibility and Limitations ................................................................................ 8 4

1.04 Contact with NIST.................................................................................................................. ..9 5

1.05 Definitions ............................................................................................................................. 10 6

1.06 Fraud, Waste and Abuse ....................................................................................................... 17 7

1.07 Other Information ................................................................................................................. 18 8

2.0 CERTIFICATIONS ...................................................................................................................... 19 9

2.01 Funding Agreement Certification .......................................................................................... 19 10

2.02 Research Activities Involving Human Subjects, Human Tissue, Data or Recordings Involving 11

Human Subjects Including Software Testing ................................................................................ 19 12

2.03 Research Applications Involving Live Vertebrate Animals or Pre-Existing Cell Lines/Tissues 13 from Vertebrate Animals .............................................................................................................. 25 14

2.04 Certifications Regarding Federal Felony and Federal Criminal Tax Convictions, Unpaid 15

Federal Tax Assessments and Delinquent Federal Tax Returns ................................................... 29 16

3.0 APPLICATION PREPARATION INSTRUCTIONS AND REQUIREMENTS ...................................... 29 17

3.01 Phase II Application Requirements ....................................................................................... 29 18

3.02 Phase II Application ............................................................................................................... 30 19

4.0 METHOD OF SELECTION AND EVALUATION CRITERIA ............................................................ 36 20

4.01 Introduction .......................................................................................................................... 36 21

Notice of Funding Opportunity March 27, 2020

4.02 Phase II Screening Criteria .................................................................................................... 36 22

4.03 Phase II Evaluation Criteria .................................................................................................. 38 23

4.04 Phase II Award Selections ..................................................................................................... 38 25

5.0 CONSIDERATIONS ................................................................................................................... 39 26

5.01 Awards .................................................................................................................................. 39 27

5.02 Reporting Requirements ....................................................................................................... 40 28

5.03 Payment Schedule ................................................................................................................ 41 29

5.04 Innovations, Inventions and Patents .................................................................................... 41 30

5.05 Cost Sharing .......................................................................................................................... 50 31

5.06 Profit or Fee .......................................................................................................................... 50 32

5.07 Joint Ventures or Limited Partnerships ................................................................................ 50 33

5.08 Research and Analytical Work .............................................................................................. 50 34

5.09 Awardee Commitments ........................................................................................................ 50 35

5.10 Summary Statements............................................................................................................ 51 36

5.11 Additional Information ......................................................................................................... 46 37

5.12 Technical Assistance for Application Preparation and Project Conduct .............................. 53 38

6.0 SUBMISSION OF APPLICATIONS .............................................................................................. 54 39

6.01 Deadline for Applications ...................................................................................................... 54 40

6.02 Address to Request Application Package .............................................................................. 55 41

6.03 Application Submission ......................................................................................................... 55 42

Notice of Funding Opportunity March 27, 2020

7.0 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES ........................................................... 57 43

8.0 SUBMISSION FORMS AND CERTIFICATIONS ........................................................................... 58 44

8.01 Required Forms and Documents .......................................................................................... 58 45

8.02 Verifying the Submission and Tracking the Application ....................................................... 65 46

8.03 Unique Entity Identifier and System for Award Management (SAM) .................................. 66 47

9.0 RESEARCH AREAS .................................................................................................................... 67 48

Appendix A. COVER SHEET ........................................................................................................... 70 49

Appendix B. CERTIFICATIONS ........................................................................................................ 72 50

Notice of Funding Opportunity March 27, 2020

US DEPARTMENT OF COMMERCE 51

NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY 52

FY 2020 SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM 53

PHASE II NOTICE OF FUNDING OPPORTUNITY (NOFO) 54

1.0 PROGRAM DESCRIPTION AND FEDERAL AWARD INFORMATION 56

1.01 Introduction 58

The National Institute of Standards and Technology (NIST) invites FY 2019 NIST SBIR 60

Phase I awardees to submit Phase II research applications under this Notice of Funding 61

Opportunity (NOFO). Only FY 2019 NIST SBIR Phase I awardees are eligible to submit 62 applications in response to this NOFO for Phase II of their projects. 63

The Small Business Innovation Research (SBIR) program was originally established in 1982 65 by the Small Business Innovation Development Act (P.L. 97-219), codified at 15 U.S.C. § 638. 66

It was then expanded and extended by the Small Business Research and Development 67

(R&D) Enhancement Act of 1992 (P.L. 102-564), and received subsequent reauthorization 68 and extensions, the most recent of which extends the SBIR program through 2022. (P.L. 69

114-328). 70

Eleven Federal agencies implement SBIR by setting aside a portion of their extramural 72 research and development budget each year to fund research applications from small 73 science and technology-based firms. The statutory purpose of the SBIR Program is to 74 strengthen the role of innovative small business concerns (SBCs) in Federally-funded 75 research or research and development (R/R&D). Specific program goals are to: 76

(1) stimulate technological innovation; (2) use small business to meet Federal R/R&D needs; 77

(3) foster and encourage participation by socially and economically disadvantaged small 78 businesses and by women-owned small businesses in technological innovation; and (4) 79 increase private sector commercialization of innovations derived from Federal R/R&D, 80 thereby increasing competition, productivity, and economic growth. 81

The NIST FY 2020 SBIR program identifies and solicits applications in topics that fall within 83

NIST’s mission and allow collaboration between NIST scientists and the SBIR awardees 84 whenever possible. 85

When reviewing applications, NIST gives high priority to SBCs that participate in or conduct 87 energy efficiency or renewable energy system R&D projects, consistent with Executive 88

Notice of Funding Opportunity March 27, 2020

Order (EO) 13329 (http://www.gpo.gov/fdsys/pkg/FR-2004-02-26/pdf/04-4436.pdf) 89

“Encouraging Innovation in Manufacturing,” the Energy Independence and Security Act of 90

2007 (P.L. 110-140 § 1203(e), codified at 15 U.S.C. § 638(z)), and the Small Business 91

Administration (SBA) Small Business Innovation Research (SBIR) and Small Business 92

Technology Transfer (STTR) Program Policy Directive, § 9, found at 93 https://www.sbir.gov/sites/default/files/SBIR-STTR_Policy_Directive_2019.pdf. 94

For any SBIR award that requires a license to use a NIST-owned invention covered by a 96 patent or patent application, the SBIR awardee will need to contact NIST’s Technology 97

Partnerships Office for a license to use the NIST-owned invention. Such awardees will be 98 granted a non-exclusive research license and will be given the opportunity to negotiate a 99 non-exclusive or an exclusive commercialization license to the NIST-owned invention, in 100 accordance with the Federal patent licensing regulations, set forth in 37 C.F.R. Part 404, and 101 to the extent that such NIST-owned invention is available for licensing and has not 102 otherwise been exclusively licensed to another party. It is the goal of this program to 103 position the SBIR awardee to use and build upon such licensed NIST-owned invention with 104 the awardee’s own innovation to develop a commercially viable product based on the NIST- 105 owned invention. 106

1.02 Three-Phase Program 108

The SBIR statute (15 U.S.C. § 638) requires the Department of Commerce to establish a 110 three-phase SBIR program by reserving a percentage of its extramural R&D budget to be 111 awarded to SBCs for innovation research. SBIR policy is provided by the SBA through the 112

SBIR/STTR Policy Directive found at https://www.sbir.gov/sites/default/files/SBIR-113

STTR_Policy_Directive_2019.pdf. 114

The funding vehicles for NIST’s SBIR program in both Phase I and Phase II are cooperative 116 agreements. NIST’s authority to implement its SBIR program through cooperative 117 agreements is 15 U.S.C. § 272(b)(4). NIST programmatic authorities for the research areas 118 listed in this NOFO are found at 15 U.S.C. § 272(b) and (c). The nature of NIST’s “substantial 119 involvement” will generally be collaboration with the awardees in carrying out the 120 projects’ approved scope of work. Grants and agreements administrative requirements set 121 forth at 2 C.F.R. Part 200 will apply to NIST SBIR awards. 122

1.02.01 Phase I - Feasibility Research 124

The purpose of Phase I is for NIST to determine the technical feasibility of the research, 126 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/SBIR-STTR_Policy_Directive_2019.pdf https://www.sbir.gov/sites/default/files/SBIR-STTR_Policy_Directive_2019.pdf

Notice of Funding Opportunity March 27, 2020 preliminary commercialization merit of the proposed effort, and the quality of the 127 awardee’s performance. The application should concentrate on describing research that 128 will significantly contribute to proving the feasibility of the proposed Phase II research 129 and commercialization potential, prerequisites to receiving further support in Phase II. 130

Each Phase I award is for up to $100,000 and up to a six (6) month period of 131 performance. Up to an additional $6,500 may be requested for Technical and Business 132

Assistance (TABA); see Section 5.11 for more information about TABA. 133

This NOFO is not soliciting applications for Phase I research. 135

1.02.02 Phase II - Research and Development 137

This NOFO provides an opportunity to all NIST FY 2019 SBIR Phase I awardees to submit a 139

Phase II application following completion of Phase I. This NOFO provides instructions for FY 140

2020 NIST SBIR Phase II application preparation and submission requirements. 141

In Phase II, work from Phase I that exhibits potential for commercial application is further 143 developed. Phase II is the R&D or prototype development phase. To apply for a Phase II 144 award, each Phase I awardee will be required to submit a comprehensive application 145 outlining the proposed research and a detailed plan to commercialize the final product. 146

Each NIST Phase II award is for up to $400,000 and up to a 24-month period of 147 performance. Up to $50,000 of the award may be proposed for Technical and Business 148

Assistance (TABA); see Section 5.11 for more information about TABA. One year after 149 completing the Phase II R&D activity, the awardee shall be required to report on its 150 commercialization activities. 151

1.02.03 Phase III - Commercialization 153

Phase III refers to work that derives from, extends, or completes an effort made under prior 155

SBIR funding agreements, but is funded by sources other than the SBIR Program. Phase III 156 work is typically oriented towards commercialization of SBIR research or technology and 157 may be for products, production, services, R/R&D or a combination thereof. 158

1.02.04 Commercialization Readiness Pilot Program 160

As allowed in Section 5123 of the SBIR/STTR Reauthorization Act of 2011, Division E of Pub. 162

L. 112-81, codified in 15 U.S.C. § 638(gg), NIST has received authorization to establish a 163

Commercialization Readiness Pilot Program (CRPP). NIST may provide follow-on funding (up 164 to an additional $100,000) to selected awardees after completion of Phase II. The funding 165

Notice of Funding Opportunity March 27, 2020 would be used to further develop Phase II technologies, to support advancement toward 166

Phase III, and to increase the likelihood of commercialization. NIST is under no obligation to 167 make any CRPP awards. 168

1.03 SBIR Applicant Eligibility and Limitations 170

1.03.01 Applicant Qualifications 172

Under this NOFO, only FY 2019 NIST SBIR Phase I awardees are eligible to submit 174 applications. Applications received from entities other than FY 2019 NIST SBIR Phase I 175 awardees will not be reviewed or considered for award. Each applicant must qualify as an 176

SBC for R/R&D purposes, as defined in Section 1.05 of this NOFO, at the time of award. In 177 addition, the primary employment of the principal investigator must be with the small 178 business at the time of the award and during the conduct of the proposed research. Primary 179 employment means that more than one-half of the principal investigator's time is spent 180 working with the small business. Primary employment with a small business precludes full-181 time employment with another organization. Occasionally, deviations from this 182 requirement may occur, which must be approved in writing by the NIST Grants Officer after 183 consultation with the SBIR Program Manager. Further, a small business may only replace 184 the principal investigator on an SBIR Phase I award if the NIST Grants Officer provides prior 185 written approval. Personnel obtained through a Professional Employer Organization or 186 other similar personnel leasing company may be considered employees of the awardee. 187

The R/R&D work must be performed in the United States. Requests for an exemption must 189 be submitted in writing at the time of application submission. Only rare and unique 190 circumstances will be considered for an exemption. The NIST Grants Officer must approve 191 each exemption and its terms in writing. 192

NIST has elected to not use the authority that would allow venture capital operating 194 companies (VCOCs), hedge funds or private equity firms to participate in the SBIR Program. 195

Therefore, applications in which work would be performed by VCOCs will not be 196 considered for award. 197

For Phase I, a minimum of two-thirds of the research and/or analytical effort must be 199 performed by the awardee. The total cost for all consultant fees, facility leases, usage fees, 200 and other subcontract/subaward or purchase agreements may not exceed one-third of the 201 total award. For Phase II, a minimum of one-half of the research and/or analytical effort 202 must be performed by the awardee. The total cost for all consultant fees, facility leases, 203 usage fees, and other subcontract/subaward or purchase agreements, excluding funds 204

Notice of Funding Opportunity March 27, 2020 requested for TABA (see Section 5.11), may not exceed one-half of the total award. 205

Each applicant will be required to provide certain information via www.sbir.gov as well as 207 other information required by the SBIR/STTR Policy Directive (see Appendices V-VI), found at 208 https://www.sbir.gov/sites/default/files/SBIR-STTR_Policy_Directive_2019.pdf. Each SBC 209 applying for an award is required to update the appropriate information in the SBA database 210 on SBIR.gov for any of its existing and prior Phase II awards. 211

Applicants may not participate in the review of applications. 213

The statement of work of an SBIR award awarded under this NOFO cannot overlap with the 215 statement of work of an existing NIST Cooperative Research and Development Agreement 216

(CRADA) with the awardee. NIST will consider the issue of any potential overlap on a case- 217 by-case basis. 218

1.03.02 Company Registry Requirements 220

SBA maintains and manages a Company Registry at http://www.sbir.gov/registration to 222 track ownership and affiliation requirements for all companies applying to the SBIR 223

Program. Each Phase II applicant must register in the Company Registry prior to 224 submitting an application. The applicant must save its information from the registration 225 in a .pdf document and append this document to the SF-424 (R&R) form as described at 226 the end of Section 8.01. of this NOFO. All applicants are required to report and/or update 227 their registration information in the SBA Company Registry prior to each SBIR application 228 submission or if any information changes prior to an award. 229

1.04 Contact with NIST 232

Applicants may contact the NIST Hollings Manufacturing Extension Partnership 235

(MEP) for technical assistance with application preparation. More information on 236 obtaining technical assistance from MEP Centers for application preparation can be 237 found in Section 5.12 of this NOFO. 238

For general programmatic, electronic submission, or grants questions, please contact the 240 appropriate individual: 241 http://www.sbir.gov/ http://www.sbir.gov/registration

Notice of Funding Opportunity March 27, 2020

Subject Area Point of Contact

Programmatic Questions Mary Clague Phone: (301) 975-4188 Fax: (301) 975-3482 E-mail: mary.clague@nist.gov or

J’aime Maynard Phone: (301) 975-8408 E-mail: jmaynard@nist.gov

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 Fax: (301) 975-6368 E-mail: dean.iwasaki@nist.gov

1.05 Definitions 245

(a) General Definitions 247

Except as specifically noted by citation or reference, all definitions below are 249 excerpted from the SBA SBIR/STTR Policy Directive, available at 250 https://www.sbir.gov/sites/default/files/SBIR-STTR_Policy_Directive_2019.pdf. 251

Applicant – The organizational entity that qualifies as an SBC at all pertinent times and 253 that submits a contract proposal or a grant application for a funding agreement under the 254

SBIR/STTR Programs. 255 mailto:mary.clague@nist.gov mailto:jmaynard@nist.gov mailto:support@grants.gov mailto:dean.iwasaki@nist.gov

Notice of Funding Opportunity March 27, 2020

Awardee – The organizational entity that receives an SBIR or STTR Phase I, Phase II, or 257

Phase III award. An “SBIR/STTR Awardee.” 258

Commercialization - The process of developing products, processes, technologies, or 260 services and the production and delivery (whether by the originating party or others) of the 261 products, processes, technologies, or services for sale to or use by the Federal government 262 or commercial markets. 263

Contract, 2 CFR §200.22 - A legal instrument by which a non-Federal entity purchases 265 property or services needed to carry out the project or program under a Federal award. 266

The term as used in this part does not include a legal instrument, even if the non-Federal 267 entity considers it a contract, when the substance of the transaction meets the definition 268 of a Federal award or subaward (see §200.92 Subaward). 269

Cooperative Agreement, 2 CFR §200.24 - A legal instrument of financial assistance between a 271

Federal awarding agency or pass-through entity and a non-Federal entity that, consistent 272 with 31 U.S.C. 6302-6305: 273

(a) Is used to enter into a relationship the principal purpose of which is to transfer anything of 274 value from the Federal awarding agency or pass-through entity to the non-Federal entity to 275 carry out a public purpose authorized by a law of the United States (see 31 U.S.C. 6101(3)); 276 and not to acquire property or services for the Federal Government or pass-through entity's 277 direct benefit or use; 278

(b) Is distinguished from a grant in that it provides for substantial involvement between the 279

Federal awarding agency or pass-through entity and the non-Federal entity in carrying out 280 the activity contemplated by the Federal award. 281

Essentially Equivalent Work - Work that is substantially the same research, which is 283 proposed for funding in more than one contract proposal or grant application submitted to 284 the same Federal agency, or submitted to two or more different Federal agencies for 285 review and funding consideration; or work where a specific research objective and the 286 research design for accomplishing the objective are the same or closely related to another 287 proposal or award, regardless of the funding source. 288

Funding Agreement - Any contract, grant, or cooperative agreement entered into between 290 any Federal agency and any SBC for the performance of experimental, developmental, or 291 research work, including products or services, funded in whole or in part by the Federal 292

Government. 293

Notice of Funding Opportunity March 27, 2020

Joint Venture – See 13 C.F.R. § 121.103(h). 295

Research or Research and Development (R/R&D) - Any activity that is: 297

(1) a systematic study directed toward greater knowledge or understanding of the 298 subject studied; 299

(2) a systematic study directed specifically toward applying knowledge and 300 innovation to meet a recognized but unmet need; or 301

(3) a systematic application of knowledge and innovation toward the production of 302 useful materials, devices, and systems or methods, including design, development, 303 and improvement of prototypes and new processes to meet specific requirements. 304

Small Business Concern (SBC) – A concern that meets the SBIR/STTR program eligibility 306 requirements set forth in 13 C.F.R.121.702, “What size and eligibility standards are applicable 307 to the SBIR and STTR programs?” (available at https://gov.ecfr.io/cgi-bin/text-308 idx?SID=d617ae64d7222b2ac946ffe72549ac14&mc=true&node=se13.1.121_1702&rgn=div8) 309

Socially and Economically Disadvantaged SBC (SDB) - See 13 C.F.R. Part 124, Subpart B. 311

Socially and Economically Disadvantaged Individual - See 13 C.F.R. §§ 124.103 and 124.104. 313

Subaward, 2 CFR §200.92 - An award provided by a pass-through entity to a subrecipient for 315 the subrecipient to carry out part of a Federal award received by the pass-through entity. It 316 does not include payments to a contractor or payments to an individual that is a beneficiary 317 of a Federal program. A subaward may be provided through any form of legal agreement, 318 including an agreement that the pass-through entity considers a contract. 319

Women-Owned Small Business (WOSB) - An SBC that is at least 51% owned by one or more 321 women, or in the case of any publicly owned business, at least 51% of the stock is owned by 322 women, and women control the management and daily business operations. 323

(b) Definitions related to rights in data developed under the SBIR program. These 325 definitions are also included in Section 5.04.02 of this NOFO. 326

All definitions below are excerpted from the SBA SBIR/STTR Policy Directive, available at 328 https://www.sbir.gov/sites/default/files/SBIR-STTR_Policy_Directive_2019.pdf. 329

Computer Database - A collection of data recorded in a form capable of being processed by a 331 computer. The term does not include Computer Software. 332 http://www.law.cornell.edu/cfr/text/13/121.103 https://gov.ecfr.io/cgi-bin/text-idx?SID=d617ae64d7222b2ac946ffe72549ac14&mc=true&node=se13.1.121_1702&rgn=div8 https://gov.ecfr.io/cgi-bin/text-idx?SID=d617ae64d7222b2ac946ffe72549ac14&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

Notice of Funding Opportunity March 27, 2020

Computer Programs - A set of instructions, rules, or routines recorded in a form that is 334 capable of causing a computer to perform a specific operation or series of operations. 335

Computer Software - Computer programs, source code, source code listings, object code 337 listings, design details, algorithms, processes, flow charts, formulae, and related material 338 that would enable the software to be reproduced, recreated, or recompiled. Computer 339

Software does not include Computer Databases or Computer Software Documentation. 340

Computer Software Documentation - Owner's manuals, user's manuals, installation 342 instructions, operating instructions, and other similar items, regardless of storage medium, 343 that explain the capabilities of the Computer Software or provide instructions for using the 344 software. 345

Data - All recorded information, regardless of the form or method of recording or the 347 media on which it may be recorded. The term does not include information incidental 348 to contract or grant administration, such as financial, administrative, cost or pricing or 349 management information. 350

Form, Fit, and Function Data - Data relating to items, components, or processes that are 352 sufficient to enable physical and functional interchangeability, and data identifying 353 source, size, configuration, mating and attachment characteristics, functional 354 characteristics, and performance requirements. For Computer Software it means data 355 identifying source, functional characteristics, and performance requirements, but 356 specifically excludes the source code, algorithms, processes, formulas, and flow charts 357 of the software. 358

Government Purpose - Any activity in which the United States Government is a party, 360 including cooperative agreements with international or multi-national defense 361 organizations or sales or transfers by the United States Government to foreign 362 governments or international organizations. Government Purposes include competitive 363 procurement, but do not include the rights to use, modify, reproduce, release, perform, 364 display, or disclose Technical Data or Computer Software for commercial purposes or 365 authorize others to do so. 366

Operations, Maintenance, Installation, or Training Purposes (OMIT) Data - Data that is 368 necessary for operation, maintenance, installation, or training purposes (but not 369 including detailed manufacturing or process data). 370

Notice of Funding Opportunity March 27, 2020

SBIR/STTR Computer Software Rights - The Federal Government’s rights during the 372

SBIR/STTR Protection Period in specific types of SBIR/STTR Data that are Computer 373

Software. 374

(1) The Federal Government may use, modify, reproduce, release, perform, display, or 376 disclose SBIR/STTR Data that are Computer Software within the Government. The 377

Federal Government may exercise SBIR/STTR Computer Software Rights within the 378

Government for: 379

(i) Use in Federal Government computers; 381

(ii) Modification, adaptation, or combination with other Computer Software, 383 provided that the Data incorporated into any derivative software are subject to the 384 rights in § 3(ee) of the SBIR/STTR Policy Directive and that the derivative software is 385 marked as containing SBIR/STTR Data; 386

(iii) Archive or backup; or 388

(iv) Distribution of a computer program to another Federal agency, without further 390 permission of the Awardee, if the Awardee is notified of the distribution and the 391 identity of the recipient prior to the distribution, and a copy of the SBIR/STTR 392

Computer Software Rights included in the Funding Agreement is provided to the 393 recipient. 394

(2) The Federal Government shall not release, disclose, or permit access to SBIR/STTR 396

Data that is Computer Software for commercial, manufacturing, or procurement 397 purposes without the written permission of the Awardee. The Federal Government 398 shall not release, disclose, or permit access to SBIR/STTR Data outside the 399

Government without the written permission of the Awardee unless: 400

(i) The non-Governmental entity has entered into a non-disclosure agreement 402 with the Government that complies with the terms for such agreements 403 outlined in § 8 of the SBIR/STTR Policy Directive; and 404

(ii) The release or disclosure is— 406

(A) To a Federal Government support service contractor or their subcontractor 408 for purposes of supporting Government internal use or activities, including 409 evaluation, diagnosis and correction of deficiencies, and adaptation, 410

Notice of Funding Opportunity March 27, 2020 combination, or integration with other Computer Software provided that 411

SBIR/STTR Data incorporated into any derivative software are subject to the 412 rights in § 3(ee) of the SBIR/STTR Policy Directive; or 413

(B) Necessary to support certain narrowly-tailored essential Government 415 activities for which law or regulation permits access of a non-Government entity 416 to a contractors’ data developed exclusively at private expense, non-SBIR/STTR 417

Data, such as for emergency repair and overhaul. 418

SBIR/STTR Data - All Data developed or generated in the performance of an SBIR or 420

STTR award, including Technical Data and Computer Software developed or 421 generated in the performance of an SBIR or STTR award. The term does not include 422 information incidental to contract or grant administration, such as financial, 423 administrative, cost or pricing or management information. 424

SBIR/STTR Data Rights - The Federal Government’s license rights in properly marked 426

SBIR/STTR Data during the SBIR/STTR Protection Period are as follows: SBIR/STTR 427

Technical Data Rights in SBIR/STTR Data that are Technical Data or any other type of 428

Data other than Computer Software; and SBIR/STTR Computer Software Rights in 429

SBIR/STTR Data that is Computer Software. Upon expiration of the protection 430 period for SBIR/STTR Data, the Federal Government has a royalty free license to use, 431 and to authorize others to use on its behalf, these data for Government Purposes, 432 and is relieved of all disclosure prohibitions and assumes no liability for 433 unauthorized use of these data by third parties, except that any such data that is 434 also protected under a subsequent SBIR/STTR award shall remain protected through 435 the protection period of that subsequent award. The Federal Government receives 436

Unlimited Rights in Form Fit, and Function Data, OMIT Data, and all unmarked 437

SBIR/STTR Data. 438

SBIR/STTR Protection Period - The period of time during which the Federal 440

Government is obligated to protect SBIR/STTR Data against unauthorized use and 441 disclosure in accordance with SBIR/STTR Data Rights. The SBIR/STTR Protection 442

Period begins at award of an SBIR/STTR Funding Agreement and ends not less than 443 twenty years from that date (See § 8(b)(4) of the SBIR/STTR Policy Directive). 444

SBIR/STTR Technical Data Rights - The Federal Government’s rights during the 446

SBIR/STTR Protection Period in SBIR/STTR Data that are Technical Data or any other 447 type of Data other than Computer Software. 448

Notice of Funding Opportunity March 27, 2020

(1) The Federal Government may, use, modify, reproduce, perform, display, 450 release, or disclose SBIR/STTR Data that are Technical Data within the 451

Government; however, the Government shall not use, release, or disclose the 452 data for procurement, manufacturing, or commercial purposes; or release or 453 disclose the SBIR/STTR Data outside the Government except as permitted by 454 paragraph (B) below or by written permission of the Awardee. 455

(2) SBIR/STTR Data that are Technical Data may be released outside the 457

Federal Government without any additional written permission of the 458

Awardee only if the non-Governmental entity or foreign government has 459 entered into a non-disclosure agreement with the Federal Government that 460 complies with the terms for such agreements outlined in § 8 of the SBIR/STTR 461

Policy Directive and the release is: 462

(i) Necessary to support certain narrowly-tailored essential Government 464 activities for which law or regulation permits access of a non-Government 465 entity to a contractors’ data developed exclusively at private expense, non-466

SBIR/STTR Data, such as for emergency repair and overhaul; 467

(ii) To a Government support services contractor in the performance of a 469

Government support services contract for internal Government use or 470 activities, including evaluation, diagnosis or modification, provided that 471

SBIR/STTR Technical Data incorporated into any derivative Data are subject to 472 the rights in § 3(ii) of the SBIR/STTR Policy Directive, and the release is not for 473 commercial purposes or manufacture; 474

(iii) To a foreign government for purposes of information and evaluation if 476 required to serve the interests of the U.S. Government; or 477

(iv) To non-Government entities or individuals for purposes of evaluation. 479

Technical Data - Recorded information, regardless of the form or method of the 481 recording, of a scientific or technical nature (including Computer Software 482

Documentation and Computer Databases). The term does not include Computer 483

Software or financial, administrative, cost or pricing, or management information, or 484 other data incidental to contract or grant administration. The term includes recorded 485

Data of a scientific or technical nature that is included in Computer Databases. 486

Unlimited Rights - The Government’s rights to access, use, modify, prepare derivative 488

Notice of Funding Opportunity March 27, 2020 works, reproduce, release, perform, display, disclose, or distribute Data in whole or in 489 part, in any manner and for any purpose whatsoever, and to have or authorize others 490 to do so. 491

1.06 Fraud, Waste and Abuse 493

As defined in the SBIR/STTR Policy Directive section 9(f), fraud includes any false 495 representation about a material fact or any intentional deception designed to deprive the 496

United States unlawfully of something of value or to secure from the United States a 497 benefit, privilege, allowance, or consideration to which an individual or business is not 498 entitled. Waste includes extravagant, careless, or needless expenditure of Government 499 funds, or the consumption of Government property, that results from deficient practices, 500 systems, controls, or decisions. Abuse includes any intentional or improper use of 501

Government resources, such as misuse of rank, position, or authority or resources. 502

Examples of fraud, waste, and abuse relating to the SBIR/STTR Program include, but are 503 not limited to: 504

(i) misrepresentations or material, factual omissions to obtain, or otherwise receive funding 506 under, an SBIR/STTR award; 507

(ii) misrepresentations of the use of funds expended, work done, results achieved, or 509 compliance with program requirements under an SBIR/STTR award; 510

(iii) misuse or conversion of SBIR/STTR award funds, including any use of award funds while 512 not in full compliance with SBIR/STTR Program requirements, or failure to pay taxes due on 513 misused or converted SBIR/STTR award funds; 514

(iv) fabrication, falsification, or plagiarism in applying for, carrying out, or reporting results 516 from an SBIR/STTR award; 517

(v) failure to comply with applicable federal costs principles governing an award; 519

(vi) extravagant, careless, or needless spending; 521

(vii) self-dealing, such as making a sub-award to an entity in which the Principal Investigator 523

(PI) has a financial interest; 524

(viii) acceptance by agency personnel of bribes or gifts in exchange for grant or contract 526

Notice of Funding Opportunity March 27, 2020 awards or other conflicts of interest that prevents the Government from getting the best 527 value; and 528

(ix) lack of monitoring, or follow-up if questions arise, by agency personnel to ensure that 530 awardee meets all required eligibility requirements, provides all required certifications, 531 performs in accordance with the terms and conditions of the award, and performs all work 532 proposed in the application. 533

Report any allegations of fraud, waste and abuse using the online Department of Commerce 535

Office of Inspector General Complaint Form, available at 536 https://www.oig.doc.gov/Pages/Hotline.aspx#complainthotline. Contact information for 537 the Office of Inspector General is available at: https://www.oig.doc.gov/pages/Contact- 538

Us.aspx. Please do not include Personally Identifiable Information (PII) through the website. 539

PII is considered to be items containing Social Security numbers, dates of birth, credit card 540 and passport numbers, or other personally identifying information that could adversely 541 affect an individual. Should you desire to provide this information, it is strongly 542 recommended that you contact the Hotline by telephone at the number listed below. 543

Phone: 545

Toll Free 800-424-5197 546

Mail: 548

Office of Inspector General Hotline 549

HCHB 7709 550

1401 Constitution Avenue, N.W. 551

Washington, DC 20230 552

1.07 Other Information 554

1.07.01 Personal and Business Information 556

The applicant acknowledges and understands that information and data contained in 558 applications for financial assistance, as well as information and data contained in financial, 559 performance and other reports submitted by applicants, may be used by the Department of 560

Commerce in conducting reviews and evaluations of its financial assistance programs. For 561 this purpose, applicant information and data may be accessed, reviewed and evaluated by 562

Department of Commerce employees, other Federal employees, and also by Federal agents 563 and contractors, and/or by non-Federal personnel, all of whom enter into appropriate 564 https://www.oig.doc.gov/Pages/online-hotline-complaint-form.aspx 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 March 27, 2020 conflict of interest and confidentiality agreements covering the use of such information. As 565 may be provided in the terms and conditions of a specific financial assistance award, 566 applicants are expected to support program reviews and evaluations by submitting required 567 financial and performance information and data in an accurate and timely manner, and by 568 cooperating with Department of Commerce and external program evaluators. In accordance 569 with 2 C.F.R. § 200.303(e), applicants are reminded that they must take reasonable 570 measures to safeguard protected personally identifiable information and other confidential 571 or sensitive personal or business information created or obtained in connection with a 572

Department of Commerce financial assistance award. 573

In addition, Department of Commerce regulations implementing the Freedom of 575

Information Act (FOIA), 5 U.S.C. § 552, are found at 15 C.F.R. Part 4, Public Information. 576

These regulations set forth rules for the Department regarding making requested materials, 577 information, and records publicly available under the FOIA. Applications submitted in 578 response to this Notice of Funding Opportunity may be subject to requests for release 579 under the Act. In the event that an application contains information or data that the 580 applicant deems to be confidential commercial information that should be exempt from 581 disclosure under FOIA, that information should be identified, bracketed, and marked as 582

Privileged, Confidential, Commercial or Financial Information. In accordance with 15 CFR § 583

4.9, the Department of Commerce will protect from disclosure confidential business 584 information contained in financial assistance applications and other documentation 585 provided by applicants to the extent permitted by law. 586

2.0 CERTIFICATIONS 589

2.01 Funding Agreement Certification 591

Awardees will be required to certify size, ownership and other SBIR Program requirements 593 at the time of award and during the funding agreement life cycle using the SBIR Funding 594

Agreement Certification and the SBIR Funding Agreement Certification – Life-Cycle 595

Certification, which are provided in Appendix B of this NOFO. 596

2.02 Research Activities Involving Human Subjects, Human Tissue, Data or Recordings 598

Involving Human Subjects Including Software Testing 599

Any application that includes research activities involving human subjects, human 601 tissue/cells, or data or recordings from or about human subjects, must satisfy the 602 requirements of the Common Rule for the Protection of Human Subjects (“Common Rule”), 603

Notice of Funding Opportunity March 27, 2020 codified for the Department of Commerce at 15 C.F.R. Part 27. Research activities involving 604 human subjects that fall within one or more of the classes of vulnerable subjects found in 45 605

C.F.R. Part 46, Subparts B, C and D must satisfy the requirements of the applicable subpart(s). 606

In addition, any such application that includes research activities on these subjects must be in 607 compliance with all applicable statutory requirements imposed upon the Department of 608

Health and Human Services (DHHS) and other Federal agencies, all regulations, policies and 609 guidance adopted by DHHS, the Food and Drug Administration (FDA), and other Federal 610 agencies on these topics, and all Executive Orders and Presidential statements of policy on 611 applicable topics. (Regulatory Resources: 612 http://www.hhs.gov/ohrp/humansubjects/index.html which includes links to FDA 613 regulations, but may not include all applicable regulations and policies). 614

NIST uses the following Common Rule definitions for research and human subjects research: 616

Research: A systematic investigation, including research development, testing and 618 evaluation, designed to develop or contribute to generalizable knowledge. Activities which 619 meet this definition constitute research for purposes of this policy, whether or not they are 620 conducted or supported under a program which is considered research for other purposes. 621

For example, some demonstration and service programs may include research activities. 622

Human Subject: A living individual about whom an investigator (whether professional or 624 student) conducting research: (i) Obtains information or biospecimens through intervention 625 or interaction with the individual, and uses, studies, or analyzes the information or 626 biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private 627 information or identifiable biospecimens. 628

(1) Intervention includes both physical procedures by which information or 630 biospecimens are gathered and manipulations of the subject or the subject's 631 environment that are performed for research purposes. 632

(2) Interaction includes communication or interpersonal contact between investigator 634 and subject. 635

(3) Private information includes information about behavior that occurs in a context in 636 which an individual can reasonably expect that no observation or recording is 637 taking place, and information which has been provided for specific purposes by an 638 individual and that the individual can reasonably expect will not be made public 639

(for example, a medical record). Private information must be individually 640 identifiable (i.e., the identity of the subject is or may readily be ascertained by the 641 http://www.hhs.gov/ohrp/humansubjects/index.html

Notice of Funding Opportunity March 27, 2020 investigator associated with the information) in order for obtaining the information 642 to constitute research involving human subjects. 643

(4) Identifiable biospecimen includes a biospecimen for which the identity of the 645 subject is or may readily be ascertained by the investigator or associated with the 646 biospecimen. 647

See 15 C.F.R. § 27.102 (Definitions). 649

1) Requirement for Federalwide Assurance. If the application is accepted for [or 651 awarded] funding, organizations that have an Institutional Review Board (IRB) are 652 required to follow the procedures of their organization for approval of exempt and 653 non-exempt research activities that involve human subjects. Both domestic and 654 foreign organizations performing exempt research requiring limited IRB review or 655 non-exempt research activities involving human subjects will be required to have 656 protocols approved by a cognizant, active IRB currently registered with the Office 657 for Human Research Protections (OHRP) within the DHHS that is linked to the 658 engaged organizations. All engaged organizations must possess a currently valid 659

Federalwide Assurance (FWA) on file from OHRP. Information regarding how to 660 apply for an FWA and register an IRB with OHRP can be found at 661 http://www.hhs.gov/ohrp/assurances/index.html. See 15 C.F.R. § 27.103. NIST 662 relies only on OHRP-issued FWAs and IRB Registrations for both domestic and 663 foreign organizations for NIST supported research involving human subjects. NIST 664 will not issue its own FWAs or IRB Registrations for domestic or foreign 665 organizations. 666

2) Administrative Review. The NIST Research Protections Office (RPO) reserves the 668 right to conduct an administrative review1 of all applications that potentially 669 include research involving human subjects and were approved by an authorized 670 non-NIST institutional entity (an IRB or entity analogous to the NIST RPO) under 15 671

C.F.R. § 27.112 (Review by Institution). If the NIST RPO determines that an 672 application includes research activities that potentially involve human subjects, the 673 applicant will be required to provide additional information to NIST for review and 674

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 March 27, 2020 approval. The documents required for funded proposals are listed in each section 675 below. Most documents will need to be produced during the proposal review 676 process; however, the Grants Officer may allow final versions of certain required 677 documents to be produced at an appropriate designated time post-award. 678

Research involving human subjects may not start until the NIST Grants Officer 679 issues an award explicitly authorizing such research. In addition, all amendments, 680 modifications, or changes to approved research and requests for continuing review 681 and closure will be reviewed by the NIST RPO. 682

3) Required documents for proposal review.