2018-NIST-SBIR-02 NOFO.pdf

FY 2018 Small Business Innovation Research Program - Phase II Notice of Funding Opportunity (2018-NIST-SBIR-02)

February 21, 2018

FY 2018

Small Business Innovation Research

(SBIR) Program – Phase II

Notice of Funding Opportunity (NOFO)

ANNOUNCEMENT

FUNDING OPPORTUNITY NUMBER: 2018-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: February 21, 2018

Closing Date: April 24, 2018 http://www.nist.gov/sbir http://www.nist.gov/sbir

February 21, 2018

Table of Contents

1.0 PROGRAM DESCRIPTION AND FEDERAL AWARD INFORMATION

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

1.07 Other Information

2.0 CERTIFICATIONS

2.01 Funding Agreement Certification

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

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

2.04 Certifications Regarding Federal Felony and Federal Criminal Tax Convictions, Unpaid Federal Tax Assessments and Delinquent Federal Tax Returns

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

February 21, 2018

4.02 Phase II Screening Criteria

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 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

7.0 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES

February 21, 2018

8.0 SUBMISSION FORMS AND CERTIFICATIONS

8.01 Required Forms and Documents

8.02 Verifying the Submission and Tracking the Application

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

9.0 RESEARCH TOPICS

9.01 Collaborations and Partnership ………………………………………………………..……………………………..57

9.02 Data and Modeling …………………………………………………….……………………………………..…….…..….58

9.03 Precision Measurements …..……………………………………………………………………………………….……65

9.04 Systems ………………………………………..……………………………………………………………….…….….……...80

Appendix A. COVER SHEET ……………………………………………………………………………………………………102

APPENDIX B. CERTIFICATIONS…….…………………..………………………………………………………………

February 21, 2018

US DEPARTMENT OF COMMERCE

NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

FY 2018 SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM

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 NIST SBIR FY 2017 Phase I awardees to submit Phase II research applications under this Notice of Funding Opportunity (NOFO). Only NIST SBIR FY 2017 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 2018 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. Subtopics set forth in Section 9 of this NOFO are intended to cultivate private sector innovation and foster and encourage participation by minority and disadvantaged persons in technological innovation.

In developing topics and subtopics and when reviewing applications, NIST gives high priority to small business concerns that participate in or conduct energy efficiency or renewable

February 21, 2018 energy system R&D projects, consistent with Executive 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) SBIR Policy Directive, § 9, found at http://www.sbir.gov/sites/default/files/sbir_pd_with_1-8- 14_amendments_2-24-14.pdf.

For any SBIR award for a subtopic 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 small business concerns for innovation research. SBIR policy is provided by the SBA through the SBIR Policy Directive found at http://www.sbir.gov/sites/default/files/sbir_pd_with_1-8-14_amendments_2-24-14.pdf.

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

February 21, 2018 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.

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 SBIR FY 2017 Phase I awardees to submit a Phase II application following completion of Phase I. This NOFO provides instructions for NIST SBIR FY 2018 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 $300,000 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 Public Law 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 supplemental funding (up to an additional ten percent of the Phase II award) 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.

1.03 SBIR Applicant Eligibility and Limitations

February 21, 2018

1.03.01 Applicant Qualifications

Under this NOFO, only FY 2017 NIST SBIR Phase I awardees are eligible to submit applications. Each applicant must qualify as a small business concern 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 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 Policy Directive (see Appendices V-VI), found at https://www.sbir.gov/sites/default/files/sbir_pd_with_1-8-14_amendments_2-24- 14.pdf. Each SBC applying for an award is required to update the appropriate information in the SBA Tech-Net database on SBIR.gov for any of its existing and prior Phase II awards.

Applicants may not participate in the selection of any topic or subtopic nor in the review of applications.

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

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. Phase II applicants must have registered 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 form as described in Section 8.01.9of 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

In the interest of competitive fairness, all oral or written communication with NIST regarding Section 9.0 Research Topics is prohibited during the Phase II open NOFO period. Questions and answers will not be accepted through, nor posted on, Grants.gov.

Applicants may also contact the NIST Hollings Manufacturing Extension Partnership (MEP) to be directed to Centers for technical assistance with application preparation.

More information on obtaining technical assistance from MEP Centers for application preparation can be found in Section 5.12 of this NOFO.

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 Fax: (301) 975-3482 E-mail: mary.clague@nist.gov or

J’aime Maynard http://www.sbir.gov/registration mailto:mary.clague@nist.gov

February 21, 2018

Subject Area Point of Contact Phone: (301) 975-8408 E-mail: jmaynard@nist.gov

Electronic Application Submission through Grants.gov

Christopher Hunton Phone: (301) 975-5718 Fax: (301) 975-6368 E-mail: grants@nist.gov or

Grants.gov Phone: 800-518-4726 E-mail: support@grants.gov

Grant Rules and Regulations Nuria Martinez Phone: (301) 975-6215 Fax: (301) 975-6368 E-mail: nuria.martinez@nist.gov

1.05 Definitions

Except as specifically noted by citation or reference, all definitions below are excerpted from the SBA SBIR Policy Directive, available at http://sbir.gov/sites/default/files/sbir_pd_with_1-8-14_amendments_2-24-14.pdf.

Applicant – The organizational entity that qualifies as a Small Business Concern (SBC) at all pertinent times and that submits a contract proposal or a grant application for a funding agreement under the SBIR Program.

Awardee – The organizational entity that receives an SBIR Phase I, Phase II or Phase III award.

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

Cooperative Agreement - A financial assistance mechanism used when substantial Federal mailto:jmaynard@nist.gov mailto:grants@nist.gov mailto:support@grants.gov mailto:nuria.martinez@nist.gov http://sbir.gov/sites/default/files/sbir_pd_with_1-8-14_amendments_2-24-14.pdf

February 21, 2018 programmatic involvement with the awardee during performance is anticipated by the issuing agency. The Cooperative Agreement contains the responsibilities and respective obligations of the parties.

Contract – A mutually binding legal relationship obligating the seller to furnish equipment, goods or services and the buyer to pay for them.

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

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

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, intensive study directed toward greater knowledge or understanding of the subject studied;

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

(3) a systematic application of knowledge toward the production of useful materials, devices, services, or methods, and includes design, development, and improvement of prototypes and new processes to meet specific requirements.

SBIR Technical Data - All data generated during the performance of an SBIR award.

SBIR Technical Data Rights - The rights an SBIR awardee obtains in data generated during the performance of any SBIR Phase I, Phase II, or Phase III award that an awardee delivers to the Government during or upon completion of a Federally-funded project, and to which the Government receives a license.

Small Business Concern (SBC) – A concern that meets the requirements set forth in 13 C.F.R.

http://www.law.cornell.edu/cfr/text/13/121.103

February 21, 2018

§ 121.702 (available at http://www.gpo.gov/fdsys/granule/CFR-2011-title13-vol1.CFR-2011-title13-vol1-sec121-702).

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 – See 2 C.F.R. § 200.92.

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.

1.06 Fraud, Waste and Abuse

As defined in the SBIR 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 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 Program include, but are not limited to:

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

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

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

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

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

http://www.gpo.gov/fdsys/pkg/CFR-2011-title13-vol1/pdf/CFR-2011-title13-vol1-sec121-801.pdf http://www.gpo.gov/fdsys/pkg/CFR-2011-title13-vol1/pdf/CFR-2011-title13-vol1-sec121-801.pdf 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

February 21, 2018

(vi) extravagant, careless, or needless spending;

(vii) self-dealing, such as making a sub-award to an entity in which the 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 or send an e-mail to:

Hotline@oig.doc.gov. Note: Because the Internet is not secure, it is possible, though unlikely, that e-mail complaints may be read by persons other than your intended source. If you are concerned about this, you may choose to call or mail. 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 or via e-mail. 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. Web submissions and e-mails containing such information will be blocked by our system administrator and will not be processed by our Complaint Department. Should you desire to provide this information, please contact the Hotline by telephone at the numbers listed below.

Phone:

Toll Free 800-424-5197 In the DC metro area 202-482-2495 TTD Toll Free 855-860-6950 TTD in the DC metro area 202-482-5923 https://www.oig.doc.gov/Pages/online-hotline-complaint-form.aspx https://www.oig.doc.gov/Pages/online-hotline-complaint-form.aspx mailto:Hotline@oig.doc.gov https://www.oig.doc.gov/pages/Contact-Us.aspx https://www.oig.doc.gov/pages/Contact-Us.aspx

February 21, 2018

Mail:

Office of Inspector General Complaint Intake Unit, Mail Stop 7886 1401 Constitution Avenue, N.W.

Washington, DC 20230

Fax:

855-569-9235

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.

In addition, Department of Commerce regulations implementing the Freedom of Information Act (FOIA), 5 U.S.C. § 552 et seq., 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

February 21, 2018 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).

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.

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

February 21, 2018

Human Subject: A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information.

(1) Intervention includes both physical procedures by which data 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 which 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.

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 non-exempt research activities that involve human subjects. Both domestic and foreign organizations performing 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. 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 Human Subjects Protection Office (HSPO) http://www.hhs.gov/ohrp/assurances/index.html

February 21, 2018 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 HSPO) under 15 C.F.R. § 27.112 (Review by Institution). If the NIST HSPO 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 HSPO.

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

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

1 Conducting an “administrative review” means that the NIST HSPO will review and verify the performing institution’s determination for research not involving human subjects or exempt human subjects research. In addition, for non-exempt human subjects research, the NIST HSPO will review and confirm that the research and performing institution(s) are in compliance with 15 C.F.R. Part 27, which means HSPO 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 an appropriate continuing review at least annually.

February 21, 2018 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.

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.

Exempt research determination with no IRB. If the application appears to NIST to include exempt research activities, and the performer of the activity or the supplier and/or the receiver of the biological materials or data 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. § 27.101(b),

(c) 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 biological materials or data from human subjects.

(3) A copy of the protocol for the research to be conducted; and/or the biological materials or data from human subjects to be collected/provided, not pre-existing

February 21, 2018 samples (i.e., will proposed research collect only information without personal identifiable information, will biological materials or data 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 biological materials or data from human subjects, provide copies of the consent forms used for collection and a description of how the materials or data 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 biological materials or data from human subjects is exempt under the Common Rule.

Research review with an IRB. If the application appears to NIST to include research activities (exempt or non-exempt) involving human subjects, and the proposed performer of the activity has 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 signed (by the study principal investigator) copy of each applicable final IRB-approved protocol.

February 21, 2018

(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 what 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.

For more information regarding research projects involving human subjects, contact Anne Andrews, Director, NIST Human Subjects Protection Office (e-mail:

anne.andrews@nist.gov; phone: 301-975-5445).

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

Any application that proposes research activities involving live vertebrate animals that are to be cared for, euthanized, or used by award recipients to accomplish research goals, teaching, or testing must meet the requirements of the Animal Welfare Act (AWA) (7 U.S.C.

§ 2131 et seq.), and the AWA final rules (9 C.F.R. Parts 1, 2, and 3), and if appropriate, the Good Laboratory Practice for Nonclinical Laboratory Studies (21 C.F.R. Part 58). In addition, such research activities should be in compliance with the “U.S. Government Principles for mailto:anne.andrews@nist.gov

February 21, 2018

Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training” (Principles). The Principles and guidance on these Principles are available in the National Research Council's “Guide for the Care and Use of Laboratory Animals,'' which can be obtained from National Academy Press, 500 5th Street, N.W., Department 285, Washington, DC 20055, or as a free PDF online at http://www.nap.edu/catalog/12910/guide-for-the-care-and-use-of-laboratory-animals-eighth.

1) Administrative Review. NIST reserves the right to conduct an administrative review2 of all applications that potentially include research activities that involve live vertebrate animals, or custom samples from, or field studies with live vertebrate animals. If the application includes research activities, field studies, or custom samples involving live vertebrate animals, the applicant will be required to provide additional information for review and approval. In addition, NIST will verify the applicant’s determination(s) of excluded samples from vertebrate animals. The documents required for funded proposals are listed in each section below. Some may be requested for a pre-review 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. If an award is issued, no research activities involving live vertebrate animals shall be initiated or costs incurred for those activities under the award until the NIST Grants Officer issues written approval. In addition, all re-approvals, amendments, modifications, changes, annual reports and closure will be reviewed by NIST.

2) Required documents for NIST proposal review. The applicant should clearly indicate in the application, by separable task, all research activities believed to include research involving live vertebrate animals and the institution(s) where the research activities involving live vertebrate animals may be conducted. In addition, the applicant should indicate any activity/task that involves an excluded or custom collection from vertebrate animals, or a field study with animals.

a) Excluded Collections from Vertebrate Animals: The requirements for review and approval by an Institutional Animal Care and Use Committee (IACUC) do not apply to

2 Conducting an “administrative review” means that the NIST HSPO will review and verify the performing institution’s IACUC’s approval of research with live vertebrate animals, and confirm that the research and performing institution(s) have an appropriate assurance and are in compliance with applicable regulations. HSPO will 1) confirm the engaged institution(s) possess, or are covered under an applicable assurance, 2) review the research study documentation submitted to the IACUC and verify the IACUC’s determination of level of risk and approval of the study for compliance with applicable regulations, 3) review and verify IACUC-approved substantive changes to an approved research study before the changes are implemented, and 4) review and verify that the IACUC receives an annual report for the study and conducts an appropriate continuing review at least every three years.

http://www.nap.edu/catalog/12910/guide-for-the-care-and-use-of-laboratory-animals-eighth http://www.nap.edu/catalog/12910/guide-for-the-care-and-use-of-laboratory-animals-eighth

February 21, 2018 proposed research using preexisting images of animals or to research plans that do not include live animals. These regulations also do not apply to obtaining stock or pre-existing items from animal material suppliers (e.g., tissue banks), such as pre-existing cell lines and tissue samples, or from commercial food processors, where the vertebrate animal was euthanized for food purposes and not for the purpose of sample collection.

For pre-existing cell lines and tissue samples originating from vertebrate animals, NIST requires that the proposer provide documentation or the rationale for the determination that the cell line or tissue is pre-existing and not a custom collection from live vertebrate animals for an activity/task within the proposal. NIST may require additional documentation to review and/or support the determination that the cells and/or tissues from vertebrate animals are excluded from IACUC review.

b) Custom Collections Harvested from Live Vertebrate Animals: NIST requires documentation for obtaining custom samples from live vertebrate animals from animal material suppliers and other organizations (i.e., universities, companies, and government laboratories, etc.). A custom sample includes samples from animal material suppliers, such as when a catalog item indicates that the researcher is to specify the characteristics of the live vertebrate animal to be used, or how a sample is to be collected from the live vertebrate animal.

c) Field Studies of Animals: Some field studies of animals may be exempt under the Animal Welfare Act from full review and approval by an animal care and use committee, as determined by each institution. Field study is defined as “… a study conducted on free-living wild animals in their natural habitat...”. 9 C.F.R. § 1.1.

However, this term excludes any study that involves an invasive procedure or that harms or materially alters the behavior of an animal under study. Field studies, with or without invasive procedures, may also require obtaining appropriate federal or local government permits (marine mammals, endangered species, etc.). If the applicant’s institution requires review and approval by an animal care and use committee, NIST will require that documentation to be provided as described below.

d) For custom collections or studies with live vertebrate animals that require review and approval by an animal care and use committee the following documentation is required:

(1) Requirement for Assurance. An applicable assurance for the care and use of the live vertebrate animal(s) to be used in the proposed research is required. NIST may request documentation to confirm an assurance, if adequate confirmation is not available through an assuring organization’s website. The cognizant IACUC

February 21, 2018 where the research activity is located may hold one or more assurances applicable to the research activity that are acceptable to NIST. These three assurances are:

i. Animal Welfare Assurance from the Office of Laboratory Animal Welfare (OLAW) indicated by the OLAW assurance number, i.e., A-1234;

ii. USDA Animal Welfare Act certification indicated by the certification number, i.e., 12-R-3456;

iii. Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) indicated by providing the organization name accredited by AAALAC as listed in the AAALAC Directory of Accredited Organizations.

(2) Documentation of Research Review by an IACUC: If the applicant’s application appears to include research activities, field studies, or custom sample collections involving live vertebrate animals the following information regarding review by an applicable IACUC may be requested during the application review process:

1. The name(s) of the institution(s) where the research involving live vertebrate animals will be conducted and/or custom samples collected.

2. The assurance type and number, as applicable, for the cognizant Institutional Animal Care and Use Committee (IACUC) where the research activity is located. [For example: Animal Welfare Assurance from the Office of Laboratory Animal Welfare (OLAW) should be indicated by the OLAW assurance number, i.e. A-1234; an USDA Animal Welfare Act certification should be indicated by the certification number i.e. 12-R-3456; and an Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) should be indicated by AAALAC.]

3. The IACUC approval date for the Animal Study Protocol (ASP) (if currently approved).

4. If the review by the cognizant IACUC is pending, the estimated start date for research involving vertebrate animals.

5. If any assurances or IACUCs need to be obtained or established, that should be clearly stated.

6. If any special permits are required for field studies, those details should be clearly provided for each instance, or indicated as pending.

If the application includes research activities involving vertebrate animals 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, which may also include field studies, custom sample collections involving live vertebrate animals:

February 21, 2018

1. A signed (by the Principal Investigator) copy of the IACUC approved ASP.

2. Documentation of the IACUC approval indicating the approval and expiration dates of the ASP.

3. If applicable, a non-duplication-of-funding letter if the ASP is funded from several sources.

4. If a new ASP will only be submitted to an IACUC if an award from NIST is issued, a draft of the proposed ASP may be requested.

5. Any additional clarifying documentation that NIST may request during review of…