NOAA SBIR Phase II FY20 NOFO - Final 7.31.pdf

FY 2020 NOAA Small Business Innovation Research Program – Phase II Open Date: July 31, 2020 Close Date: October 14, 2020

SBIR

FY 2020 Small Business Innovation Research

Phase II

Notice of Funding Opportunity (NOFO)

This NOFO is open only to those small business concerns that were awarded a SBIR Phase I grant in response to the FY2019 Phase I NOFO

NOAA‐OAR‐OAR‐TPO‐2019‐2005899

U.S. DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration http://www.techpartnerships.noaa.gov

Funding Opportunity Number: NOAA‐OAR‐OAR‐TPO‐ 2020‐2006595

Assistance Listings or Catalog of Federal Domestic Assistance

(CFDA) Number:

11.021 NOAA Small

Business Innovation Research (SBIR) Program

Opening Date: July 31, 2020 Closing Date: October 14, 2020

Table of Contents

1.0 PROGRAM DESCRIPTION AND FEDERAL AWARD INFORMATION

1.1 INTRODUCTION

1.2 THREE‐PHASE PROGRAM

1.2.01 Phase I – Feasibility Research

1.2.02 Phase II – Research and Development (R&D)

1.2.03 Phase III – Commercialization

1.3 MANUFACTURING‐RELATED PRIORITY

1.4 ENERGY EFFICIENCY AND RENEWABLE ENERGY PRIORITY

1.5 SBIR APPLICANT ELIGIBILITY AND LIMITATION

1.5.01 Applicant Qualification

1.5.02 Company Registry Requirements

1.5.03 Performance Benchmark Ratings Requirements

1.6 CONTACT WITH NOAA

1.7 DEFINITIONS

1.8 FRAUD, WASTE, AND ABUSE

1.9 OTHER INFORMATION

1.9.01 Personal and Business Information

2.0 CERTIFICATIONS

2.1 FUNDING AGREEMENT CERTIFICATIONS

2.2 RESEARCH ACTIVITIES INVOLVING HUMAN SUBJECTS, HUMAN TISSUE, DATA OR RECORDINGS INVOLVING HUMAN SUBJECTS

2.2.01 Protection of Human Subjects

2.2.02 IRB Education Documentation

2.3 RESEARCH PROJECT INVOLVING LIVE VERTEBRATE ANIMALS

2.4 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

3.1 PHASE II APPLICATION REQUIREMENTS

3.2 PHASE II PROJECT NARRATIVE (TECHNICAL CONTENT)

4.0 METHOD OF SELECTION AND EVALUATION CRITERIA

4.1 EVALUATION AND SELECTION PROCESS

4.2 PHASE II SCREENING CRITERIA

4.3 PHASE II EVALUATION CRITERIA

4.4 PHASE II AWARD SELECTIONS

4.5 FEDERAL AWARDING AGENCY REVIEW OF RISK POSED BY APPLICANTS

4.6 RELEASE OF APPLICATION REVIEW INFORMATION

5.0 CONSIDERATIONS

5.1 AWARDS

5.2 REPORTING REQUIREMENTS

5.3 PAYMENT SCHEDULE

5.4 INNOVATIONS, INVENTIONS AND PATENTS

5.4.01 Proprietary Information

5.4.02 Rights in Data Developed Under SBIR Funding Agreements

5.4.03 NOAA‐Owned Inventions

5.4.04 Patent Rights

5.4.05 Invention Reporting

5.5 COST SHARING

5.6 PROFIT OR FEE

5.7 JOINT VENTURES OR LIMITED PARTNERSHIPS

5.8 RESEARCH AND ANALYTICAL WORK

5.9 AWARDEE COMMITMENTS

5.10 SUMMARY STATEMENTS

5.11 ADDITIONAL INFORMATION

5.12 TECHNICAL ASSISTANCE FOR APPLICATION PREPARATION AND PROJECT CONDUCT

5.13 NOAA GRANT MANAGEMENT OFFICE STATEMENTS

6.0 SUBMISSION OF APPLICATIONS

6.1 DEADLINE FOR APPLICATIONS

6.2 APPLICATION PACKAGE

6.3 APPLICATION SUBMISSION

7.0 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES

8.0 SUBMISSION FORMS AND CERTIFICATIONS

8.1 REQUIRED APPLICATION FORMS AND DOCUMENTS

8.2 VERIFYING THE SUBMISSION AND TRACKING THE APPLICATION

8.3 UNIQUE ENTITY IDENTIFIER AND SYSTEM FOR AWARD MANAGEMENT (SAM)

APPENDICES – CERTIFICATIONS, SBIR COVER PAGE AND CHECKLIST

U.S. DEPARTMENT OF COMMERCE

NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION

FY 2020 SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM – Phase II

NOTICE OF FUNDING OPPORTUNITY (NOFO)

1.0 PROGRAM DESCRIPTION AND FEDERAL AWARD INFORMATION

1.1 Introduction

The U.S. Department of Commerce (DOC) National Oceanic and Atmospheric Administration (NOAA) invites small businesses to submit research proposals under this NOFO. The Small Business Innovation Research (SBIR) Program is not a substitute for existing unsolicited proposal mechanisms. Unsolicited proposals are not accepted under the SBIR program.

Only Fiscal Year (FY) 2020 Phase II applications may be submitted in response to this NOFO. Phase I applications are not being accepted at this time. Only FY 2019 NOAA SBIR Phase I awardees in response to NOFO number NOAA‐OAR‐OAR TPO‐2019‐ 2005899 with project start dates of January 1, 2020 and project end dates of no later than September 30, 2020 are eligible to submit a Phase II application in response to this

NOFO.

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 set aside a portion of their extramural R&D budget each year to fund research proposals from small science and technology‐based firms. The goals of the SBIR program are to: stimulate technological innovation; strengthen the role of small business in meeting Federal R&D needs; foster and encourage participation by socially and economically disadvantaged Small Business Concerns and by women‐ owned SBCs, in technological innovation; and increase private sector commercialization of innovations derived from federal research and development funding. The NOAA SBIR Program identifies and solicits proposals in subtopics that fall within NOAA’s mission.

NOAA is not obligated to make any awards under this NOFO, and all awards are subject to the availability of funds. NOAA is not responsible for any costs expended by the applicant in the development of the proposal and prior to award of any finance assistance award.

1.2 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 Small Business Administration (SBA) through the SBIR Policy Directive found on http://www.sbir.gov. The NOAA specific program authority will vary depending on the nature of the proposed project. A list of the most prevalent assistance authorities are 15 U.S.C. 1540; 16 U.S.C. 661 et seq.; 16 U.S.C. 1456c; 15 U.S.C. 2901 et. seq.; 33 U.S.C.

883a‐d; 33 USC 893a; 33 U.S.C. 1442; 49 U.S.C. 44720(b).

The funding vehicle for this announcement is through a grant. This NOFO is for Phase II applications only. Unsolicited proposals will not be accepted through the SBIR Program. NOAA has the unilateral right to select SBIR research topics and awardees in both Phase I and Phase II and award several or no financial assistance awards under a given subtopic.

1.2.01 Phase I – Feasibility Research

This NOFO does not request proposals for Phase I; however, a description of Phase I is provided here. The purpose of Phase I is to determine the scientific, technical, and commercial merit and feasibility of the proposed research and the quality of performance of the small business concern receiving an award. Therefore, the Phase I proposal should concentrate on research that will significantly contribute to proving the feasibility of the proposed research, a prerequisite to further support in Phase II.

Applicants are encouraged to consider, and discuss in their proposal, whether the research or research and development (R&D) being proposed to NOAA also has private sector potential, either for the proposed application or as a basis for other applications. Only DOC NOAA SBIR Phase I awardees from the previous year will be eligible to submit a Phase II application.

1.2.02 Phase II – Research and Development (R&D)

This NOFO requests proposals for Phase II from FY 2019 Phase I NOAA SBIR awardees only. 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.

Phase II awards shall be for no more than $400,000. The period of performance for the

Phase II award will depend upon the scope of the research but is typically no more than 24 months. For planning purposes, NOAA anticipates making Phase II awards with grant start dates of February 1, 2021. This date should be used by all applicants as a proposed start date.

1.2.03 Phase III – Commercialization

Under Phase III, the small business entity obtains funding from either, the private sector, a non‐SBIR Government source, or both, to develop the prototype into a viable product or non‐ R&D service for sale in the domestic or international marketplace. SBIR 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, Research / Research and Development (R/R&D) or a combination thereof.

1.3 Manufacturing‐Related Priority

Executive Order (EO) 13329 “Encouraging Innovation in Manufacturing” requires SBIR agencies, to the extent permitted by law and in a manner consistent with the mission of that department or agency, to give high priority within the SBIR programs to manufacturing‐related R&D. “Manufacturing‐related” is defined as “relating to manufacturing processes, equipment and systems; or manufacturing workforce skills and protection.”

The NOAA SBIR Program solicits manufacturing‐related projects through many of the programs subtopics. Further, NOAA encourages innovation in manufacturing by giving high priority, where feasible, to projects that can help the manufacturing sector through technological innovation in a manner consistent with NOAA’s mission

1.4 Energy Efficiency and Renewable Energy Priority

The Energy Independence and Security Act of 2007 (P.L. 110‐140) directs SBIR Programs to give high priority to small business concerns that participate in or conduct energy efficiency or renewable energy system R&D projects.

The NOAA SBIR Program solicits energy efficiency or renewable energy system R&D projects through many of the program subtopics. Further, NOAA encourages innovation in energy efficiency or renewable energy system R&D by giving high priority, where feasible, to projects that conduct energy efficiency or renewable energy system R&D through technological innovation in a manner consistent with NOAA’s mission. This prioritization will not interfere with the core project selection criteria: scientific and technical merit and the potential for commercial success.

1.5 SBIR Applicant Eligibility and Limitation

1.5.01 Applicant Qualification

Each applicant must qualify as a small business concern for research or research and development (R/R&D) purposes, as defined in Section 1.7 of this NOFO, at the time of the award and at any other time set forth in the SBA’s regulations at 13 CFR 121.701‐

121.705. Each awardee, at the time of the award (but not at the time of the application), must submit a certification (See Appendix A) stating that it meets the size, ownership, and other requirements of the SBIR Program and at any other time set forth in SBA’s regulations at 13 CFR 121.701‐705 in order to qualify for the award.

Eligible applicants include only those small business concerns as described above that were awarded a NOAA SBIR Phase I grant in response to NOFO number NOAA‐OAR‐ OAR TPO‐2019‐2005899 that had a performance period start date of January 1, 2020 and an end date no later than September 30, 2020. No other small business concerns are eligible to submit an application in response to this NOFO.

For Phase II, a minimum of one‐half of the research and/or analytical effort must be performed by the applicant. The total cost for all consultant fees, facility leases, usage fees, and other contract/subcontract/subaward or purchase agreements may not exceed one‐half of the total award.

For Phase II, the primary employment of the principal investigator (PI) must be with the small business concern (SBC) at the time of the award and during the conduct of the proposed project.

Primary employment means that more than one‐half of the principal investigator’s time is spent in the employ of the SBC (as an employee and not a contractor or consultant). Primary employment with an SBC precludes full‐time employment with another organization.

For Phase II, all work must be performed by the SBC and its subcontractors in the United States.

“United States” means the fifty states, the territories and possessions of the United States, the Commonwealth of Puerto Rico, the District of Columbia, The Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau. In rare and unique circumstances, a waiver to the requirement that all work be performed in the United States may be requested.

For example, where a supply/material or other item or project requirement is not available in the United States, NOAA may allow that particular portion of the R&D work to be performed or obtained in a country outside of the United States.

If a waiver is requested, it must be submitted to the NOAA SBIR Program Manager. The waiver request must be submitted in writing and must include specific information about where work performed or supplies received from outside the United States are being considered and a detailed rationale explaining steps taken to locate potential United States sources; if any United States sources were located and any potential concerns for use of those sources; and any potential cost differences between United States sources and foreign sources, if applicable. This waiver request shall be submitted via email to the NOAA SBIR Program Manager (listed in section 1.6) at least fourteen calendar days prior to the NOFO closing date of October 14, 2020. It is in the firm’s best interest to submit these waiver requests as soon as they are known. Waivers are only approved in rare and unique circumstances.

Venture Capital Participation: NOAA elects not to use the authority that would allow venture capital operating companies (VCOCs), hedge funds, or private equity firms to participate in the SBIR Program.

NOAA may not enter into, or continue, an existing CRADA with an awardee under this program.

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‐STTR_Policy_Directive_2019.pdf.

Each SBC applying for an award is required to update the appropriate information in SBIR.gov for any of its existing and prior SBIR awards.

1.5.02 Company Registry Requirements

SBA maintains and manages a Company Registry at http://www.sbir.gov/registration to track ownership and affiliation requirements for all companies applying to the SBIR Program. Each Phase II applicant must register in the Company Registry prior to submitting an application. The applicant must save its information from the registration in a .pdf document and append this document to the SF‐424 form as described at the end of Section 8.1 of this NOFO. All applicants are required to report and/or update their registration information in the SBA Company Registry prior to each SBIR application submission or if any information changes prior to an award.

1.5.03 Performance Benchmark Ratings Requirements

Performance benchmark rating requirements are only applicable to Phase I; however, information is provided here for future reference.

All Phase I applicants with a current Small Business Administration (SBA) assessment of their Phase I to Phase II Transition Rate must, at the time of the application under a Phase I NOFO, have satisfied the requirements of that Performance Benchmark to be eligible for a new Phase I award. NOAA will not consider (and will automatically disqualify) proposals from firms that are currently ineligible for Phase I awards as a result of failing to meet the benchmark rate at the last assessment.

The Phase I to Phase II Transition Rate requirement applies only to SBIR Phase I applicants that have received more than 20 (21 or more) Phase I awards over the past five (5) fiscal years (excluding the most recent year). For these applicants, the ratio of the number of Phase II awards (awarded during the past five (5) fiscal years) to the number of Phase I awards (awarded during the past five (5) years excluding the most recent year) must be at least 0.25. On June 1st of each year, the SBA assesses the Performance Benchmark rates for all applicable SBIR and Small Business Technology Transfer (STTR) awardees in the Company Registry. STTR is another program that expands funding opportunities in the federal innovation research and development arena. See https://www.sbir.gov/about/about‐sttr. Performance Benchmark rates are based on a company’s total SBIR/STTR awards, across all the participating federal agencies. Companies that fail to meet the Performance Benchmark requirements are not eligible to submit a Phase I proposal for a period of one year from the assessment:

from June 1st through May 31st. Note that this does not affect a company’s eligibility for Phase II or Phase III awards.

All applicants should verify their Transition Rate eligibility for Phase I awards. When logged in to the Company Registry at https://www.sbir.gov/registration, awardees can view their last assessed Transition Rate by clicking on the “Performance Benchmark” side‐bar. These company‐specific rates appear under the heading “At Last Assessment.”

A thumbs‐up/thumbs‐down indicator shows whether or not the company passed the benchmark rates at the last assessment. If at any time, a company believes the award information on SBIR.gov is not correct, it should notify SBA using the dispute link provided. If a company’s dispute of the data used for the rates is under review, it will see “TBD” under the “At Last Assessment” heading. Companies with less than the threshold number of awards (21 Phase I awards for the Transition Rate) will see “N/A” displayed because the requirement did not apply to them.

Under the heading “Current (On‐Going)”, the page displays a running calculation of the benchmark rates using the next years’ time periods (each period moved up by one year) and current data in the system. Companies should monitor these rates to anticipate their standing for each upcoming June 1 Assessment

General information on the Performance Benchmark requirements is available at https://www.sbir.gov/performance‐benchmarks

1.6 Contact with NOAA

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

Subject Area Point of Contact

Programmatic Questions Richard Fulton NOAA SBIR Program Manager Phone: (301) 628‐1067 Richard.Fulton@noaa.gov

Janet Johnson Russell NOAA SBIR Program Officer Phone: 301‐628‐1062 Janet.J.Russell@noaa.gov

Electronic Application Submission through https://www.grants.gov/

Grants.gov Phone: 1‐800‐518‐4726 Email: support@grants.gov

Grant Administrative Rules and Regulations

Lamar Revis Phone: (301) 628‐1308 Email: Lamar.Revis@noaa.gov

1.7 Definitions

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

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

Application – Also referred to as a “proposal”

Authorized Organizational Representative ‐ The individual(s), named by the applicant/recipient organization, who is legally authorized to act for the applicant/recipient and to assume the obligations imposed by the federal laws, regulations, requirements, and conditions that apply to grant applications or awards.

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. As used here, commercialization includes both Government and private sector markets.

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.

Funding Agreement Officer. Per the SBIR Policy Directive, a funding agreement officer is defined as a federal contracting officer, a grants officer, or a cooperative agreement officer.

Grant. A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity authorized by law of the United States (31 U.S.C. 6101(3)). A grant is used whenever the Federal agency anticipates no substantial programmatic involvement with the awardee during performance.

Innovation. Something new or improved, having marketable potential, including: (1) development of new technologies: (2) refinement of existing technologies: or (3) development of new applications for existing technologies

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

National Environmental Policy Act (NEPA) The National Environmental Policy Act, or NEPA, is a United States environmental law that promotes the enhancement of the environment and was enacted as law on January 1, 1970 (P.L. 91‐190). All NOAA SBIR Phase I and Phase II awards must go through an agency internal NEPA assessment before a full award is made. The purpose is to capture any details of the project that may potentially or inadvertently pollute/affect the environment.

Principal Investigator (PI)/Project Manager (PM) The one individual designated by the applicant to provide the scientific and technical direction to a project supported by a funding agreement

Project Narrative – This is the main document outlining the detailed innovative solution by the applicant. Under this NOFO, it is interchangeable with the “Technical Proposal”

Proposal – Also referred to as an “application.”

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 Policy Directive – As mandated by the SBIR legislation, the Small Business Administration (SBA) authors this policy that outlines how the SBIR program is run in each participating agency. The link to this policy can be found at www.sbir.gov.

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. § 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.

Technical Proposal – See “Project Narrative” above

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.

1.8 Fraud, Waste, and Abuse

All applicants must complete the DOC Office of Inspector General (OIG) mandatory training and sign and submit the certification of completion form along with their application. The link to the Fraud, Waste, and Abuse training slides is located here:

http://www.techpartnerships.noaa.gov/SBIR.aspx. Certification can be found at the end of the training module. All applicants must print, sign, and submit certification of completion as an attachment (as per end of Section 8.1).

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;

(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) the 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/Hotline.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

Mail:

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

Washington, DC 20230

Fax:

855‐569‐9235

1.9 Other Information

1.9.01 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. Sec. 552, are found at 15 C.F.R. Part 4, Public Information. These regulations set forth rules for the Department regarding making requested materials, information, and records publicly available under the FOIA.

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

2.0 CERTIFICATIONS

2.1 Funding Agreement Certifications

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 (At Time of Award)” and the “SBIR Funding Agreement Certification (Life‐Cycle Certification)”, which are provided in Appendix A and Appendix B of this NOFO, respectively. Awardees must submit Life‐Cycle Certification both prior to receiving more than 50% of the total award amount and prior to final payment or disbursement to verify compliance with specific SBIR/STTR program requirements.

2.2 Research Activities Involving Human Subjects, Human Tissue, Data or Recordings Involving Human Subjects

2.2.01 Protection of Human Subjects

Any application that includes participation in research involving human subjects, human tissue/cells, data or recordings involving human subjects must meet the requirements of the Common Rule for the Protection of Human Subjects (“Common Rule”), codified for the Department of Commerce (DOC) at 15 C.F.R. Part 27. In addition, any such proposal that includes research on these topics must be in compliance with any statutory requirements imposed upon the Department of Health and Human Services (DHHS) and other Federal agencies regarding these topics, all regulatory policies and guidance adopted by DHHS, the Food and Drug Administration, and other Federal agencies on these topics, and all Executive Orders and Presidential statements of policy on these topics.

NOAA reserves the right to make an independent determination of whether an applicant’s research involves human subjects. If NOAA determines that your research project involves human subjects, you will be required to provide additional information for review and approval. If an award is issued, no research activities involving human subjects shall be initiated or costs incurred under the award until the NOAA Grants Officer issues written approval. Retroactive approvals are not permitted.

NOAA will accept applications that include research activities involving human subjects that have been or will be approved by an Institutional Review Board (IRB) currently registered with the Office for Human Research Protections (OHRP) within the DHHS and that will be performed by entities possessing a currently valid Federal wide Assurance (FWA) on file from OHRP that is appropriately linked to the cognizant IRB for the protocol. 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.

Generally, NOAA does not fund research involving human subjects in foreign countries.

NOAA will consider, however, the use of preexisting tissue, cells, or data from a foreign source on a limited basis if all of the following criteria are satisfied:

1. the scientific source is considered unique,

2. an equivalent source is unavailable within the United States,

3. an alternative approach is not scientifically of equivalent merit, and

4. the specific use qualifies for an exemption under the Common Rule.

Any award issued by NOAA is required to adhere to all Presidential policies, statutes, guidelines, and regulations regarding the use of human embryonic stem cells. The DOC follows the NIH Guidelines by supporting and conducting research using only human embryonic stem cell lines that have been approved by NIH in accordance with the NIH Guidelines. Detailed information regarding NIH Guidelines for stem cells is located on the NIH Stem Cell Information website: http://stemcells.nih.gov. The DOC will not support or conduct any type of research that the NIH Guidelines prohibit NIH from funding. The DOC will review research using human embryonic stem cell lines that it supports and conducts in accordance with the Common Rule and NOAA implementing procedures, as appropriate.

Any request to support or conduct research using human embryonic stem cell lines not currently approved by the NIH, will require that the owner, deriver, or licensee of the human embryonic stem cell line apply for and receive approval of the registration of the cell line through the established NIH application procedures:

http://hescregapp.od.nih.gov/NIH_Form_2890_Login.htm. Due to the timing uncertainty associated with establishing an embryonic stem cell line in the NIH registry, the use of existing human embryonic stem cell lines in the NIH Embryonic Stem Cell Registry may be preferred by applicants or current award recipients. The NIH Embryonic Stem Cell Registry is located at: http://grants.nih.gov/stem_cells/registry/current.htm.

An applicant or current award recipient proposing to use a registered embryonic stem cell line will be required to document an executed agreement for access to the cell line with the provider of the cell line and acceptance of any established restrictions for use of the cell line, as may be noted in the NIH Embryonic Stem Cell Registry.

If the proposal includes exempt and/or non‐exempt research activities involving human subjects the following information is required in the application:

(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 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 FWAs or IRB registrations are being applied for, that should be clearly stated.

Additional documentation may be requested, as warranted, during review of the proposal, but may include the following for research activities involving human subjects that are planned in the first year of the award:

(1) A signed (by the study principal investigator) copy of each applicable final IRB‐ approved protocol;

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

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

(4) A brief description of what portions of the IRB submitted protocol are specifically included in the proposal submitted to NOAA, if the protocol includes tasks not applicable to the proposal, or if the protocol is supported by multiple funding sources. For protocols with multiple funding sources, NOAA 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 NOAA is issued, a draft of the proposed protocol may be requested;

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

2.2.02 IRB Education Documentation

A signed and dated letter is required from the Organizational Official who is authorized to enter into commitments on behalf of the organization documenting that appropriate IRB education has been received by the Organizational Official, the IRB Coordinator or such person that coordinates the IRB documents and materials if such a person exists, the IRB Chairperson, all IRB members, and all key personnel associated with the application. The NOAA requirement of documentation of education is consistent with NIH notice OD‐00‐039 (June 5, 2000). Although NOAA will not endorse an educational curriculum, there are several curricula that are available to organizations and investigators that may be found at: http://grants.nih.gov/grants/guide/notice‐ files/NOT‐OD‐00‐039.html

2.3 Research Project Involving Live Vertebrate Animals

Any proposal that includes research involving live vertebrate animals must be in compliance with the “U.S. Government Principles for 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‐thecare‐and‐use‐of‐laboratory‐ animals‐eighth. In addition, such proposals must meet the requirements of the Animal Welfare Act (AWA) (7 U.S.C. § 2131 et seq.), the AWA 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). These regulations do not apply to proposed research using preexisting images of animals or to research plans that do not include live animals that are being cared for, euthanized, or used by the project participants to accomplish research goals, teaching, or testing. These regulations also do not apply to obtaining animal materials from commercial processors of animal products or to animal cell lines or tissues from tissue banks.

NOAA reserves the right to make an independent determination of whether your research involves live vertebrate animals. If NOAA determines that your research project involves live vertebrate animals, you will be required to provide additional information for review and approval. If an award is issued, no research activities involving live vertebrate animals subjects shall be initiated or costs incurred under the award until the NOAA Grants Officer issues written approval.

If the proposal includes research activities involving live vertebrate animals, the following information is required in the proposal:

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

(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; a 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 (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.

Additional documentation will be requested, as warranted, during review of the proposal, but may include the following for research activities involving live vertebrate animals that are planned in the first year of the award:

(1) A signed (by the Principal Investigator) copy of the IACUC approved Animal Study Proposal (ASP);

(2) Documentation of the IACUC approval indicating the approval and expiration dates of the ASP; and

(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 NOAA issued, a draft of the proposed ASP may be requested.

(5) Any additional clarifying documentation that NOAA may request during review of proposals to perform the NOAA administrative review of research involving live vertebrate animals.

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

In accordance with Federal appropriations law, an authorized representative of the selected applicant(s) may be required to provide certain pre‐award certifications regarding federal felony and federal criminal tax convictions, unpaid federal tax assessments, and delinquent federal tax returns. As with NOAA’s typical grants process, forms will be sent out to “selected for award” applicants during negotiation with the Grants Officer.

3.0 APPLICATION PREPARATION INSTRUCTIONS AND REQUIREMENTS

3.1 Phase II Application Requirements

NOAA reserves the right not to forward an application for technical review if NOAA determines the application has insufficient scientific and technical information or is missing any of the required forms and documents listed in Section 8.1. Applications that do not pass the screening criteria (outlined in Section 4.2) will be rejected without further consideration.

Applicants should utilize the SBIR forms in Appendix C and D to ensure that eligibility requirements are met and that all required information is submitted, respectively.

A proposal must be self‐contained and written with all the care and thoroughness of a scientific paper submitted for publication. It should indicate a thorough knowledge of the current status of research in the subtopic area addressed by the proposal. Each proposal should be checked carefully by the applicant to ensure inclusion of all essential material needed for a complete evaluation. The proposal will be peer reviewed as a scientific paper. All units of measurement should be in the metric system.

The applicant must provide sufficient information to demonstrate that the proposed work represents a sound approach to the investigation of an important scientific or engineering innovation worthy of support. The proposal must not only be responsive to the specific NOAA program interests described in the original Phase I subtopic, but also serve as the basis for technological innovation leading to new commercial products, processes, or services that benefit the public.

The proposal should be direct, concise, and informative. Promotional and other material not related to the project should be omitted.

As required by the SBIR Policy Directive, NOAA will notify the various applicants whether they have been recommended for a potential award within 90 calendar days of the closing date of this NOFO. If selected for potential award and approved by the Grants Officer, the applicant can anticipate receiving an actual award within 180 calendar days of the closing date of the NOFO. The SBC applicant shall not proceed with work until an official award is received and accepted.

All applicants are required to provide information for SBA’s database (www.sbir.gov).

The following are examples of the data to be entered by applicants into the SBA database:

Any business concern or subsidiary established for the commercial application of a product or service for which an SBIR award is made.

Revenue from the sale of new products or services resulting from the research conducted under each Phase II award.

Additional investment from any source, other than Phase I or Phase II awards, to further the research and development conducted under each Phase II award.

Updated information in the SBA database on sbir.gov for any prior award received by the SBC. The SBC may apportion sales or additional investment information relating to more than one Phase II award among those awards, if it notes the apportionment for each award.

All awardees are required to update appropriate information on the award in the database upon completion of the last program objective under the funding agreement and is requested to voluntarily update the information in the database annually thereafter for a minimum period of five (5) years.

3.2 Phase II Project Narrative (Technical Content)

A complete application must include a Project Narrative (also called the Technical Proposal) as described below and all other forms and documents listed in Section

8.1 “Required Application Forms and Documents” of this NOFO. Pages should be of standard size (8 1/2” x 11”; 21.6 cm x 27.9 cm) with margins of 2.5 cm and type at least 10‐point font. All units of measurement should be presented in metric units. The document should be converted into the Adobe Portable Document Format (PDF) prior to submission to NOAA.

Please review Section 8.1 for the entire list of required application forms and documents to submit as part of a complete application package.

The following sections are required in the Project Narrative. All headings and sections must be included. There is no total page limit. If a particular section does not apply, please include in the heading, followed by N/A.

1. Title page. This is one full page long and must identify all of the following information: Project title, company name, company representative, and principal investigator by full name, title, organization, telephone number, mailing address, e‐mail address, the NOAA SBIR Phase II NOFO identification number, the total requested funds, the proposed project period of performance, and the application submission date.

2. Project abstract and summary of potential commercial application of the research results. The applicant must submit a one page project abstract (limited to 200 words) and summary of potential commercial application of the research results (limited to 100 words). Please include key project identifying information (e.g., the project title, company name, principal investigator’s name) at the top of this page.

In the event that the application is funded, this abstract and summary of potential commercial applications will be published on the NOAA SBIR and SBIR.gov websites and provided to the SBA and therefore should not contain proprietary information.

3. Identification and Significance of the Problem or Opportunity. Make a clear statement of the specific research problem or opportunity addressed, its innovativeness, commercial potential, and explanation of importance.

4. Phase I Summary. This summarizes Phase I activities and key results and findings related to this specific application. The summary should demonstrate that the Phase I project was successful in achieving the objectives identified in the funded Phase I application. If any objectives were not achieved, please explain why. No specific format requirements except that it must only be two pages maximum.

5. Phase II Technical Objectives. State the specific objectives of the Phase II research or research and development efforts.

6. Phase II Work Plan. Include a detailed description of the Phase II research and development plan. The plan should indicate what will be done, where it will be done, and how the research will be carried out.