Final_FY25 SBIR Phase II NOFO (1).pdf

SBIR

Small Business Innova�on Research

No�ce of Funding Opportunity (NOFO)

FY2025 Phase II

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

FY 2024 Phase I NOFO: NOAA-OAR-TPO-2024-2008184

Funding Opportunity Number: NOAA-OAR-TPO-2025-0002

Assistance Lis�ngs or Catalog of Federal Domes�c Assistance(CFDA) Number:

11.021 NOAA Small Business Innova�on

Research (SBIR) Program

Opening Date: January 10, 2025

Closing Date: March 14, 2025

U.S. DEPARTMENT OF COMMERCE

Na�onal Oceanic and Atmospheric Administra�on h�p://www.techpartnerships.noaa.gov http://www.techpartnerships.noaa.gov/

Table of Contents

US DEPARTMENT OF COMMERCE 3

1.0 PROGRAM DESCRIPTION AND FEDERAL AWARD INFORMATION 3

1.1 Introduc�on 3

1.2 Three-Phase Program 3

Phase I – Feasibility Research 4 Phase II – Research and Development 4

1.3 Manufacturing-Related Priority 4

1.4 Energy Efficiency and Renewable Energy Priority 5

1.5 SBIR Applicant Eligibility and Limita�on 5

Applicant Qualifica�on 5 Company Registry Requirements 6 Performance Benchmark Ra�ngs Requirements 6

1.6 Contact with NOAA 7

1.7 Fraud, Waste and Abuse 7

1.8 Other Informa�on 8

Personal and Business Informa�on 8

2.0 CERTIFICATIONS 9

2.1 Funding Agreement Cer�fica�ons 9

2.2 Research Ac�vi�es Involving Human Subjects, Human Tissue, Data or Recordings Involving Human Subjects 9

Protec�on of Human Subjects 9 IRB Educa�on Documenta�on 11

2.3 Research Project Involving Live Vertebrate Animals 11

3.0 APPLICATION PREPARATION INSTRUCTIONS AND REQUIREMENTS 12

3.1 Phase II Applica�on Requirements 12

3.2 Phase II Applica�on 13

Project Narra�ve 13 SBIR Cover Page and Project Abstract 13 Technical Content 14 Commercializa�on Plan 17

4.0 METHOD OF SELECTION AND EVALUATION CRITERIA 19

4.1 Evalua�on and Selec�on Process 19

4.2 Phase II Screening Criteria 19

4.3 Phase II Evalua�on Criteria 2 1

4.4 Phase II Award Selec�ons 21

4.5 Federal Awarding Agency Review of Risk Posed By Applicants 2 2

4.6 Release of Applica�on Review Informa�on 22

5.0 CONSIDERATIONS 22

5.1 Awards 22

5.2 Repor�ng Requirements 2 3

5.3 Payment Schedule 23

5.4 Innova�ons, Inven�ons and Patents 24

5.4.1 Proprietary Informa�on 24

5.4.2 Rights in Data Developed Under SBIR Funding Agreements 25

5.4.3 NOAA-Owned Inven�ons 2 9

5.4.4 Patent Rights 29

5.4.5 Inven�on Repor�ng 29

5.5 Cost Sharing 29

5.6 Profit or Fee 30

5.7 Joint Venture or Limited Partnerships 30

5.8 Research and Analy�cal Work 30

5.9 Awardee Commitments 30

5.10 Summary Statements 3 1

5.11 Addi�onal Informa�on 31

5.12 Technical Assistance for Applica�on Prepara�on and Project Conduct 3 2

5.13 NOAA Grant Management Office Statements 32

6.0 SUBMISSION OF APPLICATIONS 41

6.1 Deadline for Applica�ons 41

6.2 Applica�on Submission 41

7.0 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES 43

8.0 SUBMISSION FORMS AND CERTIFICATIONS 43

8.1 Required Applica�on Forms and Documents 43

8.2 Verifying the Submission and Tracking the applica�on 4 5

9.0 RESEARCH TOPICS 46

Appendix A. Defini�ons 4 7 Appendix B. SBIR Funding Agreement Cer�fica�on (At Time of Award) 4 9 Appendix C. SBIR Funding Agreement Cer�fica�on (Life-Cycle Cer�fica�on) 52 Appendix D. Cover Page 5 4 Appendix E. Small Business Innova�on Research (SBIR) Program Phase II Applica�on Checklist 5 7

Helpful Hints 5 7 Are you eligible? 5 7 Are you registered? 5 7

Appendix F. Performance Benchmark Ra�ngs Requirements 60

US DEPARTMENT OF COMMERCE

NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION

FY 2025 SMALL BUSINESS INNOVATION RESEARCH (SBIR)

PROGRAM NOTICE OF FUNDING OPPORTUNITY (NOFO)

1.0 PROGRAM DESCRIPTION AND FEDERAL AWARD INFORMATION

1.1 Introduc�on

The Department of Commerce (DOC) Na�onal Oceanic and Atmospheric Administra�on (NOAA) invites small businesses to submit research proposals under this NOFO. The Small Business Innova�on Research (SBIR) Program is not a subs�tute for exis�ng unsolicited proposal mechanisms. Unsolicited proposals are not accepted under the SBIR program.

Only FY 2024 NOAA SBIR Phase I awardees under NOFO number NOAA-OAR-TPO-2024-2008184 with project start dates of August 1, 2024, and project end dates of no later than January 31, 2025, are eligible to submit a Phase II applica�on in response to this NOFO.

The Small Business Innova�on Research (SBIR) program was originally established in 1982 by the Small Business Innova�on 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 Enhancement Act of 1992 (P.L. 102-564) and received subsequent reauthoriza�on and extensions, the most recent of which extends the SBIR program through 2025. (P.L.

117-183).

Each Federal agency with an extramural budget for Research/Research and Development (R/R&D) in excess of $100,000,000 must par�cipate in the SBIR program and spend (obligate) a minimum percentage of their extramural R/R&D budgets (obliga�ons) of not less than 3.2% of such budget in fiscal year 2017 and for the percentage required by statute for each fiscal year a�er for awards to small business concerns (SBCs) for R/R&D under the SBIR program. The objec�ves of the SBIR program are to: s�mulate technological innova�on in the private sector; strengthen the role of small business in mee�ng Federal R&D needs; foster and encourage par�cipa�on by businesses owned by socially and economically disadvantaged persons and women-owned SBCs in technological innova�on; and increase private sector commercializa�on of innova�ons derived from federal R&D funding.

Fostering diversity by encouraging the par�cipa�on of individuals from na�onally underrepresented groups in the scien�fic research workforce is a longstanding interest of Congress, and a key component of NOAA’s commitment to diversity, equity, inclusion, and accessibility (e.g., Public Law 114-329, American Innova�on and Compe��veness Act of 2017, and h�ps://techpartnerships.noaa.gov/abou�po/dei-statement/ ). Increasing par�cipa�on by socially and economically disadvantaged and women-owned small businesses is cri�cal to the success of the SBIR program.

1.2 Three-Phase Program

The SBIR statute (15 U.S.C. § 638) requires the DOC to establish a three-phase SBIR program by reserving a https://techpartnerships.noaa.gov/abouttpo/dei-statement/ percentage of its extramural R&D budget to be awarded to SBCs R&D. SBIR policy is provided by the Small Business Administra�on (SBA) through the SBIR Policy Direc�ve found at: h�p://www.sbir.gov and is incorporated here by reference. The NOAA-specific program authority will vary depending on the nature of the proposed project. A list of the most prevalent assistance authori�es 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; and 49 U.S.C. 44720(b).

The NOAA SBIR program iden�fies and solicits proposals on topics that fall within NOAA’s mission. NOAA has the unilateral right to select SBIR research topics and awardees in both Phase I and Phase II and award several or no grants under a given topic. 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. Only proposals that are directly responsive to the topics described in NOAA-OAR-TPO-2024-2008184 will be considered.

Phase I – Feasibility Research This NOFO does not request proposals for Phase I; however, a descrip�on of Phase I is provided here. The purpose of Phase I is to determine the scien�fic, technical, and commercial merit and feasibility of the proposed research and the quality of performance of the SBC receiving an award. The Phase I proposal should focus on research that will significantly contribute to evalua�ng the feasibility of the project, a prerequisite to further support in Phase II. Applicants are strongly encouraged to consider and discuss in their proposal, the commercial applica�on and private sector poten�al for the proposed effort.

NOAA Phase I awards provide up to $190,000 with up to a six (6) month period of performance. The number of awards is dependent on NOAA’s budget. To accommodate the Phase II award process, no-cost extensions are not permi�ed in Phase I projects that intend to advance to Phase II. If an awardee requests a no-cost extension for the Phase I project, the awardee will be ineligible to submit an applica�on for Phase II.

Phase II – Research and Development This NOFO requests proposals for FY 2025 Phase II from FY 2024 Phase I NOAA SBIR awardees only. In Phase II, work from Phase I that exhibits poten�al for commercial applica�on is further developed. Phase II is the R&D or prototype development phase. While the number of awards is dependent on NOAA’s budget, NOAA an�cipates providing approximately 18 awards. To apply for a Phase II award, each Phase I awardee will be required to submit a comprehensive applica�on outlining the proposed research and a detailed plan to commercialize the final product. NOAA Phase II awards provide up to $690,000 with up to a twenty-four (24) month period of performance. For planning purposes, NOAA’s goal is to make Phase II awards around August of fiscal year 202 5 4 .

Phase III - Commercializa�on Under Phase III, the small business en�ty obtains funding from either the private sector, a non-SBIR Government source, or both, to commercialize the SBIR research or technology. SBIR Phase III includes 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.

1.3 Manufacturing-Related Priority

Execu�ve Order (EO) 13329 “Encouraging Innova�on in Manufacturing” requires SBIR agencies, to the extent permi�ed 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 “rela�ng to http://www.sbir.gov/ manufacturing processes, equipment, and systems; or manufacturing workforce skills and protec�on.”

The NOAA SBIR Program solicits manufacturing-related projects through many of the topics described in this NOFO. Further, NOAA encourages innova�on in manufacturing by giving high priority, where feasible, to projects that can help the manufacturing sector through technological innova�on in a manner consistent with NOAA’s mission. This priori�za�on will not interfere with the core project selec�on criteria: scien�fic and technical merit and the poten�al for commercial success.

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 SBCs that par�cipate 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 topics described in this NOFO. Further, NOAA encourages innova�on 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 innova�on in a manner consistent with NOAA’s mission. This priori�za�on will not interfere with the core project selec�on criteria: scien�fic and technical merit and the poten�al for commercial success.

1.5 SBIR Applicant Eligibility and Limita�on

Applicant Qualifica�ons Each applicant must qualify as an SBC for R/R&D purposes, as defined in this sec�on of the NOFO, at the �me of the award and at any other �me set forth in the SBA’s regula�ons at 13 CFR 121.701- 121.705. Each awardee, at the �me of the award (but not at the �me of the applica�on), must submit a cer�fica�on (See Appendix B) sta�ng that it meets the size, ownership, and other requirements of the SBIR Program and at any other �me set forth in SBA’s regula�ons at 13 CFR 121.701-121.705 in order to qualify for the award.

In addi�on, the primary employment of the principal inves�gator (PI) must be with the SBC at the �me of the award and during the conduct of the proposed project. Primary employment means that at least 51% of the PI’s �me is spent in the employ of the SBC. Primary employment with a SBC precludes full-�me employment with another organiza�on. Further, an SBC may only replace the principal inves�gator on an SBIR Phase II award if the NOAA Grants Officer provides prior wri�en approval. Requests for a waiver of the requirement must be submi�ed in wri�ng at the �me of applica�on submission. Only rare and unique circumstances will be considered for an exemp�on. The NOAA Grants Officer, in consulta�on with the SBIR Program Manager, must approve each exemp�on and its terms in wri�ng.

For Phase II, a minimum of one-half of the research and/or analy�cal 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.

Applicants (and any affiliated individuals) may not par�cipate in the selec�on of any topic. Addi�onally, they may not par�cipate in the review of proposals. All associated en��es to applicants to this NOFO (including Guest Researchers, Coopera�ve Research and Development Agreement (CRADA) partners and others working with

NOAA) may only submit a proposal if they:

● Had no role in developing or reviewing the topic;

● Have not been the recipient of any informa�on on the topic not available in the NOFO or by other public means; and

● Have not received any assistance from DOC in preparing the proposal for this specific NOFO (including any 'informal' reviews) prior to submission.

Each applicant will be required to provide certain informa�on via www.sbir.gov as well as other informa�on required by the SBIR Policy Direc�ve (see Appendices V-VI), found at:

h�ps://www.sbir.gov/sites/default/files/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.pdf . Each SBC applying for an award is required to update the appropriate informa�on in SBIR.gov for any of its exis�ng and prior SBIR awards.

Venture Capital Par�cipa�on : NOAA elects not to use the authority that would allow venture capital opera�ng companies (VCOCs), hedge funds, or private equity firms to par�cipate in the SBIR Program. Applica�ons in which work would be performed by VCOCs, hedge funds, or private equity firms will not be considered for award.

Company Registry Requirements SBA maintains and manages a Company Registry at: h�p://www.sbir.gov/registra�on to track ownership and affilia�on requirements for all companies applying to the SBIR Program. Each Phase II applicant must register in the Company Registry prior to submi�ng an applica�on. The applicant must save its informa�on from the registra�on in a .pdf document and append this document to the SF-424 form as described at the end of Sec�on 8.1 of this NOFO. All applicants are required to report and/or update their registra�on informa�on in the SBA Company Registry prior to each SBIR applica�on submission or if any informa�on changes prior to an award.

Performance Benchmark Ra�ngs Requirements Performance benchmark ra�ng requirements are only applicable to Phase I; however, informa�on is provided here for future reference. All Phase I applicants with a current SBA assessment of their Phase I to Phase II Transi�on Rate must, at the �me of the applica�on under this FY25 NOFO, have sa�sfied the requirements of that Performance Benchmark to be eligible for a new Phase I award. NOAA will automa�cally 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. For addi�onal informa�on, see Appendix F.

1.6 Contact with NOAA

For general programma�c, electronic submission, or grants ques�ons, please contact the appropriate individual:

Subject Area Point of Contact Programma�c Ques�ons The SBIR Team

Email: noaa.sbir@noaa.gov Subject Line: NOAA-OAR-TPO-2025-0002 http://www.sbir.gov/ https://www.sbir.gov/sites/default/files/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.pdf https://app.www.sbir.gov/company-registration/overview

Electronic Applica�on Submission through Grants.gov at:

h�ps://www.grants.gov/

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

Grant Administra�ve Rules and Regula�ons

Raishan Adams Email: raishan.adams@noaa.gov

1.7 Fraud, Waste and Abuse

Preven�on of Fraud, Waste, and Abuse is very important to the NOAA SBIR program. All applicants must complete the DOC OIG agency mandatory training and submit the cer�fica�on of comple�on along with their applica�on. The Fraud, Waste, and Abuse training can be found, under “Resources for Applicants” at:

h�ps://techpartnerships.noaa.gov/wp-content/uploads/2022/02/DOC-SBIR-Mandatory-Training-Slides-and-Cer� fica�on-Form.pdf . Cer�fica�on can be found at the end of the training module. All applicants must print, sign, and submit cer�fica�on of comple�on as an a�achment to their applica�on (See Sec�on 8.1).

As defined in the SBIR Policy Direc�ve sec�on 9(f), fraud includes any false representa�on about a material fact or any inten�onal decep�on designed to deprive the United States unlawfully of something of value or to secure from the United States a benefit, privilege, allowance, or considera�on to which an individual or business is not en�tled. Waste includes extravagant, careless, or needless expenditure of Government funds, or the consump�on of Government property, that results from deficient prac�ces, systems, controls, or decisions.

Abuse includes any inten�onal or improper use of Government resources, such as misuse of rank, posi�on, or authority or resources. Examples of fraud, waste, and abuse rela�ng to the SBIR Program include, but are not limited to:

i. misrepresenta�ons or material, factual omissions to obtain, or otherwise receive funding under, an SBIR award;

ii. misrepresenta�ons 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. fabrica�on, falsifica�on, or plagiarism in applying for, carrying out, or repor�ng 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 en�ty in which the PI has a financial interest;

viii. acceptance by agency personnel of bribes or gi�s in exchange for grant or contract awards or other conflicts of interest that prevents the Government from ge�ng the best value; and

ix. lack of monitoring, or follow-up if ques�ons arise, by agency personnel to ensure that awardee meets all required eligibility requirements, provides all required cer�fica�ons, performs in accordance with the terms and condi�ons of the award, and performs all work proposed in the applica�on.

Report any allega�ons of fraud, waste and abuse using the online Department of Commerce Office of Inspector General Complaint Form , available at: h�ps://www.oig.doc.gov/Pages/Hotline.aspx or send an e-mail to :

https://www.grants.gov/ https://techpartnerships.noaa.gov/wp-content/uploads/2022/02/DOC-SBIR-Mandatory-Training-Slides-and-Certification-Form.pdf https://techpartnerships.noaa.gov/wp-content/uploads/2022/02/DOC-SBIR-Mandatory-Training-Slides-and-Certification-Form.pdf https://www.oig.doc.gov/Pages/online-hotline-complaint-form.aspx https://www.oig.doc.gov/Pages/Hotline.aspx 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 informa�on for the Office of Inspector General is available at: h�ps://www.oig.doc.gov/contact/ . .

Please do not include Personally Iden�fiable Informa�on (PII) through the website or via email. PII is considered to be items containing Social Security numbers, dates of birth, credit card and passport numbers, or other personally iden�fying informa�on that could adversely affect an individual. Web submissions and e-mails containing such informa�on will be blocked by our system administrator and will not be processed by our Complaint Department. Should you desire to provide this informa�on, 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 Cons�tu�on Avenue, N.W. Washington, DC 20230

Fax: 855-569-9235

1.8 Other Informa�on

Personal and Business Informa�on

The applicant acknowledges and understands that informa�on and data contained in applica�ons for financial assistance, as well as informa�on and data contained in financial, performance and other reports submi�ed by applicants, may be used by the DOC in conduc�ng reviews and evalua�ons of its financial assistance programs.

For this purpose, applicant informa�on and data may be accessed, reviewed and evaluated by DOC 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 confiden�ality agreements covering the use of such informa�on. As may be provided in the terms and condi�ons of a specific financial assistance award, applicants are expected to support program reviews and evalua�ons by submi�ng required financial and performance informa�on and data in an accurate and �mely manner, and by coopera�ng with the DOC 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 iden�fiable informa�on and other confiden�al or sensi�ve personal or business informa�on created or obtained in connec�on with a DOC financial assistance award.

In addi�on, DOC regula�ons implemen�ng the Freedom of Informa�on Act (FOIA), 5 U.S.C. Sec. 552, are found at 15 C.F.R. Part 4, Public Informa�on. These regula�ons set forth rules for the Department regarding making requested materials, informa�on, and records publicly available under the FOIA. Applica�ons submi�ed in response to this NOFO may be subject to requests for release under the Act. In the event that an applica�on contains informa�on or data that the applicant deems to be confiden�al commercial informa�on that should be exempt from disclosure under FOIA, that informa�on should be iden�fied, bracketed, and marked as Privileged, Confiden�al, Commercial or Financial Informa�on. In accordance with 15 CFR § 4.9, the DOC will protect from disclosure confiden�al business informa�on contained in financial assistance applica�ons and other documenta�on provided by applicants to the extent permi�ed by law.

https://www.oig.doc.gov/contact/

2.0 CERTIFICATIONS

2.1 Funding Agreement Cer�fica�ons

Awardees will be required to cer�fy size, ownership, and other SBIR Program requirements at the �me of award and during the funding agreement life cycle using the “SBIR Funding Agreement Cer�fica�on (At Time of Award)” and the “SBIR Funding Agreement Cer�fica�on (Life-Cycle Cer�fica�on)”, which are provided in Appendix B and Appendix C of this NOFO, respec�vely. Awardees must submit Life-Cycle Cer�fica�on 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 program requirements .

2.2 Research Ac�vi�es Involving Human Subjects, Human Tissue, Data or Recordings Involving Human Subjects

Protec�on of Human Subjects Any applica�on that includes par�cipa�on in research involving human subjects, human �ssue/cells, data or recordings involving human subjects must meet the requirements of the Common Rule for the Protec�on of Human Subjects (“Common Rule”), codified for the DOC at 15 C.F.R. Part 27. In addi�on, 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 Administra�on (FDA), and other Federal agencies on these topics, and all Execu�ve Orders and Presiden�al statements of policy on these topics.

NOAA reserves the right to make an independent determina�on 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 addi�onal informa�on for review and approval. If an award is issued, no research ac�vi�es involving human subjects shall be ini�ated or costs incurred under the award un�l the NOAA Grants Officer issues wri�en approval. Retroac�ve approvals are not permi�ed.

NOAA will accept applica�ons that include research ac�vi�es involving human subjects that have been or will be approved by an Ins�tu�onal Review Board (IRB) currently registered with the Office for Human Research Protec�ons (OHRP) within the DHHS and that will be performed by en��es possessing a currently valid Federal wide Assurance (FWA) on file from OHRP that is appropriately linked to the cognizant IRB for the protocol.

Informa�on regarding how to apply for a FWA and register an IRB with OHRP can be found at:

h�p://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 preexis�ng �ssue, cells, or data from a foreign source on a limited basis if all of the following criteria are sa�sfied:

1. the scien�fic source is considered unique;

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

3. an alterna�ve approach is not scien�fically of equivalent merit; and

4. the specific use qualifies for an exemp�on under the Common Rule.

Any award issued by NOAA is required to adhere to all Presiden�al policies, statutes, guidelines, and regula�ons http://www.hhs.gov/ohrp/assurances/index.html regarding the use of human embryonic stem cells. The DOC follows the Na�onal Ins�tutes of Health (NIH) Guidelines by suppor�ng and conduc�ng research using only human embryonic stem cell lines that have been approved by NIH in accordance with the NIH Guidelines. Detailed informa�on regarding NIH Guidelines for stem cells is located on the NIH Stem Cell Informa�on website: h�p://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 implemen�ng 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 registra�on of the cell line through the established NIH applica�on procedures:

h�p://hescregapp.od.nih.gov/NIH_Form_2890_Login.htm . Due to the �ming, uncertainty associated with establishing an embryonic stem cell line in the NIH registry, the use of exis�ng 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: h�p://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 restric�ons 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 ac�vi�es involving human subjects the following informa�on is required in the applica�on:

1. The name(s) of the ins�tu�on(s) where the research will be conducted;

2. The name(s) and ins�tu�on(s) of the cognizant IRB(s), and the IRB registra�on number(s);

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

4. The FWAs associated with all organiza�ons engaged in the planned research ac�vity linked to the cognizant IRB;

5. If the IRB review(s) is pending, the es�mated 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 registra�ons are being applied for, that should be clearly stated.

Addi�onal documenta�on may be requested, as warranted, during review of the proposal, but may include the following for research ac�vi�es involving human subjects that are planned in the first year of the award:

1. A signed (by the study principal inves�gator) copy of each applicable final IRB-approved protocol;

2. A signed and dated approval le�er from the cognizant IRB(s) that includes the name of the ins�tu�on housing each applicable IRB, provides the start and end dates for the approval of the research ac�vi�es, and any IRB-required interim repor�ng or con�nuing review requirements;

3. A copy of any IRB-required applica�on informa�on, such as documenta�on of approval of special clearances (i.e. biohazard, HIPAA, etc.) conflict-of-interest le�ers, or special training requirements;

4. A brief descrip�on of what por�ons of the IRB submi�ed protocol are specifically included in the proposal submi�ed to NOAA, if the protocol includes tasks not applicable to the proposal, or if the protocol is supported by mul�ple funding sources. For protocols with mul�ple funding sources, NOAA will not approve the study without a non-duplica�on-of-funding le�er indica�ng 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 submi�ed to an IRB if an award from NOAA issued, a dra� of the http://stemcells.nih.gov/ http://hescregapp.od.nih.gov/NIH_Form_2890_Login.htm http://hescregapp.od.nih.gov/NIH_Form_2890_Login.htm http://grants.nih.gov/stem_cells/registry/current.htm proposed protocol may be requested;

6. Any addi�onal clarifying documenta�on that NOAA may request during review of proposals to perform the NOAA administra�ve review of research involving human subjects. ( See 15 C.F.C. § 27.112 (Review by Ins�tu�on)).

IRB Educa�on Documenta�on A signed and dated le�er is required from the Organiza�onal Official who is authorized to enter into commitments on behalf of the organiza�on documen�ng that appropriate IRB educa�on has been received by the Organiza�onal 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 applica�on. The NOAA requirement of documenta�on of educa�on is consistent with NIH no�ce OD-00-039 (June 5, 2000). Although NOAA will not endorse an educa�onal curriculum, there are several curricula that are available to organiza�ons and inves�gators that may be found a t: h�p://grants.nih.gov/grants/guide/no�ce-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 U�liza�on and Care of Vertebrate Animals Used in Tes�ng, Research, and Training” (Principles). The Principles and guidance on these Principles are available in the Na�onal Research Council's “Guide for the Care and Use of Laboratory Animals,'' which can be obtained from Na�onal Academy Press, 500 5th Street, N.W., Department 285, Washington, DC 20055, or as a free PDF online at:

h�p://www.nap.edu/catalog/12910/guide-for-thecare-and-use-of-laboratory- animals-eighth . In addi�on, 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 Prac�ce for Nonclinical Laboratory Studies (21 C.F.R Part 58). These regula�ons do not apply to proposed research using pre-exis�ng images of animals or to research plans that do not include live animals that are being cared for, euthanized, or used by the project par�cipants to accomplish research goals, teaching, or tes�ng. These regula�ons also do not apply to obtaining animal materials from commercial processors of animal products or to animal cell lines or �ssues from �ssue banks.

NOAA reserves the right to make an independent determina�on 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 addi�onal informa�on for review and approval. If an award is issued, no research ac�vi�es involving live vertebrate animal subjects shall be ini�ated or costs incurred under the award un�l the NOAA Grants Officer issues wri�en approval.

If the proposal includes research ac�vi�es involving live vertebrate animals, the following informa�on is required in the proposal:

1. The name(s) of the ins�tu�on(s) where the animal research will be conducted;

2. The assurance type and number, as applicable, for the cognizant Ins�tu�onal Animal Care and Use

Commi�ee (IACUC) where the research ac�vity 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 cer�fica�on should be indicated by the cer�fica�on number i.e. 12-R-3456; and an Associa�on for the Assessment and Accredita�on of Laboratory Animal Care (AAALAC) should be indicated by AAALAC];

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html http://www.nap.edu/catalog/12910/guide-for-thecare-and-use-of-laboratory-http://www.nap.edu/catalog/12910/guide-for-thecare-and-use-of-laboratory-

3. The IACUC approval date (if currently approved);

4. If the review by the cognizant IACUC is pending, the es�mated start date for research involving vertebrate animals;

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

Addi�onal documenta�on will be requested, as warranted, during review of the proposal, but may include the following for research ac�vi�es involving live vertebrate animals that are planned in the first year of the award:

1. A signed (by the Principal Inves�gator) copy of the IACUC approved Animal Study Proposal (ASP);

2. Documenta�on of the IACUC approval indica�ng the approval and expira�on dates of the ASP; and

3. If applicable, a non-duplica�on-of-funding le�er if the ASP is funded from several sources;

4. If a new ASP will only be submi�ed to an IACUC if an award from NOAA issued, a dra� of the proposed

ASP may be requested, and;

5. Any addi�onal clarifying documenta�on that NOAA may request during review of proposals to perform the NOAA administra�ve review of research involving live vertebrate animals.

3.0 APPLICATION PREPARATION INSTRUCTIONS AND REQUIREMENTS

3.1 Phase II Applica�on Requirements

Applicants should use the SBIR forms in Appendix D and E to ensure that eligibility requirements are met and that all required informa�on is submi�ed, respec�vely.

A proposal must be self-contained and wri�en with all the care and thoroughness of a scien�fic paper submi�ed for publica�on. It should indicate a thorough knowledge of the current status of research in the topic area addressed by the proposal. Each proposal should be checked carefully by the applicant to ensure inclusion of all essen�al material needed for a complete evalua�on. The proposal will be peer-reviewed as a scien�fic paper. All units of measurement should be in the metric system.

The applicant must provide sufficient informa�on to demonstrate that the proposed work represents a sound approach to the inves�ga�on of an important scien�fic or engineering innova�on worthy of support. The proposal must not only be responsive to the specific NOAA program interests but also serve as the basis for technological innova�on leading to new commercial products, processes, or services that benefit the public.

The proposal should be direct, concise, and informa�ve. Promo�onal and other material not related to the project should be omi�ed. Do not include hyperlinks to websites or other resources.

Only FY 2025 Phase II applica�ons may be submi�ed in response to this NOFO. Phase I applica�ons are not being accepted at this �me.

All applicants are required to provide informa�on for SBA’s database ( www.sbir.gov ). The following are examples of the data to be entered by applicants into the database:

● Any business concern or subsidiary established for the commercial applica�on of a product or service for which an SBIR award is made;

● Revenue from the sale of new products or services resul�ng from the research conducted under each Phase II award;

● Addi�onal investment from any source, other than Phase I or Phase II awards, to further the research http://www.sbir.gov/ and development conducted under each Phase II award;

● Updated informa�on in the SBA database on sbir.gov for any prior award received by the SBC. The SBC may appor�on sales or addi�onal investment informa�on rela�ng to more than one Phase II award among those awards, if it notes the appor�onment for each award; and

● All awardees are required to update appropriate informa�on on the award in the database upon comple�on of the last program objec�ve under the funding agreement and are requested to voluntarily update the informa�on in the database annually therea�er for a minimum period of five years.

3.2 Phase II Applica�on

The Project Narra�ve, including the Cover Page, Project Abstract, and Technical Content, is limited to 25 pages, including references cited. The only excep�on to the 25-page limit is for SBCs addressing the requirement related to prior SBIR Phase II Awards as listed in Sec�on 3.3 (14). Addi�onal pages beyond the 25-page limit will not be considered in the evalua�on process. The Commercializa�on Plan is limited to 10 pages.

A complete applica�on must include a Project Narra�ve and Commercializa�on Plan (described below) and all other forms and documents listed in Sec�on 8.1 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, Arial or Times New Roman 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 Sec�on 8.1 for the en�re list of required applica�on forms and documents to submit as part of a complete applica�on package.

Project Narra�ve The Project Narra�ve por�on of the applica�on requires the following:

a. SBIR Phase II Cover Page pages 1 and 2 (Appendix D);

b. Project Abstract page 3; and

c. Technical Content pages 4 through 25.

SBIR Cover Page and Project Abstract SBIR Cover Page A completed SBIR Cover Page is a required part of the Project Narra�ve. The Cover Page is counted as pages 1 and 2 of the Project Narra�ve (Appendix D).

Project Abstract Applicants will be required to include a one-page project summary of the proposed R/R&D including at least the following:

(1) Name and complete address of SBC;

(2) Name and �tle of Principal Inves�gator;

(3) Par�cipa�ng Agency name, Program Solicita�on number, and Program Solicita�on topic;

(4) Title of project;

(5) Technical abstract; and

(6) Summary of the an�cipated results and implica�ons of the approach and the poten�al commercial applica�ons of the research.

The technical abstract and summary of an�cipated results are limited to two hundred words each. Project abstracts will be provided to the SBA and should not contain proprietary informa�on. Awardee’s abstract and summary of poten�al commercial applica�ons will be published on the NOAA SBIR website and SBIR.gov. The Project Abstract is counted as page 3 of the Project Narra�ve.

Technical Content

1. Iden�fica�on and Significance of the Problem or Opportunity. Provide a clear statement of the specific research problem or opportunity addressed, its innova�veness, commercial poten�al, and explana�on of importance. Explain how it applies to a relevant topic and fulfills the NOAA mission.

2. Phase I Summary. Summarize Phase I ac�vi�es and key results and findings related to this applica�on.

The summary should demonstrate that the Phase I project was successful in achieving the objec�ves iden�fied in the funded Phase I applica�on. If any objec�ves were not achieved, please explain why.

(Two pages maximum).

3. Phase II Technical Objec�ves. State the specific objec�ves of the Phase II research and development efforts.

4. Phase II Work Plan. Include a detailed descrip�on 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.

The method(s) planned to achieve each objec�ve or task should be discussed in sufficient detail.

5. Related Research or Research and Development (R/R&D). Describe previous R/R&D that is directly related to the applica�on, including any conducted by the PI or by the proposing SBC. Describe how the R/R&D relates to the proposed effort, and describe any planned coordina�on with outside sources. The applicant must persuade evaluators of their awareness of key, recent R/R&D conducted by others in the specific topic area.

6. Key Individuals and Bibliography of Related Work. Iden�fy key individuals involved in Phase II, including their related educa�on, experience, current and previous posi�on �tles and employers, and publica�ons.

Where vitae are extensive, summaries that focus on the most relevant experience and publica�ons are desired and may be necessary to meet applica�on size limita�ons.

7. Rela�onship with Future R/R&D. Discuss the significance of the Phase I effort in providing a founda�on for the Phase II R/R&D effort. Also state the an�cipated results and products of the proposed approach if Phase II of the project is successful.

8. Facili�es and Equipment. Provide a detailed descrip�on, availability, and loca�on of instrumenta�on and physical facili�es proposed for Phase II.

9. Consultants, Contracts, and Sub-awards. The purpose of this sec�on is to show that any third-party research assistance would materially benefit the proposed effort and that arrangements for such assistance are in place at �me of applica�on submission. It is important that these individuals be clearly iden�fied as consultants, sub-awardees, or subcontractors. This should match and be reflected in the budget tables and budget narra�ve sec�ons.

For Phase II, a minimum of one half of the research and/or analy�cal effort must be performed by the awardee. Outside involvement in the project is encouraged where it strengthens the conduct of the research but is not a requirement of the program. The total cost for all consultant fees, facility leases, usage fees, and other subcontract/subaward or purchase agreements may not exceed half the total award.

No individual or en�ty may serve as consultant, contractor, or sub-recipient if they (a) had any role in sugges�ng, developing, or reviewing the NOAA topic; or (b) have been the recipient of any NOAA informa�on on the topic not available to the public.

The following defini�ons apply to this NOFO:

● Consultant - A person outside the firm, named in the applica�on as contribu�ng to the research, must provide a signed statement confirming his/her availability, role in the project, and agreed consul�ng rate for par�cipa�on in the project.

● Contract - Similarly, where a contract is involved in the research, the contractor ins�tu�on must furnish a le�er signed by an appropriate official describing the programma�c arrangements and confirming its agreed par�cipa�on in the research, with its proposed budget for this par�cipa�on.

● Sub-awards - As the funding instrument used in this program is financial assistance, an awardee might pass through funds to another organiza�on to carry out part of the Federally-supported project. A “subaward” rela�onship fits the circumstances more appropriately than a contract to carry out part of the Federally-supported project. See 2 CFR §§ 200.1 (sub-award), 200.1 (sub-recipient), and 200.331 (Sub-recipient and contractor determina�ons), respec�vely.

The applicant must also include Le�ers of Commitment from any par�cipa�ng consultants, subawards, or subcontractors signed by an appropriate official of that ins�tu�on describing the programma�c arrangements and confirming its agreed par�cipa�on in the research, with its proposed budget and budget jus�fica�on for this par�cipa�on included as a�achments as part of the applica�on package.

10. Coopera�ve Research and Development Agreements (CRADA). State if the applicant is a current CRADA partner with NOAA, or with any other Federal agency, naming the agency, �tle of the CRADA, and any rela�onship with the proposed work. An Agency may NOT enter into, or con�nue, a CRADA with an awardee under this NOFO on the subtopic of the award.

11. Guest Researcher. State if the applicant or any of its consultants or subcontractors is a guest researcher at NOAA, naming the sponsoring laboratory.

12. Cost Sharing. Cost sharing is not required and is not considered during the evalua�on process for Phase II applica�ons. Cost sharing or matching funds are not to be included in the Research and Related Budget form. The amount and planned use of these funds can be described in the technical narra�ve.

13. Technical and Business Assistance (TABA) Request for use of TABA: 15 U.S.C. § 638(b) permits SBIR Phase II awardees to enter into agreements with one or more vendors for the vendor(s) to provide to the awardee Technical and Business Assistance (TABA). NOAA is able to fund TABA assistance to all NOAA SBIR Phase II grantees. Grant recipients have two op�ons for receiving TABA assistance: (1) u�lize services provided by a NOAA vendor or (2) iden�fy their own TABA assistance provider. This sec�on of the proposal should describe whether an applicant intends to use NOAA vendor-provided TABA services or have iden�fied their own TABA assistance provider.

● If you wish to receive TABA assistance from NOAA’s vendor, you do not need to include this expense in your budget. If you are awarded a Phase II grant, you will receive no�fica�on from NOAA and follow-up contact from NOAA’s TABA vendor on what services are available to you and how to obtain these services at no cost to your small business.

● If you wish to u�lize your own TABA assistance provider, you are required to include this as “Other Direct Costs” in your budget, provide a detailed budget jus�fica�on, and a signed le�er of commitment from the provider. You may include up to $50,000 for assistance. Please note that this commercializa�on assistance does count toward the maximum grant amount of $650,000.

Funding is limited to services received that comply with 15 U.S.C. § 638(b). TABA may be obtained from en��es such as public or private organiza�ons; including from an agency of or other en�ty established or funded by a State that facilitates or accelerates the commercializa�on of technologies or assists in the crea�on and growth of private enterprises that are commercializing technology. Applicants acquire TABA services described above on their own.

Small business applicants must include the request to exercise this authority from NOAA at the �me of applica�on and demonstrate in their SBIR Phase II proposal that the TABA vendor(s) or en�ty(ies) selected can provide the specific TABA services needed. In addi�on, costs must be included in the applica�on. The TABA vendors/provider(s) may not be the small business applicant, an affiliate of the small business applicant, an investor of the small business applicant, or a subcontractor or consultant of the small business applicant otherwise required as part of the paid por�on of the research effort (e.g., research partner or research ins�tu�on).

14. Similar Applica�ons or Awards. WARNING— While it is permissible to submit iden�cal applica�ons or applica�ons containing a significant amount of Essen�ally Equivalent Work for considera�on under numerous Federal Agency Program Solicita�ons, it is unlawful to enter into Funding Agreements requiring Essen�ally Equivalent Work (see 15 U.S.C. § 638(bb)(3)). If no equivalent applica�on is under considera�on or award for equivalent work received, a statement to that effect must be included in this sec�on of the project narra�ve of the applica�on.

If there is any ques�on concerning this, it must be disclosed to the solici�ng agency or agencies before award.

If an Applicant elects to submit iden�cal proposals or proposals containing a significant amount of Essen�ally Equivalent Work under other Federal Agency Program Solicita�ons, a statement must be included in each such proposal indica�ng:

i. The name and address of the Federal Agencies to which proposals were submi�ed or from which awards were received;

ii. Date of proposal submission or date of award;

iii. Title, number, and date of Program Solicita�ons under which proposals were submi�ed or awards received;

iv. The specific applicable research topics for each proposal submi�ed or award received;

v. Titles of research projects;

vi. Name and �tle of Principal Inves�gator/Project Manager for each proposal submi�ed or award received

Commercializa�on Plan

The commercializa�on plan must be a separate document that provides informa�on to NOAA regarding how the poten�al awardee will convert their research into commercial applica�ons. The Commercializa�on Plan is limited to 10 pages.

A major objec�ve of the SBIR program is…