FY24 SBIR Phase II NOFO_Final.pdf

SBIR

Small Business Innovation Research

Notice of Funding Opportunity (NOFO)

FY2024 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 2023 Phase I NOFO: NOAA-OAR-TPO-2023-2007691

Funding Opportunity Number: NOAA-OAR-TPO-2024-2008239

Assistance Listings or Catalog of Federal Domestic Assistance(CFDA) Number:

11.021 NOAA Small Business Innovation Research

(SBIR) Program

Opening Date: January 31, 2024

Closing Date: April 24, 2024

U.S. DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration http://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 Introduction 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 Limitation 5

Applicant Qualification 5

Company Registry Requirements 6

Performance Benchmark Ratings Requirements 6

1.6 Contact with NOAA 7

1.7 Fraud, Waste and Abuse 7

1.8 Other Information 8

Personal and Business Information 8

2.0 CERTIFICATIONS 9

2.1 Funding Agreement Certifications 9

2.2 Research Activities Involving Human Subjects, Human Tissue, Data or Recordings Involving Human Subjects 9

Protection of Human Subjects 9

IRB Education Documentation 11

2.3 Research Project Involving Live Vertebrate Animals 11

3.0 APPLICATION PREPARATION INSTRUCTIONS AND REQUIREMENTS 12

3.1 Phase II Application Requirements 12

3.2 Phase II Application 13

Project Narrative 13

SBIR Cover Page and Project Abstract 13

Technical Content 14

Commercialization Plan 17

4.0 METHOD OF SELECTION AND EVALUATION CRITERIA 19

4.1 Evaluation and Selection Process 19

4.2 Phase II Screening Criteria 19

4.3 Phase II Evaluation Criteria 20

4.4 Phase II Award Selections 21

4.5 Federal Awarding Agency Review of Risk Posed By Applicants 21

4.6 Release of Application Review Information 22

5.0 CONSIDERATIONS 22

5.1 Awards 22

5.2 Reporting Requirements 22

5.3 Payment Schedule 23

5.4 Innovations, Inventions and Patents 24

5.4.1 Proprietary Information 24

5.4.2 Rights in Data Developed Under SBIR Funding Agreements 25

5.4.3 NOAA-Owned Inventions 28

5.4.4 Patent Rights 29

5.4.5 Invention Reporting 29

5.5 Cost Sharing 29

5.6 Profit or Fee 29

5.7 Joint Venture or Limited Partnerships 29

5.8 Research and Analytical Work 30

5.9 Awardee Commitments 30

5.10 Summary Statements 30

5.11 Additional Information 31

5.12 Technical Assistance for Application Preparation and Project Conduct 31

5.13 NOAA Grant Management Office Statements 32

6.0 SUBMISSION OF APPLICATIONS 37

6.1 Deadline for Applications 37

6.2 Application Submission 37

7.0 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES 38

8.0 SUBMISSION FORMS AND CERTIFICATIONS 39

8.1 Required Application Forms and Documents 39

8.2 Verifying the Submission and Tracking the application 41

Appendix A. Definitions 43

Appendix B. SBIR Funding Agreement Certification (At Time of Award) 45

Appendix C. SBIR Funding Agreement Certification (Life-Cycle Certification) 48

Appendix D. Cover Page 50

Appendix E. Small Business Innovation Research (SBIR) Program Phase II Application Checklist 52

Helpful Hints 52

Are you eligible? 52

Are you registered? 52

Appendix F. Performance Benchmark Ratings Requirements 54

US DEPARTMENT OF COMMERCE

NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION

FY 2024 SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM

NOTICE OF FUNDING OPPORTUNITY (NOFO)

1.0 PROGRAM DESCRIPTION AND FEDERAL AWARD INFORMATION

1.1 Introduction

The 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 FY 2023 NOAA SBIR Phase I awardees under NOFO number NOAA-OAR-TPO-2023-2007691 with project start dates of September 1, 2023, and project end dates of no later than February 29, 2024, 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 Enhancement Act of 1992 (P.L. 102-564) and received subsequent reauthorization 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 participate in the SBIR program and spend (obligate) a minimum percentage of their extramural R/R&D budgets (obligations) of not less than 3.2% of such budget in fiscal year 2017 and for the percentage required by statute for each fiscal year after for awards to small business concerns (SBCs) for R/R&D under the SBIR program. The objectives of the SBIR program are to: stimulate technological innovation in the private sector; strengthen the role of small business in meeting Federal R&D needs; foster and encourage participation by businesses owned by socially and economically disadvantaged persons and women-owned SBCs in technological innovation; and increase private sector commercialization of innovations derived from federal R&D funding.

Fostering diversity by encouraging the participation of individuals from nationally underrepresented groups in the scientific 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 Innovation and Competitiveness Act of 2017, and https://techpartnerships.noaa.gov/abouttpo/dei-statement/). Increasing participation by socially and economically disadvantaged and women-owned small businesses is critical 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 percentage of its extramural R&D budget to be awarded to SBCs R&D. SBIR policy is provided by the Small Business Administration (SBA) through the SBIR Policy Directive found at: http://www.sbir.gov and is https://techpartnerships.noaa.gov/abouttpo/dei-statement/ http://www.sbir.gov/ 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 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; and 49 U.S.C. 44720(b).

The NOAA SBIR program identifies 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-2023-2007691 will be considered.

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 SBC receiving an award. The Phase I proposal should focus on research that will significantly contribute to evaluating 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 application and private sector potential for the proposed effort.

NOAA Phase I awards provide up to $175,000 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 permitted 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 application for Phase II.

Phase II – Research and Development This NOFO requests proposals for FY 2024 Phase II from FY 2023 Phase I NOAA SBIR awardees only. In Phase II, work from Phase I that exhibits potential for commercial application is further developed. Phase II is the R&D or prototype development phase. While the number of awards is dependent on NOAA’s budget, NOAA anticipates providing approximately 18 awards. 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. NOAA Phase II awards provide up to $650,000 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 2024.

Under Phase III, the small business entity 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

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 topics described in this

NOFO. 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. This prioritization will not interfere with the core project selection criteria: scientific and technical merit and the potential 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 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 topics described in this NOFO. 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

Applicant Qualification Each applicant must qualify as an SBC for R/R&D purposes, as defined in this section of the 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 B) 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 121.701-121.705 in order to qualify for the award.

In addition, the primary employment of the principal investigator (PI) must be with the SBC at the time of the award and during the conduct of the proposed project. Primary employment means that at least 51% of the PI’s time is spent in the employ of the SBC. Primary employment with a SBC precludes full-time employment with another organization. Further, an SBC may only replace the principal investigator on an SBIR Phase II award if the NOAA Grants Officer provides prior written approval. Requests for a waiver of the requirement must be submitted in writing at the time of application submission. Only rare and unique circumstances will be considered for an exemption. The NOAA Grants Officer, in consultation with the SBIR Program Manager, must approve each exemption and its terms in writing.

For Phase II, a minimum of one-half of the research and/or analytical effort must be performed by the awardee.

The total cost for all consultant fees, facility leases, usage fees, and other subcontract/subaward or purchase agreements may not exceed one-half of the total award.

Applicants (and any affiliated individuals) may not participate in the selection of any topic. Additionally, they may not participate in the review of proposals. All associated entities to applicants to this NOFO (including Guest Researchers, Cooperative 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 information 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.

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

The R/R&D 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, and the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau. Requests for a waiver to the requirement that all work be performed in the United States must be submitted in writing at the time of application submission. Only rare and unique circumstances will be considered for an exemption. The NOAA Grants Officer, in consultation with the SBIR Program Manager, must approve each exemption and its terms in writing.

If a waiver is requested, it must be submitted in writing, with the application package. The waiver request 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. Waivers are only approved in rare and unique circumstances.

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/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.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.

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. Applications 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: 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.

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 SBA assessment of their Phase I to Phase II Transition Rate must, at the time of the application under this FY24 NOFO, have satisfied the requirements of that Performance Benchmark to be eligible for a new Phase I award. NOAA will automatically disqualify http://www.sbir.gov/ https://www.sbir.gov/sites/default/files/SBA%20SBIR_STTR_POLICY_DIRECTIVE_May2023.pdf http://www.sbir.gov/registration 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 additional information, see Appendix F.

1.6 Contact with NOAA

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

Subject Area Point of Contact

Programmatic Questions Email: noaa.sbir@noaa.gov

Electronic Application Submission through Grants.gov at:

https://www.grants.gov/

Grants.gov

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

Grant Administrative Rules and Regulations

Raishan Adams Email: raishan.adams@noaa.gov

1.7 Fraud, Waste and Abuse

Prevention 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 certification of completion along with their application. The Fraud, Waste, and Abuse training can be found, under “Resources for Applicants” at:

https://techpartnerships.noaa.gov/sbir/. Certification can be found at the end of the training module. All applicants must print, sign, and submit certification of completion as an attachment to their application (See 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;

https://www.grants.gov/ https://techpartnerships.noaa.gov/sbir/

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. 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 email. 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

1.8 Other Information

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 DOC in conducting reviews and evaluations of its financial assistance programs.

For this purpose, applicant information 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 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 the DOC and external program https://www.oig.doc.gov/Pages/online-hotline-complaint-form.aspx https://www.oig.doc.gov/Pages/Hotline.aspx https://www.oig.doc.gov/pages/Contact-Us.aspx 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 DOC financial assistance award.

In addition, DOC 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 NOFO 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 DOC 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 B and Appendix C 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 program requirements.

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

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 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 (FDA), 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 a 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 National Institutes of Health (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:

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

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 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)).

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 pre-existing 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 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-involving live vertebrate animal 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, and;

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.

3.0 APPLICATION PREPARATION INSTRUCTIONS AND REQUIREMENTS

3.1 Phase II Application Requirements

Applicants should use the SBIR forms in Appendix D and E 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 topic 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 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. Do not include hyperlinks to websites or other resources.

Only FY 2024 Phase II applications may be submitted in response to this NOFO. Phase I applications are not being accepted at this time.

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 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; and

● 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 are requested to voluntarily update the information in the database annually thereafter for a minimum period of five years.

3.2 Phase II Application

The Project Narrative, including the Cover Page, Project Abstract, and Technical Content, is limited to 25 pages, including references cited. The only exception to the 25-page limit is for SBCs addressing the requirement related to prior SBIR Phase II Awards as listed in Section 3.3 (14). Additional pages beyond the 25-page limit will not be considered in the evaluation process. The Commercialization Plan is limited to 10 pages.

A complete application must include a Project Narrative and Commercialization Plan (described below) and all other forms and documents listed in Section 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 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.

Project Narrative

The Project Narrative portion of the application 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 Narrative. The Cover Page is counted as pages 1 and 2 of the Project Narrative (Appendix D).

http://www.sbir.gov/

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 title of Principal Investigator;

(3) Participating Agency name, Program Solicitation number, and Program Solicitation topic;

(4) Title of project;

(5) Technical abstract; and

(6) Summary of the anticipated results and implications of the approach and the potential commercial applications of the research.

The technical abstract and summary of anticipated results are limited to two hundred words each. Project abstracts will be provided to the SBA and should not contain proprietary information. Awardee’s abstract and summary of potential commercial applications will be published on the NOAA SBIR website and SBIR.gov. The Project Abstract is counted as page 3 of the Project Narrative.

Technical Content

1. Identification and Significance of the Problem or Opportunity. Provide a clear statement of the specific research problem or opportunity addressed, its innovativeness, commercial potential, and explanation of importance. Explain how it applies to a relevant topic and fulfills the NOAA mission.

2. Phase I Summary. Summarize Phase I activities and key results and findings related to this 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.

(Two pages maximum).

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

4. 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.

The method(s) planned to achieve each objective 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 application, 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 coordination 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. Identify key individuals involved in Phase II, including their related education, experience, current and previous position titles and employers, and publications.

Where vitae are extensive, summaries that focus on the most relevant experience and publications are desired and may be necessary to meet application size limitations.

7. Relationship with Future R/R&D. Discuss the significance of the Phase I effort in providing a foundation for the Phase II R/R&D effort. Also state the anticipated results and products of the proposed approach if Phase II of the project is successful.

8. Facilities and Equipment. Provide a detailed description, availability, and location of instrumentation and physical facilities proposed for Phase II.

9. Consultants, Contracts, and Sub-awards. The purpose of this section 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 time of application submission. It is important that these individuals be clearly identified as consultants, sub-awardees, or subcontractors. This should match and be reflected in the budget tables and budget narrative sections.

For Phase II, a minimum of one half of the research and/or analytical 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 entity may serve as consultant, contractor, or sub-recipient if they (a) had any role in suggesting, developing, or reviewing the NOAA topic; or (b) have been the recipient of any NOAA information on the topic not available to the public.

The following definitions apply to this NOFO:

● Consultant - A person outside the firm, named in the application as contributing to the research, must provide a signed statement confirming his/her availability, role in the project, and agreed consulting rate for participation in the project.

● Contract - Similarly, where a contract is involved in the research, the contractor institution must furnish a letter signed by an appropriate official describing the programmatic arrangements and confirming its agreed participation in the research, with its proposed budget for this participation.

● Sub-awards - As the funding instrument used in this program is financial assistance, an awardee might pass through funds to another organization to carry out part of the Federally-supported project. A “subaward” relationship 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 determinations), respectively.

The applicant must also include Letters of Commitment from any participating consultants, subawards, or subcontractors signed by an appropriate official of that institution describing the programmatic arrangements and confirming its agreed participation in the research, with its proposed budget and budget justification for this participation included as attachments as part of the application package.

10. Cooperative 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, title of the CRADA, and any relationship with the proposed work. An Agency may NOT enter into, or continue, 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 evaluation process for Phase II applications. 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 narrative.

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 options for receiving TABA assistance: (1) utilize services provided by a NOAA vendor or (2) identify their own TABA assistance provider. This section of the proposal should describe whether an applicant intends to use NOAA vendor-provided TABA services or have identified 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 notification 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 utilize your own TABA assistance provider, you are required to include this as “Other Direct Costs” in your budget, provide a detailed budget justification, and a signed letter of commitment from the provider. You may include up to $50,000 for assistance. Please note that this commercialization 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 entities such as public or private organizations; including from an agency of or other entity established or funded by a State that facilitates or accelerates the commercialization of technologies or assists in the creation 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 time of application and demonstrate in their SBIR Phase II proposal that the TABA vendor(s) or entity(ies) selected can provide the specific TABA services needed. In addition, costs must be included in the application. 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 portion of the research effort (e.g., research partner or research institution).

14. Similar Applications or Awards. WARNING—While it is permissible to submit identical…