Amendment_0001_-_FY2016_SBIR_Phase_I_Solicitation.pdf

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing items 8 and 15, and returning or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

7. ADMINISTERED BY (If other than Item 6) CODE

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION

NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO.

IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15C. DATE SIGNED

15A. NAME AND TITLE OF SIGNER (Type or print)

16C. DATE SIGNED

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

NSN 7540-01-152-8070

Previous edition unusable

A0001

Joan Clarkston, Contract Specialist joan.e.clarkston@noaa.gov, 816-426-7469

(a) The purpose of this amendment is to correct sections 3.3.1, 3.3.3, 3.3.4, 8.1.1F, 8.4.1W, and 9.7. Changes are marked in red in the attached document.

(b) The proposal due date remains unchanged. All proposals are due by January 14, 2016 at 4:00 p.m. EST.

NOAA/AGO/EAD, 601 E 12TH STREET, RM 1734

KANSAS CITY, MO 64106, USA

JOAN CLARKSTON, 816-426-7469

NRMC0009-16-00123

NOAA2016-1

1 1

12/14/2015

10/20/2015

Digitally signed by CLARKSTON.JOAN.ELIZABETH.1245173870 DN: c=US, o=U.S. Government, ou=DoD, ou=PKI, ou=OTHER, cn=CLARKSTON.JOAN.ELIZABETH.1245173870 Date: 2015.12.14 13:06:19 -06'00'

12/14/2015

SBIR

Small Business

Innovation Research

FY2016

Program Solicitation: NOAA2016-1 Amendment 0001 dated December 14, 2015 Opening Date: October 20, 2015

Closing Date: January 14, 2016

U.S. DEPARTMENT OF COMMERCE

National Oceanic and Atmospheric Administration http://www.techpartnerships.noaa.gov http://www.techpartnerships.noaa.gov/ http://en.wikipedia.org/wiki/File:NOAA_logo.svg http://en.wikipedia.org/wiki/File:US-DeptOfCommerce-Seal.svg

TABLE OF CONTENTS

1.0 PROGRAM DESCRIPTION

1.1 Introduction

1.2 Three-Phase Program

1.2.1 Phase I – Feasibility Research __________________________________________________________________ 6

1.2.2 Phase II – Research and Development (R&D) ______________________________________________________ 6

1.2.3 Phase III – Commercialization __________________________________________________________________ 7

1.3 Manufacturing-related Priority

1.4 Energy Efficiency and Renewable Energy Priority

1.5 Eligibility and Limitations

1.6 Contact with NOAA

1.7 Definitions

1.7.1 – Commercialization _________________________________________________________________________ 11

1.7.2 – Essentially Equivalent Work _________________________________________________________________ 11

1.7.3 – Feasibility ________________________________________________________________________________ 11

1.7.4 - Funding Agreement ________________________________________________________________________ 12

1.7.5 – Historically Underutilized Business Zone (HUBZone) Small Business Concern _________________________ 12

1.7.6 – Innovation _______________________________________________________________________________ 12

1.7.7 – Joint Venture _____________________________________________________________________________ 12

1.7.8 – Principal Investigator (PI)/Project Manager (PM) ________________________________________________ 12

1.7.9 – Primary Employment _______________________________________________________________________ 12

1.7.10 – Prototype _______________________________________________________________________________ 13

1.7.11 – Research or Research and Development (R/R&D) ______________________________________________ 13

1.7.12 – SBIR Technical Data _______________________________________________________________________ 13

1.7.13 – SBIR Technical Data Rights _________________________________________________________________ 13

1.7.14 – Small Business Concern (SBC) _______________________________________________________________ 13

1.7.15 – Socially and Economically Disadvantaged Small Business Concern _________________________________ 13

1.7.16 – Subcontract _____________________________________________________________________________ 14

1.7.17 – Women-Owned Small Business _____________________________________________________________ 14

1.8 Fraud, Waste and Abuse

2.0 CERTIFICATIONS

2.1 Certification of Size, Ownership, and SBIR Program Requirements

2.2 Research Projects with Human Subjects, Human Tissue, Data or Recordings Involving Human Subjects

2.2.1 Protection of Human Subjects ________________________________________________________________ 15

2.2.2 IRB Education Documentation ________________________________________________________________ 18

2.3 Research Projects Involving Vertebrate Animals

2.4 Funding Agreement Addendums

2.4.1 SBIR Funding Agreement Certification __________________________________________________________ 20

2.4.2 SBIR Funding Agreement Certification – Life Cycle Certification _____________________________________ 25

3.0 PROPOSAL PREPARATION INSTRUCTIONS AND REQUIREMENTS

3.1 Proposal Requirements

3.2 Phase I Proposal Limitations

3.3 Phase I Proposal Submission Forms and Technical Content

3.3.1 Proposal Cover Sheet ________________________________________________________________________ 30

3.3.2 Data Collection Requirement _________________________________________________________________ 31

3.3.3 Project Summary ___________________________________________________________________________ 32

3.3.4 Technical Content __________________________________________________________________________ 32

3.4 Similar Proposals or Awards. *** WARNING ***

3.5 Prior SBIR Phase II Awards

3.6 Proposed Budget

3.7 Multiple Proposals

4.0 METHOD OF SELECTION AND EVALUATION CRITERIA

4.1 Introduction

4.2 Phase I Screening Criteria

4.3 Phase I Evaluation and Selection Criteria

4.4 Phase II Evaluation and Selection Criteria

4.5 Release of Proposal Review Information

5.0 CONSIDERATIONS

5.1 Awards

5.2 Reports

5.3 Payment Schedule

5.4 Deliverables

5.5 Innovations, Inventions, and Patents

5.5.1 Proprietary Information _____________________________________________________________________ 42

5.5.2 Rights in Data Developed under SBIR Contracts __________________________________________________ 43

5.5.3 Copyrights _________________________________________________________________________________ 44

5.5.4 Patents ___________________________________________________________________________________ 44

5.5.5 Invention Reporting _________________________________________________________________________ 44

5.6 Considerations

5.7 Additional Information

5.8 Technical Assistance for Proposal Preparation and Project Conduct

6.0 SUBMISSION OF PROPOSALS

6.1 Deadline for Proposals and Modifications

6.2 Proposal Submission

6.3 Warning

7.0 SCIENTIFIC AND TECHNICAL INFORMATION SOURCES

7.1 General Information

7.2 Oceanic and Atmospheric Science

7.3 SBIR National Conferences

8.0 RESEARCH TOPICS

9.0 SUBMISSION FORMS AND CERTIFICATIONS

9.1 NOAA Small Business Innovation Research (SBIR) Phase I Cover Page

9.2 NOAA SBIR Project Summary Form

9.3 NOAA SBIR Proposed Budget

9.4 NOAA SBIR Budget Instructions

9.5 SBIR Funding Agreement Certification

9.6 SBIR Funding Agreement Certification – Life Cycle Certification

9.7 NOAA/SBIR CHECKLIST

DEPARTMENT OF COMMERCE

NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION

PROGRAM SOLICITATION FOR SMALL BUSINESS INNOVATION RESEARCH (SBIR)

1.0 PROGRAM DESCRIPTION

1.1 Introduction

The Department of Commerce (DOC) National Oceanic and Atmospheric Administration (NOAA) invites small businesses to submit research proposals under this solicitation. Firms with the capability to conduct research and development (R&D) in any of the topic areas listed in Section 8 of this solicitation and to commercialize the results of that R&D are encouraged to participate. 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.

The SBIR program was originally established in 1982 by the Small Business Innovation Development Act (P.L. 97-219). It was then expanded by the Small Business Research and Development Enhancement Act of 1992, extending the program to the year 2000 and then to 2008. The program was reauthorized under Public Law 112-81, Section E and extended through September 30, 2017.

Eleven federal agencies set aside a portion of their extramural R&D budget each year to fund research proposals from small science and technology-based firms. The 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 socially and economically disadvantaged persons and women-owned small business concerns in technological innovation; and increase private sector commercialization of innovations derived from federal research and development. The NOAA SBIR Program identifies and solicits proposals in subtopics that fall within NOAA’s mission.

NOAA is not obligated to make any awards under this solicitation and all awards are subject to the availability of funds.

NOAA is not responsible for any costs expended by the proposer in the development of the proposal and prior to award of any contract.

1.2 Three-Phase Program

Legislation requires the Department of Commerce to establish a three-phase SBIR program by reserving a percentage of its extramural R&D budget to be awarded to small business concerns for innovation research. SBIR policy is provided by the Small Business Administration (SBA) through the SBA Policy Directive.

The funding vehicles for NOAA’s SBIR program in both Phase I and Phase II are contracts.

While the Phase II proposal process is covered in this announcement, this solicitation is for Phase I proposals only. A separate solicitation will not be issued requesting Phase II proposal submissions. Unsolicited proposals will not be accepted through the SBIR Program.

A Phase II proposal can be submitted only by a Phase I awardee. NOAA has the unilateral right to select SBIR research topics and awardees in both Phase I and Phase II and award several or no contracts under a given subtopic.

1.2.1 Phase I – Feasibility Research

The purpose of Phase I is to determine the scientific, technical, and commercial merit and feasibility of the proposed research and the quality of performance of the small business concern receiving an award. Therefore, the proposal should concentrate on research that will significantly contribute to proving the feasibility of the proposed research, a prerequisite to further support in Phase II. NOAA Phase I awards are up to $120,000 with up to a six (6) month period of performance. Proposers are encouraged to consider, and discuss in their proposal, whether the research or research and development being proposed to NOAA also has private sector potential, either for the proposed application or as a base for other applications. Only DOC NOAA SBIR Phase I awardees will be eligible to submit a Phase II proposal.

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

All firms that are awarded Phase I contracts under this solicitation will be given the opportunity to submit a Phase II proposal immediately following completion of Phase I. Phase II is the R&D or prototype development phase. It will require a comprehensive proposal outlining the research in detail, a detailed plan to commercialize the final product, and may require a company presentation to the NOAA SBIR Selection Committee. Instructions for Phase II proposal preparation and submission requirements will be provided to Phase I awardees toward the end of the Phase I period of performance. Phase II applicants will be required to provide information for the Small Business Administration (SBA) Database System (http://sbir.gov) when advised this system can accept their input.

Further information regarding Phase II proposals and SBA Database requirements will be provided to all firms receiving Phase I contracts. The following provides information for submitting a Phase II proposal to the Department of Commerce (DOC) National Oceanic and Atmospheric Administration (NOAA) SBIR program.

Phase II awards shall be for no more than $400,000. The period of performance for Phase II will depend upon the scope of the research, but should not exceed 24 months. For planning purposes, NOAA’s goal is to make Phase II awards in the month of June.

http://sbir.gov/

Each Phase II proposal will be evaluated against the criteria set forth in Solicitation NOAA 2016-1 (see Section 4.4). Phase II award decisions will be made based upon scientific and technical quality, commercial potential and available funds. Final recommended award decisions will be made by the NOAA Technology Partnerships Committee (TPC) to the Contracting Officer (CO) based upon rankings assigned by reviewers and consideration of other factors which includes possible duplication of ongoing research and the importance of the proposed research as it relates to NOAA mission needs.

Phase II proposals should be more comprehensive than Phase I proposals and are NOT limited to 26 pages. One year after completing Phase II R&D activity the awardee shall be required to report on their commercialization activities.

1.2.3 Phase III – Commercialization

Under Phase III, the proposer is required to obtain funding from either, the private sector, a non-SBIR Government source, or both, to develop the prototype into a viable product or non- R&D service for sale in the Federal government and/or domestic and international private sector markets. SBIR Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. Phase III work is typically oriented towards commercialization of SBIR research or technology and may be for products, production, services, Research / Research and Development (R/R&D) or a combination thereof.

1.3 Manufacturing-related Priority

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

The NOAA SBIR Program solicits manufacturing-related projects through many of the subtopics described in this Solicitation. 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 described in Section 4.3.

1.4 Energy Efficiency and Renewable Energy Priority

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

The NOAA SBIR Program solicits energy efficiency or renewable energy system R&D projects through many of the subtopics described in this Solicitation. 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 Eligibility and Limitations

Proposers for both Phase I and Phase II must qualify as a small business concern for research or research and development (R/R&D) purposes (Section 1.7.11) 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 must submit a certification (See Section 2.4.1 and 9.5) stating that it meets the size, ownership and other requirements of the SBIR Program at the time of award, and at any other time set forth in SBA’s regulations at 13 CFR 121.701-705.

For Phase I, a minimum of two-thirds of the research and/or analytical effort must be performed by the awardee 1. For Phase II, a minimum of one-half of the research and/or analytical effort must be performed by the awardee.

For both Phase I and Phase II, the primary employment of the principal investigator (PI) must be with the small business concern (SBC) at the time of the award and during the conduct of the proposed project 2. Primary employment means that more than one-half of the principal investigator’s time is spent in the employ of the SBC. Primary employment with a SBC precludes full-time employment with another organization.

For both Phase I and Phase II, all work must be performed by the SBC and its subcontractors in the United States. “United States” means the fifty states, the territories and possessions of the United States, the Commonwealth of Puerto Rico, the District of Columbia, the Republic of the Marshall Islands, the Federated States of Micronesia, and the Republic of Palau.

However, based on a rare and unique circumstance, for example, a supply or material or

1 In determining whether the awardee is complying with the requirement of performing at least two-thirds of the research and/or analytical effort during Phase I and one-half for Phase II, the government will consider the amount of an SBIR awardee’s operational costs that is paid to outside contractual parties, such as subcontractors, consultants, and independent contractors. In contrast, expenditures for employee labor, materials, and related overhead and profit, will generally be categorized as effort performed by the awardee. Note that an SBIR awardee’s operational costs that are directly expended towards facility leases, usage fees, and University partnerships, or similar paid arrangements with other organizations will generally be considered payments to outside contractual parties.

2 When evaluating the question of primary employment of the principal investigator, the government will consider whether the individual has completed an Internal Revenue Service W-4 or W-9 form with the business. The business represents that individuals that have completed a W-4 form (and receives a W-2 form for filing of income taxes) are employees, while individuals that have completed a W-9 form (and receives a 1099-MISC form for filing of income taxes) are not employees. Instead, the latter are considered to be independent contractors, consultants, or subcontractors.

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

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

In accordance with the SBIR/STTR Reauthorization Act of 2011, each SBIR agency must determine whether an applicant for a Phase I award that has won multiple prior SBIR awards meets the benchmark requirements for progress towards commercialization before making a new Phase I award to the applicant. Small business concerns are assessed on June 1 of each year using their prior Phase I and Phase II SBIR and STTR awards across all SBIR agencies.

The Phase II Transition Rate Benchmark sets the minimum required number of Phase II awards the applicant must have received for a given number of Phase I awards received during the specified period. NOAA’s minimum Phase I to Phase II transition rate to be eligible to receive a new Phase I award, is 0.25 over the past 5 fiscal years, excluding the most recently completed fiscal year. This transition rate benchmark applies only to Phase I applicants that have received more than 20 Phase I awards over the past 5 fiscal years, excluding the most recently completed fiscal year. This requirement does not apply to companies that have received 20 or fewer Phase I awards over the 5 year period. For those companies that have received more than 20 Phase I awards over the past 5 years, SBA posts the company transition rates on the Company Registry at SBIR.gov. Information on the Phase I to Phase II Transition Rate requirement is available at https://www.sbir.gov/performance-benchmarks.

Applicants to this solicitation that may have received more than 20 Phase I awards across all federal SBIR/STTR agencies over the past five (5) years should, prior to proposal preparation, verify that their company’s Transition Rate on the Company Registry at SBIR.gov meets or exceeds the minimum benchmark rate of 0.25. The transition rate is calculated as the total number of SBIR and STTR Phase II awards a company received during the past 5 fiscal years divided by the total number of SBIR and STTR Phase I awards it received during the past 5 fiscal years excluding the most recently completed year.

SBA calculates individual company transition rates using SBIR and STTR award information across all federal agencies. SBA will identify, on June 1 of each year, the companies that fail to meet the benchmark. These companies will not be eligible to receive a Phase I award for a https://www.sbir.gov/performance-benchmarks https://www.sbir.gov/performance-benchmarks period of one year from that date. SBA will notify the companies and the relevant officials at the participating agencies.

If a company believes that the information used was incomplete or inaccurate, it may provide feedback through the Company Registry at www.sbir.gov. SBA accepts requests for reconsideration of the eligibility determination from April 1st through April 30th of each year.

Additional information on the Transition benchmark is available at SBIR.gov.

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

Unsolicited proposals or proposals not responding to subtopics listed herein are not eligible for SBIR awards. Only proposals that are directly responsive to the subtopics as described in Section 8 will be considered.

Potential awardees (along with their consultants or subcontractors) may not participate in the selection of any topic or subtopic. Additionally, they may not or participate in the review of proposals. All offerors ( including Guest Researchers, contractors, 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 subtopic

• Have not been the recipient of any information on the subtopic not available in the solicitation or other public means

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

NOAA may not enter into, or continue an existing CRADA with an awardee on the subtopic of the award.

1.6 Contact with NOAA

In the interest of competitive fairness, oral or written communication with NOAA or any of its components, other than the contacts provided immediately below, concerning additional information on the technical topics described in Section 8 of this solicitation is strictly prohibited.

For general information on the NOAA SBIR program contact:

Vince Garcia, NOAA SBIR Program Manager 1305 East West Highway, Room 7605 Silver Spring, MD 20910

Telephone: (301) 713-3565 x184 Email: vincent.garcia@noaa.gov

For information on the solicitation and other related contractual issues contact:

Joan Clarkston, Contracting Officer

DOC/NOAA-EAD-KC

601 East 12th Street, Room 1734 Kansas City, MO 64106

Telephone: (816) 426-7469

E-mail: Joan.E.Clarkston@noaa.gov

In order to permit timely posted responses, all questions pertaining to the solicitation and its subtopics are due no later than Wednesday, December 2, 2015 at 2:00 PM Eastern. After that date and time, NO ADDITIONAL QUESTIONS SHALL BE ACCEPTED.

Additional scientific and technical information sources are listed in Section 7.

1.7 Definitions

1.7.1 – Commercialization

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

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

1.7.2 – Essentially Equivalent Work

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

1.7.3 – Feasibility

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

mailto:t@noaa.gov mailto:Joan.E.Clarkston@noaa.gov

1.7.4 - Funding Agreement

Any contract, grant, or cooperative agreement entered into between any Federal agency and any small business concern (SBC) for the performance of experimental, developmental, or research work, including products or services, funded in whole or in part by the Federal Government.

For purposes of this Solicitation, NOAA intends to award contracts in accordance with the Federal Acquisition Regulation.

1.7.5 – Historically Underutilized Business Zone (HUBZone) Small Business Concern (See 13 CFR Part 126 for additional details)

Status as a qualified HUBZone Small Business Concern is determined by the Small Business Administration.

1.7.6 – Innovation

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

1.7.7 – Joint Venture

See 13 CFR 121.103(h).

NOAA has elected to not permit award to a small business concern that is majority-owned by venture capital operating company(s), hedge fund(s), or private equity firm(s).

1.7.8 – Principal Investigator (PI)/Project Manager (PM)

The one individual designated by the applicant to provide the scientific and technical direction to a project supported by a funding agreement.

1.7.9 – Primary Employment

The primary employment of the principal investigator/project manager must be with the SBC at the time of award and during the conduct of the proposed project. Primary employment means that more than one half of the PI/PM’s time is spent in the employ of the small business concern. This precludes full-time employment with another organization (also see Section 1.5).

1.7.10 – Prototype

A model of something to be further developed, which includes designs, protocols, questionnaires, software, and devices.

1.7.11 – Research or Research and Development (R/R&D)

Any activity that is (a) a systematic, intensive study directed toward greater knowledge or understanding of the subject studied; (b) a systematic study directed specifically toward applying new knowledge to meet a recognized need; or (c) a systematic application of knowledge toward the production of useful materials, devices, systems, or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements.

In general, the NOAA SBIR program will fund Phase I and Phase II proposals with objectives that can be defined by (b) and (c) in the above paragraph.

1.7.12 – SBIR Technical Data

All data generated during the performance of a SBIR award.

1.7.13 – SBIR Technical Data Rights

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

1.7.14 – Small Business Concern (SBC)

A concern that meets the requirements set forth in 13 CFR 121.702.

1.7.15 – Socially and Economically Disadvantaged Small Business Concern

See 13 CFR 124, Subpart B.

1.7.16 – Subcontract

Any agreement, other than one involving an employer-employee relationship, entered into by an awardee of a funding agreement calling for supplies or services for the performance of the original funding agreement.

1.7.17 – Women-Owned Small Business

An SBC that is at least 51% owned by one or more women, or in the case of any publically owned business, at least 51% of the stock is owned by women, and women control the management and daily business operations.

1.8 Fraud, Waste and Abuse

Fraud includes any false representation about a material fact or any intentional deception designed to deprive the United States unlawfully of something of value or to secure from the United States a benefit, privilege, allowance, or consideration to which an individual or business is not entitled. Waste includes extravagant, careless, or needless expenditure of Government funds, or the consumption of Government property, that results from deficient practices, systems, controls, or decisions. Abuse includes any intentional or improper use of Government resources, such as misuse of rank, position, or authority or resources. Examples of fraud, waste, and abuse relating to the SBIR Program include, but are not limited to:

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

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

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

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

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

(vi) extravagant, careless, or needless spending;

(vii) self-dealing, such as making a sub-award to an entity in which the PI has a financial interest;

(viii) acceptance by agency personnel of bribes or gifts in exchange for grant or contract awards or other conflicts of interest that prevents the Government from getting the best value;

and

(ix) 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 to:

Department of Commerce Office of Inspector General Complaint Intake Unit, Mail Stop 7886

1401 Constitution Avenue, N.W.

Washington, DC 20230

Telephone:

Local 202-482-2495 Toll free 1-800-424-5197

TTD 1-855-860-6950

Email: hotline@oig.doc.gov

Fax: 855-569-9235

Website: http://www.oig.doc.gov/Pages/online-hotline-complaint-form.aspx

2.0 CERTIFICATIONS

2.1 Certification of Size, Ownership, and SBIR Program Requirements

Awardees will be required to certify size, ownership and other SBIR Program requirements with the submission of SBIR proposal, at the time of award, and during the funding agreement life cycle. A copy of these certifications is provided in Section 2.4.1, 2.4.2, 9.5 and 9.6.

2.2 Research Projects with Human Subjects, Human Tissue, Data or Recordings Involving Human Subjects

2.2.1 Protection of Human Subjects

Any proposal that includes contractor 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 mailto:hotline@oig.doc.gov http://www.oig.doc.gov/Pages/online-hotline-complaint-form.aspx

Department of Commerce (DOC) at 15 C.F.R. Part 27. In addition, any such proposal that includes research on these topics must be in compliance with any statutory requirements imposed upon the Department of Health and Human Services (DHHS) and other Federal agencies regarding these topics, all regulatory policies and guidance adopted by DHHS, the Food and Drug Administration, and other Federal agencies on these topics, and all Executive Orders and Presidential statements of policy on these topics.

NOAA reserves the right to make an independent determination of whether a proposer’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 CO issues written approval. Retroactive approvals are not permitted.

NOAA will accept proposals 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. NOAA will not issue a single project assurance (SPA) for any IRB reviewing any human subjects protocol proposed to NOAA.

Information regarding how to apply for an FWA and register an IRB with OHRP can be found at http://www.hhs.gov/ohrp/assurances/index.html.

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

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

(1) the scientific source is considered unique,

(2) an equivalent source is unavailable within the United States,

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

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

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

Any request to support or conduct research using human embryonic stem cell lines not currently approved by the NIH, will require that the owner, deriver or licensee of the human http://www.hhs.gov/ohrp/assurances/index.html http://stemcells.nih.gov/ 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.

A proposer 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 proposal:

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

(2) The name(s) and institution(s) of the cognizant IRB(s), and the IRB registration number(s);

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

(4) The FWAs associated with all organizations engaged in the planned research activity linked to the cognizant IRB;

(5) If the IRB review(s) is pending, the estimated start date for research involving human subjects;

(6) The IRB approval date (if currently approved for exempt or non-exempt research);

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

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

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

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

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

http://hescregapp.od.nih.gov/NIH_Form_2890_Login.htm http://grants.nih.gov/stem_cells/registry/current.htm

(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 nonduplication-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.

2.2.2 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 proposal. 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 which may be found at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

2.3 Research Projects Involving Vertebrate Animals

Any proposal that includes research involving live vertebrate animals must be in compliance with 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. In addition, such proposals must meet the requirements of the Animal Welfare Act (7 U.S.C. § 2131 et seq.), 9 C.F.R. Parts 1, 2, and 3, and if appropriate, 21 C.F.R. Part 58. These regulations do not apply to proposed research using preexisting images of animals or to research plans that do not include live animals that are being cared for, euthanized, or used by the project participants to accomplish research goals, teaching, or testing. These regulations also do not apply to obtaining animal materials from commercial processors of animal products or to animal cell lines or tissues from tissue banks.

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

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

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 nonduplication-of-funding letter if the ASP is funded from several sources.

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

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

2.4 Funding Agreement Addendums

2.4.1 SBIR Funding Agreement Certification

SBIR Funding Agreement Certification

All small businesses must complete this certification with their proposal submission and any other time set forth in the funding agreement that is prior to performance of work under this award. This includes checking all of the boxes and having an authorized officer of the awardee sign and date the certification each time it is requested.

Please read carefully the following certification statements. The Federal government relies on the information to determine whether the business is eligible for a Small Business Innovation Research (SBIR) Program award. A similar certification will be used to ensure continued compliance with specific program requirements during the life of the funding agreement. The definitions for the terms used in this certification are set forth in the Small Business Act, SBA regulations (13 C.F.R. part 121), the SBIR Policy Directive and also any statutory and regulatory provisions referenced in those authorities.

If the funding agreement officer believes that the business may not meet certain eligibility requirements at the time of award, they are required to file a size protest with the U.S. Small Business Administration (SBA), who will determine eligibility. At that time, SBA will request further clarification and supporting documentation in order to assist in the verification of any of the information provided as part of a protest. If the funding agreement officer believes, after award, that the business is not meeting certain funding agreement requirements, the agency may request further clarification and supporting documentation in order to assist in the verification of any of the information provided.

Even if correct information has been included in other materials submitted to the Federal government, any action taken with respect to this certification does not affect the Government’s right to pursue criminal, civil, or administrative remedies for incorrect or incomplete information given in the certification. Each person signing this certification may be prosecuted if they have provided false information.

The undersigned has reviewed, verified and certifies that (all boxes must be checked):

(1) The business concern meets the ownership and control requirements set forth in 13 C.F.R.

§121.702.

[_] Yes [_] No

(2) If a corporation, all corporate documents (articles of incorporation and any amendments, articles of conversion, by-laws and amendments, shareholder meeting minutes showing director elections, shareholder meeting minutes showing officer elections, organizational meeting minutes, all issued stock certificates, stock ledger, buy-sell agreements, stock transfer agreements, voting agreements, and documents relating to stock options, including the right to convert non-voting stock or debentures into voting stock) evidence that it meets the ownership and control requirements set forth in 13 C.F.R. § 121.702.

[_] Yes [_] No [_] N/A

Explain why N/A: ______________________________________________________

(3) If a partnership, the partnership agreement evidences that it meets the ownership and control requirements set forth in 13 C.F.R. §121.702.

[_] Yes [_] No [_] N/A

(4) If a limited liability company, the articles of organization and any amendments, and operating agreement and amendments, evidence that it meets the ownership and control requirements set forth in 13 C.F.R §121.702.

[_] Yes [_] No [_] N/A

(5) The birth certificates, naturalization papers, or passports show that any individuals it relies upon to meet the eligibility requirements are U.S. citizens or permanent resident aliens in the United States.

[_] Yes [_] No [_] N/A

(6) It has no more than 500 employees, including the employees of its affiliates.

(7) SBA has not issued a size determination currently in effect finding that this business concern exceeds the 500 employee size standard.

(8) During the performance of the award, the principal investigator will spend more than one half of his/her time as an employee of the awardee or has requested and received a written deviation from this requirement from the funding agreement officer.

[_] Yes [_] No [_] Deviation approved in writing by funding agreement officer: ________%

(9) All, essentially…