Final_2019_Phase_II_SBIR_Solicitation_.docx

ENVIRONMENTAL PROTECTION AGENCY

SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM PHASE II SOLICITATION

68HE0D19

ISSUE DATE: March 18, 2019 CLOSING DATE: May 1, 2019

*CAUTION - Proposals submitted in response to this solicitation will be valid for 300 days.

Your proposal in Portable Document Format (PDF) (including all appendices) shall be received via FedConnect by 12:00p.m. (noon) eastern standard time on May 1, 2019. Offerors are responsible for submitting timely offers through FedConnect, any offer received through FedConnect after the exact time specified above will be considered ‘late’ and will not be considered. Your proposal shall be attached in FedConnect as one PDF (including all appendices). Only proposals received in Portable Document Format (PDF) will be considered for award.

IMPORTANT:

Proposals shall be submitted via the FedConnect web portal (www.fedconnect.net). In order to submit proposals, offerors must register in FedConnect at www.fedconnect.net, see main page of FedConnect website for registration instructions. For assistance in registering or for other FedConnect technical questions please call the FedConnect Help Desk at (800) 899-6665 or email at support@fedconnect.net.

It is the responsibility of Offerors to submit proposals in FedConnect with sufficient time to ensure they are received by the date and time specified. Only proposals received by the date and time specified via FedConnect will be considered for award.

Table of Contents

Appendix 4 – Documentation for Commercialization Option Appendix 5 – Representations and Certifications 41

PHASE II SOLICITATION FOR SMALL BUSINESS INNOVATION RESEARCH

I. SBIR PROGRAM DESCRIPTION

The Environmental Protection Agency (EPA) Small Business Innovation Research (SBIR) Program Phase II solicitation is now open for those companies who successfully competed for a Phase I award under the FY 2016 EPA Phase I SBIR Solicitation:

SOL-NC-17-00028 Closing Date: December 19, 2017 A. Purpose of EPA’s SBIR Program Every Federal agency with an extramural research and development (R&D) budget over $100 million is required by law to have a Small Business Innovation Research (SBIR) program. For the Environmental Protection Agency (EPA), the SBIR program provides the only way it can directly award R&D funding to small businesses. Each agency implements the program in a phased manner that follows the technology development continuum: research, development, demonstration, commercialization, and utilization. The number of phases an agency supports depends on its program needs and budget. Generally, there are two phases: the first is for proof of concept, and the second is intended to move the technology as far as possible toward full-scale commercialization. The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives resulting from the Phase I/II R/R&D activities with non-SBIR funding.

The EPA’s needs result from its mission to protect human health and the environment. Because its needs are large and the available funding is small, the EPA seeks innovative technologies that offer new approaches to meeting its needs— not incremental improvements of existing technologies.

For the EPA, success means that the technologies it supports will in fact be used to solve the problems for which they are being developed; therefore, for Phase I applications EPA considered commercialization potential to be as important as technical potential in evaluating proposals. For Phase II applications, EPA will consider commercialization progress and potential to be as important as technical progress and potential and it will evaluate proposals accordingly.

SBIR proposals should directly pertain to the EPA's mission of protecting human health and the environment. Proposals should also consider the lifecycle environmental impacts of the technology itself, including (if applicable) minimizing resource use, minimizing toxicity of materials, efficient use of water and energy, minimizing pollution, and minimizing the impacts of disposal. The proposed research must be responsive to the topics included in this solicitation. The research should be the basis for technological innovation resulting in new commercial products, processes, or services that benefit the public and promote the growth of the small business.

The EPA will follow a two-stage evaluation process to make funding decisions. The two stages are: external peer review and internal programmatic review. The evaluation criteria that will be used in each stage are described later in the solicitation.

B. Phase I to Phase II Transition Rate Benchmark Companies with multiple SBIR/STTR awards must meet minimum performance requirements to be eligible to apply for a new Phase I or Direct-to-Phase II award. The purpose of these requirements is to ensure that Phase I applicants that have won multiple prior SBIR/STTR awards are making progress towards commercializing the work done under those awards. The Phase I to Phase II Transition Rate addresses the extent to which an awardee progresses a project from Phase I to Phase II. The Commercialization Benchmark addresses the extent to which an awardee has moved past Phase II work towards commercialization. All offerors for an SBIR or STTR award must be registered on www.SBIR.gov. Offerors should be sure to update their information on the Company Registry at least once per year. To open or update an SBIR/STTR Company Registry account, go to www.sbir.gov/user and register as a Small Business User. After the registration is complete, the SBA will issue your company a unique SBC Control ID and .pdf file to be attached to this application.

Descriptions of these rates, and consequences of failure to meet these rates can be found on SBA’s website at: https://www.sbir.gov/performance-benchmarks.

C. SBIR Phase II Research Topics For this Phase II solicitation, the topics are the same as in the Phase I solicitation. Applicants must select the same topic that they selected for their Phase I project. The topics are:

1. Clean and Safe Water

· Topic 1A: Removal of PFOA/PFAS from Drinking Water

· Topic 1B: Removal of PFOA/PFAS from Wastewater

· Topic 1C: Replacements for PVC and PE Water Pipes

2. Air Quality

· Topic 2A: Capturing Carbon Dioxide from Vehicles

· Topic 2B: Converting Carbon Dioxide from Vehicles

· Topic 2C: Product Loss Prevention and/or Mitigation in the Oil and Natural Gas Sector

· Topic 2D: Developing More Stable Metal Alloy Tubes for Use in High Temperature Processes

3. Land Revitalization

· Topic 3A: Remediation of PFAS-Contaminated Soil and Sediment

4. Homeland Security

· Topic Code 4A: Decontamination of Category A Viruses on Porous Materials and Sensitive Equipment

· Topic Code 4B: Packaging Materials for On-Site Fumigation and Transport of Category A Virus-Infected Items

5. Manufacturing

· Topic Code 5A: Greener Manufacturing of Plastics

· Topic Code 5B: Greener Plastic Materials and Products

6. Building Construction Materials

· Topic Code 6A: Greener Interior Construction Materials

· Topic Code 6B: Greener Exterior Construction Materials D. Phase II

1. Process Upon completion of their Phase I project, Phase I awardees are eligible to apply for follow-on Phase II funding. Phase II is the principal R&D effort. It should be completed in 24 months. It has two objectives. The first is to continue the R&D initiated under Phase I, and take it at least through full-scale testing of the technology. The second is to work with partners, investors, and customers to fully commercializing the technology and obtain widespread utilization.

Phase II applicants should have made significant progress in their commercialization planning and implementation during their Phase I project.

The EPA recognizes that a full demonstration of a technology’s capability and full-scale commercialization may require, in effect, a Phase III that utilizes non-EPA Federal and/or private sector funds. Phase II projects should position their technologies to successfully move into and through such a Phase III.

The EPA anticipates making approximately five (5) Phase II awards, each in the amount of $300,000 with a 24-month term of performance. In Phase II, the EPA is also offering a commercialization option of $100,000 to companies that can secure third-party investment for the commercialization of their technology. To implement this, the Agency requires a “Commercialization Option” under which Phase II offerors shall submit a proposal for $100,000 of additional EPA funding based on having obtained at least $100,000 of private sector funding.

The proposal shall document the receipt of these latter funds from one or more third-party investors, such as a venture capital firm, an individual "angel" investor, a state or local funding source, another company under a partnership, licensing, or joint venture arrangement, or any combination of third parties. The EPA funds must be used to further commercialize the technology funded in Phase II. The entire Phase II proposal, including the documentation submitted in support of the commercialization option, will be evaluated together.

2. Evaluation For Phase II, the EPA will use a two-stage evaluation process similar to that used for Phase I. There will be an external peer review, followed by an internal programmatic review. Programmatic balance and available funding may also be used in making funding decisions. The evaluation process is described in Section V.

E. Phase III

(THIS SOLICITATION IS FOR PHASE II PROPOSALS ONLY)

The EPA strongly encourages Phase II awardees who do not think they will be able to achieve full-scale commercialization by the end of Phase II to diligently plan for and pursue during Phase II non-EPA SBIR sources of funding to achieve full- scale commercialization and utilization of their technology. That third phase could be funded by:

(1) Non-Federal sources of capital—including investors, commercial partners, licensing, etc.

(2) Federal non-SBIR sources that support any necessary continued R&D and product development.

(3) Federal non-SBIR funds for purchasing and/or domestic and international marketing of the technology.

The objective of Phase III, where appropriate, is for the small business to pursue commercialization objectives resulting from the Phase I/II R/R&D activities. The SBIR program does not fund Phase III.

F. Guidelines Each offeror submitting a Phase II proposal must qualify as a small business for research or R&D purposes at the time of award of the Phase II funding agreement. In addition, the primary employment of the principal investigator must be with the small business firm, both at the time of contract award and during the conduct of the proposed research. Principal investigators who appear to be employed by a university must submit a letter from the university stating that the principal investigator, if awarded a SBIR contract, will become a less-than-half-time employee of the university.

Also, a principal investigator who appears to be a staff member of both the applicant and a second employer must submit a letter from the second employer stating that, if awarded a SBIR contract, s/he will become a less than half-time employee of the second employer. Letters demonstrating that these requirements have been fulfilled shall be included in the offeror’s proposal. Failure to do so may jeopardize award. Also, for Phase II, the research or R&D work must be performed in the United States. (For the definition of the “United States”, see Section II. J.)

G. Phase II Commercialization Option All offerors are required to submit proposals for the Phase II Commercialization Option. Proposals failing to meet this requirement will be considered non-responsive to the solicitation. (See Section IV.C.8 and Appendix 4: Documentation Required for Approval of Commercialization Option.)

The purpose of the additional Phase II funding is to accelerate the project to the commercialization stage. Funds provided by EPA must be designated strictly for advancing the research-related elements of the project. EPA will exercise the option up to $100,000 after the company (i.e., contractor) provides documentation showing that at least $100,000 has been transferred to the contractor from one or more third parties. (See Appendix 4 for required documentation.) The total $200,000 should be spent during the Phase II contract period (which can be extended one year). EPA will evaluate all Phase II proposals, including the commercialization option, in accordance with the criteria specified in Section V. The Government is not obligated to fund any specific Phase II option.

H. Inquiries All inquiries concerning this solicitation shall be submitted to the EPA Contracting Officer Matthew Growney via the FedConnect web portal (www.fedconnect.net).

I. Fraud, Waste, and Abuse To report fraud, waste, or abuse in EPA programs, contact the OIG Hotline by:

E-mail: OIG_Hotline@epa.gov Postal Mail:

EPA Inspector General Hotline 1200 Pennsylvania Avenue NW Mail code 2431T Phone: 1-888-546-8740, Fax: 1-202-566-2599

II. DEFINITIONS

For purposes of this solicitation, the following definitions apply:

A. Research or Research and Development (R/R&D) Any Activity that is:

(1) A systematic, intensive study directed toward greater knowledge or understanding of the subject studied;

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

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

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

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

D. Small Business Concern A small business concern is one that, at the time of award of Phase I and Phase II contracts, meets all of the following criteria:

(1) Is organized for profit, with a place of business located in the United States;

(2) Is more than 50 percent owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States, or by another for-profit business concern that is more than 50% owned and controlled by one or more individuals who are citizens of, or permanent resident aliens in, the United States; and

(3) Has no more than 500 employees, including affiliates;

(4) Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust, or cooperative, except that, where the form is a joint venture, there can be no more than 49 percent participation by business entities in the joint venture.

E. Socially and Economically Disadvantaged Small Business Concern A socially and economically disadvantaged small business concern is one that is at least 51% owned and controlled by one or more socially and economically disadvantaged individuals, or an Indian tribe, including Alaska Native Corporations (ANCs), a Native Hawaiian Organization (NHO), or a Community Development Corporation (CDC). Control includes both the strategic planning (as that exercised by boards of directors) and the day-to-day management and administration of business operations. See 13 CFR 124.109, 124.110, and 124.111 for special rules pertaining to concerns owned by Indian tribes (including ANCs), NHOs, or CDCs, respectively.

F. Socially and Economically Disadvantaged Individual A member of any of the following groups:

(1) Black Americans;

(2) Hispanic Americans;

(3) Native Americans (American Indians, Eskimos, Aleuts, or Native Hawaiians);

(4) Asian-Pacific Americans (persons with origins from Burma, Thailand, Malaysia, Indonesia, Singapore, Brunei, Japan, China (including Hong Kong), Taiwan, Laos, Cambodia (Kampuchea), Vietnam, Korea, The Philippines, U.S. Trust Territory of the Pacific Islands (Republic of Palau), Republic of the Marshall Islands, Federated States of Micronesia, the Commonwealth of the Northern Mariana Islands, Guam, Samoa, Macao, Fiji, Tonga, Kiribati, Tuvalu, or Nauru);

(5) Subcontinent Asian Americans (persons with origins from India, Pakistan, Bangladesh, Sri Lanka, Bhutan, the Maldives Islands, or Nepal); and

(6) Other groups designated from time to time by SBA pursuant to Section 124.103(d) of the 13 CFR Ch.1 (1-1-02 Edition).

G. Woman-Owned Small Business Concern A small business concern that is at least 51 percent owned by and controlled by a woman or women. Control includes both the strategic planning (as that exercised by boards of directors) and the day-to-day management and administration of business operations.

H. Historically Underutilized Business Zone (HUBZone) A small business concern meeting the following requirements:

(1) It must be a small business by SBA standards;

(2) It must be owned and controlled at least 51% by U.S. citizens, or a Community Development Corporation, an agricultural cooperative, or an Indian tribe;

(3) Its principal office must be located within a “Historically Underutilized Business Zone,” which includes lands considered “Indian Country” and military facilities closed by the Base Realignment and Closure Act;

(4) At least 35% of its employees must reside in a HUBZone.

I. Primary Employment More than one-half of the principal investigator's time is spent in the employ of the small business concern.

J. United States The 50 States, the Territories and possessions of the Federal Government, 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.

K. Commercialization The process of developing marketable products or services and producing and delivering products or services for sale (whether by the originating party or by others) to Government or commercial markets.

L. SBIR Technical Data All data generated during the performance of a SBIR award.

M. SBIR Technical Data Rights The rights a small business concern 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.

III. CERTIFICATIONS

The Section K Representations and Certifications are located in Appendix 5. Refer to IV. Proposal Preparation Instructions and Requirements see section E ‘Attachment 4: Representations and Certifications’ for instructions on proposal preparation.

Please Note: Majority Ownership in Part by Multiple Venture Capital, Hedge Fund, and Private Equity Firms. For this EPA SBIR FY 2019-20 solicitation, the EPA’s SBIR Program will not accept proposals from or make awards to small business concerns that are owned in majority part by multiple venture capital operating companies, hedge funds, or private equity firms. Small business concerns with such ownership are ineligible to submit proposals under this solicitation.

IV. PROPOSAL PREPARATION INSTRUCTIONS AND REQUIREMENTS

A. Proposal Cover Sheet and Pages Proposals shall be submitted in Portable Document Form (PDF) in response to this Phase II solicitation. Your proposal shall be attached in FedConnect as one PDF (including all attachments). Only proposals received in Portable Document Format (PDF) will be considered for award. The offeror shall complete the Proposal Cover Sheet (Appendix 1) and use it as page 1 of each copy of each proposal. No other cover shall be permitted. The original copy of the cover sheet shall contain the electronic or pen-and-ink signatures of the principal investigator and the corporate/business official authorized to sign the proposal. The total costs requested on Appendix 1 (Proposal Cover Sheet) must match the total costs proposed on Appendix 3 (SBIR Proposal Summary Budget). The amount must not exceed $300,000 on Appendix 1 and 3, and $100,000 on Appendix 3-A, “SBIR Commercialization Option Proposal Summary Budget”. If your firm intends to incur any additional costs beyond the budget limit of $300,000 or $100,000, please provide a statement indicating that your firm will be responsible for any additional cost beyond the budget limits.

Offerors shall properly enter their Phase I Research Topic Code and Topic Title on both their Proposal Cover Sheet (Appendix 1) and Project Summary (Appendix 2). Pages (including enclosures or attachments such as letters of recommendation) should be of standard size (8 ½ in x 11 in; 21.6 cm x 27.9 cm) with 2.5 cm margins and type no smaller than 10-point font size. All pages shall be consecutively numbered. There is NO page limit for Phase II proposals. Offerors may reformat the forms to correct spacing and pagination errors; however, identical information shall be provided.

Offerors should prepare their technical proposal as succinctly as possible. Quality of information is more important than quantity. Elaborate brochures or other presentations beyond that which is sufficient to present a complete and effective proposal are neither necessary nor desired. Clarity, brevity and logical organization should be emphasized during proposal preparation.

B. Project Summary The offeror shall complete the Project Summary form (Appendix 2) and use it as page 2 of their proposal. Offerors may reformat the forms to correct spacing and pagination errors; however, identical information shall be provided. Offerors shall properly enter their Phase I Research Topic Code and Topic Title on both their Proposal Cover Sheet (Appendix 1) and Project Summary (Appendix 2). The project summary shall be 200 words or less and shall include a brief description of the problem or opportunity, the innovation, project objectives, description of the effort, the environmental benefits and the results of Phase I (see Part C.2 below). In summarizing anticipated results, the implications of the approach and the potential commercial applications of the research shall be stated. THE PROJECT SUMMARY IS USED EXTENSIVELY DURING THE EXTERNAL PEER REVIEW AND INTERNAL PROGRAMMATIC REVIEW. The project summary and proposal title from Appendix 2 of the successful proposals will be published by EPA and, therefore, shall not contain proprietary information. No changes shall be allowed.

C. Technical and Commercial Content: Phase I Proposal The Phase I proposal requirements are described in this section. Begin the main body of the Phase I technical and commercial proposal on page 3, after the proposal cover sheet and project summary. Note that there are THREE attachments required as part of the complete Phase I proposal as follows:

Attachment 1: Phase I Quality Assurance Statement Attachment 2: Cost Breakdown/Proposed Budget Attachment 3: Representations and Certifications The main body of the technical and commercial proposal shall contain sections that, respond to each of the following requirements:

Technical Requirements

(1) The Innovation

(a) Describe the innovation in sufficient technical depth for a knowledgeable reviewer to understand why it is innovative and how it could benefit the target customers

(b) Describe the technology’s current stage of development—bench/pilot/field—and what must be done to reach the next stage

(c) Describe the demonstrations you will carry out to help move the technology to the next stage—including scale, facilities, partners, other resource needs and availability, etc.

(d) Describe the key technical challenges for bringing the technology to market and how you will overcome them

(e) Describe the current and planned intellectual property associated with this project and how you plan to protect it

(2) Technical Approach

(a) What questions must be answered to determine the technical feasibility of the proposed concept?

(b) What are the key objectives you plan to accomplish during Phase I to answer those questions?

(c) Describe the technical milestones you plan to meet to achieve each objective

(d) Provide a visual timeline projecting the planned achievement of these objectives and milestones during the project

(3) Technical Challenges

(a) Describe the key performance characteristics, including costs, necessary to meet customer needs

(b) Describe how competing technologies—both in the marketplace and being developed—perform against these metrics

(c) Explain how your technology will perform against these metrics compared with the competing technologies

(d) Describe the environmental benefits and costs associated with the lifecyle (inputs, manufacture, use, and reuse/recycle/treatment/disposal) of your technology. How will this Life Cycle Assessment be fleshed out in significant detail during Phase I and who will be responsible for doing so.

Commercialization Requirements

(4) Market Opportunity

(a) Describe the target market for the innovation—including nature, size, business and economic dynamics, etc.

(b) Describe how you validated the market opportunity—e.g., the number of interviews with customers and others, published studies (cite), industry journal articles, consultants, etc.

(c) Describe the drivers for and barriers to selling to your target market, including regulatory

(d) Describe your customers and your basic business model

(e) Describe the competition. How do you expect the competitive landscape to change by the time your product enters the market?

(5) Company/Team

(a) Describe the company founders and key participants (including Principal Investigator (PI)) in this proposed project and their role and level of effort as part of or in support of this project. How does the background and experience of the team enhance the credibility of the effort—e.g., have they previously taken similar technologies to market?

(b) Will you have consultants or subcontractors working on this project? If so, what will be their expertise, affiliation, and contribution to the project?

(c) Describe your vision for the company and the company’s expected impact over the next five years

(d) If the company has existing operations, describe how the proposed effort would fit into these activities. Describe the revenue history, if any, for the past three years. Include government funding and private investment

(6) Commercialization Approach

(a) Describe your commercialization approach for taking the technology from its current stage of development to occupying a dominant position in the target market

(b) Provide estimates of the revenue potential, detailing your underlying assumptions

(c) What resources will you need to implement your commercialization approach?

(d) Describe your plan and expected timeline to secure these resources

(e) Describe the commercialization objectives you plan to accomplish during the Phase I project and provide milestones and a visual timeline for achieving them

(f) What are the prospects for the technology to have commercial applications in addition to the proposed application and what would they be?

Other Requirements

(1) Phase II Commercialization Option Proposal (REQUIRED). Provide a 1- to 3-page proposal describing the commercialization option. The Commercialization Option Proposal shall also include a fully completed, signed budget form (see Appendix 3A) in Attachment 3 of the Phase II proposal. The budget form shall only contain the proposed cost associated with the EPA optional funding amount up to $100,000.

The proposed Commercialization Option Work Plan shall describe the expanded R&D activity to be performed under the Commercialization Option, what will be done, where it will be done and how the R&D will be conducted. The additional EPA funded work proposed under the Phase II Commercialization Option shall be an expansion of the work being performed in the basic Phase II project. The work planned shall be discussed in sufficient detail to enable a scientific and technical evaluation. A work schedule shall also be provided. Contractors may plan to request up to one additional year, if needed, to complete the Phase II Commercialization Option.

The proposal shall also include a description of the expected third-party investment, including what activities are to be conducted and the form and total amount of expected third- party financing. Signed third party commitment letters or letters of interest from third parties are encouraged but not required.

While the EPA funds must be used for the proposed new R&D efforts, the third-party funds can be used for prototypes, demonstration or other R&D and/or commercialization efforts, including market research, advertising and understanding or targeting customer needs, patent support, leveraging/pursuing strategic or financial investors, marketing and business planning.

EPA may unilaterally exercise the Phase II Commercialization Option at any time during the Phase II contract. (See Appendix 4 for documentation required for approval of the Commercialization Option.) The Option proposal and budget (Appendix 3A) are required to be submitted as part of the Phase II proposal. For the option to be exercised the required documentation in Appendix 4 shall be received by the Contracting Officer no later than 90 days before the end of the Phase II contract. An extension to the 90-day due date will not be allowed

(2) Similar or Closely Related SBIR Awards. If the small business concern has received ANY prior Phase I or Phase II award(s) from EPA or any Federal agency for similar or closely related research in the prior 5 fiscal years, submit the name of the awarding agency, date of award, funding agreement number, amount, topic or subtopic title, follow- on agreement amount, source and date of commitment and current commercialization status. DESCRIBE THE TECHNICAL DIFFERENCES AND REASONS WHY THE PROPOSED NEW PHASE II RESEARCH IS DIFFERENT FROM RESEARCH CONDUCTED UNDER PRIOR SBIR AWARDS.

(3) Duplicate or Equivalent SBIR Proposals. A firm may elect to submit essentially equivalent work under other federal program solicitations. In these cases, a statement shall be included in each such proposal indicating: the name and address of the agencies to which proposals were submitted or from which awards were received; date of proposal submission or date of award; title, number, and date of solicitations under which proposals were submitted or awards received; specific applicable research topics for each proposal submitted or award received; titles of research projects; name and title of project manager or principal investigator for each proposal submitted or award received.

(4) Prior SBIR Phase II Awards. If the small business concern has received ANY Phase II award from any Federal agency in the prior 5 fiscal years, submit name of awarding agency, date of award, funding agreement number, amount, topic or subtopic title, follow-on agreement amount, source and date of commitment and current commercialization status for each Phase II award.

D. Attachment 1: Phase II Quality Assurance Statement In your proposal provide a Phase II Quality Assurance Summary. This summary is approximately 1 paragraph to 1 page long and describes expected key elements of the Phase II Quality Assurance Plan (QAP) and steps that will be taken to prepare the plan.

With their first monthly report, Phase II awardees shall include a QAP which provides information on whether or not research involves development of environmental technology (whether hardware-based or via new techniques), environmental data collection or processing, modeling or method development. The QAP is typically 1 to 3 pages. The QAP addresses each section below by including the required information, referencing the specific location of the information in the research plan, or explaining why the section does not apply to the proposed research.

(1) Identify the individual who will be responsible for the quality assurance (QA) and quality control (QC) aspects of the research along with a brief description of this person’s functions, experience and authority within the firm. Describe the firm’s general approach for conducting quality research. (QA is a system of management activities to ensure that a process or product is of the type and quality needed for the project. QC is a system of activities that measure the attributes and performance of a process or product against the standards defined in the project to verify that they will meet those stated requirements.)

(2) Discuss project objectives, including quality objectives, any hypotheses to be tested, and the quantitative and/or qualitative procedures that will be used to evaluate the success of the project. Include any plans for peer or other reviews of the study design or analytical methods.

(3) Address the collection of new primary data, if applicable: (Note: In this case the word “sample” is intended to mean any finite part of a statistical population whose properties are studied to gain information about the whole. If certain attributes listed below do not apply to the type of samples to be used in the research, simply explain why those attributes are not applicable.)

(4) Discuss the plan for sample collection and analysis. As applicable, include sample type(s), frequency, locations, sample sizes, sampling procedures, and the criteria for determining acceptable data quality (e.g., precision, accuracy, representativeness, and completeness, comparability, or data quality objectives). Describe the procedures for the handling and custody of samples including sample collection, identification, preservation, transportation, storage and how the accuracy of test measurements will be verified. Describe or reference each analytical method to be used, any QA or QC checks or procedures with the associated acceptance criteria, and any procedure that will be used in the calibration and performance evaluation of the analytical instrumentation. Discuss the procedures for overall data reduction, analysis and reporting. Include a description of all statistical methods to make inferences and conclusions, acceptable error rates and any statistical software to be used.

(5) Address the use of existing/secondary data (i.e., data previously collected for other purposes or from other sources), if applicable: Describe or reference each analytical method to be used, any QA or QC checks or procedures with the associated acceptance criteria, and any procedures that will be used in the calibration and performance evaluation of the analytical instrumentation. Discuss the procedures for overall data reduction, analysis and reporting. Include a description of all statistical methods to make inferences and conclusions, acceptable error rates and any statistical software to be used.

(6) Address method development, if applicable: (Note: The data collected for use in method development or evaluation should be described in the QAP as per the guidance in Sections 3 and/or 4 above.) Describe the scope and application of the method, any tests (and measurements) to be conducted to support the method development, the type of instrumentation that will be used and any required instrument conditions (e.g., calibration frequency), planned QC checks and associated criteria (e.g., spikes, replicates, blanks), and tests to verify the method’s performance.

(7) Address development or refinement of models, if applicable: (Note: The data collected for use in the development or refinement of models should be described in the QAP as per the guidance in sections 3 and/or 4 above.)

(8) Discuss the scope and purpose of the model, key assumptions to be made during development/refinement, requirements for code development and how the model will be documented. Discuss verification techniques to ensure the source code implements the model correctly. Discuss validation techniques to determine that the model (assumption and algorithms) captures the essential phenomena with adequate fidelity. Discuss plans for long- term maintenance of the model and associated data.

(9) Address development or operation of environmental technology, if applicable: (Note: The data collected for use in the development or evaluation of the technology should be described in the QAP as per the guidance in sections 3 and/or 4 above.)

(10) Describe the overall purpose and anticipated impact of the technology. Describe the technical and quality specifications of each technology component or process that is to be designed, fabricated, constructed and/or operated. Discuss the procedure to be used for documenting and controlling design changes. Discuss the procedure to be used for documenting the acceptability of processes and components, and discuss how the technology will be benchmarked and its effectiveness determined. Discuss the documentation requirements for operating instructions/guides for maintenance and use of the system(s) and/or process(s).

(11) Discuss data management activities (e.g., record-keeping procedures, data-handling procedures, and the approach used for data storage and retrieval on electronic media). Include any required computer hardware and software and address any specific performance requirements for the hardware/software configuration used.

E. Attachment 2: Phase II Cost Breakdown/Proposed Budget Fully complete the two (2) budget forms (see Appendices 3 and 3A) and incorporate them into the proposal. Note that there is no travel required for a Phase II kick-off meeting.

F. Attachment 3: Representations and Certifications A Representations and Certifications Package is located in Appendix 5. Please fill out completely, sign, and return with the proposal. Completion of this package is required before any award can be made. Failure to complete fully and sign this package could delay award.

V. METHOD OF SELECTION AND EVALUATION CRITERIA

All Phase II proposals will be initially screened to determine responsiveness. As noted in Section I, proposals that fail to include a Phase II Commercialization Option Proposal and Budget with their proposals will not be considered for review or award (see Section IV.A. ). Proposals passing this initial screening will be reviewed for technical and commercial merit by external peer reviewers, using the technical evaluation criteria described below. For Phase II, the EPA will use a two-stage evaluation process similar to that used for Phase I. There will be an external peer review, plus an internal programmatic review that considers programmatic balance, Agency priorities, and available funding. EPA is under no obligation to fund any proposal or any specific number of proposals in a given topic. It also may elect to fund several or none of the proposed approaches to the same topic or subtopic.

A. Technical Evaluation Criteria All Phase II proposals will be evaluated and judged on a competitive basis by a peer review panel of technical and commercial experts external to EPA. All peer reviewers are required to sign an agreement to protect the confidentiality of all proposal materials they review and the discussions within the peer review panel, and certify that no conflict of interest exists between them and the offeror. Based on this review, the panel will assign adjectival ratings of “Highly Recommend,” “Recommend” or “Not Recommend” to each proposal. Proposals rated “Not Recommend” will not be considered for award.

B. External Peer Review The following six criteria will be used in the external peer review of the Phase II proposals. Each of the peer review criteria are equally weighted.

Phase II Technical Criteria

(1) The Innovation – Degree to which proposal addresses the innovation including such factors as: why technology is innovative and how it could benefit target customers; what must be done to reach the next stage of development; identification of key technical challenges for bringing the technology to market and how they will be overcome; and the intellectual property associated with this project and how it will be protected.

(2) Technical Approach – Degree to which proposal addresses the technical approach including factors such as: what questions must be answered to determine the technical feasibility of the proposed concept and how these will be addressed; and adequacy of Quality Assurance Statement.

(3) Technical Challenges – Degree to which proposal addresses the technical challenges including factors such as: key performance characteristics including costs, necessary to meet customer needs; description of competing technologies; a lifecycle approach to solving the problem addressing environmental benefits and costs associated with the inputs, manufacture, use, and reuse/recycle/treatment/disposal of the technology.

Phase II Commercialization Criteria

(4) Market Opportunity – Degree to which the proposal addresses the market opportunity including factors such as: target market for the innovation and how market was validated; the drivers for and barriers to selling to target market; description of customers and basic business model; and description of competition and how the competitive landscape is expected to change by the time product enters the market.

(5) Company/Team – Degree to which proposal addresses the company/team (including Principal Investigator (PI)) and factors such as: how qualified company/team is to carry out the proposed work and is balanced between technical and business skills; has adequate resources available to carry out the proposed activities; and has a track record taking similar technologies (including SBIR-funded projects) to market.

(6) Commercialization Approach – Degree to which proposal presents a commercialization approach that can successfully take technology from its current stage of development to market.

C. EPA Programmatic Review Phase II proposals that receive ratings of "Highly Recommend" and "Recommend" from the external peer review panel will be subject to an internal relevancy review by EPA staff. Please note that not all of the proposals rated “Highly Recommend” or “Recommend” will receive a contract award. Many of these proposals are worthy of funding but EPA does not have sufficient SBIR budget to fund them. Proposals will be rated using the three Phase II Programmatic review criteria described below. Projects will not be funded if EPA determines the proposed research is already being supported by EPA or another source. Each of the programmatic relevancy review criteria are equally weighted.

Phase II Internal Programmatic Relevancy Review Criteria

(1) The potential of the technology to meet Agency program priorities.

(2) The potential of the technology to advance sustainability, including environmental, economic, and societal benefits.

(3) The potential of the technology to be widely used, have broad application, and/or to impact large segments of the population.

D. Company Registry Requirements

(1) The Small Business Administration (SBA) maintains and manages a Company Registry at www.SBIR.gov to track ownership and affiliation requirements for all companies applying to the SBIR Program. The SBIR Policy Directive requires each small business concern (SBC) applying for a Phase I or Phase II award to register in the Company Registry prior to submitting a proposal.

(2) Offerors must provide a .pdf copy of their SBA SBC registration and shall append this document to the last page of your technical proposal.

(3) All SBCs will report and/or update ownership information to SBA prior to each SBIR proposal submission or if any information changes prior to award. For example, if a concern that registers on the Company Registry becomes majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms after the time it submitted its initial proposal (or other formal response) to a Phase I or Phase II SBIR announcement or solicitation, the SBC must update the Company Registry.

VI. CONSIDERATIONS

A. Phase II Contract Reporting Requirements

(1) During the duration of the contract, the contractor shall furnish a monthly report stating progress.

One (1) copy of the report shall be submitted electronically to the EPA Contract level Contracting Officer Representative, the EPA Technical Specialist(s), and the EPA Contract Specialist. All reports shall include the following information: EPA contract number, company name, project title and period covered by report. Specific areas of interest shall include progress (both technical and commercial) and difficulties encountered during the reporting period, and a statement of activities anticipated during the subsequent reporting period. The report shall include any changes in personnel associated with the project. Also, the first month's report shall contain an updated work plan and schedule of accomplishments for the subsequent months of the project. The Monthly Report shall include, as an attachment, a copy of the monthly invoice for the same period.

The monthly reports shall be submitted within 7 calendar days after the end of the reporting periods.

If the Phase II Option is executed by contract modification, the contractor shall be required to report R/R&D and commercialization progress associated with the Option, including progress using EPA SBIR funds and progress using the non-SBIR funds. The monthly report shall indicate expenditures of SBIR and non-SBIR funds.

(2) The first monthly report shall also include a copy of the Phase II Quality Assurance Plan for EPA approval. (See Section IV.E; Attachment 2).

(3) The first monthly report shall also include a revised commercialization work plan and accomplishment schedule for Phase II activities. Progress implementing the commercialization work plan shall be reported in the monthly reports.

(4) One copy of a comprehensive final report on the Phase II project shall be submitted electronically by the completion date of the contract. One (1) copy of the report shall be submitted electronically to the EPA Contract level Contracting Officer Representative, the EPA Technical Specialist(s) and the EPA Contract Specialist. This final report shall include a single-page project summary as the first page, identifying the purpose of the research, a brief description of the conducted research, research findings or results, verification reports, and commercial applications of the research in a final paragraph. The balance of the report shall indicate in detail the research objectives, research work carried out, results obtained, and estimates of technical feasibility.

(5) One (1) copy of a 2- to 5-page executive summary of the final report for Phase II shall be submitted electronically to the Contract level Contracting Officer Representative, the EPA Technical Specialist(s), and the EPA Contract Specialist by the completion date of the contract. The report shall be cleared for the general public and will be published on EPA's SBIR Web site. This shall be a true summary of the report, including the purpose of the project, work carried out and results. The summary should stress innovation and potential commercialization.

The executive summary shall be submitted 7-10 days after the completion date of the contract.

(6) EPA support shall be credited in any and all reports, publications, presentations, and announcements with the following statement: “This work was supported by the EPA SBIR Program under contract number 68HE0D19Cxxxx.”.

B. Payment Schedule Monthly progress payments will be allowed for SBIR Phase II contractors at a maximum rate of 85% of total costs incurred for each reporting period. The remainder shall be paid upon receipt and acceptance of the final report. Pursuant to the provisions of FAR 52.232-25, PROMPT PAYMENT (JAN 2017), payment will be rendered within thirty (30) days after receipt of a proper invoice for each reporting period. Appropriate provisions will be included in the contract.

C. Innovations, Inventions, and Patents

(1) LIMITED RIGHTS INFORMATION AND DATA

(a) PROPRIETARY INFORMATION.

Information contained in unsuccessful proposals will remain the property of the offeror. The EPA may, however, retain copies of all proposals.