STTR DOD 20.C BAA_Amendment1_10_21_20.pdf

Participating DoD Components:

• Missile Defense Agency (MDA)

• National Geospatial-Intelligence Agency (NGA)

IMPORTANT

Deadline for Receipt: Proposals must be completely submitted no later than 12:00 p.m. ET, October 27, 2020.

Proposals submitted after 12:00 p.m. will not be evaluated. The final proposal submission includes successful completion of all firm level forms, all required volumes, and electronic corporate official certification.

Classified proposals will not be accepted under the DoD STTR Program.

This BAA and the Defense SBIR/STTR Innovation Portal (DSIP) sites are designed to reduce the time and cost required to prepare a formal proposal. The DSIP is the official portal for DoD SBIR/STTR proposal submission.

Proposers are required to submit proposals via DSIP; proposals submitted by any other means will be disregarded.

Proposers submitting through this site for the first time will be asked to register. Effective with this announcement, firms are required to register for a login.gov account and link it to their DSIP account. See section

4.14 for more information regarding registration.

The Small Business Administration, through its SBIR/STTR Policy Directive, purposely departs from normal

Government solicitation formats and requirements and authorizes agencies to simplify the SBIR/STTR award process and minimize the regulatory burden on small business. Therefore, consistent with the SBA SBIR/STTR

Policy Directive, the Department of Defense is soliciting proposals as a Broad Agency Announcement.

SBIR/STTR Updates and Notices : To be notified of SBIR/STTR opportunities and to receive e-mail updates on the DoD SBIR and STTR Programs, you are invited to subscribe to our Listserv by visiting https://www.dodsbirsttr.mil/submissions/login and clicking “DSIP Listserv” located under Quick Links.

Help Desk: If you have questions about the Defense Department's SBIR or STTR Programs, please call the DoD

SBIR/STTR Help Desk at 1-703-214-1333, or email to DoDSBIRSupport@reisystems.com (Monday through

Friday, 9:00 a.m. to 5:00 p.m. ET).

DEPARTMENT OF DEFENSE

SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM

STTR 20.C Program Broad Agency Announcement (BAA)

AMENDMENT 1, October 21, 2020 The purpose of Amendment 1 is to extend the deadline for receipt of proposals to Tuesday, October 27, 2020 at 12:00 PM ET. Changes are noted in red text below.

August 25, 2020: DoD BAA issued for pre-release September 23, 2020: DoD begins accepting proposals

October 27, 2020: Deadline for receipt of proposals no later than 12:00 p.m. ET https://www.dodsbirsttr.mil/submissions/login mailto:DoDSBIRSupport@reisystems.com

Table of Contents

1.0 INTRODUCTION

2.0 PROGRAM DESCRIPTION

2.1 Objectives

2.2 Three Phase Program

3.0 DEFINITIONS

3.1 Performance Benchmarks for Progress toward Commercialization

3.2 Commercialization

3.3 Cooperative Research and Development

3.4 Essentially Equivalent Work

3.5 Export Control

3.6 Federal Laboratory

3.7 Foreign Nationals

3.8 Fraud, Waste, and Abuse

3.9 Funding Agreement

3.10 HBCU/MI - Historically Black Colleges and Universities and Minority Institutions

3.11 Certified HUBZone Small Business Concern

3.12 Principal Investigator

3.13 Proprietary Information

3.14 Research Institution

3.15 Research or Research and Development

3.16 Research Involving Animal Subjects

3.17 Research Involving Human Subjects

3.18 Research Involving Recombinant DNA Molecules

3.19 Service-Disabled Veteran-Owned Small Business (SDVOSB)

3.20 Small Business Concern (SBC)

3.21 Subcontract

3.22 United States

3.23 Women-Owned Small Business Concern

4.0 PROPOSAL FUNDAMENTALS

4.1 Introduction

4.2 Proposer Eligibility and Performance Requirements

4.3 Joint Ventures

4.4 Majority Ownership in Part

4.5 Conflicts of Interest

4.6 Classified Proposals

4.7 Research Involving Human Subjects

4.8 Research Involving Animal Subjects

4.9 Research Involving Recombinant DNA Molecules

4.10 Debriefing/Technical Evaluation Narrative

4.11 Pre-Award and Post Award BAA Protests

4.12 Phase I Award Information

4.13 Questions about this BAA and BAA Topics

4.14 Registrations and Certifications

4.15 Promotional Materials

4.16 Prior, Current, or Pending Support of Similar Proposals or Awards

4.17 Fraud and False Statements

4.18 State and Other Assistance Available

4.19 Discretionary Technical and Business Assistance (TABA)

5.0 PHASE I PROPOSAL

5.1 Introduction

5.2 Summary of Component Programs

5.3 Marking Proprietary Proposal Information

5.4 Phase I Proposal Instructions

6.0 PHASE I EVALUATION CRITERIA

7.0 PHASE II PROPOSAL INFORMATION

7.1 Introduction

7.2 Proposal Provisions

7.3 Commercialization Strategy

7.4 Phase II Evaluation Criteria

7.5 Phase II Award Information

7.6 Adequate Accounting System

7.7 Phase II Enhancement Policy

7.8 Commercialization Readiness Program (CRP)

8.0 CONTRACTUAL REQUIREMENTS

8.1 Other Contract Requirements

8.2 Prohibition on Contracting with Persons that have Business Operations with the Maduro

Regime

8.3 Copyrights

8.4 Patents

8.5 Technical Data Rights

8.6 Invention Reporting

8.7 Final Technical Reports - Phase I through Phase III

Missile Defense Agency (MDA) _______________________________________________ MDA 1 - 23 National Geospatial-Intelligence Agency (NGA) ___________________________________ NGA 1 - 12

1.0 INTRODUCTION

MDA and NGA hereafter referred to as DoD Components, invite small business firms and research institutions to jointly submit proposals under this BAA for the Small Business Technology Transfer (STTR) Program. Firms with the capability to conduct research and development (R&D) in any of the defense-related topic areas described in Section 12.0 and to commercialize the results of that R&D are encouraged to participate.

The STTR Program, although modeled substantially on the Small Business Innovation Research (SBIR) Program, is a separate program and is separately financed. Subject to availability of funds, DoD Components will support high quality cooperative research and development proposals of innovative concepts to solve the listed defense-related scientific or engineering problems, especially those concepts that also have high potential for commercialization in the private sector. Partnerships between small businesses and Historically Black Colleges and Universities (HBCUs) or Minority Institutions (MIs) are encouraged, although no special preference will be given to STTR proposals from such proposers.

This BAA is for Phase I proposals only. A separate BAA will not be issued requesting Phase II proposals, and unsolicited proposals will not be accepted. All firms that are awarded Phase I awards originating from this BAA will be eligible to participate in Phases II competitions and potential Phase III awards.

DoD Components will notify Phase I awardees of the Phase II proposal submission requirements.

Submission of Phase II proposals will be in accordance with instructions provided by individual Components. The details on the due date, content, and submission requirements of the Phase II proposal will be provided by the awarding DoD Component either in the Phase I award or by subsequent notification. If a firm submits their Phase II proposal prior to the dates provided by the individual Components, it may be rejected without evaluation.

DoD is not obligated to make any awards under Phase I, Phase II, or Phase III, and all awards are subject to the availability of funds. DoD is not responsible for any monies expended by the proposer before the issuance of any award.

2.0 PROGRAM DESCRIPTION

2.1 Objectives

The objectives of the DoD STTR Program include stimulating technological innovation, strengthening the role of small business in meeting DoD research and development needs, fostering and encouraging participation by minority and disadvantaged persons in technological innovation, and increasing the commercial application of DoD-supported research or research and development results.

RT&L Technology Focus Area Definitions

Focus Area Description

5G Technologies enabling the 5G spectrum to increase speed over current networks, to be more resilient and less susceptible to attacks, and to improve military communication and situational awareness.

Artificial Intelligence

(AI)/ Machine

Learning (ML)

Systems that perceive, learn, decide, and act on their own. Machine-learning systems with the ability to explain their rationale, characterize their strengths and weaknesses, and convey understanding of how they will behave in the future.

Autonomy

Technology that can deliver value by mitigating operational challenges such as: rapid decision making; high heterogeneity and/or volume of data; intermittent communications; high complexity of coordinated action; danger to mission; and high persistence and endurance.

Biotechnology

Biotechnology is any technological application that harnesses cellular and biomolecular processes. Most current biotech research focuses on agent detection, vaccines, and treatment. Future advances in biotechnology will improve the pro tection of both the general public and military personnel from biological agents, among numerous other potential applications.

Cybersecurity

Prevention of damage to, protection of, and restoration of computers, electronic communications systems, electronic communications services, wire communication, and electronic communications, including information contained therein, to ensure its availability, integrity, authentication, confidentiality, and nonrepudiation.

Directed Energy (DE) Technologies related to production of a beam of concentrated electromagnetic energy, atomic, or subatomic particles.

Hypersonics

Innovative concepts or technologies that enable, or directly support, weapons or aircraft that fly at or near hypersonic speeds and/or innovation that allows for enhancing defensive capability against such systems.

Microelectronics Critical microcircuits used in covered systems , custom-designed, custom-manufactured, or tailored for specific military application, system, or environment.

Networked

Command, Control, and Communications

(C3)

Fully networked command control and communications including: command and control (C2) interfaces, architectures, and techniques (e.g., common software interfaces and functional architectures and improved C2 processing/decision making techniques); communications terminals (e.g, software-defined radio (SDRs)/apertures with multiple networks on the same band and multi-functional systems); and apertures and networking technologies (e.g., leveraging/managing a diverse set of links across multiple band and software defined networking/ network slicing).

Nuclear

Technologies supporting the nuclear triad-including nuclear command, control, and communications, and supporting infrastructure. Modernization of the nuclear force includes developing options to counter competitors' coercive strategies, predicated on the threatened use of nuclear or strategic non-nuclear attacks.

Quantum Science

Technologies related to matter and energy on the atomic and subatomic level. Areas of interest: clocks and sensors; networks; computing enabling technologies (e.g., low temperature amplifiers, cryogenics, superconducting circuits, photon detectors);

communications (i.e., sending/receiving individual photons); and manufacturing improvements.

Space Technologies supporting space, or applied to a space environment.

General Warfighting

Requirements (GWR)

Warfighting requirements not meeting the descriptions above; may be categorized into

Reliance 21 areas of interest.

The DoD SBIR/STTR Programs follow the policies and practices of the Small Business Administration (SBA) SBIR Policy Directive updated on May 2, 2019. The guidelines presented in this BAA incorporate and make use of the flexibility of the SBA SBIR/STTR Policy Directive to encourage proposals based on scientific and technical approaches most likely to yield results important to the DoD and the private sector. The SBIR Policy Directive is available at: https://www.sbir.gov/sites/default/files/SBIR- STTR_Policy_Directive_2019.pdf.

2.2 Three Phase Program

The STTR Program is a three-phase program. Phase I is to determine, to the extent possible, the scientific, technical, and commercial merit and feasibility of ideas submitted under the STTR Program.

Phase I awards are made in accordance with the SBA Policy Directive guidelines, current version. The period of performance is generally between six to twelve months with twelve months being the maximum period allowable. Proposals should concentrate on research or research and development which will significantly contribute to proving the scientific and technical feasibility, and commercialization potential of the proposed effort, the successful completion of which is a prerequisite for further DoD support in Phase II. Proposers are encouraged to consider whether the research or research and development being proposed to DoD Components also has private sector potential, either for the proposed application or as a base for other applications.

Phase II awards will be made to firms on the basis of results of their Phase I effort and/or the scientific merit, technical merit, and commercialization potential of the Phase II proposal. Phase II awards are made in accordance with the SBA Policy Directive guidelines, current version. The period of performance is generally 24 months. Phase II is the principal research or research and development effort and is expected to produce a well-defined deliverable prototype. A Phase II contractor may receive up to one additional, sequential Phase II award for continued work on the project.

Under Phase III, the Proposer is required to obtain funding from either the private sector, a non-STTR Government source, or both, to develop the prototype into a viable product or non-R&D service for sale in military or private sector markets. STTR Phase III refers to work that derives from, extends, or completes an effort made under prior STTR funding agreements, but is funded by sources other than the STTR Program. Phase III work is typically oriented towards commercialization of STTR research or technology.

3.0 DEFINITIONS

The following definitions from the SBA STTR Policy Directive and the Federal Acquisition Regulation (FAR) apply for the purposes of this BAA:

3.1 Performance Benchmarks for Progress toward Commercialization

In accordance with the SBA SBIR-STTR Policy Directive Sec 6(a)(7), DoD established a threshold for the application of a benchmark where it is applied only to Phase I applicants that have received more than twenty (20) awards over the prior five (5) fiscal years as determined by the Small Business Administration. The ratio of Phase II awards received to Phase I awards received during this period must be at least 0.25. Additional information on performance benchmarking for Phase I applicants can be found at https://www.sbir.gov/performance-benchmarks.

https://www.sbir.gov/sites/default/files/SBIR-STTR_Policy_Directive_2019.pdf https://www.sbir.gov/sites/default/files/SBIR-STTR_Policy_Directive_2019.pdf https://www.sbir.gov/performance-benchmarks

3.2 Commercialization

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

3.3 Cooperative Research and Development

For the purposes of the STTR Program this means research and development conducted jointly by a small business concern and a research institution in which not less than 40% of the work is performed by the small business concern, and not less than 30% of the work is performed by the single research institution.

The percentage of work is usually measured by both direct and indirect costs; however, proposers should verify how it will be measured with their DoD contracting officer during contract negotiations.

3.4 Essentially Equivalent Work

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

3.5 Export Control

The International Traffic in Arms Regulations (ITAR), 22 CFR Parts 120 through 130, and the Export Administration Regulations (EAR), 15 CFR Parts 730 through 799, will apply to all projects with military or dual-use applications that develop beyond fundamental research, which is basic and applied research ordinarily published and shared broadly within the scientific community. More information is available at https://www.pmddtc.state.gov/ddtc_public.

NOTE: Export control compliance statements found in the individual component proposal instructions are not meant to be all inclusive. They do not remove any liability from the submitter to comply with applicable ITAR or EAR export control restrictions or from informing the Government of any potential export restriction as fundamental research and development efforts proceed.

3.6 Federal Laboratory

As defined in 15 U.S.C. §3703, means any laboratory, any federally funded research and development center (FFRDC), or any center established under 15 U.S.C. §§ 3705 & 3707 that is owned, leased, or otherwise used by a Federal agency and funded by the Federal Government, whether operated by the Government or by a contractor.

3.7 Foreign Nationals

Foreign Nationals (also known as Foreign Persons) as defined by 22 CFR 120.16 means any natural person who is not a lawful permanent resident as defined by 8 U.S.C. § 1101(a)(20) or who is not a protected individual as defined by 8 U.S.C. § 1324b(a)(3). It also means any foreign corporation, business association, partnership, trust, society or any other entity or group that is not incorporated or organized to do business in the United States, as well as international organizations, foreign governments and any agency or subdivision of foreign governments (e.g., diplomatic missions).

https://www.pmddtc.state.gov/ddtc_public

“Lawfully admitted for permanent residence” means the status of having been lawfully accorded the privilege of residing permanently in the United States as an immigrant in accordance with the immigration laws, such status not having changed.

"Protected individual’’ means an individual who (A) is a citizen or national of the United States, or (B) is an alien who is lawfully admitted for permanent residence, is granted the status of an alien lawfully admitted for temporary residence under 8 U.S.C. § 1160(a) or 8 U.S.C. § 1255a(a)(1), is admitted as a refugee under 8 U.S.C. § 1157, or is granted asylum under Section 8 U.S.C. § 1158; but does not include

(i) an alien who fails to apply for naturalization within six months of the date the alien first becomes eligible (by virtue of period of lawful permanent residence) to apply for naturalization or, if later, within six months after November 6, 1986, and (ii) an alien who has applied on a timely basis, but has not been naturalized as a citizen within 2 years after the date of the application, unless the alien can establish that the alien is actively pursuing naturalization, except that time consumed in the Service's processing the application shall not be counted toward the 2-year period.

3.8 Fraud, Waste, and Abuse

a. 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.

b. 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.

c. Abuse includes any intentional or improper use of Government resources, such as misuse of rank, position, or authority or resources.

d. The STTR Program training related to Fraud, Waste and Abuse is available at:

https://www.sbir.gov/tutorials/fraud-waste-abuse/. See Section 4.18 for reporting Fraud, Waste, and Abuse.

3.9 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. Only the contract method will be used by DoD Components for all STTR awards.

3.10 HBCU/MI - Historically Black Colleges and Universities and Minority Institutions

Listings for the Historically Black Colleges and Universities (HBCU) and Minority Institutions (MI) are available through the Department of Education Web site, http://www.ed.gov/about/offices/list/ocr/edlite-minorityinst.html.

3.11 Certified HUBZone Small Business Concern

An SBC that has been certified by SBA under the Historically Underutilized Business Zones (HUBZone) Program (13 C.F.R. § 126) as a HUBZone firm listed in the Dynamic Small Business Search (DSBS).

https://www.sbir.gov/tutorials/fraud-waste-abuse/tutorial-1 http://www.ed.gov/about/offices/list/ocr/edlite-minorityinst.html http://www.ed.gov/about/offices/list/ocr/edlite-minorityinst.html

3.12 Principal Investigator

The principal investigator/project manager is the one individual designated by the applicant to provide the scientific and technical direction to a project supported by the funding agreement.

For both Phase I and Phase II, the primary employment of the principal investigator must be with the small business firm or research institution at the time of award and during the conduct of the proposed project. Primary employment means that more than one-half of the principal investigator's time is spent in the employ of the small business firm or research institution. This precludes full-time employment with another organization. Occasionally, deviations from this requirement may occur, and must be approved in writing by the contracting officer after consultation with the agency SBIR/STTR Program Manager/Coordinator. Further, a small business firm or research institution may replace the principal investigator on an SBIR/STTR Phase I or Phase II award, subject to approval in writing by the contracting officer.

3.13 Proprietary Information

Proprietary information is information that you provide which constitutes a trade secret, proprietary commercial or financial information, confidential personal information or data affecting the national security.

3.14 Research Institution

Any organization located in the United States that is:

a. A university.

b. A nonprofit institution as defined in Section 4(5) of the Stevenson-Wydler Technology

Innovation Act of 1980.

c. A contractor-operated federally funded research and development center, as identified by the

National Science Foundation in accordance with the government-wide Federal Acquisition Regulation issued in accordance with Section 35(c)(1) of the Office of Federal Procurement

Policy Act. A list of eligible FFRDCs is available at: https://www.nsf.gov/statistics/ffrdclist/.

3.15 Research or Research and Development

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, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements.

3.16 Research Involving Animal Subjects

All activities involving animal subjects shall be conducted in accordance with DoDI 3216.01 “Use of Animals in DoD Programs,” 9 C.F.R. parts 1-4 “Animal Welfare Regulations,” National Academy of Sciences Publication “Guide for the Care & Use of Laboratory Animals,” as amended, and the Department of Agriculture rules implementing the Animal Welfare Act (7 U.S.C. §§ 2131-2159), as well as other applicable federal and state law and regulation and DoD instructions.

https://www.nsf.gov/statistics/ffrdclist/

“Animal use” protocols apply to all activities that meet any of the following criteria:

a. Any research, development, test, evaluation or training, (including experimentation) involving an animal or animals.

b. An animal is defined as any living or dead, vertebrate organism (non-human) that is being used or is intended for use in research, development, test, evaluation or training.

c. A vertebrate is a member of the subphylum Vertebrata (within the phylum Chordata), including birds and cold-blooded animals.

See DoDI 3216.01 for definitions of these terms and more information about the applicability of DoDI

3216.01 to work involving animals.

3.17 Research Involving Human Subjects

All research involving human subjects shall be conducted in accordance with 32 C.F.R. § 219 “The Common Rule,” 10 U.S.C. § 980 “Limitation on Use of Humans as Experimental Subjects,” and DoDI

3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research,” as well as other applicable federal and state law and regulations, and DoD component guidance. Proposers must be cognizant of and abide by the additional restrictions and limitations imposed on the DoD regarding research involving human subjects, specifically as they regard vulnerable populations (DoDI 3216.02), recruitment of military research subjects (DoDI 3216.02), and informed consent and surrogate consent (10 U.S.C. § 980) and chemical and biological agent research (DoDI 3216.02). Food and Drug Administration regulation and policies may also apply.

“Human use” protocols apply to all research that meets any of the following criteria:

a. Any research involving an intervention or an interaction with a living person that would not be occurring or would be occurring in some other fashion but for this research.

b. Any research involving identifiable private information. This may include data/information/specimens collected originally from living individuals (broadcast video, web-use logs, tissue, blood, medical or personnel records, health data repositories, etc.) in which the identity of the subject is known, or the identity may be readily ascertained by the investigator or associated with the data/information/specimens.

See DoDI 3216.02 for definitions of these terms and more information about the applicability of DoDI

3216.02 to research involving human subjects.

3.18 Research Involving Recombinant DNA Molecules

Any recipient performing research involving recombinant DNA molecules and/or organisms and viruses containing recombinant DNA molecules shall comply with the National Institutes of Health Guidelines for Research Involving Recombinant DNA Molecules, dated January 2011, as amended. The guidelines can be found at: https://osp.od.nih.gov/wp-content/uploads/2013/06/NIH_Guidelines.pdf. Recombinant DNA is defined as (i) molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in living cells or (ii) molecules that result from the replication of those described in (i) above.

3.19 Service-Disabled Veteran-Owned Small Business (SDVOSB)

A small business concern owned and controlled by a Service-Disabled Veteran or Service-Disabled Veterans, as defined in Small Business Act 15 USC § 632(q)(2) and SBA’s implementing SDVOSB regulations (13 CFR 125).

https://osp.od.nih.gov/wp-content/uploads/2013/06/NIH_Guidelines.pdf

3.20 Small Business Concern (SBC)

A concern that meets the requirements set forth in 13 C.F.R. § 121.702 (available here).

An SBC must satisfy the following conditions on the date of award:

a. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor;

b. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that if the concern is a joint venture, each entity to the venture must meet the requirements set forth in paragraph (c) below;

c. Is more than 50% directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other small business concerns (each of which is more than 50% directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these; and

d. Has, including its affiliates, not more than 500 employees. (For explanation of affiliate, see www.sba.gov/size.)

3.21 Subcontract

A subcontract is 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. This includes consultants.

3.22 United States

"United States" means the fifty states, the territories and possessions of the Federal Government, the Commonwealth of Puerto Rico, the Republic of the Marshall Islands, the Federated States of Micronesia, the Republic of Palau, and the District of Columbia.

3.23 Women-Owned Small Business Concern

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

4.0 PROPOSAL FUNDAMENTALS

4.1 Introduction

The proposal must provide sufficient information to demonstrate to the evaluator(s) that the proposed work represents an innovative approach to the investigation of an important scientific or engineering problem and is worthy of support under the stated criteria. The proposed research or research and development must be responsive to the chosen topic, although it need not use the exact approach specified in the topic. Anyone contemplating a proposal for work on any specific topic should determine that:

a. The technical approach has a reasonable chance of meeting the topic objective,

b. This approach is innovative, not routine, with potential for commercialization and http://www.gpo.gov/fdsys/pkg/CFR-2011-title13-vol1/pdf/CFR-2011-title13-vol1-sec121-702.pdf http://www.sba.gov/size

c. The proposing firm has the capability to implement the technical approach, i.e., has or can obtain people and equipment suitable to the task.

4.2 Proposer Eligibility and Performance Requirements

a. Each proposer must qualify as a small business for research or research and development purposes and certify to this on the Cover Sheet of the proposal. The eligibility requirements for the SBIR/STTR programs are unique and do not correspond to those of other small business programs (see Section 3.15 of this BAA). Proposers must meet eligibility requirements for Small Business Ownership and Control (see 13 CFR § 121.702 and Section 4.4 of this BAA).

b. A minimum of 40% of each STTR project must be conducted by the small business concern and a minimum of 30% of the effort performed by the single research institution, as defined in Section

3.10. The percentage of work is usually measured by both direct and indirect costs.

c. For both Phase I and II, the principal investigator must be primarily employed with the small business firm or the research institution. At the time of award of a Phase I or Phase II contract, the small business concern must have at least one employee in a management position whose primary employment is with the small business and who is not also employed by the research institution. Primary employment means that more than one half (50%) of the employee's time is spent with the small business. Primary employment with a small business concern precludes full-time employment at another organization.

d. For both Phase I and Phase II, all research or research and development work must be performed by the small business concern and its subcontractors in the United States.

e. Benchmarks. Proposers with prior SBIR/STTR awards must meet two benchmark requirements for Progress towards Commercialization as determined by the Small Business Administration (SBA) on June 1 each year.

(1) For all proposers with greater than 20 Phase I awards over the past five fiscal years excluding the most recent year, the ratio of Phase II awards to Phase I awards must be at least 0.25.

(2) For all proposers with greater than 15 Phase II awards over the last ten fiscal years excluding the last two years, the proposer must have received, to date, an average of at least $100,000 of sales and/or investments per Phase II award received or have received a number of patents resulting from the STTR work equal to or greater than 15% of the number of Phase II awards received during the period.

Consequence of failure to meet the benchmarks:

• SBA will identify and notify Agencies on June 1st of each year the list of companies which fail to meet minimum performance requirements. These companies will not be eligible to submit a proposal for a Phase I award for a period of one year from that date.

• Because this requirement only affects a company’s eligibility for new Phase I awards, a company that fails to meet minimum performance requirements may continue working on its current ongoing SBIR/STTR awards and may apply for and receive new Phase II and Phase III awards.

• To provide companies with advance warning, SBA notifies companies on April 1st if they are failing the benchmarks. If a company believes that the information used was not complete or accurate, it may provide feedback through the SBA Company Registry at www.sbir.gov.

• In addition, SBA has posted a Guide to SBIR/STTR Program Eligibility to help small businesses understand program eligibility requirements, determine if they will be eligible at the time of award, and accurately complete necessary certifications.

http://www.sbir.gov/ http://sbir.gov/sites/default/files/elig_size_compliance_guide.pdf

• The benchmark information on the companies will not be available to the public.

• More detail is available at https://www.sbir.gov/performance-benchmarks.

f. A small business concern must negotiate a written agreement between the small business and the research institution allocating intellectual property rights and rights to carry out follow-on research, development, or commercialization (see Model Agreement for the Allocation of Rights).

4.3 Joint Ventures

Joint ventures and limited partnerships are permitted, provided that the entity created qualifies as a small business in accordance with the Small Business Act, 13 U.S.C. § 121.701.

4.4 Majority Ownership in Part

Majority ownership in part by multiple venture capital, hedge fund, and private equity firms: Small businesses that are owned in majority part by multiple venture capital operating companies (VCOCs), hedge funds, or private equity funds are ineligible to submit applications or receive awards for opportunities in this BAA. Please check Component instructions for further information.

4.5 Conflicts of Interest

Contract awards to firms owned by or employing current or previous Federal Government employees could create conflicts of interest for those employees which may be a violation of federal law.

4.6 Classified Proposals

Classified proposals will not be accepted under the DoD STTR Program. If topics will require classified work during Phase II, the proposing firm must have a facility clearance in order to perform the Phase II work. For more information on facility and personnel clearance procedures and requirements, please visit the Defense Security Service Web site at: http://www.dss.mil/index.html.

4.7 Research Involving Human Subjects

All research involving human subjects, to include use of human biological specimens and human data, shall comply with the applicable federal and state laws and agency policy/guidelines for human subject protection (see Section 3.13).

Institutions to be awarded funding for research involving human subjects must provide documentation of a current Federal Assurance of Compliance with Federal regulations for human subject protection, for example a Department of Health and Human Services, Office for Human Research Protections Federalwide Assurance (http://www.hhs.gov/ohrp). Additional Federal Assurance documentation may also be requested by the awarding DoD Component. All institutions engaged in human subject research, to include subcontractors, must also have a valid Assurance. In addition, personnel involved in human subjects research must provide documentation of completing appropriate training for the protection of human subjects. Institutions proposing to conduct human subject research that meets one of the exemption criteria in 32 CFR 219.101 are not required to have a Federal Assurance of Compliance.

Proposers should clearly segregate research activities involving human subjects from other research and development activities in their proposal.

https://www.sbir.gov/performance-benchmarks http://www.acq.osd.mil/osbp/sbir/docs/allocationofrights.pdf http://www.acq.osd.mil/osbp/sbir/docs/allocationofrights.pdf http://www.dss.mil/index.html http://www.hhs.gov/ohrp/

If selected, institutions must also provide documentation of Institutional Review Board (IRB) approval or a determination from an appropriate official in the institution that the work meets one of the exemption criteria with 32 CFR 219. As part of the IRB review process, evidence of appropriate training for all investigators should accompany the protocol. The protocol, separate from the proposal, must include a detailed description of the research plan, study population, risks and benefits of study participation, recruitment and consent process, data collection and data analysis.

The amount of time required for the IRB to review and approve the protocol will vary depending on such things as the IRB’s procedures, the complexity of the research, the level of risk to study participants and the responsiveness of the Investigator. The average IRB approval process can last between one and three months. Once the IRB has approved the research, the awarding DoD Component will review the protocol and the IRB’s determination to ensure that the research will be conducted in compliance with DoD and DoD Component policies. The DoD review process can last between three to six months. Ample time should be allotted to complete both the IRB and DoD approval processes prior to recruiting subjects. No funding can be used towards human subjects research until ALL approvals are granted.

Submitters proposing research involving human and/or animal use are encouraged to separate these tasks in the technical proposal and cost proposal in order to avoid potential delay of contract award.

4.8 Research Involving Animal Subjects

All research, development, testing, experimentation, education or training involving the use of animals shall comply with the applicable federal and agency rules on animal acquisition, transport, care, handling, and use (see Section 3.12).

For submissions containing animal use, proposals should briefly describe plans for their Institutional Animal Care and Use Committee (IACUC) review and approval.

All Recipients must receive their IACUC’s approval as well as secondary or headquarters-level approval by a DoD veterinarian who is trained or experienced in laboratory animal medicine and science. No animal research may be conducted using DoD funding until all the appropriate DoD office(s) grant approval. Submitters proposing research involving human and/or animal use are encouraged to separate these tasks in the technical proposal and cost proposal in order to avoid potential delay of contract award.

4.9 Research Involving Recombinant DNA Molecules

All research involving recombinant DNA molecules shall comply with the applicable federal and state law, regulation and any additional agency guidance. Research shall be approved by an Institutional Biosafety Committee.

4.10 Debriefing/Technical Evaluation Narrative

After final award decisions have been announced, the technical evaluations of the submitter's proposal may be provided to the submitter. Please refer to the Component-specific instructions of your topics of interest for Component debriefing processes.

4.11 Pre-Award and Post Award BAA Protests

Interested parties have the right to protest as prescribed in FAR 33.106(b) and FAR 52.233-2. For purposes of pre-award protests related to the terms of this BAA, protests should be served to the Contracting Officer

(listed below). For the purposes of a protest related to a selection or award decision, protests should be served to the point-of-contact (POC) listed in the instructions of the DoD Component that authored the topic.

For protests filed with the Government Accountability Office (GAO), a copy of the protest shall be submitted to the Contracting Officer listed below (pre-award ONLY) or DoD Component POC (selection/award decision ONLY) within one day of filing with the GAO. Protests of small business status of a selected firm may also be made to the Small Business Administration.

Washington Headquarters Services (WHS) Acquisition Directorate 1155 Defense Pentagon Washington, DC 20301-1155

Ms. Chrissandra Smith DoD SBIR/STTR BAA Contracting Officer E-mail: chrissandra.smith.civ@mail.mil

4.12 Phase I Award Information

All Phase I and Direct to Phase II proposals will be evaluated and judged on a competitive basis. Proposals will be initially screened to determine responsiveness. Proposals passing this initial screening will be technically evaluated by engineers or scientists to determine the most promising technical and scientific approaches. Each proposal will be judged on its own merit. DoD 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.

a. Number of Phase I Awards . The number of Phase I awards will be consistent with the

Component’s RDT&E budget, the number of anticipated awards for interim Phase I modifications, and the number of anticipated Phase II contracts. No Phase I contracts will be awarded until evaluation of all qualified proposals for a specific topic is completed.

b. Type of Funding Agreement. Each Phase I proposal selected for award will be funded under negotiated contracts or purchase orders and will include a reasonable fee or profit consistent with normal profit margins provided to profit-making firms for R/R&D work. Firm Fixed Price, Firm- Fixed-Price Level of Effort, Labor Hour, Time & Material, or Cost-Plus-Fixed-Fee type contracts can be negotiated and are at the discretion of the Component Contracting Officer.

c. Dollar Value . The Phase I contract value varies among the DoD Components; it is therefore important for proposing firms to review Component-specific instructions for the Component to which they are applying for any specific instructions regarding award size.

d. Timing. The SBA STTR Policy Directive, Section 7(c)(1)(ii), states that agencies should issue the Phase I award no more than 180 days after the closing date of the BAA. However, across DoD, the median time between the date that the STTR BAA closes and the award of a Phase I contract is approximately four months. Normally proposing firms will be notified of selection or non-selection status for a Phase I award within 90 days of the closing date for this BAA.

4.13 Questions about this BAA and BAA Topics

a. General STTR Questions/Information.

(1) Help Desk. The DoD SBIR/STTR Help Desk is prepared to address general questions about this BAA, the proposal preparation and electronic submission process and other program-related areas. The Help Desk may be contacted from 9:00 a.m. to 5:00 p.m. ET Monday through Friday at:

mailto:chrissandra.smith.civ@mail.mil

• Phone: 1-703-214-1333

• E-mail: DoDSBIRSupport@reisystems.com

(2) Websites. The Defense SBIR/STTR Innovation Portal (DSIP) Web site at https://www.dodsbirsttr.mil/submissions/login has information on the DoD SBIR/STTR Program, including:

• SBIR and STTR Program opportunities

• Topics Search engine

• Topic Q&A (formerly SITIS)

• All Electronic Proposal Submission for Phase I and Phase II Proposals.

Firms submitting through this site for the first time will be asked to register on https://www.dodsbirsttr.mil/submissions.

(3) SBIR/STTR Updates and Notices: To be notified of SBIR/STTR opportunities and to receive e-mail updates on the DoD SBIR and STTR Programs, you are invited to subscribe to our Listserv by visiting https://www.dodsbirsttr.mil/submissions/login and clicking “DSIP Listserv” located under Quick Links.

b. General Questions about a DoD Component. General questions pertaining to a particular DoD Component should be submitted in accordance with the instructions given at the beginning of that Component's topics, in Section 12.0 of this BAA.

c. Direct Contact with Topic Authors. From Aug 25, 2020 to Sep 22, 2020, this BAA is issued for Pre-Release with the names of the topic authors and their phone numbers and e-mail addresses. During the pre-release period, proposing firms have an opportunity to contact topic authors by telephone or e-mail to ask technical questions about specific BAA topics.

Questions should be limited to specific information related to improving the understanding of a particular topic’s requirements. Proposing firms may not ask for advice or guidance on solution approach and you may not submit additional material to the topic author. If information provided during an exchange with the topic author is deemed necessary for proposal preparation, that information will be made available to all parties through Topic Q&A (formerly SITIS). After this period questions must be asked through SITIS as described below.

d. Topic Q&A (formerly SITIS). Once DoD begins accepting proposals on Sep 23, 2020, no further direct contact between proposers and topic authors is allowed, unless the Topic Author is responding to a question submitted during the Pre-release period. However, proposers may submit written questions through Topic Q&A at https://www.dodsbirsttr.mil/submissions/login. In Topic Q&A, the questioner and respondent remain anonymous and all questions and answers are posted electronically for general viewing.

Questions are limited to technical information related to improving the understanding of a topic’s requirements. Any other questions, such as those asking for advice or guidance on solution approach, will not receive a response. Proposing firms may locate the topic to which they want to submit a technical question by using the Topic Search feature on this Web site.

Then, using the form at the bottom of the topic description, enter and submit the question.

Answers are generally posted within seven (7) business days of question submission (answers will also be e-mailed directly to the inquirer).

mailto:DoDSBIRSupport@reisystems.com https://www.dodsbirsttr.mil/submissions/login https://www.dodsbirsttr.mil/submissions

The Topic Q&A for this BAA opens on Aug 25, 2020 and closes to new questions on Oct 8, 2020 at 12:00 PM ET. Once the BAA closes to proposal submission, no communication of any kind with the topic author or through Topic Q&A regarding your submitted proposal is allowed.

Proposing firms are advised to monitor Topic Q&A during the BAA period for questions and answers. Proposing firms should also frequently monitor DSIP for updates and amendments to the topics.

4.14 Registrations and Certifications

Proposing firms must be registered in the Defense SBIR/STTR Innovation Portal (DSIP) in order to prepare and submit proposals. All users will be required to register for a login.gov account and link it to their DSIP account. To register in Login.gov, click the Login/Register button in the top right corner on the DSIP Submissions homepage and follow the steps to register. If you already have a Login.gov account, you can link your existing Login.gov account with your DSIP account. Job Aids and Help Videos to walk you through the process are in the Learning & Support section of DSIP, here:

https://www.dodsbirsttr.mil/submissions/learning-support/training-materials.

Please note that the email address you use for Login.gov should match the email address associated with your existing DSIP account. If you do not recall the email address associated with your DSIP account, or if you already have an existing Login.gov account using a different email address, you will need your Firm’s DUNS number and your Firm PIN in order to link your Login.gov account with your DSIP account. If the email address associated with your existing DSIP account has been used for multiple DSIP accounts within your Firm, you will also need your Firm’s DUNS number and your Firm PIN in order to link your Login.gov account with your DSIP account. The Firm PIN can be obtained from your Firm Admin. You can view the Firm Admin’s contact information by entering your Firm’s DUNS number when prompted. If you are the Firm Admin, please ensure that you contact all DSIP users in your Firm and provide them with the Firm PIN.

It is recommended that you complete your Login.gov setup as soon as possible to avoid any delays in your proposal submissions.

Before the DoD Components can award a contract, proposing firms must be registered in the System for Award Management (SAM). If you were previously registered in CCR, your information has been transferred to SAM. However, it is in the firm’s interest to visit SAM and ensure that all of the firm’s data is up to date from SAM and other databases to avoid delay in award.