DEPARTMENT OF DEFENSE

SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM

SBIR 20.1 Program Broad Agency Announcement (BAA)

December 10, 2019: DoD BAA issued for pre-release

January 14, 2020: DoD begins accepting proposals

February 12, 2020: Deadline for receipt of proposals no later than 8:00 p.m. ET

Participating DoD Components:

• Department of the Army

• Department of the Navy

• Department of the Air Force

• Defense Health Agency (DHA)

• Defense Logistics Agency (DLA)

• Defense Microelectronics Activity (DMEA)

• National Geospatial-Intelligence Agency (NGA)

• Office of the Secretary of Defense - ManTech (OSD/ManTech)

• United States Special Operations Command (USSOCOM)

IMPORTANT

Deadline for Receipt: Proposals must be completely submitted no later than 8:00 p.m. ET, February 12, 2020. Proposals submitted after 8:00 p.m. will not be evaluated.

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

A Phase I Template is provided at https://www.dodsbirsttr.mil/submissions/learning-support to assist small businesses to generate a Phase I Technical Volume (Volume 2).

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 at https://sbir.defensebusiness.org/

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.

Table of Contents

1.0 INTRODUCTION

The Army, Navy, Air Force, DHA, DLA, DMEA, NGA, OSD – ManTech, and USSOCOM, hereafter referred to as DoD Components, invite small business firms to submit proposals under this BAA for the Small Business Innovation Research (SBIR) 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.

While the Phase II proposal process is covered in this announcement, this BAA is for Phase I proposals only unless the Component is participating in the Direct to Phase II Program. Air Force, Navy, DHA, DLA, OSD – ManTech, and USSOCOM are offering Direct to Phase II topics for the SBIR 20.1 BAA – see the Component-specific instructions for more information.

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 Phase 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.

1. PROGRAM DESCRIPTION

2. Objectives

The objectives of the DoD SBIR 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.

More than half of the topics in this BAA address the DoD Research, Technology & Laboratory’s (RT&L) top priority technology focus areas, outlined below.

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 protection 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 Program follows the policies and practices of the Small Business Administration (SBA) SBIR Policy Directive updated on February 24, 2014. The guidelines presented in this BAA incorporate and make use of the flexibility of the SBA SBIR 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: http://www.sbir.gov/sites/default/files/sbir_pd_with_1-8- 14_amendments_2-24-14.pdf.

3. Three Phase Program

The SBIR 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 SBIR Program. Phase I awards are typically between $100,000-$167,500 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 typically $500,000 to $1,100,000 in size and 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-SBIR 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. SBIR Phase III refers to work that derives from, extends, or completes an effort made under prior SBIR funding agreements, but is funded by sources other than the SBIR Program. Phase III work is typically oriented towards commercialization of SBIR research or technology.

1. DEFINITIONS

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

2. 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.

3. 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

Research and development conducted jointly by a small business concern and a research institution. For purposes of the STTR Program, 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. For purposes of the SBIR Program, this refers to work conducted by a research institution as a subcontractor to the small business concern. At least two-thirds of the research and/or analytical work in Phase I must be conducted by the proposing firm.

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.

4. 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/?id=ddtc_kb_article_page&sys_id=24d528fddbfc930044f9ff621f961987.

NOTE: Export control compliance statements found in the individual Component-specific 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).

“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

1. 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.

2. 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.

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

4. The SBIR Program training related to Fraud, Waste and Abuse is available at: https://www.sbir.gov/tutorials/fraud-waste-abuse/tutorial-1. See Section 4.19 for reporting Fraud, Waste and Abuse.

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 SBIR awards.

9. 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.

9. 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).

9. 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 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. 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.

9. 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.

9. 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/.

9. Research or Research and Development

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.

9. 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.

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

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

2. 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.

3. 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.

9. 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 DoDD 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 (DoDD 3216.02), recruitment of military research subjects (DoDD 3216.02), and informed consent and surrogate consent (10

U.S.C. § 980) and chemical and biological agent research (DoDD 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:

1. 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.

2. 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 DoDD 3216.02 for definitions of these terms and more information about the applicability of DoDI 3216.02 to research involving human subjects.

9. 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.

9. 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).

9. 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:

1. 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;

2. 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;

3. 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

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

9. 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.

9. 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.

9. 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.

1. PROPOSAL FUNDAMENTALS

Unless otherwise specified, Section 4 applies to both Phase I and Phase II.

2. 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:

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

2. This approach is innovative, not routine, with potential for commercialization and

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

3. Proposer Eligibility and Performance Requirements

1. Each proposer must qualify as a small business concern as defined by 13 C.F.R §§ 701-705 at time of award and certify to this in the Cover Sheet section 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).

2. A minimum of two-thirds of the research and/or analytical work in Phase I must be conducted by the proposing firm. For Phase II, a minimum of one-half (50%) of the research and/or analytical work must be performed by the proposing firm. The percentage of work is measured by both direct and indirect costs.

3. For both Phase I and II, the primary employment of the principal investigator must be with the small business firm at the time of the award and during the conduct of the proposed effort. Primary employment means that more than one-half of the principal investigator's time is spent with the small business. Primary employment with a small business concern precludes full-time employment at another organization.

4. 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.

5. 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 (currently FY 2013-2017), 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 (currently FY 2007-2016), 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 SBIR 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 1^st 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 1^st 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.

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

4. Joint Ventures

Joint ventures and limited partnerships are permitted, provided that the entity created qualifies as a small business in accordance with the Code of Federal Regulations, 13 CFR § 121.701.

5. 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.

6. 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

7. Classified Proposals

Classified proposals will not be accepted under the DoD SBIR 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.

8. 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 3.12).

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 Federal-wide 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.

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 subject research until ALL approvals are granted.

9. 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 3.11).

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.

10. 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.

11. Debriefing

Please refer to the Component-specific instructions for your topics of interest. It is important to note that some Component-unique debriefing processes exist; in those cases, the Component debriefing instructions supersede instructions provided here. The process may include these methods: An unsuccessful proposer that submits a request for a debriefing within 30 days of being notified that their proposal was not selected for award will be provided a debriefing which may be done orally, in writing, or by any other method acceptable to the contracting officer. The request should be emailed to the DoD organization that provided such notification to the proposer. Be advised that a proposer that fails to submit a timely request is not entitled to a debriefing, although untimely debriefing requests may be accommodated at the Government's discretion.

12. BAA Protests

Interested parties may have the right to protest this BAA by filing directly with the agency by serving the Contracting Officer (listed below) with the protest, or by filing with the Government Accountability Office (GAO). If the protest is filed with the GAO, a copy of the protest shall be received in the office designated below within one day of filing with the GAO. The protesting firm shall obtain written and dated acknowledgment of receipt of the protest from:

SBIR/STTR Contracting Office 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

13. Selection and Award Protests

Protest of Phase I and Phase II selections and awards need to be directed to the contracting officer from the awarding DoD Component or by filing with the Government Accountability Office (GAO). If the protest is filed with the GAO, a copy of the protest shall be received in the office of the DoD Component within one day of filing with the GAO. To ensure a timely protest, protesters should secure the name of the Component Contracting Officer before submitting a protest with GAO. Protests of the small business status of a selected firm may also be made to the Small Business Administration.

14. Phase I Award Information

1. 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.

2. 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.

3. Dollar Value. The Phase I contract value varies among the DoD Components; it is therefore important for proposing firms to understand Section 5.2, “Summary of Component Programs,” for the Component to which they are applying for any specific instructions regarding award size.

4. Timing. The SBA SBIR 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 SBIR 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.

1. Phase II Award Information

1. Number of Phase II Awards. The number of Phase II awards will depend upon the results of the Phase I efforts and the availability of funds. Historically, approximately 40% of the Phase I awards will result in Phase II projects. This is merely an advisory estimate and the Government may make no awards, fewer awards, or more awards.

2. Type of Funding Agreement. Each Phase II proposal selected for award will be funded under a negotiated contract 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 Level of Effort, Firm-Fixed- Price, Labor Hour, Time & Material, Cost-Plus-Fixed-Fee or Other Transaction Authority type contracts can be negotiated and are at the discretion of the Component Contracting Officer.

3. Average Dollar Value. The typical size of award varies across the DoD Components. Information on award size will be provided in DoD Component-specific instructions for submission of Phase II proposals.

4. Timing. Across DoD, the median time between DoD's receipt of a Phase II proposal and the award of a Phase II contract is six months.

16. Questions about this BAA and BAA Topics

1. General SBIR 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:

   • Phone: 1-703-214-1333

   • E-mail: dodsbirsupport@reisystems.com

2. Web sites. The DoD SBIR/STTR Web site at https://sbir.defensebusiness.org/ has information on the DoD SBIR/STTR Program, including:

   • Topics Search engine

   • Technical Q&A through the SBIR Interactive Topic Information System (SITIS)

   • Links to 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 via https://sbir.defensebusiness.org/.

2. 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.

3. Direct Contact with Topic Authors. From December 10, 2019 to January 13, 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 SITIS (SBIR/STTR Interactive Topic Information System). After this period questions must be asked through SITIS as described below.

4. SITIS Q&A System. Once DoD begins accepting proposals on January 14, 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 SITIS at https://sbir.defensebusiness.org/topics. In SITIS, 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 page, enter and submit the question. Answers are generally posted within seven working days of question submission. (Answers will also be e- mailed directly to the inquirer when the inquirer provides an e-mail address.)

The SITIS Q&A online service for this BAA opens on January 14, 2020 and closes to new questions on January 22, 2020, at 8:00 p.m. Typically questions and answers will be posted between January 08 and February 12, 2020. Once the BAA closes to proposal submission, no communication of any kind with the topic author or SITIS regarding your submitted proposal is allowed.

Proposing firms are advised to monitor SITIS during the BAA period for questions and answers. Proposing firms should also frequently check the SBIR/STTR Portal for updates and amendments to the topics.

17. Registrations and Certifications

Proposing firms must be registered in the DoD Submission system at: https://www.dodsbirsttr.mil/submissions/ in order to prepare and submit proposals.

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. SAM replaced the Central Contractor Registration (CCR), Online Representations and Certifications Application (ORCA), and the Excluded Parties List System (EPLS). SAM allows firms interested in conducting business with the federal government to provide basic information on business capabilities and financial information. To register, visit www.sam.gov.

Follow instructions found on the SAM Web site on how to obtain a Commercial and Government Entry (CAGE) code and Data Universal Numbering System (DUNS) number. Once a CAGE code and DUNS

number are obtained, update the firm’s profile on the DoD Submission Web site at https://www.dodsbirsttr.mil/submissions/.

In addition to the standard federal and DoD procurement certifications, the SBA SBIR Policy Directive requires the collection of certain information from firms at time of award and during the award life cycle. Each firm must provide this additional information at the time of the Phase I and Phase II award, prior to final payment on the Phase I award, prior to receiving 50% of the total award amount for a Phase II award, and prior to final payment on the Phase II award.

18. Promotional Materials

Promotional and non-project related discussion is discouraged, and additional information provided via Universal Resource Locator (URL) links or on computer disks, CDs, DVDs, video tapes or any other medium will not be accepted or considered in the proposal evaluation.

19. Prior, Current, or Pending Support of Similar Proposals or Awards

IMPORTANT -- While it is permissible, with proposal notification, to submit identical proposals or proposals containing a significant amount of essentially equivalent work (see Section 3.3) for consideration under numerous federal program BAAs or solicitations, it is unlawful to enter into contracts or grants requiring essentially equivalent effort. If there is any question concerning prior, current, or pending support of similar proposals or awards, it must be disclosed to the soliciting agency or agencies as early as possible. See Section 5.4.c(11).

20. Fraud and False Statements

Knowingly and willfully making any false, fictitious, or fraudulent statements or representations may be a felony under the Federal Criminal False Statement Act (18 U.S.C. Sec 1001), punishable by a fine of up to

$10,000, up to five years in prison, or both.

The Department of Defense, Office of Inspector General Hotline (“Defense Hotline”) is an important avenue for reporting fraud, waste, abuse, and mismanagement within the Department of Defense. The Office of Inspector General operates this hotline to receive and investigate complaints or information from contractor employees, DoD civilians, military service members and public citizens. Individuals who wish to report fraud, waste or abuse may contact the Defense Hotline at (800) 424-9098 between 8:00 a.m. and 5:00 p.m. Eastern Time or visit http://www.dodig.mil/Components/Administrative-Investigations/DoD- Hotline/Hotline-Complaint/ to submit a complaint. Mailed correspondence should be addressed to the Defense Hotline, The Pentagon, Washington, DC 20301-1900, or e-mail addressed to hotline@dodig.mil.

21. Adequate Accounting System

In order to reduce risk to the small business and avoid potential contracting delays, it is suggested that companies interested in pursuing Phase II SBIR contracts and other contracts of similar size with the Department of Defense (DoD), have an adequate accounting system per General Accepted Accounting Principles (GAAP), Generally Accepted Government Auditing Standards (GAGAS), Federal Acquisition Regulation (FAR) and Cost Accounting Standards (CAS) in place. The accounting system will be audited by the Defense Contract Audit Agency (DCAA). DCAA’s requirements and standards are available on their Website at: http://www.dcaa.mil and click on “Guidance” and then click on “Audit Process Overview

• Information for Contractors,” and also at: http://www.dcaa.mil and click on “Checklists and Tools” and then click on “Pre-award Accounting System Adequacy Checklist.”

22. State and Other Assistance Available

Many states have established programs to provide services to those small business firms and individuals wishing to participate in the Federal SBIR Program. These services vary from state to state, but may include:

• Information and technical assistance;

• Matching funds to SBIR recipients;

• Assistance in obtaining Phase III funding.

Contact your State SBIR/STTR Support office at https://www.sbir.gov/state_services?state=105813# for further information. Small Businesses may seek general administrative guidance from small and disadvantaged business utilization specialists located in various Defense Contract Management activities throughout the continental United States.

23. Discretionary Technical and Business Assistance (TABA)

DoD is not mandating the use of TABA pending further SBA guidance and establishment of a limit on the amount of technical and business assistance services that may be received or purchased by a small business concern that has received multiple Phase II SBIR or STTR awards for a fiscal year. However, proposers should carefully review individual component instructions to determine if TABA is being offered and follow specific proposal requirements for requesting TABA funding

1. PHASE I PROPOSAL

2. Introduction

This BAA and the DoD SBIR/STTR Submission Web site are designed to reduce the time and cost required to prepare a formal proposal. Since the guidance on allowable content may vary by Component, it is the proposing firm’s responsibility to consult the Component-specific instructions for detailed guidance.

A complete proposal consists of:

Volume 1: Proposal Cover Sheet

Volume 2: Technical Volume

Volume 3: Cost Volume

Volume 4: Company Commercialization Report – not in use for 20.1 BAA

Volume 5: Supporting Documents

Volume 6: Fraud, Waste and Abuse Training

The Submission Web site provides a structure for providing these five sections, but the proposing firm must begin entering its proposal by providing information for the Proposal Cover Sheet. Once the firm begins a Proposal Cover Sheet they will be assigned a proposal number. Please make note of this proposal number and print it for future reference.

Volume 5, Supporting Documents, was implemented beginning with the SBIR 18.2 BAA cycle.

• Volume 5 is provided for small businesses to submit additional documentation to support the Technical Volume (Volume 2) and the Cost Volume (Volume 3).

• Volume 5 is available when submitting Phase I and Phase II proposals.

• Please refer to the Component-specific instructions for your topics of interest to see how each program office will be handling the Volume 5 information.

Volume 6

Fraud, Waste and Abuse Training, was implemented beginning with the SBIR 18.3 BAA cycle.

• Please refer to the Component-specific instructions for your topics of interest to see how each program office will be handling the Volume 6 Fraud, Waste and Abuse Training information.

In addition, a Phase I Proposal Template is available on the Submission Web site to provide helpful guidelines for completing each section of your complete Phase I technical proposal. This template was implemented with the SBIR 18.2 BAA cycle.

To submit a proposal, the proposer must click the green “Submit Proposal” button. If the proposal status is “In Progress” it will not be considered “Submitted.” For a more detailed explanation, visit: https://www.dodsbirsttr.mil/submissions/. The proposer may add the remaining volumes or modify the Proposal Cover Sheet until BAA close. It is the proposing firm’s responsibility to verify that the Technical Volume does not exceed the page limit after upload to the DoD SBIR/STTR Submission site by clicking on the “Verify Technical Volume” icon.

Please refer to Component-specific instructions how a technical volume is handled if the stated page count is exceeded.  Some Components will reject the entire technical proposal if the proposal exceeds the stated page count.

Signatures are not required on the electronic forms at the time of submission. If the proposal is selected for award, the DoD Component program will contact the proposer for signatures at the time of award.

3. Summary of Component Programs

4. Marking Proprietary Proposal Information

Proposers that include in their proposals data that they do not want disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall:

1. Mark the first page of each Volume of the proposal submission with the following legend:

"This proposal includes data that shall not be disclosed outside the Government and shall not be duplicated, used, or disclosed-in whole or in part-for any purpose other than to evaluate this proposal. If, however, a contract is awarded to this proposer as a result of-or in connection with-the submission of this data, the Government shall have the right to duplicate, use, or disclose the data to the extent provided in the resulting contract. This restriction does not limit the Government's right to use information contained in this data if it is obtained from another source without restriction. The data subject to this restriction are contained in pages [insert numbers or other identification of sheets]"; and

2. Mark each sheet of data it wishes to restrict with the following legend:

"Use or disclosure of data contained on this page is subject to the restriction on the first page of this volume."

The DoD assumes no liability for disclosure or use of unmarked data and may use or disclose such data for any purpose.

Restrictive notices notwithstanding, proposals and final reports submitted through the DoD Submission Web site may be handled, for administrative purposes only, by support contractors. All support contractors are bound by appropriate non-disclosure agreements.

5. Phase I Proposal Instructions

1. Proposal Cover Sheet (Volume 1)

On the DoD Submission Web site at https://www.dodsbirsttr.mil/submissions/, prepare the Proposal Cover Sheet. The Cover Sheet must include a brief technical abstract of no more than 200 words that describes the proposed R&D project with a discussion of anticipated benefits and potential commercial applications. Do not include proprietary or classified information in the Proposal Cover Sheet. If your proposal is selected for award, the technical abstract and discussion of anticipated benefits may be publicly released on the Internet. Once the Cover Sheet is saved, the system will assign a proposal number. You may modify the cover sheet as often as necessary until the BAA closes.

2. Format of Technical Volume (Volume 2)

1. Type of file: The Technical Volume must be a single Portable Document Format (PDF) file, including graphics. Perform a virus check before uploading the Technical Volume file. If a virus is detected, it may cause rejection of the proposal. Do not lock or encrypt

the uploaded file. Do not include or embed active graphics such as videos, moving pictures, or other similar media in the document.

2. Length: Please refer to Component-specific instructions for how a technical volume is handled if the stated page count is exceeded.  Some Components will reject the entire technical proposal if the proposal exceeds the stated page count.

3. Layout: Number all pages of your proposal consecutively. Those who wish to respond must submit a direct, concise, and informative research or research and development proposal (no type smaller than 10-point on standard 8-1/2" x 11" paper with one-inch margins). The header on each page of the Technical Volume should contain your company name, topic number, and proposal number assigned by the DoD SBIR/STTR Submission Web site when the Cover Sheet was created. The header may be included in the one-inch margin.

3. Content of the Technical Volume (Volume 2)

The Technical Volume should cover the following items in the order given below:

1. Identification and Significance of the Problem or Opportunity. Define the specific technical problem or opportunity addressed and its importance.

2. Phase I Technical Objectives. Enumerate the specific objectives of the Phase I work, including the questions the research and development effort will try to answer to determine the feasibility of the proposed approach.

3. Phase I Statement of Work (including Subcontractors’ Efforts)

1. Provide an explicit, detailed description of the Phase I approach. If a Phase I option is required or allowed by the Component, describe appropriate research activities which would commence at the end of Phase I base period should the Component elect to exercise the option. The Statement of Work should indicate what tasks are planned, how and where the work will be conducted, a schedule of major events, and the final product(s) to be delivered. The Phase I effort should attempt to determine the technical feasibility of the proposed concept. The methods planned to achieve each objective or task should be discussed explicitly and in detail. This section should be a substantial portion of the Technical Volume section.

2. This BAA may contain topics that have been identified by the Program Manager as research or activities involving Human/Animal Subjects and/or Recombinant DNA. In the event that Phase I performance includes performance of these kinds of research or activities, please identify the applicable protocols and how those protocols will be followed during Phase I. Please note that funds cannot be released or used on any portion of the project involving human/animal subjects or recombinant DNA research or activities until all of the proper approvals have been obtained (see Sections 4.7 - 4.9).

4. Related Work. Describe significant activities directly related to the proposed effort, including any conducted by the principal investigator, the proposing firm, consultants, or others. Describe how these activities interface with the proposed project and discuss any planned coordination with outside sources. The technical volume must persuade reviewers of the proposer's awareness of the state-of-the-art in the specific topic. Describe previous work not directly related to the proposed effort but similar. Provide the following: (1) short description,

(2) client for which work was performed (including individual to be contacted and phone number), and (3) date of completion.

5. Relationship with Future Research or Research and Development

1. State the anticipated results of the proposed approach if the project is successful.

2. Discuss the significance of the Phase I effort in providing a foundation for Phase II research or research and development effort.

3. Identify the applicable clearances, certifications and approvals required to conduct Phase II testing and outline the plan for ensuring timely completion of said authorizations in support of Phase II research or research and development effort.

6. Commercialization Strategy. Describe in approximately one page your company's strategy for commercializing this technology in DoD, other Federal Agencies, and/or private sector markets. Provide specific information on the market need the technology will address and the size of the market. Also include a schedule showing the quantitative commercialization results from this SBIR project that your company expects to achieve.

7. Key Personnel. Identify key personnel who will be involved in the Phase I effort including information on directly related education and experience. A concise technical resume of the principal investigator, including a list of relevant publications (if any), must be included (Please do not include Privacy Act Information). All resumes will count toward the page limitations for Volume 2.

8. Foreign Citizens. Identify any foreign citizens or individuals holding dual citizenship expected to be involved on this project as a direct employee, subcontractor, or consultant. For these individuals, please specify their country of origin, the type of visa or work permit under which they are performing and an explanation of their anticipated level of involvement on this project. Proposers frequently assume that individuals with dual citizenship or a work permit will be permitted to work on an SBIR project and do not report them. This is not necessarily the case and a proposal will be rejected if the requested information is not provided. Therefore, firms should report any and all individuals expected to be involved on this project that are considered a foreign national as defined in Section 3.5 of the BAA. You may be asked to provide additional information during negotiations in order to verify the foreign citizen’s eligibility to participate on a SBIR contract. Supplemental information provided in response to this paragraph will be protected in accordance with the Privacy Act (5 U.S.C. 552a), if applicable, and the Freedom of Information Act (5 U.S.C. 552(b)(6)).

9. Facilities/Equipment. Describe available instrumentation and physical facilities necessary to carry out the Phase I effort. Justify equipment purchases in this section and include detailed pricing information in the Cost Volume. State whether or not the facilities where the proposed work will be performed meet environmental laws and regulations of federal, state (name), and local Governments for, but not limited to, the following groupings: airborne emissions, waterborne effluents, external radiation levels, outdoor noise, solid and bulk waste disposal practices, and handling and storage of toxic and hazardous materials.

10. Subcontractors/Consultants. Involvement of a university or other subcontractors or consultants in the project may be appropriate. If such involvement is intended, it should be identified and described according to the Cost Breakdown Guidance. A minimum of two- thirds of the research and/or analytical work in Phase I, as measured by direct and indirect

costs, must be conducted by the proposing firm, unless otherwise approved in writing by the Contracting Officer. SBIR efforts may include subcontracts with Federal Laboratories and Federally Funded Research and Development Centers (FFRDCs). A waiver is no longer required for the use of federal laboratories and FFRDCs; however, proposers must certify their use of such facilities on the Cover Sheet of the proposal.

11. Prior, Current, or Pending Support of Similar Proposals or Awards. If a proposal submitted in response to this BAA is substantially the same as another proposal that was funded, is now being funded, or is pending with another Federal Agency, or another or the same DoD Component, you must reveal this on the Proposal Cover Sheet and provide the following information:

    1. Name and address of the Federal Agency(s) or DoD Component to which a proposal was submitted, will be submitted, or from which an award is expected or has been received.

    2. Date of proposal submission or date of award.

    3. Title of proposal.

    4. Name and title of principal investigator for each proposal submitted or award received.

    5. Title, number, and date of BAA(s) or solicitation(s) under which the proposal was submitted, will be submitted, or under which award is expected or has been received.

    6. If award was received, state contract number.

    7. Specify the applicable topics for each SBIR proposal submitted or award received.

Note: If this does not apply, state in the proposal "No prior, current, or pending support for proposed work."

4. Content of the Cost Volume (Volume 3)

Complete the Cost Volume in the format shown in the Cost Breakdown Guidance by using the on- line cost volume form on the DoD Submission Web site. Some items in the Cost Breakdown Guidance may not apply to the proposed project. If that is the case, there is no need to provide information on each and every item. What matters is that enough information be provided to allow us to understand how you plan to use the requested funds if a contract is awarded.

1. List all key personnel by name as well as by number of hours dedicated to the project as direct labor.

2. While special tooling and test equipment and material cost may be included under Phases I, the inclusion of equipment and material will be carefully reviewed relative to need and appropriateness for the work proposed. The purchase of special tooling and test equipment must, in the opinion of the Component Contracting Officer, be advantageous to the Government and should be related directly to the specific topic. These may include such items as innovative instrumentation or automatic test equipment. Title to property furnished by the Government or acquired with Government funds will be vested with the DoD Component, unless it is determined that transfer of title to the contractor would be more cost effective than recovery of the equipment by the DoD Component.

3. Cost for travel funds must be justified and related to the needs of the project.

4. Cost sharing is permitted for proposals under this BAA; however, cost sharing is not required nor will it be an evaluation factor in the consideration of a Phase I proposal.

5. A Phase I Option (if applicable) should be fully costed separately from the Phase I (base) approach.

6. All subcontractor costs and consultant costs must be detailed at the same level as prime contractor costs in regard to labor, travel, equipment, etc. Provide detailed substantiation of subcontractor costs in your cost proposal. Enter this information in the Explanatory Material section of the on-line cost proposal form. The Supporting Documents Volume (Volume 5) may be used if additional space is needed.

When a proposal is selected for award, you must be prepared to submit further documentation to the Component Contracting Officer to substantiate costs (e.g., an explanation of cost estimates for equipment, materials, and consultants or subcontractors). For more information about cost proposals and accounting standards, see http://www.dcaa.mil. Click on “Guidance” and then click on “Audit Process Overview Information for Contractors.”

5. Company Commercialization Report (Volume 4) The Company Commercialization Report Volume will NOT be available during the STTR 20.1 BAA cycle. Therefore, no Commercialization Achievement Index will be generated. Volume 4 will be available for future DoD BAA cycles.

6. Supporting Documents (Volume 5)

The Supporting Documents Volume was implemented beginning with the SBIR 18.2 BAA. Volume 5 is provided for small businesses to submit additional documentation to support the Technical Volume (Volume 2) which is limited to 20 pages, and the Cost Volume (Volume 5). The Supporting Documents Volume is available for use for submitting Phase I and Phase II proposals for both the DoD SBIR and STTR Programs.

Documents that are acceptable and may be included in Volume 5 are:

1. Letters of Support

2. Additional Cost Information

3. Funding Agreement Certification

4. Technical Data Rights (Assertions)

5. Lifecycle Certification

6. Allocation of Rights

7. Other

Please refer to the Component-specific instructions for your topics of interest to learn how each program office will be handling the Volume 5 information.

7. Fraud, Waste and Abuse Training (Volume 6)

The Fraud, Waste and Abuse Training Certification was implemented beginning with the SBIR 18.3 BAA cycle. Please refer to the Component-specific instructions for your topics of interest to see how each program office will be handling the Fraud, Waste and Abuse Training (Volume 6) information.

6. Phase I Proposal Checklist

The Proposer’s proposal shall be in accordance with Section 5.0. A complete proposal consists of:

• Volume 1: Proposal Cover Sheet

• Volume 2: Technical Volume

• Volume 3: Cost Volume

• Volume 4: Company Commercialization Report – not in use for 20.1 BAA

• Volume 5: Supporting Documents

• Volume 6: Fraud, Waste and Abuse Training

Those responding to this BAA should note the proposal preparation tips listed below:

1. Read and follow all instructions contained in this BAA, including the Component-specific instructions listed in Section 12.0 of the DoD Component to which the firm is applying.

2. Register the firm on the secure, password-protected DoD Submission Web site at https://www.dodsbirsttr.mil/submissions/ and, as instructed on the Web site, prepare the firm’s submission.

3. Register the firm with SBA’s Company Registry at www.sbir.gov and provide the SBA SBC Identification Number on each proposal Cover Sheet submitted in response to this BAA.

4. Check that the cost adheres to the Component criteria specified and the cost on the Cover Sheets matches the cost in the Cost Volume.

5. Check that the Project Abstract and other content provided on the Cover Sheets contain NO proprietary information.

6. Mark proprietary information within the Technical Volume as instructed in Section 5.3.

7. The content in the Technical Volume, including the option (if applicable), includes the items in Section 5.4.c.

8. That the header on each page of the technical volume should contain the company name, topic number, and proposal number. (The header may be included in the one-inch margins.)

9. Limit your Technical Volume to page limits outlined in Component Instructions. Refer to Component-specific instructions for how a technical volume in excess of page limits is handled. Some Components will reject the entire technical proposal if it exceeds the page limit.

10. A Phase I Template to assist in preparing your Technical Volume is available on the SBIR/STTR Submission Web site at https://www.dodsbirsttr.mil/submissions/learning-support/firm-templates.

6.0 PHASE I EVALUATION CRITERIA

Proposals will be evaluated based on the criteria outlined below, unless otherwise specified in the Component-specific instructions. Selections will be based on best value to the Government considering the following factors which are listed in descending order of importance:

1. The soundness, technical merit, and innovation of the proposed approach and its incremental progress toward topic or subtopic solution.

2. The qualifications of the proposed principal/key investigators, supporting staff, and consultants. Qualifications include not only the ability to perform the research and development but also the ability to commercialize the results.

3. The potential for commercial (Government or private sector) application and the benefits expected to accrue from this commercialization.

Cost reasonableness and realism shall also be considered to the extent appropriate.

Technical reviewers will base their conclusions only on information contained in the proposal. It cannot be assumed that reviewers are acquainted with the firm or key individuals or any referenced experiments.

Relevant supporting data such as journal articles, literature, including Government publications, etc., should be contained or referenced in the proposal and will count toward the page limit.

1. PHASE II PROPOSAL

2. Introduction

Unless the Component is participating in the Direct to Phase II, Phase II proposals may only be submitted by Phase I awardees. Submission of Phase II proposals are not permitted at this time and, if submitted, may be rejected without evaluation. Phase II proposal preparation and submission instructions will be provided by the DoD Components to Phase I awardees. See Component-specific instructions for more information on Direct to Phase II Program preparation and submission instructions.

3. Proposal Provisions

IMPORTANT -- While it is permissible, with proposal notification, to submit identical proposals or proposals containing a significant amount of essentially equivalent work for consideration under numerous federal program BAAs and solicitations, it is unlawful to enter into contracts or grants requiring essentially equivalent effort. If there is any question concerning this, it must be disclosed to the soliciting agency or agencies as early as possible. If a proposal submitted for a Phase II effort is substantially the same as another proposal that was funded, is now being funded, or is pending with another Federal Agency, or another or the same DoD Component, you must reveal this on the Cover Sheet and provide the information required in Section 5.4.c(11).

Due to specific limitations on the amount of funding and number of awards that may be awarded to a particular firm per topic using SBIR/STTR program funds, Head of Agency Determinations are now required before a different agency may make an award using another agency’s topic. This limitation does not apply to Phase III funding. Please contact your original sponsoring agency before submitting a Phase II proposal to an agency other than the one who sponsored the original topic.

Section 4(b)(1)(i) of the SBIR and the STTR Policy Directives provide that, at the agency’s discretion, projects awarded a Phase I under a solicitation for SBIR may transition in Phase II to STTR and vice versa. A firm wishing to transfer from one program to another must contact their designated technical monitor to discuss the reasons for the request and the agency’s ability to support the request. The transition may be proposed prior to award or during the performance of the Phase II effort. Agency disapproval of a request to change programs shall not be grounds for granting relief from any contractual performance requirement. All approved transitions between programs must be noted in the Phase II award or award modification signed by the contracting officer that indicates the removal or addition of the research institution and the revised percentage of work requirements.

4. How to Submit

Each Phase II proposal must be submitted through the DoD SBIR/STTR Submission Web site by the deadline specified in the Component-specific instructions. Each proposal submission must contain a Proposal Cover Sheet, Technical Volume, and Cost Volume.

5. Commercialization Strategy

At a minimum, your commercialization strategy must address the following five questions:

1. What is the first product that this technology will go into?

2. Who will be the customers, and what is the estimated market size?

3. How much money will be needed to bring the technology to market, and how will that money be raised?

4. Does the company contain marketing expertise and, if not, how will that expertise be brought into the company?

5. Who are the proposing firm’s competitors, and what is the price and/or quality advantage over those competitors?

The commercialization strategy must also include a schedule showing the anticipated quantitative commercialization results from the Phase II project at one year after the start of Phase II, at the completion of Phase II, and after the completion of Phase II (i.e., amount of additional investment, sales revenue, etc.). For further Phase II requirements, please refer to the Component-specific instructions.

8.0 PHASE II EVALUATION CRITERIA

Phase II proposals will be evaluated based on the criteria outlined below, unless otherwise specified in the Component-specific instructions. Selections will be based on best value to the Government considering the following factors which are listed in descending order of importance:

1. The soundness, technical merit, and innovation of the proposed approach and its incremental progress toward topic or subtopic solution.

2. The qualifications of the proposed principal/key investigators, supporting staff, and consultants. Qualifications include not only the ability to perform the research and development but also the ability to commercialize the results.

3. The potential for commercial (Government or private sector) application and the benefits expected to accrue from this commercialization.

Cost reasonableness and realism shall also be considered to the extent appropriate.

Technical reviewers will base their conclusions only on information contained in the proposal. It cannot be assumed that reviewers are acquainted with the firm or key individuals or any referenced experiments.

Relevant supporting data such as journal articles, literature, including Government publications, etc., should be contained or referenced in the proposal and will count toward the page limit.

9.0 PHASE II ENHANCEMENT POLICY

To further encourage the transition of SBIR research into DoD acquisition programs as well as the private sector, certain DoD Components have developed their own Phase II Enhancement policy. Under this policy, the Component will provide a Phase II awardee with additional Phase II SBIR funding if the company can match the additional SBIR funds with non-SBIR funds from DoD acquisition programs or the private sector.

Phase II projects that qualify under Phase II Enhancement may:

1. Extend an existing Phase II contract for up to one year and

2. Match with SBIR funds, up to $537,500 of non-SBIR funds from either DoD non-SBIR Programs or from an outside investor.

Phase II Enhancement requirements and matching rates vary by Component. See each Component's instructions in Section 12.0 of this BAA. Phase II Enhancement applications must be prepared and submitted through the DoD SBIR/STTR Submission Web site at https://www.dodsbirsttr.mil/submissions/. DoD retains the discretion not to approve or fund any Phase II Enhancement application and to review contractor eligibility at the time of selection.

10.0 COMMERCIALIZATION READINESS PROGRAM (CRP)

The SBIR/STTR Reauthorization Act of 2011 established the Commercialization Pilot Program (CPP) as a long-term program titled the Commercialization Readiness Program (CRP).

Each Military Department (Army, Navy, and Air Force) has established a Commercialization Readiness Program. Additionally, each Department has developed criteria and processes to identify projects with the potential for rapid transition to Phase III and that are expected to meet high priority needs of their Department. A project's inclusion in the CRP is by invitation and at the discretion of the Departments.

CRP participants may receive a variety of assistance services and/or opportunities to facilitate the transition of their projects. Participation in the CRP may also include modifications to existing Phase II contracts with additional non-SBIR funding, as well as additional SBIR funding beyond the normal SBIR funding guidelines, to enhance ongoing projects with expanded research, development, test, or evaluation to accelerate transition and commercialization. Additional reporting on CRP participants and results achieved is required.

1. CONTRACTUAL REQUIREMENTS

2. Other Contract Requirements

Upon award of a contract, the contractor will be required to make certain legal commitments through acceptance of Government contract clauses in the Phase I contract. The outline that follows is illustrative of the types of provisions required by the Federal Acquisition Regulation that will be included in the Phase I contract. This is not a complete list of provisions to be included in Phase I contracts, nor does it contain specific wording of these clauses. While a Phase II contract may include some or all of the provisions below, additional provisions will be required. Copies of complete general provisions will be made available prior to award.

1. Standards of Work. Work performed under the contract must conform to high professional standards.

2. Inspection. Work performed under the contract is subject to Government inspection and evaluation at all reasonable times.

3. Examination of Records. The Comptroller General (or a fully authorized representative) shall have the right to examine any directly pertinent records of the contractor involving transactions related to this contract.

4. Default. The Government may terminate the contract if the contractor fails to perform the work contracted.

5. Termination for Convenience. The contract may be terminated at any time by the Government if it deems termination to be in its best interest, in which case the contractor will be compensated for work performed and for reasonable termination costs.

6. Disputes. Any dispute concerning the contract which cannot be resolved by agreement shall be decided by the contracting officer with right of appeal.

7. Contract Work Hours. The contractor may not require an employee to work more than eight hours a day or forty hours a week unless the employee is compensated accordingly (that is, receives overtime pay).

8. Equal Opportunity. The contractor will not discriminate against any employee or applicant for employment because of race, color, religion, sex, or national origin.

9. Affirmative Action for Veterans. The contractor will not discriminate against any employee or applicant for employment because he or she is a disabled veteran.

10. Affirmative Action for Handicapped. The contractor will not discriminate against any employee or applicant for employment because he or she is physically or mentally handicapped.

11. Officials Not to Benefit. No member of or delegate to Congress shall benefit from the contract.

12. Covenant Against Contingent Fees. No person or agency has been employed to solicit or secure the contract upon an understanding for compensation except bona fide employees or commercial agencies maintained by the contractor for the purpose of securing business.

13. Gratuities. The contract may be terminated by the Government if any gratuities have been offered to any representative of the Government to secure the contract.

14. Patent Infringement. The contractor shall report each notice or claim of patent infringement based on the performance of the contract.

15. Military Security Requirements. The contractor shall safeguard any classified information associated with the contracted work in accordance with applicable regulations.

16. American Made Equipment and Products. When purchasing equipment or a product under the SBIR funding agreement, purchase only American-made items whenever possible.

17. Unique Identification (UID). If your proposal identifies hardware that will be delivered to the government be aware of the possible requirement for unique item identification in accordance with DFARS 252.211-7003.

18. Publication Approval. Government review and approval will be required prior to any dissemination or publication, except within and between the Contractor and any subcontractors, of

classified and non-fundamental information developed under this contract or contained in the reports to be furnished pursuant to this contract.

19. Animal Welfare. Contracts involving research, development, test, evaluation, or training on vertebrate animals will incorporate DFARS clause 252.235-7002.

20. Protection of Human Subjects. Effective 29 July 2009, contracts that include or may include research involving human subjects in accordance with 32 CFR Part 219, DoD Directive 3216.02 and 10 U.S.C. 980, including research that meets exemption criteria under 32 CFR 219.101(b), will incorporate DFARS clause 252.235-7004.

21. E-Verify. Contracts exceeding the simplified acquisition threshold may include the FAR clause 52.222-54 “Employment Eligibility Verification” unless exempted by the conditions listed at FAR 22.1803.

22. ITAR. In accordance with DFARS 225.7901-4, Export Control Contract Clauses, the clause found at DFARS 252.225-7048, Export-Controlled Items (June 2013), must be included in all BAAs/solicitations and contracts. Therefore, all awards resulting from this BAA will include DFARS 252.225-7048. Full text of the clause may be found at http://farsite.hill.af.mil/reghtml/Regs/far2afmcfars/fardfars/Dfars/Dfars252_220.htm?zoom_highlig ht=dfars+252%2E225-7048#P4543_324418.

23. Cybersecurity. Any Small Business Concern receiving an SBIR award is required to provide adequate security on all covered contractor information systems. Specific security requirements are listed in DFARS 252.204.7012, and compliance is mandatory.

3. Commercialization Updates in Phase II

If, after completion of Phase I, the contractor is awarded a Phase II contract, the contractor shall be required to periodically update the following commercialization results of the Phase II project through the Web site at https://www.dodsbirsttr.mil/submissions/:

1. Sales revenue from new products and non-R&D services resulting from the Phase II technology;

2. Additional investment from sources other than the federal SBIR/STTR Program in activities that further the development and/or commercialization of the Phase II technology;

3. Whether the Phase II technology has been used in a fielded DoD system or acquisition program and, if so, which system or program;

4. The number of patents resulting from the contractor's participation in the SBIR/STTR Program;

5. Growth in number of firm employees; and

6. Whether the firm has completed an initial public offering of stock (IPO) resulting, in part, from the Phase II project.

These updates on the project will be required one year after the start of Phase II, at the completion of Phase II, and subsequently when the contractor submits a new SBIR or STTR proposal to DoD. Firms that do not submit a new proposal to DoD will be asked to provide updates on an annual basis after the completion of Phase II.

4. Copyrights

With prior written permission of the Contracting Officer, the awardee may copyright (consistent with appropriate national security considerations, if any) material developed with DoD support. DoD receives a royalty-free license for the Federal Government and requires that each publication contain an appropriate acknowledgment and disclaimer statement.

5. Patents

Small business firms normally may retain the principal worldwide patent rights to any invention developed with Government support. The Government receives a royalty-free license for its use, reserves the right to require the patent holder to license others in certain limited circumstances, and requires that anyone

exclusively licensed to sell the invention in the United States must normally manufacture it domestically. To the extent authorized by 35 USC 205, the Government will not make public any information disclosing a Government-supported invention for a period of five years to allow the awardee to pursue a patent. See also Invention Reporting in Section 11.6.

6. Technical Data Rights

Rights in technical data, including software, developed under the terms of any contract resulting from proposals submitted in response to this BAA generally remain with the contractor, except that the Government obtains a royalty-free license to use such technical data only for Government purposes during the period commencing with contract award and ending five years after completion of the project under which the data were generated. This data should be marked with the restrictive legend specified in DFARS 252.227-7018. Upon expiration of the five-year restrictive license, the Government has unlimited rights in the SBIR data. During the license period, the Government may not release or disclose SBIR data to any person other than its support services contractors except: (1) For evaluation purposes; (2) As expressly permitted by the contractor; or (3) A use, release, or disclosure that is necessary for emergency repair or overhaul of items operated by the Government. See DFARS clause 252.227-7018, "Rights in Noncommercial Technical Data and Computer Software – Small Business Innovation Research (SBIR) Program."

If a proposer plans to submit assertions in accordance with DFARS 252.227-7017, those assertions must be identified and assertion of use, release, or disclosure restriction MUST be included with your proposal submission. The contract cannot be awarded until assertions have been approved.

7. Invention Reporting

SBIR awardees must report inventions to the Component within two months of the inventor’s report to the awardee. The reporting of inventions may be accomplished by submitting paper documentation, including fax, or through the Edison Invention Reporting System at www.iedison.gov for those agencies participating in iEdison.

8. Final Technical Reports - Phase I through Phase III

1. Content: A final report is required for each project phase. The reports must contain in detail the project objectives, work performed, results obtained, and estimates of technical feasibility. A completed SF 298, "Report Documentation Page,” will be used as the first page of the report. submission resources at http://www.dtic.mil/dtic/submit/guidance_on_submitting_docs_to_dtic.html. In addition, monthly status and progress reports may be required by the DoD Component.

2. SF 298 Form “Report Documentation Page” Preparation:

1. If desirable, language used by the company in its Phase II proposal to report Phase I progress may also be used in the final report.

2. For each unclassified report, the company submitting the report should fill in Block 12 (Distribution/Availability Statement) of the SF 298, "Report Documentation Page,” with the following statement: “Distribution authorized to U.S. Government only; Proprietary Information, (Date of Determination). Other requests for this document shall be referred to the Component SBIR Program Office.” Note: Data developed under a SBIR contract is subject to SBIR Data Rights which allow for protection under DFARS 252.227-7018 (see Section

11.5, Technical Data Rights). The sponsoring DoD activity, after reviewing the company's

entry in Block 12, has final responsibility for assigning a distribution statement.

For additional information on distribution statements see the following Defense Technical Information Center (DTIC) Web site: http://www.dtic.mil/dtic/pdf/distribution_statements_and_reasons.pdf

3. Block 14 (Abstract) of the SF 298, "Report Documentation Page" must include as the first sentence, "Report developed under SBIR contract for topic [insert BAA topic number. [Follow with the topic title, if possible.]” The abstract must identify the purpose of the work and briefly describe the work conducted, the findings or results and the potential applications of the effort. Since the abstract will be published by the DoD, it must not contain any proprietary or classified data and type “UU” in Block 17.

3. Block 15 (Subject Terms) of the SF 298 must include the term "SBIR Report".

3. Submission: In accordance with DoD Directive 3200.12 and DFARS clause 252.235-7011, a copy of the final report shall be submitted (electronically or on disc) to:

Defense Technical Information Center ATTN: DTIC-OA (SBIR)

8725 John J Kingman Road, Suite 0944 Ft. Belvoir, VA 22060-6218

Delivery will normally be within 30 days after completion of the Phase I technical effort.

Other requirements regarding submission of reports and/or other deliverables will be defined in the Contract Data Requirements List (CDRL) of each contract.

Special instructions for the submission of CLASSIFIED reports will be defined in the delivery schedule of the contract.

DO NOT E-MAIL Classified or controlled unclassified reports, or reports containing SBIR Data Rights protected under DFARS 252.227-7018.