AF X20.3 SBIR CSO_Amendement 1.pdf

DEPARTMENT OF THE AIR FORCE (AF)

SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM

X20.3 SBIR COMMERCIAL SOLUTIONS OPENING (CSO)

AMENDMENT 1, 21 SEPTEMBER 2020

AF VENTURES TOPICS

Includes AFVentures Topics AF203-CSO1 and AF203-DCSO1, as well as SMC Pitch Day Topic AF203-CSO2, AFLCMC/RSO Pitch Day Topic AF203-CSO3, Simulators Pitch Day Topic, AF203-DCSO2, Digital Engineering Pitch Day Topic AF203-DCSO3, and Materials and Manufacturing Topic AF203-DCSO4.

Revisions to this CSO are in red text. Read and follow carefully as many updates have been made.

25 August 2020: Issued for pre-release 23 September 2020: Begin accepting proposals

22 October 2020: Full proposals due no later than 12:00 p.m. ET

IAW with Section 879 of the National Defense Authorization Act (NDAA) for Fiscal Year 2017 (P.L. 114-328), Congress has authorized the Defense CSO Pilot Program. This program allows agencies to obtain solutions or potential new capabilities fulfilling requirements, closing capability gaps, or providing potential technological advancements. Consistent with FY17 NDAA Section 879, AF is soliciting proposals under a CSO. This solicitation is intended for informational purposes and reflects current planning. If there is inconsistency between the information in the CSO and resulting awards, if any, the awards’ terms and conditions take precedent.

IMPORTANT

Deadline for Receipt: No exceptions will be made for the submission deadline above. AF recommends early submission, as computer traffic gets heavy near announcement closing. Do not wait until the last minute . AF is not responsible for missed proposal submission due to servers being “down” or inaccessible .

How to Submit: All proposals must be prepared and submitted through the Department of Defense (DOD) SBIR/STTR Innovation Portal (DSIP), https://www.dodsbirsttr.mil/. Ensure the proposal email address is accurate. AF is not responsible for missed notifications due to firms changing mailing address/email address/ company points of contact after submission without notifying the AF. Classified proposals are NOT accepted.

CSO Changes: The instructions/topic information are significantly revised – read carefully.

SBIR/STTR Updates and Notices:

• The CSO of record is found at https://beta.sam.gov/ and https://www.dodsbirsttr.mil/ (select ‘Topics’; scroll down to ‘SITIS & Topics/Instructions’ header and select ‘AFX’ tab). Proposals must meet all CSO of record requirements at proposal submission deadline .

• To receive AF Ventures and other AF innovation opportunity notifications, register at https://af-ventures.com/ and https://www.afwerx.af.mil/join.html.

Help Desk: For AF SBIR/STTR Program questions, contact the AF Help Desk at 1-855-855-5360 or usaf.team@afsbirsttr.us. For Defense SBIR/STTR Innovation Portal (DSIP) questions or issues, contact the

DoD SBIR/STTR Help Desk at DoDSBIRSupport@reisystems.com https://www.dodsbirsttr.mil/ https://beta.sam.gov/ https://www.dodsbirsttr.mil/ https://af-ventures.com/ https://af-ventures.com/ https://af-ventures.com/ https://www.afwerx.af.mil/join.html mailto:usaf.team@afsbirsttr.us.

mailto:DoDSBIRSupport@reisystems.com

TABLE OF CONTENTS

1.0 INTRODUCTION 4

2.0 PROGRAM DESCRIPTION 5

2.1 Objectives 5

2.2 Three Phase Program 7

2.3 AF Special Topic Information 7

3.0 DEFINITIONS 7

3.1 Certified HUBZone Small Business Concern 7

3.2 Commercial Solutions Opening (CSO) 7

3.3 Commercialization 7

3.4 Essentially Equivalent Work 7

3.5 Export Control 7

3.6 Federal Laboratory 7

3.7 Foreign Nationals 7

3.8 Fraud, Waste and Abuse 8

3.9 Funding Agreement 8

3.10 Innovative 8

3.11 Other Transaction 8

3.12 Performance Benchmarks for Progress Toward Commercialization 8

3.13 Principal Investigator 8

3.14 Proprietary Information 9

3.15 Research Involving Animal Subjects 9

3.16 Research Involving Human Subjects 9

3.17 Research Involving Recombinant DNA Molecules 9

3.18 Research or Research and Development 9

3.19 Service-Disabled Veteran-Owned Small Business (SDVOSB) 10

3.20 Small Business Concern (SBC) 10

3.21 Subcontract 10

3.22 United States 10

3.23 Women-Owned Small Business Concern 10

4.0 PROPOSAL FUNDAMENTALS 11

4.1 Introduction 11

4.2 Offeror Eligibility and Performance Requirements 11

4.3 Joint Ventures 12

4.4 Administrative Proposal Requirements 12

4.5 Majority Ownership in Part 13

4.6 Conflicts of Interest 13

4.7 Classified Proposals 13

4.8 Research Involving Human Subjects 14

4.9 Research Involving Animal Subjects 14

4.10 Research Involving Recombinant DNA Molecules 14

4.11 Use of Unmanned Aerial Systems (UAS) 14

4.12 Proposal Status and Feedback 15

4.13 CSO Protests, Selection and Award Protests 15

4.14 Phase I Award Information 15

4.15 Phase II and Direct to Phase II Award Information 15

4.16 Questions about this CSO and CSO Topics 16

4.17 Identifying RDT&E in SBIR/STTR Proposals 17

4.18 Promotional Materials 17

4.19 Fraudulent or False Statements 17

4.20 State and Other Assistance Available 17

4.21 Government Use of Support Contractors on AF SBIR/STTR Program 17

4.22 Innovation in Manufacturing 17

5.0 PHASE I PROPOSAL 18

6.0 PHASE I EVALUATION CRITERIA 33

7.0 PHASE II PROPOSAL 34

8.0 PHASE II EVALUATION CRITERIA 36

9.0 DIRECT TO PHASE II PROPOSAL 37

10.0 DIRECT TO PHASE II EVALUATION CRITERIA 54

11.0 CONTRACTUAL REQUIREMENTS 55

12.0 VOLUNTARY DIRECT TO PHASE II MATCHING FUNDS GUIDANCE 59

13.0 TOPIC INDEX with Phase I and Direct to Phase II Topics 62

13.1 AF203-CSO1 Title: Phase I Open Call for Innovative Defense-Related 63

Dual-Purpose Technologies/Solutions with a Clear Air Force Stakeholder Need

13.2 AF203-CSO2 Title: Space Force Pitch Day 66

13.3 AF203-CSO3 Title: AF Life Cycle Management Center Rapid Sustainment 70

Office (AFLCMC/RSO) Pitch Day

13.4 AF203-DCSO1 Title: Direct to Phase II Open Call for Innovative Defense- 72

Related Dual-Purpose Technologies/Solutions with a Clear Air Force Stakeholder Need

13.5 AF203-DCSO2 Title: Simulators Pitch Day 2020 Projects for Lightweight or 76 Modular Simulators (Revised)

13.6 AF203-DCSO3 Title: Digital Engineering Pitch Day (Revised) 79

13.7 AF203-DCSO4 Title: Industry Technologies Advancing Materials and 80

Manufacturing Processes for Attritable Structures, Engines, and Sensors of Autonomous Unmanned Aerial and Space Systems (Not a Pitch Day topic)

Attachments:

1. X20.3 Customer Memorandum MANDATORY TEMPLATE

2. X20.3 Funds Matching Form

3. X20.3 AF Ventures Phase I Sample Pitch Deck

1.0 INTRODUCTION

The Air Force (AF) invites small business firms to submit proposals under this CSO for the Small Business Innovation Research (SBIR) Program. Firms with the capability to conduct research and development (R&D) in the AF-related topics described in Section 13.0 and to commercialize the results are encouraged to participate.

The 2014 Quadrennial Defense Review (QDR) established innovation as a central line of effort in the United States’ (US’) national defense strategy. The US’ decisive military advantage over its adversaries and peer competitors is steadily eroding. Consequently, under section 879 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017 (Pub. L. 114-328) Contracting Officers may acquire innovative commercial items, technologies, or services using a competitive procedure called a Commercial Solutions Opening (CSO).

Under the CSO, DoD may competitively select proposals received in response to a general solicitation, similar to a Broad Agency Announcement, based on proposal review by Government scientific, technological, or other subject-matter experts. CSO use in accordance with Class Deviation 2018-O0016 is considered competitive for the purposes of 10 U.S.C. chapter 127 and FAR 6.102. Contracting officers shall treat items, technologies, and services acquired under a CSO as commercial items. The full definition of commercial items, i.e., products and services, under FAR 2.101 applies. This CSO includes no requirement for a commercial product or service be an already developed, off-the-shelf item.

This CSO seeks innovative, commercial technologies proposed to create new AF solutions or potential new capabilities fulfilling requirements, closing capability gaps, or providing potential technological advancements.

This CSO may result in the award of prototype projects, which include not only commercially available technologies fueled by commercial or strategic investment, but also concept demonstrations, pilots, and agile development activities incrementally improving commercial technologies, existing Government-owned capabilities, or concepts for broad Defense application(s). The Government reserves the right to award a contract or an Other Transaction for any purpose, to include a prototype, under this CSO. The AF also reserves the right to award all, part, or none of the proposals received. The Federal Government is not responsible for any monies expended by the applicant before award, if selected. The SBIR/STTR Programs are not substitutes for existing unsolicited proposal mechanisms. Unsolicited proposals are not accepted under the AF SBIR/STTR Programs for Phase I or Phase II.

Information related to the AF Small Business Program is found at http://www.airforcesmallbiz.af.mil/. The site contains contracting opportunities within AF, as well as business information and upcoming outreach/conference events. Other informative sites include the Small Business Administration (SBA), www.sba.gov, and Procurement Technical Assistance Centers, http://www.aptacus.us.org. These centers provide Government contracting assistance and guidance to small businesses, typically at no cost.

http://www.airforcesmallbiz.af.mil/ http://www.sba.gov/ http://www.aptacus.us.org/

2.0 PROGRAM DESCRIPTION

2.1 Objectives

The AF SBIR Program’s objectives include stimulating technological innovation, strengthening the small business role in meeting DoD R&D needs, fostering and encouraging minority and disadvantaged persons in technological innovation, and increasing commercial application of DoD-supported R/R&D results.

The eight (8) Technology Areas below represent AF Strategic priorities. The list also includes a Blue Sky area for solutions not covered under the other eight technology areas. These areas pertain to Topics AF203-CSO1 and AF203-DCSO1 ONLY. Information regarding AF requirements for the remaining opportunities sought under this solicitation is found in the other individual topics. Technical areas are marked as “TA-001” through “TA- 009”.

TA-001Aerospace Systems Technology: Includes turbine engines; alternate fuels for unmanned vehicles and hypersonic systems; supersonic speed; high temperature materials; hypersonic vehicle manufacturing;

air breathing propulsion; hypersonic guidance/control systems; aerospace vehicles; control, power & thermal management; high speed systems; rocket propulsion; and turbine engines.

TA-002 Materials and Manufacturing Technology: New applications for radar and electro-optic sensors, including structural and functional materials; manufacturing technologies; and operations support. Also includes COVID-19 pandemic materials and manufacturing advances.

TA-003 Directed Energy Technology: Includes powerful electromagnetics; electro-optics; high power electromagnetics; laser systems; and ground-based electro optical /infrared space situational awareness.

TA-004 Human Performance, including Medical Technologies: Includes disease prevention/mitigation; rapid emergency medical response and trauma management; environmental remediation; advanced materials;

biological/cognitive research, human capabilities including training, decision-making, bioeffects, and human-centered intelligence, surveillance, and reconnaissance (ISR); and COVID-19 pandemic human performance and medical response advances/solutions.

TA-005 Sensors Technology: New applications for radar and electro-optic sensors, including spectrum warfare;

trusted, resilient mission systems; multi-domain sensing autonomy; enabling devices and components, radio frequency (RF) sensing; and electronic optic (EO) sensing.

TA-006 Munitions Technology: Effects with hyper-precision and speed against ground, sea, or air targets in all weather conditions, day or night. This includes ordnance sciences; terminal seeker sciences; munitions; airframe;

guidance; navigation and control; modeling and simulation; and evaluation sciences.

TA-007 Information Technology: Includes command, control, communications, computer, cyber and intelligence;

enabling technologies for quantum computing in cryogenics and photon detection; improve algorithms; address data quality; optimize human-machine coordination; adversary effort disruption; autonomous systems teaming; machine perception, reasoning and intelligence; human and autonomy systems trust and interaction; addressing high-performance, low power embedded processing; developing algorithms for self-configuring, self-healing, and resource allocation; behavioral issues development; develop self-securing network development; develop cyber effects and consequences capability assessments; quantum clocks, sensors, and quantum communications technologies; autonomy, command and control, and decision support; processing and exploitation; cyber science technology, connectivity; and dissemination; and COVID-19 pandemic information sciences’ advances/solutions.

TA-008 Space Vehicles Technology: Includes space component technology; flying state of the art satellite space experiments; advanced space resilience technologies; space communication and navigation technologies; space awareness, command and control, and space environment; low earth orbit nano-satellites; and simulation and training.

TA-009 Blue Sky: Use to propose solutions not envisioned under one of the eight technology areas above.

The AF SBIR Program follows the policies and practices of the Small Business Administration (SBA) SBIR/STTR Policy Directive (2 May 19), https://www.sbir.gov/sites/default/files/SBIR- STTR_Policy_Directive_2019.pdf. This CSO incorporates and makes use of Policy Directive flexibilities to encourage proposals based on scientific and technical approaches most likely to yield important results for the AF and private sector.

2.2 Three Phase Program

The SBIR/STTR Program consists of Phases I, II, and III. Phase I is to determine, to the extent possible, the scientific and technical merit and feasibility of ideas with commercial potential. Proposals should concentrate on R/R&D significantly contributing to proving scientific and technical feasibility and the proposed effort’s commercialization potential, wherein successful completion is required to obtain further AF support, e.g., a Phase II award. Proposers should consider whether the R/R&D proposed to the AF has private sector potential, either for the proposed application or as the basis for other applications.

Phase II awards are based on Phase I results, including commercialization potential, relevance to Defense needs, and the Phase II proposal’s technical merit. Phase II is the principal R/R&D effort, expected to produce a well-defined deliverable prototype. Phase II awardees may receive one additional, sequential Phase II award to continue the project. There is also the possibility for a third Phase II award under the Commercialization Assistance Pilot Program (CAPP). Additionally, agencies may provide opportunities to apply for Phase IIB awards seeking to bridge the gap between Phase II and III. Proposals for these opportunities, if/when available, are sought through separate, discreet solicitation cycles.

SBIR/STTR Phase IIIs include work deriving from, extending, or completing efforts made under prior SBIR/STTR funding agreements but funded by non-SBIR/STTR Program sources. This can be private sector, non-SBIR/STTR Government sources, or both. Phase III work is typically oriented towards commercializing SBIR/STTR research or technology.

2.3 Consolidated Topic Information (NOTE: This chart applies to Topics AF203-CSO1 and AF203-

DCSO1. For the remaining topics, information may be found within the individual material.)

CHART 1 Phase I Phase II and Direct to Phase II

Technical Volume (Vol 2)

Additional Info

(Vol 5)

Award Amount

Technical & Reporting Duration

Technical Volume (Vol 2)

Additional Info

(Vol 5)

Technical

Reporting Duration

Initial Award Amount

NTE 5 15-slide NTE 3 mo.; 2 mo. NTE 15 15-slide NTE 15 Max $750K pages deck $50,000 tech, 1 mo. pages deck mo.; 12 SBIR funds;

reporting mo. tech, may exceed 3 mo. this amount reporting with cost share or match.

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

3.0 DEFINITIONS

The following definitions from the SBA SBIR/STTR Policy Direction, the Federal Acquisition Regulation (FAR), and 10 USC 2371b apply to this CSO:

3.1 Certified HUBZone Small Business Concern: An SBC 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).

3.2 Commercial Solutions Opening (CSO): A competitive procedure Contracting Officers may use to acquire innovative commercial items, technologies or services.

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

3.4 Essentially Equivalent Work: Work substantially the same research, proposed for funding in more than one application submitted to the same Federal agency, or two or more different Federal agencies for review and funding consideration. It may also include work where a specific research objective and the research design for accomplishing project objective are the same or closely related to another proposal or award, regardless of funding source.

3.5 Export Control: The International Traffic in Arms Regulations (ITAR), 22 CFR Parts 120 through projects with military or dual-use applications beyond fundamental research. Fundamental research 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_public_portal_itar_landing.

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 USC § 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 two (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 two (2)-year period.

https://www.pmddtc.state.gov/?id=ddtc_public_portal_itar_landing

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.

3.9 Funding Agreement: Any contract, grant, cooperative agreement, or Other Transaction for Prototype 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.

3.10 Innovative:

(1) Any new technology, process, or method, including research and development; or

(2) Any new application of an existing technology, process, or method.

3.11 Other Transaction: Refers to the type of Other Transaction Agreement (OTA) that may be placed as a result of this CSO. This type of OT is authorized by 10 U.S.C 2371b for prototype projects directly relevant to enhancing the mission effectiveness of military personnel and the supporting platforms, systems, components, or material proposed to be acquired or developed by the DoD, or for the improvement of platforms, systems, components, or materials in use by the armed forces. This type of OTA is treated by DoD as an acquisition instruments, commonly referred to as an “other transaction” for a prototype or a Section 2371b “other transaction.” The definition of a "prototype project" in the context of an OT is as follows: a prototype project addresses a proof of concept, model, reverse engineering to address obsolescence, pilot, novel application of commercial technologies for defense purposes, agile development activity, creation, design, development, demonstration of technical or operational utility, or combinations of the foregoing. A process, including a business process, may be the subject of a prototype project.

This authority also allows for a noncompetitive, follow-on OT for Production to an OT for Prototype competitively awarded and successfully completed. This statute requires advanced consideration be given and notice be made for follow-on OT for Production potential. It is a necessary precondition for such a follow-on award. As such, this solicitation documents, and resulting OTs for Prototype will include notice, follow-on OTs for Production are possible.

3.12 Performance Benchmarks for Progress Toward Commercialization: IAW the SBA SBIR/STTR Policy Directive Section 4.(a)(3), DoD’s established benchmark threshold applies only to Phase I applicants with more than 20 awards in the prior five fiscal years. The ratio of Phase I awards to Phase II awards received during the period must be at least 4:1. Additional information can be found at https://www.sbir.gov/performance-benchmarks.

3.13 Principal Investigator: The principal investigator/project manager is the 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 SBC 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 SBC. 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 AF SBIR Program Manager/Coordinator.

Further, an SBC may replace the principal investigator on an SBIR Phase I or Phase II award, subject to approval in writing by the Contracting Officer.

https://www.sbir.gov/performance-benchmarks https://www.sbir.gov/performance-benchmarks https://www.sbir.gov/performance-benchmarks

3.14 Proprietary Information: Proprietary information includes trade secrets, as well as commercial or financial information.

3.15 Research Involving Animal Subjects: ”Activities involving animal subjects shall be conducted in accordance with DoDI 3216.01, “Use of Animals in DoD Programs”; 9 CFR parts 1-4; National Academy of Sciences Publication “Guide for the Care & Use of Laboratory Animals” as amended; Department of Agriculture rules implementing the Animal Welfare Act (7 U.S.C. §§ 2131-2159); and other applicable Federal/DoD/local laws, regulations, and instructions.

“Animal use” protocols apply to activities meeting 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) being used or 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 applicability to work involving animals

3.16 Research Involving Human Subjects : All research involving human subjects shall be conducted in accordance with 32 C.F.R. § 219 “The Common Rule”, 10 USC §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. Offerors 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:

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

3.17 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.

3.18 Research or Research and Development (R/R&D):

a. A systematic, intensive study directed toward greater knowledge or understanding of the subject studied;

b. A systematic study directed specifically toward applying new knowledge to meet a recognized need; or

c. A systematic application of knowledge toward the production of useful materials, devices, systems, or https://osp.od.nih.gov/wp-content/uploads/2013/06/NIH_Guidelines.pdf https://osp.od.nih.gov/wp-content/uploads/2013/06/NIH_Guidelines.pdf methods, including prototype or process design, development, and improvement to meet specific requirements.

d. Intended broadly to include the work performed under a funding agreement with the government. It includes R&D in all fields, including the physical sciences, engineering, etc. Research is systematic study directed toward fuller scientific knowledge or understanding of the subject studied. Development is systematic use of the knowledge and understanding gained from research, for the production of useful materials, devices, systems, or methods, including the design and development of prototypes and processes.

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).

3.20 Small Business Concern (SBC): A concern meeting the requirements set forth in 13 CFR.

§ 121.702. 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: 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 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.

http://www.sba.gov/size http://www.sba.gov/size

4.0 PROPOSAL FUNDAMENTALS

Unless otherwise specified, this section applies to Phase I and II proposals, including Direct to Phase II.

4.1 Introduction: The proposal must provide sufficient information to demonstrate to the reviewers the proposed work represents an innovative approach to investigation of important scientific or engineering problems and is worthy of support under the stated criteria. The proposed R/R&D must be responsive to the chosen topic.

Before submitting a proposal, offerors should assess the intended effort to determine:

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

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 Offeror Eligibility and Performance Requirements

a. Each proposer must qualify as a small business concern IAW 13 C.F.R §§ 701-705 at time of award and certify to this on the proposal Cover Sheet. SBIR/STTR eligibility requirements are unique and do not correspond to other business programs (see Section 3.15 of this CSO). Proposers must meet eligibility requirements for Small Business Ownership and Control IAW 13 CFR § 121.702 and Section 4.4 of this

CSO.

b. 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 work percentage is measured by both direct and indirect costs.

c. 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 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.

d. All Phase I and Phase II R/R&D work must be performed by the small business concern and its subcontractors in the U.S.

e. Benchmarks. Proposers with prior SBIR/STTR awards must meet two benchmark requirements for progress toward commercialization as determined by the Small Business Administration (SBA) on 1 June 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 2015-2019), 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 2008-2018), 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:

o SBA will identify and provide Agencies annually on 1 June the list of companies failing to meet minimum performance requirements. These companies will not be eligible to submit Phase I proposals for one year from that date.

o This requirement only affects a company’s eligibility for new Phase I awards. Companies failing to meet minimum performance requirements may continue work on current, ongoing SBIR/STTR awards. They may also apply for and receive new Phase II awards. Likewise, they are not prohibited from receiving Phase III awards.

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

o 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 award, and accurately complete necessary certifications.

o Companies’ benchmark information is not available to the public.

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

4.4 Administrative Proposal Requirements: The AF SBIR/STTR Center of Excellence (CoE) is committed to reducing Phase I and II proposal-to-award lead times. To this end, processes and tools have been developed allowing for rapid, streamlined contracting via periodic expedited contracting events. Such speed dictates stringent administrative practices in the proposal submission process.

Therefore, proposals not meeting the requirements as identified below will not be considered for award.

4.4.1 Registrations and Certifications . Firms shall be registered in the DoD SBIR/STTR Innovation Portal (DSIP) to prepare and submit proposals, https://www.dodsbirsttr.mil/submissions/login.

Firms shall register in the System for Award Management (SAM), https://www.sam.gov/, to be eligible for proposal acceptance. Follow instructions therein to obtain a Commercial and Government Entity (CAGE) code and Dunn and Bradstreet (DUNS) number. Firms shall also verify registration for “All Contracts”, not just “Grants”. Firms registered to compete for grants only at the time of proposal submission will not be considered for award. Addresses must be consistent between the proposal and SAM at award. Previously registered firms are advised to access SAM to ensure all company data is current before proposal submission and, if selected, award.

In addition to the standard Federal and DoD procurement certifications, the SBA SBIR/STTR Policy Directive requires certain information be collected from firms at award and during the award life cycle.

Each firm will be asked to provide this additional information at the time of award, prior to receiving 50% of the total award amount, and prior to final payment.

4.4.2 Prior, Current, or Pending Support of Similar Proposals or Awards . It is permissible, with proper notification, to submit identical proposals or proposals containing a significant amount of essentially equivalent work (see Section 3.3) for consideration under multiple Federal program solicitations. However, it is unlawful to enter into contracts, grants, cooperative agreements, Other Transactions, or other award types, requiring essentially equivalent effort. Questions concerning prior, current, or pending support of similar proposals or awards shall be disclosed to the soliciting agency or agencies as early as possible.

4.4.3 Proprietary Information. Information constituting a trade secret, commercial or financial information, confidential personal information, or data affecting national security must be clearly marked. It shall be treated in confidence to the extent permitted by law. Awards for selected proposals will incorporate the Work Plan, in whole or part, by reference or as an attachment. Therefore, the

Work Plan shall be Non-Proprietary and marked accordingly.

http://www.sbir.gov/ http://sbir.gov/sites/default/files/elig_size_compliance_guide.pdf https://www.dodsbirsttr.mil/submissions/login https://www.sam.gov/

Proprietary and/or classified information shall not be included in the Proposal Cover Sheet. The term “Component” on the Cover Sheet refers to the soliciting AF organization, i.e., AFWERX, AFLCMC, SMC, etc. Proposals submitted to the wrong Command will not be considered for award.

4.5 Majority Ownership in Part: Small businesses owned in majority part by multiple venture capital operating companies (VCOCs), hedge funds, or private equity funds are ineligible to submit proposals under this

CSO.

4.6 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. Proposing firms should contact the cognizant Ethics Counselor from the employee’s Government agency for further guidance if in this situation.

4.7 Classified Proposals: Classified proposals will not be accepted in response to this CSO. If efforts will require classified work during Phase II performance, the proposing firm must have or obtain a facility clearance.

Additional information on facility and personnel clearance procedures and requirements can be found at the

Defense Security Service site, http://www.dss.mil/index.html.

4.8 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 AF. All institutions engaged in human subject research, to include subcontractors, must also have a valid Assurance. In addition, personnel involved in human subject 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. 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 AF 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.

http://www.dss.mil/index.html http://www.hhs.gov/ohrp/

4.9 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.

4.10 Research Involving Recombinant DNA Molecules

All research involving recombinant DNA molecules shall comply with the applicable Federal and state laws and regulations and any additional agency guidance. Research shall be approved by an Institutional Biosafety Committee.

4.11 Use of Unmanned Aircraft Systems (UAS)

All activities involving the operation of Unmanned Aerial Systems shall be conducted IAW Department of Defense Memo entitled “Guidance for the Domestic Use of Unmanned Aircraft Systems in the U.S. National Airspace, dated 18 August 2018 and DOD memo entitled, “Delegation Authority to Approve Exemptions for Using Commercial-Off-The-Shelf Unmanned Aerial Systems in Support of Urgent Needs, dated 16 November 2018. Contractor personnel operating DoD or DoD-contracted UAS in U.S. National Airspace, whether or not the domestic use is related to an intelligence activity, will comply with all laws, regulations, and guidance relating to the operation of UAS in U.S. National Airspace. Specific programs utilizing UAS are required to obtain an exemption for operational use of a UAS; therefore, additional documentation may be requested by the AF to support an exemption request. The DOD exemption approval process can require as long as two months. No funding can be used for contracted-UAS operations until ALL approvals are granted.

4.12 Proposal Status and Feedback

The Principal Investigator (PI) and Corporate Official (CO) indicated on the Proposal Cover Sheet (Volume 1) will be notified by email regarding proposal selection or non-selection. The SBC will receive a notification for each proposal submitted. Please read each notification carefully and note the proposal number referenced. If changes occur to the company mail or email address(es) or points of contact after proposal submission, the information must be provided to the AF at sbir@afwerx.af.mil. The message shall include the subject line, “20.3 Address Change”.

Feedback requests will be provided to offerors with proposals determined “Not Selectable” ONLY . Requests shall be submitted in writing within 30 calendar days after non-selection notification receipt. Written feedback requests shall be submitted via AFRL.SBIR.STTR_FeedbackRequests@us.af.mil. Requests for feedback shall include the company name and the telephone number/e-mail address for a specific point of contact, as well as an alternate.

Additionally, the request shall include the proposal number(s). If the preceding information is not included in the request, it will not be fulfilled. Feedback requests received more than 30 calendar days after non-selection notification receipt will be fulfilled at the Contracting Officers' discretion. Unsuccessful offerors are entitled to no more than one feedback response for each proposal. The Contracting Officer may also delay feedback dissemination until all awards resulting from the solicitation are finalized.

Release of Proposal Review Information. After final award decisions have been announced, the peer review of the applicant’s proposal may be provided to the offeror. The identity of the reviewer shall not be disclosed. Requests mailto:support@afwerx.af.mil mailto:AFRL.SBIR.STTR_FeedbackRequests@us.af.mil may be sent to the address above. The same information required for feedback requests shall be required for release of proposal review information. If not included in the request, it will not be fulfilled.

It is anticipated all proposal reviews will be complete, selection decisions made, and notification letters sent within approximately 90 calendar days of solicitation close. Please refrain from contacting the AF SBIR/STTR Center of Excellence for proposal status before that time.

4.13 CSO, Selection, and Award Protests

Interested parties may have the right to protest this CSO by serving the Contracting Officer, Ms. Kris Croake, kristina.croake@us.af.mil, with the protest, by filing with the Government Accountability Office (GAO), or by filing U.S. Court of Federal Claims. Protest of selections or awards should also be directed to Ms. Croake, filed with GAO, or filed with the U.S. Court of Federal Claims. If the protest is filed with GAO, a copy of the protest shall be received by the AF Legal Operations Agency within one day of filing. Protests of a selected firm’s small business status should be directed to the SBA.

4.14 Phase I Award Information

a. Number of Phase I Awards . The number of awards will depend upon funds availability. The Government reserves the right to make no awards under this solicitation. The Federal Government is not responsible for any costs incurred before award receipt.

b. Type of Funding Agreement. Phase I awards will be made as firm-fixed-price purchase orders.

c. Dollar Value . Maximum Phase I award value will be $50,000, unless otherwise stated in the specific topic.

d. Timing. It is intended peer review, proposal selection, negotiations, and award will be complete within 180 calendar days of solicitation close.

4.15 Phase II and Direct to Phase II Award Information

a. Number of Awards . The number of awards will depend upon funds availability. The Government reserves the right to make no awards under this solicitation. The Federal Government is not responsible for costs incurred before award receipt.

b. Type of Funding Agreement. Phase II awards are executed as firm-fixed-price contracts or Other Transactions for Prototype, including reasonable profit consistent with profit-making R/R&D firms. The Small Business Administration SBIR/STTR Policy Directive states, “Except as expressly excluded or limited by statute, awarding agencies must provide for a reasonable fee or profit on SBIR/STTR Funding Agreements, consistent with normal profit margins provided to profit-making firms for R/R&D work.”

Therefore, zero dollar profit proposals cannot be accepted. Awards may be negotiated; award type is at the Contracting Officer’s discretion.

a. Average Dollar Value . Maximum Phase II contract value is found in Section 2.3, Chart 1.

b. Timing. It is intended that peer review, proposal selection, negotiations, and award will be complete within 180 calendar days of solicitation close.

4.16 Questions about this CSO and CSO Topics

c. General SBIR Questions/Information

1. Help Desk. The DoD SBIR/STTR Help Desk is prepared to address general questions about this CSO, the proposal preparation and electronic submission process and other program- related areas. The Help Desk may be contacted from 9:00 a.m.