REV1_AF_19.3_CSO.docx

DEPARTMENT OF THE AIR FORCE

SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM

SBIR 19.3 PILOT COMMERCIAL SOLUTIONS OPENING (CSO)

FOR AFWERX SPECIAL TOPICS

This solicitation applies to Air Force 19.3 “Special Topics” (AF193-CSO1, AF193-DCSO1) and is not effective for any other topics within the Air Force or the DoD.

August 23, 2019: AF CSO issued for pre-release September 24, 2019: AF begins accepting proposals October 23, 2019: AF Deadline for receipt of proposals no later than 8:00 p.m. ET In accordance with Section 879 of the National Defense Authorization Act for Fiscal Year 2017 (Public Law 114-328) has authorized the use of the Defense Commercial Solutions Opening Pilot Program. This Pilot Program allows the agency to obtain solutions or potential new capability that fulfill requirements, close capability gaps, or provide potential technological advancements. Therefore, consistent with Section 879 of the FY17 NDAA, the Air Force is soliciting proposals under a Commercial Solutions Opening.IMPORTANT

Deadline for Receipt: Proposals must be completely submitted no later than 8:00 p.m. ET, October 23, 2019 to the DoD Submission Web site at https://sbir.defensebusiness.org/. Proposals submitted after 8:00 p.m. ET or to the wrong location will not be evaluated.

The AF recommends that you complete your submission early, as computer traffic gets heavy near the announcement closing and could slow down the system. Do not wait until the last minute. The AF will not be responsible for proposals being denied due to servers being “down” or inaccessible. Please assure that your e-mail address listed in your proposal is current and accurate. The AF is not responsible for ensuring notifications are received by firms changing mailing address/e-mail address/company points of contact after proposal submission without proper notification to the AF. Changes of this nature that occur after proposal submission or award (if selected) for Phase I and II shall be sent to the Air Force SBIR/STTR site address, afsbirsttr-info@us.af.mil.

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

USAF Special Topics Changes:

· USAF Special Topic released as a CSO instead of a BAA for SBIR 19.3 Cycle.

· RAPID Matching Ratio for all government matching changed to 2:1 (SBIR to non-SBIR funds)

· Matching Funds (RAPID) are required to apply for AF193-DCSO1 (Direct to Phase II)

· A phase I Template is optional and provided to assist small businesses to generate their proposals

SBIR/STTR Updates and Notices: To be notified of SBIR/STTR opportunities and to receive e-mail updates on the DoD SBIR/STTR Programs, you are invited to subscribe by e-mailing sbiroutreach@u.group. To be notified of USAF Special Topics updates and other Air Force innovation opportunities, please register here: https://www.afwerx.af.mil/join.html.

Help Desk: If you have questions about the AF SBIR/STTR Programs, please call the AF SBIR/STTR Help Desk at 1-800-222-0336, or email to AFSBIRSTTR-Info@us.af.mil, or visit the AF SBIR/STTR Web site at https://www.afsbirsttr.af.mil/. If you have any questions about the USAF Special Topics, please visit https://www.afwerx.af.mil/sbir.html or email to sbir@afwerx.af.mil.

TABLE OF CONTENTS

1.0 INRODUCTION

2.0 PROGRAM DESCRIPTION

2.1 Objectives

2.2 Three Phase Program

2.3 CSO Pilot Procedure

2.4 AF Special Topic Information

3.0 DEFINITIONS

3.1 Performance Benchmarks for Progress Toward Commercialization

3.2 Commercialization

3.3 Essentially Equivalent Work

3.4 Export Control

3.5 Foreign Nationals

3.6 Fraud, Waste and Abuse

3.7 Funding Agreement

3.8 Certified HUBZone Small Business Concern

3.9 Proprietary Information

3.10 Research or Research and Development

3.11 Research Involving Animal Subjects

3.12 Research Involving Human Subjects

3.13 Research Involving Recombinant DNA Molecules

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

3.15 Small Business Concern (SBC)

3.16 Subcontract

3.17 United States

3.18 Women-Owned Small Business Concern

3.19 Federal Laboratory

3.20 Principal Investigator

3.21 Commercial Solutions Opening

3.22 Innovative

3.23 Other Transaction Authority

3.24 RAPID Investment

4.0 PROPOSAL FUNDAMENTALS

4.1 Introduction

4.2 Offeror Eligibility and Performance Requirements

4.3 Joint Ventures

4.4 Majority Ownership in Part

4.5 Conflicts of Interest

4.6 Classified Proposals

4.7 Research Involving Human Subjects

4.8 Research Involving Animal Subjects

4.9 Research Involving Recombinant DNA Molecules

4.10 Use of Unmanned Aerial Systems (UAS)

4.11 Proposal Status and Feedback

4.12 CSO Protests

4.13 Selection and Award Protests

4.14 Phase I Award Information

4.15 Phase II Award Information

4.16 Questions about this CSO and CSO Topics

4.17 Registrations and Certifications

4.18 Promotional Materials

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

4.20 Fraudulent or False Statements

4.21 State and Other Assistance Available

4.22 Government Use of Support Contractors on AF SBIR/STTR Program

5.0 PHASE I PROPOSAL

5.1 Introduction

5.2 Marking Proprietary Proposal Information

5.3 Phase I Proposal Instructions

5.4 Phase I Proposal Checklist

6.0 PHASE I EVALUATION CRITERIA

7.0 PHASE II PROPOSAL

7.1 Introduction

7.2 Proposal Revisions

7.3 How to Submit

7.4 Commercialization Strategy

8.0 PHASE II EVALUATION CRITERIA

9.0 DIRECT TO PHASE II PROPOSAL

9.1 Introduction

9.2 Proposal Provisions

9.3 Direct to Phase II Open Topic

9.4 Proposal Submission

9.5 RAPID Phase II Overview

9.6 Phase II Proposal Preparation Instructions

9.7 Proposal Content

10.0 DIRECT TO PHASE II EVALUATION CRITERIA

11.0 COMMERCIALIZATION READINESS PROGRAM (CRP)

12.0 CONTRACTUAL REQUIREMENTS

12.1 Other Contract Requirements

12.2 Commercialization Update in Phase II

12.3 Copyrights

12.4 Patents

12.5 Technical Data Rights

12.6 Invention Reporting

12.7 Final Technical Reports – Phase I through Phase III

13.0 RAPID PHASE II MATCHING FUNDS GUIDANCE

13.1 What Qualifies as a RAPID Investment

13.2 Qualifying RAPID Investments

14.0 AFWERX TOPICS

14.1 AF193-CSO1 TITLE: Open Call for Innovative Defense-Related Dual-Purpose Technologies/Solutions with a Clear Air Force Stakeholder Need

14.2 AF193-DCSO1 TITLE: Direct to Phase II Open Call for Innovative Defense-Related Dual-Purpose Technologies/Solutions with a Clear Air Force Stakeholder Need

1.0 INTRODUCTION

Firms must ensure their proposal meets all requirements of this CSO currently posted on FEDBIZOPS and the DoD website at the time the announcement closes.

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 any of the AF-related topics described in Section 14.0 and to commercialize the results of that R&D are encouraged to participate.

The 2014 Quadrennial Defense Review (QDR) established innovation as a central line of effort in the national defense strategy of the United States. The decisive military advantage of the United States 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 a CSO, the Department of Defense may competitively select proposals received in response to a general solicitation, similar to a Broad Agency Announcement, based on a review of proposals by scientific, technological, or other subject-matter expert peers. Use of a CSO in accordance with Class Deviation 2018-O0016 is considered to be a competitive procedure for the purposes of 10 U.S.C. chapter 127 and FAR 6.102. Finally, contracting officers shall treat items, technologies, and services acquired using a CSO as commercial items.

While the Phase II proposal process is covered in this announcement, this CSO is for Phase I proposals in addition to Direct to Phase II proposals.

A separate CSO 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 CSO will be eligible to participate in Phase II competitions and potential Phase III awards. The AF will notify Phase I awardees of the Phase II proposal submission requirements. Submission of Phase II proposals will be in accordance with instructions provided within this CSO. The details on the due date, content, and submission requirements of the Phase II proposal will be provided by the AF 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 AF, it may be rejected without evaluation. All SBIR/STTR Phase II awards made on topics from solicitations prior to and including Solicitation 19.2 will be conducted in accordance with the procedures specified in those solicitations.

The AF Program Manager is Mr. David Shahady, The AF SBIR/STTR Program Office can be contacted at afsbirsttr-info@us.af.mil. For general inquiries or problems with the electronic submission, contact the DoD SBIR/STTR Help Desk via email at sbirhelpdesk@u.group (9:00 a.m. to 6:00 p.m. ET, Monday through Friday). For technical questions about the topics during the pre-announcement period (23 August 2019 through 24 September 2019), please visit https://afwerx.af.mil/sbir.html or email sbir@afwerx.af.mil. For information on obtaining answers to your technical questions during the formal announcement period (24 September 2019 through 23 October 2019, go to https://sbir.defensebusiness.org. Your complete proposal must be submitted via the submissions site at https://sbir.defensebusiness.org/ on or before the 8:00 pm ET, 23 October 2019 deadline.

The AF 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. The AF is not responsible for any monies expended by the proposer before the issuance of any award. The Air Force reserves the right to award a contract or an Other Transaction for any purpose, to include prototype, as a result of this CSO.

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

2.0 PROGRAM DESCRIPTION

2.1 Objectives

The objectives of the AF 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.

The DoD 10 Technology Focus Areas of interest are (proposals are not required to address topics in these 10 Technology Focus Areas of interests but these do represent Air Force Strategic priorities):

1. Artificial Intelligence: Improve algorithms, address data quality, optimize human-machine coordination and disrupt adversaries' efforts.

2. Autonomy: Address teaming of autonomous systems; machine perception, reasoning and intelligence; human and autonomy systems trust and interaction.

3. Communications: Addressing high-performance, low power embedded processing and developing algorithms for self-configuring, self-healing and resource allocation.

4. Cyber: Address behavioral issues, develop self-securing networks and develop methodologies to assess cyber effects and consequences.

5. Directed Energy: Address power scaling, jitter reduction, laser size and weight, adaptive optics, beam propagation and target tracking.

6. Hypersonics: Address high temperature materials, hypersonic vehicle manufacturing, air breathing propulsion and hypersonic guidance and control systems.

7. Microelectronics: Develop economically competitive domestic manufacturing capabilities, improve radiation hardening and develop radio frequency (RF) technologies for specialty applications with nuclear, space and electronic warfare capabilities.

8. Quantum Sciences: Address quantum clocks and sensors, quantum communications technologies and develop enabling technologies for quantum computing in the areas of cryogenics and photon detection.

9. Space: Developing low earth orbit nano-satellites for missile warning, intelligence, surveillance, reconnaissance, navigation and communications.

10. Biotechnology: applications related to disease prevention and mitigation, rapid emergency medical response and trauma management, environmental remediation, and advanced materials.

The AF SBIR Program follows the policies and practices of the Small Business Administration (SBA) SBIR/STTR Policy Directive updated on May 2, 2019. The guidelines presented in this CSO 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 AF 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.

2.2 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 a maximum of $50,000. The period of performance is generally three months. 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 AF support in Phase II. Proposers are encouraged to consider whether the research or research and development being proposed to the AF also has private sector potential, either for the proposed application or as the basis 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 $25,000 to $1,500,000 in size and the period of performance is generally between 6 and 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.

2.3 CSO Pilot Procedure

This CSO is a competitive solicitation (posted on a Government Point of Entry (www.fbo.gov through 23 October 2019) seeking solution proposals from SBCs. This CSO seeks innovative, commercial technologies that propose new solutions or potential new capabilities that fulfill requirements, close capability gaps, or provide potential technological advancements in support of the AF. 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 that can incrementally improve 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, as a result of this CSO.

2.4 AF Special Topic Information

The Air Force SBIR/STTR Program office is continuing to pilot new processes via “AF Special Topics” (AF193-CSO1) in order to accelerate technologies to the warfighter. The AF Special Topics are different in several ways from the standard AF SBIR/STTR proposal, award and execution. Special Topics have shortened technical durations, reduced reporting requirements, and varying award amounts compared to normal SBIR Topics. There are additional unique features associated with each of the Special Topics that are listed in the sections below. Consolidated information on all SBIR topics can be found in Chart 1.

CHART 1: CONSOLIDATED SPECIAL SBIR TOPIC INFORMATION

Technical Volume (Vol 2) Additional Info (Vol 5)

(Vol 2) Additional Info (Vol 5)

AF193-CSO1

Video interview.

Video interview.

*Maximum of $1,500,000 SBIR Funding; can exceed this amount with matching government funds.

Special Topics AF193-CSO1 and AFI 193-DCSO1 AF193-CSO1 and AFI193-DCSO1 are sponsored by AFWERX (https://www.afwerx.af.mil/) a catalyst for agile Air Force engagement across industry, academia, and non-traditional contributors to create transformative opportunities and foster an Air Force culture of innovation.

For all Special Topics: The Phase I proposals shall include a technical volume (uploaded in Volume 2) that shall not exceed 5 pages and a slide deck not to exceed 15 slides (uploaded in Volume 5). The technical volume and slide deck will be reviewed holistically. It is recommended (but not required) that more detailed information is included in the technical volume and higher level information is included in the pitch deck. The cost volume (Volume 3) for the Special Topics will cover the total effort broken down into the specified technical and reporting periods (See Chart 1 for specific times). AF 193-CSO1 shall follow the Phase I Work Plan Outline as noted in the “Phase I Work Plan Outline” section 5.3c except that there is only one required Progress report and no requirement for a Technical review due to the short technical duration. Final reporting for Phase I awardees will take the form of a presentation (with a SF298) in accordance with the contract.

It is critical that proposers for the Special Topics are registered in the System for Award Management, https://www.sam.gov/; you will not be eligible for an award if not registered. Additionally, verify that you are registered to receive contracts (not just grants) and that your address matches between your proposal and SAM.

The AF 193-CSO1 call for Phase II proposals shall occur shortly after Phase I award. The AF Special Topics will have specific Phase II instructions. Unless otherwise stated in the Special Topics paragraphs above, all other requirements as noted in the following sections apply to the AF Special Topics. If there are any questions with the AF Special Topics, please contact afsbirsttr-info@us.af.mil.

3.0 DEFINITIONS

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

3.1 Performance Benchmarks for Progress Toward Commercialization In accordance with the SBA SBIR Policy Directive Sec 4.(a)(3), 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.

3.2 Commercialization

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

3.3 Essentially Equivalent Work

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

3.4 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 are not all-inclusive and do not remove submitters’ liability to 1) comply with applicable ITAR/EAR export control restrictions or 2) inform the Government of potential export restrictions as efforts proceed.

3.5 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.

3.6 Fraud, Waste and Abuse

a. Fraud includes any false representation about a material fact or any intentional deception designed to deprive the United States unlawfully of something of value or to secure from the United States a benefit, privilege, allowance, or consideration to which an individual or business is not entitled.

b. Waste includes extravagant, careless or needless expenditure of Government funds, or the consumption of Government property, that results from deficient practices, systems, controls, or decisions.

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

d. The SBIR Program training related to Fraud, Waste and Abuse is available at: https://training.defensebusiness.org/fwa. See Section 4.19 for reporting Fraud, Waste and Abuse.

3.7 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.

3.8 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).

3.9 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.

3.10 Research or Research and Development

Any activity that is:

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

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

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

3.11 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:

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

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

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

See DoDI 3216.01 for definitions of these terms and more information about the applicability of DoDI 3216.01 to work involving animals.

3.12 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. 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.

3.13 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.

3.14 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).

3.15 Small Business Concern (SBC)

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

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

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

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

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

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

3.16 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.

3.17 United States

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

3.18 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.

3.19 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.

3.20 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.

3.21 Commercial Solutions Opening

A competitive procedure contracting officers may use to acquire innovative commercial items, technologies or services.

3.22 Innovative

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

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

3.23 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.

3.24 RAPID Investment

See Section 13.0 of this CSO for an extensive discussion on RAPID Investment.

4.0 PROPOSAL FUNDAMENTALS

Unless otherwise specified, Section 4.0 applies to both Phase I and Phase II proposals, including Direct to Phase II proposals.

4.1 Introduction

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

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

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

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 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 CSO). Proposers must meet eligibility requirements for Small Business Ownership and Control (see 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 percentage of work is measured by both direct and indirect costs.

c. 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.

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

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

· At this time, SBA is not compiling a list of companies that will be deemed ineligible to submit a proposal for a new Phase I (or Direct-to-Phase II) award due to failure to meet the Commercialization Benchmark requirement.

4.3 Joint Ventures

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

4.4 Majority Ownership in Part

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

4.5 Conflicts of Interest

Contract awards to firms owned by or employing current or previous Federal Government employees could create conflicts of interest for those employees which may be a violation of federal law. Proposing firms should contact the cognizant Ethics Counselor from the employee’s Government agency for further guidance if in this situation.

4.6 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.

4.7 Research Involving Human Subjects

All research involving human subjects, to include use of human biological specimens and human data, shall comply with the applicable federal and state laws and agency policy/guidelines for human subject protection (see Section 3.12).

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.

4.8 Research Involving Animal Subjects

All research, development, testing, experimentation, education or training involving the use of animals shall comply with the applicable federal and agency rules on animal acquisition, transport, care, handling, and use (see Section 3.11).

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.

4.9 Research Involving Recombinant DNA Molecules

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

4.10 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 last as much as two months. No funding can be used for contracted-UAS operations until ALL approvals are granted.

4.11 Proposal Status and Feedback

The Principal Investigator (PI) and Corporate Official (CO) indicated on the Proposal Cover Sheet (Volume 1) will be notified by e-mail 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 and Topic Number referenced. If changes occur to the company mail or email address(es) or company points of contact after proposal submission, the information should be provided to the AF at afsbirsttr-info@us.af.mil and sbir@afwerx.af.mil.

Any feedback requests must be submitted in writing within 30 calendar days after receipt of notification of non-selection. Written requests for feedback must be submitted via www.afsbirsttr.af.mil through the SBIR system. Requests for feedback should include the company name and the telephone number/e-mail address for a specific point of contact, as well as an alternate. Additionally, include the topic number under which the proposal(s) was submitted, and the proposal number(s). Feedback requests received more than 30 calendar days after receipt of notification of non-selection will be fulfilled at the Contracting Officers' discretion. Unsuccessful offerors are entitled to no more than one feedback response for each proposal.

IMPORTANT: Proposals submitted to the AF are received and evaluated by different offices within the Air Force and handled on a Topic-by-Topic basis. Each office operates within their own schedule for proposal evaluation and selection. Updates and notification timeframes will vary by office and Topic. If your company is contacted regarding a proposal submission, it is not necessary to contact the AF to inquire about additional submissions. Additional notifications regarding your other submissions will be forthcoming.

We anticipate having all the special topic proposals evaluated and our Phase I contract decisions within approximately 30 calendar days of proposal receipt. All questions concerning the status of a proposal, or feedback, should be directed to sbir@afwerx.af.mil.

4.12 CSO Protests

Interested parties may have the right to protest this CSO 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:

Ms. Kristina Croake AF SBIR/STTR Contracting Officer

4.13 Selection and Award Protests

Protest of Phase I and Phase II selections and awards need to be directed to the AF SBIR/STTR Contracting Officer 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. Protests of the small business status of a selected firm may also be made to the Small Business Administration.

4.14 Phase I Award Information

a. Number of Phase I Awards. The number of Phase I awards will be consistent with the AF RDT&E budget, the number of anticipated awards for interim Phase I modifications, and the number of anticipated Phase II contracts. No Phase I contracts will be awarded until evaluation of all qualified proposals for a specific topic is completed.

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

c. Dollar Value. The Phase I contract values are stated in Chart 1 of Section 2.4 of this CSO.

d. Timing. The SBA SBIR Policy Directive, Section 7(c) (1) (ii), states that agencies should issue the Phase I award no more than 180 calendar days after the closing date of the solicitation. Normally proposing firms will be notified of selection or non-selection status for a Phase I award within 30 calendar days of the closing date for this CSO.

4.15 Phase II Award Information

a. Number of Phase II Awards.