Research Opportunities for ISS Utilization NRA September 2023_02.15.2023.pdf

National Aeronautics and Space Administration

Johnson Space Center

Human Exploration and Operations Mission Directorate

2101 NASA Parkway

Houston, TX 77058

RESEARCH OPPORTUNITIES FOR ISS UTILIZATION

NASA Research Announcement: NNJ13ZBG001N

Soliciting Proposals for Exploration Technology Demonstration and

National Lab Utilization Enhancements

Catalog of Federal Domestic Assistance (CFDA) Number: 43.007

ISSUED: November 14, 2012

UPDATED: February 15, 2023

PROPOSALS ACCEPTED November 30, 2012 THROUGH December 31, Contents

I. Funding Opportunity Description

A. Scope

B. Overview of ISS Utilization Focus Areas

1. Focus Area 1 – In Space Production Applications (InSPA)

2. Focus Area 2 – (Deleted)

3. Focus Area 3 – Purchase of Resources for Commercial Purposes

4. Focus Area 4 – Private Astronaut Missions to the International Space Station (ISS)

5. Focus Area 5 – (Deleted)

C. ISS Integration Requirements

D. References to Unique NASA Capabilities

E. NASA Safety Policy

F. Availability of Funds for Award

G. Additional Funding Restrictions

H. Guidebook for Proposers Responding to a NASA Notice of Funding Opportunity (NOFO)

II. Award Information

III. Eligibility Information

IV. White Paper, Proposal and Submission Information

V. Proposal Review Information

VI. Award Administration Information

VII. Contacts

VIII. Other Information

I. Funding Opportunity Description

A. Scope

This announcement is for the development of research or related hardware with enhanced capabilities; modification of existing hardware to enable increased efficiencies (e.g. less crew time or up mass); development of tools that allow analyses of samples and specimens on orbit;

enhanced infrastructure capabilities on the International Space Station (ISS) (e.g.

communications or research throughput); concepts contributing to the development of a sustainable, scalable, and profitable non-NASA demand for LEO services; broad commercial use of the ISS; development of flight, training, and outreach products; and specific commercialization, technology demonstration, and other ISS program-supported projects as detailed in specific Focus Areas.

B. Overview of ISS Utilization Focus Areas The unprecedented opportunity exists in using the ISS platform to advance key technologies and other capabilities for the next steps in commercialization of space, in-space operations, and advancing space exploration. The ISS is a one of a kind laboratory that offers access to microgravity, constant crew support, robotic servicing, and the harshness of the space environment.

For reference, below are links to research guides detailing the capabilities of the ISS:

https://www.nasa.gov/connect/ebooks/researchers_guide_tech_demo_detail.html http://www.nasa.gov/mission_pages/station/research/researcher_guide/

The 2005 NASA Authorization Act designated the U.S. segment of the ISS as a National Laboratory and directed NASA to develop a plan to "increase the utilization of the ISS by other Federal entities and the private sector…" As the nation's newest national laboratory, the ISS will further strengthen relationships among NASA, other Federal entities, and private sector leaders in the pursuit of national priorities for the advancement of science, technology, engineering, and mathematics. The ISS National

Laboratory will also open new paths for the exploration and economic development of sSpace.

The National Laboratory concept is an opportunity to expand the U.S. economy in space-based research, applications and operations. The ISS represents a unique and highly visible national asset with surplus capacity available for a wide spectrum of applications. NASA will continue to cover the cost of operating and maintaining the ISS and is highly motivated to work with other agencies and organizations to pursue applications.

NASA seeks proposals to enhance the unique capabilities of the ISS and utilize the ISS to develop and/or operate systems or facilities that may lead to a sustainable non-NASA demand for a human-rated LEO platform. These proposals should demonstrate ability to provide a stimulus to the U.S.

economy through development of a sustainable, scalable, and profitable non-NASA demand for

LEO services.

The topics listed in the Focus Areas below span the broad interests of NASA but should not be considered as the entire scope. NASA welcomes white papers and proposals in all areas relevant to the National Lab mission, NASA’s LEO commercialization goals (https://cms.nasa.gov/leo-economy/low-earth-orbit-economy), and NASA’s technology development and other interests, not only those listed in this document.

https://www.nasa.gov/connect/ebooks/researchers_guide_tech_demo_detail.html http://www.nasa.gov/mission_pages/station/research/researcher_guide/ https://cms.nasa.gov/leo-economy/low-earth-orbit-economy https://cms.nasa.gov/leo-economy/low-earth-orbit-economy

General Focus Areas of Interest

1) Innovative uses of the ISS or ISS hardware that leverage existing capabilities to stimulate both utilization of the ISS and economic development in the U.S.

2) Other improvements to existing ISS capabilities, including but not limited to infrastructure, in-situ analytical tools, and communication/data transmittal, to increase the efficiency and effectiveness of the technology demonstrations and science investigations performed on the ISS.

3) Unique partnering arrangements that leverage NASA's existing capabilities but increase the commercial participation in research, technology development, on board services, and other commercial activities.

4) Broad uses of the ISS and its resources by the U.S. commercial sector.

Formatted: Font: Italic

Specific Focus Areas

1. Focus Area 1 – In Space Production Applications (InSPA):

Introduction: The International Space Station (ISS) remains the premier microgravity research and development laboratory for those seeking to develop and demonstrate advanced materials and emerging technologies for in-space production and manufacturing of products for use on Earth. NASA intends to make awards through this

Focus Area to small and large U.S. businesses that seek to develop and demonstrate technologies on the ISS that lead to commercially viable and sustainable InSPA in low-Earth orbit (LEO) that advance solutions for national interest or public benefit by leveraging the capabilities and resources of the ISS. NASA intends through these awards to provide the support needed by U.S. companies during early-stage development to validate game-changing materials and production processes that give U.S. industry a competitive edge amidst increasing global competition.

Strategic Goals: NASA hopes to accomplish three major goals for InSPA awards:

1. Serving national interests by developing technologies that strengthen U.S. technological leadership, improve national security, and create high-quality jobs.

2. Providing benefits to humanity by developing products that significantly improve the quality of life for people on Earth.

3. Enabling the development of an economy in LEO by stimulating scalable and sustainable non-NASA utilization of future commercial LEO destinations or orbital platforms.

Objectives of this Focus Area: Successful proposals will mature in-space manufacturing concepts that produce high-value items for use on Earth with potential for scalability and capturing sizeable markets, creating new markets, or disrupting existing Earth-based technologies by taking advantage of the unique environment of the

ISS NL. Reference NASA’s LEO Economy website for further information about NASA’s strategic goals:

https://www.nasa.gov/leo-economy/opportunities-to-stimulate-demand.

Areas of Special Interest: NASA is seeking proposals in the technology areas identified in Figure 1, but will consider other technologies that may lead to a scalable, financially self-sustaining in space production capability in LEO for on-Earth applications.

Figure 1: Areas of Interest with Example Technologies (Not Inclusive)

Areas of Interest Example Technologies

Advanced Materials • Metal Organic Frameworks

• Metamaterials

• Ceramics

• Container-less Processing

• Exotic Glasses & Fibers

• Alloys

Crystal Production • Inorganic Crystals

• Large Molecule Crystals

• Small Molecule Crystals

• Uniform Crystals

• Industrial Crystals

Thin Film Deposition • Artificial Retinas

• Semiconductors

• Graphene

Tissue Engineering and

Regenerative Medicine

• Disease Modelling

• Tissue Chips

• Organoids

• Stem Cells

• 3D Bio-fabrication

Access to ISS National Lab (NL) Resources: NASA and the Center for the Advancement of Science In Space

(CASIS), as operator of the ISS NL, partner with U.S. industry, academia, and other Government agencies to utilize the ISS NL to develop, demonstrate and advance technologies for in-space production applications, while leveraging experienced Implementation Partners with microgravity tested equipment. All selected payloads are subject to review processes established by CASIS, described here, and will be provided access to ISS NL resources (up mass, down mass, USOS crew time, data transmission, power, etc.) including flight manifesting and increment operations planning. If selected for award through this NRA, access to ISS NL resource allocation requires a User Agreement to be signed with CASIS for utilization of the ISS NL. Experienced

Implementation Partners offer Payload Hardware Development and/or Mission Integration and Operations

(MI&O) services to assure the payload meets ISS interface and safety requirements (see Reference Documents below). Reference the ISS National Lab list of Implementation Partners for more information:

https://www.issnationallab.org/implementation-partners/.

InSPA Phases: NASA has identified three InSPA phases (reference Figure 2) to characterize technology maturation from early concept studies through financially self-sustaining LEO production technologies. These are unique to InSPA and do not correlate with Small Business Innovation and Research (SBIR) Phases. The expected award ranges defined below are not provided as a guideline, but rather, to assist proposers in understanding the potential cost of developing, integrating, and operating complex research hardware on the

ISS. Proposers should estimate and submit the actual cost for the specific project being proposed, consulting experts and experienced ISS National Lab implementation partners for insight as appropriate.

1) InSPA Phase 1: Early proof-of-concept studies and/or basic flight hardware development with a minimum set of flight demonstrations on ISS to achieve Technology Readiness Level (TRL) of 7 and a Market

Readiness level (MRL) of 5. Typical awards are expected to be in the range of $2.0M - $3.0M for scenarios where new hardware development is required. The goals of Phase 1 (i.e. exit criteria) are:

• To demonstrate hardware performance and validate the scientific basis for the technology benefit in a LEO space environment.

• To establish a minimum level of production control to repeatedly produce the intended product to a quality/performance level comparable to Earth-based state of the art.

• To refine the business case with preliminary revenue forecasts based on actual microgravity demonstrations, and letters of support from potential customers/partners.

2) InSPA Phase 2: Design maturation and advanced flight hardware development with additional flight demonstrations on ISS to achieve a TRL of 8 and MRL of 7. Typical awards are expected to be in the range of $2.5M - $3.5M, with an expectation of some degree of cost-sharing (reference Cost Sharing guideline below). The goals of Phase 2 (i.e. exit criteria) are:

• To demonstrate full control of hardware and processes to meet specific performance standards for the application. These are often set by the customer and should be to a level of quality/performance that is significantly better than possible on Earth.

• To refine the business case to a level that successfully captures significant investor commitment.

3) InSPA Phase 3: Scaled Flight hardware production and in-flight operations on either ISS NL or an alternative commercial LEO destination/platform to demonstrate commercial operations and end-to-end logistics model producing sufficient quantities to achieve a TRL of 9 and MRL of 9 to close the business case. Typical awards are expected to be in the range of $1.0M - $2.0M with an expectation of significant cost-sharing (reference Cost Sharing guideline below). The goals of Phase 3 are:

• Demonstrate scaling to commercial quantities and quality to support market demand, including supply chain and regulatory approvals.

• To establish formal agreements with U.S. LEO transportation and destination partners for transition to commercial operations.

• Begin transition to commercial platform(s) and achieve sustainable revenues.

Figure 2: InSPA Phase Description

Note: Current awardees must submit a renewal proposal through this NRA for a follow-on award to either extend the current phase (if not successfully achieving the stated goals) or to move into a subsequent phase

(Reference Section 2.5 of the NRA Guidebook). It is not required to receive an award for a previous phase to seek an award for a later phase.

Reference NASA Technology Readiness Levels (TRL):

https://www.nasa.gov/directorates/heo/scan/engineering/technology/technology_readiness_level

Reference Market Readiness Levels (MRL): Market Readiness Levels

Note: Reduced Gravity Risk Mitigation Flights: Parabolic or sub-orbital flight testing may be beneficial for risk mitigation and functional demonstration of hardware and procedures in a relevant environment prior to ISS on-orbit operations. Where appropriate, proposers may address how parabolic or sub-orbital flight testing is beneficial for the proposed InSPA technology. More information about how to request separate funding for parabolic and/or sub-orbital flight testing as part of a proposal to this NRA may be found at this NASA Flight Opportunities program website:

https://www.nasa.gov/directorates/spacetech/flightopportunities/opportunities/iss-utilization

Cost-Sharing: NASA requests that proposers attempt to achieve a cost-sharing target for Phases 2 and 3

(reference Figure 3) as a measure of market confidence in the technology and business case. This target level is

InSPA Phase 1

Basic Flight Hardware

Development and Demonstration in Microgravity for proof of

Commercial Viability

(Goal - TRL 7, MRL 5)

InSPA Phase 2

Advanced Flight Hardware

Development and Demonstration in Microgravity for proof of

Production Quality

(Goal - TRL 8, MRL 7)

InSPA Phase 3

Scaled/Automated Production

Facility Development and

Operation in Commercial

Microgravity Environment

(Goal – TRL 9, MRL 9) not mandatory and serves as a guideline only but will be a factor in the proposal evaluation. The size of the company and its ability to contribute will be considered.

Figure 3: Guideline for InSPA Cost-Sharing

Notes:

1. Non-NASA investment includes contributions from sources internal and external to the company, in-kind labor and materials, access to facilities and equipment, internal Research and Development funds and the like, with higher weighting on external investment as a measure of the market’s confidence.

2. Past investments made within the last 3 years may be counted, if related, however, at least 50% of the contribution must occur during the award period.

3. Does not apply to the value of access to ISS NL resources such as upmass, crew time, and downmass.

Focus Area 1A - Government Fiscal Year (GFY) 2022 Call for InSPA Proposals

NASA intends to make awards for new starts according to the schedule below (reference Table 1), with renewal of existing awards occurring throughout the year as appropriate. Renewal awards for continuation of previous NRA awards (whether an extension of the existing phase or beginning a new Phase) do not have set schedule dates, but rather are dependent on the schedule for completion of the existing contract milestones.

Table 1: Schedule for New Starts

Action Due Date

White Papers Due 11/3/2021

NASA Response 12/3/2021

Proposals Due 2/11/2022

Awards Announced (Estimated) 3/25/2022

Contract Start (Estimated) 5/20/2022

The Government reserves the right to select one or multiple proposals for selection and award. In addition, the

Government reserves the right to not make award(s) based on budgetary constraints or programmatic goals.

The Government may also select only parts of a proposal for award.

White Paper and Proposal Content: Respondents shall identify the InSPA phase characterizing stage of development incorporating content outlined in Section IV.B.3 of this NRA and submit a proposal for the full scope of that phase, including for renewal proposals. White papers shall also include a summary of the

Business Approach as described below. In addition to the scientific/technical/management plan referenced in

Section 2.13 of the NRA Guidebook, proposals shall also describe the total estimated cost (with phasing by

Fiscal Year) and business approach for all phases as described below and a proposed work plan for the applicable phase, including but not limited to: major tasks, ground and flight testing, project schedule, contract payment milestones and deliverables, and price to the Government. The Work Plan shall include delivery of flight product sample(s) to the Government for independent test and evaluation tied to the contract milestones.

i. Business Approach: Describe the business approach to reach long-term profitability (unsubsidized), including a detailed roadmap through 2030 for proposals only. The Approach should include, at a minimum, the following (not to exceed two (2) additional pages for white papers and ten (10) additional pages for proposals beyond NRA Guidebook limitations):

Proposal Requirements Phase 1 Phase 2 Phase 3

- Leadership Team, including key employees leading and/or responsible for business, operational and science/technology execution. Describe current organization and staffing.

X X X

- Commercial Product Offering, including anticipated scaling, quantities and pricing with comparison to earth-based alternatives

X X X

- Target market(s), including size and anticipated annual growth rate, including key assumptions

X X X

- Self Assessment of Market Readiness Level at the beginning and end of the proposed work plan

X X X

- Marketing Plan and targeted direct customers and/or

Industry Partners, and Business Development

Strategy, including substantiation of interest/support

(i.e. letters of intent)

X X

- Capitalization Strategy including corporate contribution/cost-sharing, as well as target ROI and exit strategy for major investors (for Phases 2, 3)

X X X

- Cash Flow Summary through 2030 showing expenses, capital investments, revenues, break-even point and profitability at the recommended transition to a commercial destination/platform. Expenses include production costs and delivery to/from LEO

X X

- Business Risks / Barriers and Mitigation Plans including Export Control and intellectual property.

X X X

Note: It is advised to take into account the items in ‘Attachment A: InSPA Lessons Learned and Items of Note’ when developing implementation strategies, schedules and cost estimates for the purposes of ensuring mission success.

ISS End of Life Assumption: although discussions are still ongoing within the Government regarding official extensions of the ISS beyond 2024, proposers may assume for planning and estimating purposes only that ISS operations are extended through at least 2028.

Evaluation Criteria: Focus Area 1 proposals will be evaluated according to Section V.A of this NRA (excluding paragraph D).

Introduction: The International Space Station (ISS) remains the premier microgravity research and development laboratory for those seeking to develop and demonstrate technologies for in-space production of new and higher performing products for use on Earth. NASA intends to make awards through this Focus Area to enable commercially viable and sustainable business opportunities in low-Earth orbit (LEO) that advance solutions for national interest or public benefit by leveraging the capabilities and resources of the ISS. NASA intends through these awards to provide the support needed by United States non-governmental entities during early-stage development to validate game-changing materials and production processes that give U.S. industry a competitive edge amidst increasing global competition. For more information on NASA’s InSPA Portfolio, visit www.nasa.gov/inspa.

1.1 – InSPA Goals and Objectives

1.1.1 Strategic Goals: NASA’s three major goals for InSPA awards are to:

1. Serve national interests by developing in-space production applications for Earth that strengthen

U.S. technological leadership, improve national security, and create high-quality jobs, and/or

2. Provide benefits to humanity by developing products in LEO that significantly improve the quality of life for people on Earth, and

3. Enable the development of a robust economy in LEO by stimulating scalable and sustainable non-

NASA utilization of future commercial LEO destinations or orbital platforms.

1.1.2 Objectives of this Focus Area: Successful proposals will mature in-space manufacturing concepts that produce high-value materials and products for use on Earth by taking advantage of the unique environment of the ISS. Concepts must have the potential for scalability and capturing sizeable markets, creating new markets, or disrupting existing Earth-based technologies and ultimately transitioning to commercial LEO destinations or platforms. Concept demonstrations utilizing the unique conditions of the LEO environment may be conducted using facilities externally attached or within the ISS. Reference NASA’s LEO Economy website for further information about NASA’s strategic goals: https://www.nasa.gov/leo-economy/low-earth-orbit-economy

1.2 InSPA Implementation Strategy

1.2.1 Microgravity Demonstrations: InSPA is a flight demonstration program that makes use of the ISS to mature the Technology Readiness Level (TRL) and Market Readiness Level (MRL) of the proposed application by supporting the development and testing of manufacturing hardware and processes. Unlike typical research experiments, NASA expects InSPA technologies to require multiple testing opportunities in a microgravity environment to optimize the manufacturing process and achieve superior performance, quality, reliability, and efficiency. Applications should have a basis in prior fundamental microgravity research that provides some assurance that the intended microgravity benefit is achievable. NASA may facilitate testing in a parabolic or sub-orbital flight opportunity as risk mitigation before testing on the ISS.

NASA will provide consultation to help the proposer select the appropriate onboard research facilities, where feasible, to support testing on ISS to lower costs and accelerate learning, and to achieve the appropriate balance between crew-tended and automated operations. NASA will require independent verification of technical claims resulting from on-orbit demonstrations. Reference Section 1.8 for definitions of TRL and MRL.

1.2.2 Award Phases: NASA has identified three InSPA award phases (see Figure 1) from early concept studies through financially self-sustaining LEO production applications. These are unique to InSPA and do not correlate with Small Business Innovation and Research (SBIR) Phases. InSPA awards may include funding to cover a portion or all of the project cost for a given phase. The award funding ranges defined http://www.nasa.gov/inspa https://www.nasa.gov/leo-economy/low-earth-orbit-economy https://www.nasa.gov/leo-economy/low-earth-orbit-economy below are not provided as a guideline to be met, but rather, to assist first-time proposers in understanding the potential cost of developing, integrating, and operating complex research and manufacturing hardware on the ISS. Proposers may consult experts and experienced ISS National Lab implementation partners for insight as appropriate.

a. InSPA Phase 1: Enable early proof-of-concept studies and/or basic flight hardware development and test through multiple demonstrations on parabolic, sub-orbital, and orbital missions on the ISS to achieve TRL of 6 and MRL of 3. Proposals should identify the improvements sought and describe the number and type of demonstration tests appropriate to achieve exit criteria for the Phase. Historically, typical Phase 1 awards have been in the range of $2.0M - $3.0M for scenarios where new hardware development was required, and less than $2M where existing ISS facilities are suitable for proof-of-concept demonstrations. The goals of Phase 1 (i.e. exit criteria) are:

i. To demonstrate hardware performance and validate the scientific basis for the technology benefit in a LEO space environment.

ii. To establish a minimum level of production control to repeatedly produce the intended product to a quality or performance level comparable to Earth-based controls or state of the art.

iii. To refine the business case with preliminary revenue forecasts based on actual microgravity demonstrations and gain support from potential partners or investors to capture a moderate level of non-NASA investment for Phase

2.

b. InSPA Phase 2: Enable design maturation and advanced flight hardware development with additional demonstrations on ISS to achieve a TRL of 8 and MRL of 7. Past awards are few in number and have been in the range of $3M - $4M, with an expectation of some degree of cost-sharing (reference Cost Sharing guideline in section 1.2.3). The goals of Phase 2 (i.e. exit criteria) are:

i. To demonstrate full control of hardware, environments, and processes to meet specific performance standards for the application. These standards are often set by the customer and should be to a level of performance or quality within the application setting that is significantly better than possible on

Earth.

ii. To refine the business case to a level that successfully captures significant investor commitment for Phase 3.

c. InSPA Phase 3: Enable scaled flight hardware production on ISS or an alternative commercial LEO destination/platform to demonstrate commercial operations and end-to-end logistics model producing sufficient quantities to achieve a TRL of 9 and MRL of 9 and to close the business case. No prior Phase 3 awards have been made to indicate a range of expected costs. (Reference Cost Sharing guideline in Section 1.2.3). The goals of Phase 3 are:

i. Demonstrate scaling to commercial quantities and quality to support market demand, including supply chain and regulatory approvals.

ii. To establish formal agreements with U.S. LEO transportation and destination partners for transition to commercial operations.

iii. Begin transition to commercial platform(s) and achieve sustainable revenues.

Figure 1: InSPA Phase Description

Note: Current awardees must submit renewal proposal through this NRA for a follow-on award to either extend the current Phase (if not successfully achieving the exit criteria) or to move into a subsequent Phase

(Reference Section 2.5 of the NASA Guidebook for Proposers). It is not required to receive an award for a previous Phase to seek an award for a later Phase.

1.2.3 Cost-Sharing: NASA requests that proposers attempt to achieve cost-sharing for Phases 2 and 3 (see

Figure 2) as a measure of market confidence in the technology and business case. This target level is not mandatory and serves as a guideline only but will be a factor in the proposal evaluation for these Phases.

Figure 2: Guideline for InSPA Cost-Sharing

Notes:

1. Non-NASA investment includes contributions from sources internal and external to the company, in-kind labor and materials, access to facilities and equipment, internal Research and Development funds and the like, with higher weighting on external investment as a measure of the market’s confidence.

2. Proposers are free to include cost-sharing as part of Phase 1 but it is not expected.

3. Past investments made within the last 3 years may be counted, if related, however, at least

50% of the contribution must occur during the award period. Contributions cannot be counted twice.

4. Does not apply to the value of ISS NL resources such as up mass, down mass, and crew time.

1.2.4 Use of ISS National Lab (ISS NL): As InSPA technologies are not required to meet NASA’s technology needs, it is expected that flight demonstrations will utilize the resources allocated to the ISS NL. NASA and the Center for the Advancement of Science In Space (CASIS), as operator of the ISS NL, are partners in this effort to utilize the ISS NL resources in the most efficient way possible, leveraging experienced

Implementation Partners with microgravity-tested equipment. All selected InSPA payloads are subject to an independent review process established by CASIS and described in their various NL Research

Announcements here. If accepted by CASIS, InSPA awardees will be provided access to ISS NL resources

(up mass, down mass, USOS crew time, data transmission, power, etc.) including flight manifesting and increment operations planning. Access to ISS NL resource allocation requires a User Agreement to be signed with CASIS for utilization of the ISS NL, described here: https://www.issnationallab.org/user-agreements/. If not accepted by CASIS, NASA may elect to sponsor the use of ISS resources through the

NASA InSPA allocation.

https://www.issnationallab.org/research-on-the-iss/solicitations/nlra2023-2/ https://gcc02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.issnationallab.org%2Fuser-agreements%2F&data=04%7C01%7Ckevin.engelbert-1%40nasa.gov%7C3baa5066a09c4efbb17808d974551f42%7C7005d45845be48ae8140d43da96dd17b%7C0%7C0%7C637668731230333597%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&sdata=ApMRc5mjR1tfvenRjKMt%2FfNHxwTgW2jtA1zVSviLw9U%3D&reserved=0 https://www.issnationallab.org/user-agreements/ https://www.issnationallab.org/user-agreements/

1.2.5 Use of ISS Implementation Partners: Experienced Implementation Partners offer Payload Hardware

Development and/or Mission Integration and Operations (MI&O) services to assure the payload meets ISS interface and safety requirements. The offeror may propose to subcontract directly with their selected

Implementation Partner, or alternatively, may propose for NASA to contract with the Implementation

Partner for requested support. Reference the ISS National Lab list of Implementation Partners for more information: https://www.issnationallab.org/implementation-partners/.

1.2.6 Use of ISS Research Hardware and Facilities: Proposers should be familiar with the capabilities of existing flight hardware and facilities on ISS used for research that are relevant to their proposed scientific and technical objectives. As a fully functioning laboratory, the ISS National Lab supports a variety of multipurpose facilities to leverage microgravity conditions to advance research. The ISS platform includes microscopes, centrifuges, and freezers (to keep specimens cold before, during, or after use). In-orbit technologies include multipurpose facilities, tools, and systems for biology and human physiology, hardware for multiple methods of macromolecular crystal growth, and even nucleic acid sequencing technologies. Further information can be found on NASA’s Space Station Research Explorer website or through consultation with the ISS National Lab or your Implementation Partner. If a desired facility is commercially owned, the proposer should negotiate directly with the Commercial Service Provider (CSP) for use of the facility and include that cost in the final price to NASA. If a desired facility is Government owned, the proposer need not include the cost of its proposed use in the price to NASA.

1.2.7 Assurance of Compliance: NASA requires that any and all proposals that request funding for human and vertebrate animal research shall be reviewed for assurance of compliance with human subjects and/or animal care and use provisions. Policies for the protection of human subjects in NASA-sponsored research projects are described in the NASA Policy Directive (NPD) 7100.8F “Protection of Human Research

Subjects”. Animal use and care requirements are described in 14 CFR 1232. Proposals using animal test subjects shall include appropriate NASA Johnson Space Center (JSC) Institutional Review Board (IRB) or

Institutional Animal Care and Use Committee (IACUC) certification, if available, or declaration of pending status if unavailable. NASA uses a just-in-time practice for approval of the use of human subjects or animals. If the IRB/IACUC certification is already approved at proposal submission, proposers shall attach a copy of the certification (not the complete protocol) as part of the proposal. After an award is made, a statement must be provided by the applicant’s institution which identifies the selected proposal by name and which certifies that the proposed work will meet all Federal and local requirements for human subjects and/or animal care and use, including relevant documentation of IRB and/or IACUC approval.

1.2.8 Vertebrate Animal Science Review (VASR): Each proposal that requires vertebrate animals must address the five points outlined in the VASR Instructions posted alongside this solicitation in NSPIRES.

The VASR requirements are in addition to IACUC requirements, if appropriate. For tissue sharing proposals, the VASR is needed only when the tissue has not been collected at the time of proposal submission and a change is necessary to the parent-experiment protocol to accommodate the experiment or additional sampling.

1.2.9 Data Management Plan (DMP): All proposals submitted under this NRA are required to submit a DMP in accordance with the NASA Plan for Increasing Access to the Results of Scientific Research. Proposers are required to address all sections of the DMP Template provided on NSPIRES alongside this NRA. See

Section 2.11 of the NASA Guidebook for Proposers.

1.3 Submission Dates and Times

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NASA intends to make selections for new starts in FY23 according to the schedules in this section, with renewal of existing awards occurring throughout the year as appropriate. Renewal awards for continuation of previous NRA awards (whether an extension of the existing phase or beginning a new Phase) do not have set schedule dates, but rather are dependent on the schedule for completion of the existing contract milestones.

Proposals for new starts in response to Focus Area 1 are only accepted per the schedules in this section. Visit

SAM.gov for up-to-date information on submission dates and times, as the dates on SAM.gov take precedence over the schedule below.

1.3.1 Tissue Engineering and Biomanufacturing

NASA requests the submission of white papers and proposals that focus on applications in the areas of regenerative medicine, tissue engineering and biomanufacturing that use space to serve markets on Earth.

Proposals should demonstrate the potential of space to produce superior biomaterials and products over what can be achieved on Earth for important terrestrial applications. This includes but is not limited to: stem cell expansion and/or differentiation in microgravity for therapeutic application(s) on Earth; an organoid culture system or multicellular culture system to model human disease for the purpose of accelerating the development of therapeutics for the treatment of disease on Earth; or a system for biofabrication of human tissue or other biocompatible material for regenerative medicine application(s) on Earth. Proposals that support the goals of the

“Cancer Moonshot” are of special interest and may include manufacturing of compounds or therapeutics to address oncology applications on Earth. Reference: Cancer Moonshot℠ - NCI

Proposers should clearly describe where gravity is impeding progress on Earth, where space has been shown to produce relevant superior outcomes, and what properties are sought from in-space development. Reference

Table 1 for relevant InSPA solicitation milestones.

For further reference, CASIS led a Biomanufacturing in Space Symposium in 2021 to identify and prioritize opportunities for LEO commercialization in the area of biomanufacturing. Papers resulting from the symposium may be accessed at www.preprints.org/manuscript/202108.0044 and https://doi.org/10.1016/j.stemcr.2021.12.001.

Table 1: Schedule for Tissue Engineering and

Biomanufacturing New Starts

Action Due Date

Step 1 White Papers Due 03/31/2023

Proposal Invitations Sent 05/05/2023

Step 2 Proposals Due 06/30/2023

Awards Announced* 08/18/2023

Contract Start* 10/01/2023

*Dates are estimated

1.3.2 Advanced Materials and Manufacturing

A future call for proposals will focus on the areas of advanced materials and manufacturing of inorganic products per the schedule in Table 2. Proposers are asked not to submit White Papers for this topic at this time.

Table 2: Schedule for Advanced Materials and

Manufacturing New Starts

Formatted Table

Formatted Table https://sam.gov/content/home https://doi.org/10.1016/j.stemcr.2021.12.001

Action Due Date

Step 1 White Papers Due June 2023

Proposal Invitations Sent July 2023

Step 2 Proposals Due September 2023

Awards Announced* November 2023

Contract Start* January 2024

*Dates are estimated

1.4 – Submission Instructions: Step 1 White Paper and Step 2 Proposal

This announcement will follow a 2-step process for proposal submissions. Step-1 of the process is submission of a White Paper. The Offeror may submit a Step-1 White Paper at any time prior to the due date of White Paper noted below. In Step-2 of the process, invited proposers will submit a full project proposal.

Except as stated below, Proposers shall prepare proposals in accordance with instructions in Focus Area 1 of this

NRA and in NFS 1852.235-72, Instructions for Responding to NASA Research Announcements. Additional information in this solicitation is subject to the default Agency rules in the Guidebook for Proposals Responding to a NASA Notice of Funding Opportunity (NOFO). Where any discrepancies exist between the instructions in

Focus Area 1 of this NRA and the Guidebook for Proposals Responding to a NASA Notice of Funding

Opportunity (NOFO), the information in Focus Area 1 of this NRA takes precedence.

Proposers must submit one white paper and one proposal for each proposed application concept as attachments electronically through NSPIRES at https://nspires.nasaprs.com/external/. Proposers are not required to complete all requested information in the NSPIRES application, as only the attached white paper and proposal will be evaluated. Hard copies will not be accepted. Use of NSPIRES requires user registration and can be problematic for first time users. NASA recommends that proposals be submitted early to avoid delays impacting the eligibility of the submission. Proposals received after the due date and time as defined in notification of this solicitation in SAM.gov are considered late and will not be evaluated in accordance with NASA’s policy as given in Section 4.1 of the Guidebook for Proposals Responding to a NASA Notice of Funding Opportunity

(NOFO) (also see Sections 3.2).

Proposers must ensure information and certifications provided in https://sam.gov/content/home are current at the time of proposal submission in order to ensure all eligibility requirements outlined in Focus Area 1 Section 1.6.7 are met.

1.4.1 – Step 1 - White Paper Submissions

For Step 1, a White Paper shall be submitted by the proposer and reviewed by NASA in accordance with the evaluation factors set forth within this announcement. All Offerors will be notified with the result of this assessment regarding that organization’s White Paper submission.

White papers shall follow the format below. The cover sheet should be clearly marked “WHITE PAPER” and the total length shall not exceed 10 pages, excluding cover page and attachments. A page is defined as being no larger than electronically formatted page of 8.5” by 11.0” with 1” margins, with Times New Roman font no smaller than

12-point. Smaller font may be used for figures, tables and charts, but must be reasonably legible. No official transmittal letter is required. All white papers must be written in English.

Section I. Administrative (not included in the page count) - Cover sheet to include the content defined in

Section 1.4.2.A.

https://nspires.nasaprs.com/external/

Section II. Summary of Proposal (10 pages total) – reference the content defined in Section 1.4.2 and include key elements of each in an abbreviated form. Use of tables, bulleted lists, short-form narratives, and the like is acceptable as long as the information is conveyed clearly.

Section III: Attachments

Attachment A: Resumes of Key Personnel (up to four total, limited to two pages each)

Attachment B: Letters of Support (limited to 1 page each)

1.4.2 Step 2 - Proposal Submissions

By invitation only, proposers shall prepare a full proposal in accordance with the instructions in this section. The cover sheet should be clearly marked “PROPOSAL” and the total proposal length shall not exceed

25 pages, excluding budget details and attachments.

A. Cover Page (1 page)

1. NRA number (NNJ13ZBG001N)

2. Focus Area

3. Proposal title

4. Lead Organization submitting proposal

5. Type of business - large, small, university, etc.

6. Contractor’s reference number (if any)

7. Other team members (if applicable) and type of business for each

8. Technical point of contact to include: title, last name, first name, street address, city, state, zip code, telephone, and electronic mail (if available)

9. Administrative point of contact to include: title, last name, first name, street address, city, state, zip code, telephone, and electronic mail (if available)

10. InSPA Phase (see section 1.2.2) for the current stage of development.

11. Total funds requested from NASA, and the amount of cost share (if any) AND

12. Date white paper was submitted.

B. Proposal Abstract (1 page)

Provide a summary of the key elements of the proposal as defined below. The abstract shall contain no proprietary or confidential information.

C. Intrinsic Merit (5 pages)

Describe the Scientific and Technical merit of the activity, including but not limited to the following:

1. Overview of the proposed application and intended product(s).

2. Value proposition of the application and relevance to the goals of this Focus Area.

3. Value of the proposed application to the LEO ecosystem, related terrestrial industry(s), and public benefits.

4. Innovation of the approach and expected product performance relative to current state-of-art.

5. Rationale for pursuing production in LEO, including relevant past microgravity research.

6. Qualifications, experience, and past accomplishments of the Principal Investigator and any Co-

Investigators.

7. ISS demonstration goals and objectives by mission and exit criteria for the proposed InSPA

Phase.

8. Approach for collecting and analyzing data, including independent 3rd party validation.

9. Expected TRL at the completion of the proposed Phase.

D. Management Approach (5 pages)

Describe the approach for managing execution of the project, including but not limited to the following:

1. Work Plan for executing the proposed InSPA Phase, including major tasks for the proposer and subcontractors or consultants.

2. Flight hardware design, development and verification approach (if applicable).

3. Ground and on-orbit test plans, including description of ground facilities.

4. Organizational structure, key project team members, and any subcontractors and/or consultants.

5. Relevant qualifications, experience, and past accomplishments for key personnel and the selected implementation partner that demonstrate competence in their assigned tasks. Include biographies in Attachment A.

6. Project schedule, including major milestones and external dependencies.

7. Cost narrative describing the total expected cost for the proposed phase, basis of estimate, key assumptions.

8. Risk Management approach and any unique or significant challenges that may arise, including preliminary mitigation plans.

E. ISS Integration and Operations Approach and Feasibility (3 pages)

Working with the selected Implementation Partner, describe the approach for integration and operations of flight hardware/samples, including but not limited to the following:

1. Detailed concept of operations, including success criteria and use of existing ISS research facilities (if applicable).

2. Approach to ensuring safety of vehicle and crew, including a listing of potential ISS hazards and recommended controls for nominal and off-nominal situations.

3. Resource needs for payload hardware, consumables, and samples for each proposed mission and in total:

• Launch mass and volume; specify ambient vs. conditioned stowage, late load, and other constraints.

• Return mass and volume; specify ambient vs. conditioned stowage, early destow, and other constraints.

• Crew time for installation, operations, and removal of payload hardware, and any in-situ analysis.

• Power and cooling; specify peak and average usage.

4. Data and imagery requirements, including frequency and sample size with rationale.

F. Business Approach and Economic Impact (10 pages)

Describe the approach to reach economic viability by 2030, including but not limited to the following:

1. Commercial product offering, including ‘Economics of One Unit’ analysis with anticipated scaling and pricing with comparison to Earth-based alternatives, and potential Minimum Viable

Product (MVP).

2. Target market(s), including size and anticipated annual growth rate, key assumptions, Total

Addressable Market (TAM), and expected market share.

3. Capitalization Strategy including sources of funds and cost-sharing with applicable commitment letters for InSPA Phases 2 & 3.

4. Qualifications, experience, and past accomplishments of the Business team. Include biographies in Attachment A.

5. Business development strategy and path to commercialization, with identified customer(s) and letters of support or commitment in Attachment B.

6. Cash Flow Summary through 2030 showing expenses, capital investments, revenues, break-even point and profitability at the recommended transition to a commercial destination/platform.

Expenses should include production costs and transportation cost to and from LEO. - Not required for InSPA Phase 1 proposals.

7. The current MRL and expected MRL at the completion of the proposed Phase.

8. Business risks and mitigation plans, including competition, barriers, export control, and intellectual property.

G. Budget Details (no page limit)

1. Define the total expected budget for the proposed Phase (by Government Fiscal Year), the price to NASA, any cost-sharing, and major assumptions.

2. Provide an estimate for the total cost for later Phases with cost-sharing.

H. Attachments

1. Attachment A: Resumes of Key Personnel (up to five total, limited to two pages each)

2. Attachment B: Letters of Support (limited to 2 pages each)

3. Attachment C: Proposed Statement of Work (SOW). A SOW template is included for reference and as a guide to aid the development of a work plan. The SOW template includes tasks that are mandatory for safe integration and operations on the ISS, many of which will be performed by the selected Implementation Partner. Additionally, the SOW includes recommended tasks that provide NASA team members and support contractors additional insight to enable increased probability of Mission Success.

4. Attachment D: Quad Chart approved for public release shall be included for use by NASA in announcing the award. Use Attachment F: Quad Chart Approved for Public Release as a template.

5. Attachment E: Submission of VASR worksheet and appropriate IRB and/or IACUC certification if using human or animal test subjects, if available, or declaration of pending status if unavailable.

6. Attachment F: Small Business Utilization

a. All proposers shall briefly describe work that will be performed by small businesses.

Proposals should also identify any work to be subcontracted that is considered “high technology.” High Technology is defined as research and development efforts that are within or advance the state-of-the-art in technology discipline and are performed primarily by professional engineers, scientists, and highly skilled and trained technicians or specialists.

proposers shall describe any potential risks or impacts to seamless performance throughout the site when subcontracting out such efforts.

b. If the subcontractor(s) is (are) known, proposers must connect the work to the subcontractor and specify the extent of commitment to use the subcontractor(s) (enforceable vs. non-enforceable commitments). (Small Business offerors shall provide this information to the extent subcontracting opportunities exist in their approach to performing the requirement.)

c. All proposers shall provide information demonstrating the extent of commitment to utilize small business concerns and to support their development. Information provided should include a brief description of established or planned procedures and organizational structure for Small Business outreach, assistance, participation in the Mentor Protégé program, counseling, market research and Small Business identification, and relevant purchasing procedures.