JOFOC - DLR3 Bed Rest - Final 80JSC022DA004.pdf

Revision: 01/2021

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION (NASA)

LYNDON B. JOHNSON SPACE CENTER (JSC)

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION (JOFOC)

For Spaceflight Analog Bedrest Principal Investigator Science New Contract Award 80JSC021D0005

1. Federal Acquisition Regulation (FAR) 6.303-1(b)(1) – Identification of the Agency and the contracting activity, and specific identification of the document as a “JOFOC.”

This document is a JOFOC prepared by NASA JSC.

The procuring Agency is NASA and the contracting activity is the Office of Procurement at

JSC.

2. FAR 6.303-2(b)(2) – The nature and/or description of the action being approved:

This justification provides the rationale for contracting by other than full and open competition to award a new Indefinite-Delivery Indefinite-Quantity (IDIQ) commercial contract with Deutsches Zentrum fur Luft-und Raumfahrt (DLR) which for the remainder of this document will be referred to as DLR. These services are for the JSC Human Health and Performance Directorate (HHPD) in support of the Human Research Program (HRP), International Space Station (ISS) Program, the Orion Multi-Purpose Crew Vehicle Program (MPCV), Gateway, and the Exploration Systems Mission Directorate (ESMD). This contract action includes all efforts associated with planning, preparing, and implementing various bedrest studies, which are comprised of one or more bedrest campaigns.

Currently, there are two purchase orders with DLR (80JSC018P0078 and 80JSC019P0010) that were recently modified and extended to accommodate the purchase of two additional bedrest campaigns. However, with this approval, NASA intends to award a new IDIQ commercial contract that has a period of performance from May 17, 2021, to December 31, 2025, for a total period of performance of 5 years. Under the new IDIQ contract, firm-fixed-price task orders will be negotiated and issued for the various bedrest campaigns as the requirements are more fully defined. Four new bedrest campaigns to study the use of strict head-down tilt during bedrest as an analog for some of the physiological adaptations experienced by astronauts during spaceflight have been identified and will be issued via a task order once this contract is awarded. Due to the complexity of the science and facility requirements to support the bedrest research, the contract should be awarded no later than May 17, 2021, to allow sufficient time for integration of the science complement and implementation of equipment and protocols.

This IDIQ contract will cover the existing requirement for bedrest research necessary for HHPD to support the ESMD and provide the capability and flexibility to procure additional bedrest studies as additional requirements are defined in the future.

JOFOC – DLR3

Revision: 01/2021

3. FAR 6.303-2(b)(3) – A description of the supplies or services required, to meet the Agency’s needs (including the estimated value):

As astronauts prepare to journey into deep space and eventually land on Mars, human research in support of space exploration is required. While investigations conducted on the ISS support these efforts, resource limitations necessitate ground-based research in spaceflight analogs to expedite answers to research and design questions. One such analog is long-duration bedrest. Typically, bedrest studies are conducted at six degrees head-down tilt, as this platform is a widely recognized and accepted model for simulating some of the physiological adaptations experienced by astronauts during spaceflight. A key question this set of bedrest campaigns will investigate is what countermeasures, if any, will mitigate the physiological changes, known as Spaceflight Associated Neuro-Ocular Syndrome (SANS), that NASA has seen in ocular structures of astronauts during spaceflight.

The HHPD requires the procurement of principal investigator services for science needs and standard measures requirements necessary to prepare, conduct, and close out for a series of four 30-day bedrest studies. This requirement is similar to the principal investigator services that were procured on the previous purchase orders implementing Artificial Gravity Bedrest studies, in which the bedrest studies lasted for periods of up to 60-days. For the 30-day bedrest studies, the contractor will be required to develop a study management plan; conduct study management; complete all preparations for bedrest campaigns; recruit and select test subjects; implement the bedrest campaigns, including conduct of scientific measures and collection of data; disseminate data, samples and reports; and provide for the appropriate medical care and safety of test subjects while undergoing the studies. The studies will investigate differing countermeasures to the SANS risk. The estimated value for the four initial bedrest studies upon issuance of the new contract should total $13.6 million. Studies one through three are about $2.8 million each, and study four is about $5.2 million. The program requires an acquisition strategy large enough to get through several years of studies, and needs to remain flexible to allow for additional studies unknown at this time that may become necessary after the initial four studies. The contract ceiling of $49.9 million with an estimated completion date of December 31, 2025, will enable implementation of additional bedrest studies as necessary to inform exploration vehicle design and investigate impacts of proposed exploration operations on humans.

4. FAR 6.303-2(b)(4) – An identification of the statutory authority permitting other than full and open competition:

The statutory authority permitting other than full and open competition for acquisitions using the procedures in FAR subpart 13.5 is 41 United States Code (U. S. C.) 1901.

5. FAR 6.303-2(b)(5) – A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited:

The rationale supporting the use of 41 U. S. C. 1901 is that this acquisition is a commercial procurement using the simplified procedures authorized by FAR subpart 13.5 and DLR is the only source that can provide the required services to satisfy the Government’s need as described in the next paragraph.

Revision: 01/2021

The envihab facility operated by DLR in Cologne, Germany, provides a unique facility and a suite of capabilities that can successfully implement HRP research objectives and ultimately reduce risk to exploration crews. The facility is state of the art with expertly trained staff that are experienced in conducting training and research on astronauts as well as ground analog subject testing and is a full-service bedrest facility.

The significant amount of research equipment and services available in this one facility ultimately reduces the risk to human subjects since they do not need to be transported by vehicle to other facilities during the studies, as well as allows for more efficient research studies that ensure quality results. Bedrest environments that do not have all of these capabilities in-house have to transport the test subjects to a hospital or other facility that can provide the additional capabilities. Such transport introduces the risk of disruption to the six degrees head down tilt orientation of the subjects. Any change in angle has the potential to increase the error in science measurements and decrease the confidence in the data collection, which will then confound the study results. Test subjects are only allowed to be tested for a fixed number of hours per day. Transport can also be time consuming, which constrains the scheduling of additional research and measures to be taken on the individual subjects. Furthermore, transporting subjects always runs the risk of unforeseen situations such as weather, traffic, or other such phenomenon which could impact the schedule and efficiency of the study.

A facility that encompasses co-located labs, equipment, and bedrest services will significantly reduce the risk of disruption of the six degrees head down tilt required to achieve maximum scientific benefit. This co-location also saves the Government time and funding by eliminating travel time that then increases the amount of time available for science, thus increasing the science return per subject cost. The DLR location offers the co-located labs, significant research equipment, and bedrest services for up to 12 subjects in one facility. Additional envihab services include the capability to maintain a strict metabolic diet with in-house dieticians, nursing, medical, and rehabilitation care. The envihab facility is the only bedrest facility in the world capable of providing an enriched carbon dioxide environment, which is critical to studying exploration vehicle life support system designs and impacts to astronauts. DLR has imaging technologies to include both Positron Emission Tomography and Magnetic Resonance Imaging, which are important for understanding physiological and neurological changes throughout the studies. The facility also has a full suite of sophisticated ocular testing equipment and highly trained operators. The facility has a short arm human centrifuge with unique capabilities for exercise, tele-robotic ultrasound, and other measurement capabilities during centrifugation.

The facility also contains several in-house laboratories to include a microbiology laboratory to provide immediate processing and storage of biological samples, which mitigates degradation of the samples. There is a psychology laboratory to support the psychological health and well-being of subjects, which is a critical component in long duration bedrest.

In addition, the facility has an adjacent virtual reality laboratory that can facilitate future studies engaging bedrest subjects performing complex tasks.

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Another unique capability of the facility is the capacity for up to 12 subjects simultaneously.

Researchers conduct a power analysis to determine how many individuals have to be tested in order to validate their results and allow extrapolation to larger populations. The larger number of subjects reduces the number of repetitions a bedrest study will require to obtain an adequate sample size. Also, larger numbers of subjects can reduce the overall schedule and funding required to complete the studies.

Per NASA analysis of the market, NASA is not aware of another facility anywhere that offers these unique research systems all within one facility that will allow multi-system research investigation. The envihab facility allows researchers access to the latest in imaging technology and flight analog research systems with an experienced staff trained in the spaceflight conditions and the execution of spaceflight research in a bedrest facility.

6. FAR 6.303-2(b)(6) – A description of the efforts made to ensure that offers are solicited from as many potential sources as practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies:

A notice to the Government Point of Entry (GPE) website (beta.sam.gov) was published on October 20, 2020, in accordance with FAR Subpart 5.2. The synopsis closed on November 05, 2020. This posting informed potential sources of NASA’s intent to award this sole-source commercial contract to DLR. No sources expressed an interest. The results of this synopsis are summarized in Section 10 below. Additionally, as background information the previous purchase order (base award) was synopsized on May 25, 2017, seeking other capable sources. The synopsis closed on June 9, 2017, with no responses.

7. FAR 6.303-2(b)(7) – A determination by the Contracting Officer (CO) that the anticipated cost to the Government will be fair and reasonable:

The CO signature on this document indicates that the CO has determined that the anticipated cost to the Government will be fair and reasonable. The contractor shall be required to submit a proposal to be evaluated and negotiated by the Government. Prior to execution of any task order, a proposal analysis will be performed. The proposal analysis will ensure that the final agreed-to price for the contract action is fair and reasonable.

The CO will also work closely with the CO’s Representative for technical analysis to determine the proposed price is fair and reasonable. This analysis includes the development of an Independent Government Cost Estimate prior to receipt of the proposal and performing a technical evaluation. The contractor’s proposal will be evaluated to determine the adequacy to meet the requirements of the Statement of Work (SOW). For example, the proposed labor hours will be evaluated to determine if skill mix and quantity is adequate to satisfy the SOW requirements. The reasonableness of any proposed indirect cost and other direct costs (materials, travel, subcontracts, etc.) will also be evaluated. Resources specific to task/delivery orders will be reviewed and negotiated based on historical information and expert knowledge in performing similar work comparing this procurement to previous bedrest studies performed for NASA by DLR in recent years.

8. FAR 6.303-2(b)(8) – Description of the market research conducted, and the results, or a statement of the reasons a market research was not conducted:

As part of our market survey, a pre-solicitation synopsis was issued as described above in six, and no responses were received. The Government also reviewed similar historical NASA acquisitions from 2004 to 2014, for bedrest studies. The previously used bedrest contractor repurposed its facility floor space at the conclusion of the 2014 bedrest study, and it no longer has the capability to perform, or further interest in participating in, bedrest studies.

In addition, an internet search was performed in 2021 to identify if any other facilities in the world are capable of performing the bedrest studies contemplated by this procurement. A Google search of “Bedrest Studies for Scientific Research” yielded limited findings, mostly covering a review of past NASA Bedrest studies, clinical studies, and a few facilities that have partnered with NASA and the European Space Agency in the past. While other bedrest studies have been performed, they were not for the same types of studies, and none have been done in facilities that have all the necessary capabilities (other than the previous bedrest studies at the envihab, which were all JSC procurements accomplished via a JOFOC) with the additional analytical support required for highly integrated research studies.

The timeframe for implementing a study in a bedrest facility requires extensive coordination and multiple ethics review boards to ensure the efficacy of the study and no harm to the subjects. Additionally, answers to critical questions this set of studies aims to obtain are needed to make near term decisions to reduce the SANS risk on the ISS as well as inform requirements for the exploration vehicles. Any course of action other than contracting with DLR would create additional burdens to the NASA exploration programs and would not be in the best interest of NASA by resulting in unacceptable delays in fulfilling the Agency’s requirements.

Upon consideration of the technical, cost, and schedule risks to NASA human spaceflight missions based on the disruption of continuity of services and unacceptable delays that would be incurred, the potential benefits from competition do not justify accepting these substantial risks to the HRP, ISS, MPCV, Gateway, and ESMD at this time. This contract strategy enables substantial mitigation of risk to human spaceflight and balances mission success for HRP, ISS, MPCV, and the ESMD with the procurement goals of the Agency.

9. FAR 6.303-2(b)(9) – Any other facts supporting the use of other than full and open competition:

None

10. FAR 6.303-2(b)(10) – A listing of the sources, if any, that expressed an interest in writing in the acquisition:

A notice of NASA’s intent to award this sole-source action was synopsized on the GPE website (beta.sam.gov) per FAR Subpart 5.2 (See Section 6 above). This posting informed potential sources of NASA’s intent to award this sole-source commercial contract to DLR.

The initial sole-source action was published on October 20, 2020, and closed on November 5, 2020, with no responses received. No sources expressed an interest.

11. FAR 6.303-2(b)(11) – A statement of actions, if any, the Agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required:

NASA will continue to assess industry facilities and capabilities to see if they can satisfy the Government’s requirements. As opportunities to fulfill new bedrest study requirements materialize, NASA will synopsize the requirement, publicize, and compare the Government’s need with the facilities and capabilities available pre-award to determine industry’s ability to competitively fulfill the requirement. Agency-wide, NASA strives to seek out new sources and make requirements open for competition when industry can meet the capabilities and qualifications.