BH4-17-013_JOFOC_envihab_Bedrest_Study_Doc_NNJ17563065R.pdf

NATIONAL AERONAUTICS AND SPACE ADMINISTRATION (NASA)

LYNDON B. JOHNSON SPACE CENTER (JSC)

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

Pursuant to 10 United States Code (U.S.C.) 2304(c)(1) and Federal Acquisition Regulation

(FAR) 6.302-1

For the Reduction of Human Spaceflight Risk Through the Use of a

Comprehensive Bed Rest Study Facility

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 International

Space Station (ISS) support these efforts, resource limitations necessitate ground-based research in spaceflight analogs to expedite answers to research questions. One such analog is bed rest.

Typically, bed rest studies are conducted at six degrees’ head-down tilt bed rest, as this platform is a widely used model for simulating some of the physiological adaptations experienced by astronauts during spaceflight. There are at least six of the 30 human risks for long duration spaceflight that can still benefit from bed rest ground-based research.

1. 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 with: envihab, in cooperation with Deutsches Zentrum für Luft-und Raumfahrt (DLR), which for the remainder of this document will be referred to as DLR. These bed rest research study services are for the JSC Human Health and Performance Directorate (HHPD) in support of the Human Research Program (HRP), ISS Program, the Orion Multi-Purpose Crew Vehicle

Program (MPCV), and the Exploration Systems Mission Directorate (ESMD). This effort will provide ground-based research into the physiological changes and health risks that occur in humans during spaceflight to support the HHPD in its effort to develop countermeasures against these changes.

2. FAR 6.303-2(b)(3) – A description of the supplies or services required, to meet the

Agency’s needs (including the estimated value): This justification provides the rationale for contracting by other than full and open competition to enter into a sole-source commercial purchase order with DLR. The requirements are to perform all activities necessary to prepare for, conduct, and close out a 60-day Artificial Gravity (AG) bed rest study. The study will consist of two periods of 60-day head down tilt, each with 12 test subjects. The contractor will be required to develop a study management plan, conduct study management, complete all preparations for AG bed rest campaigns, recruit and select test subjects, implement the bed rest campaigns in accordance with the Integrated Requirements

Document, disseminate data and reports, and provide for the appropriate medical care and safety of test subjects while undergoing the studies.

This will allow continued ground-based research into the physiological changes occurring in humans during spaceflight to support the HHPD in its effort to develop countermeasures against those changes.

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Enclosure

The anticipated period of performance for this effort is 2.5 years. The overall potential not-to-exceed cost is approximately .

3. FAR 6.303-2(b)(4) – An identification of the statutory authority permitting other than full and open competition: The applicable statutory authority is 10 U.S.C. 2304(c)(1) and

FAR 6.302-1, “Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements.” The services required by the agency are available from only one responsible source, no other type of supplies or services will satisfy agency requirements, and full and open competition need not be provided for. DLR operates the only known facility that contains all of the capabilities necessary to perform this bed rest ground-based research. The bed rest studies are critical to develop countermeasures against human risks for long duration spaceflight.

4. FAR 6.303-2(b)(5)&(9) – A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited and any other facts supporting the use of other than full and open competition: 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 bed rest 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. Bed rest environments that do not have all of these capabilities in-house have to transport the test subjects to a hospital or other facility which 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 the science measurement and decrease the confidence in the end result, 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 bed rest services will significantly reduce the risk of six degrees’ head down tilt disruption. This 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 bed rest services in one facility. These types of services include the capability to maintain a strict metabolic diet with in-house nursing and medical care. The facility also provides an enriched Carbon dioxide (CO2) environment which is critical during a bed rest study for NASA to better understand the Visual Impairment Intracranial Pressure (VIIP) syndrome, NASA’s highest

BH4-17-013-JOFOC Comprehensive Bed Rest Study Facility 3 human health risk. There is a chamber facility with the capability to adjust gas composition and atmospheric pressure which is critical to VIIP syndrome research where CO2 is considered to be a contributing factor. DLR has imaging technologies to include both positron emission tomography (PET) and magnetic resonance imaging (MRI). The PET and

MRI technologies are important for understanding physiological and neurological changes throughout the studies. The facility has a short arm human centrifuge with unique capabilities for exercise, tele-robotic ultrasound, and other measurement capabilities during centrifugation. This allows subjects to exercise which is a known counter measure for the physiological effect of weightlessness.

The facility also contains several in-house laboratories to include a microbiology laboratory to provide immediate processing 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 bed rest. In addition, the facility has an adjacent virtual reality laboratory that can facilitate future studies engaging bed rest subjects performing complex tasks.

Another unique capability of the facility is the capacity for up to 12 subjects, which is a benefit for investigations requiring long duration bed rest studies simulating effects of microgravity on the human body. Researchers conduct a power analysis to show 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 bed rest 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.

NASA is not aware of another facility anywhere that offers these unique research systems all within one facility that will allow multi-system research investigations. This 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 bed rest facility.

5. 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 pre-solicitation synopsis for this effort was issued on the Federal Business Opportunities website on May 25, 2017, and was looking for other capable sources. The synopsis closed on June 9, 2017, with no responses received.

6. FAR 6.303-2(b)(7) – A determination by the contracting officer that the anticipated cost to the Government will be fair and reasonable: The Contracting Officer (CO) will ensure the proposed cost is fair and reasonable based upon a thorough cost evaluation in accordance with FAR 15.404-1. The CO will also work closely with the CO Representative to determine if the proposed price, cost and fee, is fair and reasonable. This includes the development of an Independent Government Cost Estimate prior to receipt of the proposal and performing a technical evaluation. The proposal will be evaluated to determine adequacy to meet the requirements of the Statement of Work (SOW). For example, the proposed labor hours will be evaluated to determine if appropriate skill mix and quantity is adequate to satisfy the

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SOW requirements. The reasonableness of any proposed indirect cost and other direct costs

(material, travel, subcontract, etc.) will also be evaluated. The CO will use cost analysis to determine all proposed rates and factors are fair and reasonable. In addition, we will enlist assistance from the Defense Contract Management Agency European branch and the

European Court of Auditors to evaluate the proposed rates. Resources specific to task/delivery orders will be reviewed and negotiated based on past experience and expert knowledge in performing similar work.

7. FAR 6.303-2(b)(8) – Description of the market survey conducted, and the results, or a statement of the reasons a market survey was not conducted: As part of our market survey, a pre-solicitation synopsis was issued and no responses were received. The

Government also reviewed similar historical NASA acquisitions from 2004-2014, for bed rest studies. The prior studies had a different focus from the current focus on behavioral health issues associated with the isolation of long duration missions. Also, the previously used bed rest contractor repurposed their facility floor space at the conclusion of the 2014 bed rest study and they no longer have the capability to perform bed rest studies.

In addition, an internet search was performed to identify if any other facilities in the world are capable of performing the bed rest studies contemplated by this procurement. A

Google search of “Bed Rest Studies for Scientific Research” yielded pages of hits. A review of the first 250 identified many past NASA Bed Rest studies, four locations conducting clinical studies, and a few facilities that have partnered with NASA and the

European Space Agency in the past. While other bed rest studies have been performed, they were not for these same types of studies and none have been done in facilities that have a short arm human centrifuge with the additional analytical support required for our highly integrated research studies as available only in the DLR facility.

Upon consideration of the above stated technical, cost, and schedule risks to NASA human spaceflight missions that would be incurred if DLR is not selected, the potential benefits from competition do not justify accepting these substantial risks to the HRP, ISS, MPCV, and ESMD at this time. This effort provides a strategy that mitigates the risks substantially and balances mission success for HRP, ISS, MPCV, and the ESMD with the procurement goals of the Agency.

8. FAR 6.303-2(b)(9) – Any other facts supporting the use of other than full and open competition, such as: The timeframe for implementing a study in a bed rest facility requires extensive coordination and multiple ethics review boards to ensure the efficacy of the study and no harm to the subjects. Any course of action other than contracting with

DLR with all of their co-located capabilities would increase technical risks and create schedule and cost burdens to the programs and would not be in the best interest of NASA by resulting in unacceptable delays in fulfilling the Agency’s requirements.

a. FAR 6.303-2(b)(9) (i) – Explanation of why technical data packages, specifications, engineering description, statements of work, or purchase descriptions suitable for full and open competition have not been developed or are not applicable: Not

Applicable, as pre-solicitation synopsis was issued and no inquiries were received. There is no other facility out there interested in competing for this work.

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9. FAR 6.303-2(b)(10) – A listing of the sources, if any, that expressed an interest in writing in the acquisition: No responses were received from the pre-solicitation synopsis posted on May 25, 2017.

10. 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 is not aware of another facility that offers the unique research systems of DLR all within one facility that will allow multi-system research investigations. NASA will continue to assess industry facilities and capabilities to see if they can satisfy the Government’s requirements. As opportunities to fulfill new bed rest study requirements materialize, NASA will 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.