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15352 Federal Register / Vol. 85, No. 53 / Wednesday, March 18, 2020 / Rules and Regulations

must be evaluated at least quarterly or Astronauts Act. The new regulations affords occupationally related medical promptly after replacement, whichever will provide for the medical monitoring monitoring services through the LSAH is more frequent. and diagnosis of conditions that are program to former U.S. Government * * * * * potentially -associated and astronauts and payload specialists at the treatment of conditions that are JSC with a 60–70 percent participation PART 39—LICENSES AND spaceflight-associated for former U.S. rate. SAFETY REQUIREMENTS FOR WELL Government astronauts and payload On March 21, 2017, the President LOGGING specialists. signed into law the National Aeronautics and Administration ■ 6. The authority citation for part 39 DATES: Effective: March 18, 2020. Transition Authorization Act of 2017, continues to read as follows: Comments due: Send comments on or Public Law 115–10 (2017). Title IV, Authority: Atomic Energy Act of 1954, before May 18, 2020. Subtitle D, the ‘‘To Research, Evaluate, Assess, and Treat Astronauts Act’’ secs. 53, 57, 62, 63, 65, 69, 81, 161, 181, 182, ADDRESSES: You may send comments, 183, 223, 234 (42 U.S.C. 2073, 2077, 2092, (hereafter ‘‘TREAT Astronauts Act’’ or identified by docket number NASA– 2093, 2095, 2099, 2111, 2112, 2201, 2232, ‘‘Act’’) is codified at Section 20149 of 2019–0004 and/or RIN number 2700– 2233, 2273, 2282); Energy Reorganization Act Title 51 of the U.S. Code. of 1974, secs. 201, 206 (42 U.S.C. 5841, AE51, by any of the following methods: • The TREAT Astronauts Act provides 5846); 44 U.S.C. 3504 note. Federal eRulemaking Portal: http:// NASA the authority to expand the www.regulations.gov. Follow the ■ 7. In § 39.65, revise paragraph (a) to voluntary monitoring program by instructions for sending comments. developing a more comprehensive read as follows: • Email: HQ-TREATAstronautsAct@ occupational surveillance program that .gov. Include docket number § 39.65 Personnel monitoring. will enable earlier detection and NASA–2019–0004 and/or RIN number (a) The licensee may not permit an diagnosis of medical conditions individual to act as a logging supervisor 2700–AE51 in the subject line of the ‘‘potentially associated’’ with or logging assistant unless that person message. spaceflight and treatment of medical • Mail: NASA Headquarters, Mail wears a personnel dosimeter at all times conditions associated with spaceflight. Code 2M21, ATTN: Gwyn E. Smith, 300 during the handling of licensed NASA currently uses data from the E St. SW, Washington, DC 20546–0001. radioactive materials. Each personnel LSAH program to tailor clinical care for Instructions: All submissions received dosimeter must be assigned to and worn individual astronauts, as well as to must include the agency name and by only one individual. Film badges inform the human systems risks, current docket number or Regulatory must be replaced at least monthly and spaceflight operations, and future Information Number (RIN) for this all other personnel dosimeters that vehicle standards. The comprehensive rulemaking. All comments received will require replacement must be replaced at occupational surveillance program will be posted without change to http:// least quarterly. All personnel dosimeters provide NASA with more www.regulations.gov, including any must be evaluated at least quarterly or comprehensive data that will ultimately personal information provided. promptly after replacement, whichever contribute to an improved Docket: For access to the docket to is more frequent. understanding of the long-term impact read background documents or of spaceflight. This enhanced program is * * * * * comments received, go to http:// expected to increase the former U.S. Dated at Rockville, Maryland, this 3rd day www.regulations.gov. of March, 2020. Government astronaut and payload FOR FURTHER INFORMATION CONTACT: specialist participation rate in the For the Nuclear Regulatory Commission. Gwyn E. Smith, Policy Manager, Office occupational surveillance program to Margaret M. Doane, of the Chief Health and Medical Officer, over 80 percent. Executive Director for Operations. 1–833–996–1685, HQ- poses significant [FR Doc. 2020–05295 Filed 3–17–20; 8:45 am] [email protected]. challenges and is full of substantial risk. BILLING CODE 7590–01–P SUPPLEMENTARY INFORMATION: NASA and its astronauts acknowledge and accept the risks of spaceflight are I. Background beyond those of ordinary daily living. NATIONAL AERONAUTICS AND NASA currently has a voluntary Participation in long duration missions SPACE ADMINISTRATION medical monitoring program, Lifetime or multiple shorter duration missions, Surveillance of Astronaut Health increases health risks such as, vision 14 CFR Part 1241 (LSAH) program, for all U.S. impairment, demineralization, and [Document Number NASA–20–028: Docket Government astronauts and payload behavioral health issues. In addition, Number—NASA–2020–0001] specialists at the NASA Johnson Space exposure to high levels of radiation and Center (JSC). Once they leave the microgravity can result in acute and RIN 2700–AE51 astronaut corps, former U.S. long-term health consequences that can Government astronauts and payload increase the risk of cancer and tissue To Research, Evaluate, Assess, and specialists rely on workers’ degeneration and have potential effects Treat (TREAT) Astronauts compensation and other U.S. on the musculoskeletal system, central AGENCY: National Aeronautics and Government programs to provide nervous system, cardiovascular system, Space Administration (NASA). diagnosis and treatment for spaceflight- immune function, and vision. ACTION: Interim final rule; request for associated conditions. There is no NASA has also seen an increase in comments. formal mechanism for NASA to receive health issues former U.S. Government diagnosis and treatment data on such astronauts and payload specialists face, SUMMARY: With this interim final rule, conditions. many years after their NASA service. the National Aeronautics and Space As of November 2019, there are One of the vital tools NASA needs to Administration (NASA) is amending its approximately 250 living former U.S. prepare for future long-duration and regulations to add a new part that will Government astronauts and payload exploration missions is more data on the implement the provisions of the TREAT specialists. The Agency currently health effects humans face in

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spaceflight. Data collected under the costs associated with the monitoring based on a NASA astronaut TREAT Astronauts Act will allow and diagnosis of a condition that is spaceflight exposure clinical NASA to examine health trends in potentially associated with spaceflight assessment. For example, as part of astronauts over the course of their and will pay, as the secondary payer, for routine monitoring, NASA provides lifetime to understand better the any medical costs associated with the bone density scanning for young physical, behavioral, microbiological, treatment of a condition that is healthy males. This testing is beyond and molecular reaction of the human associated with spaceflight. This the accepted standard of care. body. These data will also contribute to includes deductibles, coinsurance, —‘‘Eligible individual’’ to include both the overall knowledge of the Agency copayments, and similar charges, but former U.S. Government astronauts and serve to identify spaceflight risks to excludes insurance premiums. Lastly, and former payload specialists who human health and develop mitigation the law limits NASA’s authority to pay have flown in space, while strategies as NASA moves ahead to for medical treatment to the role of specifically excluding others who are long-duration and exploration missions. secondary payer. The type of primary not included in these groups. U.S. Given the fact that there are so few coverage available to former U.S. Government astronaut is defined in astronauts and such limited data, Government astronauts and payload the TREAT Astronauts Act as the increased participation to get more data specialists will depend on their status at meaning given the term ‘‘Government is critical. NASA is learning daily of the the time of their active astronaut career astronaut’’ in 51 U.S.C. 50902, except untoward effects of human spaceflight and any current health plan, Federal it does not include an individual who on the human body. In order to prepare benefits program, or other workers’ is an international partner astronaut. for the in 2024, NASA needs to compensation coverage that may apply. The term ‘‘Government astronaut’’ is understand these effects so appropriate For former U.S. Government astronauts defined in 51 U.S.C. 50902. mitigation measures can be taken now. and payload specialists who believe For clarification, the following are This program will inform future they have a condition related to their specifically excluded: generations by providing health data spaceflight, they must first seek (1) Astronauts of other United States showing the effects of spaceflight treatment from the Department of Government agencies—only astronauts activities on active and former U.S. Defense Military Health System, the who participate in NASA programs are Department of Labor Office of Workers’ Government astronauts and payload eligible under the TREAT Astronauts Compensation Programs Division of specialists and thereby ensuring that Act, so if Department of Defense or Federal Employees’ Compensation, or their legacy and NASA’s mission Department of Labor, for example, had through their private health insurance, continues. This data will become astronauts, they would not be covered where applicable. The JSC Flight increasingly valuable to improving our under the TREAT Astronauts Act; Medicine Clinic will assist the former understanding of many diseases humans (2) Employees of commercial U.S. Government astronauts and face on Earth. spaceflight companies who were never payload specialists with these processes employed by NASA nor a member of the II. Section-by-Section Analysis as well as filing a claim with NASA. Uniformed Services assigned to Section 1241.10 Covered Medical Care Section 1241.15 Definitions NASA—commercial spaceflight This section establishes key tenets of This section defines terms used in the astronauts, i.e., astronauts who flew for the program as defined in the TREAT TREAT Astronauts Act and this rule. commercial spaceflight companies, even Astronauts Act unless specifically stated We define: if they participated in a mission to a otherwise. NASA will provide —‘‘Conditional payments’’ as described NASA vehicle, say the International monitoring and diagnosis for conditions in the TREAT Astronauts Act. This , are not eligible under the potentially associated with spaceflight helps ensure the U.S. Government TREAT Astronauts Act; and treatment for conditions associated astronauts and payload specialists get (3) International partner astronauts— with spaceflight. For clarity and ease of prompt monitoring, diagnosis, and a term used specifically for NASA’s reading, we are using ‘‘spaceflight- treatment for potential spaceflight- partners in the International Space associated condition’’ as defined in 14 associated conditions, prior to Station, excluding , are CFR 1241.15 versus ‘‘condition primary payer formal claim specifically excluded in the TREAT associated with spaceflight’’ as used in submission and adjudication, as Astronauts Act; the TREAT Astronauts Act. Monitoring, appropriate. (4) Employees of foreign diagnosis, and treatment will be —‘‘Cost sharing’’ as described in the governments—astronauts who have provided by a local health care provider TREAT Astronauts Act prescribes that flown to space with NASA but are not if it is unadvisable for the former U.S. former U.S. Government astronauts U.S. Government astronauts are not Government astronaut or payload and payload specialists participating eligible; and specialist to travel to the JSC. A in the program will receive (5) Private individuals or tourists who provision has been added to also allow monitoring, diagnosis, and treatment have flown in space—private for monitoring, diagnosis, and treatment without cost sharing obligation. This individuals and tourists who have flown at a local health care provider if it is means that medical monitoring, to space with NASA, but are not U.S. advantageous to the Government. For diagnosis, or treatment authorized Government astronauts are not eligible; example, if additional tests are needed under this Act shall be provided and after the individual has returned home without any deductible, copayment, (6) Former astronauts, including from JSC, they could be done locally if or other cost sharing obligation. members of the Uniformed Services, it is more cost effective. NASA will —‘‘Monitoring, diagnosis, and and former payload specialists who provide medical monitoring, diagnosis, treatment’’ as consistent with current have not flown in space—The definition and treatment without a cost sharing use in the medical community. of U.S. Government astronauts includes obligation imposed on the former U.S. Diagnosis and treatment are provided, only those individuals who have flown Government astronaut or payload consistent with the accepted standard into space, and therefore, those who specialist. This means NASA will pay, of care. However, due to the unique have not flown to space are not eligible as a secondary payer, for any medical nature of spaceflight, monitoring is under the TREAT Astronauts Act.

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We use the term ‘‘eligible individual’’ covers travel expenses for its Section 1241.30 Program Participation in this rule instead of the compound occupational surveillance program and and Claims Submission term ‘‘former U.S. Government will extend this no cost sharing across This section details the steps an astronaut and former payload the program. Monitoring of potentially eligible individual must take, with specialists’’ as used in the TREAT spaceflight-associated conditions is assistance from the JSC Flight Medicine Astronauts Act to clarify specifically nominally provided at the JSC Flight Clinic, to participate in this program. who may participate in this program. Medicine Clinic. When necessary, due Former U.S. Government astronauts and —‘‘Program’’ to mean the medical to the health of the former U.S. payload specialists already receive an monitoring, diagnosis, and treatment Government astronaut or payload annual invitation from NASA to authorized by the TREAT Astronauts specialist, monitoring may be provided participate in NASA’s occupational Act to enhance the readability of the locally, so as not to burden the eligible surveillance program. No claim is rule. individual with travel. In addition, required to participate in NASA’s —‘‘Primary Payer’’ as it is commonly NASA may also opt to use a provider occupational surveillance program. This used within the medical community. local to the eligible individual, if it is current program has a 60–70 percent Primary payer means the entity that otherwise advantageous to the participation rate. Eligible individuals pays first, up to the limits of its Government. This allows NASA to must first seek primary coverage before coverage. submitting a claim to NASA, as NASA —‘‘Secondary Payer’’ to mean the entity reduce costs as much as possible. Diagnosis and treatment is handled on is a secondary payer. The type of that pays after all primary payers have primary coverage available to former paid, up to the limits of their a case-by-case basis, with the location of the provider dependent on the medical U.S. Government astronauts and coverage. This means NASA will pay, payload specialists will depend on their in toto, as the secondary payer for any appropriateness of the facility, patient, preferences, cost effectiveness, and status at the time of their active monitoring and diagnosis for astronaut career and any current health other pertinent factors. Each case is potentially spaceflight-associated plan, Federal benefits program, or other different and this allows NASA to conditions and for any treatment for workers’ compensation coverage that provide the best possible care for each spaceflight-associated conditions. may apply. For former U.S. Government This includes any out-of-pocket cost- eligible individual. Eligible individuals astronauts and payload specialists who sharing expenses not covered by the who agree to participate in this program believe they have a condition related to primary payers. must agree that NASA is entitled to their spaceflight, they must first seek —‘‘Spaceflight-Associated Condition’’ to copies of any medical records associated treatment from the Department of mean the same as the TREAT with the monitoring, diagnosis, and Defense Military Health System, the Astronauts Act ‘‘condition associated treatment. They must further agree to Department of Labor Office of Workers’ with spaceflight.’’ This change in submit all paperwork necessary for Compensation Programs Division of terminology enhances readability of NASA to obtain copies of these records. Federal Employees’ Compensation, or the rule. And finally, they must agree that NASA —‘‘TREAT Astronauts Act Board through their private health insurance, may use and disclose this data within where applicable. If the eligible (TAAB)’’ as the internal NASA board the limits of the law. that makes recommendations to the individual is enrolled, or eligible to be NASA Administrator or designee. The NASA will provide monitoring and enrolled in the U.S. Department of internal NASA charter for this board diagnosis of eligible individuals for Veterans Affairs (VA) health care system will detail the functions, membership, conditions potentially associated with and chooses to obtain care and services and operations. The decision-making spaceflight and treatment for through VA, the individual will receive process is detailed in 14 CFR 1241.6. spaceflight-associated conditions. health care benefits in accordance with NASA provides a lifetime occupation chapter 17 of title 38, United States Section 1241.20 Eligibility surveillance program, which includes a Code, as implemented by the Secretary This section addresses eligibility of standard set of monitoring offered of Veterans Affairs. Moreover, as to the the former U.S. Government astronauts yearly to former U.S. Government costs of VA care and services, there will and payload specialists. There are astronauts and payload specialists. In be no ‘‘coordination of benefits,’’ as this currently approximately 250 former U.S. addition to this yearly offering, term is generally understood in the Government astronauts and payload additional monitoring is provided, as health care industry, between VA and specialists who may participate in this necessary, based on each eligible NASA. That is, VA would pay the full program. Eligible individuals must also individual’s medical needs. A provision cost of the care. Under the TREAT meet other requirements defined herein has been added specifically for NASA to Astronauts program, the eligible to receive monitoring, diagnosis, and also request autopsies, as part of individual may seek reimbursement treatment under this program. monitoring, be performed as they may from NASA for any out-of-pocket copayment(s) he or she paid to VA for Participation is strictly voluntary, that contribute substantially to the care of a condition that NASA is, NASA cannot require former U.S. knowledge of spaceflight or determines is associated with Government astronaut and payload pathology. specialists to participate. spaceflight; and finally, VA has no As mentioned previously, NASA is special treatment authority (or Section 1241.25 Basic Program not authorized to provide monitoring copayment exemption) for former U.S. This section describes the basic and diagnosis for conditions not Government astronauts and payload components of the program offered to potentially associated with spaceflight specialists seeking treatment for former U.S. Government astronauts and or treatment for conditions not conditions associated with spaceflight. payload specialists. In addition to spaceflight-associated. Should a As to compensation for disability providing monitoring, diagnosis, and condition be diagnosed that is not related to service in the Armed Forces, treatment, NASA, as part of the no cost related to spaceflight, the individual an eligible individual who has Veteran sharing obligation, will also cover travel will be referred to their primary care status is free to file a claim for disability expenses incurred. NASA currently physician. compensation with the Veterans

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Benefits Administration, pursuant to 38 allowable by law. As a condition of program. While an internet posting and CFR part 3. The JSC Flight Medicine participating in the program, eligible a single meeting has been found Clinic will assist the former U.S. individuals will have consented to insufficient to replace publication in the Government astronauts and payload allowing NASA to collect this Federal Register, see Utility Solid Waste specialists with these processes as well information. Activities Grp. v. EPA, 236 F.3d 749, as filing a claim with NASA. 754 (D.C. Cir. 2001), NASA’s efforts to This section also details the specific Section 1241.50 Records, provide actual notice was much more information required to submit a claim Confidentially, Privacy and Data Use expansive and successful. See Common to NASA and identifies a website where This section states that NASA will Carrier Conference-Irregular Route v. additional information is available. The adhere to all required privacy United States, 534 F.2d 981, 982 (D.C. NASA Flight Medical Clinic will assist regulations and policies and will enter Cir. 1976) (finding notice adequate eligible individuals with claims into data sharing agreements with other because the affected parties were submission, but is not authorized to agencies as necessary to obtain required ‘‘generally on notice’’ through conduct prepare the claim on behalf of the data. of agency). Based on the forgoing, the eligible individual. agency has concluded that the III. Effect of Rulemaking Section 1241.35 Claims Review and individuals affected by this regulation Title 14 of the Code of Federal Decision have received actual notice and that Regulations, as revised by this interim publication in the Federal Register is This section explains the review and final rulemaking, represents NASA’s not necessary. Nevertheless, for the decision-making process for claims implementation of its legal authority on avoidance of potential controversy and submitted to NASA by eligible this subject. Other than future because of potential public interest, individuals. The TREAT Astronauts Act amendments to this regulation or NASA has decided to publish these Board (TAAB) is an internal NASA governing statutes, no contrary guidance regulations as an interim final rule in board of physicians who will review or procedures are authorized. All the Federal Register. claims submitted to NASA. The TAAB existing or subsequent NASA guidance In accordance with 5 U.S.C. 553, the will consider all information, including must be read to conform with this Administrator of NASA has also information about other exposures, rulemaking, if possible, or if not concluded that there is good cause to provided for a case and consult with possible, such guidance is superseded publish this rule without prior other experts and specialists as by this rulemaking. for public comment. Good appropriate. The TAAB will provide a cause may be shown when the Agency recommendation to the Administrator or IV. Regulatory Analysis Section finds that ‘‘notice and public procedure designee who will make the final Administrative Procedure Act (APA) thereon are impracticable, unnecessary, decision on approval or denial of the or contrary to the public interest.’’ See claim. The eligible individual will be The Administrative Procedure Act 5 U.S.C. 553(b)(B). Furthermore, in notified of the decision promptly and, requires notice of any proposed rule to accordance with 5 U.S.C. 553, the should the claim be denied, be afforded be published in the Federal Register Administrator of NASA has concluded the opportunity to submit additional ‘‘unless persons subject thereto are there is good cause to publish this rule information for reconsideration of the named and either personally served or with an immediate effective date. An claim. There is no limit to the number otherwise have actual notice thereof in agency may dispense with the required of times an eligible individual can accordance with the law,’’ 5 U.S.C. 30 day effective date if ‘‘as otherwise submit new information through a 553(b). NASA has determined that provided by the agency for good cause reconsideration request. through its extensive outreach efforts found and published with the rule.’’ See that actual notice has been provided to 5 U.S.C. 553(d)(3). Section 1241.40 Payment of Approved all interested parties—250 former As explained above, on March 21, Claims astronauts and payload specialists, 2017, the President signed into law the This section details the payment including several current Federal NASA Transition Act of 2017. The process for approved claims. NASA employees, and that this rule has no TREAT Astronauts Act, which is part of payments are applied secondarily to effect on the public beyond the 250 the NASA Transition Act of 2017, gives other U.S. Government entities or former astronauts. In drafting these NASA the authority to provide former primary payers and may include the regulations, NASA officials met with U.S. Government astronauts and remaining out-of-pocket costs from former U.S. Government astronauts and payload specialists medical monitoring primary payer coverage. Travel payload specialists, communicating and and diagnosis for conditions that are expenses are paid consistent with the soliciting input from as many potentially spaceflight associated and Federal Travel Regulations and may individuals as possible, through a treatment for conditions that are include expenses for an assistant should variety of venues, including spaceflight associated. the eligible individual need travel communications from the former NASA As directed by Congress in section assistance. Conditional payments are Administrator, professional meetings, 443 of Public Law 115–10, NASA first also allowed to ensure the eligible the Potomac Institute for Policy Studies, entered into an arrangement with an individual gets the care needed the annual astronaut reunion, independent external organization to promptly. NASA may attempt to recover newsletters, online via the Life Sciences undertake an independent estimate of these costs from the primary payer or Data Archive and NASA TREAT the cost to the Administration and the the eligible individual if the claim is Astronauts Act websites, as well as Federal Government to implement and subsequently denied. personal communications with former administer activities under the TREAT astronauts on how best to implement Astronauts Act. This cost estimate was Section 1241.45 Collaboration With the program. These mechanisms have submitted to both the House Science, Other Agencies allowed us to notify the small group of Space and Technology Committee and This section simply states that NASA interested individuals and enabled them the Senate Commerce, Science and will collaborate with other agencies as opportunities to provide NASA with Transportation Committee on , necessary to acquire medical records as input regarding the development of this 2018. NASA also, as directed by

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Congress, carried out a study on any data to NASA. Given the fact that there waiting period is intended to give potential privacy or legal issues related are so few astronauts and such limited affected parties time to adjust their to the possible sharing beyond the data, increased participation to get more behavior before the final rule takes Federal Government of data acquired data is critical. NASA is learning daily effect. Given the limited number of under the TREAT Astronauts Act. This of the untoward effects of human parties affected by the new rule, the was submitted to both the House spaceflight on the human body. In order facts that participation is voluntary and Science, Space and Technology to prepare for the Moon in 2024, NASA those impacted would like to be treated Committee and the Senate Commerce, needs to understand these effects so that immediately, the urgency of the matter, Science and Transportation Committee we can take appropriate mitigation and the discussion above, good cause on January 2, 2018. With the completion measures now. has been shown. of these reports, NASA then began As discussed more fully above, it is For these reasons, the Agency will drafting these regulations. critical for NASA to start treating former publish this rule without prior In drafting these regulations, NASA U.S. Government astronauts and opportunity for public comment and officials met with former U.S. payload specialists for medical with an immediate effective date. Thus, Government astronauts and payload conditions that we are now beginning to the Administrator issues this rule as an specialists, as discussed more fully understand many years later may be the interim final rule with request for above. NASA also met with officials results of their prior space flight comments. from the Department of Labor, exposure. We have also learned more Executive Order 12866—Regulatory Department of Veterans’ Affairs, and the recently of the urgency of early Planning and Review and Executive Defense Health Agency, critical partner diagnosis and treatment and that former Order 13563—Improving Regulation agencies, who have an important stake astronauts may present symptoms and Regulatory Review in the outcome, on how best to differently than the general population. collaborate and how to implement any Due to the small population of Executive Orders (E.O.) 12866 and required data sharing agreements. astronauts, it is imperative that we 13563 direct agencies to assess all costs Good Cause. To establish a good increase our collection of data and benefits of available regulatory cause exception to the APA requirement immediately so that we can utilize it to alternatives and, if regulation is to publish a proposed rule, an Agency mitigate the risks of spaceflight to future necessary, to select regulatory must show that notice would be either and current astronauts and take care of approaches that maximize net benefits impracticable, unnecessary, or contrary those former astronauts with conditions (including potential economic, to the public interest. See 5 U.S.C. associated with spaceflight. Since environmental, public health and safety 553(b)(B). An agency is further required Astronaut ’s 2015–2016 effects, distributive impacts, and to establish good cause for publishing a record year in space, nineteen equity). E.O. 13563 emphasizes the substantive rule less than 30 days before astronauts have participated in longer importance of quantifying both costs its effective date. See 5 U.S.C. 553(d)(3). space duration flights of up to one year, and benefits, reducing costs, NASA believes that publication of a and NASA’s goal is to return to the harmonizing rules, and promoting proposed rule is unnecessary and that Moon by 2024. By increasing the flexibility. This rule is a significant there is good cause for the effective date population of former astronauts who are regulatory action and has been reviewed of this rule to be less than 30 days after being monitored, NASA will be able to by the Office of Management and the date of publication. better understand the effects of space Budget in accordance with E.O. 12866. Human poses significant challenges and is full of risk. flight and institute ameliorative Executive Order 13771—Reducing With more recent long-duration space measures. Regulations and Controlling Regulatory The unnecessary prong of the good flight missions, NASA has seen the Costs cause inquiry is ‘‘confined to those increased health risks that current U.S. situations in which the administrative This rule is not expected to be an E.O. Government astronauts face, such as rule is a routine determination, 13771 regulatory action because this vision impairment, bone rule is expected to be related to agency demineralization, and exposure to insignificant in nature and impact, and inconsequential to the industry and the organization, management, or radiation. NASA has also seen the personnel. increased health risks that former U.S. public. See Mack Trucks, Inc., v. EPA, Government astronauts and payload 682 F.3d 87, 94 (D.C. Cir. 2012). This Regulatory Flexibility Act new rule applies only to a very limited specialists face, many years after their It has been certified that this rule is NASA service. Consequently, it is and easily discernable group of beneficiaries—approximately 250 not subject to the Regulatory Flexibility critical that NASA move forward with Act (5 U.S.C. 601) because it would not this rule without delay to ensure claims former U.S. Government astronauts and payload specialists. It does not affect have a significant economic impact on that are associated with human a substantial number of small entities. spaceflight are fully covered. any other member of the public in any One of the vital tools NASA needs to significant way and, therefore, advanced Paperwork Reduction Act notice is unnecessary.1 prepare for future long-duration and This rule contains information The Agency has also established good exploration missions is data on the collection requirement subject to the cause for dispensing with the 30-day health effects human face in spaceflight. Paperwork Reduction Act of 1995 (44 delay in the effective date in accordance NASA needs these data to better U.S.C. 3501 et seq.). These requirements with 5 U.S.C. 553(d)(3). Unlike the understand the physical, behavioral, are found under Office of Management notice and comment requirements, microbiological, and reaction on the and Budget control number 2700–0171, which are designed to ensure public molecular level of the human body to an NASA TREAT Astronauts Act. extended period of time in space. participation in rulemaking, the 30-day Former U.S. Government astronauts and Unfunded Mandates Reform Act of 1995 1 As discussed above, the Agency believes that payload specialists who voluntarily actual notice has been provided to former This rule will not result in the participate in this program will be astronauts rendering the publication requirement of expenditure by state, local, and tribal consenting to providing their medical the APA unnecessary. governments, in the aggregate, or by the

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private sector, of $100,000,000 or more (c) Medical monitoring, diagnosis, Monitoring means the NASA in any one year, and it will not and treatment authorized and described astronaut spaceflight exposure clinical significantly or uniquely affect small in paragraph (a) of this section may be assessment of medical and governments. provided by a local health care provider psychological health status by licensed if the NASA Administrator or designee health professionals. List of Subjects in 14 CFR Part 1241 determines it is unadvisable for the means an Health, Medical, Astronaut. eligible individual to travel to the NASA individual other than a NASA astronaut ■ For reasons set forth in the preamble, (JSC) due to the (commander, pilot, and mission NASA adds part 1241 to 14 CFR chapter individual’s condition or if it is specialist) whose presence was required V to read as follows: otherwise advantageous to the onboard the vehicle to Government. perform specialized functions with PART 1241—TO RESEARCH, (d) Medical monitoring, diagnosis, respect to operation of one or more EVALUATE, ASSESS, AND TREAT and treatment authorized and described payloads or other essential mission (TREAT) ASTRONAUTS in paragraph (a) of this section will be activities. provided without a cost sharing Primary Payer means the entity, U.S. Sec. obligation imposed on the eligible Government agency or private health 1241.05 Purpose and scope individual. insurer, which is responsible to make 1241.10 Covered medical care (e) NASA is a secondary payer. payment to the eligible individual first, 1241.15 Definitions up to the limits of its coverage or 1241.20 Eligibility § 1241.15 Definitions. 1241.25 Basic program authority. 1241.30 Program participation and claims Conditional Payment means a NASA Program means the medical submission payment to a medical provider or monitoring, diagnosis, and treatment 1241.35 Claims review and decisions eligible individual to pay for the cost of authorized by the TREAT Astronauts 1241.40 Payment of approved claims medical monitoring, diagnosis, and Act. 1241.45 Collaboration with other agencies treatment. Such conditional payments Secondary Payer means the entity that 1241.50 Records, confidentially, privacy, may be made prior to a formal pays after all primary payers have paid, and data use determination that a psychological or up to the limits of their coverage. Authority: 51 U.S.C. 20149. medical condition is spaceflight- Secondary payments, as described in associated if payment has not been the TREAT Astronauts Act, are § 1241.05 Purpose and scope. made or cannot reasonably be expected payments or reimbursement for the (a) This part establishes a program to be made promptly by the primary medical monitoring, diagnosis, or and sets out the eligibility requirements payer. treatment secondary to any obligation of and procedures to effectuate section 443 Cost Sharing means a multiparty the U.S. Government or any third party of the ‘‘To Research, Evaluate, Assess, arrangement under which costs of a under any other provision of law or and Treat Astronauts Act of 2017.’’ program are shared by the involved contractual agreement to pay for or (b) The purpose of this program is to parties, according to an agreed upon provide such medical monitoring, provide medical monitoring and formula. For this program, there is no diagnosis, or treatment. diagnosis of former U.S. Government cost sharing obligation by the eligible Spaceflight-Associated Condition astronauts and payload specialists for individual. The eligible individual is means a medical or psychological conditions the Administrator considers responsible for insurance premiums. condition that the NASA Administrator potentially associated with spaceflight Diagnosis means the identification of or designee designated by the NASA and to provide treatment of former U.S. a medical or psychological condition Administrator determines is at least as Government astronauts and payload consistent with the exercise of likely as not to have resulted from specialists for conditions the professional clinical judgment and participation in spaceflight-related Administrator considers associated with accepted standard of care by licensed activities. spaceflight. health professionals. Treatment means the accepted Eligible Individual means a former § 1241.10 Covered medical care. standard of clinical care for a medical or United States Government astronaut, psychological condition by licensed (a) Subject to the limitations in including a member of the Uniformed health professionals. paragraph (b) of this section, an eligible Services, or a former payload specialist TREAT Astronauts Act means section individual, as defined in § 1241.15, is who has flown in space, as defined in 443 of the ‘‘To Research, Evaluate, eligible for: the TREAT Astronauts Act. The Assess, and Treat Astronauts Act of (1) Monitoring and diagnosis for following individuals are specifically 2017.’’ potentially spaceflight-associated excluded from eligible individuals: TREAT Astronauts Act Board or conditions; and (1) Astronauts of other United States TAAB means the internal NASA review (2) Treatment for spaceflight- Government agencies; board that provides recommendations to associated conditions. (2) Employees of commercial the NASA Administrator or designee as (b) Medical monitoring, diagnosis, spaceflight companies who were never to whether or not a medical claim and treatment authorized and described employed by NASA nor a member of the initiated by an eligible individual meets in paragraph (a) of this section will not Uniformed Services assigned to NASA; the standards for spaceflight association be provided for any condition that is (3) International partner astronauts; for medical monitoring, diagnosis, and found by the NASA Administrator or (4) Employees of foreign governments; treatment under the TREAT Astronauts designee to have resulted from a cause (5) Private individuals or tourists who Act. other than the eligible individual’s have flown in space; and U.S. Government Agency means participation in spaceflight-related (6) Former astronauts, including ‘‘agency’’ as defined in 5 U.S.C. 551. activities. Should a condition be members of the Uniformed Services, diagnosed that is not related to and former payload specialists who § 1241.20 Eligibility. spaceflight, the individual will be have not flown in space. (a) This section sets forth those referred to their primary care physician. JSC means Johnson Space Center. persons who, by the provisions of the

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TREAT Astronauts Act, are eligible to (2) Individualized monitoring will be consistent with 5 U.S.C. Chapter 81 and participate in this program. A provided, as necessary. 20 CFR part 10 before making a claim determination by the Administrator or (3) NASA may pay for and obtain under the TREAT Astronauts Act. designee that a person is eligible does autopsies of eligible individuals, who (2) Members of the Uniformed not automatically entitle such a person previously consented in writing or with Services. Eligible individuals who were to medical monitoring, diagnosis, and consent of the next of kin, when such members of the Uniformed Services treatment under the TREAT Astronauts autopsy would contribute substantially during their active astronaut or payload Act. to the knowledge of spaceflight specialist career, or who are otherwise (b) Only eligible individuals defined physiology or pathology. NASA will determined to be eligible by their in § 1241.15 are entitled to medical coordinate with the Armed Forces Uniformed Service and who believe monitoring, diagnosis, and treatment Medical Examiner System for such they have sustained a spaceflight- under this part. autopsies. associated condition must contact their (c) Participation in this program is (c) Treatment. NASA will provide or Service to determine eligibility for strictly voluntary. NASA may not arrange for the treatment of spaceflight- health and dental care and/or coverage require an eligible individual to associated conditions. through the Military Health System of participate in this program. (1) Treatment will be secondary to the Department of Defense, consistent any services provided by primary with 10 U.S.C. Chapter 55 and 32 CFR § 1241.25 Basic program. payers. part 199 before making a claim under (a) General—(1) Scope. Subject to all (2) Should urgency dictate, NASA the TREAT Astronauts Act. applicable definitions, conditions, may provide for conditional payments (3) Former Civil Servants who were limitations, or exclusions specified in for treatment. also Members of the Uniformed this part, NASA will provide medical (d) Exclusions and limitations. In Services. Eligible individuals whose monitoring and diagnosis of potentially addition to any definitions, active astronaut career spanned both spaceflight-associated conditions and requirements, conditions, or limitations military and civil service will first treatment of a spaceflight-associated enumerated and described in other submit a notice to the Department of conditions, as well as any associated sections of this part, the following are Labor who will work with the travel expenses for the eligible specifically excluded: Department of Defense. individual’s lifetime. (1) Medical monitoring or diagnosis of (4) Eligible individuals with claims denied or partially covered. If the (2) Location of medical monitoring, an eligible individual for any medical or eligible individual’s claim under diagnosis, and treatment. (i) Medical psychological condition that is not paragraphs (c)(1), (2), or (3) of this monitoring will be provided for eligible potentially associated with human section is either denied or covered only individuals at the JSC. spaceflight; and in part by the primary payer, the eligible (ii) When travel is inadvisable due to (2) Treatment of an eligible individual for any medical or psychological individual can apply for medical the health of the eligible individual or monitoring, diagnosis, and treatment when otherwise advantageous to the condition that is not associated with human spaceflight. under this program. Government, monitoring may be (d) Diagnosis and Treatment or Other provided at a location other than the § 1241.30 Program participation and Benefits-Veterans. An eligible JSC. claims submission. individual who is enrolled, or eligible to (iii) Diagnosis and treatment will be (a) General program participation. An be enrolled, in the U.S. Department of provided for eligible individuals at eligible individual, or their authorized Veterans Affairs (VA) health care system locations determined by the medical representative, who seek to participate may opt instead to seek his or her care appropriateness of the facility, patient in this program must provide the and services through the VA. Under the preferences, cost effectiveness, and information set forth in paragraph (e)(2) TREAT Astronauts program, the eligible other pertinent factors. of this section to NASA. The JSC Flight individual may seek reimbursement (3) Right to information. As a Medicine Clinic will assist eligible from NASA for any out-of-pocket condition precedent to participation in individuals through these processes. copayment(s) he or she paid to VA for this program, NASA is entitled to (b) NASA’s occupationally related care of a condition that NASA receive copies of medical records from medical monitoring services. (1) Eligible determines is associated with any physician, hospital or other person, individuals will receive an annual spaceflight. The individual may also health insurance company, institution, invitation from NASA to participate in apply for disability compensation with or entity (including a local, state, or U.S. NASA’s occupational surveillance the Department of Veterans Affairs, Government agency) providing medical program; Veterans Benefits Administration, monitoring, diagnosis, and treatment to (2) [Reserved] pursuant to 38 CFR part 3. the eligible individual for which claims (c) Primary payer coverage of (e) Submitting claims for medical or requests for approval for medical diagnosis and treatment services. (1) monitoring, diagnosis, and treatment monitoring, diagnosis, and treatment are Former Civil Servants. Eligible under this program—(1) Claim required. submitted to NASA. As part of this individuals who were civil servant (i) No medical diagnosis and treatment condition precedent, NASA may require employees during their active astronaut may be extended under the TREAT eligible individuals to complete such or payload specialist career who believe Astronauts Act without submission of a medical releases needed to facilitate they have sustained a spaceflight- complete claim form to the JSC Flight obtaining such information as legally associated condition and are seeking Medicine Clinic. required by state and Federal law. coverage for medical treatment under (ii) NASA will provide specific forms (b) Monitoring and Diagnosis. NASA this part must submit a notice of injury appropriate for making a claim for will provide monitoring and diagnosis and claim for compensation through medical monitoring, diagnosis, and for eligible individuals for conditions their agency to the Department of Labor, treatment. Claim forms may be obtained potentially associated with spaceflight. Office of the Workers’ Compensation from the JSC Flight Medicine Clinic. (1) Standardized monitoring will be Programs Division of Federal Contact information can be found at: offered routinely at the JSC. Employees’ Compensation (DFEC) https://www.nasa.gov/hhp/treat-act.

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(2) Information required. Each claim those experienced during their career as (2) If the claim is denied in for medical monitoring, diagnosis, and active U.S. Government astronauts or accordance with § 1241.35, NASA may treatment under this program will be in payload specialists, the TAAB will seek to recover such conditional writing and include, at a minimum: consider that history when making its payments from the eligible individual in (i) Statement of eligibility describing recommendation. accordance with 31 U.S.C. Chapter 37. the employment and spaceflight history (e) The NASA Administrator or that justifies medical monitoring, designee will review each claim and § 1241.45 Collaboration with other agencies. diagnosis, and treatment under this associated TAAB recommendation to program; determine whether the claim should be Copies of records generated from (ii) History and diagnosis of medical approved or denied. A typical case can medical monitoring, diagnosis, and or psychological condition; be reviewed within 30 calendar days, treatment collected by primary payer (iii) Medical documentation in but cases that are more complex may facilities and/or relevant health care support of the claim. Healthcare take additional time. providers will be acquired by NASA. providers must be licensed and (f) The decision will be provided to NASA will collaborate with the permitted to practice under state law the eligible individual within seven Department of Defense Military Health and not be on the Centers for Medicare calendar days of the final decision by System, Department of Veterans Affairs, & Medicaid Services (CMS) List of the NASA Administrator or designee. and Department of Labor Office of Excluded Individuals and Entities, Decisions not in favor of the eligible Workers’ Compensation and other found at: https://healthdata.gov/ individual will include information on entities for acquisition of copies of these dataset/list-excluded-individuals-and- how to request reconsideration. medical records as allowed by law. entities; (g) An eligible individual or their § 1241.50 Records, confidentiality, privacy, (iv) Documentation of the decisions authorized representative may request and data use. reconsideration of the decision at any and/or payments made by the primary (a) Records on individuals created or time if new information is obtained that payer (i.e., other U.S. Government obtained pursuant to this regulation that enhances the claim. Reconsideration agencies and/or private health insurer) are subject to the Privacy Act of 1974, requests can be made to the JSC Flight regarding the claim; as amended, 5 U.S.C. 552a, will be (v) Justification for determination that Medicine Clinic. maintained in accordance with the the psychological or medical condition (h) Requests for reconsideration are NASA’s Privacy Act System of Records. is associated with spaceflight; reviewed by the TAAB and decisions (b) NASA will, as necessary, enter (vi) Expenses for which they are made by the Administrator or designee, into data sharing agreements with other seeking reimbursement, to include following the same process described in agencies and/or entities to receive such documentation of all out-of-pocket paragraphs (b) through (f) of this data and/or seek signed medical releases costs; and section. from the eligible individuals, or their (vii) The signature of the eligible authorized representatives, in individual or their authorized § 1241.40 Payment of approved claims. (a) The NASA Administrator or accordance with law. representative. (c) NASA’s collection, use, and (3) Responsibility for perfecting claim. designee is responsible for ensuring that disclosure of this data will be in It is the responsibility of the eligible medical monitoring, diagnosis, and accordance with the Privacy Act of individual, authorized representative, or treatment to eligible individuals under 1974, NASA’s implementing regulations the authorized provider acting on behalf this program is paid only to the extent at 14 CFR part 1212, and NASA’s of the eligible individual to perfect a described in this part. privacy policies, where applicable. claim for submission. NASA will assist (b) Payment for medical monitoring, eligible individuals with claims diagnosis, and treatment is applied Nanette Smith, submission, but is not authorized to secondarily to primary payers and may Team Lead, NASA Directives and prepare a claim on behalf of the eligible include the remaining out-of-pocket Regulations. individual. costs from primary payer coverage. [FR Doc. 2020–04784 Filed 3–17–20; 8:45 am] (c) NASA will pay necessary travel BILLING CODE 7510–13–P § 1241.35 Claims review and decisions. expenses related to this program (a) NASA will establish the TREAT consistent with the Federal Travel Astronauts Act Board (TAAB) to review Regulations. COMMODITY FUTURES TRADING claims for medical monitoring, (d) NASA may provide conditional COMMISSION diagnosis, and treatment under this payments for medical monitoring, program. This review is independent of diagnosis, and treatment that is 17 CFR Part 30 any review conducted by primary obligated to be paid by the U.S. payers. Government or other primary payers RIN 3038–AE86 (b) The TAAB will review each claim prior to a final decision by NASA in submitted by the eligible individual, in accordance with § 1241.35. Such Foreign Futures and Options consultation with specialists, as requests for conditional payments can Transactions appropriate. A typical case will be be made to JSC Flight Medicine Clinic. AGENCY: Commodity Futures Trading reviewed within 30 calendar days, but Such payments are permitted when Commission. cases that are more complex may take payment for such medical monitoring, ACTION: Final rule. additional time. diagnosis, and treatment has either not (c) The TAAB will make a been made or will not be made SUMMARY: The Commodity Futures recommendation to the Administrator or promptly. Trading Commission (Commission) is designee for each claim stating whether (1) NASA may seek to recover costs issuing a final rule that amends its the condition is determined to be associated with conditional payments regulations governing the offer and sale spaceflight associated. from the U.S. Government, private of foreign futures and options to (d) For those eligible individuals who health insurance company, or other customers located in the U.S. The have had other exposures in addition to primary payer as allowable by law. amended regulation codifies the process

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