To Research, Evaluate, Assess, and Treat (TREAT) Astronauts
| Published date | 18 November 2020 |
| Citation | 85 FR 73410 |
| Record Number | 2020-24639 |
| Section | Rules and Regulations |
| Court | National Aeronautics And Space Administration |
Federal Register, Volume 85 Issue 223 (Wednesday, November 18, 2020)
[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Rules and Regulations]
[Pages 73410-73411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24639]
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NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
14 CFR Part 1241
[Document Number NASA-20-091; Docket Number-NASA-2020-0001]
RIN 2700-AE51
To Research, Evaluate, Assess, and Treat (TREAT) Astronauts
AGENCY: National Aeronautics and Space Administration (NASA).
ACTION: Final rule.
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SUMMARY: The National Aeronautics and Space Administration (NASA) is
adopting, without change, an interim rule that implements the
provisions of the TREAT Astronauts Act to provide for the medical
monitoring and diagnosis of conditions that are potentially
spaceflight-associated and treatment of conditions that are
spaceflight-associated for former U.S. Government astronauts and
payload specialists.
DATES: Effective: November 18, 2020.
FOR FURTHER INFORMATION CONTACT: Gwyn E. Smith, Manager, Policy
Development and Integration, Office of the Chief Health and Medical
Officer, 202.358.0584.
SUPPLEMENTARY INFORMATION:
I. Background
NASA published an interim rule in the Federal Register at 85 FR
15352 on March 18, 2020, that implements the provisions of the TREAT
Astronauts Act. The rule provides for the medical monitoring and
diagnosis of conditions that are potentially spaceflight-associated and
treatment of conditions that are spaceflight-associated for former U.S.
Government astronauts and payload specialists. NASA is adopting this
interim rule as a final rule without change.
II. Public Comment Discussion
NASA issued interim final rule, ``To Research, Evaluate, Assess,
and Treat (TREAT) Astronauts,'' which was published in the Federal
Register on March 18, 2020 (85 FR 15352). The public comment period on
the interim final rule closed on May 18, 2020, and NASA received six
comments from two former astronauts, three individuals interested in
former astronaut health care, and an individual from Taiwan who asked a
question about Formosan astronauts, not related to this rule. No
significant issues or questions were raised by the commenters and no
changes were made to the rule. Relevant questions and comments
presented are addressed in routine communications with the former
astronauts. NASA would like to thank all commenters for their
thoughtful responses.
One commenter recommended rewording the definition of ``spaceflight
associated condition'' to make it more understandable, specifically
asking what the phrase ``determines is at least as likely as not to
have resulted from participation in spaceflight-related activities''
meant. NASA, when making determinations on the association between
health outcomes and occupational exposures related to spaceflight,
relies on available evidence, including an individual's clinical
history, epidemiological assessments, and data from human research, as
well as expert medical opinion. Because direct causation is very
difficult to establish in many cases, a determination of presumptive
association between spaceflight and a health outcome requires that the
evidence and expert medical opinion together suggest that the
spaceflight exposures received by an individual are as likely to cause
the health outcome, as to not cause the health outcome. The focus of
NASA's inquiry is whether spaceflight exposures contributed to the
health condition, not all other possible exposures. Using ``at least as
likely as not'' as the criterion for decision making lowers the
threshold for determining an association between spaceflight exposures
and health outcomes, accounting for possible uncertainties involved in
making such a determination. NASA chose this approach based on the
processes used by other Federal agencies who must make similar
determinations when direct causation cannot otherwise be established.
Another commenter had several questions about specifically how NASA
would implement this rule, asking how a former astronaut would know
what conditions would be considered related to spaceflight and if the
NASA Flight Medicine Clinic would be an advocate on their behalf. NASA
is developing internal policy and procedures for NASA employees
necessary to implement this rule. In addition, NASA will continue to
communicate with former astronauts through multiple media, including
the annual astronaut reunion, newsletters, online via the Life Sciences
Data Archive, and NASA TREAT Astronauts Act websites, as well as
personal communications with former astronauts.
Several commenters offered supporting thoughts such as, ``. . . the
TREAT Astronauts Act as nothing but a resourceful and helpful program .
. .'' and ``To gain more support to pass this rule, I recommend
ensuring more scientists and doctors will be hired at NASA to observe
former astronauts and payload specialists, so that this effort does not
take away from other important NASA programs'' and asked how this Act
would increase former astronaut participation and to elaborate on the
differences between the Lifetime Surveillance of Astronaut Health
(LSAH) program and TREAT Astronauts Act. NASA appreciates the support
for this rule and provides detailed information to former astronauts on
the specifics of the implementation of this rule. NASA anticipates
increased participation from former astronauts, based on discussions
with them as to the benefits of the program and to future astronauts.
The LSAH program provides lifetime monitoring for former astronauts
while the TREAT Astronauts Act provides funding for treatment of
spaceflight associated conditions. More details can be found at https://www.nasa.gov/hhp/treat-act.
III. Regulatory Analysis Section
Executive Order 12866--Regulatory Planning and Review and Executive
Order 13563--Improving Regulation and Regulatory Review
Executive Orders (E.O.) 12866 and 13563 direct agencies to assess
all costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, distributive impacts, and equity). E.O.
13563 emphasizes the importance of quantifying both costs and benefits,
reducing costs, harmonizing rules, and promoting flexibility. This rule
is not a significant regulatory action and has not been reviewed by the
Office of Management
[[Page 73411]]
and Budget in accordance with E.O. 12866.
Executive Order 13771--Reducing Regulations and Controlling Regulatory
Costs
This rule is not an E.O. 13771 regulatory action because final rule
is not significant under E.O. 12866.
Regulatory Flexibility Act
It has been certified that this rule is not subject to the
Regulatory Flexibility Act (5 U.S.C. 601) because it would not have a
significant economic impact on a substantial number of small entities.
Paperwork Reduction Act
This rule contains information collection requirement subject to
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These
requirements are found under Office of Management and Budget control
number 2700-0171, NASA TREAT Astronauts Act.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local, and
tribal governments, in the aggregate or by the private sector, of
$100,000,000 or more in any one year, and it will not significantly or
uniquely affect small governments.
List of Subjects in 14 CFR Part 1241
Astronaut, Health, Medical.
Interim Rule Adopted as Final Without Change
PART 1241--TO RESEARCH, EVALUATE, ASSESS, AND TREAT (TREAT)
ASTRONAUTS
Accordingly, the interim rule adding 14 CFR part 1241 which was
published at 85 FR 15352 on March 18, 2020, is adopted as final without
change.
Nanette Smith,
Team Lead, NASA Directives and Regulations.
[FR Doc. 2020-24639 Filed 11-17-20; 8:45 am]
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