To Research, Evaluate, Assess, and Treat (TREAT) Astronauts, 73410-73411 [2020-24639]
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Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Rules and Regulations
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Issued on November 6, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2020–25379 Filed 11–17–20; 8:45 am]
BILLING CODE 4910–13–P
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
National Aeronautics and
Space Administration (NASA).
ACTION: Final rule.
AGENCY:
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:
khammond on DSKJM1Z7X2PROD with RULES
SUMMARY:
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 spaceflightassociated 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.
VerDate Sep<11>2014
16:14 Nov 17, 2020
Jkt 253001
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
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
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
E:\FR\FM\18NOR1.SGM
18NOR1
Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Rules and Regulations
and Budget in accordance with E.O.
12866.
ACTION:
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]
BILLING CODE 7510–13–P
DEPARTMENT OF COMMERCE
Bureau of Industry and Security
khammond on DSKJM1Z7X2PROD with RULES
15 CFR Parts 734, 748, 750, 758, 762,
764, and 766
[Docket No. 201110–0299]
RIN 0694–AH81
Revisions to Export Enforcement
Provisions
Bureau of Industry and
Security, Commerce.
AGENCY:
VerDate Sep<11>2014
16:14 Nov 17, 2020
Jkt 253001
Final rule.
In this final rule, the Bureau
of Industry and Security (BIS) is
amending and clarifying certain
provisions of the Export Administration
Regulations (EAR) to promote
compliance with existing EAR
requirements and implement the export
enforcement portions of the Export
Control Reform Act of 2018 (ECRA).
ECRA affirmed existing authorities
under the EAR and provided expanded
export control authorities to the
Secretary of Commerce (Secretary). BIS
is also amending certain provisions of
the EAR not strictly related to the
implementation of ECRA concerning the
issuance of licenses and denial orders
and the payment of civil penalties.
DATES: This rule is effective November
18, 2020.
FOR FURTHER INFORMATION CONTACT: John
Sonderman, Director, Office of Export
Enforcement, Bureau of Industry and
Security, Phone: (202) 482–5079, Email:
EEinquiry@bis.doc.gov.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
On August 13, 2018, the President
signed into law the John S. McCain
National Defense Authorization Act for
Fiscal Year 2019, which included the
Export Control Reform Act of 2018
(ECRA) (50 U.S.C. 4801–4852). In its
enactment, ECRA repealed most of the
Export Administration Act of 1979
(EAA), which had lapsed. ECRA
continues existing authorities under the
EAR that had been issued pursuant to,
and been maintained in force under, the
EAA until its lapse, and thereafter under
the International Emergency Economic
Powers Act (IEEPA). ECRA provides the
Secretary of Commerce (Secretary) with
additional authorities to ensure the
implementation of effective export
controls in furtherance of U.S. national
security and foreign policy interests.
Accordingly, BIS is amending the
EAR to reflect enforcement authorities
and to update certain EAR provisions to
make them consistent with ECRA. These
amendments include replacing existing
references to the EAA currently in the
EAR with references to ECRA and other
export laws and regulations. There are
also amendments to the EAR that reflect
the expanded scope of authority
provided to the Secretary in ECRA.
Specifically, this rule amends the EAR
to implement the following enforcement
provisions: Pre-license checks (PLCs)
and post-shipment verifications (PSVs)
(in §§ 734.11 and 750.4 of the EAR);
overseas investigative authority;
searches, inspections, detentions, and
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
73411
seizures, and related authorities
concerning exports, reexports, and
transfers (in-country) (in § 734.11 of the
EAR and in part 758 of the EAR,
specifically in §§ 758.7, 758.8, and
758.9); inspection of books, records, and
other information (in §§ 758.7 and 762.7
of the EAR); and violations and
penalties under ECRA (in part 764 of the
EAR, and specifically in §§ 748.4, 764.1,
764.2, 764.3, and 766.25).
Revisions to Enforcement Provisions To
Implement ECRA
Pre-License Checks and Post-Shipment
Verifications
In new § 734.11 of the EAR, BIS is
including a reference to BIS’s authority
to conduct PLCs and PSVs outside the
United States. BIS is also amending
§ 750.4(b)(2) of the EAR to clarify that
the results of PLCs, when available, will
be communicated to licensing officials
within existing timeframes governing
the conduct of PLCs, and will be
considered in determining the outcome
of a license application. These changes
are consistent with ECRA section
1761(a)(7) (50 U.S.C. 4820(a)(7)), which
sets forth the Secretary’s authority to
conduct PLCs and PSVs, and provide
increased transparency regarding the
purposes for which information is
collected.
Inspection of Books, Records, and Other
Information
BIS is amending § 762.7(a) of the EAR
regarding the production for inspection
of books, records, and other information
required to be kept pursuant to the EAR
by persons located within the United
States to align with ECRA section
1761(a)(2) (50 U.S.C. 4820(a)(2)). This
includes the removal of references to the
authority of the U.S. Customs Service,
which is not reflected in ECRA. This
change does not affect the authorities of
other agencies or officials under other
statutes and regulations.
BIS is amending § 762.7(b) of the EAR
to specify that persons located outside
the United States must produce for
inspection books and other information
required to be kept pursuant to the EAR
in addition to records as specified in
ECRA section 1761(a)(2) (50 U.S.C.
4820(a)(2)). BIS is also specifying in
§ 762.7(b) of the EAR that only officials
of the United States designated by BIS
may rely on the authority in ECRA to
require persons outside the United
States to produce for inspection the
books, records, and other information
such persons are required to keep
pursuant to the EAR. Consequently, BIS
is removing from § 762.7(b) of the EAR
the existing reference to requests for
E:\FR\FM\18NOR1.SGM
18NOR1
Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 7510-13-P