Paroling, Recommitting, and Supervising Federal Prisoners: Prisoners Serving Sentences Under the United States and District of Columbia Codes, 70013-70014 [2019-27340]
Download as PDF
Federal Register / Vol. 84, No. 245 / Friday, December 20, 2019 / Rules and Regulations
https://www.fda.gov/regulatory-information/
search-fda-guidance-documents/proceduresmeetings-medical-devices-advisorycommittee.
*33. FDA Guidance, ‘‘Public Availability of
Advisory Committee Members’ Financial
Interest Information and Waivers,’’ March
2014, available at https://www.fda.gov/
regulatory-information/search-fda-guidancedocuments/public-availability-advisorycommittee-members-financial-interestinformation-and-waivers.
List of Subjects in 21 CFR Part 882
Medical devices, Neurological
devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 882 is
amended as follows:
PART 882—NEUROLOGICAL DEVICES
1. The authority citation for part 882
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
2. Revise § 882.5800 to read as
follows:
■
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§ 882.5800 Cranial electrotherapy
stimulator.
(a) Identification. A cranial
electrotherapy stimulator is a
prescription device that applies
electrical current that is not intended to
induce a seizure to a patient’s head to
treat psychiatric conditions.
(b) Classification. (1) Class II (special
controls) when intended to treat
insomnia and/or anxiety. The special
controls for this device are:
(i) A detailed summary of the clinical
testing pertinent to use of the device to
demonstrate the effectiveness of the
device to treat insomnia and/or anxiety.
(ii) Components of the device that
come into human contact must be
demonstrated to be biocompatible.
(iii) The device must be designed and
tested for electrical safety and
electromagnetic compatibility (EMC) in
its intended use environment.
(iv) Appropriate software verification,
validation, and hazard analysis must be
performed.
(v) The technical parameters of the
device, including waveform, output
mode, pulse duration, frequency, train
delivery, maximum charge, and energy,
must be fully characterized and verified.
(vi) The labeling for the device must
include the following:
(A) The intended use population and
the intended use environment;
(B) A warning that patients should be
monitored by their physician for signs
of worsening;
(C) A warning that instructs patients
on how to mitigate the risk of
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16:09 Dec 19, 2019
Jkt 250001
headaches, and what to do should a
headache occur;
(D) A warning that instructs patients
on how to mitigate the risk of dizziness,
and what to do should dizziness occur;
(E) A detailed summary of the clinical
testing, which includes the clinical
outcomes associated with the use of the
device, and a summary of adverse
events and complications that occurred
with the device;
(F) Instructions for use that address
where to place the electrodes, what
stimulation parameters to use, and
duration and frequency of treatment
sessions. This information must be
based on the results of clinical studies
for the device;
(G) A detailed summary of the device
technical parameters, including
waveform, output mode, pulse duration,
frequency, train delivery, and maximum
charge and energy; and
(H) Information on validated methods
for reprocessing any reusable
components between uses.
(vii) Cranial electrotherapy stimulator
devices marketed prior to the effective
date of this reclassification must have
an amendment submitted to the
previously cleared premarket
notification (510(k)) demonstrating
compliance with these special controls.
(2) Class III (premarket approval)
when intended to treat depression.
(c) Date premarket approval
application (PMA) or notice of
completion of product development
protocol (PDP) is required. A PMA or
notice of completion of a PDP is
required to be filed with the Food and
Drug Administration on or before March
19, 2020, for any cranial electrotherapy
stimulator device with an intended use
described in paragraph (b)(2) of this
section, that was in commercial
distribution before May 28, 1976, or that
has, on or before March 19, 2020, been
found to be substantially equivalent to
any cranial electrotherapy stimulator
device with an intended use described
in paragraph (b)(2) of this section, that
was in commercial distribution before
May 28, 1976. Any other cranial
electrotherapy stimulator device with an
intended use described in paragraph
(b)(2) of this section shall have an
approved PMA or declared completed
PDP in effect before being placed in
commercial distribution.
Dated: December 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27295 Filed 12–19–19; 8:45 am]
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70013
DEPARTMENT OF JUSTICE
Parole Commission
28 CFR Part 2
[Docket No. USPC–2018–02]
Paroling, Recommitting, and
Supervising Federal Prisoners:
Prisoners Serving Sentences Under
the United States and District of
Columbia Codes
United States Parole
Commission, Justice.
ACTION: Final rule.
AGENCY:
The United States Parole
Commission is amending its rule
allowing hearings by videoconference to
include parole termination hearings.
DATES: This regulation is effective
December 20, 2019.
FOR FURTHER INFORMATION CONTACT:
Helen H. Krapels, General Counsel, U.S.
Parole Commission, 90 K Street NE,
Third Floor, Washington, DC 20530,
telephone (202) 346–7030. Questions
about this publication are welcome, but
inquiries concerning individual cases
cannot be answered over the telephone.
SUPPLEMENTARY INFORMATION: Since
early 2004, the United States Parole
Commission has been conducting some
parole proceedings by videoconference
to cut down on delays in scheduling inperson hearings and conserve
Commission resources. The Commission
originally initiated the use of
videoconference in parole release
hearings as a pilot project in 2004 and
then extended the use of
videoconferencing to institutional
revocation hearings in 2005, followed
by probable cause hearings in 2007.
Using videoconference for termination
hearings is a natural progression in the
use of this technology.
Conducted pursuant to 28 CFR 2.43(c)
and 2.95(c), the primary objective of a
termination hearing is to obtain
information which assists the
Commission in determining whether or
not early termination of parole is
appropriate. The subject is usually
represented by an attorney, and the
community supervision officer or the
U.S. Probation officer provides a
recommendation based on the subject’s
compliance with parole requirements.
Given the limited purpose of the
hearing, other witnesses are usually not
present, and the hearing does not
typically last long. The amendment will
save travel time and expense, allowing
the Commission to conduct termination
hearings in a more expeditious manner.
In the interim rule with request for
comments (83 FR 58500 (Nov. 20,
SUMMARY:
E:\FR\FM\20DER1.SGM
20DER1
70014
Federal Register / Vol. 84, No. 245 / Friday, December 20, 2019 / Rules and Regulations
jbell on DSKJLSW7X2PROD with RULES
2018)), we encouraged the public to
comment on our changes. We received
written comments from the Public
Defender Service for the District of
Columbia (PDS) and one anonymous
comment. We discuss those public
comments below.
Public Comment From the Public
Defender Service
PDS objects to amending § 2.25 to
include parole termination hearings,
and renews its prior objections to the
use of videoconference for probable
cause hearings. PDS’s comments, both
past and present, characterize
videoconference as a barrier to due
process which unjustifiably denies a
subject the opportunity to appear in
person before the Commission. The
Commission does not agree with this
proposition. Termination hearings are
limited in scope. Unlike revocation
hearings, when all facets of the case are
explored, witnesses testify, and the
status of the offender is finally
determined, the purpose of a
termination hearing is to obtain
information regarding the parolee’s
conduct in the community. The liberty
interest implicated in a revocation
hearing is not implicated in a
termination hearing. At a termination
hearing, the subject does not face the
possibility of a loss of freedom as a
result of termination being denied. See
Henderson v. Sims, 223 F.3d 267, 274
(4th Cir. 2000); Little v. Thomas, 719
F.2d 50, 52 (3d Cir. 1982). Further, there
is no constitutional or statutory
entitlement to early termination of
parole supervision. See Myers v. U.S.
Parole Comm’n, 813 F.2d 957, 960 (9th
Cir. 1987). Thus, the fact that the
parolee’s appearance for the termination
hearing will be by videoconference does
not violate due process.
PDS recommends that termination
hearings only be conducted by
videoconference in circumstances
where either distance or physical
hardship renders the subject unable to
appear in person. While the
Commission agrees that
videoconferencing may be appropriate
in the circumstances described by PDS,
the Commission does not agree that the
rule should be so narrow. It is within
the Commission’s discretion to
determine when conducting a
termination hearing by videoconference
is appropriate.
PDS also raises concerns about
technological issues, stating that
experiencing technical difficulties
during a hearing would completely
undermine the value of having a hearing
at all. Over the years, the Commission’s
experience has been that the quality of
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16:09 Dec 19, 2019
Jkt 250001
the transmission has improved and the
personal interactions among the hearing
participants does not appreciably
decline with the use of
videoconferencing.
Anonymous Comment
The Commission also received an
anonymous comment in support the use
of videoconferencing for parole
termination hearings. The comment,
while acknowledging the issue of losing
face-to-face contact, described the
amendment as a logical practice that
will increase the efficiency of the
termination process.
Executive Orders 12866 and 13563
This regulation has been drafted and
reviewed in accordance with Executive
Order 12866, ‘‘Regulation Planning and
Review,’’ section 1(b), Principles of
Regulation, and in accordance with
Executive Order 13565, ‘‘Improving
Regulation and Regulatory Review,’’
section 1(b), General Principles of
Regulation. The Commission has
determined that this rule is not a
‘‘significant regulatory action’’ under
Executive Order 12866, section 3(f),
Regulatory Planning and Review, and
accordingly this rule has not been
reviewed by the Office of Management
and Budget.
Business Regulatory Enforcement
Fairness Act of 1996 Subtitle E—
Congressional Review Act, now codified
at 5 U.S.C. 804(2). The rule will not
result in an annual effect on the
economy of $100,000,000 or more; a
major increase in costs or prices; or
significant adverse effects on the ability
of United States-based companies to
compete with foreign-based companies.
Moreover, this is a rule of agency
practice or procedure that does not
substantially affect the rights or
obligations of non-agency parties, and
does not come within the meaning of
the term ‘‘rule’’ as used in Section
804(3)(C), now codified at 5 U.S.C.
804(3)(C). Therefore, the reporting
requirement of 5 U.S.C. 801 does not
apply.
List of Subjects in 28 CFR Part 2
Administrative practice and
procedure, Prisoners, Probation and
Parole.
The Final Rule
Accordingly, the U. S. Parole
Commission adopts the interim rule
amending 28 CFR part 2, which was
published at 83 FR 58500 on November
20, 2018, as final without change.
■
Patricia K. Cushwa,
Chairman (Acting), U.S. Parole Commission.
Executive Order 13132
[FR Doc. 2019–27340 Filed 12–19–19; 8:45 am]
This rule will not have substantial
direct effects on the States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government. Under Executive
Order 13132, this rule does not have
sufficient federalism implications
requiring a Federalism Assessment.
BILLING CODE 4410–31–P
Regulatory Flexibility Act
RIN 1625–AA08
The rule will not have a significant
economic impact upon a substantial
number of small entities within the
meaning of the Regulatory Flexibility
Act, 5 U.S.C. 605(b).
Unfunded Mandates Reform Act of
1995
The rule will not cause State, local, or
tribal governments, or the private sector,
to spend $100,000,000 or more in any
one year, and it will not significantly or
uniquely affect small governments. No
action under the Unfunded Mandates
Reform Act of 1995 is necessary.
Small Business Regulatory Enforcement
Fairness Act of 1996 (Subtitle E—
Congressional Review Act)
These rule is not a ‘‘major rule’’ as
defined by Section 804 of the Small
PO 00000
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Fmt 4700
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DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket Number USCG–2019–0945]
Special Local Regulation; St. Thomas
Lighted Boat Parade, St. Thomas, U.S.
Virgin Island
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a special local regulation
for the St. Thomas Lighted Boat Parade
marine event. The special local
regulation is for certain navigable waters
of Crown Bay, Haulover Cay, and St.
Thomas Harbor, St. Thomas, U.S. Virgin
Islands. The special local regulation is
necessary to ensure the safety of vessels,
spectators, and public during the event.
Entry of vessels or persons into this
zone is prohibited unless specifically
authorized by the Captain of the Port
San Juan or a designated representative.
SUMMARY:
E:\FR\FM\20DER1.SGM
20DER1
Agencies
[Federal Register Volume 84, Number 245 (Friday, December 20, 2019)]
[Rules and Regulations]
[Pages 70013-70014]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27340]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Parole Commission
28 CFR Part 2
[Docket No. USPC-2018-02]
Paroling, Recommitting, and Supervising Federal Prisoners:
Prisoners Serving Sentences Under the United States and District of
Columbia Codes
AGENCY: United States Parole Commission, Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The United States Parole Commission is amending its rule
allowing hearings by videoconference to include parole termination
hearings.
DATES: This regulation is effective December 20, 2019.
FOR FURTHER INFORMATION CONTACT: Helen H. Krapels, General Counsel,
U.S. Parole Commission, 90 K Street NE, Third Floor, Washington, DC
20530, telephone (202) 346-7030. Questions about this publication are
welcome, but inquiries concerning individual cases cannot be answered
over the telephone.
SUPPLEMENTARY INFORMATION: Since early 2004, the United States Parole
Commission has been conducting some parole proceedings by
videoconference to cut down on delays in scheduling in-person hearings
and conserve Commission resources. The Commission originally initiated
the use of videoconference in parole release hearings as a pilot
project in 2004 and then extended the use of videoconferencing to
institutional revocation hearings in 2005, followed by probable cause
hearings in 2007. Using videoconference for termination hearings is a
natural progression in the use of this technology.
Conducted pursuant to 28 CFR 2.43(c) and 2.95(c), the primary
objective of a termination hearing is to obtain information which
assists the Commission in determining whether or not early termination
of parole is appropriate. The subject is usually represented by an
attorney, and the community supervision officer or the U.S. Probation
officer provides a recommendation based on the subject's compliance
with parole requirements. Given the limited purpose of the hearing,
other witnesses are usually not present, and the hearing does not
typically last long. The amendment will save travel time and expense,
allowing the Commission to conduct termination hearings in a more
expeditious manner.
In the interim rule with request for comments (83 FR 58500 (Nov.
20,
[[Page 70014]]
2018)), we encouraged the public to comment on our changes. We received
written comments from the Public Defender Service for the District of
Columbia (PDS) and one anonymous comment. We discuss those public
comments below.
Public Comment From the Public Defender Service
PDS objects to amending Sec. 2.25 to include parole termination
hearings, and renews its prior objections to the use of videoconference
for probable cause hearings. PDS's comments, both past and present,
characterize videoconference as a barrier to due process which
unjustifiably denies a subject the opportunity to appear in person
before the Commission. The Commission does not agree with this
proposition. Termination hearings are limited in scope. Unlike
revocation hearings, when all facets of the case are explored,
witnesses testify, and the status of the offender is finally
determined, the purpose of a termination hearing is to obtain
information regarding the parolee's conduct in the community. The
liberty interest implicated in a revocation hearing is not implicated
in a termination hearing. At a termination hearing, the subject does
not face the possibility of a loss of freedom as a result of
termination being denied. See Henderson v. Sims, 223 F.3d 267, 274 (4th
Cir. 2000); Little v. Thomas, 719 F.2d 50, 52 (3d Cir. 1982). Further,
there is no constitutional or statutory entitlement to early
termination of parole supervision. See Myers v. U.S. Parole Comm'n, 813
F.2d 957, 960 (9th Cir. 1987). Thus, the fact that the parolee's
appearance for the termination hearing will be by videoconference does
not violate due process.
PDS recommends that termination hearings only be conducted by
videoconference in circumstances where either distance or physical
hardship renders the subject unable to appear in person. While the
Commission agrees that videoconferencing may be appropriate in the
circumstances described by PDS, the Commission does not agree that the
rule should be so narrow. It is within the Commission's discretion to
determine when conducting a termination hearing by videoconference is
appropriate.
PDS also raises concerns about technological issues, stating that
experiencing technical difficulties during a hearing would completely
undermine the value of having a hearing at all. Over the years, the
Commission's experience has been that the quality of the transmission
has improved and the personal interactions among the hearing
participants does not appreciably decline with the use of
videoconferencing.
Anonymous Comment
The Commission also received an anonymous comment in support the
use of videoconferencing for parole termination hearings. The comment,
while acknowledging the issue of losing face-to-face contact, described
the amendment as a logical practice that will increase the efficiency
of the termination process.
Executive Orders 12866 and 13563
This regulation has been drafted and reviewed in accordance with
Executive Order 12866, ``Regulation Planning and Review,'' section
1(b), Principles of Regulation, and in accordance with Executive Order
13565, ``Improving Regulation and Regulatory Review,'' section 1(b),
General Principles of Regulation. The Commission has determined that
this rule is not a ``significant regulatory action'' under Executive
Order 12866, section 3(f), Regulatory Planning and Review, and
accordingly this rule has not been reviewed by the Office of Management
and Budget.
Executive Order 13132
This rule will not have substantial direct effects on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government. Under Executive Order 13132, this rule does not
have sufficient federalism implications requiring a Federalism
Assessment.
Regulatory Flexibility Act
The rule will not have a significant economic impact upon a
substantial number of small entities within the meaning of the
Regulatory Flexibility Act, 5 U.S.C. 605(b).
Unfunded Mandates Reform Act of 1995
The rule will not cause State, local, or tribal governments, or the
private sector, to spend $100,000,000 or more in any one year, and it
will not significantly or uniquely affect small governments. No action
under the Unfunded Mandates Reform Act of 1995 is necessary.
Small Business Regulatory Enforcement Fairness Act of 1996 (Subtitle
E--Congressional Review Act)
These rule is not a ``major rule'' as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996 Subtitle E--
Congressional Review Act, now codified at 5 U.S.C. 804(2). The rule
will not result in an annual effect on the economy of $100,000,000 or
more; a major increase in costs or prices; or significant adverse
effects on the ability of United States-based companies to compete with
foreign-based companies. Moreover, this is a rule of agency practice or
procedure that does not substantially affect the rights or obligations
of non-agency parties, and does not come within the meaning of the term
``rule'' as used in Section 804(3)(C), now codified at 5 U.S.C.
804(3)(C). Therefore, the reporting requirement of 5 U.S.C. 801 does
not apply.
List of Subjects in 28 CFR Part 2
Administrative practice and procedure, Prisoners, Probation and
Parole.
The Final Rule
0
Accordingly, the U. S. Parole Commission adopts the interim rule
amending 28 CFR part 2, which was published at 83 FR 58500 on November
20, 2018, as final without change.
Patricia K. Cushwa,
Chairman (Acting), U.S. Parole Commission.
[FR Doc. 2019-27340 Filed 12-19-19; 8:45 am]
BILLING CODE 4410-31-P