Paroling, Recommitting, and Supervising Federal Prisoners: Prisoners Serving Sentences Under the United States and District of Columbia Codes, 66124-66125 [2018-27803]
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Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Rules and Regulations
(F) 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;
(G) A detailed summary of the device
technical parameters;
(H) Where appropriate, validated
methods and instructions for
reprocessing of any reusable
components;
(I) The following statement,
prominently placed: ‘‘Warning: ECT
device use may be associated with:
disorientation, confusion, and memory
problems’’; and
(J) Absent performance data
demonstrating a beneficial effect of
longer term use, generally considered
treatment in excess of 3 months, the
following statement, prominently
placed: ‘‘Warning: When used as
intended this device provides shortterm relief of symptoms. The long-term
safety and effectiveness of ECT
treatment has not been demonstrated.’’
(ix) Patient labeling must be provided
and include:
(A) Relevant contraindications,
warnings, precautions;
(B) A summation 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;
(C) Information on how the device
operates and the typical course of
treatment;
(D) The potential benefits;
(E) Alternative treatments;
(F) The following statement,
prominently placed: ‘‘Warning: ECT
device use may be associated with:
Disorientation, confusion, and memory
problems’’;
(G) Absent performance data
demonstrating a beneficial effect of
longer term use, generally considered
treatment in excess of 3 months, the
following statement, prominently
placed: ‘‘Warning: When used as
intended this device provides shortterm relief of symptoms. The long-term
safety and effectiveness of ECT
treatment has not been demonstrated’’;
and
(H) The following statements on
known risks of ECT, absent performance
data demonstrating that these risks do
not apply:
(1) ECT treatment may be associated
with disorientation, confusion and
memory loss, including short-term
(anterograde) and long-term
(autobiographical) memory loss
following treatment. Based on the
majority of clinical evidence, these side
VerDate Sep<11>2014
16:56 Dec 21, 2018
Jkt 247001
effects tend to go away within a few
days to a few months after the last
treatment with ECT. Although the
incidence of permanent cognitive
memory loss was not supported by the
clinical literature, some patients have
reported a permanent loss of memories
of personal life events (i.e.,
autobiographical memory);
(2) Patients treated with ECT may
experience manic symptoms (including
euphoria and/or irritability, impulsivity,
racing thoughts, distractibility,
grandiosity, increased activity,
talkativeness, and decreased need for
sleep) or a worsening of the psychiatric
symptoms they are being treated for;
and
(3) The physical risks of ECT may
include the following (in order of
frequency of occurrence):
(i) Pain/somatic discomfort (including
headache, muscle soreness, and nausea);
(ii) Skin burns;
(iii) Physical trauma (including
fractures, contusions, injury from falls,
dental and oral injury);
(iv) Prolonged or delayed onset
seizures;
(v) Pulmonary complications
(hypoxemia, hypoventilation,
aspiration, upper-airway obstruction);
(vi) Cardiovascular complications
(cardiac arrhythmias, heart attack, high
or low blood pressure, and stroke); and
(vii) Death.
(2) Classification: Class III (premarket
approval) for the following intended
uses: schizophrenia, bipolar manic
states, schizoaffective disorder,
schizophreniform disorder, and
catatonia or a severe MDE associated
with MDD or BPD in:
(i) Patients under 13 years or
(ii) Patients 13 years and older who
are not treatment-resistant or who do
not require a rapid response due to the
severity of their psychiatric or medical
condition.
(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 FDA on or
before March 26, 2019, for any
electroconvulsive therapy 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 26,
2019, been found to be substantially
equivalent to any electroconvulsive
therapy device with an intended use
described in paragraph (b)(2) of this
section, that was in commercial
distribution before May 28, 1976. Any
other electroconvulsive therapy device
with an intended use described in
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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 18, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–27809 Filed 12–21–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF JUSTICE
28 CFR Part 2
[Docket No. USPC–2018–03]
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 revising a rule that
authorizes the Chairman to delegate a
Commissioner to conduct parole
hearings. This procedural change will
permit a Commissioner to conduct
parole hearings and vote on the decision
resulting from the proceeding, providing
for a more efficient use of agency
resources.
SUMMARY:
This regulation is effective
December 26, 2018.
DATES:
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: The U.S.
Parole Commission is revising its rule at
28 CFR 2.59 that authorizes the
Chairman to delegate a Commissioner to
act as a Hearing Examiner, but
disqualifies the Commissioner from
voting in the case as a Commissioner
during the proceeding. The authority of
U.S. Parole Commissioners to conduct
hearings and make decisions for
offenders under the Commission’s
jurisdiction is inherent in the
Commission’s authority under 18 U.S.C.
4203. Moreover, 18 U.S.C. 4203(c)(1)
specifically authorizes the Commission
to delegate to any Commissioner or
commissioners the powers to grant or
deny parole, impose conditions on an
order granting parole, modify or revoke
parole, etc. With the potential windingup of the agency in two years, having
E:\FR\FM\26DER1.SGM
26DER1
Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Rules and Regulations
Commissioners conduct parole hearings
and also vote in the same proceeding is
a more efficient use of resources to
balance the agency’s workload and
promote continuity of the agency’s
business. This is a procedural change
only, and will not implicate the merits
of any prisoner’s case for parole or affect
the way in which hearings are
conducted. Hence, notice and public
comment is not required.
The revised rule will take effect on
December 26, 2018.
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
This 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).
amozie on DSK3GDR082PROD with RULES
Small Business Regulatory Enforcement
Fairness Act of 1996 (Subtitle E—
Congressional Review Act)
This rule is not a ‘‘major rule’’ as
defined by Section 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996 Subtitle E—
16:56 Dec 21, 2018
Jkt 247001
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 amends 28 CFR part 2 as
follows:
PART 2—[AMENDED]
1. The authority citation for part 2
continues to read as follows:
■
Authority: 18 U.S.C. 4203(a)(1) and
4204(a)(6).
■
2. Revise § 2.59 to read as follows:
§ 2.59
Delegation to Commissioners.
There is hereby delegated to
Commissioners the authority to conduct
hearings, with the Commissioner’s
consent, and the powers enumerated in
18 U.S.C. 4203(b) to grant or deny
parole or mandatory release, impose
reasonable conditions of parole or
mandatory release, modify or revoke
parole or mandatory release.
Dated: December 18, 2018.
Patricia K. Cushwa,
Chairman (Acting), U.S. Parole Commission.
Unfunded Mandates Reform Act of
1995
This 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.
VerDate Sep<11>2014
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.
[FR Doc. 2018–27803 Filed 12–21–18; 8:45 am]
BILLING CODE 4410–31–P
DEPARTMENT OF JUSTICE
28 CFR Part 16
[CPCLO Order No. 006–2018]
Privacy Act of 1974; Implementation
Office of the Inspector General,
United States Department of Justice.
ACTION: Final rule.
AGENCY:
The Office of the Inspector
General (OIG), a component within the
United States Department of Justice
(DOJ or Department), is finalizing its
SUMMARY:
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66125
Privacy Act exemption regulations for
the system of records titled, ‘‘Data
Analytics Program Records System,’’
JUSTICE/OIG–006, which were
published as a Notice of Proposed
Rulemaking (NPRM) on March 28, 2018.
Specifically, the Department’s
regulations will exempt the records
maintained in JUSTICE/OIG–006 from
one or more provisions of the Privacy
Act and implement other administrative
changes. The exemptions are necessary
to avoid interference with the law
enforcement functions and
responsibilities of OIG. The Department
received 21 comments on the NPRM,
none of which addressed the substance
of the proposed Privacy Act exemption
regulations for JUSTICE/OIG–006.
DATES: This final rule is effective
January 25, 2019.
FOR FURTHER INFORMATION CONTACT:
Jonathan M. Malis, General Counsel,
Office of the Inspector General,
Department of Justice, 950 Pennsylvania
Avenue NW, Washington, DC 20530,
phone: (202) 514–3435.
SUPPLEMENTARY INFORMATION: Pursuant
to the Inspector General Act of 1978, as
amended, Inspectors General, including
the DOJ Inspector General, are
responsible for conducting, supervising,
and coordinating audits and
investigations to recognize and mitigate
fraud, waste, and abuse by programs
and operations of the Federal agency for
which their office is established. On
March 28, 2018, OIG published a
System of Records Notice (SORN) for its
system of records titled, ‘‘Data Analytics
Program Records System,’’ JUSTICE/
OIG–006, 83 FR 13309 (March 28, 2018),
for the records collected to implement
its data analytics (DA) program. The DA
program will assist with the
performance of OIG audits,
investigations, and reviews, and
accommodate the requirements of the
Digital Accountability and
Transparency Act of 2014, Public Law
113–101, 128 Stat. 1146. Specifically,
the DA program will provide OIG:
timely insights from the data already
stored in DOJ databases that OIG has
legal authorization to access and
maintain; the ability to monitor and
analyze data for patterns and
correlations that signal wasteful,
fraudulent, or abusive activities
impacting Department performance and
operations; the ability to find, acquire,
extract, manipulate, analyze, connect,
and visualize data; the capability to
manage vast amounts of data; the ability
to identify significant information that
can improve decision quality; and the
ability to mitigate risk of waste, fraud,
and abuse.
E:\FR\FM\26DER1.SGM
26DER1
Agencies
[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Rules and Regulations]
[Pages 66124-66125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27803]
=======================================================================
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DEPARTMENT OF JUSTICE
28 CFR Part 2
[Docket No. USPC-2018-03]
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 revising a rule that
authorizes the Chairman to delegate a Commissioner to conduct parole
hearings. This procedural change will permit a Commissioner to conduct
parole hearings and vote on the decision resulting from the proceeding,
providing for a more efficient use of agency resources.
DATES: This regulation is effective December 26, 2018.
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: The U.S. Parole Commission is revising its
rule at 28 CFR 2.59 that authorizes the Chairman to delegate a
Commissioner to act as a Hearing Examiner, but disqualifies the
Commissioner from voting in the case as a Commissioner during the
proceeding. The authority of U.S. Parole Commissioners to conduct
hearings and make decisions for offenders under the Commission's
jurisdiction is inherent in the Commission's authority under 18 U.S.C.
4203. Moreover, 18 U.S.C. 4203(c)(1) specifically authorizes the
Commission to delegate to any Commissioner or commissioners the powers
to grant or deny parole, impose conditions on an order granting parole,
modify or revoke parole, etc. With the potential winding-up of the
agency in two years, having
[[Page 66125]]
Commissioners conduct parole hearings and also vote in the same
proceeding is a more efficient use of resources to balance the agency's
workload and promote continuity of the agency's business. This is a
procedural change only, and will not implicate the merits of any
prisoner's case for parole or affect the way in which hearings are
conducted. Hence, notice and public comment is not required.
The revised rule will take effect on December 26, 2018.
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
This 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
This 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)
This 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
Accordingly, the U. S. Parole Commission amends 28 CFR part 2 as
follows:
PART 2--[AMENDED]
0
1. The authority citation for part 2 continues to read as follows:
Authority: 18 U.S.C. 4203(a)(1) and 4204(a)(6).
0
2. Revise Sec. 2.59 to read as follows:
Sec. 2.59 Delegation to Commissioners.
There is hereby delegated to Commissioners the authority to conduct
hearings, with the Commissioner's consent, and the powers enumerated in
18 U.S.C. 4203(b) to grant or deny parole or mandatory release, impose
reasonable conditions of parole or mandatory release, modify or revoke
parole or mandatory release.
Dated: December 18, 2018.
Patricia K. Cushwa,
Chairman (Acting), U.S. Parole Commission.
[FR Doc. 2018-27803 Filed 12-21-18; 8:45 am]
BILLING CODE 4410-31-P