66124 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 

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 

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 

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 windingup of the agency in two years, having 


amozie on DSK3GDR082PROD with RULES
Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Rules and Regulations 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] 

■ 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. 

[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 

AGENCY: Office of the Inspector General, 

United States Department of Justice. 

ACTION: Final rule. 

SUMMARY: The Office of the Inspector 

General (OIG), a component within the 

United States Department of Justice 

(DOJ or Department), is finalizing its 

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. 


amozie on DSK3GDR082PROD with RULES