66102 Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Rules and Regulations 

INTERNATIONAL TRADE 

COMMISSION 

19 CFR Part 220 

Rules Relating to the Submission and 

Consideration of Petitions for Duty 

Suspensions and Reductions 

AGENCY: United States International 

Trade Commission. 

ACTION: Final rule. 

SUMMARY: The United States 

International Trade Commission 

(Commission) is adopting as a final rule 

the interim rule published on 

September 30, 2016. The rule concerns 

the submission and consideration of 

petitions for duty suspensions and 

reductions under the American 

Manufacturing and Competitiveness Act 

of 2016. 

DATES: Effective date: December 26, 

2018. 

FOR FURTHER INFORMATION CONTACT: Lisa 

R. Barton, Secretary, telephone (202) 

205–2000 or William Gearhart, Esquire, 

Office of the General Counsel, United 

States International Trade Commission, 

telephone (202) 205–3091. Hearingimpaired individuals may obtain 

information on this matter by contacting 

the Commission’s TDD terminal at 202– 

205–1810. Members of the public may 

obtain general information concerning 

the Commission by accessing its website 

at https://www.usitc gov. 

SUPPLEMENTARY INFORMATION: The 

preamble below is designed to assist 

readers in understanding this final rule. 

This preamble provides background 

information and a regulatory analysis of 

the rule. 

This rule is being promulgated in 

accordance with the Administrative 

Procedure Act (5 U.S.C. 553) (APA), and 

will be codified in 19 CFR part 220. 

Background 

Section 335 of the Tariff Act of 1930 

(19 U.S.C. 1335) authorizes the 

Commission to adopt such reasonable 

procedures, rules and regulations as it 

deems necessary to carry out its 

functions and duties. In addition, 

section 3(b)(5) of the American 

Manufacturing Competitiveness Act of 

2016 (19 U.S.C. 1332 note) (the Act) 

directs the Commission to prescribe and 

publish, in the Federal Register and on 

a publicly available internet website of 

the Commission, procedures to be 

complied with by members of the public 

in submitting petitions for duty 

suspensions and reductions under 

section 3(b)(1)(A) of the Act. 

The Commission is adopting as a final 

rule, without change, the interim rule 

published in the Federal Register on 

September 30, 2016 (81 FR 67144) 

governing the submission and 

consideration of petitions for duty 

suspensions and reductions under the 

Act. In its notice announcing the 

interim rule, the Commission invited 

members of the public to file written 

comments on the rule. The Commission 

asked members of the public to file such 

comments no later than November 29, 

2016; no written comments were filed. 

The principal provisions of the Act 

relating to the submission and 

consideration of petitions for duty 

suspensions and reductions are set out 

in section 3 of the Act. Section 3 

establishes a process for the submission 

and consideration of petitions for duty 

suspensions. It also lists the types of 

information that must be included in a 

petition, and requires that petitioners 

submit disclosure forms with respect to 

such duty suspensions and reductions. 

Section 3 requires the Commission to 

publish on its website all the petitions 

that contain the required information 

and the related disclosure forms. It also 

requires that the Commission provide 

opportunity for members of the public 

to submit comments to the Commission 

on the petitions published. Section 3 

requires that the Commission submit 

preliminary and final reports on the 

petitions that meet the statutory 

requirements to the House Committee 

on Ways and Means and Senate 

Committee on Finance (the 

Committees), and it sets out the types of 

information to be included in those 

reports. Finally, section 3 sets out a 

timeline, in the form of specific dates or 

numbers of days, under which the 

Commission must complete each step in 

the process, beginning with the filing of 

petitions and ending with the 

submission of the Commission’s final 

report. 

The American Manufacturing 

Competitiveness Act provided for two 

periods during which the Commission 

would receive and consider petitions 

and submit reports to the Committees, 

with the first beginning no later than 

October 15, 2016, and the second 

beginning no later than October 15, 

2019. The Commission submitted its 

report to the Committees on petitions 

received during this first period in 

August 2017. On September 13, 2018, 

the President signed the Miscellaneous 

Tariff Bill Act of 2018 (Pub. L. 115–239), 

that approved legislation implementing 

certain temporary duty suspensions and 

reductions based on the Commission’s 

report. The duty suspensions and 

reductions became effective on October 

13, 2018, and remain in effect through 

December 31, 2020. 

The process under which the 

Commission received and considered 

petitions for duty suspensions and 

reductions was new with the American 

Manufacturing Competitiveness Act. 

Previously, the Commission had 

provided technical assistance to the 

Committees on duty suspension/ 

reduction bills introduced by Members 

of Congress under procedures 

established by the Committees. 

Possible Additional Amendments to 

Part 220 

The Commission gained considerable 

experience in applying the interim rule 

to petitions submitted and considered 

with respect to its first report. Based on 

that experience, the Commission may 

propose several amendments to this 

final rule in the near future, with the 

intent that the amendments be in place 

before October 15, 2019. Should the 

Commission propose changes to part 

220, the Commission expects to do so by 

first issuing a notice of proposed 

rulemaking and request for comments, 

and after considering those comments, 

by adopting a final rule. 

Regulatory Analysis 

The Commission has determined that 

this final rule does not meet the criteria 

described in section 3(f) of Executive 

Order 12866 (58 FR 51735, October 4, 

1993) and thus does not constitute a 

‘‘significant regulatory action’’ for 

purposes of the Executive Order. 

The Regulatory Flexibility Act (5 

U.S.C. 601 et seq.) is inapplicable to this 

rulemaking because it is not one for 

which a notice of proposed rulemaking 

is required under 5 U.S.C. 553 or any 

other statute. 

This final rule does not contain 

federalism implications warranting the 

preparation of a federalism summary 

impact statement pursuant to Executive 

Order 13132 (64 FR 43255, August 10, 

1999). 

No actions are necessary under title II 

of the Unfunded Mandates Reform Act 

of 1995, Public Law 104–4 (2 U.S.C. 

1531–1538), because the final 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 

(adjusted annually for inflation), and 

will not significantly or uniquely affect 

small governments. 

This final rule does not constitute a 

‘‘major’’ rule as defined by section 251 

of the Small Business Regulatory 

Enforcement Fairness Act of 1996 (5 

U.S.C. 801 et seq.). Moreover, it is 

exempt from the reporting requirements 

of that Act because it contains rules of 

agency organization, procedure, or 


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Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Rules and Regulations 66103 

1ECT devices with intended uses outside the 

scope of those listed in paragraphs 21 CFR 

882.5940(b)(1) and (2) are considered 

postamendments device, that are subject to 

classification under section 513(f)(1) of the FD&C 

Act or, if the relevant requirements are met, under 

section 513(f)(2) of the FD&C Act. 

practice that do not substantially affect 

the rights or obligations of non-agency 

parties. 

The rule does not contain any 

information collection requirements 

subject to the provisions of the 

Paperwork Reduction Act (44 U.S.C. 

3501 et seq.). 

PART 220—PROCESS FOR 

CONSIDERATION OF PETITIONS FOR 

DUTY SUSPENSIONS AND 

REDUCTIONS 

■ Accordingly, the interim rule that was 

published at 81 FR 67144 on September 

30, 2016, is adopted as a final rule 

without change. 

By order of the Commission. 

Lisa Barton, 

Secretary to the Commission. 

[FR Doc. 2018–27768 Filed 12–21–18; 8:45 am] 

BILLING CODE 7020–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 882 

[Docket No. FDA–2014–N–1210] 

Neurological Devices; Reclassification 

of Electroconvulsive Therapy Devices; 

Effective Date of Requirement for 

Premarket Approval for 

Electroconvulsive Therapy Devices for 

Certain Specified Intended Uses 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final order. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

order to reclassify the electroconvulsive 

therapy (ECT) device for use in treating 

catatonia or a severe major depressive 

episode (MDE) associated with major 

depressive disorder (MDD) or bipolar 

disorder (BPD) in patients age 13 years 

and older who are treatment-resistant or 

who require a rapid response due to the 

severity of their psychiatric or medical 

condition, which is a preamendments 

class III device, into class II (special 

controls). FDA is also issuing this final 

order to require the filing of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP) for the preamendments 

class III ECT devices for all other uses 

that are not being reclassified to class II 

(product code GXC). 

DATES: This order is effective on 

December 26, 2018. See further 

discussion in section V, Implementation 

Strategy. 

FOR FURTHER INFORMATION CONTACT: 

Carlos Pen ̃ a, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 2680, Silver Spring, 

MD 20993, 301–796–6610, carlos.pena@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Table of Abbreviations/Commonly Used 

Acronyms in This Document 

II. Background 

A. Reclassification 

B. Requirement for Premarket Approval 

C. Valid Scientific Evidence 

III. Public Comments in Responding to the 

Proposed Order 

A. Comments in Support of Reclassifying 

ECT Into Class II 

B. Comments on Reclassifying ECT Based 

on Safety and Effectiveness 

C. Comments on Patient Concerns 

D. Comments on Regulatory Process of the 

Proposed Order 

E. Comments on Labeling Concerns 

F. Comments Outside the Scope of This 

Final Order 

IV. The Final Order 

V. Implementation Strategy 

A. Date To File a PMA 

B. Compliance With Special Controls 

VI. Codification of Orders 

VII. Analysis of Environmental Impact 

VIII. Paperwork Reduction Act of 1995 

IX. References 

I. Table of Abbreviations/Commonly 

Used Acronyms in This Document 

TABLE OF ABBREVIATIONS AND

ACRONYMS

Abbreviation 

or acronym What it means 

510(k) .......... Premarket Notification. 

2011 Panel .. 2011 Neurological Devices Panel 

Meeting. 

AACAP ........ American Academy of Child and Adolescent Psychiatry. 

APA ............. American Psychiatric Association. 

BPD ............. Bipolar Disorder. 

CANTAB ...... Cambridge Neuropsychological Test 

Automated Battery. 

CFR ............. Code of Federal Regulations. 

CGI–I ........... Clinical Global Impressions-Improvement scale. 

ECT ............. Electroconvulsive Therapy Device. 

FDA ............. Food and Drug Administration. 

FDARA ........ FDA Reauthorization Act of 2017. 

FDASIA ....... Food and Drug Administration Safety 

and Innovation Act. 

FD&C Act .... Federal Food, Drug, and Cosmetic 

Act. 

FR ................ Federal Register. 

IDE .............. Investigational Device Exemption. 

MAUDE ....... Manufacturer and User Facility Device Experience. 

MDD ............ Major Depressive Disorder. 

MDE ............ Major Depressive Episode. 

MDR ............ Medical Device Reporting. 

M–ECT ........ Maintenance ECT. 

MMSE .......... Mini Mental State Exam. 

OMB ............ Office of Management and Budget. 

PDP ............. Product Development Protocol. 

PMA ............. Premarket Approval Application. 

PRA ............. Paperwork Reduction Act of 1995. 

Ref ............... Reference 

TABLE OF ABBREVIATIONS AND

ACRONYMS—Continued 

Abbreviation 

or acronym What it means 

RWD ............ Real-World Data. 

RWE ............ Real-World Evidence. 

SE ................ Safety and Effectiveness. 

U.S.C. .......... United States Code. 

WFSBP ........ World Federation of Societies of Biological Psychiatry. 

II. Background 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act), establishes a 

comprehensive system for the regulation 

of medical devices intended for human 

use. Section 513 of the FD&C Act (21 

U.S.C. 360c) established three categories 

(classes) of devices, reflecting the 

regulatory controls needed to provide 

reasonable assurance of their safety and 

effectiveness (SE). The three categories 

of devices are class I (general controls), 

class II (special controls), and class III 

(premarket approval). 

Under section 513(d) of the FD&C Act, 

devices that were in commercial 

distribution before the enactment of the 

1976 amendments, May 28, 1976 

(generally referred to as preamendments 

devices) are classified after FDA has: (1) 

Received a recommendation from a 

device classification panel (an FDA 

advisory committee); (2) published the 

panel’s recommendation for comment, 

along with a proposed regulation 

classifying the device; and (3) published 

a final regulation classifying the device. 

FDA has classified most 

preamendments devices under these 

procedures. 

Devices that were not in commercial 

distribution prior to May 28, 1976 

(generally referred to as 

postamendments devices) 1 are 

automatically classified by section 

513(f) of the FD&C Act into class III 

without any FDA rulemaking process. 

Those devices remain in class III and 

require premarket approval unless, and 

until, the device is reclassified into class 

I or II or FDA issues an order finding the 

device to be substantially equivalent, in 

accordance with section 513(i) of the 

FD&C Act, to a predicate device that 

does not require premarket approval. 

The Agency determines whether new 

devices are substantially equivalent to 

predicate devices by means of 

premarket notification procedures in 

section 510(k) of the FD&C Act (21 


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