Rules Relating to the Submission and Consideration of Petitions for Duty Suspensions and Reductions, 66102-66103 [2018-27768]

Download as PDF 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 United States International Trade Commission. ACTION: Final rule. AGENCY: 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. amozie on DSK3GDR082PROD with RULES SUMMARY: 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 VerDate Sep<11>2014 16:56 Dec 21, 2018 Jkt 247001 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. PO 00000 Frm 00026 Fmt 4700 Sfmt 4700 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 E:\FR\FM\26DER1.SGM 26DER1 Federal Register / Vol. 83, No. 246 / Wednesday, December 26, 2018 / Rules and Regulations 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.). FOR FURTHER INFORMATION CONTACT: PART 220—PROCESS FOR CONSIDERATION OF PETITIONS FOR DUTY SUSPENSIONS AND REDUCTIONS Table of Contents 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. 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. amozie on DSK3GDR082PROD with RULES SUMMARY: VerDate Sep<11>2014 16:56 Dec 21, 2018 Jkt 247001 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: 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) .......... 2011 Panel .. Premarket Notification. 2011 Neurological Devices Panel Meeting. American Academy of Child and Adolescent Psychiatry. American Psychiatric Association. Bipolar Disorder. Cambridge Neuropsychological Test Automated Battery. Code of Federal Regulations. Clinical Global Impressions-Improvement scale. Electroconvulsive Therapy Device. Food and Drug Administration. FDA Reauthorization Act of 2017. Food and Drug Administration Safety and Innovation Act. Federal Food, Drug, and Cosmetic Act. Federal Register. Investigational Device Exemption. Manufacturer and User Facility Device Experience. Major Depressive Disorder. Major Depressive Episode. Medical Device Reporting. Maintenance ECT. Mini Mental State Exam. Office of Management and Budget. Product Development Protocol. Premarket Approval Application. Paperwork Reduction Act of 1995. Reference AACAP ........ APA ............. BPD ............. CANTAB ...... CFR ............. CGI–I ........... ECT ............. FDA ............. FDARA ........ FDASIA ....... FD&C Act .... FR ................ IDE .............. MAUDE ....... MDD ............ MDE ............ MDR ............ M–ECT ........ MMSE .......... OMB ............ PDP ............. PMA ............. PRA ............. Ref ............... PO 00000 Frm 00027 Fmt 4700 Sfmt 4700 66103 TABLE OF ABBREVIATIONS AND ACRONYMS—Continued Abbreviation or acronym What it means RWD ............ RWE ............ SE ................ U.S.C. .......... WFSBP ........ Real-World Data. Real-World Evidence. Safety and Effectiveness. United States Code. 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 1 ECT 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. E:\FR\FM\26DER1.SGM 26DER1

Agencies

[Federal Register Volume 83, Number 246 (Wednesday, December 26, 2018)]
[Rules and Regulations]
[Pages 66102-66103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27768]



[[Page 66102]]

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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. Hearing-impaired 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

[[Page 66103]]

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

0
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
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