[Federal Register Volume 84, Number 89 (Wednesday, May 8, 2019)]
[Rules and Regulations]
[Pages 20023-20027]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-09479]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[Docket No. DEA-484]


Schedules of Controlled Substances: Placement of beta-
Hydroxythiofentanyl in Schedule I

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: With the issuance of this final rule, the Drug Enforcement 
Administration places beta-hydroxythiofentanyl (N-[1-[2-hydroxy-2-
(thiophen-2-yl)ethyl]piperidin-4-yl]-N-phenylpropionamide), also known 
as N-[1-[2-hydroxy-2-(2-thienyl)ethyl]-4-piperidinyl]-N-phenyl-
propanamide, including its isomers, esters, ethers,

[[Page 20024]]

salts, and salts of isomers, esters and ethers, in schedule I of the 
Controlled Substances Act. This rule continues the imposition of the 
regulatory controls and administrative, civil, and criminal sanctions 
applicable to schedule I controlled substances on persons who handle 
(manufacture, distribute, import, export, engage in research, conduct 
instructional activities or chemical analysis, or possess), or propose 
to handle beta-hydroxythiofentanyl.

DATES: This final rule is effective May 8, 2019.

FOR FURTHER INFORMATION CONTACT: Lynnette M. Wingert, Regulatory 
Drafting and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; Mailing Address: 8701 Morrissette Drive, 
Springfield, Virginia 22152; Telephone: (202) 598-6812.

SUPPLEMENTARY INFORMATION:

Legal Authority

    The Controlled Substances Act (CSA) provides that proceedings for 
the issuance, amendment, or repeal of the scheduling of any drug or 
other substance may be initiated by the Attorney General (1) on his own 
motion; (2) at the request of the Secretary of the Department of Health 
and Human Services (HHS),\1\ or (3) on the petition of any interested 
party. 21 U.S.C. 811(a). This action was initiated by the former Acting 
Administrator of the Drug Enforcement Administration (DEA) on his own 
motion and an evaluation of all other relevant data by the DEA, and is 
supported by a recommendation from the Assistant Secretary for Health 
of the HHS (Assistant Secretary). This action continues the imposition 
of the regulatory controls and administrative, civil, and criminal 
sanctions of schedule I controlled substances on any person who handles 
or proposes to handle beta-hydroxythiofentanyl.
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    \1\ As discussed in a memorandum of understanding entered into 
by the Food and Drug Administration (FDA) and the National Institute 
on Drug Abuse (NIDA), the FDA acts as the lead agency within the HHS 
in carrying out the Secretary's scheduling responsibilities under 
the CSA, with the concurrence of NIDA. 50 FR 9518, March 8, 1985. 
The Secretary of the HHS has delegated to the Assistant Secretary 
for Health of the HHS the authority to make domestic drug scheduling 
recommendations. 58 FR 35460, July 1, 1993.
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Background

    On May 12, 2016, the DEA published a final order in the Federal 
Register amending 21 CFR 1308.11(h) to temporarily place beta-
hydroxythiofentanyl (N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-
4-yl]-N-phenylpropionamide) in schedule I of the CSA pursuant to the 
temporary scheduling provisions of 21 U.S.C. 811(h). 81 FR 29492. That 
temporary order was effective on the date of publication, and was based 
on findings by the Acting Administrator of the DEA that the temporary 
scheduling of beta-hydroxythiofentanyl was necessary to avoid an 
imminent hazard to public safety pursuant to 21 U.S.C. 811(h)(1). 
Section 201(h)(2) of the CSA \2\ requires that the temporary control of 
this substance expire two years from the effective date of the 
scheduling order, which was May 12, 2018. However, the CSA also 
provides that during the pendency of proceedings under 21 U.S.C. 
811(a)(1) with respect to the substance, the temporary scheduling of 
that substance may be extended for up to one year. Id. Accordingly, on 
May 10, 2018, the DEA extended the temporary scheduling of beta-
hydroxythiofentanyl by one year, until May 12, 2019. 83 FR 21834. On 
May 10, 2018, the DEA published a notice of proposed rulemaking (NPRM) 
to permanently control beta-hydroxythiofentanyl in schedule I of the 
CSA. 83 FR 21826.
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    \2\ 21 U.S.C. 811(h)(2).
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DEA and HHS Eight Factor Analyses

    On April 27, 2018, the HHS provided the DEA with a scientific and 
medical evaluation and scheduling recommendation for beta-
hydroxythiofentanyl entitled ``Basis for the recommendation to place 
[beta]-hydroxythiofentanyl and its isomers, esters, ethers, salts and 
salts of isomers, esters and ethers into Schedule I of the Controlled 
Substances Act (CSA).'' After considering the eight factors in 21 
U.S.C. 81l(c), including consideration of the substance's abuse 
potential, lack of legitimate medical use in the United States, and 
lack of accepted safety for use under medical supervision, the 
Assistant Secretary of the HHS recommended that beta-
hydroxythiofentanyl be controlled in schedule I of the CSA. In 
response, the DEA conducted its own eight-factor analysis of beta-
hydroxythiofentanyl and concluded that this substance warrants control 
in schedule I of the CSA. Both the DEA and HHS 8-Factor analyses are 
available in their entirety under the tab ``Supporting Documents'' of 
the public docket for this action at http://www.regulations.gov under 
Docket Number ``DEA-484.''

Determination to Schedule beta-Hydroxythiofentanyl

    After a review of the available data, including the scientific and 
medical evaluation and the scheduling recommendation from the HHS, the 
former Acting Administrator of the DEA published a NPRM entitled 
``Schedules of Controlled Substances: Placement of beta-
Hydroxythiofentanyl into Schedule I,'' proposing to control beta-
hydroxythiofentanyl. 83 FR 21826, May 10, 2018. The NPRM provided an 
opportunity for interested persons to file a request for hearing in 
accordance with the DEA regulations on or before June 11, 2018. No 
requests for such a hearing were received by the DEA. The NPRM also 
provided an opportunity for interested persons to submit written 
comments on the proposal up to June 11, 2018. All of the comments 
received are summarized below, along with the DEA's response.

Comments Received

    The DEA received 25 comments on the proposed rule to control beta-
hydroxythiofentanyl in schedule I of the CSA. Ten commenters were in 
favor of controlling beta-hydroxythiofentanyl as a schedule I 
controlled substance, and one commenter was in favor of controlling 
beta-hydroxythiofentanyl as a schedule II controlled substance. One 
commenter supporting the rule submitted responses nine times 
(generating eight duplicative responses). Six commenters submitted 
responses that were outside the scope of the action.

Support of the Proposed Rule

    Ten commenters supported controlling beta-hydroxythiofentanyl as a 
schedule I controlled substance. One commenter urged the DEA to 
maintain the status of beta-hydroxythiofentanyl as a schedule I 
controlled substance. Another commenter stated it is concerning that 
the DEA was unable to permanently control beta-hydroxythiofentanyl as a 
schedule I substance within the two year time frame. Three commenters 
stated that because beta-hydroxythiofentanyl has no approved medical 
use, it should be controlled as a schedule I substance. Specifically, 
one commenter stated that placing beta-hydroxythiofentanyl in a 
different schedule within the CSA would foster recreational use of this 
substance. Further, four commenters noted that beta-hydroxythiofentanyl 
and other fentanyl derivatives pose significant health risk to the 
public. Specifically, one commenter stated that fentanyl and its 
derivatives have been found in numerous samples of other street drugs 
such as heroin and cocaine and classifying beta-hydroxythiofentanyl as 
a schedule I controlled substance illustrates the true

[[Page 20025]]

stance of the government in protecting the public.
    DEA Response: The DEA agrees with the comments in support for this 
rulemaking. With regard to the comment related to the timeliness of 
permanent control of beta-hydroxythiofentanyl by the DEA, the DEA is in 
compliance with the provisions of a temporary scheduling action. 
Section 201(h)(2) of the CSA \3\ requires that the temporary control of 
a substance expires two years from the effective date of the scheduling 
order. The Administrator may, during the pendency of proceedings under 
subsection 21 U.S.C. 811(a)(1), extend the temporary scheduling for up 
to one year.
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    \3\ 21 U.S.C. 811(h)(2).
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Comments Suggesting Placement in Schedule II

    One commenter stated that beta-hydroxythiofentanyl similar to 
fentanyl should be placed in schedule II of the CSA because it is an 
analog of fentanyl and has some medical use in the United States.
    DEA Response: The Assistant Secretary, through a letter dated 
January 13, 2016, notified the former Acting Administrator of the DEA 
that beta-hydroxythiofentanyl is not the subject of any approved new 
drug application (NDA) or investigational new drug application (IND). 
According to HHS, there is no approved drug product containing beta-
hydroxythiofentanyl. HHS concluded that beta-hydroxythiofentanyl lacks 
accepted medical use in the United States. If a controlled substance 
has no such currently accepted medical use, it must be placed in 
schedule I.\4\
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    \4\ See Notice of Denial of Petition, 66 FR 20038 (Apr. 18, 
2001) (``Congress established only one schedule--schedule I--for 
drugs of abuse with `no currently accepted medical use in treatment 
in the United States' and `lack of accepted safety for use . . . 
under medical supervision.' '').
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Other Comments

    One commenter expressed concerns about the roles of phones in 
classroom and wants smart phones out of public schools. Another 
commenter highlighted the gap in medical education system and 
emphasized the need for physicians to handle difficulties associated 
with prescription drug abuse. Another commenter stated that words 
matter when handling complex issues like powerful prescription drugs. 
Three commenters misinterpreted beta-hydroxythiofentanyl as fentanyl 
and expressed that access to their fentanyl medications, especially the 
fentanyl transdermal patch, should not be denied.
    DEA Response: The comment about phones in classrooms and the 
comment that words matter when handling powerful prescription drugs are 
unrelated to this scheduling action.
    With regard to the gap in medical education system and the need to 
educate physicians to tackle prescription drug abuse, the DEA has 
worked aggressively to improve its communication and cooperation with 
registrant medical professionals by maintaining an open dialogue with 
national associations such as the American Medical Association, 
Federation of State Medical Boards, and other groups to address 
diversion problems and educate the medical community on improving 
prescribing practices. In May 2018, the DEA initiated a nationwide 
program to train individual practitioners through Practitioner 
Diversion Awareness Conferences (PDACs) throughout the country. In 
addition to the PDAC training, the DEA has also sent correspondence to 
1.3 million prescribers nationwide, alerting them of the Centers for 
Disease Control and Prevention (CDC) recommendation (part of CDC's 
Prescribing Guideline for Chronic Pain) for opioid prescribing for 
acute pain and alerted practitioners to a free training webinar 
available from CDC. The DEA is also working on similar correspondence 
to alert these same practitioners about resources available from the 
Substance Abuse and Mental Health Services Administration (SAMHSA) to 
locate substance abuse treatment providers in their state.
    This rule will not affect patient access to FDA-approved fentanyl 
medications (such as the fentanyl transdermal patch) because the rule 
is limited to beta-hydroxythiofentanyl, a synthetic opioid with no 
currently accepted medical use in treatment in the United States.

Scheduling Conclusion

    Based on consideration of all comments, the scientific and medical 
evaluation and accompanying recommendation of the HHS, and the DEA's 
consideration of its own eight-factor analysis, the DEA finds that 
these facts and all other relevant data constitute substantial evidence 
of potential for abuse of beta-hydroxythiofentanyl. As such, the DEA is 
scheduling beta-hydroxythiofentanyl as a controlled substance under the 
CSA.

Determination of Appropriate Schedule

    The CSA establishes five schedules of controlled substances known 
as schedules I, II, III, IV, and V. The CSA also outlines the findings 
required to place a drug or other substance in any particular schedule. 
21 U.S.C. 812(b). After consideration of the analysis, recommendation 
of the Assistant Secretary for HHS, and review of all other available 
data, the Acting Administrator of the DEA, pursuant to 21 U.S.C. 811(a) 
and 21 U.S.C. 812(b)(1), finds that:
    1. beta-Hydroxythiofentanyl has a high potential for abuse;
    2. beta-Hydroxythiofentanyl has no currently accepted medical use 
in treatment in the United States; and
    3. There is a lack of accepted safety for use of beta-
hydroxythiofentanyl under medical supervision.
    Based on these findings, the Acting Administrator of the DEA 
concludes that beta-hydroxythiofentanyl (N-[1-[2-hydroxy-2-(thiophen-2-
yl)ethyl]piperidin-4-yl]-N-phenylpropionamide), including its isomers, 
esters, ethers, salts, and salts of isomers, esters and ethers, 
warrants control in schedule I of the CSA. 21 U.S.C. 812(b)(1).

Requirements for Handling beta-Hydroxythiofentanyl

    Upon the effective date of this final rule, beta-
hydroxythiofentanyl will continue \5\ to be subject to the CSA's 
schedule I regulatory controls and administrative, civil, and criminal 
sanctions applicable to the manufacture, distribution, dispensing, 
importing, exporting, research, and conduct of instructional 
activities, including the following:
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    \5\ beta-Hydroxythiofentanyl is currently subject to schedule I 
controls on a temporary basis, pursuant to 21 U.S.C. 811(h). 81 FR 
29492, May 12, 2016.
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    1. Registration. Any person who handles (manufactures, distributes, 
dispenses, imports, exports, engages in research, or conducts 
instructional activities or chemical analysis with, or possesses) beta-
hydroxythiofentanyl, or who desires to handle beta-hydroxythiofentanyl, 
must be registered with the DEA to conduct such activities pursuant to 
21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 
1301 and 1312.
    2. Disposal of stocks. beta-Hydroxythiofentanyl must be disposed of 
in accordance with 21 CFR part 1317, in addition to all other 
applicable federal, state, local, and tribal laws.
    3. Security. beta-Hydroxythiofentanyl is subject to schedule I 
security requirements and must be handled and stored pursuant to 21 
U.S.C. 821, 823, and in accordance with 21 CFR 1301.71-1301.93.

[[Page 20026]]

    4. Labeling and Packaging. All labels and labeling for commercial 
containers of beta-hydroxythiofentanyl must comply with 21 U.S.C. 825 
and 958(e) and must conform with 21 CFR part 1302.
    5. Quota. Only registered manufacturers are permitted to 
manufacture beta-hydroxythiofentanyl in accordance with a quota 
assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 
1303.
    6. Inventory. Every DEA registrant whose registration currently 
authorizes handling beta-hydroxythiofentanyl and who possesses any 
quantity of beta-hydroxythiofentanyl on the effective date of this 
final rule must maintain an inventory of all stocks of beta-
hydroxythiofentanyl on hand, pursuant to 21 U.S.C. 827 and 958, and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Any person who 
becomes registered with the DEA on or after the effective date of this 
final rule must take an initial inventory of all stocks of beta-
hydroxythiofentanyl on hand pursuant to 21 U.S.C. 827 and 958, and in 
accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    After the initial inventory, every DEA registrant must take a new 
inventory of all stocks of controlled substances (including beta-
hydroxythiofentanyl) on hand every two years pursuant to 21 U.S.C. 827 
and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.
    7. Records and Reports. Every DEA registrant must maintain records 
and submit reports with respect to beta-hydroxythiofentanyl, pursuant 
to 21 U.S.C. 827 and 958(e), and in accordance with 21 CFR parts 1304 
and 1312.
    8. Order Forms. Every DEA registrant who distributes beta-
hydroxythiofentanyl must comply with the order form requirements, 
pursuant to 21 U.S.C. 828, and 21 CFR part 1305.
    9. Importation and Exportation. All importation and exportation of 
beta-hydroxythiofentanyl must be in compliance with 21 U.S.C. 952, 953, 
957, and 958, and in accordance with 21 CFR part 1312.
    10. Liability. Any activity involving beta-hydroxythiofentanyl not 
authorized by, or in violation of, the CSA or its implementing 
regulations is unlawful, and may subject the person to administrative, 
civil, and/or criminal sanctions.

Regulatory Analyses

Executive Orders 12866, 13563, and 13771, Regulatory Planning and 
Review, Improving Regulation and Regulatory Review, and Reducing 
Regulation and Controlling Regulatory Costs

    In accordance with 21 U.S.C. 811(a), this scheduling action is 
subject to formal rulemaking procedures done ``on the record after 
opportunity for a hearing,'' which are conducted pursuant to the 
provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for 
scheduling a drug or other substance. Such actions are exempt from 
review by the Office of Management and Budget (OMB) pursuant to section 
3(d)(1) of Executive Order 12866 and the principles reaffirmed in 
Executive Order 13563.
    This final rule does not meet the definition of an Executive Order 
13771 regulatory action. OMB has previously determined that formal 
rulemaking actions concerning the scheduling of controlled substances, 
such as this rule, are not significant regulatory actions under Section 
3(f) of Executive Order 12866.

Executive Order 12988, Civil Justice Reform

    This regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate 
drafting errors and ambiguity, minimize litigation, provide a clear 
legal standard for affected conduct, and promote simplification and 
burden reduction.

Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. The rule does not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or the distribution of power 
and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This rule does not have tribal implications warranting the 
application of Executive Order 13175. It does not have substantial 
direct effects on one or more Indian tribes, on the relationship 
between the Federal Government and Indian tribes, or on the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes.

Regulatory Flexibility Act

    The Acting Administrator, in accordance with the Regulatory 
Flexibility Act, 5 U.S.C. 601-602, has reviewed this final rule and by 
approving it, certifies that it will not have a significant economic 
impact on a substantial number of small entities. On May 12, 2016, the 
DEA published a final order to temporarily place beta-
hydroxythiofentanyl in schedule I of the CSA pursuant to the temporary 
scheduling provisions of 21 U.S.C. 811(h). On May 10, 2018, the DEA 
published a temporary scheduling order extending the temporary 
placement of beta-hydroxythiofentanyl in schedule I of the CSA for up 
to one year pursuant to 21 U.S.C. 811(h)(2). Accordingly, all entities 
that currently handle or plan to handle beta-hydroxythiofentanyl have 
already established and implemented the systems and processes required 
to handle this substance. There are currently 20 registrations 
authorized to handle beta-hydroxythiofentanyl, as well as a number of 
registered analytical labs that are authorized to handle schedule I 
controlled substances generally. These 20 registrations represent 18 
entities, of which 14 are small entities. Therefore, the DEA estimates 
14 small entities are affected by this rule.
    A review of the 20 registrations indicates that all entities that 
currently handle beta-hydroxythiofentanyl also handle other schedule I 
controlled substances, and have established and implemented (or 
maintain) the systems and processes required to handle beta-
hydroxythiofentanyl. Therefore, the DEA anticipates that this rule will 
impose minimal or no economic impact on any affected entities; and 
thus, will not have a significant economic impact on any of the 14 
affected small entities. Therefore, the DEA has concluded that this 
rule will not have a significant effect on a substantial number of 
small entities.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 
2 U.S.C. 1501 et seq., the DEA has determined and certifies that this 
action will not result in any Federal mandate that may result ``in the 
expenditure by State, local, and tribal governments, in the aggregate, 
or by the private sector, of $100,000,000 or more (adjusted for 
inflation) in any one year . . .'' Therefore, neither a Small 
Government Agency Plan nor any other action is required under UMRA of 
1995.

[[Page 20027]]

Paperwork Reduction Act of 1995

    This action does not impose a new collection of information under 
the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action 
will not impose recordkeeping or reporting requirements on State or 
local governments, individuals, businesses, or organizations. An agency 
may not conduct or sponsor, and a person is not required to respond to, 
a collection of information unless it displays a currently valid OMB 
control number.

Congressional Review Act

    This final rule is not a major rule as defined by section 804 of 
the Small Business Regulatory Enforcement Fairness Act of 1996 
(Congressional Review Act (CRA)). This rule will not result in: An 
annual effect on the economy of $100,000,000 or more; a major increase 
in costs or prices for consumers, individual industries, Federal, 
State, or local government agencies, or geographic regions; or 
significant adverse effects on competition, employment, investment, 
productivity, innovation, or on the ability of United States-based 
enterprises to compete with foreign-based enterprises in domestic and 
export markets. However, pursuant to the CRA, the DEA has submitted a 
copy of this final rule to both Houses of Congress and to the 
Comptroller General.

Determination To Make Rule Effective Immediately

    The DEA is making the rule effective on the date of publication in 
the Federal Register as allowed under the good cause exception in 5 
U.S.C. 553(d)(3). This final rule amends the regulations to permanently 
control beta-hydroxythiofentanyl in schedule I of the CSA. This action 
continues control of the substance as it is currently controlled until 
May 12, 2019 by virtue of the temporary scheduling order (83 FR 21834, 
May 10, 2018). The May 2018 temporary scheduling order extended 
temporary control of the substance, which was first established in the 
May 10, 2016, final order. 81 FR 29492. That May 2016 final order was 
effective on the date of publication, and was based on findings by the 
Acting Administrator of the DEA that the temporary scheduling of beta-
hydroxythiofentanyl was necessary to avoid an imminent hazard to the 
public safety pursuant to 21 U.S.C. 811(h)(1). Therefore, the DEA 
believes it is unnecessary and contrary to the public interest to delay 
the effectiveness of this final rule by 30 days.

List of Subjects in 21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Reporting and recordkeeping requirements.

    For the reasons set out above, the DEA amends 21 CFR part 1308 as 
follows:

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
1. The authority citation for 21 CFR part 1308 continues to read as 
follows:

    Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.


0
 2. In Sec.  1308.11:
0
a. Redesignate paragraphs (b)(16) through (65) as (b)(17) through (66);
0
b. Add new paragraph (b)(16); and
0
c. Remove and reserve paragraph (h)(3).
    The addition reads as follows:


Sec.  1308.11  Schedule I.

* * * * *
    (b) * * *

(16) N-[1-[2-hydroxy-2-(thiophen-2-yl)ethyl]piperidin-4-yl]-N-      9836
 phenylpropionamide (Other name: beta-Hydroxythiofentanyl)....
 

* * * * *

    Dated: May 2, 2019.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2019-09479 Filed 5-7-19; 8:45 am]
 BILLING CODE 4410-09-P